The Bipolar Generator section of the G3 RF Workstation and accessories are indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery including:
• Adenoidectomy
• Cysts
• Head, Neck, Oral, and Sinus Surgery
• Mastoidectomy
• Myringotomy with effective Hemorrhage Control
• Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
• Nasopharyngeal / Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
• Neck Dissection (Radical and Modified Neck Dissection)
• Neck Mass
• Papilloma Keloids
• Submucosal Palatal Shrinkage
• Tonsillectomy
• Traditional Uvulopalatoplasty (RAUP)
• Tumors
• Tissue in the Uvula/Soft Palate for the Treatment of Snoring
• Uvulopalatopharyngoplasty (UPPP)
• Parotidectomy

The Gyrus ACMI Dissector Plasma Knife is indicated for resection and coagulation of soft tissue and hemostasis of blood vessels in head and neck surgery including Neck Dissection, (Radical and Modified Neck Dissection), Tonsillectomy, Parotidectorny and UPPP when used with the bipolar generator section of the G3 Workstation.

Device Description

The Gyrus ACMI® G3 Generator is an electrosurgical generator containing five key components: A dual output electrosurgical generator; Monopolar output side Bipolar output side Disposables; Monopolar electrodes (TCRF) Bipolar PlasmaCision Electrodes -Connector Cables Monopolar return pad; and Footswitch.

The Gyrus G3 System Generator has two principal modes of operation dependant on which type of electrode is attached - The monopolar mode has controls for maximum temperature and has readouts for total energy delivered, impedance, temperature and time of energy delivery. - The bipolar mode has controls for output for two thermocouples and power. The unit has readouts for set power and waveform type and power. Connectors on the front panel include a monopolar connector for active electrode and dispersive electrode and connectors for PlasmaCision electrodes and bipolar instruments. The device is operated by a foot pedal, connected on the back panel.

The Dissector Plasma Knife is a single use disposable bipolar instrument designed for use with the G3 generator within an ambient air environment. The instrument incorporates a suction channel which the SS generates which of fluids and gases during operative procedures when connected to an appropriate suction facility.

AI/ML Overview

The provided text is a 510(k) summary for the Gyrus ACMI G3 Generator and Accessories - Dissector Plasma Knife. It describes the device, its intended uses, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or specific studies proving the device meets acceptance criteria in the way typically expected for performance claims (e.g., sensitivity, specificity, accuracy, or functional metrics with numeric thresholds).

Instead, this document focuses on substantial equivalence to an existing predicate device (Gyrus ACMI G3 Generator and Accessories - Dissector Plasma Knife K041285). The core argument is that "The Gyrus ACMI® G3 Generator and Accessories - Dissector Plasma Knife are identical to the identical features of the predicate. There are no changes to the design of the generator or instrument pursuant to this submission. Therefore In summary, the Gyrus ACMI is substantially equivalent to the predicate device and presents no new questions of safety or efficacy."

Therefore, for your request, I must conclude that the provided text does not offer the detailed information you are seeking regarding acceptance criteria and performance studies.

Here's a breakdown of why this information is missing based on your template:

1. Table of acceptance criteria and reported device performance:

Missing. The document claims identity to a predicate device, implying that its performance is implicitly accepted as equivalent to the predicate. No specific performance metrics or acceptance criteria are stated.

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

Missing. No new testing or clinical data is presented for this 510(k) submission, as it relies on substantial equivalence to a previous device.

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

Missing. Not applicable, as no new test set or ground truth establishment is described.

4. Adjudication method for the test set:

Missing. Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Missing. Not applicable. This device is an electrosurgical tool, not an AI-assisted diagnostic or interpretive device.

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

Missing. Not applicable. This is not an algorithmic device.

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

Missing. Not applicable.

8. The sample size for the training set:

Missing. Not applicable.

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

Missing. Not applicable.

In summary: The provided 510(k) notification states the new device is substantially equivalent to a previously cleared predicate device because there are "no changes to the design of the generator or instrument." This type of submission relies on the prior clearance of the predicate device and does not typically require new performance studies or the establishment of new acceptance criteria for the current submission when the device is identical.

