(186 days)
The device is indicated only for use in flushing compatible intravenous tubing systems and in dwelling intravascular access devices. Not to be used for any other purposes.
Spectra Medical's, Sodium Chloride Injection, 0.9%, USP, 10 mL Ampule
This document is a 510(k) summary for a medical device called "Sodium Chloride Injection, 0.9%, USP, 10 mL Ampule" by Spectra Medical. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting new performance data from a specific study. Therefore, most of the requested information about acceptance criteria and a study proving their fulfillment is not present in this document.
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:
This document does not specify any acceptance criteria or report new performance data for Spectra Medical's device. The core argument for clearance is "substantial equivalence" to a predicate device (K023740 - Syrex Pre-filled Syringe with 0.9% Sodium Chloride).
The document explicitly states:
- "There has been no change to the performance characteristics of the device system."
- "There has been no change to the fundamental scientific technology."
- "Spectra Medical's Chloride Injection, 0.9%, USP, 10 mL Ampule is identical to the predicate device. The difference is that the Spectra medical product is in a 10 mL ampule whereas the predicate device is in a syringe."
Therefore, no acceptance criteria or new reported performance are provided for this specific submission as it relies on the predicate device's established performance.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
No test set or new data is presented in this 510(k) summary. The submission relies on the existing data and performance characteristics of the predicate device.
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. No new test set or ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No new test set or adjudication process is described.
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 a Sodium Chloride Injection, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to human readers and AI is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a Sodium Chloride Injection, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No new ground truth was established for this submission. The "truth" for this submission is that its formulation and intended use are identical to a legally marketed predicate device, with only a change in packaging (ampule vs. syringe).
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.
In summary:
This 510(k) submission is for a device that is considered "substantially equivalent" to a previously cleared predicate device. The basis for this equivalence is that the product (0.9% Sodium Chloride Injection) is identical to the predicate device in terms of its composition, performance characteristics, and fundamental scientific technology. The only difference highlighted is the packaging (10 mL ampule vs. syringe). Therefore, no new clinical studies, performance data, or detailed acceptance criteria are presented in this document for the Spectra Medical device itself, as it is deemed to meet the established safety and effectiveness of its predicate.
§ 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).