(90 days)
The MarrowStim™ Concentration Kit and the MarrowStim™ Mini Concentration Kit are intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.
The MarrowStim™ Concentration Kit and MarrowStim™ Mini Concentration Kit consist of a table-top, swinging bucket centrifuge and accessories to allow for preparation of platelet poor plasma and platelet concentrate from blood, and for preparation of a cell concentrate from bone marrow.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and FDA clearance letter for the MarrowStim™ Concentration Kit and MarrowStim™ Mini Concentration Kit, which are centrifuges. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Harvest SmartPReP2 Centrifuge System, K052925) rather than presenting new performance study data with specific acceptance criteria.
Therefore, I cannot provide the requested information. The document explicitly states:
- "Documentation is provided which demonstrated the · MarrowStim™ Concentration Kit and MarrowStim™ Mini Concentration Kit to be substantially equivalent to other legally marketed devices."
- This indicates that direct comparative performance studies against acceptance criteria for the new device were likely not the primary method of clearance, but rather a comparison to an existing, cleared device.
The FDA letter also includes a warning:
- "The safety and effectiveness of this device for in vivo indications for use has not been established." This further confirms that no clinical studies proving safety and effectiveness for in vivo use were part of this submission.
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CCT ) 1 2007
510(k) Summary
Biomet Manufacturing Corp. Manufacturer: P.O. Box 587 56 East Bell Drive Warsaw, Indiana 46581 Biomet Biologics, Inc. Submitted By: P.O. Box 587 56 East Bell Drive Warsaw, Indiana 46581 Proprietary Name: MarrowStim™ Concentration Kit and MarrowStim™ Mini Concentration Kit Classification name: General purpose laboratory equipment labeled or promoted for a specific medical use (21 CFR 862.2050) Centrifuge for Clinical Use Common/Usual Name: Product Code: JQC, FGF, KSS Substantial Equivalence: Documentation is provided which demonstrated the · MarrowStim™ Concentration Kit and MarrowStim™ Mini Concentration Kit to be substantially equivalent to other legally marketed devices. The MarrowStim™ Concentration Kit and MarrowStim™ Device Description: Mini Concentration Kit consist of a table-top, swinging bucket centrifuge and accessories to allow for preparation of platelet poor plasma and platelet concentrate from blood, and for preparation of a cell concentrate from bone marrow. The MarrowStim™ and MarrowStim™ Mini Concentration Kits have the same indications for use for which the Harvest SmartPReP2 Centrifuge System (K052925) was cleared. Intended Use: The Marrow Stim™ Concentration Kit and the MarrowStim™ Mini Concentration Kit are intended to be used in the clinical laboratory or intraoperatively at pointof-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.
Material: Polymeric Medical Grade Plastics
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 1 2007
Mary L. Verstynen Biomet Manufacturing Corp. 56 East Bell Drive Warsaw, Indiana 46582
Re: K071934
Trade/Device Name: MarrowStim ™ Concentration Kit and MarrowStim ™ Mini Concentration Kit Regulation Number: 21 CFR 862.2050 Regulation Name: Centrifuge for Clinical Use Regulatory Class: Class I Product Code: JQC Dated: July 5, 2007 Received: July 19, 2007
Dear Ms. Verstynen:
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.
The Office of In Vitro Diagnostic Device Evaluation and Safety has determined that there is reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings and Precautions section of the device's labeling:
The safety and effectiveness of this device for in vivo indications for use has not been established.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can
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Page 2 - Mary L. Verstynen
be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Bett Zosterf
Robert L. Becker, Jr., M.D. Ph.D. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K071934
Device Name: MarrowStim™ Concentration Kit and MarrowStim™ Mini Concentration Kit
Indications For Use:
The MarrowStim™ Concentration Kit and the MarrowStim™ Mini Concentration Kit are intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.
Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)
Page 1 of 1
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K071934
§ 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
(a)
Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.(b)
Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.