(60 days)
0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacture for the appropriate device.
The Predicate Device, 510(k) Number: K111034, AMUSA consists of a plastic syringe filled with 0.9% Sodium Chloride Flush Solution that is terminally sterilized. The predicate device filud path of 10 Section Onlonde Hush Oolution that is terminally sterlized. This is a single use device.
The Modified Device, the subject of this 510 (k), consists of a plastic syringe filled with 0.9% Sodium Chlerida Fluch Calification that the United on the Sodium Chloride Flush Solution that is terminally sterilized. The modified device fluid path sterile has a Sterility Assurance Level (SAL) of 108. This is a single use device.
The provided text describes a 510(k) submission for a medical device, the "0.9% Sodium Chloride Flush Syringe". However, it is not a study report for an AI/ML powered device, but rather a submission for a standard medical device that has undergone a change in component supplier.
Therefore, the information requested regarding acceptance criteria and studies for an AI/ML device (e.g., performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert qualifications, MRMC studies, ground truth establishment) is not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device for a physical product by verifying technical characteristics and conducting non-clinical testing.
Here's what can be extracted from the provided text, adapted to the context of a traditional medical device submission:
1. A table of acceptance criteria and the reported device performance:
Since this is a Class II medical device being evaluated for substantial equivalence after a component supplier change, the acceptance criteria are not in terms of AI performance metrics, but rather in terms of demonstrating that the modified device is as safe and effective as the predicate device.
| Acceptance Criteria Category | Description | Reported Device Performance |
|---|---|---|
| Design | The modified device should have the same design as the currently marketed predicate device. | "The technical characteristics for the modified device do not differ from those of the currently marketed device. These devices have the same design..." |
| Fundamental Science | The modified device should have the same fundamental scientific characteristics as the predicate device. | "...the same fundamental scientific characteristics..." |
| Labeling | The modified device should have the same label as the predicate device. | "...the same label..." |
| Intended Use | The modified device should have the same intended use as the predicate device. | "...have the same intended use." (Intended use: "0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacture for the appropriate device.") |
| Sterility Assurance Level (SAL) | The modified device's fluid path must maintain a sterile SAL of 10⁻⁶. (While not explicitly stated as an "acceptance criteria" here, it's a critical safety parameter for terminally sterilized devices and the text mentions it for the modified device). | The modified device fluid path sterile has a Sterility Assurance Level (SAL) of 10⁻⁶. (The predicate device is also "terminally sterilized" implicitly suggesting a similar SAL). |
| "Substantial Equivalence" | Non-clinical verification testing must demonstrate that the modified device performs in an equivalent manner to the predicate device and is safe and effective when used as intended, covering chemical-physical, functional, and product stability aspects. | "Non-clinical verification testing for the proposed change involved chemical-physical, functional, and product stability testing. The results of testing conducted verifies the modified terminally sterilized syringe performed in an equivalent manner to the predicate terminally sterilized syringe and is safe and effective when used as intended." (Specific quantitative results for these tests are not provided in this summary but were presumably submitted to the FDA.) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for the "chemical-physical, functional, and product stability testing." It only mentions that these tests were conducted.
- Data Provenance: Not explicitly stated, however, the testing would have been conducted by the manufacturer, AMUSA, or a qualified contract lab under their direction, as part of the regulatory submission process in the United States. It is "prospective" to the decision of equivalence, meaning it was performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable here. Ground truth in the context of this device relates to established engineering and quality standards for medical devices (e.g., sterility, material compatibility, functional performance). The "experts" would be the engineers, scientists, and quality assurance personnel performing and interpreting the non-clinical tests, and the FDA reviewers evaluating the submission. Their qualifications are assumed to be appropriate for their roles.
4. Adjudication method for the test set:
Not applicable in the context of ground truth for an AI/ML device. The "adjudication" for this type of device is the FDA's regulatory review process, where they evaluate the submitted data against regulatory requirements and accepted 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:
Not applicable. This device is not an AI/ML product and does not involve human readers interpreting data with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an AI/ML algorithm.
7. The type of ground truth used:
The "ground truth" for this device is based on established engineering principles, material science, microbiology (for sterility), and functional performance standards relevant to sterile, single-use medical devices. It would involve objective measurements from the chemical-physical, functional, and product stability tests.
8. The sample size for the training set:
Not applicable. This device does not involve a training set as it's not an AI/ML model.
9. How the ground truth for the training set was established:
Not applicable.
§ 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).