NES REPROCESSED VARICOSE VEIN RF CATHETER by Northeast Scientific, Inc.

NES Reprocessed Varicose Vein RF Catheters are specially designed electrosurgical catheters. RF (radiofrequency) energy is delivered to an intravascular catheter in order to heat a blood vessel to a predetermined heat and coagulate that blood vessel. NES Reprocessed Varicose Vein RF Catheters incorporate a hand piece, a flexible shaft and a distal tip section containing the RF (radiofrequency) electrode.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Northeast Scientific, Inc. NES Reprocessed Varicose Vein RF Catheter (K090661), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Safety: Device must not pose undue risks to patients or users after reprocessing.	Demonstrated via Biocompatibility Validation of Reprocessing and Sterilization Validation. The overall conclusion states the reprocessed catheters are "safe."
Effectiveness: Device must perform its intended function of endovascular coagulation of blood vessels for superficial vein reflux.	Demonstrated via Function Test(s), and performance testing on animals which "demonstrates that NES Reprocessed Varicose Vein RF Catheters perform as originally intended." The overall conclusion states the reprocessed catheters are "effective."
Substantial Equivalence: Device must perform comparably to the predicate device (VNUS® ClosureFast™ Catheter, Model CF7-7-60 (K061373)).	Performance data (bench, laboratory, animal testing) was conducted to demonstrate substantial equivalence. The conclusion explicitly states the reprocessed catheters are "substantially equivalent to the predicate device."
Integrity/Reliability: Device must maintain its physical integrity and packaging over time.	Demonstrated via Packaging Validation.
Compliance to Standards: Device must meet relevant industry standards.	Compliance with IEC60601-1, IEC60601-2-2, IEC60601-1-2 is stated.

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

Sample Size: The document does not specify exact sample sizes for each test (Biocompatibility, Sterilization, Function, Packaging, Animal Testing). It only broadly states that "Bench, laboratory and animal testing was conducted."
Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the nature of bench, lab, and animal testing for a reprocessed device, it's highly likely this was prospective testing conducted at Northeast Scientific, Inc. facilities or contracted labs.

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

This information is not provided in the given summary. The "ground truth" for this type of device (reprocessed electrosurgical catheter) is established through objective performance metrics from bench, lab, and animal testing rather than human expert interpretation of data like images.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods are typically used when there's subjective human interpretation involved (e.g., in diagnostic image analysis), which is not the primary method for evaluating the performance of this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not provided and is not applicable to this device. This device is an electrosurgical catheter, not an AI-powered diagnostic tool requiring human reader studies.

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

This information is not provided and is not applicable to this device. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance was established through:

Objective measurements and scientific validations:
- Biocompatibility tests (e.g., cytotoxicity, sensitization, irritation)
- Sterilization efficacy tests (e.g., sterility assurance level)
- Function tests (e.g., RF energy delivery, temperature control, mechanical integrity)
- Packaging integrity tests
- Animal studies: Demonstrating the intended physiological effect (coagulation of blood vessels) in a living system.

8. The Sample Size for the Training Set

This information is not provided and is not applicable to this device. As a physical medical device, it does not involve machine learning or "training sets" in the conventional sense. The "training" of the device's design implicitly comes from engineering principles and prior knowledge of electrosurgical catheters.

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

This information is not provided and is not applicable to this device for the reasons stated in point 8.

Summary

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K090661

510 (K) Summary

Date Prepared: 18 August 2009

510(k) number: K090661

Applicant Information:

Northeast Scientific, Inc. 29 S. Commons Road Waterbury, CT 06704

Contact Person:	Craig Allmendinger
Phone:	203-756-2111
Fax:	203-757-5532

Device Information:
Classification:	Class II
Trade Name:	NES Reprocessed Varicose Vein RF Catheter
Classification Name:	Electrosurgical Device (21 CFR § 878.4400)
Product Code:	NUJ
Device Description:	NES Reprocessed Varicose Vein RF Catheters are specially designed electrosurgical catheters. RF (radiofrequency) energy is delivered to an intravascular catheter in order to heat a blood vessel to a predetermined heat and coagulate that blood vessel. NES Reprocessed Varicose Vein RF Catheters incorporate a hand piece, a flexible shaft and a distal tip section containing the RF (radiofrequency) electrode.
Predicate Device:	The NES Reprocessed Varicose Vein RF Catheter is substantially equivalent in intended use and operation to the "VNUS® ClosureFast™ Catheter, Model CF7-7-60 (K061373)"

Intended Use: NES Reprocessed Varicose Vein RF Catheters are intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Northeast Scientific, Inc. NES Reprocessed Varicose Vein RF Catheter Traditional 510(k)

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Performance Data:	Bench, laboratory and animal testing was conducted to demonstrate performance (safety and effectiveness) of NES Reprocessed Varicose Vein RF Catheters. This included the following tests: Biocompatibility Validation of Reprocessing Sterilization Validation Function Test(s) Packaging Validation Performance testing on animals demonstrates that NES Reprocessed Varicose Vein RF Catheters perform as originally intended
Conclusion:	Northeast Scientific, Inc. concludes that the reprocessed catheters are safe, effective and substantially equivalent to the predicate device as described herein.
Standards:	IEC60601-1, IEC60601-2-2, IEC60601-1-2

Performance Data:

Bench, laboratory and animal testing was conducted to demonstrate performance (safety and effectiveness) of NES Reprocessed Varicose Vein RF Catheters. This included the following tests: Biocompatibility Validation of Reprocessing Sterilization Validation Function Test(s) Packaging Validation Performance testing on animals demonstrates that NES Reprocessed Varicose Vein RF Catheters perform as originally intended

Conclusion:

Northeast Scientific, Inc. concludes that the reprocessed catheters are safe, effective and substantially equivalent to the predicate device as described herein.

Standards:

IEC60601-1, IEC60601-2-2, IEC60601-1-2

Northeast Scientific, Inc. NES Reprocessed Varicose Vein RF Catheter
Traditional 510(k)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

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

NOV 30 2011

Northeast Scientific, Inc. % Mr. Craig Allmendinger Chief Executive Officer 29 South Commons Road Waterbury, Connecticut 06704

Re: K090661

Trade/Device Name: NES Reprocessed Varicose Vein RF Catheter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: May 25, 2010 Received: May 26, 2010

Dear Mr. Allmendinger:

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, Or us 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 contractlied to contractliability 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 (and r 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. Your 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.

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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/ucm1118009.htm faou 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.

LKHlin!

am H. Maisel, MD, MPH Deputy Center Director of Science Center for Devices and Radiological Health

Enclosure

List of Model(s):

NES Reprocessed Varicose Vein RF Catheter

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INDICATIONS FOR USE STATEMENT PAGE (IFU)

Company: Northeast Scientific, Inc.

Device Name: NES Reprocessed Varicose Vein RF Catheter

Device Size: CF7-7-60cm

510k #: K090661

INDICATIONS FOR USE

The NES Reprocessed Varicose Vein RF Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux

Prescription use >> (Part 21 CFR 801 subpart D)

AND/OR

Over the counter Use (21 CFR 801 subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)

(Division Sign-Ort), Orthopedic, and Restorative Devices

510(k) Number K090661

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.