The XO Cath Microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic or therapeutic materials into the vessel.

Device Description

The subject XO Cath Microcatheter is a single-lumen, metal alloy shaft with micro-cuts for flexibility, designed to support a guidewire during access of the peripheral vasculature, and to provide a conduit for the delivery of embolic applications. The XO Cath Microcatheter is available in two lumen sizes, 2.0Fr and 2.6Fr.

The XO Cath 2.0Fr and 2.6Fr Microcatheters are available with a straight or bern tip shape to aid with accessing challenging anatomy. The distal outer surface of the microcatheter is coated with a hydrophilic coating. Radiopaque markers are located at the distal tip to facilitate fluoroscopic visualization. The proximal end incorporates a standard luer for ease of use and to connect with a syringe.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the XO Cath Microcatheter, demonstrating its substantial equivalence to a predicate device. It is a medical device, specifically a microcatheter, and therefore the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance bench testing conducted to demonstrate its functional equivalence to the legally marketed predicate device, rather than a clinical study or AI model validation study.

Here's a breakdown of the requested information based on the provided text, focusing on the device performance testing rather than a software algorithm or AI model:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All data met pre-determined acceptance criteria," but it does not explicitly list the numerical acceptance criteria for each test or the specific numerical results for the XO Cath Microcatheter. Instead, it relies on a comparative analysis to the predicate device.

Table: Acceptance Criteria and Reported Device Performance (as inferred from the text)

Test Category	Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Comparative Analysis	Demonstrates comparability to predicate device in:	Demonstrated comparability to predicate device in:
	- Intended use	- Same intended use
	- Indications for use	- Same indications for use
	- Fundamental scientific technology	- Same fundamental scientific technology
	- Material properties (same or similar)	- Same or similar material properties
	- Operating principle (same or similar)	- Same or similar operating principle
	- Performance specifications (similar)	- Similar performance specifications
	- Patient-user interface (similar)	- Similar patient-user interface
Functional Testing	Met pre-determined acceptance criteria for all tests.	All data met pre-determined acceptance criteria. (No specific numerical results provided in this summary)
	Specific Functional Tests:
	- Static Burst Pressure	Met criteria
	- Maximum Infusion Pressure	Met criteria
	- Maximum Flow Rate	Met criteria (e.g., 2.0Fr x 130cm: 3.0 mL/s; 2.6Fr x 130cm: 5.8 mL/s - comparable to predicate)
	- Kink Radius	Met criteria
	- Tensile Testing	Met criteria
	- Torque Testing	Met criteria
	- Coating Lubricity	Met criteria
	- Coating Durability	Met criteria
	- Fluid Leak Testing	Met criteria
	- Hub Assembly Air Leak	Met criteria
	- Physical Embolic Testing	Met criteria
	- Liquid Embolic Exposure Testing	Met criteria
	- Radiopacity	Met criteria
Biocompatibility	Verified according to ISO 10993-1 and FDA guidance for an external communicating device (<24hrs) to circulating blood.	All tests (Cytotoxicity, Sensitization, Irritation/Intracutaneous Toxicity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis Assay, Complement Activation Assay, Partial Thromboplastin Time (PTT), Blood Platelet and Leukocyte Count Testing, LAL Pyrogenicity) successfully performed.
Design Verification	Met applicable design and performance requirements throughout shelf life, conform to standards, demonstrate substantial equivalence.	Material Verification, Dimensional Verification, Visual Verification, Functional/Simulated Use Testing, Packaging, Sterilization performed.

2. Sample size used for the test set and the data provenance

The document describes bench testing and biocompatibility testing rather than a "test set" of patient data for an algorithm. Therefore, "sample size" here refers to the number of devices or materials tested. The exact sample sizes for each bench test are not specified in this summary.

Data Provenance: The testing was conducted by Transit Scientific, LLC, to support a 510(k) submission to the FDA. This implicitly means the testing was performed in a controlled laboratory environment, likely in the US, and is prospective in the sense that the testing was specifically designed and executed to gather data for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this document. The submission is for a physical medical device (microcatheter), not an AI/software device that requires expert ground truth labeling of patient data. The "ground truth" for this device's performance is established through adherence to engineering specifications, recognized standards, and direct comparison to a predicate device's established performance characteristics via bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers are evaluating and labeling data (e.g., radiology images) to establish a consensus "ground truth" for a dataset. This document concerns a physical device's performance through bench testing, not human interpretation of data.

