ClariVein IC

K201907 · Merit Medical Systems, Inc. · KRA · Aug 6, 2020 · Cardiovascular

Device Facts

• Record ID: K201907
• Device Name: ClariVein IC
• Applicant: Merit Medical Systems, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Aug 6, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ClariVein IC is indicated for the infusion of physician-specified agents in the peripheral vasculature (e.g., superficial veins, saphenous veins).

Device Story

ClariVein IC is a specialty infusion catheter (45cm, 65cm, 85cm lengths) used for delivering physician-specified agents into peripheral vasculature. The device consists of a catheter shaft, infusion port, and rotatable wire connected to an integral, self-contained motor drive unit (MDU). The MDU features a syringe support, handle grip, wire rotation speed selectors, and a trigger for physician-controlled infusion. The device is operated by a physician in a clinical setting. It is a single-use, disposable device that does not contain medicants. The catheter is compatible with 18G or larger peripheral catheters or 4Fr or larger introducers. By providing controlled infusion and wire rotation, the device facilitates the delivery of agents to the target vessel, potentially benefiting patients undergoing peripheral vascular procedures.

Clinical Evidence

No new clinical or bench testing was conducted. Substantial equivalence is supported by literature and post-market customer data confirming the safety and performance of the device for the expanded indications for use.

Technological Characteristics

Catheter assembly with rotatable wire and integral motor drive unit (MDU). Dimensions: 0.035" (2.7F) OD. Materials are biocompatible and identical to the predicate. Single-use, sterile. No phthalates or latex. MDU provides mechanical rotation and infusion control.

Indications for Use

Indicated for infusion of physician-specified agents into peripheral vasculature, including superficial and saphenous veins.

Regulatory Classification

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.

Predicate Devices

• ClariVein IC (K153502)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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

| General<br>Provisions | Submitter Name:<br>Address:<br>Telephone Number:<br>Contact Person:<br>Date Prepared:<br>Registration Number: | Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>[phone]<br>Michaela Rivkowich<br>07/08/2020<br>1721504 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:<br>Common/Usual Name:<br>Classification Name:<br>Premarket Notification:<br>Regulatory Class:<br>Product Code:<br>21 CFR §:<br>Review Panel: | ClariVein® IC<br>Intravascular Catheter, Infusion Catheter,<br>Cannula<br>Continuous Flush Catheter<br>K201907<br>Class II<br>KRA<br>870.1210<br>Cardiovascular |
| Predicate<br>Device | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | ClariVein® IC<br>Continuous Flush Catheter<br>K153502<br>Merit Medical Systems, Inc.<br>This predicate has not been subject to a design-related recall. |
| Reference<br>Device | No reference devices were used in this submission. | |
| Device<br>Description | The ClariVein IC is a specialty infusion catheter available in multiple lengths<br>(45cm, 65cm, 85cm). The catheter assembly, including the catheter shaft,<br>infusion port, and rotatable wire, is connected by means of a cartridge to an<br>integral self-contained motor drive unit (MDU). The MDU includes the syringe<br>support, handle grip, wire rotation speed selectors, and trigger features for<br>physician-controlled infusion of a physician-specified agent. The .035" (2.7F)<br>outside diameter of the ClariVein IC catheter is compatible with an 18 gauge or<br>greater short peripheral catheter or a 4Fr or greater introducer to gain vascular<br>access. The ClariVein IC is labeled sterile for single use and is provided with<br>instruction for its safe and effective use. It has no serviceable or reusable<br>parts. It is entirely disposable post procedure. The ClariVein IC does not<br>include medicants or agents. The ClariVein IC is not made of phthalate or latex<br>material manufactured parts. It has been determined to be biocompatible for its<br>intended use.<br>The associated accessory includes a 5mL piston style, luer syringe as a<br>convenience for the user. | |
| Indications for<br>Use | The ClariVein IC is indicated for the infusion of physician-specified agents in<br>the peripheral vasculature (e.g., superficial veins, saphenous veins). | |
| Comparison to<br>Predicate<br>Device | The subject ClariVein IC has the same overall basic design, controlling<br>mechanism, energy source, technology, operating characteristics, materials<br>and components as the predicate, currently marketed ClariVein IC. The<br>reason for submitting this Special 510(k) is the addition of examples of<br>peripheral vasculature to the indications for use statement. The intended use<br>of the device is the same. | |
| Safety &<br>Performance<br>Data | No performance standards have been established under Section 514 of the<br>Food, Drug and Cosmetic Act for these devices. | |
| | The fundamental scientific characteristics of the subject ClariVein IC are the<br>same as the predicate device. No new performance testing was required to be<br>conducted for the subject ClariVein IC. | |
| | All materials of the subject device are used in the legally marketed predicate<br>ClariVein IC with the same intended use, patient contact, processing and<br>sterilization methods. No new biocompatibility testing was required for these<br>materials. | |
| | Clinical safety and performance information found in the literature,<br>supplemented with post -market customer reported data, support the addition<br>of examples of peripheral vasculature to the Indications for Use statement. | |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, design and materials, the subject ClariVein<br>IC meets the requirements that are considered essential for its intended use<br>and is substantially equivalent to the predicate device, the ClariVein IC,<br>K153502, manufactured by Merit Medical Systems, Inc. | |

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