(20 days)
Not Found
No
The summary describes a device for infrared coagulation and does not mention any AI or ML components or functionalities.
Yes
The device is described as treating hemorrhoids and other lesions, which are therapeutic actions.
No
The device is described as a coagulator intended for treatment, not for diagnosing conditions.
No
The device description explicitly mentions "PRECISION Endoscopic Infrared Coagulator with single-use disposable MAXiguide flexible light guide" and describes it as designed to "coagulate blood and tissue," indicating a physical device with hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is used directly on the patient's body (in the colon and rectum) to treat lesions and coagulate tissue. It is a therapeutic device, not a diagnostic one that analyzes samples.
The description clearly states its intended use is for "treatment of hemorrhoids and other lesions" and to "coagulate blood and tissue." This is a direct intervention on the patient, not an analysis of a biological sample.
N/A
Intended Use / Indications for 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 endoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.
Product codes (comma separated list FDA assigned to the subject device)
KNS, FEH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
colon and rectum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
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.
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).
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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
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
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
2
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 (800) 638-2041 or (301) 796-7100 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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Image /page/3/Picture/0 description: The image shows the logo for Optim LLC. The logo consists of the word "Optim" in a bold, sans-serif font, with the letters slightly overlapping. To the right of the "m" and slightly above, the letters "LLC" are written in a smaller font. Below the word "Optim", the phrase "A Jone Company" is written in a smaller, lighter font.
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