MRI COMPATIBLE BIOPSY NEEDLES

K962977 · Manan Medical Products, Inc. · KNW · Oct 9, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K962977
• Device Name: MRI COMPATIBLE BIOPSY NEEDLES
• Applicant: Manan Medical Products, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Oct 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

Needles can be used in MRI, Flouroscopic, CT and Mammographic procedures for obtaining biopsies of various tissues.

Device Story

Line of specialized needles (Chiba, Spinal, Automatic Cutting, General Purpose Introducer, Techna-Cut Biopsy, Super-Core Biopsy, Breast Localization, Simon Breast Localization) designed for use in MRI, CT, fluoroscopic, and mammographic environments. Needles facilitate tissue biopsy collection. Operated by clinicians in clinical/radiology settings. Devices provide physical access to target tissue for diagnostic sampling or localization. Benefit includes compatibility with imaging modalities to guide precise tissue acquisition.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Needles constructed for compatibility with MRI, CT, fluoroscopic, and mammographic imaging environments. Form factors include various biopsy and localization needle designs. Non-electronic, mechanical devices.

Indications for Use

Indicated for patients requiring tissue biopsies during MRI, fluoroscopic, CT, or mammographic procedures.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

Mr. Michael Plishka
New Product Development
Manan Medical Products, Inc.
2200 Carlson Drive
Northbrook, Illinois 60062

OCT - 9 1997

Re: K962977
Trade Name: MRI Chiba Needle, MRI Spinal Needle, MRI Automatic Cutting
Needle, MRI General Purpose Introducer Needle, MRI Techna-Cut Biopsy Needle,
MRI Super-Core Biopsy Needle, MRI Breast Localization Needle, and MRI Simon
Breast Localization Needle
Regulatory Class: II
Product Code: KNW
Dated: August 26, 1997
Received: September 2, 1997

Dear Mr. Plishka:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 devices in the Federal Register. Please note: this response to your premarket notification submissions

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Page 2 - Mr. Michael Plishka

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.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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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510(K) Number (if known): K962977

## Device Name:

- MRI Chiba Needle
- MRI Spinal Needle
- MRI Automatic Cutting Needle
- MRI General Purpose Introducer Needle
- MRI Techna-Cut Biopsy Needle
- MRI Super-Core Biopsy Needle
- MRI Breast Localization Needle
- MRI Simon Breast Localization Needle

## Indications For Use:

Needles can be used in MRI, Flouroscopic, CT and Mammographic procedures for obtaining biopsies of various tissues.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐ (Optional Format 1-2-96)


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