K Number
K083275
Device Name
PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2
Manufacturer
Date Cleared
2009-06-09

(215 days)

Product Code
Regulation Number
876.4300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
Not Found
More Information

Not Found

Not Found

No
The summary describes a device that uses infrared energy for treatment and does not mention any AI or ML capabilities.

Yes
The device is intended for the "treatment of hemorrhoids," which qualifies it as a therapeutic device.

No
The device is described as an Endoscopic Infrared Coagulator intended for the treatment of hemorrhoids by transmitting infrared energy. Its purpose is therapeutic, not diagnostic.

No

The device is described as an "Endoscopic Infrared Coagulator" with a "flexible light guide," which are physical hardware components used for treatment. The description does not indicate it is solely software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is used for the treatment of hemorrhoids by transmitting infrared energy. This is a therapeutic intervention performed directly on the patient's tissue.
  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used for diagnosis, monitoring, or screening.

This device is a therapeutic device used for a medical procedure, not a diagnostic test performed on a sample.

N/A

Intended Use / 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.

Product codes

KNS

Device Description

Not Found

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
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.(b)
Classification. Class II (performance standards).

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)(240) 276-0115
21 CFR 884.xxx(Obstetrics/Gynecology)(240) 276-0115
21 CFR 892.xxx(Radiology)(240) 276-0120
Other(240) 276-0100

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 (800) 638-2041 or (240) 276-3150 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