(78 days)
Baxter Sterile Water for Device Care and Sterile Saline for Device Care are indicated for irrigation and flushing of medical devices. Baxter Sterile Water for Device Care and Sterile Saline for Device Care are not indicated for intravascular injection.
Sterile Water for Device Care and Sterile Saline for Device Care in 250 mL plastic containers for single use.
The provided document, K051370, is a 510(k) premarket notification for "Sterile Water for Device Care" and "Sterile Saline for Device Care." This is a regulatory submission for medical devices, specifically for irrigation and flushing solutions. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/software performance metrics (like accuracy, sensitivity, specificity) is not applicable here.
Instead, the "acceptance criteria" for such a device are related to demonstrating substantial equivalence to a legally marketed predicate device, focusing on material composition, manufacturing processes, sterility, and intended use. The "study" that proves the device meets these criteria is typically a demonstration of equivalence through non-clinical tests (e.g., biocompatibility testing, stability testing, sterility testing, chemical characterization), rather than a clinical trial or a performance study with human readers or AI algorithms.
Here's a breakdown of the relevant information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
As this is not a performance study for an AI or diagnostic device, a direct table of statistical acceptance criteria and reported device performance (e.g., sensitivity, specificity) is not relevant. Instead, the "acceptance criteria" revolve around demonstrating equivalence to predicate devices in terms of:
| Acceptance Criterion | Reported Performance / Equivalence Justification |
|---|---|
| Intended Use | Indicated for irrigation and flushing of medical devices, identical to predicate devices. |
| Technological Characteristics | Sterile Saline for Device Care is the existing Baxter Sterile Saline for Catheter Care with only a name change. Sterile Water for Device Care is the same as Sterile Saline for Catheter Care except for the solution (sterile water instead of saline). The container-closure system, plastic materials, and sterilization are identical to marketed Baxter Sterile Saline for Catheter Care products. |
| Safety and Effectiveness | "There are no new issues of safety or effectiveness" compared to the predicate devices. |
| Sterility | Implied by the name "Sterile Water/Saline" and the identical sterilization process to the predicate. Specific sterility test results are not detailed in this summary but would be part of the full submission. |
| Biocompatibility | Implied by the use of existing materials and container systems from the predicate device. Specific biocompatibility test results are not detailed but would be part of the full submission. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This device is a sterile solution, not an AI or diagnostic device that uses a "test set" of data for performance evaluation in the traditional sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth in the context of AI or diagnostic imaging is irrelevant for this type of device.
4. Adjudication Method for the Test Set
Not applicable.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device or a device involving human interpretation, so MRMC studies are irrelevant.
6. Standalone (Algorithm only without human-in-the-loop performance) Study
Not applicable. This is not an algorithm or AI device.
7. Type of Ground Truth Used
Not applicable.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Study Proving Device Meets Acceptance Criteria:
The "study" in this context is the 510(k) Premarket Notification process itself, which involves providing documentation demonstrating substantial equivalence to predicate devices.
The document states:
- "The subjects of this submission are a name change for a previously cleared medical device and the addition of Sterile Water for Device Care to the product line."
- "The proposed Sterile Saline for Device Care is the existing Baxter Sterile Saline for Catheter Care. Only the name is changed."
- "The Sterile Water for Device Care is the same as Sterile Saline for Catheter Care except for the solution, which is sterile water instead of saline. The container-closure system, plastic materials, and sterilization are the same as those used in marketed Baxter Sterile Saline for Catheter Care products."
- "There are no new issues of safety or effectiveness."
These statements constitute the manufacturer's rationale and evidence that the proposed devices are substantially equivalent to the predicate devices and therefore meet the safety and effectiveness requirements. The FDA's issuance of the 510(k) clearance signifies their agreement with this assessment, based on the nonclinical tests and data submitted (which are not fully detailed in this summary document but would have been part of the complete submission).
In summary, for this type of device, the "acceptance criteria" are regulatory benchmarks for substantial equivalence and the "study" is the comprehensive documentation and testing (non-clinical) provided to the FDA to demonstrate that equivalence.
§ 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.