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, electrical current is delivered between pairs of probes in a series of pulses. The waveform of the current is adjustable as determined by clinician-chosen parameters. These parameters include volts/cm, pulse length, number of pulses to be delivered between electrode pairs, distance between probes, and the timing mode (90PPM, 240PPM or ECG synchronization). Up to six probes may be placed in an array within the tissue. The array are matched as pairs by the system. When probes are activated via a foot-pedal, the scheduled current is delivered to tissue between subsequent pairs of probes. Soft tissue between the probes is ablated.

AI/ML Overview

Please note that the provided document is a 510(k) summary for a medical device which aims to demonstrate substantial equivalence to a predicate device. It is not a clinical study report or a publication detailing a clinical trial with acceptance criteria and statistical analysis of a new device's performance against a pre-defined set of criteria in a clinical setting.

Therefore, many of the requested categories, such as "Sample size used for the test set," "Number of experts used to establish ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "Standalone performance," are not directly applicable or explicitly stated in this type of regulatory submission. The document focuses on demonstrating that modifications to an existing device do not alter its safety or effectiveness.

However, I will extract and present the information that is available and relevant to your request based on the provided text.

Acceptance Criteria and Device Performance (Based on Technical and Safety Requirements for Substantial Equivalence)

The document primarily focuses on verifying that the modified NanoKnife System continues to meet its specified performance and safety requirements, which are implicitly the "acceptance criteria" for substantial equivalence to the predicate device. The performance data section describes the types of tests conducted to ensure this.

Acceptance Criteria (Implied)	Reported Device Performance
Functional/Performance Specifications:
- ECG synchronization operation is correct	Verified (Performance testing confirms specifications met)
- Power supply regulation is correct	Verified (Performance testing confirms specifications met)
- AC/DC board voltages are within specification	Verified (Performance testing confirms specifications met)
- Charge bank verification is successful	Verified (Performance testing confirms specifications met)
- Hardware safety measures (e.g., over/under current pulse intervention, overlength pulse) are functional	Verified (Performance testing confirms specifications met)
- Field Programmable Gate Array firmware functionality is correct	Verified (Performance testing confirms specifications met)
- Voltage and current accuracy is within specification	Verified (Performance testing confirms specifications met)
- Pulse duration is accurate	Verified (Performance testing confirms specifications met)
- Minimum capacitance is met	Verified (Performance testing confirms specifications met)
- Pulse amplitude is accurate	Verified (Performance testing confirms specifications met)
- Pulse frequency is accurate	Verified (Performance testing confirms specifications met)
- Pulse intervals are correct	Verified (Performance testing confirms specifications met)
- Pulse count is accurate	Verified (Performance testing confirms specifications met)
- Maximum energy delivered is within specification	Verified (Performance testing confirms specifications met)
- Emergency Stop Button functionality is correct	Verified (Performance testing confirms specifications met)
Environmental/Durability:
- Withstands shipping environmental and vibration/handling stress	Verified (Ship testing environmental and vibration/handling)
- Meets reliability standards	Verified (Reliability testing)
Electromagnetic Compatibility (EMC):
- Complies with EN 60601-1-2:2001/A1:2006	Verified (EMC testing confirms compliance)
Electrical Safety:
- Complies with IEC 60601-1-2:2001/A1:2004	Verified (Electrical safety testing confirms compliance)
Software Validation:
- Software performs as specified and validated	Verified (Software validation testing)
Shelf Life:
- Single Electrode Probes have a 3-year shelf life	Demonstrated (Increased shelf life specification based on testing/analysis)
Biological Impact (Thermal Ablation):
- Potential thermal ablation volumes lie within electroporation volumes	Verified via worst-case computational modeling (Pennes bioheat model, finite element analysis)

Detailed Information as Available from the Document:

A table of acceptance criteria and the reported device performance:
(See table above) These are implicitly the acceptance criteria for determining substantial equivalence based on the technical changes. The "reported device performance" is that the device "meets all the specified performance specifications."
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document describes engineering and in-vitro testing of the modified device, not a clinical study with a "test set" in the sense of patient data. Therefore, information on sample size for a test set (e.g., number of patients/cases), data provenance (country of origin), or retrospective/prospective nature is not applicable or provided. The tests mentioned are laboratory-based.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable as the document describes technical/engineering testing, not a clinical study requiring expert-established ground truth on patient data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the document does not describe a clinical study requiring adjudication of expert-derived ground truth.
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:
This information is not applicable. The device (NanoKnife System) is an electrosurgical device for soft tissue ablation, not an AI-powered diagnostic or interpretive tool that assists human readers. No MRMC study is mentioned or relevant to this type of device and submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The NanoKnife System is a medical device (hardware and software) that performs a physical intervention (ablation). It is not an algorithm designed for standalone diagnostic performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the engineering and performance testing described:
- Functional/Performance Testing: The "ground truth" is adherence to predefined engineering specifications, design requirements, and regulatory standards (e.g., voltage accuracy, pulse duration, EMC compliance).
- Biological Impact Modeling: The "ground truth" for the modeling was based on established physics and biological models (Pennes bioheat model, finite element analysis) using "clinically-relevant input parameters."
The sample size for the training set:
This information is not applicable. The NanoKnife System is not an AI/machine learning device that requires a "training set" in the conventional sense. The "training" for such a device would be its design, development, and testing against engineering specifications.
How the ground truth for the training set was established:
This information is not applicable for the reasons stated in point 8.

