The NanoKnife System is a software-controlled low-energy direct-current (LEDC) generator which surgically ablates soft tissue. Included for use with the system are the NanoKnife Single Electrode Probes and optional Probe Spacer. With the NanoKnife System, a voltage applied between pairs of probes in a series of pulses. The waveform of the voltage is adjustable as determined by clinician-chosen parameters. These parameters include volts/cm, pulse length, number of pulses to be delivered between electrode pairs, the distance between probes, and the timing mode (90PPM or ECG synchronization). Up to six probes may be placed in an array within the tissue. The probes of the array are matched as pairs by the system. When probes are activated via a foot-pedal, the scheduled voltage is delivered to tissue between subsequent pairs of probes. Soft tissue between the probes is ablated.

AI/ML Overview

The provided FDA 510(k) summary for the Angiodynamics NanoKnife System (K183385) does not detail acceptance criteria or a comparative effectiveness study involving human readers with and without AI assistance, as the device is an electrosurgical device for soft tissue ablation, not an AI/imaging diagnostic device.

However, based on the information provided regarding performance testing of the device, I will extract and present the relevant information to address the prompt's requests as much as possible, focusing on the device's technical and safety performance rather than AI-specific criteria.

Here's a breakdown of the acceptance criteria (implied by compliance with standards and performance data) and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/imaging diagnostic device, performance is not measured in terms of metrics like sensitivity, specificity, or AUC. Instead, performance is demonstrated through adherence to safety and performance standards, and comparison to a predicate device's operational characteristics.

Acceptance Criteria Category	Specific Criteria (Implied by Compliance)	Reported Device Performance
Safety	Compliance with IEC 60601-1 (medical electrical equipment safety)	Device tested against ES60601-1:2005/(R)2012 And A1:2012.
	Compliance with IEC 60601-1-2 (electromagnetic compatibility)	Device tested against IEC 60601-1-2 Edition 4.0 2014-02. Modifications made to improve EMC performance to comply with the new revision.
	Compliance with IEC 60601-1-6 (usability)	Device tested against IEC 60601-1-6 Edition 3.1 2013-10.
Biocompatibility	Compliance with ISO 10993 (biological evaluation of medical devices)	Additional biocompatibility testing performed per ISO 10993-1:2009/(R)2013 due to standard changes. Patient contact materials are identical to predicate.
Sterilization	Compliance with ISO 11135, ISO 10993-7, ASTM F1980 (sterilization of healthcare products)	Additional sterilization testing performed due to consensus standard changes. Design of sterilized disposable probes and cycle are identical to predicate.
Software/Firmware	Compliance with IEC 62304 (medical device software life cycle processes)	Device tested against IEC 62304 Edition 1.1 2015-06. Firmware and UI software updated to support new components.
Functionality/Performance (Ablation)	Similar ablation performance to predicate device across expected operating conditions.	Animal study conducted to characterize thermal effects on tissue. The overall performance of the subject device was similar to the performance of the predicate device. Ablation volume similarity demonstrated with a P-value of 0.670 for comparison of mean ablation volume between predicate (NK 2.2) and subject (NK 3.0).
Mechanical/Packaging	Compliance with ASTM D4169 (shipping containers performance), ASTM F1886-98 (seal strength)	Device tested against these standards.
Electrosurgical Specific Guidance	Compliance with FDA Electrosurgical Devices Guidance	Device evaluated against FDA guidance document: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, dated August 15, 2016 (specifically Section E, subsection 1, regarding thermal effects).

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

The document explicitly mentions an "animal study" was conducted for "System Testing" to characterize the device's performance over the expected range of operating conditions, particularly for evaluating "Thermal Effects on Tissue."

Test Set Description: Animal study data.
Sample Size: The exact number of animals or ablation procedures performed in the animal study is not specified in the provided text.
Data Provenance: Not explicitly stated (e.g., country of origin, specific institution), but animal studies are typically conducted under controlled laboratory conditions. The document does not specify whether it was retrospective or prospective, but animal studies for device characterization are generally prospective.

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

Not Applicable. This device is an electrosurgical ablation system, not an AI diagnostic tool requiring expert interpretation of images for ground truth establishment. The "ground truth" for its performance relates to physical parameters like ablation volume, which would be measured directly in the animal study.

4. Adjudication Method for the Test Set

Not Applicable. As above, this is a physical device performance test (ablation volume), not a diagnostic interpretation where adjudication of human judgments would be necessary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI-assisted diagnostic device. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant for this type of device.

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

Not Applicable. This is a hardware electrosurgical device with control software. Its "standalone performance" is its ability to deliver the specified electrical parameters and achieve the intended ablation effect, as demonstrated in the animal study. There is no independent "algorithm" in the sense of an AI model whose performance is measured in isolation.

7. The Type of Ground Truth Used

Direct Measurement/Experimental Observation: For the performance study (animal study), the "ground truth" was likely the directly measured ablation volume or tissue effect observed in the animal models, rather than expert consensus, pathology in the diagnostic sense, or long-term outcomes data as might be used for diagnostic tools. The P-value for ablation volume comparison supports this.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/machine learning system that requires a "training set" of data in the conventional sense. Its "training" or development involves engineering design, component selection, software development, and iterative testing/validation.

