The Gyrus ACMI Inc. PKS Omni Instrument is intended for electrosurgical coagulation, mechanical grasping, and dissection of tissue, and sealing of vessels up to 3mm, during the performance of laparoscopic and general (open) surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation.

Device Description

The PKS Omni Instrument is a single-use device with a classic laparoscopic so layout, with a 5mm shaft available in several lengths from 15 to 45cm, supporting symmetrically opening steel jaws. These are curved in a manner similar to Maryland forceps and other laparoscopic graspers, and contain bipolar electrosurgical elements that allow coagulation, cutting and vessel sealing. It is intended for use with the Gyrus ACMI G400 workstation

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Gyrus ACMI Inc. PKS Omni Instrument. This is for an electrosurgical device, and the information provided focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study with detailed performance metrics against acceptance criteria. Therefore, most of the requested information (acceptance criteria table, sample sizes, expert details, adjudication, MRMC study, standalone performance, ground truth types, training set details) is not available in the provided text.

Here's a summary of what can be extracted based on the nature of a 510(k) submission for this type of device:

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

This information is not provided in a traditional clinical study format. For electrosurgical devices, acceptance criteria are generally established through bench testing (e.g., burst pressure for vessel sealing, energy delivery consistency, mechanical strength, biocompatibility), and performance is demonstrated against these engineering specifications. The 510(k) summary focuses on "substantial equivalence" to predicate devices rather than direct clinical performance metrics.

2. Sample size used for the test set and the data provenance:

Not applicable in the context of this 510(k) summary. This submission doesn't describe a clinical "test set" in the way one would for an AI/diagnostic device. Performance is typically established through bench validation, and for a 510(k), this involves comparing the new device's technical characteristics to those of predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is not an AI/diagnostic tool requiring expert-established ground truth for a test set. Its safety and effectiveness are established through engineering and performance testing.

4. Adjudication method 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 an electrosurgical instrument, not an AI-assisted diagnostic tool.

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

Not applicable.

7. The type of ground truth used:

For this type of device, "ground truth" would relate to validated engineering specifications and performance benchmarks (e.g., vessel sealing strength measured in ex vivo tissues, cutting efficiency, heat dissipation, biocompatibility testing results). The document does not detail these specific "ground truths."

8. The sample size for the training set:

Not applicable. This device is not an AI system that undergoes "training."

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

Not applicable.

Summary based on the provided document:

The 510(k) notification for the Gyrus ACMI Inc. PKS Omni Instrument focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This is a common pathway for medical devices that are similar in intended use, technological characteristics, and principles of operation to devices already on the market.

The key arguments for substantial equivalence are:

Intended Use: The device is intended for electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 3mm, in laparoscopic and general (open) surgical procedures, used with the Gyrus ACMI G400 workstation. This intended use is stated to be similar to the predicate devices.
Technological Characteristics: The device is described as a single-use device with a classic laparoscopic layout, 5mm shaft, symmetrically opening steel jaws, and bipolar electrosurgical elements for coagulation, cutting, and vessel sealing. It utilizes Gyrus's PlasmaKinetic (PK) technology, relying on simultaneous contact of both active and return electrodes with tissue.
Principles of Operation: The device induces cutting or coagulating/sealing tissue effects when the applicable generator mode is actuated, similar to its predicate devices.
Materials: Constructed of similar materials as other Gyrus ACMI electrosurgical devices.

The document explicitly states: "The Gyrus ACMI Inc. PKS Omni Instrument, as described in this submission, is substantially equivalent to the predicates in intended use, principles of operation and fundamental scientific technology and raises no new issues of safety and effectiveness."

Predicate Devices cited:

Gyrus Medical Inc. Zip Wing Cutting Dissector (K023493)
Gyrus Medical Open Forceps (K024286)
Gyrus Medical Plasma Seal (K061975)
Gyrus Medical Plasmacision and Plasmablend Electrodes (K050460)
Valleylab Ligasure Sealing System/ Ligasure V (K031011)
Gyrus General Purpose Electrosurgical Generator (K050550)

The FDA's decision letter confirms that the device is "substantially equivalent" to the referenced predicate devices, allowing it to be marketed. This regulatory pathway does not typically involve the type of clinical performance studies with detailed acceptance criteria, sample sizes, and ground truth establishment that would be associated with novel diagnostic algorithms or AI devices. Performance is inferred through similarity to devices already proven safe and effective.

