(251 days)
The generator is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in surgery.
The Gyrus General Purpose Electrosurgical Generator operates only in bipolar mode. It has controls for output waveform type and power. The unit has readouts for set power and waveform. There are two custom 9-way connectors on the front panel for PlasmaCision instruments and PlasmaKinetic bipolar instruments. The foot pedal is connected on the back panel. Accessories included with the generator are the disposable instruments, footswitch and a power cable.
The provided text describes a 510(k) premarket notification for the "Gyrus General Purpose Electrosurgical Generator System." This document is for a medical device and outlines its intended use and comparison to predicate devices, ultimately leading to an FDA determination of substantial equivalence.
However, the provided text does not contain any information regarding acceptance criteria or a specific study that proves the device meets acceptance criteria in the context of performance metrics (sensitivity, specificity, accuracy, etc.) typically associated with AI/software-as-a-medical-device (SaMD).
Instead, this document focuses on regulatory approval based on substantial equivalence to predicate devices. The "performance testing" mentioned is to validate the device's functional performance in line with these predicate devices, not typically a clinical study with detailed statistical outcomes for an AI algorithm.
Therefore, many of the requested items cannot be answered from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be answered from the provided text. The document states "Performance testing has been done to validate the performance of the device," but it does not provide specific acceptance criteria (e.g., minimum output power, waveform stability within a tolerance) or the numerical results of such testing. This type of detail is usually found in a separate performance test report, not in the summary document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be answered from the provided text. The document does not describe a "test set" in the context of data for an AI algorithm, nor does it mention sample sizes, data provenance, or whether any human data was used for performance evaluation beyond general "performance testing" of the hardware.
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)
- Cannot be answered from the provided text. There is no mention of experts establishing ground truth, as this is not a study evaluating an algorithmic output that requires such annotations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be answered from the provided text. Not relevant to this type of device submission.
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
- Cannot be answered from the provided text. No MRMC study is mentioned, nor is any AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be answered from the provided text. This device is an electrosurgical generator, which is hardware, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be answered from the provided text. Ground truth is not discussed in the context of an algorithmic evaluation. The ground truth for this device's performance would likely be engineering specifications and safety standards.
8. The sample size for the training set
- Cannot be answered from the provided text. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Cannot be answered from the provided text. Not applicable.
Summary of what is present:
- Device Name: Gyrus General Purpose Electrosurgical System (Generator & Accessories)
- Intended Use: The generator is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in surgery.
- Comparison Basis: Substantial equivalence to predicate devices: K041285 (Gyrus ENT G3 System), K031085 (Gyrus Superpulse® System), K002906 (Harmonic Scalpel®).
- Regulatory Status: 510(k) clearance, Class II medical device.
- Performance Claim: "Performance testing has been done to validate the performance of the device." (Details of this testing are absent from the provided text).
The provided text is a regulatory clearance document, not a detailed scientific study report on performance metrics for an AI/SaMD product.
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510(k) Pre-market Notification Gyrus General Purpose Electrosurgical Generator System
NOV - 9 2001
Page 1 of (2)
510(k) Su ffectiveness
Gyrus General Purpose Electrosurgical System (Generator & Accessories)
| Submitted by: | Gyrus Medical, Inc.6655 Wedgwood Road, Suite 160Maple Grove, MN 55311-3602 |
|---|---|
| Contact Person: | Mark A. JensenGroup Vice President RA/QA |
| Telephone:763 416 3005Facsimile:763 416 3070 | |
| Date Summary Prepared: | October 18, 2005 |
| Name of the Device: | |
| Proprietary Name: | Gyrus General Purpose Electrosurgical System |
| Project Name: | E07 General Purpose Electrosurgical Generator |
| Common/Usual Name: | Electrosurgical Generator and Accessories |
| Classification Name: | Electrosurgical Cutting & Coagulation Device andAccessories (per 21 CFR 878.4400) |
| Brand Name: | Not yet assigned |
| Predicate Devices: | K041285 (Gyrus ENT G3 System)K031085 (Gyrus Superpulse® System)K002906 (Harmonic Scalpel®) |
Description:
The Gyrus General Purpose Electrosurgical Generator operates only in bipolar mode. It has controls for output waveform type and power. The unit has readouts for set power and waveform.
There are two custom 9-way connectors on the front panel for PlasmaCision instruments and PlasmaKinetic bipolar instruments. The foot pedal is connected on the back panel.
Accessories included with the generator are the disposable instruments, footswitch and a power cable.
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510(k) Pre-market Notification
Gyrus General Purpose Electrosurgical Generator System
page 2 of (2)
Statement of Intended Use:
The generator is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in surgery.
Classification:
The Gyrus General Purpose Electrosurgical Generator is a Class II medical device.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Comparison to Predicate Devices:
The Gyrus General Purpose Electrosurgical Generator has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. Performance testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification demonstrate that the device is substantially equivalent to predicate devices and is safe and effective in its intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 9 2005
Mark Jensen Group Vice President RA/QA Gyrus Medical, Inc. 6655 Wedgwood Road, Suite 160 Maple Grove, Minnesota 55311-3602
Re: K050550
Trade/Device Name: Gyrus General Purpose Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 1, 2005 Received: November 1, 2005
Dear Mr. Jensen:
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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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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Axirbaye Buehmo
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
Gyrus General Purpose Electrosurgical Generator
The generator is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in surgery.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Page 1 of 1
barbare Buend
(Division Division of General, Restorative, and Neurological Devices
510(k) Number K050550
§ 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.