(56 days)
The VNUS Vessel and Tissue Coagulation System (proprietary name: TBD) is intended for use in vessel and tissue coagulation.
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.
The provided document describes the "VNUS Vessel and Tissue Coagulation System" and details its substantial equivalence to predicate devices, but it does not contain the specific information required to complete the detailed table and answer the questions about acceptance criteria and a study proving device performance.
Here's why and what information is missing:
- Acceptance Criteria & Reported Performance: The document states, "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." However, it does not provide a table of specific quantitative acceptance criteria (e.g., coagulation time, tissue penetration depth, temperature thresholds) or the reported device performance metrics against those criteria.
- Sample Size and Data Provenance: This information is not provided. The document generally mentions "in-vitro testing" but gives no details about the sample sizes used, whether it was animal or human tissue, or the origin of any data.
- Number of Experts & Qualifications: Not mentioned.
- Adjudication Method: Not mentioned.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned, and highly unlikely for this type of electrosurgical device. MRMC studies are typically for diagnostic imaging interpretation.
- Standalone Performance: While "in-vitro testing" implies standalone performance, no specific metrics or study details are provided.
- Type of Ground Truth: Not explicitly stated, although for in-vitro coagulation tests, the ground truth would likely be based on direct measurement of tissue coagulation effects.
- Training Set Sample Size & Ground Truth Establishment: This device is a hardware system, not an AI/ML algorithm. Therefore, there wouldn't typically be a "training set" in the sense of machine learning. The "training" would be related to device validation against engineering specifications and predicate device performance.
Conclusion:
The provided document is a 510(k) summary for a medical device that establishes substantial equivalence based on technological characteristics and general safety/effectiveness. It does not contain the detailed, quantitative performance study data or acceptance criteria typically found in reports for AI/ML devices or more complex clinical trials.
If this were a document about an AI device, the missing information would be critical for evaluating its performance. As it pertains to an electrosurgical device, the 510(k) focuses on demonstrating equivalence to existing, legally marketed devices.
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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
§ 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.