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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Resources for You

BK120048 Letter

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 

Intra-Lock International                                                                                       January 28, 2013
Attention: Diana Taylor
Regulatory Affairs Manager
6560 West Rogers Circle, Bldg 24
Boca Raton, FL 33487
 
Re: BK 120048
Trade/Device Name: Intra-Spin System
Regulation Number: 21 CFR 864.9245
Regulation Name: Automated blood cell separator
Regulatory Class: Class II
Product Code: ORG
Dated: January 7, 2013
Received:   January 9, 2013
 
Dear Ms Taylor:
 
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CBER does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
 
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
 
Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
 
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health’s (CDRH’s) Office of Compliance. Also, please note the regulation entitled, ²Misbranding by reference to premarket notification² (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 
 
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638‑2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
                                                                       
Sincerely yours,
 
 /s/
 
Celia M Witten, PhD, MD
Director
Office of Cellular, Tissue, and Gene Therapies
Center for Biologics Evaluation and Research
 
           
Enclosure


 

Indications for Use (CBER/OCTGT)
 
 
 
510(k) Number (if known): BK 120048  
                       
Device Name: Intra-Spin System
 
Indications for Use:  The Intra-SpinTMSystem is intended to be used for the safe and rapid preparation of autologous platelet rich fibrin (PRF) from a small sample of blood at the patient's point of care. The PRF is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.