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510(k) Data Aggregation
(254 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 manufacturer for the appropriate device.
The new device, the subject of this 510(k), consists of a 20 mL, non-sterile plastic syringe filled with 20 mL of 0.9% Sodium Chloride Flush Solution USP that is terminally sterilized. The new devine is starle on the outside and has a sterile fluid path. The Sterility Assurance Level (SAL) is 10°. The syringe may be used on a sterile field if packaging is not damaged and aseptic technique is used. This is a ningle use device. The solution contains no preservatives, or antimicrobial agents. No plasticizers, additives, crosslink agents, reagents, colorants, inks, adhesives, surfactants, detergents, used during the manufacture of the syringes. The 20mL filled with 0.9% Sodium Chloride Flush Solution in a 20mL syringe is the only model which is subject to this 510(k). Other models previously cleared under 510K (K120836) consists of a non-sterile plastic 12 cc syringe filled with 3 mL, 5 mL, or 10 mL of 0.9% Sodium Chloride Flush Solution that is terminal sterilized.
This document is a 510(k) premarket notification for a medical device called the "0.9% Sodium Chloride Flush Syringe". It's a submission to the FDA to demonstrate that the new device is substantially equivalent to a previously cleared predicate device.
Here's an analysis of the provided text in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in the way one might expect for a diagnostic or AI-driven device. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing various technical characteristics and outlining the types of tests performed.
However, based on the "Technological/Substantial Equivalence Comparison Table" (Page 5) and the accompanying text, we can infer some "acceptance criteria" through the lens of equivalence and the types of tests performed to ensure that equivalence is met.
| Acceptance Criteria (Inferred from Equivalence and Testing) | Reported Device Performance (New Device) |
|---|---|
| Intended Use (Same as predicate) | "0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices." (Identical to predicate) |
| Design (Identical to predicate) | "New device has the same design as predicate." |
| Chemical Composition of Barrel (Same as predicate) | "Non-sterile Polypropylene PF-535 Resin" (Same as predicate) |
| Chemical Composition of Plunger (Same as predicate) | "Non-sterile Black Pharmaceutical Grade Rubber (Not made with Natural Rubber Latex)" (Same as predicate) |
| Chemical Composition Tip Cap (Same as predicate) | "Non-sterile Basell PF535 Polypropylene, Alpha Gray TPE G968B 4170" (Same as predicate) |
| Environment (Same as predicate) | "Positive Differential Controlled and Monitored" (Same as predicate) |
| Energy Source (Same as predicate) | "There is not an energy source. The device is operated mechanically." (Same as predicate) |
| Non-Pyrogenic (Same as predicate) | "Entire device is nonpyrogenic" (Same as predicate) |
| No Additives, Latex, or Preservatives (Same as predicate) | "No additives, natural rubber, or preservatives were used in the manufacture of the syringes." (Same as predicate) |
| Sterile Barrier Package (Same as predicate) | "Sterile barrier Pouch polypropylene film 3-6 mil" (Same as predicate) |
| Sterility Assurance Level (SAL) (Same as predicate: 10⁻⁶) | "10⁻⁶" (Same as predicate) |
| Sterility Labeling of Device (Same as predicate) | "Fluid path and outside of device are sterile." (Same as predicate) |
| Sterilization Method (Same as predicate: Gamma) | "Gamma" (Same as predicate) |
| Expiry Dating (Same as predicate: 2 years) | "2 years" (Same as predicate) |
| Filling Process (Same as predicate) | "The filling process occurs in a positive differential, monitored, and controlled environment. The solution is contained in a sterile closed system." (Same as predicate) |
| Bench and Stability Testing (Same tests as predicate, demonstrating equivalent performance) | "The same Bench and Stability tests were performed on the new device as the predicate device. Bench and Stability tests included: • Sterility • Pyrogen (LAL) analysis • pH • Water Loss • Iron • Heavy Metals • Sodium, Chloride • Particulate Matter" (Implied to have met predicate performance standards) |
Key Differences and Specific Performance:
- Size and Fill Volumes:
- Predicate: 3 mL/12 mL; 5 mL/12 mL, 10 mL/12 mL
- New Device: 20 mL/20 mL (This is the primary change in the new device, and verification testing was done to ensure equivalence despite this change).
