CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140

K100744 · Neuwave Medical, Inc. · NEY · Oct 22, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100744
• Device Name: CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140
• Applicant: Neuwave Medical, Inc.
• Product Code: NEY · General, Plastic Surgery
• Decision Date: Oct 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NeuWave Medical Certus 140 2.45 GHz Ablation System and Accessories are intended for the ablation (coagulation) of soft tissue. The Certus 140 2.45 GHz Ablation System is not intended for use in cardiac procedures.

Device Story

System uses three 2.45 GHz microwave generators to deliver energy for soft tissue ablation; controlled via touch-screen interface. Supports up to three probes simultaneously; power output scales based on connected probe count (140W for one, 95W/probe for two, 65W/probe for three). Probes include temperature-sensing thermocouples and CO2-based cooling system; CO2 also powers 'Tissu-Loc' function to adhere probe to tissue. Used in clinical facilities for percutaneous or open surgical procedures by clinicians. Output provides thermal coagulation of target tissue; benefits include controlled ablation of soft tissue. System automatically manages CO2 tank switching.

Clinical Evidence

Ex-vivo studies conducted to compare performance against a predicate device. No human clinical trial data presented.

Technological Characteristics

2.45 GHz microwave energy source; three independent generators. Probes: 17-gauge (percutaneous) or 13-gauge (open surgical) with integrated thermocouples. CO2 cooling system. Touch-screen interface. Compliance with UL 60601-1, IEC 60601-1, IEC 60601-2-2, IEC 60601-2-6, IEC 60601-1-2, EN ISO 11607-1, and ISO 10993-1.

Indications for Use

Indicated for soft tissue ablation. Contraindicated in pregnant patients and patients with implantable pacemakers or other electronic implanted devices. For facility use only under clinician orders.

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

• ValleyLab Microwave Ablation Generator (072687, K053535)
• ValleyLab Cool-Tip RF Generator, Cool-Tip RF System and Accessories (K052796, K053290)
• EndoCare CryoCare Surgical System, Model Cryo 20 (K023757)
• Microsurgeon Microwave Tissue Ablation Device (070023)
• Boston Scientific RF 3000 Generator (K000241)

Submission Summary (Full Text)

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| Date: | October 5, 2010 | K100744 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Subject: | 510(k) Summary of Safety and Effectiveness Information for the<br>NeuWave Medical Certus 140 2.45 GHz Ablation System and Accessories | |
| Company: | NeuWave Medical, Inc.<br>3529 Anderson Street<br>Madison, WI 53704 | OCT 2 2 2010 |
| FDA Establishment# | TBD | |
| Contact: | Dan Kosednar, Director of Regulatory Affairs and Quality Assurance<br>P – 608-512-1592<br>F – 608-512-1509 | |
| Proprietary: | Certus 140 2.45 GHz Ablation System and Accessories | |
| Common: | System, Ablation, Microwave and Accessories | |
| Classification: | General and Plastic Surgery, 73 NEY, 21 CFR 878.4440 | |

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.

## Predicate Devices

The Certus 140 2.45 GHz Ablation System and Accessories is substantially equivalent to the following currently marketed device:

- ValleyLab Microwave Ablation Generator Class II 21CFR878.4400, which has been the . subject of a cleared 510(k) with FDA log number 072687 and K053535.
- ValleyLab Cool-Tip RF Generator, Cool-Tip RF System and Accessories Class II -. 21CFR878.4400, which has been the subject of a cleared 510(k) with FDA log number K052796 and K053290.
- EndoCare CryoCare Surgical System, Model Cryo 20 Class II 21CFR878.4350, which . has been the subject of a cleared 510(k) with FDA log number K023757.
- Microsurgeon Microwave Tissue Ablation Device Class II 21CFR878.4400, which has . been the subject of a cleared 510(k) with FDA log number 070023
- Boston Scientific RF 3000Generator Class II 21CFR878.4400, which has been the . subject of a cleared 510(k) with FDA log number K000241

### Intended Use

The NeuWave Medical Certus 140 2.45 GHz Ablation System and Accessories are intended for the ablation (coagulation) of soft tissue.

The Certus 140 2.45 GHz Ablation System is not intended for use in cardiac procedures.

