(42 days)
Electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
The device is a Class II medical device. The Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLLY Forceps is a modification to the predicate device cleared under K904993. The Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLLY Forceps is identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The forceps jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K90493. The intended use, Electrosurgical Coagulation, Grasping and Dissection, during surgical procedures is similar to the predicate devices cleared under K904993. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices.
The provided text is a 510(k) summary for the Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLLY Forceps. This document asserts substantial equivalence to a predicate device and does not involve a study to prove acceptance criteria in the manner you've described for AI/CADe devices.
The device is an electrosurgical instrument, not a diagnostic AI/CADe device. Therefore, the questions related to clinical study design, AI performance metrics, ground truth, and expert evaluation are not applicable to this 510(k) submission.
The core of this 510(k) submission is that the new device is "identical in construction (with the exception of shaft length) and in component materials" to a predicate device (K904993). The modification has not altered the fundamental technology or intended use.
Therefore, many of the requested fields cannot be filled. I will answer the applicable parts based on the type of device and submission.
1. A table of acceptance criteria and the reported device performance
For this type of device, acceptance criteria are typically met by demonstrating substantial equivalence to a predicate device through engineering design, material equivalence, and stated intended use. Performance in terms of accuracy metrics (sensitivity, specificity, etc.) as you would find for an AI/CADe system is not applicable here.
| Acceptance Criteria (Implied for medical device equivalence) | Reported Device Performance (as per 510(k) summary) |
|---|---|
| Material Equivalence: Identical component materials to predicate device. | The device is identical in component materials when compared to the predicate device. |
| Construction Equivalence: Identical construction to predicate device (allowing for minor, non-fundamental modifications). | The device is identical in construction (with the exception of shaft length) when compared to the predicate device. The modification has not altered the fundamental technology of the predicate device. |
| Intended Use Equivalence: Similar intended use to predicate device. | The intended use, Electrosurgical Coagulation, Grasping and Dissection, during surgical procedures is similar to the predicate devices. |
| Energy Source Equivalence: Same energy type as predicate device. | The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices. |
| Safety and Effectiveness: No new issues of safety and effectiveness are raised by the modifications. | Gyrus Medical Inc. believes that no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study assessing performance against a test set. This is a submission demonstrating substantial equivalence to a previously cleared device based on design and material comparisons.
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. No ground truth was established by experts for a test set in the context of an AI/CADe device study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This is not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/CADe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of electrosurgical instrument, "ground truth" typically refers to established engineering standards, biocompatibility testing (if new materials were introduced, which was not the case here), and functional testing to ensure the device performs its intended mechanical and electrical actions safely. These aspects are handled via internal testing and compliance with recognized standards, not clinical ground truth establishment as in diagnostic studies.
8. The sample size for the training set
Not applicable. This is not an AI/CADe device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/CADe device.
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F: 510(k) Summary
March 31, 2003
| Company: | Gyrus Medical, Inc.6655Wedgwood RoadMaple Grove, MNTel. No. (763) 416-3000FAX. No. (763) 416-3070 |
|---|---|
| Contact: | Mercedes BayaniDirector, Regulatory & Clinical Affairs |
| Common/Usual Name: | Electrosurgical Instruments |
| Classification Name: | Electrosurgical Cutting and Coagulation Device AndAccessories (21 CFR 878.4400) |
| Proprietary Name: | Everest Bipolar MACRO, MICRO & MOLLY Forceps andGyrus Bipolar MACRO, MICRO & MOLLY Forceps |
The device is a Class II medical device. The Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLLY Forceps is a modification to the predicate device cleared under K904993. The Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLLY Forceps is identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The forceps jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K90493. The intended use, Electrosurgical Coagulation, Grasping and Dissection, during surgical procedures is similar to the predicate devices cleared under K904993. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices.
In conclusion, as the design, materials of construction and intended use of the Modified Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLLY Forceps is similar to that of the predicate devices currently cleared, Gyrus Medical Inc. believes that no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent.
Page 10 of 10
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines forming the body and wings. The logo is black and white.
Public Health Service
MAY 1 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mercedes Bayani Director, Regulatory Affairs Gyrus Medical, Inc. 6655 Wedgwood Road Maple Grove, Minnesota 55311-3602
Re: K031078
Trade/Device Name: Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLL Y Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 31, 2003 Received: April 24, 2003
Dear Ms. Bayani:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.
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Page 2 - Ms. Mercedes Bayani
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Everest Bipolar MACRO,MICRO & MOLLY Forceps and Gyrus Device Name: Bipolar MACRO, MICRO, & MOLLY Forceps
Indications for Use:
Electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE) (Optional Format 3-10-98)
(Posted July 1, 1998)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K631678
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.