MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE

K052802 · Manan Medical Products, Inc. · KNW · Nov 1, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K052802
• Device Name: MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE
• Applicant: Manan Medical Products, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Nov 1, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

For harvesting soft tissue biopsy specimens.

Device Story

Sterile, disposable biopsy needle; stainless steel cannula with echogenic tip; stainless steel spring-loaded stylet; plastic handle. Used for soft tissue sampling; clinician advances device to target site; spring-loaded mechanism enables single-handed specimen collection; device removed and sample expelled from stylet notch. Used in clinical settings by healthcare professionals.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stainless steel cannula and stylet; plastic handle. Sizes: 14-20 gauge; lengths: 9-20 cm. Features echogenic tip for ultrasound visualization. Sterile, disposable, single-use device.

Indications for Use

Indicated for harvesting soft tissue biopsy specimens. Prescription use only.

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.

Predicate Devices

• Manan Super-Core Biopsy Needle (K950732)
• Medical Device Technologies Super-Core Biopsy Needle (K974814)

Submission Summary (Full Text)

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Manan Medical Products, Inc. Special 510(k) Manan Bio-Cut Soft Tissue Biopsy Needle

K052802

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# PREMARKET NOTIFICATION [510(K)] SUMMARY

| Trade Name: | Manan Bio-Cut Soft Tissue Biopsy Needle |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Biopsy needle |
| Classification Name: | Instrument, biopsy (per 21 CFR section 876.1075) |
| Manufacturer's Name: | Manan Medical Products, Inc.<br>241 W. Palatine Road<br>Wheeling, IL 60090 |
| Corresponding Official: | Nicohl Wilding<br>Manager Regulatory Affairs<br>241 W. Palatine Road<br>Wheeling, IL 60090<br>Phone: [phone] ext, 331<br>Fax: [phone] |
| Predicate Device(s): | Manan Super-Core Biopsy Needle K950732.<br>Medical Device Technologies Super-Core Biopsy Needle<br>K974814 |
| Device Description: | The biopsy instrument is a sterile disposable device which<br>features a stainless steel cannula with an echogenic tip, and a<br>stainless steel stylet which is spring loaded and fitted into a<br>plastic handle permitting single handed specimen collection.<br><br>Sizes are available in 14 - 20 gauge needles. The length of<br>the needles ranges between 9 and 20 cm.<br><br>The needle is used by advancing the entire device to the site<br>of soft tissue sampling. The needle is advanced with gentle<br>but firm pressure. Once the needle is in position, the sample<br>is taken and the device is removed from the sampling site.<br>The sample can then be expelled from the stylet notch. |
| Intended Use: | For harvesting soft tissue biopsy specimens. |
| Technological<br>Characteristics: | The biopsy needles are available in 14 - 20 gauge sizes and<br>lengths from 9 to 20 centimeters. |

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#### CONFIDENTIAL

This document and the information contained herein may not be reproduced, used or disclosed without written permission from Manan Medical Products, Inc.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized representation of the human form. The human form is depicted with three abstract figures, symbolizing the department's focus on health and well-being. The seal is in black and white.

Public Health Service

NOV - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nicohl Wilding Manager Regulatory Affairs Manan Medical Products, Inc. 241 West Palatine Road Wheeling, Illinois 60090

Re: K052802

Trade/Device Name: Manan Bio-Cut Soft Tissue Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW Dated: October 26, 2005 Received: October 27, 2005

Dear Ms. Wilding:

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- Nicohl Wilding

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely yours,

Barbara Bruckner

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K052802

# INDICATIONS FOR USE

510(k) Number:

Device Name: Manan Bio-Cut Soft Tissue Biopsy Needle

## Indications for Use:

The Bio-Cut Soft Tissue Biopsy Needle is intended for harvesting soft tissue biopsy specimens.

× Prescription Use (per 21 CFR 801.109) and/or

] Over-The-Counter Use

# (PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buchup
(Division Sign-Off)

Division of General, Restora and Neurological Devices

510(k) Number K052802