(145 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of AI or ML.
No.
The device is described as a catheter intended for short-term access to the peripheral arterial circulation system, not for treating a disease or condition.
No.
The device is a peripherally inserted catheter intended for short-term access to the peripheral arterial system, not for diagnosing medical conditions.
No
The device description clearly outlines physical components such as a catheter, needle, and guidewire, and the performance studies focus on physical properties and functionality of these hardware components. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- ARTLINE Function: The ARTLINE device is a catheter designed to be inserted into the peripheral arterial circulation system. Its purpose is to provide access to the arterial system for a short period. It is a device used within the body for access, not for testing specimens taken from the body.
- Intended Use: The intended use clearly states it's for "access to the peripheral arterial circulation system." This is an in-vivo (within the body) function.
- Device Description: The description details a catheter, needle, and guidewire for insertion into a blood vessel. This aligns with an in-vivo access device.
- Lack of IVD Indicators: There is no mention of analyzing specimens, performing tests on samples, or providing diagnostic information based on laboratory analysis.
Therefore, the ARTLINE device is a medical device used for in-vivo access, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ARTLINE Device is intended to permit access to the peripheral arterial circulation system for short term access (less than 30 days).
Product codes
DQY, DQX
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral Arterial Vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).
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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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: 801-773-7798 Fax: 801-820-8007 Email: jkfaulkner@hlic.net
DATE PREPARED:
February 8, 2016
NAME OF MEDICAL DEVICE:
| Proprietary Name: | ARTLINE |
|---|---|
| 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: | |
| Health Line, ARTLINE | ||
| Catheter | Predicate Device: ARROW | |
| INTL. Radial Artery Catheter | ||
| (K810675) | ||
| Same Intended Use | Yes | Yes |
| Prescription Device (Rx Only) | Yes | Yes |
| Biocompatible Polyurethane | ||
| Catheter | Yes | Yes |
| Biocompatible Materials of | ||
| Fabrication | Yes | Yes |
| Design | Yes | Yes |
| Intended Anatomical Location | Yes, Peripheral Arterial | |
| Vasculature | Yes, Peripheral Arterial | |
| 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.