BMN I TYPE MARROW ASPIRATION NEEDLE

K020987 · H.S. Hospital Service S.R.L. · KNW · Jun 25, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K020987
• Device Name: BMN I TYPE MARROW ASPIRATION NEEDLE
• Applicant: H.S. Hospital Service S.R.L.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Jun 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

This biopsy instrument is used for drawing of osteomedullary substance and or for Explantation of bone marrow

Device Story

The BMN “I” Type Marrow Biopsy Needle is a manual surgical instrument designed for the collection of bone marrow and osteomedullary tissue. It is used by clinicians in a clinical setting to perform biopsies. The device functions as a mechanical tool for tissue extraction; it does not involve electronic components, software, or automated processing. The clinician manually inserts the needle into the bone to retrieve the sample, which is then used for diagnostic evaluation. The device provides a physical means to obtain tissue samples for clinical decision-making regarding bone marrow health.

Clinical Evidence

No clinical data provided. The device is a manual surgical instrument; substantial equivalence is based on design and intended use.

Technological Characteristics

Manual bone marrow biopsy needle. Mechanical device; no energy source, software, or connectivity. Materials and dimensions are consistent with standard biopsy instrumentation for osteomedullary sampling.

Indications for Use

Indicated for the collection of osteomedullary substance and bone marrow explantation in patients requiring bone marrow biopsy.

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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BMN "I" TYPE

# 510 (k) SUMMARY

K0209f7

JUN 2 5 2002

| > Applicant | : H.S. Hospital Service S.p.A.<br>Via Naro, 81 - 00040 Pomezia (Roma) Italy |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| > Contact Person | : MMC International, LLC<br>Mr. Lucio Improta<br>10147 Umberland Place - Boca Raton, FL 33428<br>Tel. [phone]<br>e-mail : [e-mail] |
| > Submission Date | : February 28, 2001 |
| > Trade Name | : BMN “I” Type Marrow Biopsy Needle |
| > Common Name | : Bone Marrow Biopsy Needle |
| > Classification Name | : 876.1075 - Biopsy instrument |

#### ❖ Indication for use :

This biopsy instrument is used for drawing of osteomedullary substance and or for Explantation of bone marrow

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

H.S. Hospital Service S.R.L. c/o Mr. Lucio Improta MMC International LLC 10147 Umberland Place Boca Raton, FL 33428

# JUN 2 5 2002

Re: K020987

Trade/Device Name: BMN "I" Type Marrow Biopsy Needle Regulation Number: 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: February 28, 2002 Received: March 27, 2002

Dear Mr. Improta:

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.

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 be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Lucio Improta

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark A. Millikens

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# PREMARKET NOTIFICATION SUBMISSION - 510 (k)

### BMN "I" TYPE

ATTACHMENT "B"

510 (k) # K020981

DEVICE NAME

BMN "I" Type Biopsy Needle

#### INDICATION FOR USE

This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Melkerson

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020987

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use