(114 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 Predicate Device, 510(k) Number: K111034, cleared on July14, 2011 consists of a plastic syringe filled with 0.9% Sodium Chloride Solution that is terminally sterilized. The predicate syringe is fluid path sterile with a Sterility Assurance Level (SAL) of 10⁻⁶. This is a single use device packaged in a dust cover.
The Modified Device, the subject of this 510 (k), consists of a plastic syringe filled with 0.9% Sodium Chloride Solution that is terminally sterilized. The modified device has a sterile exterior in addition to the sterility of the fluid, fluid path and the exterior of the device. The package that maintains the sterility of the modified device has a Sterility Assurance Level (SAL) is 10⁻⁶. This is a single use device.
Technical Data: The technical characteristics of the syringe for the modified device do not differ from those of the currently marketed predicate device. These syringes have the same design, the same functional characteristics, and have the same intended use. The proposed modification involves a change in packaging from the dust cover with a sterile barrier package for use in a sterile field. All other aspects of the syringe design remain the same.
This document is a 510(k) summary for a medical device called the "0.9% Sodium Chloride Flush Syringe". It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
The 510(k) is for a physical medical device (saline flush syringe), not an AI/ML software device. Therefore, the questions related to AI/ML device performance, ground truth, expert adjudication, training/test sets, and MRMC studies are not applicable to the provided text.
The "study" mentioned here is a series of non-clinical verification tests for the physical changes to the syringe (specifically, the sterile packaging).
Here's how I can address the prompts based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative format for device performance as one would expect for an AI/ML device. Instead, it refers to:
| Aspect | Acceptance Criteria (Implicit from "equivalent manner", "consistent performance") | Reported Device Performance |
|---|---|---|
| Sterility | Sterility Assurance Level (SAL) of 10⁻⁶ | Modified device achieves SAL of 10⁻⁶ (fluid path, fluid, exterior). |
| Physical Design | Same design as predicate device | Modified device has the same design as the predicate with sterile barrier packaging. |
| Functional Characteristics | Consistent functional performance as predicate device | Non-clinical verification testing found equivalent performance for the modified device. |
| Material Selections | Same material selections as predicate device | Modified device has the same material selections as the predicate. |
| Intended Use | Same intended use as predicate device | Modified device has the same intended use. |
| Chemical-Physical Properties | Equivalent chemical-physical properties to predicate device | Non-clinical verification testing verified equivalent performance. |
| Package Validation | Package maintains sterility and performs equivalently to predicate | Package validation studies verified equivalent performance. |
Explanation: The "acceptance criteria" here are largely implied by the concept of "substantial equivalence" to the predicate device. The goal was to demonstrate that modifications (specifically to the sterile packaging) did not negatively impact the safety or effectiveness of the device, making it perform in an "equivalent manner."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document mentions "non-clinical verification testing" which included "chemical-physical, functional, and package validation studies" but does not detail the sample sizes for these tests.
- Data Provenance: Not specified, but these would be laboratory test results related to the physical syringe and its packaging, likely conducted by the manufacturer (AMUSA) or a contracted lab. The manufacturer's address is Nashville, TN, USA. These tests are prospective in the sense that they were conducted for the purpose of this 510(k) submission.
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. This pertains to a physical medical device. Ground truth as typically understood for AI/ML algorithms (e.g., diagnostic labels) is not relevant here. The "ground truth" for the tests would be the established performance characteristics for medical devices (e.g., SAL for sterility, validated functional tests).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This pertains to a physical medical device. Adjudication methods are typically for resolving discrepancies in expert interpretations, which is not relevant here.
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 physical medical device, not an AI/ML system, so no MRMC study would be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device; there is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this physical device would be derived from standardized testing protocols and specifications for medical devices, specifically related to sterility, material properties, functional performance (e.g., fluid delivery), and package integrity. These are objective measures, not expert consensus or pathology in the AI/ML sense.
8. The sample size for the training set
- Not applicable. This is a physical medical device; there is no training set for an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for an AI/ML algorithm.
§ 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).