The Thermedx 37~5 electrocautery probes are indicated for electrosurgical cutting and coagulation during a variety of urological, gynecological, laparoscopic and general surgical procedures.

Device Description

The Thermedx 37~5 electrode probes are electrosurgical devices which enable the user to have the functions of cutting and coagulation along with suction and irrigation in a single hand held device. These probes are intended to be used in conjunction with the Trumpet valve disposable assembly (model number TV0002), The probes come in a variety of tip configurations. Monopolar electrodes include a J Hook. L Hook. Spatula and Needle tip. . All electrodes have working dimensions of 33 cm in length and 5 mm diameter. Electrodes are manufactured of biocompatible materials per ISO 10993 and are safe, effective and durable for their intended use. All electrodes have an ABS coupling to connect to the trumpet valve disposable assembly and are connected to an electrosurgical unit with a cable of PVC insulation and copper wires.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

This submission does not provide specific quantitative acceptance criteria or detailed device performance metrics in the format of a table. The document focuses on demonstrating substantial equivalence to predicate devices. The "performance" assessment is qualitative, asserting that the new device has "similar technological characteristics" and "minor differences are not significant with respect to the safety or effectiveness."

The key performance claims are:

Electrosurgical cutting and coagulation capability.
Suction and irrigation capabilities (for the integrated hand-held device).
Compliance with electrical safety (IEC 601-2-2) and biocompatibility (ISO 10993-1) standards.

Since no specific numerical acceptance criteria or test results are provided in the summary, a table cannot be constructed with performance values. The primary acceptance criterion for this 510(k) submission was the demonstration of substantial equivalence to predicate devices, which was achieved through:

Same intended use.
Similar technological characteristics.
Compliance with relevant safety standards (IEC 601-2-2 and ISO 10993-1).

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

No specific test set or data provenance (e.g., country of origin, retrospective/prospective) is described for demonstrating the performance of the device. The submission explicitly states: "No animal or clinical test results were required to demonstrate substantial equivalence." This indicates that no human or animal test data was used for this 510(k) submission from the perspective of a "test set." The evaluation relied on technical comparisons and compliance with recognized standards.

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

Not applicable. Since no animal or clinical test results were required for substantial equivalence, there was no "ground truth" to be established by experts in the context of clinical or performance data for this submission. The ground truth for regulatory acceptance was based on a comparison to predicate devices and compliance with established standards.

4. Adjudication Method for the Test Set

Not applicable. As no test set data was presented or required for this 510(k) submission, there was no adjudication method used for such data.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No animal or clinical test results were required to demonstrate substantial equivalence." This type of study would involve human readers and clinical data, which was not part of this submission.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is an electrosurgical probe, a physical medical instrument, not an algorithm or AI software. Therefore, there is no concept of "standalone (algorithm only)" performance in this context.

7. Type of Ground Truth Used

The "ground truth" for this 510(k) submission was based on:

Predicate Device Equivalence: The primary ground truth was the established safety and effectiveness of the identified predicate devices (Modulap Disposable Electrosurgical Probes, Genicon Re-Usable Monopolar Probes, Stryker Stiletto Electrosurgical Probe, Conmed Electrosurgical Probe). The new device was deemed substantially equivalent to these devices.
Compliance with Standards: Compliance with recognized international standards for electrical safety (IEC 601-2-2) and biocompatibility (ISO 10993-1) served as a "ground truth" for basic safety and performance characteristics.

No clinical expert consensus, pathology, or outcomes data from the new device was used to establish ground truth for this submission, as such data was not required.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm requiring a training set. The "training" for the device's design and manufacture would involve engineering principles, materials science, and adherence to quality system regulations, rather than data-driven machine learning.

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

Not applicable. As there is no AI/ML algorithm and thus no "training set," the concept of establishing ground truth for a training set is not relevant to this device submission.

Summary

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K102275
page 1 of 2

510(k) Summary

MAR 2 5 2011

Traditional 510(k) Notification Thermedx 37~5TM Electrode Probes Thermedx, LLC

, ﺗ Applicant Thermedx, LLC 31200 Solon Rd. Unit#1, Solon Oh 44139 440-542-0883 Contact Person: John R. Scoville, Jr., VP Quality and Regulatory Affairs Date Prepared: March 23, 2011

Device Name

Proprietary Name: Thermedx 37~5TM Electrocautery Probes Common Name: Electro Cautery Probe Classification Name: Electrosurgical Cutting and Coagulation and Accessories (product code GEI)

Indications for Use

The Thermedx 37~5 electrocautery probes are indicated for electrosurgical cutting and coagulation during a variety of urological, gynecological, laparoscopic and general surgical procedures.

Device Description

Substantial Equivalence

The monopolar electrode probes included in the 37-5 fluid management system are substantially equivalent in terms of safety and effectiveness to the following devices.

Modulap Disposable Electrosurgical Probes (K994319, KP83623) ATC Technologies part numbers l . 4180, 4181, 4182 and 4183
1. Genicon Re-Usable Monopolar Probes (K061417), Genicon, part numbers 707-005-133, 707-005-233 and 707-005-333.
Stryker Stiletto Electrosurgical Probe (K963765), Stryker Endoscopy 3.
Conmed Electrosurgical Probe (K012018), Conmed 4.

Technological Comparison

This 510(k) Notification demonstrates the substantial equivalence of the Thermedx 37-5 using the substantial equivalence criteria in FDA's K86-3 510(k) Guidance. The new device has the same intended use as the predicate devices, and the minor differences in indications for use statements do not alter the device's intended therapeutic effect. The new device also has similar technological characteristics to those of the predicate devices, and the minor differences are not significant with respect to the safety or effectiveness of the new device. All devices were tested to the same electrical safety and biological testing standards (IEC 601-2-2 and ISO 10993-1) demonstrating equivalence. No animal or clinical test results were required to demonstrate substantial equivalence.

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Safety and Effectiveness

The Thermedx 37~5 Electrocautery probes have been developed in accordance with FDA's design controls requirements. The design and development process has ensured that all applicable safety and effectiveness issues are addressed, including but not limited to labeling, shelf life, biocompatibility and electrical safety. The product has been fully verified to comply with its established specifications and applicable standards and validated to ensure the device is safe and effective.

All statements and representations set forth above regarding or related to "substantially equivalent" or "substantial equivalence" are in the limited context of the definition and purpose of substantial equivalence in the Federal Food, Drug, and Cosmetic Act, as amended, and applicable regulations of the Food and Drug Administration, and are not made in the context of, for any purpose related to, or as an admission against interest under, any other laws or regulations, including patent laws (whether in the context of patent infringement or otherwise).

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

Thermedx, LLC % Mr. John R. Scoville 31200 Solon Road, Unit #1 Solon, Ohio 44139 -

MAR 2 5 2011

Re: K102275

Trade/Device Name: Thermedx 37-5 Electrocautery Probes, Models: MPJ200, MPL210, MPJ220, MPJ230 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 07, 2011 Received: March 08, 2011

Dear Mr. Scoville:

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

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Page 2 - Mr. John Scoville

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Henry B. Reite
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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Indications for Use Form (Text Version)

Indications for Use

510(k) Number (if known):

Device Name: Thermedx 37~5™ Electrocautery Probes

Indications for Use:

The Thermedx 37~5 electrocautery probes are indicated for electrosurgical cutting and coagulation during a variety of urology, gynecology, laparoscopy and general surgery procedures.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

Page __ of ___

510(k) Number K102275

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.