5. 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

This question is not applicable. An MRMC study is relevant for AI/software devices where human readers' performance with and without AI assistance is being evaluated. This document is for a physical microcatheter and does not involve AI or human image interpretation studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This submission is for a physical medical device, not a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this type of device, the "ground truth" is established by:

Adherence to engineering specifications and design requirements.
Compliance with recognized industry standards (e.g., ISO 10993-1 for biocompatibility).
Performance characteristics demonstrated through rigorous bench testing that simulate clinical use conditions and measure physical properties (e.g., flow rate, pressure resistance, kink resistance).
Comparison to the established performance profile of the predicate device. The predicate device itself serves as a benchmark of "safe and effective."

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This question is not applicable. There is no "training set."

Summary

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November 29, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Transit Scientific, LLC % Spencer Walker Director of Regulatory Affairs University of Utah, Center for Medical Innovation 10 North 1900 East, EHSL Rm. 22 Salt Lake City, Utah 84112

Re: K231821

Trade/Device Name: XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: October 27, 2023 Received: October 30, 2023

Dear Spencer Walker:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Samuel G. Raben -S

for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices

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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) K231821

Device Name

XO Cath Microcatheter (E20-090-S, E20-130-S, E20-175-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-110-S, E26-130-S, E26-175-S, E26-175-S, E26-220-S, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)

Indications for Use (Describe)

The XO Cath Microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic or therapeutic materials into the vessel.

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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Image /page/4/Picture/0 description: The image shows the logo for Transit Scientific. The logo is in black and white and features the words "TRANSIT" stacked on top of "SCIENTIFIC." The word "TRANSIT" is in a bold, sans-serif font, while the word "SCIENTIFIC" is in a thinner, sans-serif font. There is a trademark symbol to the right of the word "SCIENTIFIC."

510(K) SUMMARY

(21 CFR 807.92)

GENERAL INFORMATION

Submitter:	Transit Scientific, LLC
Contact Person:	Spencer Walker, MSc – Director of Regulatory AffairsUniversity of Utah/ Center for Medical Innovation10 North 1900 East, Rm. 22BSalt Lake City, UT 84112(801) 708-2238Spencer.walker@hsc.utah.edu
Date Prepared:	June 20, 2023
Trade Name:	XO Cath Microcatheter
Classification Name:	Continuous Flush Catheter21 CFR §870.1210, Product Code KRA
Device Class:	Class II
Predicate Device:	510(k) No.: K163701Model: Direxion and Direxion Hi-Flo Torqueable MicrocatheteManufacture: Boston Scientific CorporationClassification: KRA

Device Description:

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Image /page/5/Picture/1 description: The image shows the logo for Transit Scientific. The logo is in black and white and features the word "TRANSIT" in large, bold letters on the top line. Below that, the word "SCIENTIFIC" is written in smaller letters. The logo has a clean and modern design.

