The Canady Plasma Coagulator devices are intended to provide gas-enhanced coagulation during general surgery procedures. The Canady Plasma Coagulator devices are Argon Plasma Coagulation Unit designed for gas enhanced coagulation when used only with the Canady Plasma Electrosurgery Unit models and compatible monopolar and/or bipolar RF handpieces.

The Canady Electrosurgery Unit Generators are intended to cut and/or coagulate tissue when used with compatible monopolar and/or bipolar RF handpieces. The Canady Electrosurgery Unit Generators are capable of monopolar argon gas enhanced coagulation when used with Canady Plasma Coagulator and probes.

Device Description

The Canady Plasma"M Electrosurgical Unit Series with Accessories is an High Frequency (HF) Electrosurgery Unit (ESU) used in combination with Canady Plasma™ Coagulators (Argon 2 and Argon 4) gas units and probes (Canady Plasma™ GIT probe and Canady Plasma™ TBS probe). The Canady Plasma (ESU) series combines (HF) voltage to electrically enhanced plasma gas (i.e. Argon) to produce a plasma gas stream. Current density upon arrival at the tissue surface from Canady Plasma Probes causes coagulation of the tissue. Canady Plasma (ESU) series is also a monopolar and bipolar RF surgical device for cutting and coagulation. It is used for tissue removal and coagulation in accordance with the operative procedure performed by the physician. The unit provides various cutting and coagulation modes to meet the physician flexibility performing the specific procedure with the device.

The Canady Plasma Electrosurgery Unit Model SS-200E is to only be used with the Canady Plasma Coagulator Argon 2. The Canady Plasma Electrosurgery Unit Model SS-601 Mca is to only be used with the Canady Plasma Coagulator Argon 4.

AI/ML Overview

The provided 510(k) summary for the Canady Plasma Electrosurgical Unit Series (K100669) focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and a study proving device performance (especially for AI/software-based devices) is not applicable or not provided in this document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not Specified	Not Specified
(No specific quantitative performance metrics or acceptance thresholds are mentioned for the device itself.)	The document states "These devices are equivalent in intended use, technological characteristics, and performance characteristics to the named predicate devices." and compliance with several NBR IEC standards for electromedical equipment (60601-1, 60601-2-2, 60601-1-2).

Explanation: In submissions for devices like electrosurgical units, the "acceptance criteria" are typically met through adherence to recognized national and international safety and performance standards for electromedical equipment, as well as demonstration of equivalence to legally marketed predicate devices. The document explicitly states compliance with relevant NBR IEC standards. No novel performance claims requiring specific clinical acceptance criteria are being made.

2. Sample Size Used for the Test Set and Data Provenance:

Sample size for test set: Not applicable. The submission does not describe a clinical study with a test set of data points for performance evaluation in the way one might for an AI/software device.
Data provenance: Not applicable. The testing described (compliance with NBR IEC standards) is typically laboratory-based engineering and electrical safety testing, not based on patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of experts: Not applicable.
Qualifications of experts: Not applicable.

Explanation: As no clinical test set with ground truth is described, this information is not relevant to this submission.

4. Adjudication Method for the Test Set:

Adjudication method: Not applicable.

Explanation: No clinical test set is described.

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

MRMC study: No.
Effect size of human reader improvement with AI vs. without AI assistance: Not applicable.

Explanation: This device is an electrosurgical unit, not an AI-assisted diagnostic or clinical decision support tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Standalone study: No.

Explanation: This device is a physical electrosurgical unit, not an algorithm. Performance is assessed through compliance with standards and equivalence to predicate devices, used directly by a physician.

7. Type of Ground Truth Used:

Type of ground truth: Not applicable.

Explanation: As this is an electrosurgical unit, the "ground truth" would relate to its physical and electrical characteristics as determined by engineering tests and adherence to standards, not clinical "ground truth" labels for a dataset.

8. Sample Size for the Training Set:

Sample size for training set: Not applicable.

Explanation: This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set was Established:

How ground truth was established: Not applicable.