Certus 140 510(k) Submission Safety Summary Page 1 of 3

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NeuWave recommends against the use of the Certus 140 2.45 GHz Ablation System in the following situations:

- . Pregnant patients – potential risks to patient and/or fetus have not been established
- Patients with implantable pacemakers or other electronic implanted electronic ● devices may be adversely affected by microwave power

The system is designed for facility use and should only be used under the orders of a clinician.

## Device Description

The system has three (3) independent 2.45 GHz microwave generators, each capable of producing up to 140W each. One, easy to use, touch-screen user interface controls the system. Up to 3 microwave ablation probes can be connected to and powered by the system at one time. The maximum selectable power for the system is 140W when one probe is connected, 95Wper probe when 2 probes are connected and 65W per probe when 3 probes are connected. An intermediate junction box or Power Distribution Module (PDM) reduces system set up complexity.

Probes are provided sterile and are intended for single patient use only. Probes are available for both percutaeous and open surgical applications. Percutaneous probes are comprised of 17 gauge needles, a probe handle, a 1.4M cable and a connector assembly. Percutaneous probes are available in Certus M and Certus ". Certus " probes are designed to perform optimally, in terms of efficiently transferring energy into tissue, in liver and kidney tissue. Certus 1400 probes are designed to perform optimally, in terms of efficiently transferring energy into tissue. All percutaeous probes are available in 15cm and 20 cm lengths.

The open surgical probe, Certus 80, is 13 gauge and available in a 25cm length.

All probes have temperature sensing thermocouples at various places along the shaft to monitor the probe temperature.

A CO2 based cooling system ensures the non-active portion of the probe does not exceed temperature requirements. Additionally, the CO2 enables the Tissu-Loc function, which can be used to adhere or stick the probe in place prior to starting ablation therapy. This function is similar in use to the stick function available on cryogenic ablation systems.

The system uses two (2) E-sized CO2 cylinders. When a tank in use empties, the system will automatically switch to using the other tank and notify the user to replace the empty tank.

### Performance Data

The Certus 140 2.45 GHz Ablation System and Accessories has been designed to comply with the applicable portions of various International Standards, including:

- . UL 60601-1:2003
- IEC 60601-1:1988 Plus Amendments .
- IEC 60601-2-2:2006 ●
- IEC 60601-2-6:1984 �
- . IEC 60601-1-2:2007
- EN ISO 11607-1:2006 .

Certus 140 510(k) Submission Safety Summary Page 2 of 3

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- . ISO 10993-1: 2003
The Certus 140 2.45 GHz Ablation System and Accessories and the predicate devices are substantially equivalent in design concepts, technologies and materials. The Certus 140 Ablation 2.45 GHz System and Accessories has been verified through rigorous testing that, in part, supports the compliance of Certus 140 2.45 GHz Ablation System and Accessories to the standards listed above.

Ex-vivo studies were conducted to compare the performance of the Certus 140 2.45 GHz Ablation System and Accessories to a predicate device.

:

Certus 140 510(k) Submission Safety Summary Page 3 of 3

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Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines and a wavy line at the bottom.

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

NeuWave Medical, Inc. % Mr. Daniel Kosednar 3529 Anderson Street Madison, Wisconsin 53704

OCT 2 2 2010

Re: K100744

Trade Name: Certus 140 2.45 GHz Ablation System and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NEY, GEI Dated: October 6, 2010 Received: October 7, 2010

Dear Mr. Kosednar:

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 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

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Page 2 - Mr. Daniel Kosednar

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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Fon
Nothin
Din

Mark N Melk Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

100744 OCT 2 2 2010

510(k) Number (if known): K

Device Name: Certus 140 2.45 GHz Ablation System and Accessories

Indications For Use:

The NeuWave Medical Certus 140 2.45 GHz Ablation System and Accessories are intended for the ablation (coagulation) of soft tissue.

The Certus 140 2.45 GHz Ablation System is not intended for use in cardiac procedures.

NeuWave recommends against the use of the Certus 140 2.45 GHz Ablation System in the following situations:

- Pregnant patients potential risks to patient and/or fetus have not been established .
- Patients with implantable pacemakers or other electronic implanted electronic . devices may be adversely affected by microwave power

The system is designed for facility use and should only be used under the orders of a clinician.

Prescription Use XXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Division Sign-Off

(Divisio (Division Sign-on), Orthopedic. Divisionomative Devices

510(k) Number K100744