(232 days)
MonuMedical TurnSignal® Stopcocks and Manifolds are indicated for fluid flow directional control and providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
MonuMedical TurnSignal® Stopcocks and Manifolds are composed of a stopcock with three port three way and or three port four way body and a handle. Male connectors also include a nut for locking over the female connector or another component. A small amount of lubricant is applied between the stopcock body and handle. The manifolds contain a Halkey Roberts Swabable Port on each stopcock. MonuMedical Stopcocks will be available in a wide variety of configuration for use according to a particular situation and the clinician's preference. Duration of use should not exceed 24 hours and 7 activations of the swabable ports. The devices are provided sterile and non-sterile.
The MonuMedical TurnSignal® Stopcocks and Manifolds are indicated for fluid flow directional control and providing access port(s) for the administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration, and transfusion.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Non-clinical Testing) | Reported Device Performance |
|---|---|
| Microbial Ingress (to support 24-hour duration of use) | Microbial Ingress challenge was successfully completed to support a duration of use of 24 hours. |
| Packaging Sterility (ISO 16775, ANSI AAMI ST67) | Compliance with ISO 16775 (Packaging for terminally sterilized medical devices) and ANSI AAMI ST67 (Sterilization of health care products-Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled 'sterile'). |
| Shipping Performance (ASTM D4169, ASTM D4332) | Compliance with ASTM D4169 (Standard Practice for Performance Testing of Shipping Containers and Systems) and ASTM D4332 (Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing). |
| Sterilization Efficacy (ISO 11137-1, ISO 11137-2) | Compliance with ISO 11137-1 (Sterilization of Health Care Products Part 1) and ISO 11137-2 (Sterilization of health care products Radiation Part 2: Establishing the sterilization dose). |
| Seal Integrity of Flexible Barrier Materials (ASTM F88, ASTM F1886, ASTM F2096) | Successful Pull seal testing (ASTM F88), Visual inspection per standard (ASTM F1886), and Bubble testing of packaging (ASTM F2096). |
| Accelerated Aging of Sterile Barrier Systems (ASTM 1980) | Aging of devices completed prior to testing per ASTM F1980. |
| Biocompatibility (ISO 10993-1) | Testing of cytotoxicity, intracutaneous, sensitization, acute systemic toxicity, hemolysis, and materials mediated pyrogen were completed in compliance with ISO 10993-1. |
| Small-bore Connectors Performance (ISO 80369-7) | Compliance with ISO 80369-7, including: |
- Falling drop Positive pressure liquid leakage testing.
- Sub atmospheric pressure Air Leakage.
- Stress Cracking.
- Resistance to Separation from Axial Load.
- Resistance to Separation from Unscrewing.
- Resistance to overriding. |
| Thread Gauge Testing (ISO 80369-20) | Compliance with ISO 80369-20. |
| Leak Testing | Successful leak testing was performed. |
| Taper Block (ISO 594-1) | Compliance with ISO 594-1 (go/no-go taper block 6% taper). |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the exact sample sizes used for each individual test. However, it indicates "performance testing completed" and "design verification testing" were performed.
The data provenance is from non-clinical bench testing conducted by MonuMedical, LLC. The location of the testing is not specified, but it aligns with the submission from a US-based company (MonuMedical, LLC, Roseville, CA). These tests are typically prospective, designed specifically to evaluate the device's performance against established standards.
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 to this type of submission. The performance assessment for material compatibility, sterile barrier integrity, and functional performance of medical devices like stopcocks and manifolds is typically based on adherence to recognized international and national consensus standards (e.g., ISO, ASTM, ANSI AAMI) and their respective test methods, not on expert consensus for "ground truth" in the same way an imaging AI algorithm would be evaluated. The standards themselves define the "ground truth" for acceptable performance.
4. Adjudication method for the test set:
This is not applicable. As stated above, performance is evaluated against established standard test methods and acceptance criteria, not through an adjudication process involving multiple experts for diagnostic accuracy.
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 is not applicable. This document describes the substantial equivalence of a physical medical device (stopcocks and manifolds), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or AI assistance evaluation is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This document describes the substantial equivalence of a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" used for all the performance tests is adherence to established international and national consensus standards and specifications. These standards define the acceptable range of performance for each physical and material characteristic of the device.
8. The sample size for the training set:
This is not applicable. There is no "training set" in the context of demonstrating substantial equivalence for this type of physical medical device. The device itself is manufactured, and its performance is verified through testing, not trained.
9. How the ground truth for the training set was established:
This is not applicable for the same reasons as #8.
§ 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.