(267 days)
Heparin Lock Flush Solution, USP product code 505701 (10 USP units/mL) and product code 504901 (100 USP Units/mL), is intended to maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
The Heparin Lock Flush Solution, USP product code 505701 comes in concentration of 10 USP Units/mL, and in strengths of 10 USP units. The Heparin Lock Flush Solution, USP product code 504901 comes in concentration of 100 USP Units/mL, and in strength of 100 USP units. These two product codes are packaged in 3 cc plastic vials.
The provided text describes a 510(k) submission for a medical device, Heparin Lock Flush Solution USP. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials as one might see for novel AI software. Therefore, the questions related to AI-specific study designs, reader performance, and ground truth establishment in a diagnostic context are not directly applicable.
Instead, the "acceptance criteria" here relate to demonstrating biocompatibility and stability, and the "study" involves laboratory testing.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was tested for) | Reported Device Performance (Test Results) |
|---|---|
| Biocompatibility | |
| Cytotoxicity (MEM Elution test) | Sample met USP and ISO requirements; found to be non-cytotoxic. |
| Hemolysis (ASTM Hemolysis Direct Contact) | Samples were found to be non-hemolytic. |
| Chemical Stability/Leachables | |
| Presence of TMTBB (HPLC limit test) | TMTBB was not detected after sterilization or over the shelf life. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of "patients" or "cases" but rather samples of the Heparin Lock Flush Solution, USP. For the biocompatibility tests (cytotoxicity, hemolysis) and the leachable test, specific quantities of the product were used. The document does not specify the exact number of solution samples tested, but it refers to "the sample" for cytotoxicity and "the samples" for hemolysis.
- Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective medical data. These were laboratory tests performed on the manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for these types of tests is established by adherence to recognized laboratory standards (USP, ISO, ASTM) and analytical methods, not by expert consensus on medical images or clinical outcomes.
4. Adjudication method for the test set:
- Not applicable. The tests performed are objective laboratory measurements with pass/fail criteria based on established scientific standards, not subjective interpretations requiring adjudication.
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 is a medical device (a pharmaceutical solution), not an AI diagnostic tool. Therefore, MRMC studies and AI-specific effectiveness measures are not relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a pharmaceutical solution, not an algorithm.
7. The type of ground truth used:
- Biocompatibility: Established by adherence to industry standards (USP, ISO, ASTM) for cytotoxicity and hemolysis. The "ground truth" is that the material must meet the specified safe limits as defined by these standards.
- Chemical Stability/Leachables: Established using a scientifically validated analytical method (HPLC limit test) to detect the presence of a specific compound (TMTBB). The "ground truth" is the verifiable absence (below detection limits) of the leachable.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
§ 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).