The biopsy instrument is a sterile disposable device which features a cannula assembly containing an outer cannula with an inner spiral snare tube at the distal tip. The device has a handle with a snare lever that can be rotated 180° to engage the snare when a biopsy sample needs to be taken. Finally the device has a stationary stylet to prevent coring during advancement, and a stylet cap which mates to the handle. Three sizes are available; 8, 11 and 13 gauge needles. The 8 and 11 gauge needles are sold in 4" and 6" lengths and have a tip configuration identical to the geometry of the existing Medical Device Technologies Manan Bone and Bone Marrow Biopsy Needle. The 13 gauge needles are sold in 2" and 3" lengths and have a less tapered tip configuration identical to a bone marrow needle currently manufactured by Ranfac.

AI/ML Overview

The provided text is a 510(k) summary for the SnareLok Bone Marrow Biopsy Needle. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's characteristics and intended use. The document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot populate the requested table or answer the specific questions below based on the provided input.

Here's a breakdown of why the information is missing and an explanation of the type of information typically found in such studies:

Acceptance Criteria and Device Performance: The document describes the device and its intended use but does not present any quantitative performance metrics (e.g., successful biopsy retrieval rates, tissue integrity scores, time to complete procedure) or associated acceptance criteria.
Sample Size and Data Provenance: Without a study being mentioned, there's no information on sample sizes, country of origin, or whether it was retrospective or prospective.
Experts and Ground Truth: There's no mention of experts or the establishment of ground truth as no performance study is described.
Adjudication Method: Not applicable as no study is mentioned.
MRMC Comparative Effectiveness Study: Not applicable. This type of study is more common for imaging-based diagnostic AI devices where human reader performance is compared with and without AI assistance. The SnareLok is a mechanical biopsy needle.
Standalone Performance: Not applicable as no performance study is mentioned.
Type of Ground Truth: Not applicable.
Training Set Sample Size and Ground Truth Establishment: Not applicable as this device is a physical instrument, not an AI/software device that would require training data.

General Explanation of What Would Be Included in a Performance Study for a Biopsy Needle (if it were present):

If a performance study for a biopsy needle were included, it would typically involve:

Acceptance Criteria: Predetermined thresholds for various performance metrics, such as:
- Specimen Adequacy Rate: The percentage of retrieved samples that are deemed sufficient for diagnosis by a pathologist. (e.g., >= 95%)
- Specimen Length/Integrity: Average length of retrieved core samples and subjective grading of fragmentation. (e.g., average length >= X mm, <Y% fragmentation)
- Procedure Success Rate: The percentage of procedures where a biopsy is successfully obtained. (e.g., >= 98%)
- Ease of Use/Handling: Often assessed qualitatively through surgeon feedback.
- Complication Rates: Incidence of adverse events (e.g., hemorrhage, infection, pain). (e.g., <Z%)
Study Design:
- Sample Size: Number of patients or procedures included in the study.
- Data Provenance: Whether data was collected prospectively in a clinical trial or retrospectively from existing records, and the geographical locations of participating institutions.
Ground Truth Establishment:
- Pathology: For biopsy devices, the gold standard for ground truth is typically histopathological evaluation of the retrieved tissue by licensed pathologists.
- Expert Consensus: For subjective assessments (e.g., ease of use, tissue integrity), multiple experts (e.g., interventional radiologists, oncologists, surgeons) might provide ratings, with consensus methods used to establish a final "truth."
Adjudication Methods: If multiple experts are involved in assessing specific outcomes (e.g., specimen adequacy), methods like "2+1" (two experts agree, a third adjudicates if they disagree), or simple majority vote might be used.
Multi-Reader Multi-Case (MRMC) / Standalone Studies: These are less common for physical biopsy instruments. MRMC is primarily for diagnostic imaging devices where human readers interpret images with or without AI assistance. Standalone studies for a physical device might involve bench testing for mechanical properties (e.g., strength, sharpness) rather than clinical performance alone.
Training Set (for AI/Software): This concept is entirely irrelevant for a traditional mechanical medical device like a biopsy needle.

In conclusion, the provided FDA 510(k) summary for the SnareLok Bone Marrow Biopsy Needle focuses on demonstrating "substantial equivalence" to predicate devices, which is primarily a regulatory pathway based on design, materials, and intended use similarity, rather than extensive clinical performance data against specific acceptance criteria. Such detailed performance studies are often required for novel devices or those undergoing a PMA (Premarket Approval) process.

