The HEALTH LINE CT MIDLINE CATHETER is indicated for short term (less than 30 days) access to the peripheral venous system for infusion, intravenous therapy and blood sampling. The HEALTH LINE CT MIDLINE CATHETER is suitable for use with power injectors.

Device Description

The HEALTH LINE CT MIDLINE CATHETER is a family of peripherally inserted peripheral catheters made from specially formulated biocompatible medical grade materials. Catheters are packaged in a tray with accessories necessary for a percutaneous micro introducer introduction (Modified Seldinger or Seldinger technique). The device is intended for short term (less than 30days) vascular access.

The HEALTH LINE CT MIDLINE CATHETER is indicated for dwell times shorter than 30 days. The HEALTH LINE CT MIDLINE CATHETER product line will have catheters in 3Fr, 4 Fr and 5 Fr single lumen, and 4 Fr and 5 Fr dual lumen. The HEALTH LINE CT MIDLINE CATHETER's are supplied in two lengths, approximately 10 and 20 cm long. All catheters are attached to an injectionmolded polyurethane hub that has extension legs with Luer lock fittings for access attachment.

AI/ML Overview

This document is a 510(k) summary for the Health Line CT Midline Catheter (K200263). The core argument for its substantial equivalence relies on its technological identity to a predicate device, the NEXUS MIDLINE CT CATHETER (K140270). Therefore, the "acceptance criteria" here refers to the equivalence to the predicate device, especially in performance, rather than a separate set of numerical thresholds for a new, independent study.

Here's a breakdown of the requested information based on the provided text:

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

The acceptance criterion for this device is substantial equivalence to the predicate device (NEXUS MIDLINE CT CATHETER, K140270). The "reported device performance" is the claim of identity or sameness with the predicate device for all critical performance aspects.

Acceptance Criterion (vs. Predicate Device K140270)	Reported Device Performance (Health Line CT Midline Catheter K200263)
Indications for Use: Identical	Identical (word-for-word match shown in table on page 5)
Intended Use: Identical	Identical
Target Population: Identical	Identical (Adults)
Duration of Use: Identical	Identical (Less than 30 days)
Insertion Method: Identical	Identical (Seldinger Technique)
Sizes: Identical	Identical (3Fr, 4Fr, 5Fr Single Lumen; 4Fr & 5Fr Dual Lumen)
Biocompatibility: Complies with ISO-10993 (leveraged from predicate)	Complies with ISO-10993 (stated as "Identical" - leveraged from predicate)
Sterilization Method: Complies with ISO 11135-1:2007 and AAMI TIR 28 (leveraged from predicate)	Complies with ISO 11135-1:2007 and AAMI TIR 28 (stated as "Identical" - leveraged from predicate)
Materials: Identical (for key components like female luer connectors, hub, catheter tubing, pinch clamps, informational clamp inserts)	Identical
Priming Volume: Identical to predicate's specifications	Identical to predicate's specifications
Max Flow Rate (ml/sec): Identical to predicate's specifications	Identical to predicate's specifications
Max Internal Catheter Pressure at Max Flow Rate (psi): Identical to predicate's specifications	Identical to predicate's specifications
Rated Burst Pressure (psi): Identical to predicate's specifications	Identical to predicate's specifications

The document states changes only include a name change, added priming instructions in the IFU, and a catheter trim tool in the kit, none of which impact the core functional characteristics used for demonstrating substantial equivalence to the predicate product.

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

This FDA 510(k) summary does not describe a specific "test set" in the context of an AI/algorithm performance study. Instead, it relies on the "technological identity" of the new device to an already cleared predicate device.

Therefore:

Sample size for test set: Not applicable, as there was no independent clinical/performance test set for this device beyond demonstrating it is identical to the predicate. Performance data was "leveraged from the predicate device."
Data provenance: Not applicable in the context of a new test set. The provenance of the predicate device's data would be from its original clearance. The changes made to this device were assessed through a risk analysis, which found "no risks... identified with these changes."

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

Not applicable. This is not a study involving expert-established ground truth for an AI/algorithm-based diagnostic device. It's a medical device clearance based on substantial equivalence to an existing device.

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

Not applicable. No test set requiring adjudication was performed as this is a substantial equivalence submission for a physical medical catheter, not an AI/diagnostic algorithm.

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-assisted diagnostic device.

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

Not applicable. This is a physical medical device (catheter), not an algorithm.

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

Not applicable. The "ground truth" for this submission is the established performance and safety of the legally marketed predicate device (NEXUS MIDLINE CT CATHETER, K140270), to which the new device is claimed to be technologically identical. The assessment relies on a comparison of specifications, materials, and intended uses.

8. The sample size for the training set

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

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

Not applicable.

