(15 days)
For the administration of Nitroglycerin solution from a container into the patient's vascular system through a vascular access device.
The proposed devices, which are the subject of this Traditional 510(k) premarket notification, consist of Nitroglycerin Sets with DUO-VENT Spike. They are single use disposable devices intended for the administration of Nitroglycerin solution from a container into the patient's vascular system through a vascular access device. These devices are the same as the current marketed devices, previously cleared under 510(k) premarket notification K832284 (cleared on December 29, 1983).
Baxter's Nitroglycerin Sets with DUO-VENT Spike are comprised of non-DEHP drip chamber with a vented spike. PVC tubing pump segment, polyethylene (PE) lined trilayer tubing, and a luer lock. On all sets there is a fixture slide clamp and an on-off roller clamp. Configurations of these sets differ in overall length, type of injection site (Interlink, Clearlink, needle-accessed, or none), and type of drip chamber (10 or 60 drops per minute).
Polyethylene lined tubing is used to administer Nitroglycerin due to the compatibility issues between the drug and polyvinyl chloride (PVC). Nitroglycerin concentration can be significantly reduced when infused using standard PVC administration sets, due to absorption into the tubing. For this reason, trilayer tubing with an inner polyethylene layer is used in Baxter's line of Nitroglycerin Sets with DUO-VENT Spike.
The basis for this premarket notification is a modification to the PE lined trilayer tubing used in Baxter's Nitroglycerin Sets with DUO-VENT Spike. The modification consists of a change to the Polyethylene material used in the inner layer of the PE lined trilayer tubing.
Along with this modification, the needle-accessed injection site (y-site) is changing from a latex-containing y-site to one that is not manufactured with latex. This proposed needle-accessed y-site is currently used in Baxter's Intravascular (IV) Administration Sets with y-site(s) and has been previously cleared under 510(k) premarket notification K142011 (cleared on August 18, 2014).
These modifications do not impact the intended use or the fundamental scientific technology of the device. No other materials of construction are being introduced into this device as part of this update. The product labels are also being updated to add the indications for use statement of the device, revise statements regarding latex and references to pump devices, and make any other changes to comply with Baxter's labeling standards.
The provided document is a 510(k) premarket notification for a medical device (Nitroglycerin Sets with DUO-VENT Spike). This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a new device meets specific acceptance criteria through a clinical study in the way an AI/ML device would. Therefore, most of the requested information regarding AI/ML study design, ground truth, experts, and sample sizes is not applicable to this document.
However, I can extract the acceptance criteria and performance related to the bench tests conducted for this device.
Here's the information that can be extracted or stated as not applicable:
1. A table of acceptance criteria and the reported device performance
| Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Clear Passage Test | Met safety and functional requirements for fluid passage | Met acceptance criteria |
| Roller Clamp Force Test | Met force requirements for proper operation | Met acceptance criteria |
| Roller Clamp Shut-Off Test | Successfully shut off fluid flow | Met acceptance criteria |
| Roller Clamp Tubing Leak Test | No leaks observed | Met acceptance criteria |
| Solvent Bond Tensile Strength Test | Met tensile strength requirements for material bonds | Met acceptance criteria |
| Solvent Bond Air Pressure Test | Met air pressure holding requirements for material bonds | Met acceptance criteria |
| Drug Compatibility Test | Maintained drug integrity (Nitroglycerin concentration) | Met acceptance criteria |
| Puncture Test (for y-site) | Withstood puncture without compromising integrity | Met acceptance criteria |
| 7-Day Indwell Test (for y-site) | Maintained integrity over 7 days in simulated use | Met acceptance criteria |
| Burst Test (for y-site) | Withstood specified internal pressure without bursting | Met acceptance criteria |
| Vacuum Leakage Test (for y-site) | No leaks observed under vacuum conditions | Met acceptance criteria |
| Coring Test (for y-site) | Did not produce significant particulate matter upon needle insertion | Met acceptance criteria |
| Insertion Force Test (for y-site) | Met requirements for acceptable insertion force | Met acceptance criteria |
| Cytotoxicity | Non-cytotoxic | Biocompatible |
| Systemic Toxicity | Non-systemically toxic | Biocompatible |
| Irritation/Intracutaneous | Non-irritating | Biocompatible |
| Sensitization | Non-sensitizing | Biocompatible |
| Hemocompatibility | Hemocompatible | Biocompatible |
| USP Physiochemical | Met USP physiochemical standards | Biocompatible |
Note: The document explicitly states "All tests met the acceptance criteria" for the performance tests and "shown to be biocompatible and appropriate for its intended use" for biocompatibility. Specific numerical acceptance criteria are not detailed in this summary, but are implicitly part of the underlying test protocols.
2. Sample size(s) used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each test. The document refers to "bench tests" and "biocompatibility assessments" which typically involve a predetermined number of samples per test type according to relevant standards (e.g., ISO, ASTM).
- Data Provenance: This is not relevant for bench testing of a physical device. The tests are conducted in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This device is a physical medical administration set, not an AI/ML diagnostic or predictive device requiring expert-established ground truth from a dataset. The "ground truth" for these tests is defined by engineering specifications and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of data (e.g., medical images for AI ground truth). This is a physical device being evaluated against objective bench test criteria.
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
- Not Applicable. This is a physical medical device, not an AI or AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this device's performance is based on established engineering specifications, material properties, and regulatory standards for safety and function of intravascular administration sets and biocompatibility (e.g., ISO-10993, USP).
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set for an AI/ML model is involved.
§ 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.