(30 days)
Not Found
No
The device description and summary of performance studies do not mention any AI or ML components or capabilities. The device is described as a mechanical infusion catheter with a motor drive unit.
No
The device is used for infusion of agents in the peripheral vasculature and is not described as treating or curing a disease or condition.
No
The device is described as an infusion catheter used for delivering agents into the peripheral vasculature, which is a treatment modality, not a diagnostic one.
No
The device description clearly outlines a physical catheter with a motor drive unit, indicating it is a hardware device, not software-only.
Based on the provided information, the ClariVein IC is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "infusion of physician specified agents in the peripheral vasculature." This describes a therapeutic or interventional procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a catheter and motor drive unit designed for delivering substances into the bloodstream. This is consistent with an in-vivo (within the living body) device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to deliver a substance, not to diagnose a condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ClariVein IC does not fit this description.
N/A
Intended Use / Indications for Use
The ClariVein IC is indicated for infusion of physician specified agents in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
KRA
Device Description
The ClariVein IC is a specialty infusion catheter with 360°rotatable fluid dispersion wire connected to a proximally located integral battery powered motor drive unit (MDU). The MDU includes the speed selector, handle grip and syringe support features which facilitate physician-controlled infusion of the selected agent. The ClariVein IC is introduced through a microintroducer. Utilizing vascular imaging, the coaxial catheter sheath with dispersion wire is navigated through the vasculature to the treatment site. Fluid delivered through the catheter assembly's infusion port, surrounds the dispersion wire and exits via an opening at the distal end of the catheter. The Clari Vein IC has no user serviceable parts or capital equipment. It is provided to the user sterile, for single patient use and is fully disposable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Nonclinical testing was performed on the Clari Vein IC to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of a stylized human figure with three profiles facing right, representing the department's focus on people and health. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2016
Vascular Insight, LLC c/o Lorraine Hanlev Vice President, Regulatory Affairs 1 Pine Hill Drive Two Batterymarch Park Suite 100 Quincy, MA 02169
Re: K153502
Trade/Device Name: ClariVein IC Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: December 1, 2015 Received: December 7, 2015
Dear Ms. Hanley:
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 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
1
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153502
Device Name ClariVein IC
Indications for Use (Describe)
The Clari Vein IC is indicated for infusion of physician specified agents in the peripheral vasculature.
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)
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510(k) SUMMARY (Page 1 of 3)
Device Name: ClariVein® IC
Date Prepared: 6 January 2016
A. Submitter/Sponsor
Vascular Insights. LLC. 1 Pine Hill Drive, Two Batterymarch Park Suite 100 Quincy, MA 02169 Telephone Number/Fax: 617-519-1109/203-350-0311 Contact Person: Lorraine M. Hanley, Vice President Regulatory Affairs
B. Device Name
| Trade Name: | ClariVein® IC |
|---|---|
| Common/Usual names: | Intravascular Catheter, Infusion Catheter, Cannula |
| Classification Names: | Continuous Flush Catheter |
| Regulation Number | 21 CFR§870.1210 |
| Classification: | Class II |
| ProCode | KRA |
| C. Predicate Device(s) | ClariVein® IC |
| 510(k) | K071468 |
| Common/Usual names: | Intravascular Catheter, Infusion Catheter, Cannula |
| Classification Names: | Continuous Flush Catheter |
| Regulation Number | 21 CFR§870.1210 |
| Classification: | Class II |
| ProCode | KRA |
D. Device Description
The ClariVein IC is a specialty infusion catheter with 360°rotatable fluid dispersion wire connected to a proximally located integral battery powered motor drive unit (MDU). The MDU includes the speed selector, handle grip and syringe support features which facilitate physician-controlled infusion of the selected agent. The ClariVein IC is introduced through a microintroducer. Utilizing vascular imaging, the coaxial catheter sheath with dispersion wire is navigated through the vasculature to the treatment site. Fluid delivered through the catheter assembly's infusion port, surrounds the dispersion wire and exits via an opening at the distal end of the catheter. The Clari Vein IC has no user serviceable parts or capital equipment. It is provided to the user sterile, for single patient use and is fully disposable.
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510(k) SUMMARY (Page 2 of 3)
E. Indication For Use
The ClariVein® IC is indicated for infusion of physician specified agents in peripheral vasculature.
