MANUAL BONE MARROW BIOPSY DEVICE

K993435 · Promex, Inc. · KNW · Dec 6, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K993435
• Device Name: MANUAL BONE MARROW BIOPSY DEVICE
• Applicant: Promex, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Dec 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

These devices are intended to be used to obtain percutaneous biopsy samples of Bone Marrow.

Device Story

Bone Marrow Aspiration Needle used to obtain percutaneous biopsy samples of bone marrow. Device features Luer fittings on cannula and adjustable depth stop (Illinois style). Constructed from 304 stainless steel and polycarbonate. Used by clinicians in clinical settings to collect tissue samples for diagnostic purposes.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: 304 stainless steel and polycarbonate. Features: Luer fittings on cannula, adjustable depth stop (Illinois style). Manual operation.

Indications for Use

Indicated for obtaining percutaneous aspiration biopsy samples of bone marrow.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Submission Summary (Full Text)

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DEC - 6 1999

K993435

510(k) Summary

## SECTION I

## PRODUCT NAME / DESCRIPTION

Trade Name:

Bone Marrow Aspiration Needle.

Same as Trade Name.

Usual Name:

Description: A. Intended Use:

B. Materials:

C. Additional Features:

These devices are intended to be used to obtain percutaneous biopsy samples of Bone Marrow.

304 Stainless Steel and polycarbonate or similar material. For more detail about materials refer to Section I - Attachments A.

Currently, Manan (Northbrook, IL) provides features such as: Luer fittings on Cannula and adjustable depth stop (Illinois style). Promex's products will incorporate these features as well.

A listing of available needle dimensions is included in Section I - Attachment B.

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DEC - 6 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joseph L. Mark Vice President Promex, Inc. 3049 Hudson Street Franklin, Indiana 46131

Re: K993435 Trade Name: Bone Marrow Aspiration Needle Regulatory Class: II Product Code: KNW Dated: October 7, 1999 Received: October 12, 1999

Dear Mr. Mark:

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 requirement, as set forth in the Ouality System Regulation (QS) 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 - Mr. Joseph L. Mark

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,

Sincerely, yours,

HyA. Rlwdle

ames E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K993435

Device Name: Bone Marrow Aspiration Biopsy Needle

Indications For Use:

These devices are intended to be used to obtain percutaneous aspiration biopsy samples of bone marrow.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Styt Rurber

(Division Sign-Off Division of General Restorative Devices K991475 510(k) Number.

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)