(71 days)
Not Found
No
The device description and performance summary focus on the mechanical function of a needle-less valve and do not mention any AI or ML components or capabilities.
No.
The device is described as a needle-free valve for accessing IV administration sets and medication vials. Its function is to facilitate the addition of medication without needles, not to treat or diagnose a disease or condition.
No
The device description indicates that the HLIC Needle-Less Valve is a needle-free valve for adding medication to IV sets, functioning as a fluid path access point. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly describes a physical, mechanical valve with a silicone stem, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for accessing IV administration sets, medication vials, blood donor collection bags, and solution bags. This is related to the delivery and management of fluids and medications within the body, not for testing samples taken from the body to diagnose conditions.
- Device Description: The description details a mechanical valve for fluid transfer, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely related to fluid management in a clinical setting.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FPA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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 (
§ 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.
0
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
1
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.
2
INTENDED USE:
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.
INDICATIONS FOR USE:
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.
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 (