VACUUM ASSISTED CORE BIOPSY DEVICE

K034021 · Suros Surgical Systems, Inc. · KNW · Sep 8, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K034021
• Device Name: VACUUM ASSISTED CORE BIOPSY DEVICE
• Applicant: Suros Surgical Systems, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Sep 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

To obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, and callors on such organs as also earlier, of breast biopsy, the product is for diagnosis only.

Device Story

Vacuum-assisted spring-loaded core biopsy device; used for percutaneous tissue sampling. Device utilizes vacuum assistance and spring-loaded mechanism to extract core biopsy samples from soft tissue and tumors in organs including liver, spleen, kidney, prostate, and breast. Operated by clinicians in a clinical setting for diagnostic purposes only. Output is a tissue core sample for pathological evaluation. Benefits include minimally invasive acquisition of diagnostic tissue.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Vacuum-assisted spring-loaded core biopsy instrument. Classified as a gastroenterology-urology-biopsy instrument (21 CFR 876.1075). Mechanical actuation via spring-loading; vacuum-assisted tissue acquisition. Form factor designed for percutaneous use.

Indications for Use

Indicated for patients requiring percutaneous core biopsy for diagnostic purposes of soft tissue and tumors in organs including liver, spleen, kidney, prostate, and breast.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 2004

Mr. Joseph L. Mark Vice President Suros Surgical Systems, Inc. 9502 Angola Court, Suite 3 INDIANAPOLIS IN 46268

Re: K034021

Trade/Device Name: Vacuum Assisted Spring Loaded Core Biopsy Device Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: 78 KNW Dated: July 23, 2004 Received: August 19, 2004

Dear Mr. Mark:

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, 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 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marker of substantial equivalence of your device to a legally premarket nother 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 If you desire specific advice to your do too to the following numbers, based on the regulation number at the top of the 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 Additionally, 101 questions of the promote of the regulation entitled, "Misbranding Other of Compliance at (501) 59 < 1057.97) you may obtain. Other general by reference to premation (3) or at the Act may be obtained from the Division of Small information on your responsionalist and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Octass http://www.fda.gov/cdrl/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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Ko34021 510(k) Number (if known): _

Vacuum Assisted Spriñg Loaded Core Biopsy Device Device Name:

## Indications For Use:

To obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, and callors on such organs as also earlier, of breast biopsy, the product is for diagnosis only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel R. Lyons

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

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)