(87 days)
To aseptically and efficiently collect osseous and marrow tissue during the drilling of skeletal structures. For the collection of autogenous bone and marrow tissues. For use with the BMCS Instrument Kit to facilitate implantation of autogenous bone and marrow tissue.
Bone and Marrow Collection System (BMCS)
This document is a 510(k) premarket notification letter from the FDA regarding a "Bone & Marrow Collection System." It indicates that the device has been found substantially equivalent to predicate devices marketed prior to May 28, 1976. This specific type of document does not contain information about acceptance criteria or specific studies demonstrating performance.
The FDA 510(k) process is primarily a demonstration of substantial equivalence to a legally marketed predicate device, not necessarily a demonstration of clinical efficacy or performance against specific, pre-defined acceptance criteria through a study as would be detailed for a novel or high-risk device. The letter simply states the device is "substantially equivalent" for its stated indications for use (found on page 2 of the document).
Therefore, based solely on the provided text, I cannot provide the information requested:
- A table of acceptance criteria and the reported device performance: Not present in this document.
- Sample size used for the test set and the data provenance: Not present in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present in this document.
- Adjudication method for the test set: Not present in this document.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present in this document. This is also highly unlikely for a bone and marrow collection system, which is a physical medical device, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not present in this document. Again, this is not relevant for this type of device.
- The type of ground truth used: Not present in this document.
- The sample size for the training set: Not present in this document.
- How the ground truth for the training set was established: Not present in this document.
For a 510(k) submission, the "study" that proves the device meets acceptance criteria is often a battery of non-clinical tests (e.g., biocompatibility, sterility, mechanical testing, performance testing compared to the predicate device) rather than clinical studies with human participants and ground truth establishment in the manner described in your prompt, especially for Class I devices like this one. The acceptance criteria would be defined by the manufacturer and often relate to these non-clinical performance aspects and comparison to the predicate. This information would typically be in the 510(k) submission itself, not the FDA's decision letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
W. Casey Fox. Ph.D., P.E. President BioMedical Enterprises, Inc. .............. 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245
JUL - 3 1997
Re: K971268 Trade Name: Bone & Marrow Collection System Regulatory Class: I Product Code: GEY Dated: April 3, 1997 Received: April 7, 1997
Dear Dr. Fox:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the ourrent Good Manufacturing Practice requirements . as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - W. Casey Fox, Ph.D., P.E.
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Indication For Use
510(k) Number (if Known): K-9-7-1-268
Device Name: Bone and Marrow Collection System (BMCS)
Indications for use: To aseptically and efficiently collect osseous and marrow tissue during the drilling of skeletal structures. For the collection of autogenous bone and marrow tissues. For use with the BMCS Instrument Kit to facilitate implantation of autogenous bone and marrow tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of General Restorative Devices | ||
| 510(k) Number | K971268 | |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use_ |
| (Optional Format 1-2-96) |
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.