(122 days)
The ClosureFast catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
The ClosureFast™ Radio Frequency Ablation catheter is a sterile, single use, disposable device with an integrated connection cable. The catheter has a 6F profile with a heating element (coil) 8 cm in length and 2.00 mm in diameter. It is available in two working lengths, 60 cm and 100 cm. A single-use limiter feature is added in the Printed Circuit Board Assembly (PCBA) housed inside the handle of the device. It establishes an effective treatment window of 2 hours after the first energy cycle. The catheter's function is to provide thermal energy to the desired treatment site via radiofrequency heating of the catheter heating element. The ClosureFast catheter is designed to be used with the ClosureRFG™ Radiofrequency Generator.
The ClosureFast™ Endovenous Radiofrequency Ablation (RFA) Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Acceptance Criteria and Device Performance:
The provided text details the performance data through design verification and validation testing, and generally states that the device "meets acceptance criteria and performance requirements." However, it does not explicitly list specific numerical acceptance criteria or the reported performance data in a table format for each test. The document provides a list of tests performed, which include:
- Mechanical
- Dimensional
- Mechanical / Tensile Strength
- Electrical
- Environmental
- Simulated Use
- Packaging Verification
- Software Verification and Validation
- Usability
- Benchtop Validation
- Sterilization Validation
- Biocompatibility
The study concluded that: "Test results demonstrate that the proposed ClosureFast catheter meets acceptance criteria and performance requirements and is acceptable for its intended use."
Additional Information (Based on the Provided Text):
- Sample size used for the test set and the data provenance: Not specified in the provided text.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. The submission focuses on device performance testing rather than clinical study data involving human experts for ground truth establishment.
- Adjudication method for the test set: Not applicable, as no clinical study or ground truth establishment by experts is described for this device's performance testing.
- 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 applicable. The device is an electro-surgical catheter, not an AI-powered diagnostic or assistive tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "Software Verification and Validation" was performed, which would be a standalone evaluation of the software components within the device. However, this is not an 'algorithm only' study in the context of diagnostic AI.
- The type of ground truth used: For the design verification and validation tests, the "ground truth" would be established by engineering specifications, regulatory standards, and established scientific principles for each test (e.g., tensile strength measurement against a specified minimum, electrical resistance within a defined range). This is not a clinical ground truth like pathology or expert consensus.
- The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set in the typical sense.
- How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 23, 2023
Medtronic, Inc. Aditi Dave Senior Regulatory Affairs Specialist 2300 Berkshire Lane North Plymouth, Minnesota 55441
Re: K223488
Trade/Device Name: ClosureFast™ Endovenous Radiofrequency Ablation (RFA) Catheter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 22, 2022 Received: December 23, 2022
Dear Aditi Dave:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.03.23 10:40:48 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K223488
Device Name
ClosureFast™ Endovenous Radiofrequency Ablation (RFA) Catheter
Indications for Use (Describe)
The ClosureFast catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the text 'K223488' in a simple, sans-serif font. The text is presented in a horizontal arrangement, with the letter 'K' followed by the numbers '223488'. The text is black and the background is white.
Image /page/3/Picture/1 description: The image shows the word "Medtronic" in a blue, sans-serif font. The letters are bold and evenly spaced. The word appears to be a logo or brand name. The background is plain white.
Page 1 of 4 Medtronic, Inc. Peripheral Vascular Health 2300 Berkshire Lane North Plymouth, MN 55441
Traditional 510(k) Summary ClosureFast Catheter
| 510(k) Summary | This summary of 510(k) safety and effectiveness information isbeing submitted in accordance with the requirements of 21 CFR807.92. |
|---|---|
| Applicant/ Submitter | Medtronic, Inc.2300 Berkshire Lane NorthPlymouth, MN 55441 |
| Contact Person | Aditi DaveSenior Regulatory Affairs SpecialistTel: 763-398-7029Email : aditi.b.dave@medtronic.com |
| Secondary Contact Person | Laura Moen-FtacekRegulatory Affairs DirectorTel : 763-398-7359Email : laura.moen-ftacek@medtronic.com |
| Date Prepared | March 21, 2023 |
| Device Trade Name | ClosureFast™ Endovenous Radiofrequency AblationCatheter |
| Device Common Name | Electrosurgical Device |
| Classification Name | Electrosurgical, Cutting & Coagulation & Accessories |
| Regulation Number | 21 CFR 878.4400 |
| Classification | Class II |
| Classification Panel | General & Plastic Surgery |
| Product Code | GEI |
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the word "Medtronic" in a bold, sans-serif font. The word is a dark blue color. The letters are closely spaced together, creating a solid block of text.
