(146 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
The device is described as a luer activated valve intended for needleless fluid delivery, which facilitates the connection between fluid lines and syringes. Its function is mechanical and does not involve any therapeutic action or treatment of a medical condition.
No
The device is a valve intended for "facilitating needleless fluid delivery," not for diagnosis. Its purpose is to manage fluid flow, as described by its mechanical components and testing.
No
The device description clearly outlines physical components (Gland Housing Assembly, Gland/Center Post Assembly) and mechanical actions, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "facilitating needleless fluid delivery." This describes a device used for administering fluids to a patient, which is a clinical procedure, not an in vitro diagnostic test.
- Device Description: The description details a mechanical valve designed to connect to luer connectors for fluid transfer. This aligns with a medical device used for patient care, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
- Performance Studies: The performance studies focus on mechanical integrity, biocompatibility, and microbial challenge, which are typical for medical devices used in fluid delivery, not for diagnostic accuracy.
- Predicate Devices: The predicate devices listed are "Needleless Connector," which are also devices used for fluid delivery in a clinical setting, not for in vitro diagnostics.
In summary, the function and purpose of the Capless Luer Activated Valve, as described, are clearly related to the delivery of fluids to a patient, which falls under the category of a medical device for clinical use, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Capless Luer Activated Valve, incorporating a luer activated valve, is intended for use in facilitating needleless fluid delivery and may be swabbed with antiseptic just prior to use, thereby eliminating the need for capping between uses.
Product codes
80FPA
Device Description
The Capless Luer Activated Valve is a two-part device consisting of a Gland Housing Assembly and a Gland/Center Post Assembly, as described below:
The Gland is a valve/gasket which provides a seal against the syringe/luer connector when the device is being utilized. The Gland incorporates a slit to accept the syringe/luer connector. The Gland is also the swabbable surface of the Capless Luer Activated Valve. The valve can be easily swabbed per hospital protocol before each connection.
The Center Post mechanically supports the Gland and serves as the primary high pressure seal to keep the fluid path closed during the resting state.
The Gland and the Center Post are mechanically press-fit together to form the Gland/Center Post Assembly.
In the resting state, the Center Post is flush with the walls of the Gland Housing, ensuring that there is no fluid path. As the device is activated by a syringe/male luer connector, the flexible Gland is forced open and the Center Post is pushed down. As the Center Post is forced further down into the Gland Housing, the fluid path is established.
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
hospital protocol
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
Mechanical Testing has been conducted on the Capless Luer Activated Valve to demonstrate that the device's performance characteristics are adequate for the intended use.
The results of the Mechanical Testing demonstrate that the NP Medical Capless Luer Activated Valves meet their performance requirements.
Full biocompatibility testing has been performed on the materials being proposed in this 510(k) submission, per ISO 10993. The materials passed all of the biocompatibility tests.
Microbial Challenge testing has been conducted on the Capless Luer Activated Valve. The results of the testing demonstrate that, in response to excessive microbial challenge conditions, the sterility of the fluid pathway was maintained.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510(K) SUMMARY
MAR - 9 1998
1. SUBMITTER:
NP Medical, Inc. 101 Union Street Clinton, MA 01510 Telephone: 978-365-2500
Contact: Mike Jones, Quality Assurance Manager Date Prepared: October 9, 1997
2. DEVICE:
Classification Name: Set, Administration, Intravascular Trade Name: NP Medical Capless Luer Activated Valve Class II per 21 CFR 880.5440 The Product Code is 80FPA
3. PREDICATE DEVICE:
The predicate device used to determine substantial equivalence for the NP Medical Capless Needleless Luer Connector is the ICU Medical Clave Needleless Connector (K915571 / K941190).
4. DEVICE DESCRIPTION:
The Capless Luer Activated Valve is a two-part device consisting of a Gland Housing Assembly and a Gland/Center Post Assembly, as described below:
The Gland is a valve/gasket which provides a seal against the syringe/luer connector when the device is being utilized. The Gland incorporates a slit to accept the syringe/luer connector. The Gland is also the swabbable surface of the Capless Luer Activated Valve. The valve can be easily swabbed per hospital protocol before each connection.
The Center Post mechanically supports the Gland and serves as the primary high pressure seal to keep the fluid path closed during the resting state.
The Gland and the Center Post are mechanically press-fit together to form the Gland/Center Post Assembly.
1
In the resting state, the Center Post is flush with the walls of the Gland Housing, ensuring that there is no fluid path. As the device is activated by a syringe/male luer connector, the flexible Gland is forced open and the Center Post is pushed down. As the Center Post is forced further down into the Gland Housing, the fluid path is established.
5. INTENDED USE:
The Capless Luer Activated Valve, incorporating a luer activated valve, is intended for use in facilitating needleless fluid delivery and may be swabbed with antiseptic just prior to use, thereby eliminating the need for capping between uses.
6. COMPARISON OF CHARACTERISTICS:
The Capless Luer Activated Valve and the currently marketed Clave Needleless Connector are very similar in design: Both devices consist of a silicone valve encapsulated within a plastic housing. Both devices have the same Intended Use.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
-
- Mechanical Testing:
Mechanical Testing has been conducted on the Capless Luer Activated Valve to demonstrate that the device's performance characteristics are adequate for the intended use.
- Mechanical Testing:
The results of the Mechanical Testing demonstrate that the NP Medical Capless Luer Activated Valves meet their performance requirements.
-
- Biocompatibility Testing:
Full biocompatibility testing has been performed on the materials being proposed in this 510(k) submission, per ISO 10993. The materials passed all of the biocompatibility tests.
- Biocompatibility Testing:
-
- Microbial Challenge Testing:
Microbial Challenge testing has been conducted on the Capless Luer Activated Valve. The results of the testing demonstrate that, in response to excessive microbial challenge conditions, the sterility of the fluid pathway was maintained.
- Microbial Challenge Testing:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 1998
Mr. Paul A. Caracciolo Ouality Assurance Manager N.P. Medical Incorporated 101 Union Street Clinton, Maryland 01510
Re : K973916 NP Medical Capless Luer Activated Valve Trade Name: Requlatory Class: II Product Code: FPA Dated: January 23, 1998 Received: January 28, 1998
Dear Mr. Caracciolo:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with annon the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Caracciolo
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timo By A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
.
INDICATIONS FOR USE STATEMENT
The Capless Luer Activated Valve, incorporating a luer activated valve, is intended for use in facilitating needleless fluid delivery and may be swabbed with antiseptic just prior to use, thereby eliminating the need for capping between uses.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patara Cucente
(Division Sign-Off Division of Dental, Info and General Hospita 510/k) Number
Prescription Use 2 OR
Over-The-Counter Use
(Optional Format 1-2-96)