Summary

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

Gyrus ACMI Inc. PKS Omni Instrument Gyrus ACMI Inc 136 Turnpike Road Southborough, MA 01772

8 1746

Traditional 510(k) Notification Summary of Safety and Effectiveness June 12, 2008

510(k) Summary of Safety and Effectiveness Gyrus ACMI Incorporated Gyrus ACMI Inc. PKS Omni Instrument

Page 1 of 2

AUG - 8 2008

General Information

Manufacturer:

Southborough, MA 01772-2104

Contact Person:

Date Prepared:

Device Description

Classification Name:

Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400), Class II General and Plastic Surgery Panel

Trade Name:

Gyrus ACMI Inc. PKS Omni Instrument

Generic/Common Name:

Electrosurgical Instruments

Gyrus ACMI Incorporated

136 Turnpike Rd.

Lorraine Calzetta

June 12, 2008

Predicate Device

Gyrus Medical Inc. Zip Wing Cutting Dissector K023493 Gyrus Medical Open Forceps K024286 Gyrus Medical Plasma Seal K061975 Gyrus Medical Plasmacision and Plasmablend Electrodes K050460 Valleylab Ligasure Sealing System/ Ligasure V K031011 Gyrus General Purpose Electrosurgical Generator K050550

Intended Uses

The Gyrus ACMI Inc.PKS Omni Instrument is intended for electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 3mm, during the performance of laparoscopic and general (open) surgical procedures. It is intended for use with the Gyrus ACMI G400 workstation cleared under K050550.

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

Gyrus ACMI Inc. PKS Omni Instrument Gyrus ACMI Inc 136 Turnpike Road Southborough, MA 01772

K081766

Traditional 510(k) Notification Summary of Safety and Effectiveness June 12, 2008

Device Description

Page 2 of 2

Technological Characteristics and Substantial Equivalence

Like the predicate Zip Wing cleared under K023493, the upper and lower jaws contain the electrical elements that when placed at the desired tissue site, induce the cutting or coagulating/sealing tissue effect as the applicable generator mode is actuated.

The device is a refinement of already proven existing technology, Gyrus's PlasmaKinetic (PK) technology developed for dry field surgery (K050460). It relies upon simultaneous contact of both active and return electrodes of the bipolar device with the tissue. Other Gyrus devices use this principle in two modes to achieve cutting and coagulation effects. The Device is constructed of similar materials as other Gyrus ACMI electrosurgical devices.

The PKS Omni is intended to offer cutting and coagulation using bipolar electrosurgical energy application in a manner similar to other devices on the market (such as Gyrus ACMI Open Forceps (K024286,) and Valley Lab Ligasure V (K031011) for coagulation of vessels, and Plasmacision electrodes (K050460) for bipolar cutting and surface coagulation of tissue).

Summary of Safety and Effectiveness

The Gyrus ACMI Inc. PKS Omni Instrument, as described in this submission, is substantially equivalent to the predicates in intended use, principles of operation and fundamental scientific technology and raises no new issues of safety and effectiveness.

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

Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text component and an abstract symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The symbol itself is an abstract representation, possibly of a stylized eagle or a similar bird-like form.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K081766

Trade/Device Name: Gyrus ACMI Inc. PKS Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 12, 2008 Received: June 20, 2008

AUG - 8 2008

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.

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.

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

Page 2 - Ms. Lorraine Calzetta

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

Mark N. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Traditional 510(k) Notification Statement of Intended Use June 12, 2008

Device Name: Gyrus ACMI Inc. PKS Omni Instrument

510(k) Number:

081766

Indications for use:

Prescription Use: X

OR Over-the-Counter Use:

(Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sign Off

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number 1081261

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.