The ClariVein™ Infusion Catheter (ClariVein™-IC) is an infusion catheter system designed to introduce physician-specified medicaments into the peripheral vasculature. Infusion is through an opening at the distal end of the catheter and fluid delivery is enhanced by the use of a rotating dispersion wire to mix and disperse the infused fluid in the blood stream and on the vessel wall. The dispersion wire, connected to an interface cartridge for proximal connection to the motorized handle, extends through the catheter lumen. Prior to drug infusion the catheter sheath is inserted into the vasculature and once the catheter tip is positioned at the treatment site, the catheter sheath is retracted to expose the dispersion wire tip. Wire rotation is controlled by a 9V DC motorized Handle Unit. The Handle Unit also provides a grip and syringe holder to facilitate physiciancontrolled infusion.

AI/ML Overview

The provided text describes the ClariVein™ Infusion Catheter and its non-clinical performance testing. However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested about sample sizes, ground truth establishment, or multi-reader studies.

The document focuses on demonstrating substantial equivalence to predicate devices and adherence to general safety standards for infusion catheters.

Here's an attempt to extract the requested information based on the provided text, combined with an explanation of what is not present:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for performance metrics. Instead, it refers to industry standards and general performance adequacy.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ISO 10555-1 ("Sterile, Single-Use Intravascular Catheters - Part 1: General Requirements")	"ClariVein™-IC will be tested in accordance with ISO 10555-1" (This indicates a commitment to meet the standard, but no specific results are reported in this document.)
Adequate performance for:	"Additional testing (i.e., Dispersion Wire Tip Fatigue, Dispersion Wire Tip Tensile Test, System Simulated Procedure, and Wire Drive System Mechanical Strength) has already been conducted and shown that ClariVein™-IC performs adequately without failure."
- Dispersion Wire Tip Fatigue	Performed adequately without failure.
- Dispersion Wire Tip Tensile Test	Performed adequately without failure.
- System Simulated Procedure	Performed adequately without failure.
- Wire Drive System Mechanical Strength	Performed adequately without failure.

Missing Information: Specific quantitative thresholds for "adequate performance" for each test are not provided. For example, what is the maximum acceptable fatigue, minimum tensile strength, or specific system performance metrics?

Study Information (Based on provided text)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document mentions "additional testing" without giving specific units or quantities for the tests (e.g., number of catheters tested for fatigue).
- Data Provenance: Not specified. The testing is non-clinical, likely conducted by the manufacturer, but the location or whether it was prospective/retrospective is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is not applicable as the "testing" described is non-clinical (mechanical and safety testing of the device itself) rather than clinical performance based on expert interpretation of medical data. There is no mention of human experts establishing ground truth for these non-clinical tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to adjudication in studies where human readers are interpreting medical data, which is not the type of study described here.
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. This is a non-clinical 510(k) submission for an infusion catheter, not an AI or imaging device requiring MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" would be established by engineering specifications, material standards, and validated testing methodologies (e.g., fatigue cycles, force applied for tensile strength, simulated physiological conditions for system performance). There is no "expert consensus" in the medical sense or pathology data involved in these types of non-clinical tests.
The sample size for the training set:
- Not applicable. This device is not an AI or machine learning model that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

Summary

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K071468 page 1 of 2.

MAR 2 0 2008

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510(k) Summary Statement

Submitter: Vascular Insights, LLC 395 Boston Post Road Madison, Connecticut 06443

Contact: John Marano President & CEO Vascular Insights, LLC Phone. 203 245 9120 Mobile. 203 376 3775 Email. jmarano@yascularinsightsllc.com

Date Prepared:	February 13, 2008
510(k) Number:	K071468
Trade Name:	ClariVein™ Infusion Catheter
Common Name:	Infusion Catheter
Classification Name:	Continuous Flush Catheter, 21 CFR 870.1210, Product Code KRA
Predicate Device(s):	Trellis Infusion System (K013635)
	Slip-Cath (K882796)

Device Description:

Intended Use:

The ClariVein™-IC is intended for the infusion of physician-specified agents in the peripheral vasculature.

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Technology:

The ClariVein™-IC is an infusion catheter system designed to introduce physicianspecified medicaments into the peripheral vasculature. Infusion is through an opening at the distal end of the Catheter and fluid delivery is enhanced by the use of a rotating dispersion wire to mix and disperse the infused fluid in the blood stream and on the vessel wall. Dispersion wire rotation is controlled by a 9V DC motorized Handle Unit, which also provides a grip and syringe holder to facilitate physician-controlled infusion. The Handle contains a speed control adjustment knob for physician-selection speed of approximately 2,000 (low), 2,500 (medium), 3,000 (medium-high), and 3,500 (high) RPM. An interlock prevents the Motor Drive Unit (and dispersion wire rotation) from being activated if the Cartridge Unit (plus catheter) is out of position. A green LED light illuminates on the Handle Unit when the Motor Drive Unit is active (and dispersion wire is rotating). The wire dispersion tip has five different configurations to be chosen by the physician. The device is single-use and disposable. All patient-contact materials in ClariVein™-IC components are suitable for medical use and are commonly used in currently marketed infusion catheters.

Clari Vein™-IC is substantially equivalent to the Trellis Infusion System (K013635) and the Slip-Cath Infusion Catheter (K882796). All three devices are intended to be used for infusion of physician-specified fluids into the peripheral vasculature. Similar to the Trellis. ClariVein™-IC, contains a sheathed dispersion wire that disperses the infused fluid and is operated via a hand-held, battery-powered motor. Similar to the Slip-Cath Infusion Catheter, ClariVein™-IC is a single lumen catheter with a diameter of approximately 3 Fr. All three catheters are disposable and are for single use.

Non-clinical Performance Testing:

Prior to marketing. Clari Vein™-IC will be tested in accordance with ISO 10555-1, "Sterile, Single-Use Intravascular Catheters - Part 1: General Requirements." Additional testing (i.e., Dispersion Wire Tip Fatigue, Dispersion Wire Tip Tensile Test, System Simulated Procedure, and Wire Drive System Mechanical Strength) has already been conducted and shown that ClariVein™-IC performs adequately without failure.

Conclusion:

Clari Vein™ IC is safe, performs adequately, and is substantially equivalent to identified predicate devices, i.e., the Trellis Infusion System (K013635) and the Slip-Cath Infusion Catheter (K882796).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2008

Vascular Insights, Inc. c/o Mr. John P. Marano 395 Boston post Road Madison, CT 06443

Re: K071468

Trade/Device Name: ClariVein Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: February 13, 2008 Received: February 13, 2008

Dear Mr. Marano:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. John P. Marano

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bram Zuiderveen

Bram Zuckermann Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K071468

Device Name:

ClariVein™ Infusion Catheter

Indications For Use:

The ClariVein™ Infusion Catheter is intended for the infusion of physician-specified agents in the peripheral vasculature.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)	Page 1 of 1
Division of Cardiovascular Devices
510(k) Number	K071468

Regulation Number and Section

§ 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).