FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

AI/ML Overview

The provided text describes a "Biopsy Tray" device and its intended use, but it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert involvement. The document, labeled as a "510(k) Summary," primarily focuses on the device's description, classification, and comparison to a predicate device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the given input.

The information provided only includes:

Submitted By: MedCare Medical Group, Inc.
Device Name: Biopsy Tray
Classification Name: Unknown
Predicate Device: Basic Stereotactic Core Kit Cat. No. MP-002 from Medical Procedures Inc.
Description: Conveniently provides auxiliary components for biopsy procedures, sterile, disposable, single-patient use.
Intended Use: "A single patient, single use, disposable device which is intended to conveniently provide components for the administration of biopsy procedures."
Technological Characteristics: Similar to the predicate device in providing components and flexibility in customization.

To answer your questions, I would need a different type of document, such as a clinical study report, a validation report, or a section within a regulatory submission that specifically addresses performance data and acceptance criteria.

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K Number

K964921

Device Name

BASIC BIOPSY TRAY. DISPOSABLE, STERILE

Manufacturer

TRINITY LABORATORIES, INC.

Date Cleared

1997-01-22

(44 days)

Product Code