BONE & MARROW CLLECTION SYSTEM

K971268 · Biomedical International Corp. · GEY · Jul 3, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971268
• Device Name: BONE & MARROW CLLECTION SYSTEM
• Applicant: Biomedical International Corp.
• Product Code: GEY · General, Plastic Surgery
• Decision Date: Jul 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1

Intended 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.

Device Story

Bone and Marrow Collection System (BMCS) collects osseous and marrow tissue during skeletal drilling. Device functions as a collection tool used in conjunction with BMCS Instrument Kit. Operated by clinicians in surgical settings to harvest autogenous tissue for implantation. System facilitates efficient, aseptic tissue recovery during orthopedic or reconstructive procedures; benefits patient by providing autogenous graft material for bone repair.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual surgical collection system for osseous and marrow tissue. Designed for use with BMCS Instrument Kit. Non-powered, mechanical device.

Indications for Use

Indicated for the aseptic collection of autogenous bone and marrow tissue during skeletal drilling procedures to facilitate subsequent implantation. Prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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 current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 your 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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# Indication For Use

510(k) Number (if Known): K971269

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)


Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use ☐ (Optional Format 1-2-96)