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510(k) Data Aggregation
(175 days)
Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline; they shall be used with an US legally marketed angiographic injectors.
The proposed devices are available in packs, which may include different configurations of syringes and accessories. The syringes are plastic, disposable syringes, which are available in various models and configurations. They are intended to be used with an U.S. legally marketed angiography injector, compatibilities are shown in Table 1.
The provided document is a 510(k) summary for the Shenzhen Baoan Medical Supplies Co., Ltd. Sterile High-pressure Angiographic Syringes for Single-use. This type of submission is for medical devices, and the "acceptance criteria" and "device performance" primarily refer to compliance with recognized standards and biocompatibility, rather than clinical efficacy or diagnostic accuracy.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various international and national standards that the device complies with, which serve as the acceptance criteria for its non-clinical performance and safety. The reported device performance is that it "complies with" these standards.
| Acceptance Criteria (Standards Complied With) | Reported Device Performance |
|---|---|
| ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | Complies |
| ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials | Complies |
| ASTM F1140/F1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages | Complies |
| ASTM F1929-12 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration | Complies |
| USP37-NF32 <85> Bacterial Endotoxins Limit | Complies |
| ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Test of sterility | Complies |
| ISO 7886-1:1993 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use | Complies |
| ISO 7886-2:1996 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven Syringe Pumps | Complies |
| ISO594:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1 | Complies |
| ISO594:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2 | Complies |
| ISO 10993-4:2002 AMD 2006 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood | Complies |
| ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity | Complies |
| ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Complies |
| ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity | Complies |
| ASTM F 756-08, Standard practice for assessment of hemolytic properties of material | Complies |
| USP37-NF32 <151> Pyrogen test | Complies |
| Biocompatibility requirements of ISO 10993 series Standards | Conforms to the requirements (for both proposed and predicate devices) |
2. Sample Size Used for the Test Set and Data Provenance:
The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications..." and lists various standards for these tests. However, it does not specify the sample sizes used for these non-clinical tests (e.g., number of syringes tested for seal strength or internal pressurization). The data provenance is generally from laboratory testing performed by the manufacturer to demonstrate compliance with the listed standards. No country of origin is explicitly stated for the testing itself, but the manufacturer is based in China. The data is prospective in the sense that the manufacturer conducted these tests to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information is not applicable to this 510(k) submission. The document focuses on the engineering and material safety aspects of a medical device (angiographic syringes), not on diagnostic accuracy where expert ground truth would be established. The "ground truth" here is compliance with established engineering and biological safety standards, which are verified through objective testing methods rather than expert consensus on images or case outcomes.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
Not applicable. Adjudication methods like "2+1" typically refer to the process of resolving discrepancies in expert interpretations (e.g., in reading medical images). Since no expert interpretations are involved in establishing the "ground truth" for these engineering and biological tests, no such adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." This type of study is relevant for assessing the clinical utility or diagnostic effectiveness of devices, often involving human readers interpreting medical data. This syringe device is a non-active, sterile, single-use product, and its evaluation focuses on its physical and biological integrity, not its interaction with clinical interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This device is a physical medical product (angiographic syringe), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.
7. The Type of Ground Truth Used:
The "ground truth" for this device's evaluation is primarily based on compliance with recognized national and international consensus standards for medical device physical performance, sterility, and biocompatibility. This involves objective measurements against predefined thresholds and specifications outlined in standards like ISO 7886, ISO 10993, ASTM F88, etc.
8. The Sample Size for the Training Set:
Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device, not an AI/ML product. The manufacturer did not develop this device using machine learning.
9. How the Ground Truth for the Training Set was Established:
The concept of a training set and its ground truth is not applicable for this device submission.
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