K Number
K970152
Device Name
BIOPSY TRAY
Date Cleared
1997-03-05

(48 days)

Product Code
Regulation Number
880.6850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
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.
More Information

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No
The summary describes a disposable tray of standard biopsy components and makes no mention of AI, ML, image processing, or any computational analysis.

No.
The document states that the device provides auxiliary components for biopsy procedures, not that the device itself performs the therapy or treatment.

No
The Biopsy Tray is described as providing auxiliary components for biopsy procedures. It collects commonly used items into a single package for convenience but does not itself perform any diagnostic function such as analyzing data or providing a diagnosis. The "intended use / indications for use" explicitly states it provides "components for the administration of biopsy procedures," not for diagnosis.

No

The device description clearly states it is a "disposable device" and lists physical components ("auxiliary components utilized during biopsy procedures"). This indicates it is a hardware-based medical device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the Biopsy Tray is for "conveniently provide components for the administration of biopsy procedures." Biopsy procedures involve taking tissue samples from the body.
  • Device Description: The description reinforces this by stating it provides "auxiliary components utilized during biopsy procedures." These are tools used during the procedure itself.
  • Lack of Diagnostic Function: There is no mention of the device being used to analyze samples outside the body to diagnose a condition. IVDs are specifically designed for testing samples like blood, urine, or tissue in vitro (in glass, or outside the living organism).

The Biopsy Tray is a procedural kit containing tools for collecting a sample, not for analyzing the sample to make a diagnosis.

N/A

Intended Use / Indications for 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.

Product codes

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Device Description

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.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

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Key Metrics

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Predicate Device(s)

Medical Procedures Inc. 2223 Eastern Ave. Baltimore, MD 21231 Basic Stereotactic Core Kit Cat. No. MP-002

Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 880.6850 Sterilization wrap.

(a)
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.(b)
Classification. Class II (performance standards).

0

K970152

(D) 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 (603)352-3230

  • (2) Name of Device:
    Biopsy Tray

Classification Name:

Unknown

  • Identification of Predicate Devices: (3)
    Medical Procedures Inc. 2223 Eastern Ave. Baltimore, MD 21231

Basic Stereotactic Core Kit Cat. No. MP-002

1

KY/US