ARTLINE

K160448 · Health Line International Corporation · DQY · Jul 12, 2016 · Cardiovascular

Device Facts

• Record ID: K160448
• Device Name: ARTLINE
• Applicant: Health Line International Corporation
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The ARTLINE Device is intended to permit access to the peripheral arterial circulation system for short term access (less than 30 days).

Device Story

ARTLINE is a single-lumen, 20ga, 4.45 cm long peripherally inserted catheter; constructed of radiopaque polyurethane with an injection-molded hub and Luer lock fittings. Device includes an echogenic needle and guidewire with slide advancer. Used by clinicians for short-term (less than 30 days) access to peripheral arterial vasculature. Operation involves inserting the catheter over the needle into the vessel, advancing the guidewire, and threading the catheter over the wire. Provides a pathway for arterial access; facilitates clinical monitoring or fluid administration. Supplied sterile and non-pyrogenic.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included air/liquid leakage, tensile strength, flow rate, priming volume, chemical testing, 6% conical fitting tests, needle penetration, and kink testing.

Technological Characteristics

Single-lumen catheter; radiopaque polyurethane tubing; injection-molded polyurethane hub; Luer lock fittings; 20ga; 4.45 cm length; kink-resistant design; echogenic needle; guidewire with slide advancer; EO sterilization; non-pyrogenic; latex-free; DEHP-free.

Indications for Use

Indicated for patients requiring short-term (less than 30 days) access to the peripheral arterial circulation system.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• ARROW RADIAL ARTERY CATHETERIZATION SET (K810675)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 12, 2016

Health Line International Corporation Mr. Joel K. Faulkner CEO 5675 West 300 South Salt Lake City, UT 84101

Re: K160448

Trade/Device Name: ARTLINE Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, DQX Dated: June 6, 2016 Received: June 8, 2016

Dear Mr. 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. 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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Brian D. Pullin -S

Bram D. Zuckerman, M.D. 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) K160448

Device Name ARTLINE

Indications for Use (Describe)

The ARTLINE Device is intended to permit access to the peripheral arterial circulation system for short term access (less than 30 days).

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 (21 CFR 807.92) for ARTLINE

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

#### ESTABLISHMENT REGISTRATION NUMBER:

3006097687

#### CONTACT:

Joel K. Faulkner Telephone: [phone] Fax: [phone] Email: [e-mail]

#### DATE PREPARED:

February 8, 2016

#### NAME OF MEDICAL DEVICE:

| Proprietary Name: | <b>ARTLINE</b> |
|--------------------|---------------------------------------------|
| Regulation Name: | Catheter Guide Wire / Percutaneous Catheter |
| Common/Usual Name: | Catheter Guide Wire / Percutaneous Catheter |

#### DEVICE CLASSIFICATION:

Classification Panel: Cardiovascular Regulatory Class: Class II DQX / DQY Product Code: 21 CFR 870.1330 Regulation Number:

#### PREDICATE DEVICES:

Proprietary Name: Regulation Name: Common/Usual Name: Classification Panel: Regulatory Class: Product Code: Regulation Number:

#### ARROW RADIAL ARTERY CATHETERIZATION SET

Wire, Guide, Catheter Catheter Guide Wire Cardiovascular Class II DQX 21 CFR 870.1330

Proprietary Name:

N/A

#### DEVICE DESCRIPTION:

The ARTLINE is a single lumen peripherally inserted catheter device designed to perform short term access to the peripheral arterial circulatory system for less than 30 days. The catheter, made of radiopaque polyurethane tubing, echogenic needle, guidewire with slide advancer. Each ARTLINE has a kink resistant catheter design. The catheter is inserted over the needle into the peripheral arterial vessel, the guide wire is advanced and the catheter is threaded over the guide wire. The catheter is supplied sterile and non-pyrogenic.

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The ARTLINE is indicated for dwell times shorter than 30 days. The ARTLINE is a 20ga single lumen catheter. The catheter is approximately 4.45 cm long. The catheters are attached to an injectionmolded polyurethane hub with Luer lock fittings for access attachment.

#### INTENDED USE:

The ARTLINE Device is intended to permit access to the peripheral arterial circulation system for short term access (less than 30 days).

#### TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:

The ARTLINE catheter uses the same fundamental technology as the predicate device.

| Substantial Equivalence Comparison | | |
|-------------------------------------------|-----------------------------------------------------|----------------------------------------------------------------------|
| Comparison Criteria | Subject Device:<br>Health Line, ARTLINE<br>Catheter | Predicate Device: ARROW<br>INTL. Radial Artery Catheter<br>(K810675) |
| Same Intended Use | Yes | Yes |
| Prescription Device (Rx Only) | Yes | Yes |
| Biocompatible Polyurethane<br>Catheter | Yes | Yes |
| Biocompatible Materials of<br>Fabrication | Yes | Yes |
| Design | Yes | Yes |
| Intended Anatomical Location | Yes, Peripheral Arterial<br>Vasculature | Yes, Peripheral Arterial<br>Vasculature |
| EO Sterilization Method | Yes | Yes |
| Packaged Sterile, Single Use | Yes | Yes |
| Non-Pyrogenic | Yes | Yes |
| Made without Latex Rubber | Yes | Yes |
| Made without DEHP | Yes | Yes |

#### Performance Tests:

- Air Leakage
- Liquid Leakage
- Tensile Strength Test
- Catheter Flow Rate
- Priming Volume
- Chemical Test
- 6% Conical Fitting
- o Liquid Leakage
- o Air Leakage
- o Separation Force
- o Unscrewing Force
- o Ease of Assembly
- o Resistance to Override
- o Stress Cracking
- Needle Penetration Test
- Kink Test

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#### CONCLUSION

The ARTLINE met all established acceptance criteria for performance testing and design verification testing. The performance testing demonstrated that the ARTLINE is substantially equivalent to the predicate device, ARROW RADIAL ARTERY CATHETERIZATION (K810675), in safety and performance.