MANAN LIVER BIOPSY KIT

K980452 · Medical Device Technologies, Inc. · KNW · Feb 18, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980452
• Device Name: MANAN LIVER BIOPSY KIT
• Applicant: Medical Device Technologies, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Feb 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Manan™ Liver Biopsy Kit is used for obtaining liver biopsies or for other biopsies of soft tissue.

Device Story

Manan Liver Biopsy Kit consists of a cutting biopsy needle featuring Menghini-type tip geometry integrated with a locking syringe. Device used by clinicians for percutaneous soft tissue and liver biopsy procedures. Needle facilitates tissue sample collection via aspiration; locking syringe maintains vacuum/pressure during procedure. Manual surgical instrument; no electronic or automated components. Benefits include standardized tissue acquisition for diagnostic pathology.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual surgical instrument. Components: Menghini-type cutting biopsy needle, locking syringe. Sterile, disposable. No energy source, software, or connectivity.

Indications for Use

Indicated for obtaining liver biopsies or other soft tissue biopsies in patients requiring diagnostic tissue sampling.

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

• Liver Biopsy Kit (K943650)

Submission Summary (Full Text)

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AMD

K980452

FEB 1 8 1998

4445-310 S.W. 35th Terrace Gainesville, Florida 32608 Gaillosvillo, FAX: [phone]

| 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™ Liver Biopsy Kit | |
| COMMON NAME: | Menghini type biopsy needle with a locking syringe | |
| CLASSIFICATION NAME: | §878.4800-Manual Surgical Instrument for General Use<br>Disposable Aspiration and Injection Needle | |
| SUBSTANTIAL EQUIVALENCE: | | |
| Company Name | Product Name | 510(k) No. |
| Manan Medical Products | Liver Biopsy Kit | K943650 |

## DESCRIPTION OF DEVICE:

The Manan Liver Biopsy Kit is composed of a cutting biopsy needle based upon the Menghini cutting tip geometry that is fitted to a locking syringe.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 1998

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

Re: K980452 Trade Name: Manan™ Liver Biopsy Kit Regulatory Class: II Product Code: KNW Dated: February 4, 1998 Received: February 5, 1998

Dear Mr. Swartz:

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 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 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

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Page 2 - Mr. Swartz

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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,

Authority, years,

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

Enclosure

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**MD**

4445-310 S.W. 35th T Gainesville, Florida 32608 TEL: [phone] FAX: [phone]

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Manan™ Liver Biopsy Kit

Indications for Use:

The Manan™ Liver Biopsy Kit is used for obtaining liver biopsies or for other biopsies of soft tissue.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

cotter

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980452