The NanoKnife System transmits low energy direct current (LEDC) energy from the Generator to Electrode Probes placed in a target area for the surgical ablation of soft tissue. The NanoKnife System includes multiple components. The first component of the system is the Generator. The Generator operates outside of the sterile field and consists of an LCD Display, Console. Power Unit and Power Cord situated on a wheeled trolley and a Double Footswitch/Foot Pedal. The last component of the NanoKnife System is the sterile, single-use, disposable Electrode Probe. The NanoKnife System has the same device configuration as the Oncobionic System with 6 Probe Output (K080202) with minor design modifications to the hardware componentry and software. The range of parameters, pulse amplitude and pulse length, have been narrowed, a third option to the unsynchronized pulse per minute has been added, and touch screen capability in the GUI have been provided to the end user. The fundamental operating principle and design of the NanoKnife System is identical to the Oncobionics predicate devices.

AI/ML Overview

The provided text contains information about the NanoKnife® System's 510(k) premarket notification. However, it does not include details about acceptance criteria, specific device performance metrics, or a study designed to prove the device meets acceptance criteria. The document focuses on demonstrating substantial equivalence to predicate devices through bench testing, rather than reporting on clinical performance against specific metrics.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample size used for the test set or data provenance.
Number of experts or their qualifications for establishing ground truth.
Adjudication method.
MRMC comparative effectiveness study results or effect size.
Standalone performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document explicitly states:

Substantial Equivalence: "The NanoKnife System is substantially equivalent to its predecessors... The NanoKnife System is a modified version of these predicate devices..." (Page 1, Section "PREDICATE DEVICE")
Testing: "All necessary bench testing was conducted on the NanoKnife System to support a determination of substantial equivalence to the predicate device. The bench testing verifies that the NanoKnife System meets all the specified performance specifications and thus, is substantially equivalent to the predicate devices." (Page 1, Section "TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION")

This indicates that the submission relied on bench testing to show that the new device's technical specifications met those of the predicate devices, thereby establishing substantial equivalence. It does not provide data from a study measuring the device's clinical performance against pre-defined acceptance criteria relevant to its intended use (surgical ablation of soft tissue).

Summary

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ANGIODYNAMICS 00

NANOKNIFE® SYSTEM 510(k) PREMARKET NOTIFICATION

SECTION 5 510(k) SUMMARY (CONT.)

510(k) Notification K /02329

GENERAL INFORMATION Applicant: AngioDynamics, Inc. Oncology 46421 Landing Parkway Fremont, CA 94538 U.S.A. Phone: -510-771-0400 FAX: 510-771-0460

Contact Person:

Michael Sharp Vice President, Regulatory and Medical Affairs AngioDynamics, Inc. 14 Plaza Drive Latham, NY 12110 U.S.A. Phone 518-795-1123 Fax: 518-932-0652

Date Prepared: August 16, 2010

DEVICE INFORMATION

The NanoKnife System transmits low energy direct current (LEDC) energy from the Generator to Electrode Probes placed in a target area for the surgical ablation of soft tissue.

Classification:

21CFR §878.4400, Electrosurgical Cutting and Coagulation Device and Accessories

Product Code: OAB

Trade Name: NanoKnife® System

Generic/Common Name:

Low energy direct current non-thermal ablation device

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SECTION 5 510(k) SUMMARY (CONT.)

PREDICATE DEVICE

The NanoKnife System is substantially equivalent to its predecessors, the Oncobionic System with 6 Probe Output (K080202) and the Oncobionic System (K080376). The NanoKnife System is a modified version of these predicate devices that has the same device configuration as the Oncobionic System with 6 Probe Output (K080202). The NanoKnife System includes singleuse, disposable Electrode Probes that are substantially equivalent to those utilized by the predicate devices.

INTENDED USE

The NanoKnife System with six outputs is indicated for the surgical ablation of soft tissue.

PRODUCT DESCRIPTION

The NanoKnife System includes multiple components. The first component of the system is the Generator. The Generator operates outside of the sterile field and consists of an LCD Display, Console. Power Unit and Power Cord situated on a wheeled trolley and a Double Footswitch/Foot Pedal. The last component of the NanoKnife System is the sterile, single-use, disposable Electrode Probe. The NanoKnife System has the same device configuration as the Oncobionic System with 6 Probe Output (K080202) with minor design modifications to the hardware componentry and software. The range of parameters, pulse amplitude and pulse length, have been narrowed, a third option to the unsynchronized pulse per minute has been added, and touch screen capability in the GUI have been provided to the end user. The fundamental operating principle and design of the NanoKnife System is identical to the Oncobionics predicate devices.

SUBSTANTIAL EQUIVALENCE

The indications for use for the NanoKnife System are identical to the indications for use for the predicate devices. The design modifications included in this 510(k) premarket notification do not affect the currently cleared intended use or indications for use or alter the fundamental scientific technology of the predicate devices. Therefore, the NanoKnife System is substantially equivalent to the predicate devices.

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary bench testing was conducted on the NanoKnife System to support a determination of substantial equivalence to the predicate device. The bench testing verifies that the NanoKnife System meets all the specified performance specifications and thus, is substantially equivalent to the predicate devices.

SUMMARY

The NanoKnife System is substantially equivalent to the predicate devices.

R.2/2

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Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or an abstract human figure. The logo is presented in black and white.

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

OCT 2 4 2011

AngioDynamics, Inc. % Experien Group, LLC Kit Cariquitan 155-A Moffett Park Drive, Suite 210 Sunnyvale, California 94089

Re: K102329

Trade/Device Name: NanoKnife® System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: OAB, GEI Dated: October 19, 2011 Received: October 24, 2011

Dear Kit Cariquitan:

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 not the Act

. ﺑ

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Page 2 - Kit Cariquitan

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 yours,

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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ANGIOID YNAMICS®

NANOKNIFE® SYSTEM 510(k) Premarket Notification

SECTION 4 INDICATIONS FOR USE STATEMENT

51/0(k) Number (if known): _k /0232 9

Device Name: NạngKnife® System

Indications For Use:

The NanoKnife System with six outputs is indicated for the surgical ablation of soft tissue.

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogalen for mxm

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

. 510(k) Number K102329

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.