F. Technology Characteristics
The ClariVein IC is a sterile, single use, low profile infusion catheter available in multiple lengths and configurations for physician selection. Its distally located catheter assembly, including the catheter shaft and a 360° rotatable dispersion wire, is connected to the proximally located motor drive unit (MDU) powered by an integral, self-contained 9V battery and circuitry. Infusion is through an opening at the distal end of the catheter and the fluid delivery is enhanced by use of a rotating dispersion wire to deliver the infused fluid into the vessel wall. The rate of rotation of the dispersion wire is physician determined and controlled via the MDU's speed selector. The device provides the user with four optional dispersion wire rotation speeds (RPM); i.e. 2,000 (Low), 2,500 (Medium), 3,000 (Medium-High) and 3,500 (High). Wire rotation is physiciancontrolled by selecting the desired rotation speed and depressing the trigger. The ClariVein IC is provided with labeling which presents instruction for the safe and effective use of the device.
The Clari Vein IC is manufactured of materials demonstrated to be biocompatible for its intended use. The ClariVein IC is not made with phthalate material or natural rubber latex. The ClariVein product does not include medicants. There are no user serviceable parts or capital equipment. The device is entirely disposable upon completion of the procedure.
G. Performance Data
The ClariVein IC has been assessed in accordance with relevant industry standards. FDA recognized standards, and FDA Guidance documents. The product has been determined to meet all relevant parts of the following industry standards and guidance documents:
| ISO 10555-1 Singular Use Intravascular Catheter | ISO 11607-1 Packaging |
|---|---|
| ISO 10993-1, -4, -5, -7, -10, -11 Biocompatibility | ISTA 2A - Transportation |
| IEC 60601-1 3rd Ed. - Electrical Safety | ISO 11135-1 - Sterilization |
| IEC 60601-2 – Electromagnetic Compatibility (EMC) | ISO 15223-1, EN 1041, Labeling |
| ISO 11070 Sterile single use intravascular introducers, dilators and guidewires |
Summary of Nonclinical Tests
Nonclinical testing was performed on the Clari Vein IC to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during testing. Testing included the follow:
Biocompatibility
| Hemocompatibility - Hemolysis | Hemocompatibility-Coagulation | Cytotoxicity |
|---|---|---|
| Direct/Indirect Contact | Unactivated Partial Thromboplastin Time | L929 Natural Red Uptake |
| Hemocompatibility | Irritation/Sensitization | Irritation/Sensitization |
| Thrombogenicity | Kligman Maximization | Intracutaneous Reactivity |
| Systemic Toxicity (acute) | Systemic Toxicity - Acute | Systemic Toxicity (acute) |
| Materials Mediated Rabbit Pyrogen | Materials Mediated Rabbit Pyrogen |
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510(k) SUMMARY (Page 3 of 3)
Performance Testing
| Visual Quality | Corrosion | Labeling Nominals |
|---|---|---|
| Test demonstrates that there are no | Test demonstrates that there are no | Test demonstrates that labeling |
| extraneous materials. | signs of corrosion. | meets unit expressions. |
| Peak Tensile Tests: | ||
| Distal Tip to Sheath | ||
| Hub to sheath at strain relief | ||
| Hub to Guide Wing | ||
| Female coupling to male coupling | ||
| Male coupling to motor drive shaft | ||
| Wire to female coupling | ||
| Test demonstrates that all joints meet | ||
| requirements. | Dispersion Wire Tests: | |
| Tensile | ||
| Fatigue | ||
| Test demonstrates that all joints | ||
| meet requirements. | Simulated Use | |
| Test demonstrates functionality | ||
| in a simulated fixture. | ||
| Liquid leak under pressure | ||
| Test demonstrates no leakage | Wire rotation Speed | |
| Test demonstrates required rotation | ||
| speed. | Torque Force to drive train | |
| Test demonstrates torque | ||
| requirements. | ||
| Syringe and check valve functionality | ||
| Test demonstrates compatible functionality. |
H. Clinical Testing
Not applicable.
I. Animal Testing
Not applicable.
J. Conclusion
Responses to questions posed in the FDA's Substantial Equivalence Decision Flow Chart lead to a determination of "substantial equivalence" for the subject ClariVein IC.
The ClariVein IC is substantially equivalent to the predicate in the following aspects:
- . Design, Function and Manufacture - the subject and predicate devices are substantially equivalent to the technological characteristics of both designs. The predicate ClariVein IC is available in 45 and 65 cm lengths; the proposed ClariVein IC introduces an 85 cm length device.
- Materials - There are no new materials used between the predicate and proposed devices.
- Indications Both the predicate and proposed devices have identical indications for use. ●
- Packaging - The subject and predicate devices utilize similar packaging configurations using industry accepted materials.
- . Sterilization - The subject and predicate devices are both sterilized utilizing a validated EO sterilization process in accordance to ISO 11135.
- . Labeling - Both the subject and predicate device have similar labeling.
Testing was conducted to show that no new risks were identified and that the performance profile is similar to the well-established predicate device cleared for market.