Inspections, Compliance, Enforcement, and Criminal Investigations
North American Medical Corporation Response Letter
Monday, January 28, 2008
Ms. Serene N. Ackall
Food and Drug Administration
Atlanta District Office
60 Eight Street, NE
Atlanta, GA 30309
RE: Your request for additional information following our response to the Warning Letter issued to North American Medical Corporation, on March 2, 2007
Dear Ms. Ackall:
We acknowledge receipt of your letter dated November 14, 2007, which was in reply to our response to your warning letter dated March 2, 2007.
Further, we would like to reiterate our statement to you that NAM has put in place a new, formalized Quality System, for which it received ISO Certification to ISO standard 13485:2003 on July 5, 2006 (please see attachment A). During the inspection of September 19 to October 12, 2006 we were still in the process of reviewing and updating older records to ensure compliance under this system. We have been fully following the new system and expect that all of our records, old and new, will soon reflect the changes made.
We are anxious to achieve and maintain full compliance with the Quality System regulation, and have implemented this new system and the review and retrofitting of old records to achieve that goal. We anticipate that the revision of older records project will be completed by March 31, 2008.
NAM was also awarded the CE Mark for the SPINA Systems with Cervical on July 10, 2007 (please see attachment B).
The following observations were noted in your letter dated November 14, 2007. Our responses are included in this letter for each observation. Attached supporting documents will be included with this response.
Observation 1, 2, 3, 4, 8 & 9 - Reply
Our procedures and documentation are available for review during your next scheduled inspection.
Observation 5 - 7 - Reply
As previously stated, [redacted] As a result, we were allowed to market this device at any time after September 09, 2005.
The prototype stage referenced was a Marketing Feasibility Study to satisfy the needs of our distributors, which resulted in cosmetic changes.
The devices which were shipped prior to September 13, 2006 as part of this study are as follows:
|Serial Number||Date Shipped||Shipped To||Status|
|42-0001-101||06/19/06||[redacted]||Evaluated and approved by Chiropractor|
|42-0002-102||07-03-06||[redacted]||Returned and Swapped for an AccuSPINA|
|42-0003-103||07/03/06||[redacted]||Returned and Swapped for an AccuSPINA|
|42-0004-104||07/13/06||[redacted]||Manufacturing Demo Machine - still with supplier for reference|
|09/13/06||[redacted]||Returned 11/06/06 and replaced by 42-0439-108|
The only [redacted] device shipped on 09/13/06 was SN [redacted], which had already been shipped for evaluation and review to [redacted], and [redacted] before being shipped to [redacted]. It was returned on 11/06/06, and subsequently shipped for further evaluation to other sites. [redacted]
Attached please find the following requested documentation, some of which were revised to ensure full compliance with both FDA and ISO Requirements:
1. QSP 7.3-4, Design Control (please see Attachment C)
a. Design Verification is addressed in Section 7.6 (p. 7 of 8)
b. Design Validation is addressed in Section 7.7 (p. 8 of 8)
2. Design Input, Form 7.3-4-2 (Attachment D)
3. Design Verification, Form 7.3-4-6 (Attachment E)
4. Design Validation, Form 7.3-4-7 (Attachment F)
The Design Output, and Verification and Validation Test Result have been previously submitted to you per your request.
Pre-market Submission Issues:
Attached please find a copy of:
5. Side-by-side comparison of the components and technological features of the DaVinci and the SPINA Systems with Cervical (Accu-SPINA) (Attachment G);
6. A revision history of the software, listing all features that have been added, removed, or changed between the time of the original clearance [redacted] and the introduction of the [redacted] (Attachment H)
7. In addition please find a copy of the decision tree which led to the conclusion that a new 510(k) was unwarranted. (Attachments I & J)
SPINA Systems with Cervical (Accu-SPINA):
In regards to your request for a new 510K submission, we would like to provide additional information. The premise that the black-light bulb; Accu-Analyzer Software for the PDA; and the Vibra-Heat Accessory are required components for the device's intended use is inaccurate. The SPINA Systems with Cervical device is a stand alone device that does not need/require the blacklight bulb, Accu-Analyzer (PDA, hand held PC), or Vibra-Heat in order to perform the functions of its intended use. These accessories are not built as part of the cleared device, and, in fact, are manufactured and supplied by independent vendors. These accessories are detachable and do not in any way impact the form, fit, or function of the device, and are made available according to user preference. The SPINA Systems with Cervical can be and has been sold without the accessories.
In reviewing the PMA submission requirements for these accessories, we relied on the guidance provided by the FDA. The "Blue Book Memo - Guidance for the CDRH Premarket Notification Review program", specifies in the section on New Devices that are Combinations of Old Devices, that "it combines devices from different classes and is classified in the highest of the predicate device classifications unless the combined devices are regulatable as separate articles, e.g., they are detachable [underline mine]. In that case, the separately regulatable articles will be regulated in separate classes"http://www.fda.gov/cdrh/k863.html.