Summary

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

June 18, 2015

Angiodynamics Incorporated Ms. Suzanne Goodman Senior Regulatory Affairs Manager 26 Forest Street Marlborough, Massachusetts 01752

Re: K150089

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 18, 2015 Received: May 19, 2015

Dear Ms. Goodman:

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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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Jennifer R. Stevenson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K150089

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)

× Prescription Use (Part 21 CFR 801 Subpart D) D Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K150089 Page 1 of 4

510(k) Summary - NanoKnife System

Date Prepared: 16 January, 2015

A. Sponsor

AngioDynamics, Inc. 603 Queensbury Avenue Queensbury Avenue Queensbury, NY 12804

B. Contact

Suzanne Goodman Senior Regulatory Affairs Manager AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752 508-658-7942

C. Device Name

Trade Name: NanoKnife System Common/Usual Name: Low energy direct current ablation device Classification Name: 21 CFR 878.4400, Electrosurgical Cutting and Coagulation Device and Accessories OAB Product Code: : D. Predicate Device(s) Trade Name: NanoKnife System (K102329)

Common/Usual Name: Classification Name:

Classification Panel:

Low energy direct current ablation device 21 CFR 878.4400, Electrosurgical Cutting and Coagulation Device and Accessories General and Plastic Surgery

E. Device Description

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F. Intended Use and Indications for Use

The intended use of the NanoKnife System is identical to the intended use of the predicate device, the NanoKnife System subject of K102329:

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

The NanoKnife System is used in the same manner as the predicate device, the NanoKnife System subject of K102329.

G. Summary of Similarities and Differences in Technological Characteristics and Performance between the Predicate and Modified Device

The NanoKnife Generator, subject of this 510(k) Premarket Notification, is a modification to the NanoKnife Generator submitted in K102329. The available ablation parameters, pulse amplitude, pulse length, maximum energy per pulse, and energy storage between recharges of the NanoKnife Generator are all identical to the predicate device. The design modifications to the NanoKnife Generator consist of hardware, firmware, software and labeling changes. Table 1 below provides a summary of these changes.

Hardware and Specifications
Component changes due to availability of components and to improvethe electromagnetic (EMC)/electromagnetic (EMI) profile of the deviceto comply with IEC 60601-1 3rd ed. standards.
Increased shelf life specification of Single Electrode Probes to 3 years(no design modification or change to functionality)
Firmware
Programming and code changes to:
• eliminate system shutdowns upon detection of over-currentconditions
• debug programming (continuous device life-cycle improvement)
• enhance software diagnostics
Software
Programming and code changes to:
• remove non-English Languages
• disable radio frequency identification (RFID) functionality
• enable functions in administrator mode (not available to users)
• add clearer warning messages to the user when using 240 PPM and90 PPM pulse modes
• debug programming (continuous device life-cycle improvement)
Labeling
System Manual Updates - reorganized and revised safety section,including expanded discussion of High Current and Over-Currentconditions
User Manual - Removed discussion of RFID functions
User Manual - Add information per IEC 60601-1 3rd ed.
Pouch/Box Label - Administrative changes

Table 1. Summary of Design Modifications

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The NanoKnife Single Electrode Probes and optional Probe Spacer are identical to the NanoKnife Single Electrode Probes and Probe Spacer utilized by the predicate NanoKnife System. Two Single Electrode Probes (15cm and 25cm lengths) are offered with the modified device. The manual actuation, material, tip configuration, and sterilization method of the NanoKnife Single Electrode Probes are all identical to the predicate device.

Furthermore, there have been no changes made to the way ablation procedures will be performed using the NanoKnife System as compared to the predicate device. Users trained in the use of the NanoKnife System predicate device are instructed to confirm that the ablation was successful using standard imaging techniques. Like its predicate device, the NanoKnife System is a tool for surgically ablating soft tissue. Both the predicate device and the NanoKnife System require visual confirmation of ablation using standard imaging techniques (e.g., CT or ultrasound) following the procedure.

H. Performance Data

The modified NanoKnife System Generator was tested per the following to support a determination of substantial equivalence:

Performance testing, including: ●
- ECG synchronization operation O
- Power supply regulation O
- AC/DC board voltages O
- Charge bank verification O
- Hardware safety measures (i.e., over/under current pulse intervention, overlength pulse, O Field Programmable Gate Array firmware functionality, etc.)
- Voltage and current accuracy O
- Pulse duration O
- Minimum capacitance O
- Pulse amplitude O
- Pulse frequency O
- Pulse intervals O
- O Pulse count
- Maximum energy delivered O
- Emergency Stop Button functionality o
Ship testing environmental and vibration/handling ●
Reliability testing
EMC testing (EN 60601-1-2:2001/A1:2006) ●
. Electrical safety testing (IEC 60601-1-2:2001/A1:2004)
Software validation testing .

The test results verify that the NanoKnife System meets all the specified performance specifications and thus, is substantially equivalent to the predicate device.

Additionally, AngioDynamics performed a series of ablation and thermal zone calculations with physical parameters input to the Pennes bioheat model utilizing an industry standard differential equation and finite element analysis tool for physics and biological systems. The results of worst-case modeling indicate that potential thermal ablation volumes lie within the boundaries of electroporation volumes where clinically-relevant input parameters are utilized.

I. Conclusion

The modified NanoKnife System is substantially equivalent to the predicate NanoKnife System (K102329). The design modifications included in this 510(k) Premarket Notification do not affect the cleared intended use or indications for use. Nor do the design modifications alter the fundamental

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technological characteristics of the predicate or raise new questions of safety and effectiveness. Where changes in technology occur, the results of performance testing confirm the modified NanoKnife System is substantially equivalent to 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.