Summary

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Medical Device Technologies, Inc. Traditional 510(k) SnareLok Bone Marrow Biopsy Needle

December, 2004

『EB』】2005

K043523

TAB 4

PREMARKET NOTIFICATION [510(K)] SUMMARY

December	, 2004
----------	--------

Trade Name:	InterV® brand SnareLok Bone Marrow Biopsy Needle
Common Name:	Biopsy needle
Classification Name:	Instrument, biopsy (per 21 CFR section 876.1075)
Manufacturer's Name:	Medical Device Technologies, Inc.3600 SW 47th AvenueGainesville, FL 32608
Corresponding Official:	Nicohl WildingManager Regulatory Affairs241 W. Palatine RoadWheeling, IL 60090Phone: (800) 424-6779 ext, 331Fax: (847) 637-3334
Predicate Device(s):	Medsol Corporation Goldenberg Bone Marrow BiopsyNeedle, K983187.
	Medical Device Technologies, Inc. Manan Bone and BoneMarrow Biopsy Needle, K980196
Device Description:	The biopsy instrument is a sterile disposable device whichfeatures a cannula assembly containing an outer cannula withan inner spiral snare tube at the distal tip. The device has ahandle with a snare lever that can be rotated 180° to engagethe snare when a biopsy sample needs to be taken. Finallythe device has a stationary stylet to prevent coring duringadvancement, and a stylet cap which mates to the handle.
	Three sizes are available; 8, 11 and 13 gauge needles. The 8and 11 gauge needles are sold in 4" and 6" lengths and havea tip configuration identical to the geometry of the existingMedical Device Technologies Manan Bone and BoneMarrow Biopsy Needle. The 13 gauge needles are sold in 2"and 3" lengths and have a less tapered tip configurationidentical to a bone marrow needle currently manufactured byRanfac.

CONFIDENTIAL This document and the information contained herein nay not be reproduced, used or disclosed without written permission from Medical Device Technologies, Ins.

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December, 2004

The needle is used by advancing it with the stylet in place, to the site of bone or marrow sampling. The needle is advanced with gentle but firm pressure, with alternating clockwisecounterclockwise rotational motion. Once the needle is in position, the stylet and stylet cap are removed and the needle is advanced with additional rotation to obtain the marrow sample. Aspiration can be used to obtain the sample by positioning a syringe to the hub of the needle and applying suction. For biopsy, the needle is advanced to a new location with rotating motion until adequate marrow is obtained. The Snare lever is rotated clockwise to its closed position to capture the marrow sample. A probe is provided which has markings that can be used to estimate the length of the sample before the needle is removed from the patient. Once the needle is removed, the SnareLok lever is turned to the open position. The sample can then be expelled from the proximal end of the needle using the probe.

A Probe Guide is also included with the SnareLok Bone Marrow Needle to provide an easy method to align the probe in the needle tip for sample expulsion, and to protect users from the sharp tip during handling.

Intended Use: For harvesting bone and/or bone marrow specimens.

Technological Characteristics:

The biopsy needles are available in 8-13 gauge sizes and lengths from 2 to 6 inches.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2005

Ms. Nichol Wilding Manager Regulatory Affairs Medical Device Technologies, Inc. 241 W. Palatine Road Wheeling, Illinois 60090

Re: K043523

K043323
Trade/Device Name: InterV® Brand SnareLok Bone Marrow Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW and FCG Dated: December 7, 2004 Received: December 20, 2004

Dear Ms. Wilding:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars the Medical Device Amendments, or 10 conimeres prod to May 20, 1978, are excordance with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Fee) that do not requent of the general controls provisions of the Act. The 1 ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations af may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found interests concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a decermination administered by other Federal agencies. You must or any I caelul suttated and registements, including, but not limited to: registration and listing (21 Compry with an the Act 31equirements, as a manufacturing practice requirements as set CFR Part 6077, adoling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Nichol Wilding

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
R. Mark A. Millmann

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

Enclosure

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INDICATIONS FOR USE

510(k) Number: K043523

Device Name: InterV® brand SnareLok Bone Marrow Biopsy Needle

Indications for Use:

The SnareLok Bone Marrow Biopsy Needle is intended for harvesting bone and/or bone marrow specimens.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evalyation (ODE)

L. Mark A. Milburn

Division of General, Restorative, and Neurological Devices

K043523

510(k) Number_

Page 1 of 1

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.