As a result of the above, should you determine, after reviewing our explanations and evidence listed below, that you still would like us to submit additional 510(k)s, we feel it would be appropriate, and the least burdensome, to submit for the individual detachable accessories only, and not for the SPINA Systems with Cervical device, which has been cleared by FDA, UL, and CE. We feel that there is no need to redesign the SPINA Systems with Cervical since it is a stand alone device per its clearances, and we have made no medical claims in regards to the offered accessories.
We would like to apologize if any misunderstanding on our part has led to lack of compliance with 21 CFR 807.81(a)(3). However we feel that we have followed the regulations appropriately and according to instructions provided to us by reviewers of the original pre-market submission.
Our original 510K submission for the SPINA Systems with Cervical included the black-light bulb,
Vibra Heat, and PDA (Accu-Analyzer, hand held PC).
Re: Black-light bulb
1. On August 18, 2005, NAM received the following instructions from Mark N. Melkenson of the FDA to "Remove the blacklight or provide a predicate blacklight...". (Please see Attachment K)
2. On August 23, 2005, NAM complied with the FDA request to remove the items from the 510(k) submission and notified the FDA of compliance with their request.
3. On August 27 to 31, 2005, NAM:
Confirmed that the black-light bulb had already been removed from the design of the SPINA Systems with Cervical, and had been replaced with a fluorescent light bulb.NB. Temporary Deviation 05-02-21 had been enacted on July 29, 2005 to replace the black-light bulb with a fluorescent bulb (see Attachment L). This temporary deviation remained in effect until the formal engineering change order, ECO 740, was made effective on April 25, 06 See Attachment M).
N.B. The predicate to the SPINA Systems with Cervical was the SPINA Systems (K002260). The predicate to that device was the DRS, which included a black-light bulb as part of its physical components and which received 510(k) clearance with this component (K981822).
Re: PDA/AccuAnalyzer/Pocket PC (names interchangeable)
1. On July 20, 2005, in response to a request from the FDA, NAM provided part/model numbers to identify the components which comprise the tested SPINA Systems with Cervical device. One of the part/model numbers provided was "Pocket PC: HP ipaq 64mb color."
2. On August 18, 2005, Mark N. Melkenson of the FDA communicated his concerns regarding the use of "Bluetooth", since "the use of Bluetooth can only be evaluated in light of what the software running on the Pocket PC is doing". As a result he instructed NAM to "please delete the Handheld PC from the scope of the submission. Please acknowledge that they will be submitted later in another 510(k).
3. On August 23, 2005, NAM complied with the FDA request to remove the items from the 510(k) submission and notified the FDA of compliance with their request.
4. On August 27 to 31, 2005, NAM:
a. Decided to discontinue the use of Bluetooth technology from the design.
b. Reviewed the FDA Requirements for the premarket approval submission of the PDA (hand Held PC) with Accu-Analyzer without Bluetooth technology and determined that a PMA was not required for the following reasons:
i. The sole function of the PDA is to store and transport patient data in much the same way as the information can be stored and transported on a CD or Flash Drive.
ii . FDA stipulates that a medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
• recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes"
iii. The PDA (hand held PC) with Accu-Analyzer:• Is not recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• Is not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, and
• Is not intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes
iv. The sole function of the Accu-Analyzer software is for synchronization with the device. It allows the doctors, at their sole discretion, to print treatment session reports to the PDA in the same manner as they would print to a printer, and to input patient data in the same fashion as if they were inputting the data through the keyboard or a mouse.
The Accu-Analyzer software:• Does not and cannot turn on/off the device
• Does not and cannot start/stop a session
• Does not and cannot communicate with the PESS in the tower
• Communicates solely with the database in the same manner that the printer and keyboard communicates with the database.
(Please see attached Attachment N)
• Furthermore, the Accu-Analyzer software is the same read/copy function of the SPINA Systems with Cervical (Accu-SPINA) software compiled to run in a mobile environment. It is also the only function of that software. (Please see Attachments O - R, source code for the Accu-Analyzer and the Accu-SPINA)
v. The PDA is NOT a medical device per FDA definition of a device and per the function of the PDA, and as a result is not subject to premarket notification.
vi. The Accu-Analyzer software was the name given to the stripped down read/copy portion of the full SPINA Systems with Cervical (Accu-SPINA) software which had already been cleared under 510 K033231, and as a result does not need re-submission under a separate 510K.
(Please see Attachment S).
