(18 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on a system for endovascular coagulation.
Yes
The device is intended for "endovascular coagulation of blood vessels in patients with superficial vein reflux," which is a treatment for a medical condition.
No
The VNUS Closure System is described as a treatment device for endovascular coagulation of blood vessels, not for diagnosing conditions.
No
The device description explicitly refers to a "System," and the intended use describes an "endovascular coagulation of blood vessels," which strongly implies a hardware component (likely a catheter or similar device) is involved in the treatment. The summary does not mention any software-only aspects.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "endovascular coagulation of blood vessels in patients with superficial vein reflux." This describes a therapeutic procedure performed within the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description "VNUS® Closure® System" further suggests a system used for a medical procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: The information does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is the defining characteristic of an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VNUS Closure System is a therapeutic device used to treat a medical condition directly within the patient.
N/A
Intended Use / Indications for Use
The VNUS Closure System is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Not Found
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)
Results of in-vitro testing demonstrate that the VNUS Closure System is safe and effective for its intended function.
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
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Date Prepared: February 11, 2000
| 510(k) number: | K030557 |
|---|---|
| ---------------- | --------- |
MAR 1 1 2003
Applicant Information:
VNUS Medical Technologies, Inc. 2200 Zanker Road, Suite F San Jose, CA 95131
| Contact Person: | Sam Nanavati |
|---|---|
| Phone Number: | (408) 473-1100 |
| Fax Number: | (408) 944-0292 |
Device Information:
Classification: Class II VNUS® Closure® System Trade Name: Electrosurgical Device and accessories (21 CFR 870.4400) Classification Name:
Equivalent Device:
The subject device is substantially equivalent in intended use and/or method of operation to the VNUS Closure System (K982816 and K003092)
Intended Use:
The VNUS Closure System is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Test Results:
Performance
Results of in-vitro testing demonstrate that the VNUS Closure System is safe and effective for its intended function.
Biocompatibility
The materials used in the VNUS Closure Catheters have been shown to be biocompatible.
Summary:
Based on the intended use, product, performance and biocompatability information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed and unmodified predicate device.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 2003
Mr. Sam Nanavati Director, Quality Assurance and Regulatory Compliance VNUS Medical Technologies, Inc. 2200 Zanker Road, Suite F San Jose, California 95131
Re: K030557
Trade/Device Name: VNUS® Closure® System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 19, 2003 Received: February 21, 2003
Dear Mr. Nanavati:
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 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.
2
Page 2 - Mr. Sam Nanavati
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 Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indication for Use Statement
510(k) Number (if known):
030557
Device Name:
Closure® System
Indications for Use:
The VNUS Closure System is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the Counter Use
(Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030557