BONE AND MARROW COLLECTION SYSTEM KIT

K971782 · Biomedical Ent., Inc. · GEY · Jul 29, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971782
• Device Name: BONE AND MARROW COLLECTION SYSTEM KIT
• Applicant: Biomedical Ent., Inc.
• Product Code: GEY · General, Plastic Surgery
• Decision Date: Jul 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1

Intended Use

To be used with the Bone and Marrow Collection System™ (BMCS). The trocar is used to cut and reflect soft-tissue allowing the BMCS to be placed on bone, the suction connector for converting the BMCS into an aspiration handle and the plunger for extruding tissue from the BMCS.

Device Story

Bone and Marrow Collection System (BMCS) Instrument Kit; manual surgical accessory set. Components include trocar for soft-tissue reflection; suction connector for aspiration handle conversion; plunger for tissue extrusion. Used by clinicians in clinical settings during bone/marrow harvesting procedures. Facilitates access to bone and retrieval of tissue samples. Mechanical operation; no electronic or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual surgical instrument kit; includes trocar, suction connector, and plunger. Non-powered, mechanical design. Materials and sterilization methods consistent with standard surgical instrument requirements.

Indications for Use

Indicated for use as an accessory instrument kit for the Bone and Marrow Collection System (BMCS) to facilitate bone and marrow tissue collection via soft-tissue reflection, aspiration, and tissue extrusion.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

W. Casey Fox, Ph.D., P.E. President BME Medical Enterprises, Inc. 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245

Re: K971782

Trade Name: Bone and Marrow Collection System Kit Regulatory Class: I Product Code: GEY Dated: May 13, 1997 Received: May 14, 1997

JUL 2 9 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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

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K971782 510(k) Number (if Known):

Device Name: Bone and Marrow Collection System (BMCS) Instrument Kit

Indications for use: To be used with the Bone and Marrow Collection System™ (BMCS). The trocar is used to cut and reflect soft-tissue allowing the BMCS to be placed on bone, the suction connector for converting the BMCS into an aspiration handle and the plunger for extruding tissue from the BMCS.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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(Division Sign-Off)

Division of General Restorative Devices

| 510(k) Number | K971782 |
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| Prescription Use (Per 21 CFR 801.109) | <div style="display:inline-block;"> <img alt="Checkmark" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAUAAAAFCAYAAACNbyblAAAAHElEQVQI12P4//8/AxMDAwMDAwMDwwMDw4wYAAAmOwEQT0j9qAAAAABJRU5ErkJggg=="/> </div> |
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OR

| Over-The-Counter Use | |
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