This document is a 510(k) Premarket Notification for a bone marrow biopsy needle, the "TrapMatic System® Set." It is a regulatory submission to the FDA, not a study report detailing acceptance criteria and device performance. Therefore, I cannot extract the requested information from the provided text.

The text primarily focuses on:

Regulatory Information: Applicant details, contact person, submission date, trade name, common name, classification, and product code.
Indication for Use: "This biopsy instrument is used for drawing of osteomedullary substance and or for expllantation of bone marrow."
FDA Communication: A letter from the FDA determining substantial equivalence to predicate devices, outlining regulatory requirements, and permitting marketing.

There is no information on:

A table of acceptance criteria or reported device performance.
Sample sizes for test sets or training sets.
Data provenance.
Number/qualifications of experts.
Adjudication methods.
MRMC studies or effect sizes.
Standalone algorithm performance.
Type of ground truth used or how it was established.

This document is a formal notification for market clearance based on substantial equivalence, not a clinical or performance study report.

Summary

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	TRAPMATIC SYSTEM® SET

MAR - 1 2004 510 (k) SUMMARY

K033616

> Applicant	: HS Hospital Service S.p.A.Via Naro,81 – 00040 Pomezia (Rome) Italy
> Contact Person	: H-S Medical, Inc.Mr. Lucio Improta1200 Clint Moore Rd. Suite # 1Boca Raton, FL 33487Tel. (561)443-3321 - Fax. (561)443-3532e-mail : hsmedicalinc@aol.com
> Submission Date	: November 02, 2003
> Trade Name	: TrapMatic System® Set Bone Marrow Biopsy Needle
> Common Name	: Bone Marrow Biopsy Needle
> ClassificationName	: 876.1075 - Biopsy instrument

な Indication for use:

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

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Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 2004

HS Hospital Service S.p.A. c/o Mr. Lucio Improta H-S Medical, Inc. 1200 Clint Moore Road, Suite #1 Boca Raton, Florida 33487

Re: K033616

Trade/Device Name: TrapMatic System® Set Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: November 2, 2003 Received: December 2, 2003

Dear Mr. Improta:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for usc stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 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 be found in the Code of Federal 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 agencics. 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), please contact the Office of Compliance at (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

uriam C. Provost

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): 033616

Device Name : TRAPMATIC® SYSTEM SET

Indications for Use :

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

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number__Ko 336/k

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.