The UNI-PICC™ is intended to be used by medical professionals for short-term or long-term peripheral access to the central venous system for infusion, intravenous therapy and for blood sampling.

The UNI-PICC™ Peripherally Inserted Central Catheter is indicated for short or long term access to the central venous system for intravenous administration of fluids, medications and/or nutritional therapy when prescribed. Blood sampling may also be conducted with UNI-PICC™.

The 3F UNI-PICC™ Peripherally inserted Central Catheter is indicated for short or long term access to the central venous system via peripheral insertion in neonates, infants and children. It may be used for administration of fluids, medications and/or nutritional therapy when prescribed.

Device Description

The UNI-PICC™ is a family of peripherally inserted central venous catheters designed to perform infusion, intravenous therapy and blood sampling. The catheters, made of radiopaque polyurethane tubing, are inserted peripherally. Each UNI-PICC™ has a kink resistant catheter design. The UNI-PICC™ kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.

The UNI-PICC™ is indicated for dwell times shorter or greater than 30 days. The UNI-PICC™ product line has catheters in 3Fr, 4 Fr and 5 Fr single lumen, 4 Fr, 5 Fr and 6 Fr dual lumen and 5 Fr and 6 Fr triple lumen. All catheters range from approximately 30 - 60 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment.

AI/ML Overview

The provided 510(k) summary for the UNI-PICC™ focuses on demonstrating substantial equivalence to predicate devices, primarily through technological comparison and performance testing that adheres to established guidance documents and standards. It does not detail specific acceptance criteria in quantitative terms nor the performance of a device against such criteria in a tabular format as you've requested for typical AI/ML medical devices.

Instead, the submission states:
"The UNI-PICC™ met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the UNI-PICC™ is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the SYNERGY™ CT PICC (K101329), 2.6F Vascu-PICC® (K102966) and Vascu-PICC® and Midline Catheters, Single, Double and Triple Lumen (K091586)."

The study described is a design verification testing based on FDA guidance and international standards, aiming to show that the UNI-PICC™ performs comparably to pre-existing, legally marketed predicate devices.

Given the nature of the information provided in the K130034 submission, I cannot create the requested table of acceptance criteria and reported device performance with quantitative metrics. The document confirms that all established acceptance criteria were met, but it does not list them or the specific performance values achieved.

Furthermore, this submission describes a traditional medical device (a catheter), not an AI/ML powered device. Therefore, questions related to test set sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable to this document.

Summary

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Health Line International Corporation 510(k) Premarket Notification Submission: UNI-PICC™

K130034

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) for UNI-PICC™

MAR 0 8 2013

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:

January 3, 2013

NAME OF MEDICAL DEVICE:

Proprietary Name: Regulation Name: Common/Usual Name:

UNI-PICC™

Percutaneous, Implanted, Long-term Intravascular Catheter Peripherally Inserted Central Catheter (PICC), single, double and triple lumen

DEVICE CLASSIFICATION:

Classification Panel: Regulatory Class: Product Code: Regulation Number: General Hospital Class II LS 21 CFR 880.5970

PREDICATE DEVICES:

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 Peripherally Inserted Central Catheter (PICC), single, double and triple lumen General Hospital Class II । ਟੈ 21 CFR 880.5970

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Proprietary Name:	2.6F Vascu-PICC® (K102966)
Regulation Name:	Percutaneous, Implanted, Long-term Intravascular Catheter
Common/Usual Name:	Peripherally Inserted Central Catheter (PICC)
Classification Panel:	General Hospital
Regulatory Class:	Class II
Product Code:	LJS
Regulation Number:	21 CFR 880.5970
Proprietary Name:	Vascu-PICC® and Midline Catheters, Single, Double andTriple Lumen (K091586)
Regulation Name:	Percutaneous, Implanted, Long-term Intravascular Catheter
Common/Usual Name:	Catheter, Intravascular, Therapeutic, Long-Term
Classification Panel:	General Hospital
Regulatory Class:	Class II
Product Code:	LJS
Regulation Number:	21 CFR 880.5970

DEVICE DESCRIPTION:

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INTENDED USE:

The UNI-PICC™ is intended to be used by medical professionals for short-term or long-term peripheral access to the central venous system for infusion, intravenous therapy and for blood sampling.

The intended use for the UNI-PICC™ has not changed from that of the SYNERGY™ CT PICC (K101329) predicate device, with the exception of the removal of power injection.

INDICATIONS FOR USE:

TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:

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

Does the new device have the same indication statements? Yes, the first paragraph of the indications for use statement is the same as the SYNERGY™ CT PICC (K101329) with the exception of the removal of power injection. The last paragraph of the indications for use statement is the same as the 2.6F Vascu-PICC® (K102966) predicate with the exception of noting the 3F size.

Do the differences alter the intended therapeutic/diagnostic/etc. effect (i.e. deciding may consider impact on safety and effectiveness)? No, the differences do not alter the intended effect of the device.

Does the new device have the same technological characteristics, e.g. design, material, etc. ? Yes. The PICC device of this submission, the UNI-PICC™, is identical to that of the predicate device (K101329). In fact, the UNI-PICC™ 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

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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.

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 11135:2007, Sterilization of Health Care Products -Requirements for Validation and Routine Control -- Ethylene Oxide Sterilization.

Biocompatibility requirements according to of ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. Test profiles for externally communicating, bloodcontacting, long-term 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 UNI-PICC™ is substantially equivalent to the noted predicate devices.

CONCLUSION

The UNI-PICC™ met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the UNI-PICC™ is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the SYNERGY™ CT PICC (K101329), 2.6F Vascu-PICC® (K102966) and Vascu-PICC® and Midline Catheters, Single, Double and Triple Lumen (K091586).

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

March 8, 2013

Ms. Nola Benstog Quality Assurance and Regulatory Affairs Director Health Line International Corporation 803 North 1250 West, Suite 1 CENTERVILLE UT 84014

Re: K130034

Trade/Device Name: UNI-PICC™ Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: January 3, 2013 Received: January 8, 2013

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.

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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-mustcomply 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/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/5/Picture/7 description: The image appears to be a stylized logo or emblem. It features a combination of geometric shapes and cursive text. The text is difficult to read due to the stylized font, but it seems to be the central element of the design. The overall impression is that of a vintage or heraldic symbol.

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

1.02 - 3.32

Enclosure

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Indications For Use

510(k) Number (if known):

Device Name: UNI-PICC™

Indications For Use:

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)

Image /page/6/Picture/12 description: The image shows the name "Sajjad H. Syed" in large, bold font on the left side of the image. To the right of the name is a digital signature with a graphic and text that reads "Digitally signed by Sajjad H. Syed". The text also includes a DN, C, OU, and CN, as well as a date and time stamp of 2013.03.05 14:32:26-05'00'.

Jision Sign-Off) sion of Anesthestology. General Hospital

510(k) Number: K130034

Page 13 of 179

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”