The ORION™ II CT CVC is intended to be used by medical professionals for short-term access to the central venous system for infusion, intravenous therapy, blood sampling and for power injection of contrast media. All ORION™ II CT CVC products have a maximum · recommended infusion rating of 5 ml/sec.

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™ III CT CVC.

Device Description

The ORION™ II 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 ORION™ II CT CVC has a kink resistant, gradual tapered catheter design. The ORION™ II CT CVC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.

The ORION™ II CT CVC is indicated for dwell times shorter than 30 days. The ORION™ II 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 ORION™ II CT CVC product line has catheters in 16 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 ORION™ II 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.

AI/ML Overview

The provided text describes the 510(k) Premarket Notification Submission for the ORION™ II CT CVC. It details the device, its intended use, a technological comparison to a predicate device, and the conclusion regarding its safety and effectiveness.

However, the document does not contain specific acceptance criteria in a tabular format, nor does it provide a detailed study report with performance metrics like sensitivity, specificity, or AUC, or information about sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, or MRMC study results (which are typically relevant for AI/radiology devices).

The document is for a Central Venous Catheter (CVC), which is a medical device for infusion, not an AI or imaging device with performance metrics related to diagnostic accuracy. Therefore, many of the requested points, particularly those related to a multi-reader multi-case study, ground truth establishment for AI, and advanced performance metrics, are not applicable to this type of submission.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "The ORION™ II CT CVC met all established acceptance criteria for performance testing and design verification testing." However, the specific numerical acceptance criteria are not detailed in the provided text. The performance reported is in terms of the device's ability to withstand certain conditions.

Acceptance Criterion (Implicit)	Reported Device Performance
Withstand power injection	Withstands power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi.
Maximum Infusion Rating	5 ml/sec
Maximum Power Injector Pressure	Not to exceed 300 psi
Dwell Time	Shorter than 30 days (Indicated)
Kink Resistance	Kink resistant (design feature)
Radiopacity	Radiopaque (material characteristic)
Sterilization	Meets ISO 11135-1:2007 (Ethylene Oxide) standards
Biocompatibility	Meets ISO-10993 Part 1 standards for externally communicating, blood-contacting, prolonged contact devices.

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

Sample size: Not specified in the provided text. The document refers to "Verification testing" and "design verification testing" being performed but does not state the number of devices tested.
Data provenance: Not applicable in the context of clinical data for a diagnostic device. The testing conducted would be bench testing/engineering verification, not clinical data from patients.

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

Not applicable. This device is a catheter, not a diagnostic imaging device that requires expert-established ground truth for a test set. Ground truth would relate to physical and chemical properties and performance under stress, established by engineering and quality assurance standards.

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

Not applicable. Adjudication methods are typically used in clinical studies for diagnostic accuracy, not for performance testing of a catheter.

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 not an algorithm.

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

For this device, "ground truth" would be established by objective measurements and scientific standards in engineering and materials testing. For example, pressure measurements, flow rates, material composition analysis, and sterility testing according to established international standards (ISO). The document references:
- FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95.
- ISO 11135-1:2007 for Sterilization.
- ISO-10993, Part 1 for Biocompatibility.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-based device that requires a training set.

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

Not applicable.

Summary

{0}------------------------------------------------

K113622

Page 15 of 144

Health Line International Corporation

510(k) Premarket Notification Submission: ORION™ II CT CVC

MAY 1 8 2012

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) for ORION™ II CT CVC

SUBMITTER:

Health Line International Corporation 803 N. 1250 W. - STE 1 Centerville, Utah 84014

ESTABLISHMENT REGISTRATION NUMBER: 3006097687

CONTACT:

Nola L. Benstog QA/RA Director Telephone: 801-773-7798 Fax: 801-820-8007 Email: nbenstog@hlic.net

DATE PREPARED:

November 30, 2011

NAME OF MEDICAL DEVICE:

Proprietary Name: Regulation Name: Common/Usual Name: ORION™ II CT CVC Intravascular Catheter Central Venous Catheter (CVC), single, double and triple lumen

DEVICE CLASSIFICATION:

