This document is a 510(k) premarket notification for a medical device (Acculis Accu2i pMTA Microwave Tissue Ablation Applicator) and focuses on establishing substantial equivalence to a predicate device. It does not contain information about a study that proves the device meets specific performance acceptance criteria as would typically be found in a clinical trial report or a comprehensive validation study.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because it is not present in the provided text.

The document primarily states:

The device's name and regulation information.
Its intended use: "intraoperative coagulation of soft tissue."
That it is substantially equivalent to a legally marketed predicate device.

There is no mention of:

Specific quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity, temperature ranges, ablation zone size).
A study design (e.g., test set, training set, experts, ground truth, MRMC study).
Any performance metrics or results.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

AUG 06 2010

Microsulis Holdings Limited % Ms. Denise Rexhaus Quality and Regulatory Manager Units 1 & 2 Falcon Court Parklands Business Park Denmead, Hampshire PO7 6XP United Kingdom

Re: K094021

Trade/Device Name: Acculis Accu2i pMTA Microwave Tissue Ablation Applicator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NEY Dated: July 23, 2010 Received: July 28, 2010

Dear Ms. Rexhaus:

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.

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Page 2 - Ms. Denise Rexhaus

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 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 vours.

Sincerely yours,

Mark A. Milliken

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 Acculis Accu2i pMTA Microwave Tissue Ablation Applicator 510(k)

AUG 06 2010

Indications for Use

402

510(k) number (if known): Unknown - not yet assigned by FDA.

Device name:

Acculis Accu2i pMTA Microwave Tissue Ablation Applicator

Indications for use:

The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.

Prescription Use _ Yes (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use No (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)

Bluden flen Off

(Div)slan Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K094021

Section 4 Page 1 of 1

Page 1 of 1

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.