INJECTOR NEEDLE/SNARE

K040961 · United States Endoscopy Group, Inc. · FDI · Jul 8, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040961
• Device Name: INJECTOR NEEDLE/SNARE
• Applicant: United States Endoscopy Group, Inc.
• Product Code: FDI · Gastroenterology, Urology
• Decision Date: Jul 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The dual lumen Injector Needle Share is indicated for use with an Olympus or Microvasive active cord for the injection of media for submucosal lift of polyps or other mucosal lesions, using direct visualization, through a flexible endoscope, prior to electrosurgical excision and for the infusion of fluid for clearing away the field of view, applying dye spray, clot removal, injection of hemostatic agents to control post-polypectomy bleeding, and tattooing of sites for future surgical purposes.

Device Story

Dual lumen Injector Needle Share; used with flexible endoscope and Olympus or Microvasive active cord; enables submucosal injection for polyp lift, fluid infusion for field clearing, dye spray, clot removal, hemostatic agent delivery, and site tattooing. Operated by physicians in clinical settings. Device facilitates electrosurgical excision and diagnostic/therapeutic endoscopic interventions; improves visualization and procedural control.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual lumen design; compatible with flexible endoscopes and specific active cords (Olympus/Microvasive). Mechanical injection/infusion device.

Indications for Use

Indicated for use in patients undergoing endoscopic procedures requiring submucosal lift of polyps/lesions, field clearing, dye spraying, clot removal, hemostatic agent injection, or site tattooing via flexible endoscope.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Submission Summary (Full Text)

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JUL - 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Gretchen Y. Cohen Executive Vice President United States Endoscopy Group, Inc. 5976 Heisley Road MENTOR OH 44060

Re: K040961

:

Trade/Device Name: Endoscopic Injection Needle/Snare, Models # 00711086 and 00711088 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Code: 78 FBK Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Product Code: 78 FDI Regulatory Class: II Dated: June 11, 2004 Received: June 14, 2004

Dear Ms. Cohen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave a rowe 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 for associated in the enactment date of 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, de rios that have ocen t tequire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r va may , aron's 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 your de 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr rass made a over regulations administered by other Federal agencies. You must of any I ederal statutes and regulations, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Party) noceming (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 5 (d(k) This letter will allow you to begin harreting, your and equivalence of your device to a legally premarket notification. The FDA inding, in basical on for your device and thus, pennits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Park (1), please If you desire specific advice for your decided on on the following numbers, based on the regulation number at the top of the letter.

| 8xx. Ixxx | [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, for questions on the promotion and enote the regulation entitled, "Mastranding
Office of Compliance at [phone]. Also, please note the international with Othice of Compliance at [phone]. Fab., promote of a production of Since by reference to premarked nouncation (21 ce Fee Act may be obtained from the Division of Small
information on your responsibilities under the Act may be of Small Case and P information on your responsionalites and consumer Assistance at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance in Assistances in Manufacturers, International and Collsamer Passential Passerial Statis [phone] or at its Internet

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): K040961

## Device Name: Injector Needle Share

## Indications for Use:

The dual lumen Injector Needle Share is indicated for use with an Olympus or Microvasive active cord for the injection of media for submucosal lift of polyps or other mucosal lesions, using direct visualization, through a flexible endoscope, prior to electrosurgical excision and for the infusion of fluid for clearing away the field of view, applying dye spray, clot removal, injection of hemostatic agents to control post-polypectomy bleeding, and tattooing of sites for future surgical purposes.

Prescription Use (Part 21 CFR 801 Subpart D)

David h. Sepsom

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