(218 days)
The VNUS® Closure™ System is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
The VNUS Closure System consists of three main components: The VNUS Closure Catheter, the VNUS RF Generator and the VNUS Instrument Cable. The Closure Catheter is provided sterile, and is a single-use, disposable device. The RF Generator is non-sterile. The Instrument Cable is autoclave sterilized by the user. An optional Footswitch for RF ON/RF OFF is provided for use at the physician's discretion.
The RF Generator is a high frequency (460kHz) electronic, bipolar, microprocessor / software controlled instrument. It allows the user to set Power, Temperature and Time values, and provides user displays of Power, Temperature and Time (setpoints and measured values) as well as measured Impedance and user messages. Audible tones provide additional feedback to the physician. The RF Generator acts to maintain the set temperature by requlating the power delivered up to the maximum set power. By doing so, the RF Generator controls the temperature at the tip of the catheter.
The Closure Catheter is used to provide RF energy to the desired treatment site and relay temperature feedback to the RF Generator. It is designed to deliver the RF energy in a bipolar manner.
The Instrument Cable is used to connect the Closure Catheter to the RF Generator.
The provided text describes the VNUS® Closure™ System and its submission for 510(k) clearance, asserting substantial equivalence to predicate devices. However, it does not contain a detailed study with specific acceptance criteria, reported device performance metrics, or information about sample sizes, expert involvement, or adjudication methods for a clinical trial.
Instead, the document states:
- Discussion of Clinical/Non-Clinical Tests and Conclusions H. Clinical/Non-Clinical tests performed by VNUS have demonstrated the substantially equivalent performance of the Closure System with predicate electrosurgery systems used for substantially equivalent indications.
- Summary of Safety and Effectiveness i. Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by VNUS, it is concluded that the Closure System is substantially equivalent to the noted predicate devices in safety and effectiveness.
This indicates that while non-clinical tests were conducted to demonstrate substantial equivalence, the document does not provide the specific details of those tests. It does not present quantifiable acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, or specific clinical outcomes), nor does it report detailed device performance against such criteria.
Therefore, I cannot populate the table or answer most of the specific questions regarding a clinical study from the provided text.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document states "Clinical/Non-Clinical tests... have demonstrated the substantially equivalent performance." This implies an unquantified level of performance deemed equivalent to predicate devices. | Not specified in the document. Specific performance metrics (e.g., success rates, complication rates, effectiveness measures) are not provided. The conclusion is solely about "substantially equivalent performance." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not mentioned in the provided text.
- Data Provenance: Not mentioned in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not mentioned in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not mentioned in the provided text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not mentioned in the provided text. The document refers to "non-clinical testing" and not specifically to a clinical comparative effectiveness study involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not mentioned in the provided text. The device described is a medical instrument (electrosurgery system), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not mentioned in the provided text, as specific clinical or non-clinical test details are absent.
8. The sample size for the training set
- Not applicable/Not mentioned. The device is a hardware system, not an AI algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable/Not mentioned.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a handwritten date, "3/17/99". The numbers are written in a simple, slightly uneven style. The slashes separating the month, day, and year are represented by vertical lines.
Appendix D:
Summary of Safety and Effectiveness
{1}------------------------------------------------
Summary of Safety and Effectiveness
- A. Determination of Substantial Equivalence VNUS® Closure™ System
- B. Common Name
Electrosurgery System/Electrosurgical Coagulator
-
C. Predicate Device(s)
Cameron-Miller Vein Eraser System (Pre-enactment) VNUS® Closure™ System (K974521) -
D. Device Description
The VNUS Closure System consists of three main components: The VNUS Closure Catheter, the VNUS RF Generator and the VNUS Instrument Cable. The Closure Catheter is provided sterile, and is a single-use, disposable device. The RF Generator is non-sterile. The Instrument Cable is autoclave sterilized by the user. An optional Footswitch for RF ON/RF OFF is provided for use at the physician's discretion.
The RF Generator is a high frequency (460kHz) electronic, bipolar, microprocessor / software controlled instrument. It allows the user to set Power, Temperature and Time values, and provides user displays of Power, Temperature and Time (setpoints and measured values) as well as measured Impedance and user messages. Audible tones provide additional feedback to the physician. The RF Generator acts to maintain the set temperature by requlating the power delivered up to the maximum set power. By doing so, the RF Generator controls the temperature at the tip of the catheter.
The Closure Catheter is used to provide RF energy to the desired treatment site and relay temperature feedback to the RF Generator. It is designed to deliver the RF energy in a bipolar manner.
The Instrument Cable is used to connect the Closure Catheter to the RF Generator.
E. Intended Use
The VNUS Closure System is intended for endovascular coaqulation of blood vessels in patients with superficial vein reflux.
F. Intended Use of Predicate Devices
The specified predicate devices are indicated for "coagulation of blood vessels in patients with superficial vein reflux" and "ablation and coagulation of blood vessels during general surgical procedures."
{2}------------------------------------------------
G. Technological Comparison
The technological characteristics and principals of operation of the VNUS Closure System are substantially equivalent to the noted predicate devices rely on the delivery of RF energy to achieve their intended use.
Discussion of Clinical/Non-Clinical Tests and Conclusions H.
Clinical/Non-Clinical tests performed by VNUS have demonstrated the substantially equivalent performance of the Closure System with predicate electrosurgery systems used for substantially equivalent indications.
Summary of Safety and Effectiveness i.
Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by VNUS, it is concluded that the Closure System is substantially equivalent to the noted predicate devices in safety and effectiveness.
John D'Angelo Vice President, Quality Assurance and Compliance VNUS Medical Technologies, Inc. August 7, 1998
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved shapes that resemble a stylized caduceus or a representation of human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 17 1999
Mr. John D'Angelo Vice President, Quality Assurance and Regulatory Affairs VNUS Medical Technologies, Inc. 238 E. Caribbean Dr. Sunnyvale, CA 94089
Re: K982816 VNUS® Closure™ System Trade Name: Regulatory Class: II Product Code: GEI Dated: December 8, 1998 December 17, 1998 Received:
Dear Mr. D'Angelo:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices
{4}------------------------------------------------
Page 2 - Mr. John D'Angelo
under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and advertising 594-4586. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Device Name: Closure™ System
510(k) Number (if known):
Indications for Use:
} )
}
) ) )
)
) ) )
)
) } ) ﺐ
) -
} --
--
)
)
) ) 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)
Over the Counter Use: (Per 21 CFR 801.109)
or
Prescription Use:
Christopher for TJC
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number _
§ 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.