The MedWaves Microwave Coagulation/Ablation System is intended for general surgical use in open procedures for the coagulation and ablation of soft tissues. The system is not intended for use in cardiac procedures.

Device Description

The MedWaves Microwave Coagulation/Ablation System consists of a microwave generator and accessories used for the surgical ablation of soft tissue. The accessories include two types of sterile, handheld, single use surgical coagulation/ablation probes and required connector cables. The two versions of coagulation/ablation probes are 15-cm in length, 14gauge in diameter, configured into large or small handle. The large handle configuration is the original blue elongated egg-shaped plastic, and the small handle is white plastic handle with 90-degree cable exit (both are made of the same ASB plastic).

The MedWaves microwave generator operates at a frequency of 902 to 928 MHz. For general surgery applications, the generator is set by the manufacturer to deliver a maximum of 32 W and is user selectable up to 28W. The system is capable of being run in two primary modes: power control mode and temperature control mode. A dynamic monitoring system within the generator maintains the set point selected by the user (either a power or temperature control point) in order to provide consistent and expected coagulation/ablation performance.

The system incorporates several monitored parameters that alert the user to potentially unsafe conditions during operation. These parameters and condition alerts include: overtemperature, over-power, inefficient microwave delivery, catheter/probe disconnect and system errors. MedWaves microwave generator utilizes firmware to monitor these processes variables and posts the ablation parameters and progress for the user on an LCD screen.

MedWaves uses proprietary antenna technology coupled with a delivery system that efficiently transmits the microwave energy to the tip of the probe. The microwave antenna is 20 mm long mounted at the distal end. Efficiency of the system relieves the requirement of having high-powered generator in order to create the desired coagulation/ablation results. The efficiency of the system allows the incorporation of monitoring and controls on the microwave energy delivery in order to deliver the most optimal performance available.

AI/ML Overview

The provided text describes the MedWaves Microwave Coagulation/Ablation System. I will extract the requested information based on the content of this document.

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

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance/Compliance
Electrical Safety/EMC	EN 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance)	Complies with EN 60601-1
	EN 60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and tests)	Complies with EN 60601-1-2
	EN 60601-2-2:2006 STD (Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and accessories)	Complies with EN 60601-2-2:2006 STD
	IEC CISPR11 Class A Group 3 (Industrial, scientific and medical equipment – Radio-frequency disturbance characteristics – Limits and methods of measurement)	Conforms to IEC CISPR11 Class A Group 3
	EN61000-3-2 (Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current emissions)	Conforms to EN61000-3-2
	EN61000-3-3 (Electromagnetic compatibility (EMC) – Part 3-3: Limits – Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current <= 16 A per phase and not subject to conditional connection)	Conforms to EN61000-3-3
	EN61000-4-2 (Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement techniques – Electrostatic discharge immunity test)	Conforms to EN61000-4-2
	EN61000-4-3 (Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement techniques – Radiated, radio-frequency, electromagnetic field immunity test)	Conforms to EN61000-4-3
	EN61000-4-4 (Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement techniques – Electrical fast transient/burst immunity test)	Conforms to EN61000-4-4
	EN61000-4-5 (Electromagnetic compatibility (EMC) – Part 4-5: Testing and measurement techniques – Surge immunity test)	Conforms to EN61000-4-5
	EN61000-4-6 (Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurement techniques – Immunity to conducted disturbances, induced by radio-frequency fields)	Conforms to EN61000-4-6
	EN61000-4-8 (Electromagnetic compatibility (EMC) – Part 4-8: Testing and measurement techniques – Power frequency magnetic field immunity test)	Conforms to EN61000-4-8
	EN61000-4-11 (Electromagnetic compatibility (EMC) – Part 4-11: Testing and measurement techniques – Voltage dips, short interruptions and voltage variations immunity tests for equipment with input current up to 16 A per phase)	Conforms to EN61000-4-11
Biocompatibility	ISO 10993 (Biological Evaluation of Medical Devices)	Complies with ISO 10993
Sterility	ANSI/AAMI/ISO 11135:1994 (Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization)	Complies with ANSI/AAMI/ISO 11135:1994
Packaging, Shelf Life	AAMI ANSI ISO 11607-1:2006 (Packaging for Terminally Sterilized Medical Devices)	Complies with AAMI ANSI ISO 11607-1:2006
Firmware Testing	AAMI ANSI IEC 62304 (Medical Device Software Software Lifecycle Processes)	Underwent firmware testing in accordance with AAMI ANSI IEC 62304
Risk Management	AAMI ANSI ISO 14971 & 14971 Al (Medical Devices - Application of Risk Management to Medical Devices)	Underwent firmware testing in accordance with AAMI ANSI ISO 14971 & 14971 Al
Mechanical & In Vitro	Intended use and published performance of currently marketed products	Catheter/Probes underwent mechanical and in vitro testing; device performed as expected and comparable to published performance of currently marketed products.
Functional	Design specifications	Functions as intended and meets design specifications through electrical, mechanical, functional, and biocompatibility tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a distinct "test set" in the context of clinical data or image analysis. The performance claims are based on compliance with established engineering and safety standards, as well as mechanical and in vitro testing of the probes. There is no mention of patient data, clinical studies, or country of origin for such data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The provided summary is for a medical device (microwave coagulation/ablation system) and focuses on engineering, safety, and performance standards. There is no mention of experts establishing ground truth for a test set in the context of diagnostic accuracy or clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no test set requiring expert adjudication for ground truth (e.g., in an image analysis context) is described.

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 device is a surgical ablation system, not a diagnostic imaging or AI-assisted diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is outside the scope of the provided information.

