MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM

K083537 · Medwaves Incorporated · NEY · Jan 15, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083537
• Device Name: MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
• Applicant: Medwaves Incorporated
• Product Code: NEY · General, Plastic Surgery
• Decision Date: Jan 15, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

System comprises microwave generator and sterile, single-use handheld probes (15-cm length, 14-gauge diameter). Generator operates at 902-928 MHz; delivers up to 32W. Used in open surgical procedures by physicians for soft tissue coagulation/ablation. System features power control and temperature control modes; dynamic monitoring maintains user-selected set points. Proprietary antenna at probe tip transmits microwave energy. Firmware monitors parameters (over-temperature, over-power, probe disconnect, system errors) and displays progress on LCD. Provides consistent coagulation/ablation performance; efficiency allows lower power requirements. Alerts notify users of unsafe conditions during operation.

Clinical Evidence

Bench testing only. Device subjected to electrical, mechanical, functional, and biocompatibility testing. Complies with EN 60601-1, EN 60601-1-2, EN 60601-2-2, ISO 10993, ANSI/AAMI/ISO 11135, and AAMI ANSI ISO 11607-1. Firmware validated per AAMI ANSI IEC 62304 and AAMI ANSI ISO 14971. Mechanical and in vitro testing confirmed performance comparable to predicate.

Technological Characteristics

Microwave generator (902-928 MHz) and 14-gauge probes. Probes made of ABS plastic. Energy delivery via proprietary distal antenna (20 mm). Modes: power control and temperature control. Connectivity: LCD display for parameter monitoring. Sterilization: Ethylene Oxide (ANSI/AAMI/ISO 11135). Firmware-based monitoring of power, temperature, and system integrity.

Indications for Use

Indicated for general surgical use in open procedures for coagulation and ablation of soft tissues. Not indicated for cardiac procedures.

Regulatory Classification

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.

Predicate Devices

• MedWaves Microwave Coagulation/Ablation System (K070356)

Submission Summary (Full Text)

{0}------------------------------------------------

#### 510(k) Summary

t

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: [phone] Fax: [phone]

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).

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

Page 1 of 3

JAN 1 5 2009

{1}------------------------------------------------

083537

Page 2 of 3

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 and<br>Routine Control of Ethylene Oxide Sterilization |
| Packaging, Shelf Life: | AAMI ANSI ISO 11607-1:2006 Packaging for Terminally Sterilize<br>Medical 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

{2}------------------------------------------------

08 35-37

Page 383

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.

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

#### 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.

{4}------------------------------------------------

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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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

{5}------------------------------------------------

# 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