2. Sample Size Used for the Test Set and Data Provenance
This document is for a medical device (flush syringe), not a diagnostic algorithm or AI product. Therefore, the concepts of "test set," "training set," "data provenance," "country of origin," and "retrospective/prospective" studies as they apply to AI/software performance evaluation do not apply to this submission.
Instead,
- The "test set" would be akin to the samples of the device itself that underwent various physical, chemical, and biological tests. The document doesn't specify the exact number of syringes tested for each benchmark, which is typical for a 510(k) summary (detailed test reports would be in the full submission, not the summary).
- The "data provenance" is derived from the testing of the manufactured devices, following established quality control and testing protocols for medical devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not an AI/diagnostic device that relies on expert interpretation of data to establish ground truth. Device performance is measured against established scientific and engineering standards (e.g., sterility, pH, particulate matter).
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. This is not an AI/diagnostic device that relies on human adjudication of results.
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 is a medical device (flush syringe), not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (flush syringe), not an algorithm.
7. The Type of Ground Truth Used
For this medical device, the "ground truth" for its performance is established by:
- Physical/Chemical Standards: Adherence to USP (United States Pharmacopeia) standards for sodium chloride solution, and specifications for materials (polypropylene, rubber, etc.).
- Biological Standards: Sterility Assurance Level (SAL) of 10⁻⁶, non-pyrogenicity (LAL analysis).
- Functional Standards: Performance during bench testing for water loss, particulate matter, etc., ensuring the syringe functions as intended.
- Stability data: To confirm the product maintains its characteristics over its shelf life (2 years).
These are objective, measurable outcomes, not expert consensus or pathology reports.
8. The Sample Size for the Training Set
Not applicable as this is a medical device, not an AI/ML algorithm requiring a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
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(283 days)
The device is intended for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
The proposed device consists of various sizes and fill volumes of plastic syringes aseptically filled with sterile 0.9% sodium chloride solution.
The provided document is a 510(k) Premarket Notification for a 0.9% Sodium Chloride Flush Syringe. This type of regulatory submission is for medical devices and does not typically include information about studies related to AI/ML device performance or clinical outcomes.
The document discusses nonclinical tests to ensure the device meets safety and performance requirements for a sterile saline flush syringe. These tests focus on aspects like stability, container/closure suitability, and functional requirements.
Therefore, I cannot provide the requested information about acceptance criteria and studies as it pertains to AI/ML device performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance), because this type of information is not relevant or present in this specific regulatory document for a non-AI/ML device.
Here's a breakdown of what can be inferred from the document regarding the device's validation, but without the AI/ML specific details:
-
Acceptance Criteria and Reported Device Performance: This would relate to the nonclinical tests.
- Acceptance Criteria (Inferred): The device is expected to meet or exceed "all functional requirements," and demonstrate "stability" and "container/closure suitability." These criteria would be defined internally by Baxter Healthcare Corporation based on relevant standards for medical devices of this type.
- Reported Device Performance: "Performance testing indicates that the proposed device meets or exceeds all functional requirements and supports its suitability for use." Specific quantitative results or detailed criteria are not provided in this summary.
-
Study That Proves the Device Meets Acceptance Criteria:
- Type of Study: Nonclinical tests (stability testing, container/closure suitability testing, performance testing).
- Description: "Test data have been generated for stability and container/closure suitability. Performance testing indicates that the proposed device meets or exceeds all functional requirements and supports its suitability for use."
Regarding the specific questions asked that are relevant to AI/ML devices, the information is not applicable or present in this document:
- A table of acceptance criteria and the reported device performance: As explained above, the acceptance criteria are general ("all functional requirements," "stability," "container/closure suitability") and specific performance metrics are not detailed.
- Sample sized used for the test set and the data provenance: Not relevant for this type of device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant for this type of device.
- Adjudication method: Not relevant for this type of device.
- Multi reader multi case (MRMC) comparative effectiveness study: Not relevant for this type of device.
- Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not relevant for this type of device.
- The type of ground truth used: Not relevant for this type of device. The "ground truth" for this device would be established by physical, chemical, and biological testing against product specifications.
- The sample size for the training set: Not relevant for this type of device.
- How the ground truth for the training set was established: Not relevant for this type of device.
This document clearly describes a conventional medical device (a pre-filled syringe) and its regulatory pathway based on substantial equivalence to a predicate device, not an AI/ML powered diagnostic or therapeutic device.
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