(56 days)
Not Found
No
The description mentions a microprocessor/software controlled instrument but does not include any terms or descriptions indicative of AI or ML capabilities.
Yes
The device is described as "intended use in vessel and tissue coagulation," which is a therapeutic purpose. It uses "bipolar, high frequency electrosurgical system" to achieve this, implying a direct medical intervention for treatment.
No
The device is intended for vessel and tissue coagulation, which is a therapeutic function, not a diagnostic one. It delivers energy to treat tissues, rather than to detect or characterize medical conditions.
No
The device description clearly outlines three main hardware components: the disposable device, the RF Generator, and the instrument cable. While the RF Generator is microprocessor/software controlled, the system is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "vessel and tissue coagulation." This is a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a system that delivers radiofrequency energy to the treatment site for coagulation. This is a physical intervention, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
In summary, the VNUS Vessel and Tissue Coagulation System is a therapeutic medical device used for surgical procedures, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The VNUS Vessel and Tissue Coagulation System (proprietary name: TBD) is intended for use in vessel and tissue coagulation.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The VNUS Vessel and Tissue Coagulation System is a bipolar, high frequency electrosurgical system designed for use in general surgical procedures where lood vessel and tissue coagulation is desired. It consist of three main components The VNUS Vessel and Tissue Coagulation Device (proprietary name; TBD), the Radiofrequency (RF) Generator, and the Instrument Cable.
The VNUS Vessel and Tissue Coagulation Device is sterile disposable device intended for a single-use only. The device's function is to deliver bipolar RF energy to the intenired treatment site and relay temperature and other feedback to the RF General The disposable device is available in three bipolar configurations for selection by the physician based on preference for method of vessel access.
The RF Generator is a high frequency electronic, bipolar, microprocessor / software controlled instrument. It allows the user to set Power, Temperature and Time viruals, and provides user displays of Power, Temperature and Time (set-noints and meanured values) as well as measured Impedance and user messages. The RF Generator remains out of the sterile field during use, and is provided non-sterile.
The instrument cable connects the disposable device to the RF generator. The Instrument Cable is provided non-sterile, and is user sterilizable by autoclave. It has been validated to multiple steam sterilization cycles. Both ends of the cable are identical to eliminate connection errors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Vessel and Tissue Coagulation System (proprietary name: TBD) 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.
K972541, K982816, K003092, K030557, K992581
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.
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Summary of Safety and Effectiveness
K 033547
A. Determination of Substantial Equivalence
JAN - 7 2004
VNUS Vessel and Tissue Coagulation System (proprietary name: TBD)
B. Common Name
Bipolar Electrosurgical Instrument
C. Predicate Device(s)
VNUS® Closure® System (K972541): VNUS® Closure® System (K982816, K003092, and K030557); Cameron-Miller Vein Eraser System (Pre-amendment); and ArthroCare Electrosurgery System (K992581)
D. Device Description
The VNUS Vessel and Tissue Coagulation System is a bipolar, high frequency electrosurgical system designed for use in general surgical procedures where lood vessel and tissue coagulation is desired. It consist of three main components The VNUS Vessel and Tissue Coagulation Device (proprietary name; TBD), the Radiofrequency (RF) Generator, and the Instrument Cable.
The VNUS Vessel and Tissue Coagulation Device is sterile disposable device intended for a single-use only. The device's function is to deliver bipolar RF energy to the intenired treatment site and relay temperature and other feedback to the RF General The disposable device is available in three bipolar configurations for selection by the physician based on preference for method of vessel access.
The RF Generator is a high frequency electronic, bipolar, microprocessor / software controlled instrument. It allows the user to set Power, Temperature and Time viruals, and provides user displays of Power, Temperature and Time (set-noints and meanured values) as well as measured Impedance and user messages. The RF Generator remains out of the sterile field during use, and is provided non-sterile.
The instrument cable connects the disposable device to the RF generator. The Instrument Cable is provided non-sterile, and is user sterilizable by autoclave. It has been validated to multiple steam sterilization cycles. Both ends of the cable are identical to eliminate connection errors.
E. Intended Use
The VNUS Vessel and Tissue Coagulation System (proprietary name: TBD) is intended for use in vessel and tissue coagulation.
F. Intended Use of Predicate Devices
The specified predicate devices are indicated for "coagulation of blood vessels in patients with superficial vein reflux" (VNUS Closure System), "ablation and conagulation of blood vessels during general surgical procedures" (Cameron Miller Vein Erager), and "for resection, ablation and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, and spinal procedures" (ArthroCare Electrosurgical system).
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G. Technological Comparison
The RF energy is widely used in electrosurgical equipment for many years. The safety and efficacy of such devices has been well established for a variety of intended uses. The use of bipolar RF energy delivery has potential advantages over monopolar systems. No grounding pads are required, and the potential for damage to adjacent tissue is minimized, as the patient is no longer the return path for electrical current. The efficiency of bipolar RF energy delivery allows systems such as the VNUS RF Generator to be used at lower voltage and power settings as compared with monopolar systems.
The technological characteristics and principals of operation of the VNUS Vessel and Tissue Coagulation Device (proprietary name: TBD) are substantially equivalent to the noted predicate devices. All devices rely on the delivery of RF energy to achient to the intended use.
Discussion of Clinical/Non-Clinical Tests and Conclusions H.
Performance
Results of in-vitro testing demonstrate that the VNUS Vessel and Tissue Coagulation System (proprietary name: TBD) is safe and effective for its intended function.
Biocompatibility
The materials used in the VNUS Vessel and Tissue Coagulation System (proprietary name: TBD) has been shown to be biocompatible.
-Summary of Safety and Effectiveness
Based upon the intended use, design, materials, function, comparison with currently marketed devices and the non-clinical testing performed by VNUS, it is concluded that the VNUS Vessel and Tissue Coagulation System (proprietary name: TBD) is substantially equivalent to the noted predicate devices.
Sanlavati
Sam Nanavati Directory, Quality and Regulatory Affairs VNUS Medical Technologies, Inc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three horizontal lines that curve upwards, resembling a stylized human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2004
Mr. Sam Nanavati Director, Clinical Affairs VNUS Medical Technologics, Inc. 2200 Zanker Road, Suite F San Jose, California 95131
Re: K033547
Trade/Device Name: VNUS® Vessel and Tissue Coagulation System Regulation Number: 21 CFR 878.4400 Regulation Name: Elcctrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 10, 2003 Received: November 12, 2003
Dcar 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 adultcration.
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 docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Fedcral 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
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. 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 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
Celia M. Witton, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
VNUS® Vessel and Tissue Coagulation System (proprietary name: TBD)
Device Name: VNUS® Vessel and Tissue Coagulation System (proprietary name: TBD)
510(k) Number (if known):
Indications for Use:
The VNUS Vessel and Tissue Coagulation System (proprietary name: TBD) is intended for use in vessel and tissue coagulation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Over the Counter Use: (Per 21 CFR 801.109)
Or
Prescription Use: V
Muriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
Number K633547