A disposable single use Biopsy Needle. The product consist of a 304 stainless steel cannula and 302 stainless steel stylet. The cannula is inserted molded into an ABS hub that provide a grip for manipulation of the Needle. Inside of the cannula is a stylet made by 302 stainless steel, inserted molded into an ABS hub. An additional patented stylet is provided to be used for trapping the sample in the cannula. An extracting 302 stainless steel wire with safety grip. The protective cover of cannula is made of polypropilene.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (TrapSystem® Set Bone Marrow Biopsy Needle) and does not contain information on acceptance criteria, device performance studies, or details relevant to artificial intelligence/machine learning (AI/ML) device performance.

Therefore, I cannot extract the requested information regarding:

A table of acceptance criteria and reported device performance.
Sample size for the test set and data provenance.
Number and qualifications of experts for ground truth.
Adjudication method for the test set.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
Standalone (algorithm only) performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This document is for a conventional medical device (a biopsy needle) seeking substantial equivalence and does not involve AI/ML components or associated performance studies as typically found in submissions for AI/ML-powered devices.

Summary

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510 (k) SUMMARY

FEB 0 5 2002

> Applicant	: HS Hospital Service S.p.A.Via Naro,81 – 00040 Pomezia (Rome) Italy
> Contact Person	: MMC International, LLCMr. Lucio Improta10147 Umberland Place – Boca Raton, FL 33428Tel. (561)477-1671 - Fax. (561)477-0863e-mail : mmcintern@aol.com
> Submission Date	: October 27, 2001
> Trade Name	: TrapSystem® Set Bone Marrow Biopsy Needle
> Common Name	: Bone Marrow Biopsy Needle
> Classification Name	> : 876.1075 - Biopsy instrument

Indication for use : 彩

This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow.

K013692 1/3

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SECTION I - PRODUCT NAME/DESCRIPTION

A. Trade Name	TrapSystem® Set Bone Marrow Biopsy Needle
B. Usual Name	: Bone Marrow Biopsy Needle
C. Description	: A disposable single use Biopsy Needle
1. Intended Use	: This biopsy instrument is intended to be used for drawing osteomedullarysubstances and or explantation of bone marrow.
2. Material	The product consist of a 304 stainless steel cannula and 302 stainless steelstylet.The cannula is inserted molded into an ABS hub that provide a grip formanipulation of the Needle.Inside of the cannula is a stylet made by 302 stainless steel, inserted moldedinto an ABS hubAn additional patented stylet is provided to be used for trapping the samplein the cannulaAn extracting 302 stainless steel wire with safety grip.The protective cover of cannula is made of polypropileneThis type of device is also referred to Promedical Ltd, PRO-B biopsyNeedle 510 (k) # K952350We will incorporate all these features into our product, therefore providingthe physician with a product that will safety assist them in their operation.A listing of needle dimension is included in Section I - Attachment C

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Image /page/2/Figure/0 description: The image shows a document excerpt with the title "PREMARKET NOTIFICATION SUBMISSION - 510 (k)". Below the title is the text "TRAPSYSTEM® SET". On the right side of the image, the date "10-27-2001" and page number "10 di 32" are visible.

Section I - Attachment C

TABLE OF DIMENSION

Code	Description
TRAPJ 1305	13G x 50mm
TRAPJ 1306	13G x 65mm
TRAPJ 1310	13G x 100mm
TRAPJ 1315	13G x 150mm
TRAPJ 1205	12G x 50mm
TRAPJ 1210	12G x 100mm
TRAPJ 1215	12G x 150mm
TRAPJ 1105	11G x 50mm
TRAPJ 1110	11G x 100mm
TRAPJ 1115	11G x 150mm
TRAPJ 1005	10G x 50mm
TRAPJ 1010	10G x 100mm
TRAPJ 1015	10G x 150mm
TRAPJ 0905	9G x 50mm
TRAPJ 0910	9G x 100mm
TRAPJ 0915	9G x 150mm
TRAPJ 0805	8G x 50mm
TRAPJ 0810	8G x 100mm
TRAPJ 0815	8G x 150mm

0	First release	31/10/2000
Release.	Description	Date

Project n° 48
---------------	--

Name:	TRAP SYSTEM ® SET
-------	------------------------------

	Prepared	Approval
Date:	18/11/1999	Date: 31/10/2000
Function:	STE	Function: DG
	Dip Ing. Mauro Rinaldi	Ing. Dario Giusti

Mod.14r0 misure e codici
--------------------------	--

K013692

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 5 2002

Lucio Improta MMC International, LLC 10147 Umberland Place Boca Raton, Florida 33428

Re: K013692

Trade Name: TrapSystem® Set Bone Marrow Biopsy Needle Regulation Number: 876.1075 Regulation Name: Gastroenterology/Urology Biopsy Instrument Regulatory Class: II Product Code: KNW Dated: October 27, 2001 Received: November 7, 2001

Dear Mr. Improta:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your device can may or subject to deen traderal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Lucio Improta

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Meriam C. Provost

fav 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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	PREMARKET NOTIFICATION SUBMISSION – 510(k)	Data: 10-27-2001
	TRAPSYSTEM® SET	Pag. 12 di 32

510 (k) # Ko13692

DEVICE NAME

TrapSystem® Set Bone Marrow Biopsy Needle

INDICATION FOR USE

This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K013692

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

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.