(28 days)
The ClariVein IC is indicated for the infusion of physician-specified agents in the peripheral vasculature (e.g., superficial veins, saphenous veins).
The ClariVein IC is a specialty infusion catheter available in multiple lengths (45cm, 65cm, 85cm). The catheter assembly, including the catheter shaft, infusion port, and rotatable wire, is connected by means of a cartridge to an integral self-contained motor drive unit (MDU). The MDU includes the syringe support, handle grip, wire rotation speed selectors, and trigger features for physician-controlled infusion of a physician-specified agent. The .035" (2.7F) outside diameter of the ClariVein IC catheter is compatible with an 18 gauge or greater short peripheral catheter or a 4Fr or greater introducer to gain vascular access. The ClariVein IC is labeled sterile for single use and is provided with instruction for its safe and effective use. It has no serviceable or reusable parts. It is entirely disposable post procedure. The ClariVein IC does not include medicants or agents. The ClariVein IC is not made of phthalate or latex material manufactured parts. It has been determined to be biocompatible for its intended use. The associated accessory includes a 5mL piston style, luer syringe as a convenience for the user.
The provided document is a 510(k) summary for the ClariVein IC device, which is a medical device for infusing agents into the peripheral vasculature. As such, it does not detail acceptance criteria or a study proving that the device meets acceptance criteria in the way that an AI/ML device submission would. Instead, the document focuses on demonstrating substantial equivalence to a predicate device.
However, I can extract information related to "performance data" which, in the context of a 510(k) for a non-AI/ML device, refers to safety and effectiveness comparisons to an existing device rather than a new performance study.
Here's a breakdown based on the categories you provided, adapted to the context of this document:
1. Table of Acceptance Criteria and Reported Device Performance
This type of table is not present in the document because it's a 510(k) submission showing substantial equivalence, not a de novo clearance or an AI/ML device performance study. The "performance" assessment here is about the device being fundamentally similar to a previously cleared device, not meeting specific quantitative performance metrics against a medical condition for which an AI/ML system would be evaluated.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of an AI/ML performance study as described. The document states:
- "No new performance testing was required to be conducted for the subject ClariVein IC."
- "Clinical safety and performance information found in the literature, supplemented with post-market customer reported data, support the addition of examples of peripheral vasculature to the Indications for Use statement."
This indicates that any "data" considered for the change in indications for use was derived from existing literature and post-market surveillance of the predicate device, not a dedicated "test set" for a new device's performance. The document does not specify sample sizes or countries of origin for this supplementary data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. There was no test set for a new performance evaluation that required expert ground truth establishment.
4. Adjudication Method
Not applicable. There was no test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a 510(k) for a physical medical catheter, not an AI/ML medical device. Therefore, an MRMC study is not relevant to this submission.
6. Standalone (Algorithm Only) Performance Study
No. This device is not an algorithm or AI system.
7. Type of Ground Truth Used
Not applicable in the AI/ML sense. The "ground truth" for this submission revolves around demonstrating that the modified device (with updated indications for use) is still safe and effective and substantially equivalent to the predicate. This is supported by:
- "fundamental scientific characteristics... are the same as the predicate device."
- "All materials of the subject device are used in the legally marketed predicate ClariVein IC with the same intended use, patient contact, processing and sterilization methods."
- "Clinical safety and performance information found in the literature, supplemented with post-market customer reported data."
8. Sample Size for the Training Set
Not applicable. There is no AI/ML component to this device, so no training set was used.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI/ML component to this device, so no training set or its ground truth was established.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 6, 2020
Merit Medical Systems, Inc. Michaela Rivkowich Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095
Re: K201907
Trade/Device Name: ClariVein IC Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: July 8, 2020 Received: July 9, 2020
Dear Ms. Rivkowich:
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
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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,
For
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201907
Device Name ClariVein IC
Indications for Use (Describe)
The ClariVein IC is indicated for the infusion of physician-specified agents in the peripheral vasculature (e.g., superficial veins, saphenous veins).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: K201907
| GeneralProvisions | Submitter Name:Address:Telephone Number:Contact Person:Date Prepared:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 316-3632Michaela Rivkowich07/08/20201721504 |
|---|---|---|
| Subject Device | Trade Name:Common/Usual Name:Classification Name:Premarket Notification:Regulatory Class:Product Code:21 CFR §:Review Panel: | ClariVein® ICIntravascular Catheter, Infusion Catheter,CannulaContinuous Flush CatheterK201907Class IIKRA870.1210Cardiovascular |
| PredicateDevice | Trade Name:Classification Name:Premarket Notification:Manufacturer: | ClariVein® ICContinuous Flush CatheterK153502Merit Medical Systems, Inc.This predicate has not been subject to a design-related recall. |
| ReferenceDevice | No reference devices were used in this submission. | |
| DeviceDescription | The ClariVein IC is a specialty infusion catheter available in multiple lengths(45cm, 65cm, 85cm). The catheter assembly, including the catheter shaft,infusion port, and rotatable wire, is connected by means of a cartridge to anintegral self-contained motor drive unit (MDU). The MDU includes the syringesupport, handle grip, wire rotation speed selectors, and trigger features forphysician-controlled infusion of a physician-specified agent. The .035" (2.7F)outside diameter of the ClariVein IC catheter is compatible with an 18 gauge orgreater short peripheral catheter or a 4Fr or greater introducer to gain vascularaccess. The ClariVein IC is labeled sterile for single use and is provided withinstruction for its safe and effective use. It has no serviceable or reusableparts. It is entirely disposable post procedure. The ClariVein IC does notinclude medicants or agents. The ClariVein IC is not made of phthalate or latexmaterial manufactured parts. It has been determined to be biocompatible for itsintended use.The associated accessory includes a 5mL piston style, luer syringe as aconvenience for the user. | |
| Indications forUse | The ClariVein IC is indicated for the infusion of physician-specified agents inthe peripheral vasculature (e.g., superficial veins, saphenous veins). | |
| Comparison toPredicateDevice | The subject ClariVein IC has the same overall basic design, controllingmechanism, energy source, technology, operating characteristics, materialsand components as the predicate, currently marketed ClariVein IC. Thereason for submitting this Special 510(k) is the addition of examples ofperipheral vasculature to the indications for use statement. The intended useof the device is the same. | |
| Safety &PerformanceData | No performance standards have been established under Section 514 of theFood, Drug and Cosmetic Act for these devices. | |
| The fundamental scientific characteristics of the subject ClariVein IC are thesame as the predicate device. No new performance testing was required to beconducted for the subject ClariVein IC. | ||
| All materials of the subject device are used in the legally marketed predicateClariVein IC with the same intended use, patient contact, processing andsterilization methods. No new biocompatibility testing was required for thesematerials. | ||
| Clinical safety and performance information found in the literature,supplemented with post -market customer reported data, support the additionof examples of peripheral vasculature to the Indications for Use statement. | ||
| Summary ofSubstantialEquivalence | Based on the indications for use, design and materials, the subject ClariVeinIC meets the requirements that are considered essential for its intended useand is substantially equivalent to the predicate device, the ClariVein IC,K153502, manufactured by Merit Medical Systems, Inc. |
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§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).