The HEALTH LINE CT CVC is indicated for short term (less than 30 days) access to the central venous system for intravenous administration of fluids, medications, blood products, and/or nutritional therapy solutions when prescribed. Blood sampling and power injection of contrast media may also be conducted with the HEALTH LINE CT CVC.

Device Description

The HEALTH LINE CT CVC is a family of central venous catheters designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies. The catheters, made of radiopaque polyurethane tubing, are inserted in a central vein. Each HEALTH LINE CT CVC has a kink resistant, gradual tapered catheter design. The HEALTH LINE CT CVC kit includes a catheter and introduction components. The catheter is supplied sterile and nonpyrogenic in a variety of kit configurations.

The HEALTH LINE CT CVC is indicated for dwell times shorter than 30 days. The HEALTH LINE CT CVC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi.

The HEALTH LINE CT CVC product line has catheters in 16 G and 14 G single lumen, 5 Fr and 7 Fr dual lumen and 7 Fr triple lumen. Catheters range from approximately 13-30 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment. All HEALTH LINE CT CVC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.

AI/ML Overview

The provided text describes a 510(k) summary for the "Health Line CT CVC" device. This device is a central venous catheter (CVC).

Important Note: The document states that the device is identical to the predicate device (Orion™ II CT CVC, K113622) in its final finished form, with only minor changes to labeling, instructions for use, and the addition of an optional suture wing component. These changes are explicitly stated to not impact the performance or safety and effectiveness of the device compared to the predicate. Therefore, the "study that proves the device meets the acceptance criteria" for this specific 510(k) is primarily based on the demonstration of substantial equivalence to the legally marketed predicate device, leveraging the predicate's existing performance and biocompatibility data.

This is not a typical AI/ML-based device submission that would involve ground truth establishment, reader studies, or detailed algorithm performance metrics. Instead, it's a traditional medical device submission relying on established equivalence principles.

Given this context, I will address the requested points, noting where the information is not applicable due to the nature of this 510(k) submission for a non-AI/ML device.

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission for a physical device, the "acceptance criteria" are primarily met through demonstrating equivalence to the predicate device and compliance with relevant standards. The performance is demonstrated through in vitro testing and biocompatibility.

Acceptance Criteria Category	Specific Criteria / Standard	Reported Device Performance (Health Line CT CVC)
Material & Design	Identical materials (e.g., Polyurethane catheter, Rigid PVC Luer connectors, Acetal pinch clamps, ABS informational clamp inserts)	All materials are identical to the predicate device.
Intended Use	Identical indications for use and intended use, including short-term access (<30 days), infusion, blood sampling, power injection.	Identical to predicate.
Technological Characteristics	Catheter dimensions (G, Fr, length), flow rates, pressure resistance.	Identical, tested to withstand 5 ml/sec with max 300 psi for power injection.
Biocompatibility	ISO 10993 compliance	Leveraged from predicate device, which complied with ISO 10993.
Sterilization	ISO 11135-1:2007 (Ethylene Oxide) & AAMI TIR 28	Complies; leveraged from predicate device. Sterilized by EtO (SAL 10-6).
Design Changes Impact	Changes (labeling, IFU, optional suture wing) must not impact performance/safety.	Stated that changes do not impact performance or safety and effectiveness.
Regulatory Compliance	21 CFR 880.5200 (Intravascular Catheter), general controls, FDA guidance.	Complies; Device is Class II.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

For this type of device (non-AI/ML, physical catheter), a "test set" in the context of an algorithm is not applicable. The performance testing is typically in vitro and would involve a sample size of devices tested to demonstrate compliance with specifications (e.g., burst pressure, flow rate, tensile strength). The document states:

"The HEALTH LINE CT CVC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi."
"The subject device is identical to the predicate device (K113622) in its final finished form. Therefore, the biocompatibility and performance data were leveraged from the predicate device."

While specific sample sizes for these tests are not provided in this summary, they would typically be determined by recognized standards and statistical rationale for the specific physical and chemical tests performed. The data provenance would be from laboratory testing conducted as part of the device development and validation, likely under GLP conditions. The document does not specify the country of origin for these test results, but implied that it's from existing documentation related to both the predicate and the current device, likely conducted internally or by contract testing labs.

3. 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)

Not applicable. This is not an AI/ML device requiring human expert annotation for ground truth. The "ground truth" for a physical device is derived from engineering specifications, material properties, and relevant performance standards.

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

Not applicable. This is not an AI/ML device requiring expert adjudication of image annotations or diagnoses.

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

Not applicable. This is not an AI/ML device; therefore, no MRMC study or human reader improvement assessment was performed.

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

Not applicable. This is not an AI/ML device with a standalone algorithm.

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

For this device, the "ground truth" for demonstrating performance is based on:

Engineering Specifications and Bench Testing: Compliance with defined parameters like burst pressure, flow rates, tensile strength, and material integrity.
Biocompatibility Standards: Adherence to ISO 10993 series for material safety.
Sterilization Validation: Compliance with ISO 11135-1 and AAMI TIR 28.
Demonstrated Performance of Predicate Device: The primary "ground truth" is that the legally marketed predicate device (Orion™ II CT CVC) has already demonstrated its safety and effectiveness for its intended use, and the current device is substantially equivalent.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set with established ground truth.

