(496 days)
Not Found
No
The description focuses on the electrosurgical mechanism and does not mention any AI/ML components or functions.
Yes
The device is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux, which is a medical treatment for a disease condition, classifying it as a therapeutic device.
No
Explanation: The device description states its purpose is for "endovascular coagulation of blood vessels," and it uses "RF (radiofrequency) energy ... to heat a blood vessel to a predetermined heat and coagulate that blood vessel." This describes a treatment or surgical intervention, not a diagnostic process to identify or characterize a condition.
No
The device description explicitly details hardware components such as a hand piece, flexible shaft, and distal tip section containing an RF electrode, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for endovascular coagulation of blood vessels in patients with superficial vein reflux." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a catheter that delivers RF energy to heat and coagulate blood vessels. This is a physical intervention within the body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens and provide information for diagnosis, monitoring, or screening. This device is clearly used in vivo (within the body) for treatment.
N/A
Intended Use / Indications for Use
NES Reprocessed Varicose Vein RF Catheters are intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Product codes (comma separated list FDA assigned to the subject device)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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)
1
| 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)
2
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