(182 days)
The ulrich Transfer Set is indicated for the transfer of OmnipaqueTM (Iohexol) contrast media as supplied in an Imaging Bulk Package to non pre-filled single-use only sterile syringes on syringe-based contrast injection systems indicated for the controlled, automatic administration on the venous side of contrast media for CT procedures. The Transfer Set is to be discarded after the contrast media container has been depleted or 8 hours have elapsed since the container was penetrated. whichever occurs first.
The ulrich Transfer Set (Transfer Set) is a sterile tubing set connection between an imaging bulk package and empty sterile syringes on single-use-only, syringe based contrast injection systems. The Transfer Set consists of a spike with protective cap and integrated air filter on one side, 20" (50.8 cm) tubing segment and one female swabable (also referenced as swabbable) valve (Swabsite Swabbable Valve - K002689) with a protective cap on the other side. The Transfer Set is to be discarded after the contrast media container has been depleted or 8 hours have elapsed since the container was penetrated, whichever occurs first.
The provided text describes the ulrich Transfer Set and its successful 510(k) submission for substantial equivalence to a predicate device. This is a medical device, and the acceptance criteria and supporting studies are focused on its safety and performance standards rather than AI/algorithm performance.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|---|
| Sterilization | ISO 11135-1:2014 (Sterilization of health care products - Ethylene oxide) to a SAL of 10⁻⁶ | Complies with the standard and achieves SAL of 10⁻⁶ |
| Shelf-Life | ISO 11607-1:2006 (Packaging for terminally sterilized medical devices - Part 1) | Complies with the standard |
| ISO 11607-2:2006 (Packaging for terminally sterilized medical devices - Part 2) | Complies with the standard | |
| Biocompatibility | ISO 10993-4:2009 (Interactions with blood) | Materials comply with the standard |
| ISO 10993-5:2009 (In vitro cytotoxicity) | Materials comply with the standard | |
| ISO 10993-10:2010 (Irritation and Skin Sensitization) | Materials comply with the standard | |
| ISO 10993-11:2006 (Systemic toxicity) | Materials comply with the standard | |
| ASTM F756-13 (Haemolytic Properties Materials) | Materials comply with the standard | |
| ASTM F619-14 (Extraction of Medical Plastics) | Materials comply with the standard | |
| USP 38 (Pyrogen Test) | Materials comply with the standard | |
| USP 38 (Bacterial Endotoxins Test) | Materials comply with the standard | |
| USP 38 (Transfusion and infusion assemblies) | Materials comply with the standard | |
| Performance - Bench | ISO 8536-4:2010 (Infusion equipment for medical use - Part 4) | Complies with its predetermined specifications and applicable standards |
| ISO 22413:2010 (Transfer sets for pharmaceutical preparations) | Complies with its predetermined specifications and applicable standards | |
| ISO 594-2 (Conical fittings with 6% (Luer) taper) | Complies with its predetermined specifications and applicable standards | |
| Microbial Ingress Testing | (Implicit: no microbial ingress) | Performed, results indicate compliance with specifications |
| Chemical Compatibility Testing | (Implicit: conformance to approved release specification of Omnipaque) | Performed, results indicate compliance with specifications |
| Extractables and Leachables Testing | (Implicit: within safe limits) | Performed, results indicate compliance with specifications |
| Intended Use & Indications for Use | Substantially equivalent to predicate device | Met through design comparison and testing |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test mentioned (e.g., number of transfer sets tested for sterility, biocompatibility, or performance). The studies are "verification results" indicating compliance with standards, implying a sufficient sample size was used as per the standard's requirements.
- Data Provenance: The studies are laboratory-based bench tests and materials testing, conducted by ulrich GmbH & Co. KG or their contracted testing facilities. The country of origin of the data would likely be Germany (where ulrich GmbH & Co. KG is located) or the location of the testing laboratories. The studies are prospective in the sense that they were conducted specifically for this 510(k) submission to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this device submission. The ulrich Transfer Set is a physical medical device (an intravascular administration set), not an AI/software device that requires expert-established ground truth for diagnostic or interpretative tasks. The "ground truth" here is defined by meeting established engineering, chemical, and biological standards (e.g., a device is sterile if it meets SAL 10⁻⁶; materials are biocompatible if they pass ISO 10993 tests).
4. Adjudication method for the test set
This is not applicable as it pertains to expert consensus on diagnostic or interpretative AI performance. The tests described are objective, quantitative measurements against predefined standards.
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. The device is an intravascular administration set, not an AI or imaging diagnostic tool. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. (If a standalone (i.e. algorithm only without human-in-the-loop performance) was done)
This is not applicable. The device is a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" in the AI/diagnostic sense is not directly applicable. The "ground truth" for the ulrich Transfer Set's performance is established by:
- International Standards: Compliance with ISO 11135-1, ISO 11607-1/2, ISO 10993 series, ISO 8536-4, ISO 22413, ISO 594-2.
- National Standards: Compliance with ASTM F756-13, ASTM F619-14, USP 38.
- Predetermined Specifications: The device's own internal design and performance specifications confirmed by testing.
8. The sample size for the training set
This is not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. See point 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.