The Gyrus ACMI® HALO PKS Cutting Forceps is indicated for electrosurgical coagulation, mechanical cutting and grasping of tissue during the performance of laparoscopic and open general surgical procedures when used in conjunction with the Gyrus ACMI General Surgery Generator (G400).

Device Description

The Gyrus ACMI®HALO PKS Cutting Forceps is a bipolar electrosurgical device that may be utilized in minimally invasive surgery for general endoscopic use to grasp, coagulate, transect, dissect and retract tissue. The Gyrus ACMI® HALO PKS Cutting Forceps is a single use, sterile accessory, to be used in conjunction with the bipolar outputs of the Gyrus General Surgery Generator (G400).

The Gyrus ACMI®HALO PKS Cutting Forceps is a modification of the Gyrus Bipolar Cutting Forceps and includes hand switching capabilities and a redesigned handle based on human factors considerations. The device handle has been ergonomically redesigned with additional areas of soft polymer around the device where the user contacts it. Thumb tabs for advancing the blade that were present on the predicate have been replaced with a pistol like trigger for user comfort. The ratchet mechanism blade activation has been redesigned and the latch mechanism has been moved to a place that allows single hand use. The HALO Cutting Forceps includes new features including hand activation, and a mode switch (Select Button) on the handpiece that allows the user to select either of up to two devices attached to the G400 generator at any one time. Selection of either device is indicated by the illumination of a green LED on top of the handpiece showing that the device has been selected. The jaws are identical as those found on the predicate Gyrus Bipolar Cutting Forceps except that they are sclectively rotatable via a rotation wheel on the device which allows for rotation of the jaws about the device shaft.

AI/ML Overview

The provided 510(k) summary for the Gyrus ACMI® HALO PKS Cutting Forceps does not contain information about specific acceptance criteria, a detailed study proving performance against acceptance criteria, or most of the requested data points (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details). The document primarily states that performance testing was conducted to establish substantial equivalence to a predicate device.

Here's an analysis of what can be extracted and a clear indication of what is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Biocompatibility requirements	Complies with ISO 10993-1.
Sterility Assurance Level (SAL)	SAL of $10^{-6}$ and complies with ISO 11135-1.
Electrical Safety (IEC 60601-1)	Complies with IEC 60601-1.
Electrical Safety (IEC 60601-2-2)	Complies with IEC 60601-2-2.
Electromagnetic Compatibility (IEC 60601-1-2)	Complies with IEC 60601-1-2.
Functional Performance (non-clinical bench and preclinical testing)	Device performance is substantially equivalent to the predicate, and modifications raise no new issues of safety and effectiveness.
Intended Use	Same as predicate; electrosurgical coagulation, mechanical cutting, grasping of tissue during laparoscopic and open general surgical procedures when used with G400 generator.
Operating Principle	Same as predicate.
Radiofrequency Generator	Same as predicate (G400).
Patient Contacting Materials	Similar to predicate.
Packaging and Sterilization Processes	Same as predicate.
Distal End Design	Not changed from predicate.
Jaws	Identical to predicate (with added rotation).
Hand Activation (new feature)	Functionally successful (implied by substantial equivalence).
Mode Switch (new feature)	Functionally successful (implied by substantial equivalence).
Rotation of Jaws (new feature)	Functionally successful (implied by substantial equivalence).
User Comfort (redesigned handle)	Achieved (implied by human factors consideration and design change).

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document states "Performance testing was utilized to establish the performance characteristics... and preclinical testing" but no specific numbers are given for the test set size for any of the performance tests.
Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective, as the testing appears to be primarily bench and preclinical in nature rather than human clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable / Not Provided. The testing described is primarily engineering and performance verification (biocompatibility, sterility, electrical safety, functional bench testing). There's no indication of a "ground truth" requiring expert consensus in the context of diagnostic or interpretive tasks.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided. As there's no mention of a ground truth established by experts or human interpretation, adjudication methods are not relevant to the described tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe any MRMC comparative effectiveness study where human readers' performance with or without AI assistance was evaluated. The device is a surgical instrument, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not Applicable. The device is a surgical instrument with electrosurgical capabilities, not an algorithm, so a standalone algorithm performance study is not relevant here. The "algorithm" here would be the physical function of the device, which was tested through bench and preclinical studies.

7. Type of Ground Truth Used

For biocompatibility: Compliance with ISO 10993-1 standards and internal testing results.
For sterility: Compliance with ISO 11135-1 standards and internal testing results demonstrating SAL of $10^{-6}$.
For electrical safety/EMC: Compliance with IEC 60601 series standards and internal testing results.
For functional performance (cutting, coagulation, grasping, rotation, etc.): Comparison against the established performance of the predicate device and internal design specifications, likely using standardized test methods for electrosurgical devices (e.g., tissue impedance, cutting force, coagulation efficacy in ex-vivo or in-vivo models). The "ground truth" would be the expected functional outcome based on the predicate and design requirements.

