(27 days)
The A-TAP is intended for use by healthcare professionals for general purpose fluid aspiration/injection.
The A-TAP device is a fluid switching medical device consisting of a clear plastic barrel body, a sliding rod, two 6% female Luer lock connections, and one 6% male Luer lock connection. The internal surface of the device barrel body is lubricated with polydimethylsiloxane (silicone). The A-TAP is a single-use only, disposable, non-pyrogenic and sterilized by Gamma irradiation.
The provided text is a 510(k) summary for the A-TAP device, which is a fluid switching medical device. The submission is a Special 510(k) due to modifications made to the previously cleared Arthrotap device (K201816) by Elcam Medical.
The acceptance criteria and study proving the device meets these criteria concern the physical and biological characteristics of the device, not an AI/ML-driven diagnostic or prognostic tool. Therefore, the questions related to AI/ML performance metrics, sample sizes for training/test sets for AI, expert adjudication of ground truth, and MRMC studies are not applicable in this context.
This document details the tests performed to demonstrate that the modified A-TAP device is substantially equivalent to its predicate.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance tests conducted to demonstrate substantial equivalence, implying that passing these tests served as the acceptance criteria. The "Reported Device Performance" is stated by the successful completion of all listed tests.
| Acceptance Criteria (Measured by Passing Standard/Method) | Reported Device Performance |
|---|---|
| Biocompatibility: | All tests successfully passed |
| Cytotoxicity (ISO 10993-5) | |
| Irritation (ISO 10993-10) | |
| Sensitization (ISO 10993-10) | |
| Acute Systemic Toxicity (ISO 10993-11) | |
| Material-Mediated Pyrogenicity (ISO 10993-11/USP) | |
| Hemolysis (ISO 10993-4) | |
| Non-Clinical (Bench) Testing: | All tests successfully passed |
| ISO 7886-1:2017 (Sterile hypodermic syringes for single use) | |
| ISO 80369-7:2021 (Small-bore connectors for liquids and gases) | |
| ISO 8536-10:2015 (Infusion equipment for medical use) | |
| ANSI/AAMI/ISO 11737-1:2018 (Sterilization of Health Care Products - Microbiological Methods - Part 1) | |
| ANSI/AAMI/ISO 11737-2:2019 (Sterilization of Medical Devices - Microbiological Methods - Part 2) | |
| Sterilization and Shelf-Life: | All tests successfully passed |
| ANSI/AAMI/ISO TIR13004:2013 (R2016)/ ISO 13004:2022 (Radiation - Substantiation of Selected Sterilization Dose) | |
| ANSI/AAMI/ISO 11137-1:2006/(R)2015 [Including: Amendment 1 (2013) and Amendment 2 (2019)] (Sterilization of Health Care Products - Radiation - Part 1) | |
| USP Bacterial Endotoxin | |
| Package Integrity: | All tests successfully passed |
| ASTM F 1980-16 (Accelerated Aging of Sterile Barrier Systems) | |
| ASTM D 4169-16 (Performance Testing of Shipping Containers and Systems) | |
| ASTM F2096-11 (Reapproved 2019) (Detecting Gross Leaks in Packaging) | |
| ASTM F88/F88M-21 (Seal Strength of Flexible Barrier Materials) | |
| USP Particulate Matter in Injections |
2. Sample Size Used for the Test Set and Data Provenance:
The document concerns a physical medical device and its components, not a data-driven AI/ML model for which test sets from patients are required. Therefore, typical "sample sizes" in the context of clinical data for AI are not applicable. The tests performed are laboratory-based, often involving a certain number of device units or material samples as specified by the respective ISO/ASTM standards. The data provenance is laboratory testing conducted by or for Elcam Medical. The document does not specify country of origin for the testing itself, nor if it was retrospective or prospective in the clinical sense, as it refers to engineering verification and validation testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. Ground truth for a physical device's performance (e.g., material compatibility, structural integrity, sterility) is established by adherence to recognized international and national standards (ISO, ASTM, USP) and the results of the specified tests, rather than expert consensus on clinical data.
4. Adjudication Method for the Test Set:
Not applicable for a physical device. Performance is determined by meeting the pass/fail criteria defined within the referenced standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
Not applicable. This type of study is relevant for diagnostic imaging AI, not for a fluid switching device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable for a physical medical device without AI components.
7. The Type of Ground Truth Used:
The ground truth used for proving the device meets acceptance criteria is based on standardized test methods and their defined performance criteria. For example, biocompatibility is evaluated against specific biological responses according to ISO standards, and mechanical integrity is evaluated against criteria set by ISO or ASTM standards. This is not derived from expert consensus, pathology, or outcomes data in the typical clinical sense, but from engineering and material science principles.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML algorithm.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).