Summary

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March 12, 2020

Health Line International Corporation Aaron Faulkner RA Director 5675 W 300 S Salt Lake City, Utah 84104

Re: K200263

Trade/Device Name: Health Line CT Midline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: January 6, 2020 Received: February 3, 2020

Dear Aaron 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200263

Device Name Health Line CT Midline Catheter

Indications for Use (Describe)

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 OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) for HEALTH LINE CT MIDLINE CATHETER (K200263)

SUBMITTER: Health Line International Corporation 5675 W 300 S Salt Lake City, Utah 84104

ESTABLISHMENT REGISTRATION NUMBER:

3010882065

CONTACT:

Aaron G. Faulkner Director Engineering Telephone: 801-773-7798 Fax: 855-228-1336 Email: agfaulkner@hlic.net

DATE PREPARED:

December 20, 2019

NAME OF MEDICAL DEVICE:

Proprietary Name:	HEALTH LINE CT MIDLINE CATHETER (K200263)
Regulation Name:	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Common/Usual Name:	Midline Catheter, single and double lumen

DEVICE CLASSIFICATION:

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

PREDICATE DEVICE:

Proprietary Name:	NEXUS MIDLINE CT (K140270)
Regulation Name:	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Common/Usual Name:	Midline Catheter, single and double lumen

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

DEVICE DESCRIPTION:

Catheter Size	PrimingVolume (ml)	Max Flow Rate(ml/sec)*	Max Internal CatheterPressure at Max FlowRate (psi)	Rated BurstPressure (psi)**
3Fr SingleLumen	0.29	1	167	251
4Fr SingleLumen	0.37	5	164	299
4Fr Dual Lumen	0.35/0.35	3	173/173	299
5Fr SingleLumen	0.38	5	112	300
5 Fr Dual Lumen	0.37/0.37	5	179/179	299

*Pressurized flow rates are determined with pump safety cut-off at 300 psi using viscous fluid at 11.8 centipoise (cP) and represents approximate flow capability of power injection of contrast media

** Max Burst Pressure is the static burst pressure failure point of the catheter when the lumen is completely occluded. WARNING: Power injector machine pressure limiting feature may not prevent over pressurization of an occluded catheter.

INTENDED USE

The HEALTH LINE CT MIDLINE CATHETER is intended to be used by medical professionals for short term percutaneous access to the peripheral venous system for infusion, intravenous therapy and for blood sampling.

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INDICATIONS FOR USE:

TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:

The HEALTH LINE CT MIDLINE CATHETER is technologically identical to the, NEXUS MIDLINE CT CATHETER (K140270), predicate device in all aspects. The Health Line CT Midline Catheter is identical to the predicate device in all aspects except for: a name change, priming instructions added to the instructions for use, and a catheter trim tool was added to the device kit. Below is a summary table comparing the HEALTH LINE CT MIDLINE Catheter to the predicate NEXUS MIDLINE CT CATHETER (K140270).

TechnologicalComparisonArea	Subject DeviceHEALTH LINE CT MIDLINE CATHETER(K200263)	Predicate DeviceNexus Midline CT Catheter(K140270)
Indications for Use:	The HEALTH LINE CT MIDLINE CATHETER isindicated for short term (less than 30 days)access to the peripheral venous system forinfusion, intravenous therapy and bloodsampling. The HEALTH LINE CT MIDLINECATHETER is suitable for use with powerinjectors.	The NEXUS™ MIDLINE CT CATHETER isindicated for short term (less than 30days) peripheral access to the peripheralvenous system for infusion, intravenoustherapy and blood sampling. The NEXUS™MIDLINE CT CATHETER is suitable for usewith power injectors. For maximum flowrate and maximum pressure that can beused during power injection, please referto the following:
		Catheter Size Priming Volume(ml) Max Labeled FlowRate (ml/sec)* Max Internal CatheterPressure at Max Flow Rate(psi) Rated BurstPressure(psi)** 3Fr Single Lumen 0.29 1 167 251 4Fr Single Lumen 0.37 5 164 299 4Fr Dual Lumen 0.35/0.35 3 173/173 299 5Fr Single Lumen 0.38 5 112 300 5 Fr Dual Lumen 0.37/0.37 5 179/179 299 * Pressurized flow rates are determined with pump safety cut-off at 300 psi using viscous fluid at 11.8centipoise (cP) and represents approximate flow capability of power injection of contrast media. ** Max Burst Pressure is the static burst pressure failure point of the catheter when the lumen iscompletely occluded. WARNING: Power injector machine pressure limiting feature may not preventover pressurization of an occluded catheter.
Intended Use:	Intended to be used by medical professionalsfor short term peripheral access to the venoussystem for infusion, intravenous therapy,blood sampling and power injection ofcontrast media.	Identical
Target Population	Adults	Identical
Duration of Use	Less than 30 days	Identical
Insertion Method	Seldinger Technique	Identical
Sizes	3Fr, 4Fr, 5Fr Single Lumen, 4Fr & 5Fr DualLumen	Identical
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

Summary of Technological Comparison of Subject Device to Predicate Devices

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Extension Leg Tubing	Polyurethane	Identical
Pinch Clamps	Acetal	Identical
Informational ClampInserts	ABS	Identical

PERFORMANCE TESTING

The subject device is identical to the predicate device (K140270) 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.

A risk analysis was performed with respect to these changes and no risks were identified with these changes.

CONCLUSION

Based on FDA's decision tree the HEALTH LINE CT MIDLINE CATHETER is substantially equivalent to the, Nexus Midline CT Catheter (K140270), predicate device.

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).