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510(k) Data Aggregation
(83 days)
STERILE FIELD SALINE PRE-FILLED SYRINGE(S)
Excelsior Sterile Field Saline Flush Syringe(s) are intended for use in flushing IV catheters and IV tubing.
The Excelsior Medical Saline pre-filled Syringe(s) in Sterile Field Packaging will contain 10ml of 0.9% sodium chloride solution, USP in a 10 ml syringe. This device will be marketed as one or two syringes packaged in a sterile pouch. Each syringe will contain a white tip cap and associated label with a clear backeround. In addition, the syringe label will contain a lot number, expiration date and graduation marking. Each filled and labeled syringe will be packaged in a pouch which is a two part envelope that contains printed information on one side and is clear on the other side.
The provided document describes the predicate device and the new device being submitted for 510(k) clearance, which is the "Excelsior Saline pre-filled Syringe(s) In Sterile Field Packaging."
Here's an analysis of the acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Equivalence to Predicate: | The Excelsior Medical Saline pre-filled Syringe(s) in Sterile Field Packaging performed in an equivalent manner to the predicate device. |
| Safety: | The device is safe when used as intended. (Inferred from the statement "safe and effective when used as intended" and the FDA's substantial equivalence determination which implies safety.) |
| Effectiveness: | The device is effective when used as intended (flushing IV catheters and IV tubing). (Inferred from the statement "safe and effective when used as intended" and the FDA's substantial equivalence determination which implies effectiveness for its intended use.) |
| Solution Content: | Each syringe contains 10ml of 0.9% sodium chloride solution, USP. (Explicitly stated in device description) |
| Sterility: | The device is provided in sterile field packaging. (Explicitly stated in device description and name, and 'sterilization' is listed as a similarity to the predicate.) |
| Shelf-Life: | Shelf-life is similar to the predicate devices. (Explicitly stated as a similarity to the predicate). Demonstrated by the "Stability Study." |
| Labeling: | Labeling is similar to the predicate devices. (Explicitly stated as a similarity to the predicate). Syringe label contains lot number, expiration date, and graduation marking. |
| Packaging: | Packaged in a sterile pouch, a two-part envelope with printed information on one side and clear on the other. (Explicitly stated in device description). |
| Intended Use: | Intended for use in flushing IV catheters and IV tubing. (Explicitly stated, and confirmed in "Indications for Use Statement"). |
| Substantial Equivalence: | The device is substantially equivalent to the predicate devices (Excelsior Medical Heparin Lock Flush Syringe and Excelsior Sterile Field Saline Flush Syringe K053120) in terms of solution, sterilization, shelf-life, and labeling, and for the stated indications for use. (Overall conclusion of the 510(k) process). |
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state a specific test set sample size in terms of the number of devices or units tested for the "Stability Study" mentioned.
- The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to this type of submission. This device is a medical product (saline syringe), not an AI or diagnostic imaging device that requires interpretation by experts to establish ground truth for a test set. The performance is assessed through laboratory and stability testing, not expert interpretation of data.
4. Adjudication method for the test set:
- This information is not applicable for the same reasons as point 3. There is no expert interpretation or consensus required for typical performance testing of a pre-filled saline syringe.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs. without AI assistance:
- A MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not the case for a pre-filled saline syringe.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- A standalone performance study of an "algorithm" was not done as this device is a physical medical product, not a software algorithm.
7. The type of ground truth used:
- For this device, the "ground truth" is established through physical and chemical testing against predetermined specifications and industry standards for saline solutions, sterility, and syringe performance. This includes:
- Chemical composition analysis: Verifying the 0.9% sodium chloride concentration (USP).
- Sterility testing: Ensuring the product is sterile.
- Physical performance testing: Checking syringe integrity, dose accuracy, flush mechanics, and packaging efficacy.
- Stability testing: Evaluating the product's integrity and sterility over time.
8. The sample size for the training set:
- The concept of a "training set" is not applicable here as this is not an AI or machine learning device. The "training" for such a device would refer to its design and manufacturing process adhering to established specifications and quality control.
9. How the ground truth for the training set was established:
- As "training set" doesn't apply directly, the "ground truth" for the design and manufacturing of such a device is established by adherence to regulations (e.g., 21 CFR 880.5200), international standards (e.g., ISO standards for medical devices and sterility), pharmacopoeial monographs (e.g., USP for sodium chloride injection), and internal company specifications based on scientific principles and predicate device performance. These standards and specifications define what constitutes a safe and effective saline flush syringe.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document states that "Design Verification is based on the Stability Study." This study, along with other unspecified tests implied by the claim of substantial equivalence, demonstrated that the Excelsior Medical Saline Syringe(s) in Sterile Field Packaging performed equivalently to the predicate devices. This equivalence was specifically noted in terms of solution (0.9% sodium chloride), sterilization, shelf-life, and labeling. The conclusion drawn is that the device is safe and effective when used as intended, which led to the FDA's determination of substantial equivalence. The FDA letter confirms that the device has met the requirements for clearance to market under the general controls provisions of the Act.
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