PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2

K083275 · Max Endoscopy, Inc. · KNS · Jun 9, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K083275
• Device Name: PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2
• Applicant: Max Endoscopy, Inc.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Jun 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PRECISION Endoscopic Infrared Coagulator (model 5100) with single-use disposable MAXi-guide flexible light guide (model 5100-240-3.2) is intended for treatment of hemorrhoids by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.

Device Story

The PRECISION Endoscopic Infrared Coagulator (Model 5100) is a medical device designed for the treatment of hemorrhoids. It functions by transmitting infrared energy to the target tissue. The system utilizes a single-use disposable MAXi-guide flexible light guide (Model 5100-240-3.2) as an accessory to standard flexible gastrointestinal endoscopes, such as colonoscopes or flexible sigmoidoscopes. The device is operated by a clinician in a clinical setting. By delivering controlled infrared energy, the device facilitates coagulation of hemorrhoidal tissue, providing a therapeutic benefit to the patient. The clinician uses the endoscope to visualize the treatment site and guides the light guide to the hemorrhoid to apply the energy.

Clinical Evidence

bench testing only

Technological Characteristics

The device consists of an infrared coagulator unit (Model 5100) and a single-use disposable flexible light guide (Model 5100-240-3.2). It operates as an accessory to flexible gastrointestinal endoscopes. The system utilizes infrared energy for tissue coagulation. It is classified under 21 CFR 876.4300 (Product Code: KNS).

Indications for Use

Indicated for the treatment of hemorrhoids in patients requiring endoscopic intervention. Used as an accessory to flexible gastrointestinal endoscopes (colonoscopes, sigmoidoscopes).

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The text is centered on the image. There is a logo to the left of the text.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN - 9 2009

R. Michael Wolf Executive Vice President MAX Endoscopy 1410 Highland Road, Suite 6 MACEDONIA OH 44056

Re: K083275

Trade/Device Name: - PRECISION Endoscopic-Infrared-Coagulator™-(Model 5100) Single-Use Disposable MAXi-guide Flexible Light Guide (Model 5100-240-3.2)

Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: May 15, 2009

Received: June 2, 2009

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

{2}------------------------------------------------

# Indications for Use

#### 510(k) Number (if known): K083275

Device Name:

PRECISION Endoscopic Infrared Coagulator™ (Model 5100) Single-Use Disposable MAXi-guide Flexible Light Guide (Model 5100-240-3.2)

#### Indications for Use:

The PRECISION Endoscopic Infrared Coagulator (model 5100) with single-use disposable MAXi-guide flexible light guide (model 5100-240-3.2) is intended for treatment of hemorrhoids by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.

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)

(Division Sign Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K083275