(70 days)
The ClosureFAST™ Radiofrequency Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
The ClosureFAST™ Radiofrequency Catheter is provided sterile, and is a single-use, disposable device. It has a 3cm radiofrequency heating element, a flexible shaft, and an integrated instrument cable. It is designed for use with the VNUS RFG2 Generator, cleared under 510(k) K040638.
The provided text describes a 510(k) submission for the ClosureFAST™ Radiofrequency Catheter, focusing on its substantial equivalence to a predicate device. It primarily concerns regulatory approval based on design and material similarity, rather than extensive clinical performance studies comparing it to a human baseline or establishing detailed performance criteria.
Therefore, many of the requested elements for an AI/device performance study (like detailed acceptance criteria, ground truth specifics, expert qualifications, MRMC studies, and sample sizes for training/test sets) are not present in this regulatory document.
However, I can extract the available information and indicate where the requested data is not provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly from "substantial equivalence") | Reported Device Performance |
|---|---|---|
| Intended Use | Identical to predicate device | Identical to predicate device |
| Technology Characteristics | Identical to predicate device's fundamental scientific technology | Identical to predicate device's fundamental scientific technology |
| Material Composition | Identical to predicate device materials | Identical to predicate device materials |
| Design Specifications | Meet established design parameters for the modified 3cm heating element | Testing demonstrates compliance with design specifications |
| Catheter Compatibility | Demonstrate compatibility with other components (e.g., VNUS RFG2 Generator) | Testing demonstrates catheter compatibility |
| Overall Performance | Substantially equivalent performance to the legally marketed predicate device | Results from testing demonstrate substantial equivalence |
Explanation of "Acceptance Criteria": In the context of a 510(k) for a device modification, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device. This means showing that the modified device is as safe and effective as the legally marketed predicate. The performance data presented focuses on comparing the new device to the predicate rather than defining independent, quantitative clinical thresholds of performance like sensitivity/specificity for diagnostic AI.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "Testing was performed on the proposed ClosureFast to compare it to the predicate device." This likely refers to bench testing and engineering verification/validation, not a clinical test set with human patients.
- Data Provenance: Not specified. The testing is described generally as "Design Verification and Validation." Given the nature of device modifications, this testing would typically be controlled laboratory and engineering tests conducted by the manufacturer, not necessarily involving human patient data from a specific country or collected retrospectively/prospectively in a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable and not provided. The ground truth for this type of device (a radiofrequency catheter) is established through engineering principles, material science, and functional testing to ensure it meets design specifications and performs its intended physical action (coagulation). It does not involve expert reader consensus on diagnostic images or patient outcomes in the way an AI diagnostic device would.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are used in studies where human readers are interpreting data or making clinical judgments that need to be reconciled to form a ground truth. For this device's testing, the "ground truth" would be objective measurements and engineering standards.
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
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices that impact human decision-making. The ClosureFAST™ Radiofrequency Catheter is a surgical tool, not a diagnostic AI.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- This information is not applicable. The device is a surgical catheter; it does not operate as a standalone algorithm. Its performance is inherent to its physical function and design.
7. The Type of Ground Truth Used
- The ground truth for this device's performance is based on engineering benchmarks, material specifications, and functional measurements (e.g., radiofrequency energy delivery, coagulation effectiveness in a controlled environment, structural integrity, dimensions). This is not a "ground truth" in the clinical sense (like pathology, expert consensus, or outcomes data).
8. The Sample Size for the Training Set
- This information is not applicable and not provided. The ClosureFAST™ Radiofrequency Catheter is a physical medical device, not an AI model that undergoes a "training" process with a dataset.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable and not provided, as there is no "training set" for this type of device.
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KII1887
A. Submitter
Covidien 15 Hampshire St. Mansfield, MA 02048 Phone: 508-452-4135
510(k) Summary
B. Contact Person
Daniel Campion Manager Regulatory Affairs
C. Date Prepared
June 30, 2011
D. Trade/Proprietary Name
ClosureFAST™ Radiofrequency Catheter
E. Common/Usual Name
Electrosurgical Device
F. Classification Name
Electrosurgical cutting and coagulation device and accessories
G. Predicate Device(s)
ClosureFAST™ Catheter (K061373)
H. Device Description
The ClosureFAST™ Radiofrequency Catheter is provided sterile, and is a single-use, disposable device. It has a 3cm radiofrequency heating element, a flexible shaft, and an integrated instrument cable. It is designed for use with the VNUS RFG2 Generator, cleared under 510(k) K040638.
-Intended Use
The ClosureFAST™ Radiofrequency Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
J. Technology Characteristics
The ClosureFAST™ Radiofrequency Catheter is identical to the predicate device in terms of its intended use and fundamental scientific technology.
The function of the ClosureFAST™ catheter is to coagulate blood vessels by delivering radiofrequency energy to a heating element on the distal end of the catheter that is positioned at a desired treatment site. The device now will be offered with a 3cm heating element, therefore allowing physicians to treat refluxing vein segments less than 7cm in length.
Image /page/0/Picture/24 description: The image shows the text "SEP - 9 2011". The text appears to be a date, with "SEP" representing the month of September. The number 9 likely represents the day of the month. The year is 2011.
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K. Materials
The ClosureFAST™ Radiofrequency Catheter is composed of the same materials as the predicate device.
L. Performance Data
Testing was performed on the proposed ClosureFast to compare it to the predicate device. Testing included Design Verification and Validation on catheter compatibility, design specifications and performance. Results from the testing demonstrate that the modified device is substantially equivalent to the legally marketed predicate device.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, which is a common symbol associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Covidien % Mr. Daniel Campion Regulatory Affairs Vascular Therapies 15 Hampshire St. Mansfield, MA 02048
SEP - 9 2011
Re: KI11887
Trade/Device Name: ClosureFast Radiofrequency Catheter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 10, 2011 Received: August 12, 2011
Dear Mr. Campion:
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. Please note: CDRH does not evaluate information related to contract liability 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 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
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Page 2 - Mr. Daniel Campion
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); 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.
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/ucm115809.htm for 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/Reportal?roblem/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,
E. Keith
Fo Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
510(k) Number (if known): _KI | | 887
Device Name: ClosureFAST™ Radiofrequency Catheter
Indications for Use: The ClosureFAST™ Radiofrequency 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 (Part 21 CRF 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111887
§ 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.