Summary

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December 10, 2019

Health Line International Corporation Joel Faulkner CEO 5675 W 300 S Salt Lake City, Utah 84117

Re: K192533

Trade/Device Name: Health Line CT CVC Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: September 12, 2019 Received: September 16, 2019

Dear Joel Faulkner:

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 medical devices and radiation-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 Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192533

Device Name Health Line CT CVC

Indications for Use (Describe)

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

(As required by 21 CFR 807.92)

SUBMITTER:

Health Line International Corporation 5675 West 300 South Salt Lake City, Utah 84104

ESTABLISHMENT REGISTRATION NUMBER:

3006097687

CONTACT:

Joel K. Faulkner CEO Telephone: 801-773-7798 Fax: 801-820-8007 Email: jkfaulkner@hlic.net

DATE PREPARED:

November 20, 2019

NAME OF MEDICAL DEVICE:

Proprietary Name:	Health Line CT CVC
Regulation Name:	Intravascular Catheter
Common/Usual Name:	Central Venous Catheter (CVC), single, double and triple lumenshort-term less than 30 days

DEVICE CLASSIFICATION:

Classification Panel:	General Hospital
Regulatory Class:	Class II
Product Code:	FOZ
Regulation Number:	21 CFR 880.5200

PREDICATE DEVICE:

Proprietary Name: Regulation Name: Common/Usual Name:

Classification Panel: Regulatory Class: Product Code: Regulation Number: Orion™ II CT CVC (K113622)

Intravascular Catheter Central Venous Catheter (CVC), single, double and triple lumen, short-term less than 30 days General Hospital Class II FOZ 21 CFR 880.5200

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DEVICE DESCRIPTION:

INDICATIONS FOR USE:

TECHNOLOGICAL COMPARISON TO PREDICATE DEVICE:

The HEALTH LINE CT CVC is IDENTICAL to the predicate device the Orion™ II CT CVC (K113622) in ALL aspects except:

New labeling, Instructions for use (IFU) (with additional instructions), addition suture wing components (to provide clinicians with additional options, if desired) in the kit configuration.
Catheter length - Exactly same as predicate.
. Insertion site – Exactly the same as predicate Orion™ II CT CVC and is placed in a central vein.
Dwell time – Exactly the same as predicate Orion™ II CVC is indicated for short term access.

The changes do not impact the performance or safety and effectiveness of the device compared to the predicate.

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The HEALTH LINE CT CVC subject device and the predicate device Orion™ II CT CVC (K113622) are manufactured by the same company, Health Line International Corporation, the submitter of this submission.

ComparisonArea	Submission DeviceHEALTH LINE CT CVC	Predicate DeviceOrion™ II CT CVC K113622
Indications for Use:	The Health Line CT CVC is indicated forshort term (less than 30 days) access tothe central venous system forintravenous administration of fluids,medications, blood products, and/ornutritional therapy solutions whenprescribed. Blood sampling and powerinjection of contrast media may also beconducted with the Health Line CT CVC.	The Orion™ II CT CVC isindicated for short term (lessthan 30 days) access to thecentral venous system forintravenous administration offluids, medications, bloodproducts, and/or nutritionaltherapy solutions whenprescribed. Blood sampling andpower injection of contrastmedia may also be conductedwith the Orion™ II CT CVC.Different- Updated with nameof catheter
Intended Use:	Intended to be used by medicalprofessionals for short term access tothe central venous system for infusion,intravenous therapy, blood samplingand power injection of contrast media	Identical
Target Population	Adults	Identical
Duration of Use	Less than 30 days	Identical
Insertion Method	Seldinger Technique	Identical
Tip Placement Location	Located just before the junction of thesuperior vena cava and the right atrium	Identical
Insertion Site	Inserted percutaneously and primarilyplaced in the internal jugular vein.Alternate insertion sites include thesubclavian vein.	Identical
Sizes	16G & 14G Single Lumen, 5 & 7 Fr DualLumen and 7 Fr Triple Lumen	Identical
Labeling	New Health Line CT CVC logo	Orion™ II CT CVC logo.
Instructions for Use	Added optional use of suture wing toinstructions, added priming volumes	Without suture winginstructions and primingvolumes.
Components	Added suture wing securement deviceto kit components.	Without suture wing.
Biocompatibility	ISO-10993	Identical
Sterilization Method	EtO (SAL 10-6)	Identical
Materials
Female Luer connectors	Rigid PVC	Identical
Hub	Polyurethane	Identical
Catheter Tubing	Polyurethane	Identical
Extension Leg Tubing	Polyurethane	Identical
Pinch Clamps	Acetal	Identical
Informational Clamp Inserts	ABS	Identical

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PERFORMANCE TESTING

The subject device is identical to the predicate device (K113622) in its final finished form. Therefore, the biocompatibility and performance data were leveraged from the predicate device. The subject device complies with FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95.

The subject device complies with sterilization requirements of ISO 11135-1:2007, Sterilization of Health Care Products – Ethylene Oxide – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices. It also complies with AAMI TIR 28, Product adoption and process equivalence for ethylene oxide sterilization.

CONCLUSION

Based on the Indications for Use, technological characteristics and performance testing; the HEALTH LINE CT CVC is substantially equivalent to the following predicate device Orion™ II CT CVC (K113622).

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).