Health Line CT CVC

K192533 · Health Line International Corporation · FOZ · Dec 10, 2019 · General Hospital

Device Facts

• Record ID: K192533
• Device Name: Health Line CT CVC
• Applicant: Health Line International Corporation
• Product Code: FOZ · General Hospital
• Decision Date: Dec 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Central venous catheter (CVC) for short-term (less than 30 days) vascular access; used for infusion, blood sampling, and power injection of contrast media. Catheter inserted percutaneously into central vein (typically internal jugular or subclavian) via Seldinger technique. Device consists of radiopaque polyurethane tubing, injection-molded polyurethane hub, extension legs with Luer lock fittings, and optional suture wing. Operates by providing a conduit for fluid delivery or withdrawal; withstands power injection up to 5 ml/sec at 300 psi. Used by medical professionals in clinical settings. Benefits include reliable central venous access for therapy and diagnostic imaging.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and leveraging of biocompatibility and performance data from the identical predicate device (K113622).

Technological Characteristics

Radiopaque polyurethane catheter; polyurethane hub; rigid PVC female Luer connectors; acetal pinch clamps; ABS clamp inserts. Dimensions: 16G/14G single lumen, 5Fr/7Fr dual lumen, 7Fr triple lumen; 13-30 cm length. Sterilization: Ethylene Oxide (EtO) per ISO 11135-1:2007 and AAMI TIR 28. Biocompatibility: ISO 10993. Non-powered, mechanical device.

Indications for Use

Indicated for adult patients requiring short-term (less than 30 days) central venous access for fluid/medication/blood/nutritional therapy, blood sampling, and power injection of contrast media.

Regulatory Classification

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.

Predicate Devices

• Orion™ II CT CVC (K113622)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> X Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] Fax: [phone] Email: [e-mail]

# DATE PREPARED:

November 20, 2019

### NAME OF MEDICAL DEVICE:

| Proprietary Name: | <i>Health Line CT CVC</i> |
|--------------------|------------------------------------------------------------------------------------------------|
| Regulation Name: | Intravascular Catheter |
| Common/Usual Name: | Central Venous Catheter (CVC), single, double and triple lumen<br>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<br>Area | Submission Device<br>HEALTH LINE CT CVC | Predicate Device<br>Orion™ II CT CVC K113622 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Health Line CT CVC is indicated for<br>short term (less than 30 days) access to<br>the central venous system for<br>intravenous administration of fluids,<br>medications, blood products, and/or<br>nutritional therapy solutions when<br>prescribed. Blood sampling and power<br>injection of contrast media may also be<br>conducted with the Health Line CT CVC. | The Orion™ II CT CVC is<br>indicated for short term (less<br>than 30 days) access to the<br>central venous system for<br>intravenous administration of<br>fluids, medications, blood<br>products, and/or nutritional<br>therapy solutions when<br>prescribed. Blood sampling and<br>power injection of contrast<br>media may also be conducted<br>with the Orion™ II CT CVC.<br><br>Different- Updated with name<br>of catheter |
| Intended Use: | Intended to be used by medical<br>professionals for short term access to<br>the central venous system for infusion,<br>intravenous therapy, blood sampling<br>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<br>superior vena cava and the right atrium | Identical |
| Insertion Site | Inserted percutaneously and primarily<br>placed in the internal jugular vein.<br>Alternate insertion sites include the<br>subclavian vein. | Identical |
| Sizes | 16G & 14G Single Lumen, 5 & 7 Fr Dual<br>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<br>instructions, added priming volumes | Without suture wing<br>instructions and priming<br>volumes. |
| Components | Added suture wing securement device<br>to kit components. | Without suture wing. |
| Biocompatibility | ISO-10993 | Identical |
| Sterilization Method | EtO (SAL 10-6) | Identical |
| <b>Materials</b> | | |
| 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).