(67 days)
The proposed device is indicated only for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
The proposed device is a sterile, single use, standard piston syringe of various sizes and fill volumes containing either 10 or 100 USP Heparin units/ml.
The provided document describes a 510(k) submission for a medical device, the "Monoject® PreFill Heparin Lock Flush Syringe." This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria and a study proving the device meets those criteria.
Therefore, much of the requested information regarding acceptance criteria, specific device performance numbers, sample sizes for test and training sets, expert involvement, and ground truth establishment cannot be extracted from the provided text.
The document primarily states that the device is "substantially equivalent in intended use, function and composition" to a predicate device and that "Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1."
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Substantially equivalent in intended use to Baxter Healthcare Corporations' Heparin Lock Flush Syringe, 510(k) No. K003245. | The proposed device is stated to be "substantially equivalent in intended use, function and composition" to the predicate device. |
| Function and Composition Equivalence: Substantially equivalent in function and composition to Baxter Healthcare Corporations' Heparin Lock Flush Syringe, 510(k) No. K003245. | The proposed device is stated to have "the same technological characteristics as the predicate devices. Each consists of Monoject® plastic syringes containing Heparin Lock Flush Solution, USP." |
| Biocompatibility: Meet the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1. | Biocompatibility testing "has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document. The testing mentioned (biocompatibility) would involve a certain number of samples, but no specific count is provided.
- Data Provenance: Not specified. Biocompatibility testing is typically performed in a laboratory setting, but the location or whether it's retrospective/prospective is not mentioned.
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/Not specified. This information is typically relevant for studies involving human interpretation (e.g., medical imaging AI). Biocompatibility testing is laboratory-based and doesn't involve "experts" establishing ground truth in the same way.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. This is relevant for studies involving human interpretation or complex data review, not for standard biocompatibility testing.
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
- No. This document does not mention an MRMC study. The device is a syringe, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device. The testing described is for the physical and chemical properties of a medical device (syringe).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For biocompatibility, the "ground truth" would be the established safety standards and chemical/biological assay results as defined by ISO 10993 and FDA guidelines. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic device would be.
8. The sample size for the training set
- Not applicable/Not specified. This document is not describing a machine learning model. If interpreted in the context of device development, "training set" might refer to early development samples, but no such details are provided.
9. How the ground truth for the training set was established
- Not applicable/Not specified. As above, this is not a machine learning context.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).