(323 days)
Disposable sterile needle retractable safety syringe is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into patient.
Disposable sterile needle retractable safety syringe is a piston syringe. The device is intended for medical purposes and consists of a protective cover, Needle base, circle ring, Pull & back part, Piston, Plunger and barrel. The needle is fixed on the syringe. The device is used to inject fluids into the body. The subject device of Disposable sterile needle retractable safety syringe is available in 0.5ml, 1ml, 3ml, 5ml and 10 ml volumes. The subject device is provided sterilized. Disposable sterile needle retractable safety syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. After the injection is completed, the groove of the upper end of the plunger locks the needle. The plunger is retracted completely after the injection. The needle is retracted completing into the barrel of the syringe.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "Disposable sterile needle retractable safety syringe" are primarily based on conformity to a set of international ISO and ASTM standards. The study demonstrates compliance with these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 7886-1:1993 (Sterile hypodermic syringes for manual use) | Conforms to ISO 7886-1:1993/Corrigendum1:1995 (Performance Testing and Barrel marking specs) |
| ISO 7886-4:2006 (Syringes with re-use prevention feature) | Conforms to ISO 7886-4:2006 (Performance Testing) |
| ISO 10993-1:2009 (Biological evaluation of medical devices - General) | Conforms to the requirement of ISO 10993 series Standards (Biocompatibility) |
| ISO 10993-4:2002 (Selection of tests for interactions with blood) | Conforms to the requirement of ISO 10993 series Standards (Biocompatibility - implicitly covered) |
| ISO 10993-5:2009 (Tests for In Vitro cytotoxicity) | No Cytotoxicity (Cytotoxicity) |
| ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Conforms to ISO 10993-7 (EO Residual) |
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | No intracutaneous reactivity (Irritation); No delayed dermal contact sensitization (Sensitization) |
| ISO 10993-11:2006 (Tests for systemic toxicity) | Conforms to the requirement of ISO 10993 series Standards (Biocompatibility - implicitly covered) |
| ISO 11607-1:2006 (Packaging for terminally sterilized medical devices) | Conforms to ISO 11607 (Packaging Integrity) |
| ISO 11607-2:2006 (Validation requirements for forming, sealing, etc.) | Conforms to ISO 11607 (Packaging Integrity - implicitly covered) |
| ISO 11135:2007 (Sterilization of health care products - EO) | SAL-10^6, Method-EO, Validation-Conforms to ISO 11135 (Sterilization) |
| ISO 11737-1:2006 (Sterilization of devices - Microbiological methods) | Conforms to the requirement of ISO 11135 and general sterilization best practices (Implicitly covered as part of sterilization validation) |
| ISO 9626-1991 (Stainless steel needle tubing) | Conforms to industry standards for materials (Needle material SUS) |
| ASTM F1980-2002 (Accelerated Aging of Sterile Medical Device Packages) | Performance Testing (Implicitly covered under packaging integrity and shelf-life considerations) |
| ASTM F1929-1998 (Detecting Seal Leaks in Porous Medical Packaging) | Performance Testing (Implicitly covered under packaging integrity) |
| Pyrogen free | Pyrogen free (Sterilization) |
| Design Specifications | Met all design specifications (General statement) |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Bench tests were conducted to verify that the subject device met all design specifications." However, it does not specify the sample size used for these bench tests.
The data provenance is from tests conducted by the manufacturer, Guangdong Haiou Medical Apparatus Stock Co., Ltd., based in China. The study appears to be retrospective in the sense that the results are being presented as part of a 510(k) submission, confirming the device meets the standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not provide information on the number of experts used or their qualifications to establish ground truth for the bench tests. The tests are based on established international standards, implying compliance with methods defined by accredited testing bodies rather than expert consensus on individual test outcomes.
4. Adjudication Method for the Test Set
This document does not describe any adjudication method. The performance is assessed against the requirements of the standards, which typically have defined pass/fail criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is more common for imaging or diagnostic devices where human interpretation plays a significant role. This document concerns a physical medical device (syringe) that is evaluated through bench testing and material compatibility.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the study is essentially a standalone (algorithm only) performance evaluation, where "algorithm" refers to the device itself and its functional characteristics tested against pre-defined performance standards. There is no human-in-the-loop component in the evaluation of the syringe's mechanical, material, or biological properties.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on the objective, empirically defined pass/fail criteria and specifications within the referenced international ISO and ASTM standards. For example, cytotoxicity is measured against a standard threshold for cellular viability, and sterility is confirmed against a Sterility Assurance Level (SAL).
8. The Sample Size for the Training Set
This product is a physical medical device (syringe), not an AI/ML algorithm that requires a "training set" in the conventional sense. Therefore, information about a training set is not applicable and not provided.
9. How the Ground Truth for the Training Set Was Established
As explained above, a "training set" is not relevant for this type of 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).