(170 days)
For use in laparoscopic minimally invasive surgical procedures to provide monopolar electrocautery capability to dissect and coagulate tissue.
The Family of Micro Electrode Instruments are intended for use in laparoscopic minimally invasive surgical procedures to provide monopolar electrocautery capability to dissect and coagulate tissue.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dielectric Insulation Test @ 3000V | Passed (100% sampling plan indicated successful testing) |
| Sterility Assurance Level (SAL) of $10^{-6}$ | Achieved after cleaning and sterilization (intended reuse) |
| Substantial Equivalence to Predicate Device | Deemed comparable in safety and effectiveness |
Study Information
Please note that this document is a summary of safety and effectiveness and primarily focuses on demonstrating substantial equivalence to a predicate device. It is not a detailed clinical trial report or a performance study with the metrics typically associated with AI/software device evaluations. Therefore, many of the requested fields below are not applicable or cannot be determined from the provided text.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: For the Dielectric Insulation Test, it states a "100% sampling plan." This implies all manufactured units (or a significant representative batch) were tested, but the exact number isn't specified.
- Data Provenance: Not applicable. The "test set" here refers to physical devices undergoing bench testing, not a dataset of medical images or patient records. The document is from the USA.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of this document, is established by adherence to engineering specifications and performance standards (e.g., dielectric breakdown at a certain voltage), not by expert consensus on medical findings.
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Adjudication method for the test set:
- Not applicable. The tests described are objective engineering measurements.
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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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical instrument, not an AI-powered diagnostic tool, so such a study would not be relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (surgical instrument), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the acceptance criteria consists of established engineering standards (e.g., dielectric strength) and the demonstrated performance of the predicate device. For sterility, it's a measurable SAL.
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The sample size for the training set:
- Not applicable. This device does not use an AI algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This device does not use an AI algorithm.
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ATTACHMENT E
PI-11
SUMMARY OF SAFETY AND EFFECTIVENESS MICRO ELECTRODE INSTRUMENTS NOV - 5 1997
The Summary of Safety and Effectiveness on Micro Elects data available and presented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
Intended Use
The Family of Micro Electrode Instruments are intended for use in laparoscopic minimally invasive surgical procedures to provide monopolar electrocautery capability to dissect and coagulate tissue.
Indications
The incorporation of monopolar electrocautery capability within the instrument provides for cutting and coagulating of intended target tissue sites.
Warning
Do not use any instrument that exhibits insulation degradation. Any damage of the insulation such as dents, scratches, cracking or splitting may allow electric current leakage and cause shock to the patient or doctor.
Caution
Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
Precaution
The user should take precautions to ensure that all minimally invasive components including laparoscope, endoscope, forceps, trocars and sleeves, electrocautery units, cables, and patient grounding plate are compatible and intended for minimally invasive surgery. It is imperative that all electrosurgical instruments be in contact with or next to the tissue or target prior to activation of the generator to eliminate the possibility of voltage/current seeking an exit through the insulation to the closet "ground". Activate generator only when instrument is in position.
Bench Test
Dielectric Insulation Test @ 3000V - 100% sampling plan.
Substantial Equivalency Information
The Family of Micro Electrode Instruments are similar to the Gynescope Electrodes
| - Gynescope Electrodes | Micro Electrodes | |
|---|---|---|
| Materials | Stainless SteelPolyvinylidene fluoride | Stainless SteelPolyvinylidene fluoride |
The Micro Electrodes are intended for reuse and following the Cleaning and Sterilization Instructions, sterilization will obtain a Sterility Assurance Level (SAL) of 106.
The intended use and technological characteristics of these devices do not vary significantly. The safety and effectiveness of the Family of Micro Electrodes are comparable to that of the Gynescope Electrodes.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 1997
Ms. Debra A. Pekar Manager of Quality Assurance and Regulatory Affairs CooperSurgical 15 Forest Parkway Shelton, Connecticut 06484
Re: K971838
Micro Electrodes Dated: October 6, 1997 Received: October 7, 1997 Regulatory class: II 21 CFR §884.4160/Product code: 85 KNF
Dear Ms. Pekar:
We have reviewed your Section 510(k) notification of intent to market the device 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (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 wititled, "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.
W.Liau Yu
Lillian Yiu, 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
Enclosure
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INTACHMENT
( )
Page ી
510(k) Number (if known): K971838
Device Name: Family of Micro Electrodes
Indications For Use:
For use in laparoscopic minimally invasive surgical procedures to provide monopolar electrocautery capability to dissect and coagulate tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) -
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Sitting/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971838
OR
Prescription Use
(Per 21 CFR 80 L.109)
Over-The-Counter Use
(Optional Formal 1-2-96)
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).