Re: VibraHeat Unit
1. During a conversation with the FDA on January 14, 2005, questions regarding the Vibra-Heat arose. The areas of concern were as follows:
a. Predicate Technology;
b. therapeutic temperatures;
c. vibrator frequency and displacement.
d. operator's manual for the Vibra-Heat
2. On March 7, 2005, NAM submitted by electronic and postal mail the requested documentation. Documentation submitted included:
a. Identification of two (2) predicate devices for the Vibra-Heat: K022387 and K935459.
b. Vibra-Heat Safety Test - Destructive/Flamibility
c. Therapeutic Skin Temperature Testing
d. Comparison to predicates for Substantial Equivalence
3. Unfortunately, although all the requested testing and documentation had been provided, it appears that the FDA was basing their determination on testing by Underwriter's Laboratories (UL), as observed in the following communications to us: "It became apparent in a telephone conversation with the sponsor that the accessory was not yet tested as part of the UL testing...". To the best of our knowledge, there is no standard specified by the FDA for this type of device, and furthermore that there is no guidance provided which dictated that the devices had to be tested by an external laboratory, UL or other.
4. As result of no. 3 above, we received communication on August 18, 2005 to "please confirm the accessory (i.e. Vibra-Heat) has been removed from the scope of the submission by the sponsor and may be reconsidered when the data is available without prejudice in a new 510(k)."
5. On August 23, 2005, NAM complied with the FDA request to remove the items from the 510(k) submission and notified the FDA of compliance with their request.
6. On August 27 to 31, 2005, NAM:
a. Redesigned the Vibra-Heat and made it a detachable accessory to satisfy the FDA requirements per "Blue Book Memo - Guidance for the CDRH Premarket Notification Review Program" for separate regulation.
b. Reviewed the FDA Requirements for the premarket approval submission of the Vibra Heat Unit and determined that a PMA was not required for the following reasons:
i. FDA regulations stipulate that "An accessory to a medical device is considered a finished device . . .". (http://www.fda.gov/cdrh/devadvice/32.html)
ii. FDA Regulations stipulate that "Accessory/component to a device take on the same classification of the "parent" device unless they are separately classified."
The Vibra Heat device is a combination of a Powered heating pad (21 CFR 890.5740, Class II) and a Therapeutic vibrator (21 CFR 890.5975, Class I), both of which are separately classified.
iii. FDA regulations stipulate that "Device classification depends on the intended use of the device and also upon indications for use." (http://www.fda.gov/cdrh/devadvice/313.html)
The Vibra Heat unit is and should be separately classified because of the difference in intended use as compared to the SPINA Cervical System.
The intended use of the SPINA Systems with Cervical specifies "to provide static, intermittent, and cycling distraction forces to relieve pressure on structures that may be causing low back [and neck] pain. It relieves pain associated with herniated discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning"
The intended use of the Vibra Heat specifies "provides dry heat therapy for body surfaces" (21 CFR 890.5740 - Class II) and "for various uses, such as relaxing muscles and relieving minor aches and pains (21 CFR 890.5975 - Class I)".
iv. FDA specifies that when two or more devices are combined, the device acquires the classification of the higher class level.
The Vibra-Heat accessory would therefore be classified as a Class II (special controls). However, both portions of this device (vibration and heat) including the higher classed "Powered Heating Pad" are exempt from premarket notification per 21 CFR 890.5740 and 21 CFR 890.5975. In addition as specified by the FDA, "FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues."(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/315.cfm?GMPPart=890#start)
What we intend to do
Our records, as documented in the Material Review Planning (MRP) system, show that of the devices manufactured during January 05, 2005 (when the black-light was added to the BOM in MRP) to July 29, 2005 (when the temporary deviation became effective), there are 70 devices in the field that may still have the black-light bulb.
We will be notifying these clients to replace the black-light bulb with a fluorescent bulb. (Please see Attachment T).
It is our belief that the Vibra Heat accessory units are in compliance with the FDA requirements based on the foregoing explanation, and do not feel that any additional steps are necessary. If, after review our explanation, you still wish us to submit a 510K for the complementary means of offering heat and massage before, during, and after use of the SPINA Systems device, please advise us what the 510(k) submission requirements are for such a device.
N.B. NAM is currently pursuing other options for the provision of heat and massage before, during, and after use of the SPINA Systems with Cervical device. We are investigating other options that are currently available for sale in the US.
PDA with Accu-Analyzer
We have renamed this device to Accu-Recorder, to better reflect its function and avoid any misconceptions. (Please see Attachment U).
Management Statement of Policy
NAM has strived to ensure that it produces quality products and maintains an excellent Quality System. We believe that we have succeeded in doing so as is evidence by our ISO and CE Certification.
It is also our intent to comply fully with all of the FDA regulations. We believe that we have reviewed and complied with all of the requests and instructions provided to us by the FDA, following the least burdensome approach, as promised by the FDA Modernization Act of 1997.
If we have been remiss in any manner, please provide a detailed explanation of miscommunication, and how we can correct it.
FDA's policy states that responses to Warning Letters will be posted on the FDA website at the Warning Letter recipients' request. We therefore request that this letter be posted on FDA's website. We have enclosed an electronic copy of this letter on CD to facilitate this posting.
Quality Department / Compliance Manager