(81 days)
Baxter Sterile Saline for Catheter Care is intended for use in flushing urinary drainage and suction catheters.
Baxter Sterile Saline for Catheter Care is indicated for flushing or cleaning urinary drainage and suction catheters.
Baxter Healthcare Corporation intends to manufacture and market Sterile Saline for Catheter Cares in 250 mL containers.
This 510(k) premarket notification for "Sterile Saline for Catheter Care" from Baxter Healthcare Corporation is a re-classification of an existing device (Sterile Saline for Respiratory Therapy Solutions) with a new indication for use. As such, the submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data for device performance against specific acceptance criteria.
Therefore, the requested information components related to device performance studies (acceptance criteria, reported performance, sample sizes, ground truth establishment, expert involvement, MRMC studies, standalone performance) are not explicitly described or provided in the given document.
Here's how we can address the request based on the provided text, highlighting the absence of typical clinical study details:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified. This submission is for a re-purposed device, and performance criteria for the new indication are not explicitly defined or measured in a study within this document. The argument for safety and effectiveness relies on the device being identical to a previously cleared product for a different, but similar, use.
- Reported Device Performance: Not reported. There are no performance metrics provided for the "Sterile Saline for Catheter Care" for its new indication because no new performance study was deemed necessary.
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Not Applicable | Not Applicable | Not Applicable |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not applicable. No new test set or clinical data for the "Sterile Saline for Catheter Care" is discussed.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No ground truth for a test set was established as no new clinical study was conducted.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No test set was adjudicated.
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
- MRMC Study: No. This is a medical device (saline solution), not an AI algorithm.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No. This is not an algorithm; it's a physical medical device (saline solution).
7. The type of ground truth used
- Type of Ground Truth: Not applicable. No new clinical ground truth was established for this submission. The basis for approval is substantial equivalence to a predicate device.
8. The sample size for the training set
- Sample Size: Not applicable. This is not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable.
Summary of the Study (or lack thereof) that Proves the Device Meets Acceptance Criteria:
The "study" that proves the device meets acceptance criteria, in this context, is the demonstration of substantial equivalence to a previously cleared predicate device.
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Study Design: This was essentially a comparative analysis of the proposed device against a predicate device, focusing on technological characteristics and intended use. It is not a clinical performance study.
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Key Argument: The core argument provided by Baxter Healthcare Corporation is:
- "The proposed Sterile Saline for Catheter Care is the same as existing Baxter Respiratory Therapy Solutions, except for the labeling."
- "The solution of normal saline and the container-closure system are the same as those used in the existing Baxter Respiratory Therapy Solutions."
- "The subject of this submission is a change in the indication for a previously cleared medical device. There are no new issues of safety or effectiveness."
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Conclusion: The FDA agreed with this assessment, stating, "We have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..." This determination implies that the safety and effectiveness for the new indication are considered equivalent to the predicate device, given the identical composition and container system. The "acceptance criteria" were therefore met by demonstrating this substantial equivalence rather than through new performance data.
§ 880.6740 Vacuum-powered body fluid suction apparatus.
(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.