MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA

K962969 · Medical Device Technologies, Inc. · KNW · Dec 6, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962969
• Device Name: MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA
• Applicant: Medical Device Technologies, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Dec 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Ultra™ Biopsy Device is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.

Device Story

Reusable handle gun for use with disposable biopsy needles; obtains multiple core samples from soft tissue (liver, kidney, prostate, breast, lesions). Operated by clinicians in clinical settings. Device provides mechanical actuation for needle deployment to retrieve tissue samples for diagnostic evaluation. Benefits include standardized, repeatable core biopsy collection.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Reusable mechanical handle gun; designed for use with disposable soft tissue biopsy needles (K921418). Manual operation; no electronic or software components.

Indications for Use

Indicated for patients requiring core tissue sampling from soft tissue organs including liver, kidney, prostate, breast, and soft tissue lesions. Contraindicated for bone 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.

Predicate Devices

• Pro Mag 2.2 (K914874)
• Biopsy Biopsy System (K871390)

Submission Summary (Full Text)

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K962969/51

MDIC

45 S.W. 35th Terrace Suite 310

Gainesville, Florida 32608

TEL: [phone] FAX: [phone]

DEC - 6 1996

# 510 (k) SUMMARY

**APPLICANT:** Medical Device Technologies, Inc.
4445-310 SW 35th Terrace
Gainesville, FL 32608

**CONTACT:** Karl Swartz
Quality Assurance Manager

**TELEPHONE:** [phone]
fax [phone]

**TRADE NAMES:** Medical Device Technologies, Inc. Ultra™

**COMMON NAME:** Reusable handle gun for use with disposable biopsy needles.

**CLASSIFICATION NAME:** Instrument, Biopsy, No. 78KNW

## SUBSTANTIAL EQUIVALENCE:

| Company Name | Product Name | 510 (k) No. |
| --- | --- | --- |
| Manan Medical Products
C.R. Bard | Pro Mag 2.2
Biopsy Biopsy System | K914874
K871390 |

## DESCRIPTION OF DEVICE:

Our company is presently authorized by the Food and Drug Administration to manufacture disposable soft tissue biopsy needles, K921418. This device is to be the reusable handle gun that will compete with the products that currently use the biopsy needles covered by this 510(k).

The Ultra™ Biopsy Device is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.

M

A member of The Marmon Group of Companies