Classification Panel: Regulatory Class: Product Code: Regulation Number:

General Hospital Class II FOZ 21 CFR 880.5200

PREDICATE DEVICE:

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

SYNERGY™ CT PICC (K101329)

Percutaneous, Implanted, Long-term Intravascular Catheter Catheter, Intravascular, Therapeutic, Long Term General Hospital Class II । ਹਵ 21 CFR 880.5970

CONFIDENTIAL

{1}------------------------------------------------

DEVICE DESCRIPTION:

{2}------------------------------------------------

INTENDED USE:

INDICATIONS FOR USE:

TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:

New device is compared to Marketed Device? Yes. It is compared to a legally marketed predicate.

Does the new device have the same indication statements? Yes, with the exception of the insertion site and the removal of the long term access indication. Additionally, the ORION™ II CT CVC indications contain solutions detail for the CVC device.

Do the differences alter the intended therapeutic/diagnostic/etc. effect (i.e. deciding may consider impact on safety and effectiveness)? No.

Does the new device have the same technological characteristics, e.g. design, material, etc.? Yes. The CVC device of this submission, the ORION™ II CT CVC, is identical to that of (K101329), SYNERGY™ CT PICC, with the exception of the length. In fact, the ORION™ II CT CVC and the SYNERGY™ CT PICC are manufactured by the same company, Health Line International Corporation, the submitter of this submission. The basic fundamental scientific technology of the device has not changed. There may be minor variations in the contents of the introduction kit components.

Could the new characteristics affect safety or effectiveness? No.

Do the new characteristics raise new types of safety and effectiveness questions? No. There are no new types of safety and effectiveness questions.

Do accepted scientific methods exist for assessing effects of the new characteristics? Yes.

CONFIDENTIAL

{3}------------------------------------------------

Health Line International Corporation 510(k) Premarket Notification Submission: ORION™ II CT CVC

The FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95 was used to determine the appropriate methods for evaluating the device's performance.

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.

Biocompatibility requirements according to of ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. Test profiles for externally communicating, bloodcontacting, prolonged contact devices will be met.

These and other standards were used to determine the appropriate methods for evaluating the device's performance.

Are performance data available to assess effects of new characteristics? Yes. Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards.

Do performance data demonstrate equivalence? Yes. Performance data gathered in design verification testing demonstrated that the ORION™ II CT CVC is substantially equivalent to the noted predicate device.

CONCLUSION

The ORION™ II CT CVC met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the ORION™ II CT CVC is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the following predicate device: SYNERGY™ CT PICC (K101329).

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three intertwined lines, representing health and medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

Public Health Service

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

Ms. Nola Benstog OA/RA Director Health Line International Corporation 803 North 1250 West, Suite 1 Centerville, Utah 84014

MAY 1 8 2012

Re: K113622

Trade/Device Name: ORION™ II CT CVC Regulation Number: 21 CFR 880.5200 Regulation Name: Catheter, Intravascular, Therapeutic, Short Term Regulatory Class: Class II Product Code: FOZ Dated: April 24, 2012 Received: April 25, 2012

Dear Ms. Benstog:

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.

{5}------------------------------------------------

Page 2- Ms. Benstog

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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Antion D. anan

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology. General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Page 13 of 144

Health Line International Corporation Health Line Tricer Hiter Hitscion Submission: ORION™ II CT CVC

Indications For Use

510(k) Number (if known):

Device Name: ORION™ II CT CVC

Indications For Use:

The ORION™ II CT CVC is indicated for short term (less than 30 days) access to the central The ORION" II CT CVC In Indicated for short confinent medications, blood products, and/or
venous system for intravenous administration of fluids, medication of venous system for intravellous auministruction of hands sampling and power injection of
nutritional therapy solutions when prescribed. Onloary II CT CVC nutritional therapy solutions and the ORION™ II CT CVC.
contrast media may also be conducted with the ORION™ III CT CVC.

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rld Clyn 5/17/12

I Vision Sion-Off) ·sion of Anesthesiology, General Hospital lection Control, Dental Davices

510(k) Number: K113622

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).