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

K122593 · Optim, LLC · FEH · Sep 13, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K122593
• Device Name: PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2
• Applicant: Optim, LLC
• Product Code: FEH · Gastroenterology, Urology
• Decision Date: Sep 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PRECISION Endoscopic Infrared Coagulator with single-use disposable MAXiguide flexible light guide is intended for treatment of hemorrhoids and other lesions in the colon and rectum when used as an accessory to a flexible colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.

Device Story

The Precision Endoscopic Infrared Coagulator is an electrosurgical accessory used with flexible endoscopes (colonoscopes/sigmoidoscopes) to coagulate blood and tissue. It treats hemorrhoids and small colorectal lesions. The device utilizes a single-use disposable Maxi-guide flexible lightguide to deliver infrared energy to the target site. Operated by a physician in a clinical setting, the device provides localized thermal coagulation to achieve hemostasis or tissue destruction. The healthcare provider visualizes the target tissue through the endoscope and applies the coagulator to the lesion. This process benefits patients by providing a minimally invasive method for managing hemorrhoids and small lesions, reducing the need for more invasive surgical procedures.

Clinical Evidence

Bench testing only. Verification testing was performed to confirm that design changes did not impact safety or effectiveness compared to the predicate device.

Technological Characteristics

Endoscopic electrosurgical accessory; infrared coagulation principle; single-use disposable flexible lightguide; intended for use with flexible gastrointestinal endoscopes. No software or complex electronic algorithms described.

Indications for Use

Indicated for the treatment of hemorrhoids and small lesions in the colon and rectum in patients requiring endoscopic intervention. Used as an accessory to flexible gastrointestinal endoscopes.

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.

Predicate Devices

• Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use disposable Maxi-guide Flexible Lightguide; Model 5100-2 (K083275)

Submission Summary (Full Text)

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K122593

#### 7.0 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirement of 21 CFR 807.92 Jeff Barrett CEO Optim LLC 64 Technology Park Rd., Sturbridge, MA 01566

Date Prepared: 17 Aug 12

Device Trade Name: Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use disposable Maxi-guide Flexible Lightguide; Model 5100-2

Device Classification Name: unit, electrosurgical, endoscopic (with or without accessories) Registration Number: 1218141

Regulation Number: 876.4300

Product Code: KNS

Classification: Class II

Review Panel: Gastroenterology / Urology

Predicate Device Information

Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use disposable Maxi-guide Flexible Lightguide; Model 5100-2 (K083275)

## Submission Device Description:

This device is designed to coagulate blood and tissue, specifically for treatment of hemorrhoids and small lesions in the colon and rectum, when used as an accessory to a flexible endoscope.

### Substantial Equivalence Summary

There are no technology differences between the predicate device and the submission device. There is no change in performance specifications between the two devices. This change is a design and labeling change that do not change the intended use or indications for use.

## Verification Testing

Verification testing results for the design changes were completed and all tests passed. Bench testing was performed to verify that the submission device is substantially equivalent to the predicate device and does not affect the safety and effectiveness of the device.

Conclusion: The submission device is substantially equivalent and as safe and effective as the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Jeff Barrett CEO Optim LLC 64 Technology Park Road STURBRIDGE MA 01566

SEP 13 2012

Re: K122593

Trade/Device Name: PRECISION Endoscopic Infrared Coagulator™ with SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE Regulation Number: 21 CFR& 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FEH Dated: August 17, 2012 Received: August 24, 2012

Dear Mr. Barrett:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-leated adverse events) (21 OFF 003), good if applicable, the electronic a forth in the quality 355cms (QS) roganism (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please IT you desire specific advice for your do need on our the contributions of the sources of the for go to map.//www.ida.gov/rtbound Drives/Health's (CDRH's) Office of Compliance. Also, please the Center for Devices and Radioregious courses to premarket notification" (21CFR Patt note the regulation onlined, "Misoraname of events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may obtain other general mormational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. Euker

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) number (if known): _ K | 22.59 3

Device name: PRECISION Endoscopic Infrared Coagulator™ with SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE

# Statement of Indication of Use

The PRECISION Endoscopic Infrared Coagulator with single-use disposable MAXiguide flexible light guide is intended for treatment of hemorrhoids and other lesions in the colon and القاب والا الا flexible sigmoidoscope, or other flexible gastrointestinal endoscope.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR . Over-The-Counter Use_ (Part 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)

Toni Martinez

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K122593

FDA 510(k) Page 18