ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT by GYRUS MEDICAL, INC.

Dissection, grasping, electrosurgical cutting, and electrosurgical coagulation to control bleeding of tissue during open surgical procedures and in general surgery.

Device Description

The device is a Class II medical device. The Zip Open Forceps with Electrosurgical Cut is a modification to the predicate device cleared under K000496. The Open Forceps is similar in construction and in component materials when compared to the predicate device. The indications for use are similar to the predicate devices cleared under K000496 and K904993. The device consists of grasping jaws connected to a handle. The handle has finger loops integrated into it to allow the physician to easily manipulate the device for grasping, dissection, electrosurgical coagulation and cutting. The overall length of the device is nine (9) inches. The device will be available in three distinct jaw configurations. The intended use of the device is to electrosurgically coagulate and cut tissue as well as to grasp and dissect tissue during the performance of open general surgical procedures. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices. 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. In addition, one jaw contains a second electrically isolated electrode element to effect electrosurgical cutting.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Zip Open Forceps with Electrosurgical Cut." This document is for a medical device that has been cleared by the FDA through the 510(k) pathway, which is a premarket notification demonstrating that the device is at least as safe and effective as a legally marketed predicate device. This pathway does not generally involve a study to "prove the device meets acceptance criteria" in the same way an AI/software device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device already on the market.

Therefore, many of the requested categories (acceptance criteria, reported performance, sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission as described in the provided text.

Here's an analysis based on the information provided, highlighting the non-applicability of certain criteria for this type of submission:

1. A table of acceptance criteria and the reported device performance

Not Applicable. The provided text is a 510(k) summary for a traditional medical instrument, not an AI or software device. The submission focuses on demonstrating "substantial equivalence" to a predicate device rather than meeting specific performance metrics against a defined acceptance criterion. The device's "performance" is implicitly tied to its ability to perform its stated indications for use (grasping, dissection, electrosurgical coagulation, and cutting) in a manner similar to existing devices.

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. As this is a traditional medical instrument submission focused on substantial equivalence, there is no mention of a "test set" in the context of evaluating an algorithm's performance with data. The assessment primarily involves comparing the design, materials, function, and indications for use against predicate devices.

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. There is no "ground truth" establishment for an algorithm's performance because this is not an AI/software device. The evaluation is based on engineering and design comparison, and potentially bench testing or animal studies if needed (though not explicitly detailed in this summary).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set or human adjudication process as described for AI/software is present here.

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 device, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is a physical electrosurgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. Refer to points 2 and 3. Ground truth as typically defined for AI validation is not a component of this type of submission.

8. The sample size for the training set

Not Applicable. There is no AI/software component, therefore no training set.

9. How the ground truth for the training set was established

Not Applicable. There is no AI/software component, therefore no training set and no associated ground truth establishment.

Summary relevant to the provided document:

The provided document describes a 510(k) premarket notification for a traditional electrosurgical instrument (Zip Open Forceps with Electrosurgical Cut). The device is a modification to a previously cleared predicate device (K000496) and shares similar construction, component materials, and indications for use.

The "study that proves the device meets the acceptance criteria" in this context is the demonstration of substantial equivalence to legally marketed predicate devices, as reviewed by the FDA. The submission argues that:

Design, materials of construction, function, and intended use are similar to predicate devices.
The device consists of grasping jaws connected to a handle with finger loops.
It operates with Bipolar Electrosurgical Energy, the same as predicate devices.
The jaws are electrically isolated from each other, with one acting as a return electrode.
One jaw contains a second electrically isolated electrode for electrosurgical cutting.
Intended Use: "Dissection, grasping, electrosurgical cutting, and electrosurgical coagulation to control bleeding of tissue during open surgical procedures and in general surgery." This is similar to the predicate devices cleared under K000496 and K904993.

The conclusion drawn by Gyrus Medical Inc. is that "no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent." The FDA's letter concurs with this determination, allowing the device to be marketed.

Therefore, for this specific device, the "acceptance criteria" are implicitly met by successfully demonstrating substantial equivalence to existing, legally marketed devices, as assessed during the 510(k) review process rather than through a separate, dedicated "perfomance study" with specific numerical acceptance criteria as would be typical for an AI device.

Summary

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JUL 1 3 2002

020585

G: 510(k) Summary

February 20, 2002

Company:	Gyrus Medical, Inc.6655Wedgwood RoadMaple Grove, MNTel. No. (763) 416-3000FAX. No. (763) 416-3070
Contact:	Frederick G. MadesRegulatory Affairs Manager
Common/Usual Name:	Electrosurgical Instruments
Classification Name:	Electrosurgical Cutting and Coagulation Device And Accessories(21 CFR 878.4400)
Proprietary Name:	Zip Open Forceps with Electrosurgical Cut

In conclusion, as the design, materials of construction, function and intended use of the Zip Open Forceps with Electrosurgical Cut 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 9 of 9

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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 consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2002

Mr. Frederick G. Mades Regulatory Affairs Manager Gyrus Medical, Inc. 6655Wedgwood Road Maple Grove, Minnesota 55311-3602

Re: K020585

Trade/Device Name: Zip Open Forceps with Electrosurgical Cut Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 11, 2002 Received: June 12, 2002

Dear Mr. Mades:

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 (OS) 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. Frederick G. Mades

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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.fida.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Stylet Rlurcha

Celia M. Witten, Ph.D., MD 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): K020585 ZIP Open Forceps with Electrosurgical Cut Device Name: Indications for Use:

Dissection, grasping, electrosurgical cutting, and electrosurgical coagulation to control bleeding of tissue during open surgical procedures and in general surgery.

Stupt Rhodes

(Division Sign-Off) Division of Gene 1, Restorative and Neurological Levices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

(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)

Regulation Number and Section

§ 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.