MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES

K980211 · Manan Medical Products, Inc. · KNW · Feb 6, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980211
• Device Name: MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES
• Applicant: Manan Medical Products, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Feb 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

These needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues through a combination of cutting and/or aspirating. The breast localization needles can be used in MRJ, Fluoroscopic, CT and Mammographic procedures to obtain breast lesion tissue.

Device Story

Manan™ MRI needles are manual surgical instruments designed for tissue biopsy and breast lesion localization. The device line includes Chiba, spinal, automatic cutting, general-purpose introducer, Techna-Cut biopsy, Super-Core biopsy, and breast localization needles (including Simon type). These needles are used by clinicians in MRI, fluoroscopic, CT, and mammographic imaging environments to obtain tissue samples via cutting or aspiration. The device functions as a mechanical tool for tissue access and sampling; it does not involve electronic processing, AI, or software. The output is a physical tissue specimen obtained by the physician to aid in diagnostic decision-making. The device benefits patients by enabling minimally invasive tissue acquisition under various imaging modalities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual surgical biopsy needles. Materials and construction are consistent with previously cleared predicate devices (K962977). Designed for compatibility with MRI, Fluoroscopic, CT, and Mammographic imaging environments. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring tissue biopsy or breast lesion localization during MRI, Fluoroscopic, CT, or Mammographic procedures. 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

• MRI Chiba Needle (K962977)
• MRI Spinal Needle (K962977)
• MRI Automatic Cutting Needle (K962977)
• MRI General Purpose Introducer Needle (K962977)
• MRI Techna-Cut Biopsy Needle (K962977)
• MRI Super-Core Biopsy Needle (K962977)
• MRI Breast Localization Needle (K962977)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a close-up of a word or abbreviation in bold, white letters against a black background. The letters appear to be "AAD" or a similar combination, with some horizontal lines underneath. The contrast between the white text and the black background makes the letters stand out.

4445-310 S.W. 35th Te Gainesville, Florida 320 TEL: [phone] FAX: [phone]

9p0211

## FEB

| | 510(k) SUMMARY | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| APPLICANT: | Medical Device Technologies, Inc.<br>4445-310 SW 35th Terrace<br>Gainesville, FL 32608 | |
| CONTACT: | Karl Swartz<br>Quality Assurance Manager | |
| TELEPHONE: | [phone]<br>fax [phone] | |
| TRADE NAMES: | Manan™ | MRI Chiba Needle<br>MRI Spinal Needle<br>MRI Automatic Cutting Needle<br>MRI General Purpose Introducer Needle<br>MRI Techna-Cut Biopsy Needle<br>MRI Super-Core Biopsy Needle<br>MRI Breast Localization Needle<br>MRI Simon Breast Localization Needle |
| COMMON NAME: | Hand-held biopsy needles. | |
| CLASSIFICATION NAME: | §878.4800 - Manual Surgical Instruments | |
| SUBSTANTIAL EQUIVALENCE: | | |
| Company Name | Product Name | 510(k) No. |
| Manan Medical Products | MRI Chiba Needle<br>MRI Spinal Needle<br>MRI Automatic Cutting Needle<br>MRI General Purpose Introducer Needle<br>MRI Techna-Cut Biopsy Needle<br>MRI Super-Core Biopsy Needle<br>MRI Breast Localization Needle | K962977 |

## DESCRIPTION OF DEVICE:

The biopsy needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues through a combination of cutting and/or aspirating.

The breast localization need in MRI, Fluoroscopic, CT and Mammographic procedures to obtain breast lesion tissue.

MRI Simon Breast Localization Needle

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 6 1998

Mr. Karl Swartz Quality Assurance Manager Medical Device Technologies, Incorporated 4445-310 SW 35th Terrace Gainesville, Florida 32608

Re: K980211

> Trade Name: Manan™ MRI Chiba, Spinal, Automatic Cutting, General Purpose Introducer, Techna-Cut Biopsy, Super-Core Biopsy, Breast Localization and Simon Breast Localization Needles Regulatory Class: II Product Code: KNW Dated: January 20, 1998 Received: January 21, 1998

Dear Mr. Swartz:

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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542

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Page 2 - Mr. Swartz

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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TEL: [phone] FAX: 352/3

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510(k) Number (if known): K980211

- Device Name: Manan™M 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
Indications for Use:

These needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues through a combination of cutting and/or aspirating.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ion of Gen 510(k) Number

**Prescription Use**
**(Per 21 CFR 801.109)**

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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Image /page/4/Picture/0 description: The image shows a logo with the letters "AAD" in bold, white font against a black background. The letters are large and fill the left side of the logo. Below the letters, there are three horizontal lines, also in white, that appear to be part of the logo's design. The right side of the logo is a solid black rectangle, providing a contrast to the white letters and lines on the left.

Gainesville, Florida 3260 TEL: [phone] FAX: [phone]

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510(k) Number (if known): K980211

Device Name: Manan™ MRI Breast Localization Needle MRI Simon Breast Localization Needle

Indications for Use:

The breast localization needles can be used in MRJ, Fluoroscopic, CT and Mammographic procedures to obtain breast lesion tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deale

(Division Sign-Off)
Division of General Restorative Devices K980211
510(k) Number

**Prescription Use**
**(Per 21 CFR 801.109)**

OR

Over-The-Counter Use_

(Optional Format 1-2-96)