Summary

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Gyrus ACMI G3Generator- Dissector Plasma Knife Gyrus ACMI Inc. 136 Turnpike Road Southborough, MA 01772

KO80844

Page 1 of 2

510(k) Summary of Safcty and Effectiveness Gyrus ACMI Inc. Gyrus ACMI G3 Generator and Accessories - Dissector Plasma Knife

General Information

AUG 1 3 2009

Manufacturer:

Contact Person:

Date Prepared:

Device Description

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

Lorraine Calzetta Regulatory Affairs Tel. #: 508-804-2752 Fax #: 508-804-2624

Dissector Plasma Knife

devices and accessories

March 18, 2008

Classification Name: Electrosurgical cutting and coagulation devices and accessories (21CFR 878.4400, Class II)

Gyrus ACMI G3 Generator and Accessories

Electrosurgical cutting and coagulation

Trade Name:

Generic/Common Name:

including Tracheal Procedures, Laryngeal

Predicate Devices

Gyrus ACMI G3 Generator and Accessories - Dissector Plasma Knife K041285

Intended Uses

Adenoidectomy	Papilloma Keloids
Cysts	Submucosal Palatal Shrinkage
Head, Neck, Oral, and Sinus Surgery	Tonsillectomy
Mastoidectomy	Traditional Uvulopalatoplasty (RAUP)
Myringotomy with effective HemorrhageControl	Tumors
Nasal Airway Obstruction by Reduction ofHypertrophic Nasal Turbinates	Tissue in the Uvula/Soft Palate for theTreatment of Snoring
Nasopharyngeal / Laryngeal indications	Uvulopalatopharyngoplasty (UPPP)
	Parotidectomy

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Gyrus ACMI® Gyrus ACMI Inc. 136 Turnpike Road Southborough, MA 01772

Traditional 510(k) Notification Statement of Intended Use

Page 2 of 2

රි

Polypectomy, and Laryngeal Lesion Debulking · Neck Mass · Neck Dissection (Radical and Modified Neck Dissection)

The Gyrus ACMI Dissector Plasma Knife is indicated for resection and coagulation of soft The Gyras From Discover Proceeds in head and neck surgery including Neck Dissection (Radical and Modified Neck Dissection), Tonsillectomy, Parotidectorny and UPPP when used with the bipolar generator section of the G3 Workstation.

Product Description

The Gyrus G3 System Generator has two principal modes of operation dependant on which 1 no Of electrode is attached - The monopolar mode has controls for maximum temperature type of boor our is analers and has readouts for total energy delivered, impedance, temperature and chergy delivered. - 110 time of energy delivery. - The bipolar mode has controls for output for two mornocouples and power. The unit has readouts for set power and waveform. Connectors on wavelonin cype and power monopolar connector for active electrode and dispersive electrode the nom panel metude ar connectors for PlasmaCision electrodes and bipolar instruments. The device is operated by a foot pedal, connected on the back panel.

The Dissector Plasma Knife is a single use disposable bipolar instrument designed for use with the G3 generator within an ambient air environment. The instrument incorporates a which the SS generates which of fluids and gases during operative procedures when connected to an appropriate suction facility.

Technological Characteristics and Substantial Equivalence

The Gyrus ACMI® G3 Generator and Accessories - Dissector Plasma Knife are The Oyrus Town® 05 Generals and identical features of the predicate. There are no changes to the design of the generator or instrument pursuant to this aronission. Therefore In summary, the Gyrus ACMI is substantially equivalent to the predicate device and presents no new questions of safety or efficacy

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Gyrus ACMI, Inc. % Ms. Lorraine Calzetta Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts 01772-2104

AUG 1 3 2009

Re: K080844

Trade/Device Name: Gyrus ACMI® G3 Generator and Accessories – Dissector Plasma Knife

Regulation Number: 21 CFR 878.4400

Regulation Name: Electrosurgical cutting and coagulation device and accessories

Regulatory Class: Class II Product Code: GEI Dated: July 12, 2009

Received: July 23, 2009

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 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

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

Page 2 - Ms. Lorraine Calzetta

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.

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Milburn

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

Enclosure

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Gyrus ACMI G3Generator- Dissector Plasma Knife Gyrus ACMI Inc. 136 Turnpike Road Southborough, MA 01772

Device Name: Gyrus ACMI® G3 Generator and Accessories - Dissector Plasma Knife

510(k) Number:

K080844

Indications for use:

• Adenoidectomy	• Papilloma Keloids
• Cysts	• Submucosal Palatal Shrinkage
• Head, Neck, Oral, and Sinus Surgery	• Tonsillectomy
• Mastoidectomy	• Traditional Uvulopalatoplasty (RAUP)
• Myringotomy with effective Hemorrhage Control	• Tumors
• Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates	• Tissue in the Uvula/Soft Palate for the Treatment of Snoring
• Nasopharyngeal / Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking	• Uvulopalatopharyngoplasty (UPPP)
• Neck Dissection (Radical and Modified Neck Dissection)	• Parotidectomy
• Neck Mass

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)

Nil R. Patel, Mxm

vision Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number.

Page 1 of 1

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.