(20 days)
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.
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.
The provided text describes a 510(k) summary for the K122593 device. Based on this document, here's an analysis of the acceptance criteria and study information:
Key Takeaways:
- This 510(k) submission is for a device that is essentially identical to a previously cleared predicate device (K083275).
- The nature of the submission is a "design and labeling change" that does not alter intended use, indications for use, or performance specifications.
- Therefore, the primary study to demonstrate substantial equivalence was verification testing and bench testing to confirm that the changes did not negatively impact safety or effectiveness, essentially showing it still performs like the predicate. There were no clinical studies (e.g., studies involving human subjects, AI performance, or even animal studies) required or discussed for this specific 510(k).
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Substantial Equivalence to Predicate Device (K083275) | Bench testing performed to verify that the submission device is substantially equivalent to the predicate device. | The submission claims "no technology differences" and "no change in performance specifications." |
| Safety and Effectiveness not affected by design/labeling changes | All verification testing results for design changes passed. Bench testing confirmed changes do not affect safety and effectiveness. | This confirms the device performs as expected and similarly to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of clinical data. The "test set" here refers to the specific units or components of the device undergoing verification/bench testing. The document does not specify the number of units tested.
- Data Provenance: Not applicable for design verification and bench testing. These are laboratory-based tests performed by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The ground truth for this submission was based on engineering specifications and the functional performance of the device against established benchmarks (i.e., its predicate). No expert human readers or clinicians were involved in establishing "ground truth" for a test set in the traditional sense of a diagnostic device study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is an electrosurgical unit, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI algorithm; it's a medical device for coagulation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission was the established performance characteristics and safety profile of the legally marketed predicate device (K083275). The verification and bench testing aimed to prove the new device performs identically to the predicate and that the minor changes did not introduce new safety or effectiveness concerns.
8. The sample size for the training set
- Not applicable. No training set was used as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
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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
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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 (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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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
§ 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).