(146 days)
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.
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.
The provided text describes a 510(k) submission for a medical device, the "NP Medical Capless Luer Activated Valve." However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific numerical acceptance criteria and the results of a study that quantifies device performance against those criteria. The submission states that performance requirements were met but does not provide the specific metrics or values.
Here's a breakdown of the available information based on your requested points:
1. A table of acceptance criteria and the reported device performance
The document mentions that mechanical, biocompatibility, and microbial challenge testing were performed and that the device "meets their performance requirements" or "passed all" tests. However, it does not specify the exact acceptance criteria or the quantitative results achieved. Without specific numerical values for acceptance criteria and device performance from the document, a table cannot be constructed with the requested level of detail.
Illustrative Table (Based on available qualitative information):
| Acceptance Criterion (Hypothetical - Not explicitly stated in document) | Reported Device Performance (As stated in document) |
|---|---|
| Mechanical Integrity: Maintain structural integrity under anticipated forces (e.g., pressure, luer connection cycles). | "The results of the Mechanical Testing demonstrate that the NP Medical Capless Luer Activated Valves meet their performance requirements." |
| Biocompatibility: Absence of adverse biological reactions (e.g., cytotoxicity, sensitization, irritation). | "Full biocompatibility testing has been performed ... The materials passed all of the biocompatibility tests." |
| Microbial Barrier/Sterility Maintenance: Prevent microbial ingress into the fluid pathway under specified challenge conditions. | "The results of the testing demonstrate that, in response to excessive microbial challenge conditions, the sterility of the fluid pathway was maintained." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the tests (Mechanical, Biocompatibility, Microbial Challenge). It also does not explicitly state the provenance of the data (country of origin, retrospective or prospective). Given that NP Medical, Inc. is located in Clinton, MA, and the submission is to the FDA, it is highly probable the testing was conducted in the USA by or for the manufacturer. The testing described (mechanical, biocompatibility, microbial challenge) is typically prospective and laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and therefore not available in the provided document. The device is a physical medical device (a luer activated valve), not an AI or diagnostic imaging device that requires expert review for ground truth establishment. The performance is assessed through laboratory testing (mechanical, chemical, microbial) rather than interpretation by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not available in the provided document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human expert assessment where there might be disagreement in interpretations (e.g., in radiology studies). This submission describes laboratory-based engineering and biological tests for a physical device, not an interpretive process.
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 information is not applicable and therefore not available in the provided document. An MRMC study is relevant for evaluating diagnostic tools, often AI-powered, where human readers interpret patient cases. The Capless Luer Activated Valve is a physical device for fluid delivery, not a diagnostic tool, and involves no "human readers" in its intended function or performance testing described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and therefore not available in the provided document. "Standalone performance" in this context usually refers to the performance of an AI algorithm alone. The NP Medical Capless Luer Activated Valve is a physical medical device, not an algorithm. Its performance is inherent in its physical and material properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" would be defined by engineering specifications and established test methods (e.g., pressure resistance, flow rates, number of activation cycles without failure). For biocompatibility, the "ground truth" is determined by standardized biological assays according to ISO 10993. For microbial challenge testing, the "ground truth" is the absence of microbial growth in the fluid pathway after being subjected to a known microbial load, following established microbiological testing protocols.
8. The sample size for the training set
This information is not applicable and therefore not available in the provided document. "Training set" refers to data used to train machine learning models. As this is a physical medical device, there is no "training set" in the context of AI. The device's design and manufacturing rely on engineering principles and material science, not machine learning.
9. How the ground truth for the training set was established
This information is not applicable and therefore not available in the provided document. As there is no AI training set for this physical device, there is no ground truth to be established for it.
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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.
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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.
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- 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:
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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
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.
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)
§ 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.