TOPCUT

• K Number: K021525
• Device Name: TOPCUT
• Manufacturer: H.S. HOSPITAL SERVICE S.R.L.
• Date Cleared: 2002-07-12 ( 63 days)
• Product Code: FCG
• Regulation Number: 876.1075
• Type: Traditional
• Panel: Gastroenterology/Urology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

This device is a disposable biopsy needle and can be used in , CT, Mammographic Radiographic and Echographic procedures to obtain biopsies of various tissues including those from Prostate, Kidney, Breast and Liver using an automatic device.

Device Description

This device is a disposable biopsy needle

AI/ML Overview

This submission (K021525) is a Premarket Notification (510(k)) for the TOPCUT™ Cutting Biopsy Needle, indicating the device's substantial equivalence to a predicate device. However, the provided document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria.

The document primarily focuses on the administrative aspects of the 510(k) submission, including:

• Applicant and contact information.
• Device trade name, common name, and classification.
• Identification of a predicate device (MANAN Medical Products, Automatic Cutting Needle), implying that the new device is being compared to this existing, legally marketed device.
• The indication for use statement for the TOPCUT™ Biopsy Needle.
• FDA's determination of substantial equivalence and subsequent approval to market the device.

To provide the requested information about acceptance criteria and a study demonstrating compliance, the original 510(k) submission document or a more detailed technical file for K021525 would be needed. This type of information is typically found in the performance data section of a 510(k) submission, which is not present in the provided excerpt.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies based on the provided text.

Summary

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JUL 1 2 2002

Owner Operator #	8010312
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PREMARKET NOTIFICATION
SUBMISSION – 510 (k)

TOPCUT
510 (k) K021525

Data:	05-10-2002
Pag.	30 di 33

Page 1 of 1

510 (k) SUMMARY

Applicant	: H.S. Hospital Service S.p.A.Via Naro, 81 – 00040 Pomezia (Roma) Italy
Contact Person	: MMC International, LLCMr. Lucio Improta10147 Umberland Place – Boca Raton, FL 33428Tel. [phone] - Fax. [phone]e-mail : [e-mail]
Submission Date	: May 10-, 2002
Trade Name	: TOPCUT™ Cutting Biopsy Needle
Common Name	: Cutting Biopsy Needle
Classification Name	: 876.1075 - Biopsy instrument
Substantial Equivalence	: This product is identical to the following predicate device:
Company Name	Product Name	510(k) #
MANAN Medical Products	Automatic Cutting Needle

Indication for use :

Indicanon for use :
This biopsy device can be used in, CT, Manmographic and Echographic and Echographic I his blopsy device can be used in, Cry neasonaling those from Prostate, Kidney, Breast and Liver using an automatic device.

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Image /page/1/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads, each head facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

H.S. Hospital Service, S.p.A. % Mr. Lucio Improta President & CEO MMC International, LLC 10147 Umberland Place BOCA RATON FL 33428

JUL 1 2 2002

Re: K021525

Trade/Device Name: TOPCUT™ Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II

Product Code: 78 FCG Dated: May 10, 2002 Received: May 10, 2002

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 use 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 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. Ilisting 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 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 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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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 one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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Image /page/3/Picture/0 description: The image shows a logo with a series of horizontal lines underneath. Below the logo, the text "Owner Operator # 8010312" is visible. The logo itself appears to be a stylized design, possibly representing a company or organization.

PREMARKET NOTIFICATION SUBMISSION - 510 (k)

TOPCUT™ 510 (k) K021525 Data: 05-10-2002

Pag. 14 di 33

510 (k) # K021525

DEVICE NAME

TOPCUT™ Biopsy Needle

INDICATION FOR USE

This device is a disposable biopsy needle and can be used in , CT, Mammographic Radiographic and Echographic procedures to obtain biopsies of various tissues including those from Prostate, Kidney, Breast and Liver using an automatic device.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) OR Over-The-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K021525

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.