8. Sample Size for the Training Set

Not Applicable / Not Provided. The device is not an AI/machine learning model, so there is no concept of a "training set" in the traditional sense. The development of the device would involve engineering design and iterative testing, not data-driven machine learning training.

9. How the Ground Truth for the Training Set Was Established

Not Applicable / Not Provided. As there is no training set, this question is not relevant.

Summary

{0}------------------------------------------------

KC100896

Gyrus ACMI®HALO PKS Cutting Forceps Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772

Special 510(k) Notification

...

: ..

.. i

510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. Gyrus ACMI® HALO PKS Cutting Forceps®

General Information

Manufacturer:

Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772-2104

Establishment Registration Number:

Contact Person:

Date Prepared: Device Description

Classification Name:

3003790304

Lorraine Calzetta Senior Regulatory Affairs Specialist

19 Apr 2010

Electrosurgical Cutting & Coagulation Device and Accessories (21 CFR 878.4400). Class II General& Restorative Surgery Panel

Trade Name:

Generic/Common Name:

Gyrus ACMI® HALO PKS Cutting Forceps®

Electrosurgical device for cutting and coagulation

Predicate Device

Gyrus Bipolar Cutting Forceps cleared under K023492 Gyrus General Surgery Generator cleared under K050550

Intended Uses

{1}------------------------------------------------

:・

Product Description

Comparison of Technological Characteristics of Device to Predicate Device

The Gyrus ACMI® HALO PKS Cutting Forceps is a single use, sterile accessory for use with the G400 Generator only, and is intended to provide the same performance as the predicate Gyrus Bipolar Cutting Forceps, but with the added utility of hand switching, rotation and attention given to user comfort The modified device and the currently marketed device share the same intended use, same operating principle, same radiofrequency generator (G400), similar patient contacting materials and same processes of packaging and sterilization. The distal end of the device has not changed. The jaws are identical as those found on the predicate Gyrus Bipolar Cutting Forceps, except that they are selectively rotatable via a rotation wheel on the device which allows for rotation of the jaws about the device shaft. The Gyrus ACMI® HALO PKS Cutting Forceps may be activated via the handpiece switch or footswitch, whereas the predicate could only be activated via a footswitch.

Summary of Performance data

Performance testing was utilized to establish the performance characteristics of the modifications of the device and determine substantial equivalence to the predicate. Performance testing includes biocompatibility testing, sterility testing, shelf life testing, design verification and validation (non-clinical bench testing and preclinical testing)

{2}------------------------------------------------

..............................................................................................................................................................................

The patient contact portions of the device have been evaluated for biocompatibility and comply with the requirements of ISO 10993-1.

The Gyrus ACMI® HALO PKS Cutting Forceps is a Single use, sterile device and has been tested to ensure a SAL of 10th and comply with the requirements of ISO 11135-1.

The device was tested to demonstrate compliance with the following electrical safety standards:

IEC 60601- Medical Electrical Equipment - Part 1: General Requirements for Safety.

IEC 60601-Medical Electrical Equipment - Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment.

IEC 60601 -- Medical Electrical Equipment Part 1-2: General Requirements for Safety: Electromagnetic Compatibility.

Non-clinical bench testing and preclinical performance testing show that the device performance is substantially equivalent to the predicate, and that the modifications raise no new issues of safety and effectiveness.

Summary of Safety and Effectiveness

The proposed modified Gyrus ACMI® HALO PKS Cutting Forceps®, as described in this submission, is substantially equivalent to the predicate device. The intended use and basic scientific technology of the device are not changed, nor is the intended user or distal end design. The proposed modifications in design do not significantly affect the safety or efficacy of the device.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Gyrus Acmi, Inc. % Ms. Lorraine Calzetta Senior Regulatory Affairs Specialist 136 Turnpike Road Southborough, Massachusetts 01772

JUN 1 7 2010

Re: K100896

Trade/Device Name: Gyrus ACMI® HALO PKS Cutting Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 18, 2010 Received: May 18, 2010

Dear Ms. Calzetta:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{4}------------------------------------------------

Page 2 - Ms. Lorraine Calzetta

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Gyrus ACMI® HALO PKS Cutting Forceps Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772

Special 510(k) Notification Intended Use Statement

...

Indications for Use

510(k) Number:

Device Name: Gyrus ACMI® HALO PKS Cutting Forceps

Indications for Use:

The Gyrus ACMI® HALO PKS Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting and grasping of tissue during the performance of laparoscopic and open general surgical procedures when used in conjunction with the Gyrus ACMI General Surgery Generator (G400).

Prescription Use: X = (Per 21 CFR 801.109)

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)

Vanderlyly

(Dision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100896

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.