Page 2 of 4
Medtronic, Inc. Peripheral Vascular Health 2300 Berkshire Lane North Plymouth, MN 55441
| Predicate Device | ClosureFast™ Radiofrequency Catheter,Models CF7-7-60, CF7-7-100 and CF7-3-60 | |
|---|---|---|
| Predicate 510(k) Number | K061373 and K111887 | |
| Predicate RegulationNumber | 21 CFR 878.4400 | |
| Indications for Use | The ClosureFast catheter is intended for endovascularcoagulation of blood vessels in patients with superficial veinreflux. | |
| Device Description | The ClosureFast™ Radio Frequency Ablation catheter is a sterile,single use, disposable device with an integrated connection cable.The catheter has a 6F profile with a heating element (coil) 8 cm inlength and 2.00 mm in diameter. It is available in two workinglengths, 60 cm and 100 cm. A single-use limiter feature is addedin the Printed Circuit Board Assembly (PCBA) housed inside thehandle of the device. It establishes an effective treatment windowof 2 hours after the first energy cycle. The catheter's function isto provide thermal energy to the desired treatment site viaradiofrequency heating of the catheter heating element. TheClosureFast catheter is designed to be used with theClosureRFG™ Radiofrequency Generator. | |
| Comparison ofTechnologicalCharacteristics: | The proposed device has the same characteristics as the predicatedevices, with the exception of the following design modifications:Heating element dimensions (length/diameter) Catheter Index Mark spacing Addition of bridge tube Addition of Single Use Limiter Instructions for use updates Table 1 below outlines the comparison in technologicalcharacteristics between the predicate and proposed device that arenot identical but are considered substantially equivalent. | |
| Parameters | ProposedDevice | Predicate Device |
| Introducer SheathCompatibility | 6F | 7F |
| Heating ElementLength | 8 cm | 7 cm 3 cm |
| Heating ElementDiameter | 2.00 mm | 2.3 mm |
| CatheterMarkings | 7.5 cm | 6.5 cm 2.5 cm |
| Bridge Tube | Yes, newcomponent | N/A |
| Single Use Limiter | Yes, newcomponent | N/A |
| Instructions for Use(IFU)(specifications) | Paper IFU (8.5"x 11" saddlestitch) and eIFUleaflet (3.5'' x3.5'' folded) | Paper IFU (4" x 9.94"Map fold) |
{5}------------------------------------------------
K223488
Table 1: Comparison between proposed and predicate device
Performance data
To demonstrate substantial equivalence of the proposed device to the predicate device, the following design verification and validation testing was performed:
- Mechanical ●
- Dimensional
- Mechanical / Tensile Strength ●
- Electrical ●
- Environmental
- Simulated Use
- Packaging Verification ●
- Software Verification and Validation
- Usability
- Benchtop Validation
- Sterilization Validation
- Biocompatibility
Test results demonstrate that the proposed ClosureFast catheter meets acceptance criteria and performance requirements and is acceptable for its intended use.
{6}------------------------------------------------
Page 4of 4 Medtronic, Inc. Peripheral Vascular Health 2300 Berkshire Lane North Plymouth, MN 55441
Summary of Substantial Equivalence
The proposed device has the following equivalencies to the predicate device:
- Intended Use ●
- Indications for Use
- Principle of Operation
- Fundamental scientific technology
- Materials of construction
- Compatibility to ClosureRFGTM Radiofrequency Generator .
- Packaging materials
- Sterilization method
The proposed device modifications do not impact the overall safety and effectiveness of the device. There are no new risks identified or significantly modified existing risks are identified due to these device modifications.
- Conclusion Based on the same intended use, technological characteristics, safety and performance testing included in the submission, Medtronic concludes the proposed ClosureFast Catheter to be substantially equivalent to the predicate ClosureFast Catheters.
§ 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.