(280 days)
The flush syringe is intended for flushing of IV catheters and IV tubing. SwabCap® is intended for use on a swab-able luer access valve as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between the line accesses. SwabCap® will disinfect the valve five (5) minutes after application and act as a physical barrier to contamination for up to ninety-six (96) hours under normal conditions if not removed. The SwabFlush™ product is provided as: 1. 10 ml fill in 10 ml saline flush syringe with integrated SwabCap®. 2. 5 ml fill in 10 ml saline flush syringe with integrated SwabCap®. 3. 3 ml fill in 10 ml saline flush syringe with integrated SwabCap®.
SwabFlush" is a saline intravenous flush syringe that is combined with an integrated SwabCap®. Each SwabFlush" syringe contains a sterile, non-pyrogenic isotonic solution of 0.9% Sodium Chloride Injection USP, 9 mg NaCl per ml, with an osmolarity of 0.3 l mOsm/mL, pH 4.5 - 7.0. A SwabCap® is a luer access valve cap that contains 70% isopropyl alcohol as a disinfectant. A SwabCap® is designed to securely fit on swab-able luer access valves. The product is intended for single-use and is provided sterile. The SwabFlush" provides the healthcare professional with immediate access to the SwabCap luer access valve disinfectant cap after an IV flush.
Here's a breakdown of the acceptance criteria and study information for the Excelsior Medical Corporation's SwabFlush™ device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Flush Syringe Component: | |
| ISO 7886-1: Sterile Hypodermic Syringes for single use standards | Met all standards. (K101270 p.3) |
| ISO 594-1&-2: Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment | Met all standards. (K101270 p.3) |
| Biocompatibility requirements per ISO 10993: Biological evaluation of medical devices | Met all requirements. (K101270 p.3) |
| Sterility Assurance Level | Sterilization validations performed to achieve the desired sterility assurance level. (K101270 p.3) |
| Ability to hold and apply a SwabCap® without affecting disinfectant content | Functions to hold and apply a SwabCap® while not affecting the disinfectant content. (K101270 p.3) |
| Saline flush compliance with 0.9% Sodium Chloride Injection USP monograph | Verified to comply. (K101270 p.3) |
| Shelf life stability (including sterility) | Controlled aging performed to verify all product requirements, including sterility, throughout the shelf life. (K101270 p.3) |
| Packaging integrity (drop, vibration, compression) | Ship testing performed on representative final packaged product for drop, vibration, and compression as specified by applicable ISTA or ASTM standards. All results met the established criteria. (K101270 p.3) |
| Syringe functional characteristics (e.g., injection force, liquid/air leakage) | Meets the same requirements as predicate syringes for syringe functional characteristics. (K101270 p.2) |
| Integrated SwabCap® Component: | |
| Disinfection of luer access valve | Will disinfect the valve five (5) minutes after application. (K101270 p.2) (This performance is based on the predicate SwabCap® K083508, as the integrated SwabCap® is identical). |
| Physical barrier to contamination | Acts as a physical barrier to contamination between line accesses for up to ninety-six (96) hours under normal conditions if not removed. (K101270 p.2) (This performance is based on the predicate SwabCap® K083508, as the integrated SwabCap® is identical). |
| Clinical Need (Overall Device) | Design Validation confirmed that SwabFlush™ meets the clinical need expected for a typical flush procedure in a simulated clinical setting. (K101270 p.3) |
Study Information
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Sample Size Used for the Test Set and Data Provenance:
- The document mentions "All results met the criteria established in the testing" for non-clinical tests (K101270 p.3). However, specific numerical sample sizes for each test mentioned (e.g., ISO standards, biocompatibility, sterilization validations, ship testing, controlled aging) are not provided.
- For the "Design Validation" to verify clinical need in a "simulated clinical setting," the sample size of participants or test runs is not specified.
- Data Provenance: This information is not explicitly stated. Given it's a 510(k) submission, the studies would likely be conducted by the manufacturer, Excelsior Medical Corporation. It doesn't specify if the studies were retrospective or prospective, though "Design Verification" and "Design Validation" generally imply prospective testing. There's no mention of the country of origin of the data beyond the manufacturer's location in Neptune, NJ.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. The studies mentioned are primarily non-clinical and simulated clinical setting evaluations. If expert assessment was used for "Design Validation," the number and qualifications of experts are not described.
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Adjudication Method for the Test Set:
- This information is not provided. Given the nature of the tests (compliance with ISO standards, physical tests, chemical verification), adjudication methods like 2+1 or 3+1 typically used for subjective diagnostic interpretations are not applicable here. The "criteria established in the testing" (K101270 p.3) implies objective pass/fail metrics.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- No, an MRMC comparative effectiveness study was not done or described. The document focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and non-clinical as well as simulated clinical testing of the device itself, rather than comparing human reader performance with and without AI assistance.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, the tests described (Design Verification and Design Validation) represent standalone performance of the device (SwabFlush™) itself. These tests evaluate the syringe's ability to meet various technical specifications and the combined device's ability to function as intended, independent of human operators beyond standard usage. However, it's not an "algorithm only" evaluation as the device is a physical product.
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The Type of Ground Truth Used:
- The "ground truth" for the non-clinical tests was based on established objective standards and specifications:
- ISO 7886-1 and ISO 594-1&-2 standards.
- ISO 10993 for biocompatibility.
- Defined Sterility Assurance Levels.
- 0.9% Sodium Chloride Injection USP monograph requirements.
- ISTA or ASTM standards for ship testing.
- Internal product design requirements and established criteria.
- For the "Design Validation," the ground truth was "the clinical need expected for a typical flush procedure in a simulated clinical setting" (K101270 p.3), which implies the device's functional performance under intended use conditions.
- The "ground truth" for the non-clinical tests was based on established objective standards and specifications:
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The Sample Size for the Training Set:
- As this is a physical medical device (syringe with an integrated cap) and not an AI or algorithm-based device, there is no "training set" in the conventional sense of machine learning. The device design and manufacturing processes are validated through the non-clinical and simulated clinical testing mentioned.
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How the Ground Truth for the Training Set Was Established:
- Since there is no "training set" for an AI model, this question is not applicable. The device's design is based on established engineering principles, materials science, and medical device regulations, not on a data-driven training process. The "ground truth" for its development and testing aligns with the predefined standards and functional requirements outlined above.
§ 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).