The Covidien Emprint™ Ablation System is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors.

The Covidien Emprint™ Ablation System is not intended for use in cardiac procedures.

Device Description

The Emprint™ Ablation System is a microwave-based system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablating) a defined volume of that tissue. The Emprint™ Ablation System utilizes a 2450 MHz 100W generator to deliver power to a single microwave ablation antenna.

The Emprint™ Ablation Generator is composed of analog and digital circuits with no software or firmware. The Emprint™ Ablation Generator provides for user setting of ablation time and ablation power (5 to 100W). With an optional temperature probe, the Emprint™ Ablation Generator can be set to monitor the temperature of a desired target and to automatically shut the generator off when the target reaches a pre-set temperature.

The Emprint™ Ablation System uses circulating room temperature normal saline to cool the non-radiating portion of the antenna shaft and to provide a more consistent ablation zone. The normal saline is pumped from an IV bag through the antenna shaft and back to the IV bag in a closed system. No saline is in contact with the patient.

The Emprint™ Ablation System consists of the following components: Emprint™ Ablation Generator (2450 MHz), Emprint™ Ablation Antenna (sterile, single use), Emprint™ Ablation Reusable Cable, and Emprint™ Ablation Pump. The system also includes the following optional components: Emprint™ Ablation Cart (with Isolation Transformer), Remote Temperature Probe (sterile, single-use), and Footswitch.

The system must be used with a standard IV bag of sterile normal saline (not provided with the system).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Emprint™ Ablation System, a microwave-based system for soft tissue ablation. However, the document does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states: "The performance of the proposed device was characterized using the same methods used for one of the predicate devices. Coagulations were conducted on several ex vivo and in vivo tissue types at various power and duration settings. The shapes of the coagulation zones created were analyzed and compared to that of the predicate. Bench testing also included verification of dimensional characteristics, surface temperatures, and skin penetration."

However, specific numerical acceptance criteria (e.g., minimum ablation zone size, maximum temperature deviation, etc.) and the precise reported performance values against these criteria are not provided in this summary. The comparison to the predicate device is mentioned as the primary method for demonstrating substantial equivalence, but the detailed results of that comparison are not given.

Therefore, a table cannot be fully constructed.

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

The document mentions "several ex vivo and in vivo tissue types" but does not specify the sample sizes for these tests.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It implies an internal study conducted by the manufacturer (Covidien llc).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not mention the use of experts to establish ground truth. The performance data focuses on physical characteristics of the ablation zone.

4. Adjudication Method for the Test Set:

Not applicable, as no expert review or human interpretation of cases is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. The document describes performance testing of the device itself (ablation characteristics) and not a study involving human readers or the AI's impact on human performance.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

This device is a physical medical instrument (microwave ablation system), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" does not apply in this context. The performance data presented relates to the device's physical capabilities and effects on tissue.

7. The Type of Ground Truth Used:

The "ground truth" for the performance evaluation appears to be the physical measurements and characteristics of the ablation zones created by the device in ex vivo and in vivo tissue, and a comparison of these to a predicate device. This is based on direct observation and measurement of the device's physical output.

8. The Sample Size for the Training Set:

The concept of a "training set" is relevant for machine learning algorithms. This device is a hardware system, not an AI algorithm, so there is no training set in the machine learning sense. The device's "training" or development would involve engineering design, testing, and optimization based on physical principles, not data input for an algorithm.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for an AI algorithm. The device's design and optimization would be based on engineering specifications and empirical testing.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through performance testing related to the physical characteristics of the ablation system. It does not provide the level of detail regarding acceptance criteria, sample sizes, expert involvement, or specific ground truth methodologies that would typically be found in an AI/software device submission.

Summary

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510(k) Summary

APR 2 8 2014

Date: April 28, 2014

510(k) Submitter/Holder

Covidien IIc 15 Hampshire Street Mansfield, MA 02048

Contact

Heather V. Nigro Senior Director, Global Regulatory Affairs Telephone: 508-452-1936 Fax: 508-452-1941 Email: heather.nigro@covidien.com

Name of Device

Trade Name: Emprint™ Ablation System Microwave ablation system and accessories Common Name: Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR § 878.4400, class II, NEY).

Purpose of Submission

The purpose of this submission is to gain clearance for a new microwave ablation system.

Predicate Devices

Emprint™ Ablation System described in this substantially equivalent to the following commercially available predicate devices:

Trade Name:	Valleylab Microwave Ablation Generator
Device Common Name:	Microwave ablation system and accessories
510(k) Number:	K072687
Manufacturer:	Covidien llc
Trade Name:	Certus 140 2.45 GHz Ablation System and Accessories
Device Common Name:	Microwave ablation system and accessories
510(k) Number:	K113237

System Description

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Ablation Generator can be set to monitor the temperature of a desired target and to automatically shut the generator off when the target reaches a pre-set temperature.

The system must be used with a standard IV bag of sterile normal saline (not provided with the system).

Intended Use

The Covidien Emprint™ Ablation System is not intended for use in cardiac procedures.

Technological Characteristics

The Emprint™ Ablation System operates at 2.450 MHz and is capable of operating up to 100 Watts. The user has the ability to select the desired power and time limits. The substantial equivalence of the Emprint™ Ablation System to the predicates is shown by similarity in intended use, indications for use, materials, and performance.

Performance Data

The performance of the proposed device was characterized using the same methods used for one of the predicate devices. Coagulations were conducted on several ex vivo and in vivo tissue types at various power and duration settings. The shapes of the coagulation zones created were analyzed and compared to that of the predicate. Bench testing also included verification of dimensional characteristics, surface temperatures, and skin penetration.

The system adheres to the applicable IEC 60601 standards.

Sterilization

The Emprint™ Ablation Generator, the Reusable Cable, the Pump, and the Cart are not provided sterile and are not used in the sterile field. These four components are reusable, and their cleaning instructions are provided in the instructions for use.

Sterilization validation was performed on the packaged Ablation Antenna and the Remote Temperature Probe according to the requirements of ISO 11135-1: 2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. The sterility assurance level for the devices is 10-6.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 28, 2014

Covidien LLC Ms. Heather Nigro Senior Director, Global Regulatory Affairs 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K133821

Trade/Device Name: Emprint Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Microwave Ablation System And Accessories Regulatory Class: Class II Product Code: NEY Dated: March 27, 2014 Received: March 28, 2014

Dear Ms. Nigro:

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. Iisting 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 - Ms. Heather Nigro

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use Statement

510(k) Number (if known): _ |< 13382 |

Device Name: Emprint™ Ablation System

Indications for Use:

JOS

The Covidien Emprint™ Ablation System is not intended for use in cardiac procedures.

Y AND/OR Over-The-Counter Counter C) Prescription Use (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

a TIN

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.