(107 days)
The ARTHROTAP is intended for use by healthcare professionals for general purpose fluid aspiration.
The ARTHROTAP 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 ARTHROTAP device barrel body is lubricated with polydimethylsiloxane (silicone). The ARTHROTAP is single-use only, non-pyrogenic, and sterilized by electron beam irradiation.
The medical device in question, ARTHROTAP, is a fluid switching medical device intended for general purpose fluid aspiration/injection. The document describes its substantial equivalence to a predicate device, the ANUTRA Feedback Aspiration Syringe (K143757), based on a comparison of technological characteristics and performance testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by meeting relevant ISO and ASTM standards. The reported device performance indicates that ARTHROTAP successfully passed these tests.
| Acceptance Criteria Category | Specific Tests/Standards Met | Reported Device Performance |
|---|---|---|
| General Syringe Performance | ISO 7886-1:2017 (Sterile hypodermic syringes for single use) sections covering: General, Limits for Acidity or Alkalinity, Limits for Extractable Metals, Lubricant, Barrel, Piston/plunger assembly (Annex B), Nozzle, Freedom from air and liquid leakage (Annex B & D), Force to operate piston (Annex E), Fit of plunger in barrel, Packaging, Labeling. | ARTHROTAP passed all applicable sections, demonstrating its general safety and functionality as a single-use fluid aspiration/injection device. Sections for graduated capacity and scale were not applicable as ARTHROTAP does not have these features. Dead space was also not applicable. The device successfully demonstrated the ability to hold a seal. |
| Small-Bore Connectors | ISO 80369-7:2016 (Small-bore connectors) and ISO 80369-20:2015 (Common Test Methods) sections covering: Dimensional Requirements, Liquid leakage from fitting assembly under pressure (Annex C), Sub-atmospheric Air leakage into fitting assembly during aspiration (Annex D), Stress Cracking (Annex E), Resistance to separation from axial load (Annex F), Resistance to separation from unscrewing (Annex G), Resistance to overriding (Annex H). | ARTHROTAP successfully met these standards, ensuring secure and leak-free connections to other medical devices like syringes and needles, addressing potential concerns about its multiple Luer connectors compared to the predicate. |
| Sterile Barrier Packaging | ASTM F1980-16 Environmental Conditioning, ASTM D4169-16 Distribution Simulation, Label Inspection for overall adhesion and legibility, ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Leak), ASTM F88 / F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials. | Packaging tests demonstrated that the ARTHROTAP maintains its sterility and integrity throughout environmental conditioning and distribution, and its labels are durable and legible. The device achieves a level of safety equivalent to the predicate. |
| Biocompatibility | ISO 10993-1:2009 (Biocompatibility) sections covering: Cytotoxicity by Elution Test, Maximization Test for Delayed Hypersensitivity, Intracutaneous Reactivity, Acute Systemic Toxicity, Evaluation of Hemocompatibility: Interaction with Blood. Also, ISO 10993-12 & USP (Pyrogenicity), USP 40 Bacterial Endotoxin (LAL), USP Particulate Matter In Injections. | ARTHROTAP was tested and found to meet all specified biological requirements as outlined in ISO 10993-1 and FDA guidance. This included all tests conducted on the predicate plus additional tests for Pyrogenicity and LAL, demonstrating safety substantially equivalent or better than the predicate. The device is safe for patient contact. |
| Sterilization | Bioburden (ANSI/AAMI/ISO 11737-1:2006), Bioburden Validation (ANSI/AAMI/ISO 11737-1:2006), VD Maximum Dose (ANSI/AAMI/ISO TIR13004:2013), Sterility Verification (ANSI/AAMI/ISO 11737-2:2009/(R) 2014), Dose Mapping (ISO 11137-1:2006), Device Sterilization (ANSI/AAMI/ISO 11737-2:2009/(R) 2014). | Sterilization testing demonstrated the safety of ARTHROTAP concerning sterility, using established and recognized methods. While not explicitly listed for the predicate, these tests confirm the ARTHROTAP's sterility. The use of e-beam irradiation, a "Category A" method, is considered equivalent to gamma irradiation used for the predicate. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test. It states that "Performance testing of ARTHROTAP was conducted and evaluated in accordance with [various ISO and ASTM standards]".
The data provenance is from non-clinical testing conducted by the manufacturer, Accuro Technologies Inc., to demonstrate substantial equivalence to a legally marketed predicate device. This is typically laboratory-based testing, not human patient data. The country of origin of the data is not explicitly stated, but the manufacturer is based in Canada.
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 device and study. The "ground truth" for the performance tests outlined (e.g., leakage, material strength, biocompatibility) is determined by meeting the quantitative and qualitative requirements of the respective international standards (ISO, ASTM). This is not typically established by human expert consensus or qualifications in the same way clinical imaging or diagnostic device studies do.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are usually relevant for expert consensus on clinical findings, particularly in studies involving interpretation of medical images or symptoms. The described tests for ARTHROTAP are objective performance and safety evaluations against established technical standards.
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
There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers. This device is a fluid switching component, not a diagnostic imaging or AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no mention of any algorithm-only or AI-related performance testing. The ARTHROTAP is a physical medical device, not a software algorithm.
7. The type of ground truth used
The "ground truth" for this device's evaluation is based on established objective technical standards (ISO and ASTM) and biocompatibility guidelines. For example:
- Performance: Meeting specified limits for leakage, operating force, dimensional requirements, etc., as defined by the international standards.
- Biocompatibility: Absence of cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, particulate matter, and detection of pyrogens/endotoxins, as per ISO 10993 and USP standards.
- Sterilization: Demonstration of sterility assurance level (SAL) according to ISO standards.
8. The sample size for the training set
This information is not applicable. The ARTHROTAP is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this device.
§ 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).