(85 days)
Not Found
No
The 510(k) summary describes a physical medical device (a central venous catheter) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is designed for the administration of fluids, medications, blood products, and nutritional therapy, which are forms of therapy.
No
The device is a central venous catheter for administering fluids, medications, and for blood sampling and contrast media injection, not for diagnosing conditions.
No
The device description clearly states it is a family of central venous catheters made of radiopaque polyurethane tubing, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for direct access to the central venous system for administering fluids, medications, blood products, and nutritional solutions, as well as for blood sampling and power injection of contrast media. These are all procedures performed in vivo (within the body).
- Device Description: The description details a catheter designed for insertion into a central vein. This is a medical device used for direct intervention within the patient's body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic purposes. IVDs typically involve tests performed on samples like blood, urine, or tissue.
Therefore, the HEALTH LINE CT CVC is a medical device used for therapeutic and diagnostic procedures performed directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Central venous system, internal jugular vein, subclavian vein, superior vena cava and the right atrium.
Indicated Patient Age Range
Adults
Intended User / Care Setting
medical professionals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Orion™ II CT CVC (K113622)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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
1
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)
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.
| 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 lumen |
| short-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:
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.
INDICATIONS FOR USE:
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.
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.
| Comparison
Area | Submission Device
HEALTH LINE CT CVC | Predicate Device
Orion™ II CT CVC K113622 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | 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. | The Orion™ II 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 Orion™ II CT CVC.
Different- Updated with name
of catheter |
| Intended Use: | Intended to be used by medical
professionals for short term access to
the central venous system for infusion,
intravenous therapy, blood sampling
and 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 the
superior vena cava and the right atrium | Identical |
| Insertion Site | Inserted percutaneously and primarily
placed in the internal jugular vein.
Alternate insertion sites include the
subclavian vein. | Identical |
| Sizes | 16G & 14G Single Lumen, 5 & 7 Fr Dual
Lumen 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 to
instructions, added priming volumes | Without suture wing
instructions and priming
volumes. |
| Components | Added suture wing securement device
to 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).