The HLIC Needle-Less Valve is intended to allow access to IV administration sets, medication vials, blood donor collection bags, and solution bags with one convenient device without the use of needles or blunt cannulas.

Device Description

The HLIC Needle-Less Valve is a needle free valve that allows the user to add medication into IV sets without the use of a needle. When the valve is in the closed position, it has a flat, smooth surface for cleaning. When the male connector of a syringe or secondary line is pushed into the valve, the silicone stem opens in the middle creating a fluid path. When the male connector is removed from the valve, the body of the valve forces the stem shut and maintains a sealed fluid path. A cap is not required to seal the valve or to maintain sterility.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for the HLIC Needle-Less Valve, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to establish diagnostic performance against specific acceptance criteria like those common for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not directly applicable to this SSEA (Summary of Safety and Effectiveness Analysis) for a non-diagnostic, non-AI medical device.

However, I can extract the relevant information pertaining to the device's performance testing and the conclusion regarding its safety and effectiveness.

Here's a breakdown based on the provided text, indicating where information is not available or not applicable for this type of device submission:

1. A table of acceptance criteria and the reported device performance

The document states that the device "met all established acceptance criteria for performance testing and design verification testing." While the specific acceptance criteria are not detailed in this public summary, the device passed them.

Acceptance Criteria Category	Reported Device Performance
Performance Testing	Met all established criteria
Design Verification Testing	Met all established criteria
Biocompatibility	Met requirements according to ISO-10993 for externally communicating, blood path, indirect, limited contact duration (<24 hours).
Power Injection Capability	Testing conducted; HLIC Needle-Less Valve is power injection capable. (Implied acceptance met).
Safety and Effectiveness	Demonstrated to be safe and effective for its intended use.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the provided summary. Performance and design verification testing typically involve various sample sizes depending on the specific test (e.g., flow rates, pressure resistance, sterility, biocompatibility).
Data Provenance: The testing was conducted by Health Line International Corporation, located in Centerville, Utah, USA. The summary does not specify whether the data was retrospective or prospective, but performance verification testing is inherently prospective, as it involves newly manufactured devices undergoing specific tests.

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

This question is not applicable to this type of device. The HLIC Needle-Less Valve is a physical medical device (an intravascular administration set component), not a diagnostic tool where "ground truth" is established by expert interpretation of medical images or data. Performance is assessed through engineering and biocompatibility tests against predefined metrics.

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

This question is not applicable to this type of device. Adjudication methods like 2+1 or 3+1 are used in studies where there is subjective interpretation (e.g., by human readers of medical images) that requires resolution in case of disagreement. The performance tests for this device involve objective measurements.

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

This question is not applicable to this type of device. MRMC studies, especially those involving AI assistance, are relevant for diagnostic devices that impact human interpretation. The HLIC Needle-Less Valve is a mechanical component, not an AI/ML diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable to this type of device. Standalone algorithm performance is relevant for AI/ML devices. The HLIC Needle-Less Valve does not have an algorithm. Its performance is assessed through its physical characteristics and functionality.

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

This question is not applicable in the traditional sense for this device. The "ground truth" for this device's performance is established by engineering specifications, regulatory standards (e.g., ISO-10993), and industry best practices for mechanical and material properties (e.g., flow rates, leak integrity, pressure resistance, biocompatibility). It is an objective standard rather than an expert interpretation.

8. The sample size for the training set

This question is not applicable to this type of device. "Training sets" are used for AI/ML models. This device is a physical medical component, not an AI model.

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

This question is not applicable to this type of device, as there is no "training set" in the context of an AI/ML model for this product.

Summary

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Health Line International Corporation 510(k) Premarket Notification Submission: HLIC Needle-Less Valve

K120548
Page 15 of 86

MAY - 4 2012

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) for HLIC NEEDLE-LESS VALVE

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:

February 21, 2012

NAME OF MEDICAL DEVICE:

Proprietary Name: Regulation Name: Common/Usual Name:

HLIC NEEDLE-LESS VALVE

Intravascular Administration Set Needle Free Injection Site

DEVICE CLASSIFICATION:

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

General Hospital Class II FPA 21 CFR 880.5440

PREDICATE DEVICE:

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

Swabsite Swabbable Valve Intravascular Administration Set Intravascular Administration Set / Swabbable Valve · General Hospital Class II FPA 21 CFR 880.5440

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DEVICE DESCRIPTION:

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INTENDED USE:

INDICATIONS FOR USE:

TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:

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

Does the new device have the same indication statements? Yes.

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 use of the device.

Does the new device have the same technological characteristics, e.g. design, material, etc.? Yes. The HLIC NEEDLE-LESS VALVE, is substantially equivalent to the Swabsite Swabbable Valve K002689. The basic fundamental scientific technology of the device has not changed.

Could the new characteristics affect safety or effectiveness? No.

Do the new characteristics raise new types of safety and effectiveness questions? No. The only new characteristic is that the HLIC NEEDLE-LESS VALVE is power injection capable. This is based upon existing test data and does not affect safety or effectiveness.

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

Power Injection testing was conducted to assess the power injection capabilities of the HLIC NEEDLE-LESS VALVE.

Biocompatibility requirements according to ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. Test profiles for externally communicating, Blood path, indirect, Limited contact duration (<24 hours) were met.

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

CONFIDENTIAL

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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 HUC NEEDLE-LESS VALVE is substantially equivalent to the noted predicate devices.

CONCLUSION

The HLIC NEEDLE-LESS VALVE met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the HLIC NEEDLE-LESS VALVE is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the following predicate device: Swabsite Swabbable Valve (K002689).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and people. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

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

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

MAY - 4 2012

Re: K120548

Trade/Device Name: HLIC NEEDLE-LESS VALVE Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FPA Dated: April 26, 2012 Received: April 27, 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.

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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 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.

Nh for

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

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Indications For Use

510(k) Number (if known): 277548

Device Name: HLIC NEEDLE-LESS VALVE

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)

Rild C. Chigan 5/4/12
(Division Sign-Off)

Division of Anesthesiology, General Hoapital Infection Control, Dental Devices

510(k) Number: K120548

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.