Table 1: XO Cath Microcatheter Model Numbers
Model No.	Description
E20-090-S	XO Cath Microcatheter – 2.0 Fr diameter, and 90cm length, Straight Tip
E20-110-S	XO Cath Microcatheter - 2.0 Fr diameter, and 110cm length, Straight Tip
E20-130-S	XO Cath Microcatheter – 2.0 Fr diameter, and 130cm length, Straight Tip
E20-150-S	XO Cath Microcatheter – 2.0 Fr diameter, and 150cm length, Straight Tip
E20-175-S	XO Cath Microcatheter - 2.0 Fr diameter, and 175cm length, Straight Tip
E20-220-S	XO Cath Microcatheter – 2.0 Fr diameter, and 220cm length, Straight Tip
E20-090-B	XO Cath Microcatheter - 2.0 Fr diameter, and 90cm length, Bern Tip
E20-110-B	XO Cath Microcatheter – 2.0 Fr diameter, and 110cm length, Bern Tip
E20-130-B	XO Cath Microcatheter – 2.0 Fr diameter, and 130cm length, Bern Tip
E20-150-B	XO Cath Microcatheter – 2.0 Fr diameter, and 150cm length, Bern Tip
E20-175-B	XO Cath Microcatheter – 2.0 Fr diameter, and 175cm length, Bern Tip
E20-220-B	XO Cath Microcatheter – 2.0 Fr diameter, and 220cm length, Bern Tip
E26-090-S	XO Cath Microcatheter – 2.6 Fr diameter, and 90cm length, Straight Tip
E26-110-S	XO Cath Microcatheter – 2.6 Fr diameter, and 110cm length, Straight Tip
E26-130-S	XO Cath Microcatheter – 2.6 Fr diameter, and 130cm length, Straight Tip
E26-150-S	XO Cath Microcatheter – 2.6 Fr diameter, and 150cm length, Straight Tip
E26-175-S	XO Cath Microcatheter - 2.6 Fr diameter, and 175cm length, Straight Tip
E26-220-S	XO Cath Microcatheter – 2.6 Fr diameter, and 220cm length, Straight Tip
E26-090-B	XO Cath Microcatheter - 2.6 Fr diameter, and 90cm length, Bern Tip
E26-110-B	XO Cath Microcatheter - 2.6 Fr diameter, and 110cm length, Bern Tip
E26-130-B	XO Cath Microcatheter – 2.6 Fr diameter, and 130cm length, Bern Tip
E26-150-B	XO Cath Microcatheter – 2.6 Fr diameter, and 150cm length, Bern Tip
E26-175-B	XO Cath Microcatheter - 2.6 Fr diameter, and 175cm length, Bern Tip
E26-220-B	XO Cath Microcatheter - 2.6 Fr diameter, and 220cm length, Bern Tip

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Image /page/6/Picture/1 description: The image shows the logo for Transit Scientific. The word "TRANSIT" is in all caps and bolded on the top line. The word "SCIENTIFIC" is in all caps on the second line, but it is not bolded.

Indications for Use:

The XO Cath Microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic or therapeutic materials into the vessel.

Comparative Analysis:

It has been demonstrated that the XO Cath Microcatheter is comparable to the predicate device in intended use, fundamental scientific technology, design, principles of operation and functional performance evaluations. The XO Cath Microcatheter has been fully assessed within the Transit Scientific Risk Management and Design Controls systems. All necessary verification steps met pre-determined acceptance criteria to determine performance as compared to the predicate.

It has been demonstrated that the XO Cath Microcatheter is comparable to the predicate device in the following manner:

Same intended use ●
Same indications for use
Same fundamental scientific technology ●
Same or similar material properties ●
Same or similar operating principle
. Similar performance specifications
Similar patient-user interface

