DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087

K061201 · United States Endoscopy Group, Inc. · FCK · May 30, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K061201
• Device Name: DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087
• Applicant: United States Endoscopy Group, Inc.
• Product Code: FCK · Gastroenterology, Urology
• Decision Date: May 30, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The dSnare Diminutive Polypectomy and Suction System is a non-diathermic device with a suction retrieval feature indicated for transendoscopic polypectomy and suction retrieval of lesions between 3mm and 7mm in size.

Device Story

The dSnare Diminutive Polypectomy and Suction System is a non-diathermic endoscopic instrument designed for the removal and retrieval of small polyps. The device is used by physicians during endoscopic procedures to perform polypectomy on lesions ranging from 3mm to 7mm. It integrates a snare mechanism for tissue excision with a suction retrieval feature to capture the excised lesion. By combining excision and retrieval into a single workflow, the device simplifies the procedure, potentially reducing procedural time and improving the efficiency of lesion removal for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-diathermic snare mechanism; integrated suction retrieval feature; designed for transendoscopic use; classified as a gastroenterology-urology biopsy instrument (21 CFR 876.1075, Product Code FCK).

Indications for Use

Indicated for transendoscopic polypectomy and suction retrieval of lesions 3mm to 7mm in size in patients undergoing endoscopic 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 3 0 2006

Mr. R. Michael Wolf Manager of Regulatory Affairs US Endoscopy Group, Inc. 5976 Heisley Road MENTOR OH 44060

Re: K061201

Trade/Device Name: dSnare™ Diminutive Polypectomy and Suction System Regulation Number: 21 CFR \$876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCK Dated: April 28, 2006 Received: May 1, 2006

Dear Mr. Wolf:

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 (Premarket Approval), 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.

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oling Public S

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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.

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

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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## Indications for Use

## 510(k) Number (if known): Y

Device Name: dSnare™ Diminutive Polypectomy and Suction System

Indications for Use:

The dSnare Diminutive Polypectomy and Suction System is a non-diathermic The dishare Dinance with a suction retrieval feature indicated for transendoscopic porfpectomy and suction retrieval of lesions between 3mm and 7mm in size.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Bergman

(Division Sign-Off) Division of Reproductive. Abdominal, and Radiological Devi 510(k) Number