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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Kimberly-Clark Corporation 04-Jun-08

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

9200 Corporate Boulevard
Rockville MD 20850


WARNING LETTER

JUN 4 2008

VIA FEDERAL EXPRESS {AND FACSIMILIE}

Thomas J. Falk
CEO and Chairman of the Board
Kimberly-Clark Corporation
351 Phelps Drive
Irving, Texas 75038

Dear Mr. Falk:

We have received the March 24, 2008, letter from Mr. Tom Gonzales, Vice President, Quality Assurance and Regulatory Affairs, Kimberly-Clark Healthcare, and Mr. Ross Mansbach, Chief Counsel, Kimberly-Clark Healthcare, and the September 10, 2007, letter, from Mr. Tom Gonzales responding to our August 31, 2007 letter. In our letter, we requested that you provide us with the FDA clearance numbers for KIMGUARD ONESTEP Simultaneous Sterilization Wrap, models KC100, KC200, KC300, KC400, KC500, and KC600, and KIMGUARD Sequential Sterilization Wrap, models KC100, KC200, KC300, KC400, KC500, and KC600, or to provide the basis for your determination that these products do not require FDA clearance. In his responses, Mr. Gonzalez stated that the models Kimberly-Clark added to its sterilization wrap product line between 1991 and 1995 were similar to the wraps previously cleared under K803294 and K881471 and that the changes were not significant enough to require submission of new 510(k)s.

Under section 201(h) of the Act, the KIMGUARD ONE-STEP Simultaneous Sterilization Wrap, models KC100, KC200, KC300, KC400, KC500, and KC600, and KIMGUARD Sequential Sterilization Wrap, models KC100, KC200, KC300, KC400, KC500, and KC600, are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body, 21 U.S.C. 321(h). The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.

The Center for Devices and Radiological Health (CDRH) has reviewed your March 24, 2008, and September 10, 2007, responses and has determined that significant changes have been made to the devices cleared under K803294 (SPUNGUARD Sterilization Wrap) and K881471 (KIMGUARD Regular and Heavy Duty Sterile Wrap) that require submission of new 510(k)s. The significant changes include the following:

1. The 510(k)-cleared SPUNGUARD Sterilization Wrap (K803294) was constructed of two layers (i.e., one layer of spunbound polypropylene bonded with a layer of meltblown polypropylene or SM). Following clearance, the construction was changed to three layers (i.e., a layer of meltblown polypropylene bonded on both sides with a layer of spunbound polypropylene or SMS). The KIMGUARD KC100 Sequential Wrap model, which is constructed of three layers, appears to be a modification of that device. It is unclear whether the change to three layers could hinder the ability of the sterilant to penetrate through the wrap to the medical device to be sterilized.

2. The 510(k)-cleared KIMGUARD Regular and Heavy Duty models (K881471) correspond most closely to the current KC200 and KC500 Sequential Wrap models, respectively. However, the specifications for tensile strength of the current models are lower than the specifications for the models cleared in K881471. Weakened wrap strength due to lower tensile strength could lead to maintenance of package integrity and product sterility issues.

3. A modification of the SPUNGUARD model cleared under K803294 was introduced in 1993 as SPUNGUARD Heavy Duty and is currently marketed as KC300 Sequential Wrap. The data you submitted indicate that KC300 is manufactured at a higher tensile strength than the cleared KC100 model. Higher tensile strength raises the concern that the KC300 wrap may hinder sterilant penetration.

4. A new KIMGUARD Midweight model was introduced in 1991, and a new SPUNGUARD Super Duty model was introduced in 1993. SPUNGUARD Super Duty and KIMGUARD Midweight were subsequently merged to create KC400 Sequential Wrap. The data you submitted indicate that KC400 is manufactured at higher tensile strength than the cleared KC100 model. Higher tensile strength raises the concern that the KC400 wrap may hinder sterilant penetration.

5. A new model of KIMGUARD was introduced in 1993 as KIMGUARD Ultra and is currently marketed as KC600 Sequential Wrap. The data you submitted indicate that KC600 has greater tensile strength than KC500, which was cleared as KIMGUARD Heavy Duty under K881471. Higher tensile strength raises the concern that the KC600 wrap may hinder sterilant penetration.

6. Two layers of each KIMGUARD Sequential Wrap model are ultrasonically bonded together to create the corresponding KIMGUARD ONE-STEP Simultaneous Wrap model. It is not clear whether this new seal can maintain package integrity or whether it may be a hindrance to sterilant penetration.

These changes to critical attributes of a sterilization wrap, such as construction, weight, and tensile strength, represent significant changes to the device which could affect sterilant penetration ability or maintenance of sterility and, consequently, the safety and efficacy of the device. Therefore, clearance of new 510(k)s is required before you may market these devices.

Failure to obtain marketing approval or clearance before you began offering your products for sale is a violation of the law. Specifically, KIMGUARD ONE-STEP Simultaneous Sterilization Wrap, models KC100, KC200, KC300, KC400, KC500, and KC600, and KIMGUARD Sequential Sterilization Wrap, models KC 100, KC200, KC300, KC400, KC500, and KC600, are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency, 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your devices is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.

Please let this office know in writing,what steps you have taken to correct the problem within fifteen (15) working days from the date you received this letter . We also ask that you explain how you plan to prevent this from happening again. If you need more time, let us know why and when you expect to complete your correction. Please direct your response or any questions you may have to Valerie A. Flournoy, Chief, General Hospital Devices Branch (HFZ-333), Office of Compliance, 9200 Corporate Boulevard, Rockville, Maryland 20850.

Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter pertains only to the issue of premarket review for your device and does not necessarily address other obligations you have under the law.

Sincerely yours,

/S/

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health