	Subject Device –(XO Cath 2.0 Fr)	Predicate –K163701 (DirexionMicrocatheter)	Subject Device –(XO Cath 2.6 Fr)	Predicate –K163701 (DirexionHi-FloMicrocatheter)
Ind. for Use	The XO CathMicrocatheter is intendedfor peripheral vascularuse. The microcathetercan be used forcontrolled and selectiveinfusion of diagnostic,embolic, or therapeuticmaterials into the vessel	The DirexionMicrocatheters isintended for peripheralvascular use. Themicrocatheter can beused for controlled andselective infusion ofdiagnostic, embolic, ortherapeutic materials intothe vessel.	The XO CathMicrocatheter isintended for peripheralvascular use. Themicrocatheter can beused for controlled andselective infusion ofdiagnostic, embolic, ortherapeutic materialsinto the vessel.	The Direxion HI-FLOTorqueableMicrocatheters isintended for peripheralvascular use. Themicrocatheter can beused for controlled andselective infusion ofdiagnostic, embolic, ortherapeutic materialsinto the vessel.
ClassificationName	Cardiovascular Device - Continuous Flush Catheter21 CFR §870.1210Product Code: KRAClass II
Single Use	Yes
Prescription (RxOnly)	Yes
Table 2: Substantial Equivalence Comparison Chart
	Subject Device -(XO Cath 2.0 Fr)	Predicate -K163701 (DirexionMicrocatheter)	Subject Device -(XO Cath 2.6 Fr)	Predicate -K163701 (DirexionHi-FloMicrocatheter)
AnatomicalAccess	Peripheral vasculature
EffectiveLength (cm)	90cm, 110cm,130cm, 150cm,175cm, and 220cm	105cm, 130cm,155cm	90cm, 110cm,130cm, 150cm,175cm, and 220cm	105cm, 130cm,155cm
Shaft OuterDiameter	Distal: 2.0 FrProximal: 2.6 Fr	Distal: 2.4 FrProximal: 2.7 Fr	Distal: 2.6 FrProximal: 2.75Fr	Distal: 2.8 FrProximal: 3.0 Fr
Inner Lumen	0.021"	0.021"	0.027"	0.027"
Max Pressure(PSI)	1200
Max Flow Rate(mL/s)	2.0Fr x 130cm:3.0 mL/s	2.4Fr x 130cm:3.1 mL/s	2.6Fr x 130cm:5.8 mL/s	2.8Fr x 130cm:5.6 mL/s
Dead SpaceVolume (mL)	2.0Fr x 130cm:0.47 mL	2.4Fr x 130cm:0.46 mL	2.6Fr x 130cm:0.66 mL	2.8Fr x 130cm:0.64 mL
HydrophilicCoating	Yes
Visibility/Radiopacity	Radiopaque Marker Bands on catheter body
GuidewireCompatibility	Max 0.018"	Max 0.018"	Max 0.021"	Max 0.021"
GuideCatheterCompatibility	Min. 0.038 in	Min. 0.035 in	Min. 0.038 in	Min. 0.038 in
EmbolicCompatibility	≤ 700 Micron spheres≤ 500 Micron particlesCoils & Plugs (max0.021" recommendedmicrocathetercompatible)Liquid Embolics(DMSO.Lipiodol/Ethiodol,Cyanoacrylateadhesives)	≤ 700 Micron spheres≤ 500 Micron particlesCoils (max 0.018"recommendedmicrocathetercompatible)Liquid Embolics(DMSO.Lipiodol/Ethiodol,Cyanoacrylateadhesives, Ethanol)	≤ 900 Micron spheres≤ 700 Micron particlesCoils & Plugs (max0.027" recommendedmicrocathetercompatible)Liquid Embolics(DMSO,Lipiodol/Ethiodol,Cyanoacrylateadhesives)	≤ 900 Micron spheres≤ 710 Micron particlesLiquid Embolics(DMSO,Lipiodol/Ethiodol,Cyanoacrylateadhesives, Ethanol)
Tip Shape	Straight, Bern	Straight, Bern, J,Swan	Straight, Bern	Straight, Bern, J,Swan
Shapable	No	Some SKUs (viasteam)	No	Some SKUs (viasteam)

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Functional Testing:

The following testing was conducted to validate and verify that the subject device was substantially equivalent to the predicate devices. All data met pre-determined acceptance criteria.

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TRANSIT
SCIENTIFIC™

Biocompatibility Biocompatibility of the complete and finished XO Cath Microcatheter ● has been verified according to the requirements and testing prescribed in ISO 10993-1 and in accordance with FDA guidance document "Use of International Standard ISO 10993-1" for an external communicating device with limited exposure (<24hrs) to circulating blood.
- Cytotoxicity O
- Sensitization O
- Irritation/ Intracutaneous Toxicity O
- Acute Systemic Toxicity O
- Material Mediated Pyrogenicity O
- Hemolysis Assay O
- Complement Activation Assay O
- Partial Thromboplastin Time (PTT) O
- Blood Platelet and Leukocyte Count Testing O
- LAL Pyrogenicity O
Design Verification Performance bench testing was conducted to ensure that the XO ● Cath Microcatheter met the applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence to the predicate system. The following performance testing was performed or fulfilled with the XO Cath Microcatheter.
- o Material Verification
- Dimensional Verification o
- Visual Verification O
- Functional/ Simulated Use Testing O
- Static Burst Pressure o
- Maximum Infusion Pressure O
- O Maximum Flow Rate
- Kink Radius O
- Tensile Testing O
- Torque Testing o
- Coating Lubricity O
- Coating Durability O
- Fluid Leak Testing O
- Hub Assembly Air Leak O
- Physical Embolic Testing O
- Liquid Embolic Exposure Testing O
- Radiopacity o
- Packaging O
- Sterilization O

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Image /page/9/Picture/1 description: The image shows the logo for Transit Scientific. The word "TRANSIT" is in large, bold, sans-serif font on the top line. Below that, in a smaller, thinner font, is the word "SCIENTIFIC" with a trademark symbol to the right. The logo is simple and modern.

Conclusion:

Based on the similarities in design between the subject and predicate devices, and the performance testing performed, the subject XO Cath Microcatheter is substantially equivalent to the cited predicate device.

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).