The Gyrus PlasmaCision Laparoscopic Spatula is indicated for resection and Coagulation of son and blood vessels in laparoscopic and general surgical when used with the Gyrus PlasmaKinetic Generator or the Gyrus PlasmaKinetic SuperPulse Generator.

Device Description

The Gyrus PlasmaCision Laparoscopic Spatula is a bipolar electrosurgical instrument with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic with the saper carbon dioxide gas or air insufflation. The instrument will pass through a 5mm cannula or through an operating laparoscope's working channel of 5mm minimum diameter. The instrument is to be used only with the Gyrus PlasmaKinetic Generator, the Gyrus SuperPulse Generator and associated 5 way connector cable. The device is intended for use in a non-irrigated (dry) environment. The device has the functionality to dissect, resect or vaporise tissue with haemostasis, to coagulate tissue and blood vessels and to blunt (cold) dissect tissue.

AI/ML Overview

The provided 510(k) summary for the Gyrus PlasmaCision Laparoscopic Spatula (K041633) does not contain a specific study with defined acceptance criteria and reported device performance in the format requested.

Instead, the summary acts as a notification to the FDA of the intent to market the device, asserting its substantial equivalence to predicate devices based on intended use and technological characteristics. It mentions that "performance validation" has been done to validate the performance of the device without detailing the specific study design, acceptance criteria, or results for device performance against those criteria.

Therefore, I cannot extract the information required for the table and other detailed questions about a specific study.

Information NOT present in this document:

A table of acceptance criteria and the reported device performance: The document states that "performance validation" has been performed but does not provide specific acceptance criteria or the reported performance data.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device (it's a surgical instrument, not an AI algorithm).
The type of ground truth used: Not mentioned.
The sample size for the training set: Not applicable for this type of device.
How the ground truth for the training set was established: Not applicable for this type of device.

Key takeaway from the document regarding performance:

The document states, "In addition, performance validation results presented in this 510(k) notification to the FDA confirm the comparison and falls substantially equivalent to predicate devices and is safe and effective in its intended use." This is a general statement of equivalence and safety, not a detailed report of a specific study with concrete acceptance criteria and quantitative performance results.

Summary

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Clinical 763-416-7239 direct 763-416-3070 fax david.chadwick@gyrusmed.com

June 15, 2004 Date Summary Prepared:

Name of the Device:

Proprietary Name:	Gyrus PlasmaCision Laparoscopic Spatula
Project Name:	Laparoscopic Spatula
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:	Gyrus PK Bipolar Needle Electrode K031079Gyrus PK Bipolar L Hook Electrode K031082Gyrus PlasmaCision Scimitar Instrument K021777

Description:

The instrument is to be used only with the Gyrus PlasmaKinetic Generator, the Gyrus SuperPulse Generator and associated 5 way connector cable. The device is intended for use in a non-irrigated (dry) environment.

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The device has the functionality to dissect, resect or vaporise tissue with haemostasis, to coagulate tissue and blood vessels and to blunt (cold) dissect tissue.

Statement of Intended Use:

The Gyrus PlasmaCision Laparoscopic Spatula is indicated for resection and The - Oyrus - Fidemation - blood vessels in laparoscopic surgery when used with the Coughallon of on the Generator or the Gyrus SuperPulse Generator. This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

Comparison to Predicate Devices:

The Gyrus PlasmaCision Laparoscopic Spatula has been carefully compared to legally The Oyuls Flasmaolores with respect to intended use and technological characteristics. In mance of over with has been done to validate the performance of the device. adonom, periormance wildation results presented in this 510(k) notification to the FDA rhe companison and fallstantially 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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2004

David E. Chadwick, Ph.D., RAC Director, Regulatory Affairs/Quality Assurance/ Clinical Gyrus Medical, Inc. 6655 Wedgwood Road Maple Grove, Minnesota 55311

Re: K041633

Ro+1035
Trade/Device Name: Gyrus PlasmaCision Laparoscopic Spatula Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 6, 2004 Received: October 7, 2004

Dear Dr. Chadwick:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 3 ro(s) premium is substantially equivalent (for the indications ferenced above and nave decembers and and marketed predicate devices marketed in interstate for use stated in the encrosure) to regardy the Medical Device Amendments, or to commerce prior to May 20, 1976, the oncordance with the provisions of the Federal Food, Drug, devices mail have been require approval of a premarket approval application (PMA). and Cosmetic Act (7tel) that to not requent to the general controls provisions of the Act. The I ou may, mercebore, manice the Act include requirements for annual registration, listing of general controls provisions of the rice, 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 If your device is classified (500 a0070) ils. Existing major regulations affecting your device can may be subject to suer additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs of events concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 lease be advised that 1 DT 0 issuals at your device complies with other requirements of the Act that i DV has intact a and regulations administered by other Federal agencies. You must or any I catal statures and registments, including, but not limited to: registration and listing (21 Comply with an the Pre- Prequentions) ; good manufacturing practice requirements as set CITY at 6077, adoning (21 OF R Part 820); and if applicable, the electronic form in the quarty by stems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - David E. Chadwick, Ph.D., RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin manisoning of substantial equivalence of your device to a legally premarket notification: "The PDF intellig sification 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 11 you desire specific darieviance at (240) 276-0115. Also, please note the regulation entitled, Connact the Office or Compremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D.
Director 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):

K041633

Device Name:

Gyrus PlasmaCision Laparoscopic Spatula

Indications For Use:

The Gyrus PlasmaCision Laparoscopic Spatula is indicated for resection and The Gylus Trasmacision Euparoscopic and Dood vessels in laparoscopic and general surgical Coagulation of son used with the Gyrus PlasmaKinetic Generator or the Gyrus PlasmaKinetic SuperPulse Generator.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) OR

Over-The-Counter Use __

Please do not write below this line-continue on another Page IF NEEDED

Miriam C. Provost

neral. Restorative, and Neurological Devices

K041633_ 510(k) Number-

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.