(53 days)
Not Found
No
The summary describes a device that uses infrared energy for coagulation and does not mention any AI or ML components, image processing, or data analysis that would typically indicate the presence of such technology.
Yes
The device is intended for the treatment of hemorrhoids and other lesions in the colon and rectum, indicating its therapeutic purpose of alleviating or curing medical conditions.
No
Explanation: The device is intended for treatment (coagulation of blood and tissue) and explicitly states its use for treatment of hemorrhoids and other lesions, rather than for diagnosis.
No
The device description explicitly mentions hardware components ("PRECISION Endoscopic Infrared Coagulator with single-use disposable MAXiguide flexible light guide") and its function involves the transmission of infrared energy, indicating a physical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of hemorrhoids and other lesions by transmitting infrared energy. This is a therapeutic intervention performed directly on the patient's tissue.
- Device Description: The description reinforces the therapeutic nature, stating it's designed to coagulate blood and tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is used to directly treat a condition within the body.
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 by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.
Product codes (comma separated list FDA assigned to the subject device)
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)
Bench testing was performed to verify that the submission device is substantially equivalent to the predicate devices 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).
0
K 130489 102
PR 1 9 2013
Image /page/0/Picture/1 description: The image shows the logo for Optim LLC, which is a company. The logo is black and white and features the company name in a bold, sans-serif font. Below the company name is the text "A Juno Company" in a smaller font. The logo is simple and professional.
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 April 2013
Device Trade Name: Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use disposable Maxi-guide Flexible Lightguide; Model 5100-2
Device Classification Name: Electrode, Flexible Suction Coagulator Registration Number: 1218141 Regulation Number: 876.4300 Product Code: FEH 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 (K122593); Precision Endoscopic Technologies, Inc.
- Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use disposable Maxi-guide . Flexible Lightguide; Model 5100-2 (K083275); MAX Endoscopy, Inc.
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.
Statement of 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 by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.
Substantial Equivalence Summary
There are no technology differences between the predicate devices and the submission device. This change is a design and labeling change to address customer needs. There are no changes to the intended use or indications for use. The purpose of the devices is to provide infrared energy to coagulate blood and tissue. The predicate devices and the submission device deliver infrared energy from a lamp using a light guide for treatment of hemorrhoids and small lesions in the colon and rectum.
1
K130489 20/2
Image /page/1/Picture/1 description: The image shows the word "Optim" in bold, black font. To the right and slightly above the "m" is the superscript "LLC". Below the word "Optim" is the phrase "A Juno Company" in a smaller, less bold font. The text is all black against a white background.
Non Clinical 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 devices 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 devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 19, 2013
Optim, LLC % Mr. Jeff Barrett CEO 64 Technology Park Road STURBRIDGE MA 01566
Re: K130489
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: April 10, 2013 Received: April 16, 2013
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.
3
Page 2 - Mr. Jeff Barrett
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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 Division of Small Manufacturers, International 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 R. Fisher -S
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
4
Image /page/4/Picture/0 description: The image shows the logo for Optim LLC. The logo is in black and white and features the word "Optim" in a bold, sans-serif font. The letters are closely spaced together, and the "m" is slightly taller than the other letters. Below the word "Optim" is the phrase "A Juno Company" in a smaller font. To the right of the "m" is the letters "LLC" in a smaller font and stacked on top of each other.
Indications for Use
510(k) number (if known): K130489
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 rectum by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.
Prescription Use_ ਮ (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)
Benjamin 2013.04.19
FDA 510(k) Page 17