(20 days)
The Endolap Resectoscope Cutting Loop Device is a momopolar electrode designed to deliver radiofrequency energy that is supplied by and electrical generator cleared for medical use. The Endolap Resectoscope Cutting Loop device is inicated for ablation and coagulation of the soft tissue and is intlended for use with compatlible resectoscopes,
Resectoscope Cutting Loop
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "ENDOlap™ Resectoscope Cutting Loop Electrode". This document, like many 510(k) clearances from 1997, does not contain detailed information about specific performance studies, acceptance criteria, or the methodology usually associated with contemporary AI/ML device evaluations.
Therefore,Based on the provided document, I cannot answer the question as it pertains to acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from 1997, which focuses on substantial equivalence to a predicate device rather than detailed performance study results that would typically include acceptance criteria, sample sizes, ground truth establishment, or AI/ML specific details like MRMC studies or standalone algorithm performance.
Here's why each specific point cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: The letter states the device is "substantially equivalent" to predicate devices, but it does not specify any quantitative acceptance criteria or report performance metrics (e.g., accuracy, sensitivity, specificity, or device-specific functional parameters) from studies.
- Sample sized used for the test set and the data provenance: There is no mention of a test set, its sample size, or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment and expert involvement are not discussed.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Adjudication methods are not mentioned.
- 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: This is a pre-AI/ML era device. No MRMC study or AI-assisted performance is mentioned.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: As this is not an AI/ML device, a standalone algorithm performance study is not applicable and not mentioned.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth type is specified.
- The sample size for the training set: There is no mention of a training set as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as there's no training set for an AI/ML model.
In summary, the provided document is a regulatory approval letter based on substantial equivalence, not a detailed technical report of a device performance study with specific criteria and results.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 1997
Mr. L. A. Tony Gilstrap Chief Operating Officer ENDOlap™, Inc. 3012 Mercy Drive Orlando, Florida 32808 Re: K974516
ENDOlap™ Resectoscope Cutting Loop Electrode Dated: November 15, 1997 Received: December 2, 1997 Regulatory class: II 21 CFR §876.4300/Product code: 78 FAS 21 CFR §876.1500/Product code: 78 FDC
Dear Mr. Gilstrap:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Yu, Ph.D.
Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) NUMBER (IF KNOWN): K974516
DEVICE NAME: Resectoscope Cutting Loop
INDICATIONS FOR USE:
The Endolap Resectoscope Cutting Loop Device is a momopolar electrode designed to deliver radiofrequency energy that is supplied by and electrical generator cleared for medical use. The Endolap Resectoscope Cutting Loop device is inicated for ablation and coagulation of the soft tissue and is intlended for use with compatlible resectoscopes,
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over - The - Counter - Use (Optional Format 1-2-96)
Robert Ratliff
OR
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 97415 16 510(k) Number .
§ 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).