Explanation: As this is not an AI/machine learning device, there is no training set and thus no ground truth establishment for a training set.

Summary of Focus in this 510(k) Submission:

The K100669 submission for the Canady Plasma Electrosurgical Unit primarily focuses on demonstrating:

Substantial Equivalence: The crucial aspect of this submission is showing that the device is "equivalent in intended use, technological characteristics, and performance characteristics to the named predicate devices." This is the cornerstone of a 510(k) submission.
Intended Use: Clearly defining the intended use, which is for gas-enhanced coagulation and general tissue cutting/coagulation during surgery.
Compliance with Standards: Adherence to recognized national and international safety standards for electromedical equipment (NBR IEC 60601-1, 60601-2-2, 60601-1-2). This indicates that the device has undergone electrical, mechanical, and electromagnetic compatibility testing to ensure it operates safely and effectively within expected parameters.

For physical medical devices like electrosurgical units, the regulatory pathway often relies on comparison to existing, legally marketed predicate devices and compliance with established safety and performance standards, rather than large-scale clinical trials establishing new performance metrics or comparative effectiveness studies involving AI.

Summary

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K100669

APR - 6 2011

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitter Information:

US Medical Innovations, LLC 2940 Winter Lake Road Lakeland, Florida 33803 Tel: 863 667-1609 Fax: 863-667-1917 Attn: Jerome Canady, M.D.

Date Summary Prepared: July 27, 2010

Application Correspondent:

Krista Oakes Senior Regulatory Consultant Emergo Group Inc. 611 West 5th Street Third Floor Austin, Texas 78701 Tel: 512-327-9997 Fax: 512-327-9998

Device Name:

Trade Name(s): Canady Plasma"" Electrosurgical Unit Series (SS-601 MCa, SS-200E)/ Canady Plasma™ Coagulator (Argon 2 and 4) with Accessories Canady Plasma™ Probes for Flexible Endoscopy

Classification Name: Electrosurgical cutting and coagulation device and accessories

Classification Regulation: 21 CFR 878.4400 Panel: General, Restorative, and Neurological Devices Product Code: GEI Class: II

Predicate Device Information:

Canady Technology, LLC Canady Plasma Probes for Flexible Endoscopy - K052035 ERBE ICC 200 - K933157 ERBE VIO 300D - K023886 ERBE VIO APC2 - K024047 ERBE APC Applications - K013348 Valley Lab Force FX - K944602 BOVIE IDS-300 K022856

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Device Description:

Intended Use:

Comparison to Predicate Devices:

These devices are equivalent in intended use, technological characteristics, and performance characteristics to the named predicate devices.

Testing and Conclusions:

The devices comply with NBR IEC 60601-1 Standard, Electromedical equipment - Part 1 - General requirements for safety, NBR IEC 60601 - 2- 2 Electromedical equipment -Part 2 - 2: Particular requirements for the safety of high frequency surgical equipment, NBR IEC 60601 - 1 - 2, Electromedical equipment - Part 1 - 2: Collateral standard: Electromagnetic compatibility - Requirements and test.

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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

US Medical Innovations LLC % TUV SUD America, Inc. Ms. Dawn Tibodeau 1775 Old Highway 8 NW, Ste 104 New Brighton, Minnesota 55112-1891

APR - 6 2511

Re: K100669

Trade/Device Name: Canady Plasma Electrosurgical Unit Series & Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 29, 2011 Received: April 6, 2011

Dear Ms. Tibodeau:

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 10 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

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Page 2 - Ms. Dawn Tibodeau

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 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/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Alij B. Rute
for

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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Section 4 - Indications for Use '

510(k) Number (if known): K100669

Device Name: Canady Plasma™ Electrosurgical Unit Series with Accessory Probes

Indications for Use:

Prescription Use _______________(Part 21 CFR 801 Subpart D) 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)

Younes M. Elgayar

(Division Division of Surgical, Orthopedia and Restorative Devices

510(k) Number K100669

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.