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

Not applicable. This is not an AI algorithm. The device, a microwave coagulation/ablation system, operates based on physical principles for tissue ablation. Its "performance" refers to its ability to generate microwave energy and ablate tissue as intended, not an algorithmic output.

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

For the mechanical and in vitro testing of the catheter/probes, the "ground truth" was likely established through established scientific methods, physical measurements, and comparison to the "published performance of currently marketed products" and "intended use" specifications. For regulatory compliance, the ground truth is adherence to the specified international and national standards (e.g., ISO, EN, AAMI).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA1990 and 21 CFR 807.92(c).

1. Submitter Information

MedWaves Incorporated 16760 West Bernardo Drive San Diego, California

Phone: (858) 946-0015 Fax: (858) 946-0016

Contact: Ted Ormsby

Date of preparation: November 24, 2008

2. Device Name

Trade name: MedWaves Microwave Coagulation/Ablation System

Common name: Microwave Tissue Coagulation/Ablation System

Classification name and reference: Class II, 21 CFR 878.4400, Electrosurgical Cutting and Coagulation Device and Accessories, Panel 79, General and Plastic Surgery

Product Code: NEY

3. Predicate Devices

The MedWaves Microwave Coagulation/Ablation System is substantially equivalent to and is a modification to the Company's own medical device:

. MedWaves Microwave Coagulation/Ablation System K070356

4. Device Description

The MedWaves Microwave Coaqulation/Ablation System consists of a microwave generator and accessories used for the surgical ablation of soft tissue. The accessories include two types of sterile, handheld, single use surgical coagulation/ablation probes and required connector cables. The two versions of coagulation/ablation probes are 15-cm in length, 14gauge in diameter, configured into large or small handle. The large handle configuration is the original blue elongated egg-shaped plastic, and the small handle is white plastic handle with 90-degree cable exit (both are made of the same ASB plastic).

MedWaves uses proprietary antenna technology coupled with a delivery system that

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JAN 1 5 2009

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083537

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efficiently transmits the microwave energy to the tip of the probe. The microwave antenna is 20 mm long mounted at the distal end. Efficiency of the system relieves the requirement of having high-powered generator in order to create the desired coagulation/ablation results. The efficiency of the system allows the incorporation of monitoring and controls on the microwave energy delivery in order to deliver the most optimal performance available.

5. Indications for Use

ﺔ

The MedWaves Microwave Coagulation/Ablation System is intended for general surgical use in open procedures for the coaqulation and ablation of soft tissues. The system is not intended for use in cardiac procedures.

6. Performance Data in Support of Substantial Equivalence

Performance testing was carried out to ensure that the MedWaves Microwave

Coagulation/Ablation System functions as intended and meets design specifications. The MedWaves Microwave Coagulation/Ablation System was subjected to a battery of electrical, mechanical, functional and biocompatibility tests.

In addition, the testing demonstrates that the MedWaves Microwave Coagulation/Ablation System complies with the following standards:

Electrical Safety/EMC:	EN 60601-1, EN 60601-1-2 and EN60601-2-2:2006 STD
Biocompatibility:	ISO 10993, Biological Evaluation of Medical Devices
Sterility:	ANSI/AAMI/ISO 11135:1994 Medical Devices - Validation andRoutine Control of Ethylene Oxide Sterilization
Packaging, Shelf Life:	AAMI ANSI ISO 11607-1:2006 Packaging for Terminally SterilizeMedical Devices

MedWaves Catheter/Probes underwent mechanical and in vitro testing in accordance with the intended use. The device performed as expected and comparable to the published performance of currently marketed products.

The MedWaves microwave generator underwent firmware testing in accordance with:

AAMI ANSI IEC 62304 Medical Device Software Software Lifecycle Processes .
. AAMI ANSI ISO 14971 & 14971 Al Medical Devices - Application of Risk Management to Medical Devices

Sufficient data were obtained to show the device is substantially equivalent to the predicate devices and meets safety and effectiveness criteria.

The device also conforms to the following standards:

IEC CISPR11 Class A Group 3 EN61000-3-2 EN61000-3-3 EN61000-4-2 EN61000-4-3 EN61000-4-4 EN61000-4-5 EN61000-4-6

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EN61000-4-8 EN61000-4-11

7. Substantial Equivalence Conclusion

Substantial equivalence is based on the MedWaves Microwave Coagulation/Ablation System having the same intended use and general technological characteristics as the predicate devices. There are no new fundamental technological differences between the MedWaves Microwave Coagulation/Ablation System and legally marketed devices. There are no new questions of safety or efficacy raised by the MedWaves Microwave Coagulation/Ablation System or any of its coagulation/ablation probes. Therefore, it can be concluded that the MedWaves Microwave Coagulation/Ablation System and accessories are substantially equivalent to and is a modification of MedWaves' own device that was cleared under K070356.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an eagle with its wings spread, with three lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medwaves Inc % Mr. Ted Ormsby President/CEO and CTO 16760 W Bernardo Drive San Diego, California 92029

JAN 1 5 2009

Re: K083537

Trade/Device Name: 14 gauge Microwave Coagulation Ablation Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NEY Dated: December 19, 2008 Received: December 22, 2008

Dear Mr. Ormsby:

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 agencics. 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 sct 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.

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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. Wilkerson

Mark N. Melkerson 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 know): K083537

Device Name: 14 gauge Microwave Coagulation Ablation Device

The MedWaves Microwave Coagulation/Ablation System is intended for general surgical i he wedviaves Microwave Goaganation and ablation of soft tissues. The system is not intended for use in cardiac procedures.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part21 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)

(Division Sign-Off)
Division of General, Restorative,

1/14/2007

and Neurological Devices

083537 510(k) Number

000003

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.