BIOPSY TRAY

K970152 · Medcare Medical Group, Inc. · FRG · Mar 5, 1997 · General Hospital

Device Facts

• Record ID: K970152
• Device Name: BIOPSY TRAY
• Applicant: Medcare Medical Group, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Mar 5, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Biopsy Tray is a single patient, single use, disposable device which is intended to conveniently provide components for the administration of biopsy procedures.

Device Story

Biopsy Tray; collection of auxiliary components for biopsy procedures; packaged in single sterile, disposable kit; used by clinicians in clinical settings; provides convenience by consolidating commonly used items; single patient use; no active components or software.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Sterile, disposable, single-use kit containing auxiliary biopsy components. No active energy source, software, or complex materials described.

Indications for Use

Indicated for patients undergoing biopsy procedures requiring auxiliary components packaged in a single sterile, disposable kit.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• Basic Stereotactic Core Kit (Cat. No. MP-002) (Medical Procedures Inc.)

Submission Summary (Full Text)

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K970152

MAR - 5 1997

## (I) 510(k) Summary:

This summary is submitted in conformance with the format described in the 21 CFR Part 807.92 interim rule dated April 28, 1992.

### (1) Submitted By:

MedCare Medical Group, Inc.
234 Old Homestead Highway
E. Swanzey, NH 03446

**Contact Person:**

Craig J. Bell
Director of Research and Development
[phone]

### (2) Name of Device:

Biopsy Tray

**Classification Name:**

Unknown

### (3) Identification of Predicate Devices:

Medical Procedures Inc.
2223 Eastern Ave.
Baltimore, MD 21231

Basic Stereotactic Core Kit
Cat. No. MP-002

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K47U152

(4) **Description of Device Subject to Premarket Notification:**

The Biopsy Tray is intended to conveniently provide the auxiliary components utilized during biopsy procedures. The components are items that are commonly used during a variety of biopsy procedures. The Biopsy Tray provides the convenience of having these items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.

(5) **Intended Use of the Device:**

The Biopsy Tray is a single patient, single use, disposable device which is intended to conveniently provide components for the administration of biopsy procedures.

(6) **Technological Characteristics**

The MedCare Biopsy Tray is similar to the predicate device in that both of the device provide a variety of components for the convenient administration of biopsy procedures. Both devices provide flexibility in componentry selection for kit customization, which provides the maximum convenience for the customer.

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