(28 days)
No reference devices were used in this submission.
No
The device description focuses on mechanical components and physician-controlled infusion, with no mention of AI/ML terms or data processing.
No.
The device is a specialty infusion catheter used for the infusion of physician-specified agents; it does not directly provide a therapeutic effect but rather facilitates the delivery of therapeutic agents.
No
The device is described as an "infusion catheter" used for "infusion of physician-specified agents." Its function is to deliver substances into the vasculature, not to diagnose a condition.
No
The device description clearly details a physical catheter assembly with a motor drive unit, syringe support, handle grip, and other hardware components. It is a physical medical device, not software-only.
Based on the provided information, the ClariVein IC is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "infusion of physician-specified agents in the peripheral vasculature." This describes a procedure performed within the body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The description details a catheter and a motor drive unit designed for delivering substances into blood vessels. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ClariVein IC's function is to deliver agents into the body, which is a therapeutic or procedural function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The ClariVein IC is indicated for the infusion of physician-specified agents in the peripheral vasculature (e.g., superficial veins, saphenous veins).
Product codes
KRA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature (e.g., superficial veins, saphenous veins)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. The fundamental scientific characteristics of the subject ClariVein IC are the same as the predicate device. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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,
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
Provisions | Submitter Name:
Address:
Telephone Number:
Contact Person:
Date Prepared:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 316-3632
Michaela Rivkowich
07/08/2020
1721504 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Premarket Notification:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | ClariVein® IC
Intravascular Catheter, Infusion Catheter,
Cannula
Continuous Flush Catheter
K201907
Class II
KRA
870.1210
Cardiovascular |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | ClariVein® IC
Continuous Flush Catheter
K153502
Merit Medical Systems, Inc.
This predicate has not been subject to a design-related recall. |
| Reference
Device | No reference devices were used in this submission. | |
| Device
Description | 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. | |
| Indications for
Use | The ClariVein IC is indicated for the infusion of physician-specified agents in
the peripheral vasculature (e.g., superficial veins, saphenous veins). | |
| Comparison to
Predicate
Device | The subject ClariVein IC has the same overall basic design, controlling
mechanism, energy source, technology, operating characteristics, materials
and components as the predicate, currently marketed ClariVein IC. The
reason for submitting this Special 510(k) is the addition of examples of
peripheral vasculature to the indications for use statement. The intended use
of the device is the same. | |
| Safety &
Performance
Data | No performance standards have been established under Section 514 of the
Food, Drug and Cosmetic Act for these devices. | |
| | The fundamental scientific characteristics of the subject ClariVein IC are the
same as the predicate device. No new performance testing was required to be
conducted for the subject ClariVein IC. | |
| | 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. No new biocompatibility testing was required for these
materials. | |
| | 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. | |
| Summary of
Substantial
Equivalence | Based on the indications for use, design and materials, the subject ClariVein
IC meets the requirements that are considered essential for its intended use
and is substantially equivalent to the predicate device, the ClariVein IC,
K153502, manufactured by Merit Medical Systems, Inc. | |
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