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

Not Applicable. As there is no training set for an AI model, the concept of establishing ground truth for it is irrelevant. The "ground truth" for the device's design and functioning is based on established engineering principles, electrical safety standards, and physiological understanding of tissue ablation.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

June 18, 2019

Angiodynamics Troy Roberts Director, Regulatory Affairs 26 Forest Street Marlborough, Massachusetts 01752

Re: K183385

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 Dated: May 22, 2019 Received: May 23, 2019

Dear Troy Roberts:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K183385

Device Name NanoKnife System

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary – K183385

The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:

Submitter Information

Company:	Angiodynamics26 Forest StreetMarlborough, MA 01752 USATelephone: 508-930-0266Fax: 508-658-7934troberts@angiodynamics.com
Contact:	Troy RobertsDirector Regulatory AffairsAngiodynamics26 Forest StreetMarlborough, MA 01752 USATelephone: 508-930-0266Fax: 508-658-7934troberts@angiodynamics.com

Date Summary Prepared:

June 18, 2019

Name of the Device

Trade Name:	NanoKnife System
Common Name:	Low energy direct current ablation device
Classification Name:	Low Energy Direct Current Thermal Ablation System
Review Panel:	General & Plastic Surgery (SU)
Regulation:	878.4400
Class:	Class II
Product Code:	OAB

Equivalence Claimed to Predicate Device

The NanoKnife System is equivalent to the NanoKnife System Version 2.2.1 (K150089), manufactured by Angiodynamics, Inc.

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

Device Description

The subject device is substantially equivalent to the predicate device. The NanoKnife System is a software-controlled low-energy direct-current (LEDC) generator which surgically ablates soft tissue. Included for use with the system are the NanoKnife Single Electrode Probes and optional Probe Spacer. With the NanoKnife System, a voltage applied between pairs of probes in a series of pulses. The waveform of the voltage is adjustable as determined by clinician-chosen parameters. These parameters include volts/cm, pulse length, number of pulses to be delivered between electrode pairs, the distance between probes, and the timing mode (90PPM or ECG synchronization). Up to six probes may be placed in an array within the tissue. The probes of the array are matched as pairs by the system. When probes are activated via a foot-pedal, the scheduled voltage is delivered to tissue between subsequent pairs of probes. Soft tissue between the probes is ablated.

Intended Use

The intended use of the predicate device and the subject device are identical. The intended use is for the surgical ablation of soft tissue.

Indications for Use

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

Summary of Similarities and Differences in Technological Characteristics and Performance between the Predicate and Subject Device

The principle of operation of the subject device is identical to the predicate device. For the subject device, the available ablation parameters (pulse amplitude, pulse length, maximum energy per pulse, etc.) are identical to the Predicate device. Two probe configurations options that were available in the predicate device NanoKnife 2.2.1 were deleted in the subject device: bipolar probe; star shaped six probe array.

The physical design of the device has been modified, primarily to replace electronic components which have become obsolete, and to ensure conformance with the 4th edition of IEC 60601-1-2. In addition, device firmware was updated to support the new components, and the User Interface software was updated. Except for improving the EMC performance to comply with the new revision of IEC 60601-1-2, these modifications did not alter the performance of the device.

The use of RFID to read tags within the probe connectors was introduced. The RFID function assures that only compatible NanoKnife Probes which have not expired are used with the NanoKnife 3.0 system.

Biocompatibility

The patient contact materials are identical to the predicate device, however additional biocompatibility testing in accordance with ISO 10993-1:2009/(R) 2013 was performed because

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

of changes that have occurred in the consensus standard since the date that the original testing included in the Predicate Device submission (K150089) was performed.

Sterilization

The design of the sterilized disposable probes and probe spacer, the sterile packaging and the sterilization cycle are identical between the subject device and the predicate device, however additional testing was performed because of changes that have occurred in the relevant consensus standards (ISO 11135 2nd Edition, ISO 10993-7 2nd Edition, and ASTM F1980-07) since the date that the original testing included in the Predicate Device submission (K150089) was performed.

Safety Data

Device safety was evaluated against the following published consensus standards and FDA guidance documents.

ES60601-1:2005/(R)2012 And A1:2012 ●
IEC 60601-1-2 Edition 4.0 2014-02 .
IEC 60601-1-6 Edition 3.1 2013-10 .
ISO 10993-1:2009/(R)2013 .
ISO 10993-7:2008-10-15 Second edition .

Performance Data

Device performance was evaluated against the following published consensus standards and FDA guidance documents.

ANSI C63.27:2017 .
ASTM D4169 .
ASTM F1886-98 ●
ASTM F1980-07 ●
EN 301 489-1 ●
EN 301 489-3 ●
IEC 62304 Edition 1.1 2015-06 ●
FDA guidance document: Premarket Notification (510(k)) Submissions for . Electrosurgical Devices for General Surgery, dated August 15, 2016

To address the recommendations contained in the FDA Guidance document "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", specifically section E (System Testing), subsection 1 (Thermal Effects on Tissue), an animal study was conducted. The purpose of the testing is to characterize how the device performs over the expected range of operating conditions. The overall performance of the subject device was similar to the performance of the predicate device. There was significant variability observed in ablation volume measurements, however this variability can be attributed to specific experimental factors that are not related to the version of the

{6}------------------------------------------------

NanonKnife system under test. The P-value (0.670) for the comparison of mean ablation volume between the Predicate device NK 2.2 and the Subject device NK 3.0, supports the substantial equivalence of the two systems.

Conclusion

The subject NanoKnife System is substantially equivalent to the predicate NanoKnife System (K150089). The device modifications included in this 510(k) Premarket Notification do not affect the cleared intended use or the fundamental technological characteristics of the predicate. The subject device is as safe and effective as the predicate device.

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.