(165 days)
Auto-Disable Syringe is used to administer intramuscular / intravenous medicines or fixed dose immunization.
The Revital Cady is an Auto Disable Fixed Dose Immunization Syringe. It is a three-piece Syringe having male 6% luer slip connection. The Syringe is supplied sterile with nonintegrated Needle having female 6% luer slip connection. The device is sterilized by ETO gas. lt is a disposable, single use and non-pyrogenic device. The Syringe is available in volume of 0.5ml and packed with a needle of 23G size. It is individually packed in blister pouch. The Syringe has an early activation auto disable feature. When the plunger is pulled back, it is connected to a stainless-steel clip inside the barrel and the auto-disable feature is activated at the start of dose administration. After completion of administration, the plunger is detached from the gasket by pulling back. The Syringe consist of four components i.e. 1. Barrel 2. Plunger 3. Gasket 4. S.S Clip The barrel is made of Polypropylene (PP) with graduated scale printed on its outer wall. The barrel has a nozzle with 6% male luer slip connector that facilitates the connection with the female luer slip connection of the needle. The graduated scale on barrel is indicated in millimetres. The plunger is a solid rod made of Polypropylene. It is used to draw fluid in and out of the barrel by pulling and pushing. The plunger has small rectangular holes on which a clip is fitted. The clip is made up of stainless steel and it is use to activate the auto disable feature. The gasket is made up of PTFE and fitted on top of the plunger. The Syringe is supplied with a Hypodermic Needle is made of three components i.e. 1. Needle tube 2. Needle hub 3. Needle cap The Needle is made up of stainless steel and bonded to the Needle hub by epoxy and UV glue. The hub and cap of the Needle is made of Polypropylene. The cap is used to protect the needle tip from damage as well as injury.
The provided text describes the Revital Cady Auto-Disable Syringe, a Class II medical device, and its substantial equivalence to predicate devices, K210464 and K211214 (for the needle). The submission focuses on non-clinical performance data to demonstrate that the device meets acceptance criteria.
Here's an organized breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The Revital Cady device, including both the syringe and the needle, was tested against various ISO standards and USP tests. The reported performance uniformly states that the results were "satisfactory" or "complied with" the respective standards, indicating that the device met the acceptance criteria defined by these standards.
| Test Parameter / Standard | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Syringe Performance | ||
| ISO 7886-1:2017 | Compliance with standard | Complied / Satisfactory |
| ISO 7886-3:2020 | Compliance with standard | Complied / Satisfactory |
| ISO 80369-7:2021 | Compliance with standard | Complied / Satisfactory |
| Needle Performance | ||
| ISO 9626:2016 | Compliance with standard | Complied / Satisfactory |
| ISO 7864:2016 | Compliance with standard | Complied / Satisfactory |
| Sterility & Biocompatibility | ||
| USP (Sterility) | Sterility | Met requirement |
| USP (Bacterial Endotoxin) | Compliance with USP | Met requirement |
| USP (Particulate Contamination) | Compliance with standard (implied) | Complied / Satisfactory |
| Cytotoxicity (ISO 10993-5:2009) | Acceptable toxicity levels | Acceptable |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Acceptable toxicity levels | Acceptable |
| Skin Sensitization (ISO 10993-10:2021) | Acceptable sensitization levels | Acceptable |
| Intracutaneous Reactivity (ISO 10993-23:2021) | Acceptable reactivity levels | Acceptable |
| Hemolysis (ISO 10993-4:2017 & ASTM F756-17) | Acceptable hemolysis | Acceptable |
| Material Mediated Pyrogenicity | No pyrogenicity | Acceptable |
| Packaging & Transit Study | ||
| ISO 11607-1:2019 | Compliance with standard | Complied |
| ISO 11607-2:2019 | Compliance with standard | Complied |
| ASTM D4169-16 | Compliance with standard | Complied |
| Sterilization Test | ||
| ISO 11135:2014/AMD 1:2018 | Compliance with standard | Complied |
| EO Residual Test | ||
| ISO 10993-7:2008/Amd 1:2019 | Meets requirements of standard | Meets requirement |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each non-clinical test. It only states that tests were "conducted" and "results were found satisfactory" or "met the requirement of the standard."
The data provenance is not explicitly mentioned in terms of country of origin or whether it was retrospective or prospective. However, safety and performance testing for Substantial Equivalence are typically conducted prospectively in a controlled laboratory environment by the manufacturer or a contracted lab. Given the manufacturer is Revital Healthcare (EPZ) Limited in Kenya and the primary correspondent is in India, the testing was likely conducted in one of these locations or by an international lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The study involves non-clinical performance and biocompatibility testing against established international standards (ISO, USP, ASTM). Ground truth in this context is determined by the objective results of these tests and their comparison to the defined acceptance criteria within the standards, not by expert consensus on subjective evaluations.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation is based on objective measurements against established technical standards, not on human adjudication of subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No clinical study is included in this submission." Therefore, an MRMC comparative effectiveness study was not performed. The submission relies solely on non-clinical performance data to demonstrate substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a physical medical device (an auto-disable syringe), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
The ground truth for device performance is defined by adherence to the quantitative and qualitative requirements outlined in the referenced international standards (e.g., ISO 7886-1, ISO 9626, ISO 10993 series, USP monographs). This includes:
- Quantitative measurements: For aspects like dose volume accuracy (implied by syringe standards), needle dimensions, bond strength, residual EO levels, particulate contamination.
- Qualitative assessment: For sterility, biocompatibility (e.g., absence of cytotoxicity, irritation), and functional performance demonstrating the auto-disable mechanism works as intended.
Essentially, the "ground truth" is compliance with these universally accepted specifications for medical devices of this type.
8. The Sample Size for the Training Set
Not applicable. This device is a physical auto-disable syringe, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical 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).