(28 days)
The Gyrus Medical Inc. Open Forceps are intended for electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.
Electrosurgical Instruments
The provided document is a 510(k) summary for the Gyrus Medical Inc. Open Forceps, which is a regulatory submission to the FDA. It does not contain a study that proves the device meets specific acceptance criteria in the way one would expect for a diagnostic or AI-driven device.
This document is for an electrosurgical device and focuses on establishing substantial equivalence to a predicate device based on its intended use and general performance characteristics. It outlines the device's function (electrosurgical coagulation, mechanical grasping, dissection, and vessel sealing) and compares it to a previously cleared device (K024286).
Therefore, I cannot provide the requested information in the format of acceptance criteria and a study proving those criteria were met, as that information is not present in the provided text.
Here is what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly stated in the document. For an electrosurgical device like the Gyrus Medical Inc. Open Forceps, acceptance criteria would typically involve engineering specifications, safety standards (e.g., electrical safety, biocompatibility), and performance benchmarks (e.g., sealing strength, reliable coagulation). However, the 510(k) summary provided does not detail these specific criteria or report performance against them. It relies on the concept of "substantial equivalence" to a predicate device (K024286).
2. Sample size used for the test set and the data provenance:
Not applicable. The document does not describe specific clinical or technical studies with test sets in the context of accuracy, sensitivity, or specificity that would involve sample sizes or data provenance for a diagnostic device. Substantial equivalence for this type of device usually relies on design comparisons, bench testing, and potentially animal studies, but details of these are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth establishment for a test set is relevant for diagnostic devices that classify or measure a condition, requiring expert adjudication. This device is an electrosurgical instrument.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable.
8. The sample size for the training set:
Not applicable. This device does not have a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what the document does provide:
- Device Name: Gyrus Medical Inc. Open Forceps
- Intended Uses: Electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during open general surgical procedures.
- Predicate Device: Gyrus Medical Open Forceps (K024286)
- Regulatory Class: Class II (Electrosurgical cutting and coagulation device and accessories, 21 CFR 878.4400)
- Regulatory Mechanism: 510(k) Premarket Notification based on "substantial equivalence" to a legally marketed predicate device.
The 510(k) process for this type of device focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering comparisons and general performance characteristics rather than detailed clinical outcome studies with predefined acceptance criteria as would be seen for a new diagnostic or AI-powered medical device.
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Gyrus Medical Inc. Open Forceps ACMI Corporation 136 Turnpike Road Southborough, MA 01772
Special 510(k) Notification Summary of Safety and Effectiveness August 4, 2006
AUG 1 0 2006 510(k) Summary of Safety and Effectiveness ACMI Corporation Gyrus Medical Inc. Open Forceps
General Information
Manufacturer:
Gyrus Medical Inc. 6655 Wedgwood Rd. Maple Grove, MN 55311-3602
Establishment Registration Number:
510(k) Submitter:
MMMM
2183680
ACMI Corporation 136 Turnpike Rd. Southborough, MA 01772-2104
. .
Establishment Registration Number:
Contact Person:
Date Prepared:
Device Description
Classification Name:
3003790304
Terrence E. Sullivan Director, Regulatory Affairs
Gyrus Medical Open Forceps
Electrosurgical Instruments
August 4, 2006
Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400), Class II General and Plastic Surgery Panel
Generic/Common Name:
Predicate Device
Trade Name:
Gyrus Medical Open Forceps
Intended Uses
The Gyrus Medical Inc. Open Forceps are intended for electrosurgical coagalation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 2006
ACMI Corporation % Mr. Terrence E. Sullivan Director, Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts 01772-2104
Re: K061975
Trade/Device Name: Gyrus Medical Inc. Open Forceps Regulatory Number: 21 CFR 878.4400 Regulatory Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 28, 2006 Received: August 1, 2006
Dear Mr. Sullivan:
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 - Mr. Terrence E. Sullivan
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 (240) 276-0115. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hubert Remer
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Gyrus Medical Inc. Open Forceps ACMI Corporation 136 Turnpike Road Southborough, MA 01772
Special 510(k) Notification -Statement of Intended Use August 4, 2006
Device Name: Gyrus Medical Inc. Open Forceps
510(k) Number:
061975
Indications for use:
The Gyrus Medical Inc. Open Forceps are intended for electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: __ X __
OR Over-the-Counter Use: _
(Per 21 CFR 801.109)
Hulbert Leeman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061975
§ 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.