The AngioDynamics, Inc. NeverTouch II Fiber is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of variose veins and varicosties associated with superficial reflux of the great saphenous vein, and for the treatment of incomprence and reflux of superficial veins of the lower extremity.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification for a device modification, specifically for the "AngioDynamics, Inc. NeverTouch II 400µm Fiber and VenaCure Procedure Kit." This is not a study or research paper describing acceptance criteria and a study to prove a device meets those criteria. Instead, it's a regulatory submission affirming substantial equivalence to a legally marketed predicate device.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria, device performance results, sample sizes for test/training sets, data provenance, expert qualifications, ground truth establishment, or any comparative effectiveness studies.

Here's why each point cannot be addressed from the given text:

A table of acceptance criteria and the reported device performance: The document states "Performance Standards: None Established" in section (j). It doesn't present any specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) for the modified device or report performance metrics against such criteria. The submission is based on substantial equivalence, implying that if the modified device is substantially similar to the predicate and doesn't introduce new risks, specific performance testing against novel criteria isn't always required in the same way a de novo device might.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance is mentioned. This is a regulatory filing, not a clinical study report.
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): No mention of experts or ground truth establishment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there's no test set or study described.
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 device is a surgical fiber, not an AI-powered diagnostic tool, and no MRMC study or AI assistance is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No ground truth is mentioned.
The sample size for the training set: Not applicable. No training set is mentioned.
How the ground truth for the training set was established: Not applicable. No training set or ground truth is mentioned.

The document is a communication from the FDA granting clearance for a modified medical device based on its substantial equivalence to previously cleared predicate devices, without detailed performance studies being explicitly presented within this particular submission.

Summary

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"Special 510(k): Device Modification" AngioDynamics, Inc. NeverTouch II 400μm Fiber and VenaCure Procedure Kit

Confidential

General Information:

ANGIODYNAMICS, Inc. intends to introduce the following device into commercial distribution:

a)	Trade Name:	AngioDynamics, Inc. NeverTouch II 400µm Fiberand VenaCure Procedure Kit
b)	Legally Marketed Device:	AngioDynamics, Inc. NeverTouch 600µm Fiberand VenaCure Procedure Kit
	510(k) Number:	K071959
b)	Common Name:	Greater Saphenous Vein Procedure Kit
c)	Classification Name:	Laser Instrument, Surgical Powered	JAN 23 200
d)	Established Registration Number:	1319211
e)	Manufacturing Site Address:	ANGIODYNAMICS, Inc.603 Queensbury AvenueQueensbury, New York12804
f)	Sterilization Site Address:	Sterigenics / IBA / Griffith Microscience27 Park Rd.Glens Falls, NY 12801
g)	Sterilizer EstablishmentRegistration Number	13196189
h)	Classification:	Accessories to Laser Instrument, SurgicalInstrumentsProduct Code: GEX21 CFR 878.4810

i) Device Equivalence:

This product is substantially equivalent to the following device:

AngioDynamics, Inc. NeverTouch 600μm Fiber VenaCure Procedure Kit, . K071959
:
CoolTouch Laser System, K040921 .
Page 3 of 23

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This device does not present additional risks to patients or different considerations regarding safety and effectiveness than those presented by the predicate devices.

Performance Standards: None Established j)

ANGIODYNAMICS® Contact Information: k)

Teri Juckett, Regulatory Affairs Manager Name:

603 Queensbury Avenue Address: Queensbury, New York 12804

Phone: (518) 798-1215 extension 1142

Fax: (518) 798-3625

I) Payment Identification Number MD6033627-956733
Page 4 of 23

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

JAN 23 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AngioDynamics, Inc. % Ms. Teri Juckett Regulatory Affairs Manager 603 Queensbury Avenue Queensbury, New York 12804

Re: K073464

Trade/Device Name: AngioDynamics, Inc. NeverTouch II 400pm Fiber Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 28, 2007 Received: December 31, 2007

Dear Ms. Juckett:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Ms. Teri Juckett

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Comrtial ce at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarlet Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K073464 Pg 1 of 1

INDICATIONS FOR USE

510(k) Application: Special 510(k): Device Modification

Device Name: AngioDynamics, Inc. NeverTouch II 400um Fiber

Indications for Use:

Prescription Use X (Per 21 CFR 801.109)

Over-the-Counter Use

Please do not write below this line - continue on another page if needed

Concurrence of CDRH, Office of Pevice Evalual

Office of Device Evaluation (ODE)

Mark A. Millan

(Division Sign-Off Division of General, Restorative, and Neurological Dev

510(k) Number

AngioDynamics NeverTouch II 400µm Fiber and VenaCure Procedure Kit, 510(k) Design History File 525

Page 7 of 23

· .

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.