TOPCUT

K021525 · H.S. Hospital Service S.R.L. · FCG · Jul 12, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K021525
• Device Name: TOPCUT
• Applicant: H.S. Hospital Service S.R.L.
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Jul 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

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 Story

TOPCUT™ is a disposable biopsy needle designed for use with automatic biopsy devices. It functions as a mechanical instrument to extract tissue samples from the prostate, kidney, breast, and liver. The device is utilized by clinicians during image-guided procedures, including CT, mammography, radiography, and ultrasound (echographic) imaging. By facilitating the collection of tissue samples, the needle assists healthcare providers in obtaining diagnostic specimens for clinical evaluation. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable biopsy needle for use with automatic biopsy devices. Mechanical design for tissue extraction. No software or electronic components.

Indications for Use

Indicated for patients requiring tissue biopsies of the prostate, kidney, breast, or liver. Used in conjunction with automatic biopsy devices during CT, mammographic, radiographic, or echographic procedures.

Regulatory Classification

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.

Predicate Devices

• MANAN Medical Products Automatic Cutting Needle

Submission Summary (Full Text)

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JUL 1 2 2002

| Owner Operator # | 8010312 |
|------------------|---------|
|------------------|---------|

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.<br>Via Naro, 81 – 00040 Pomezia (Roma) Italy | |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Contact Person | : MMC International, LLC<br>Mr. Lucio Improta<br>10147 Umberland Place – Boca Raton, FL 33428<br>Tel. [phone] - Fax. [phone]<br>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

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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.

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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