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510(k) Data Aggregation
(246 days)
The Shifeng Disposable Syringe with or without needle are intended to be used to inject fluid into, or withdraw fluids from, part of the body below the surface of the skin.
The ShiFeng Disposable Syringe is a sterile, single use device consisting of a needle attached to a syringe. The ShiFeng Disposable Syringe manufactured by Chengdu Xinjin Shifeng Medical Apparatus & Instruments Co., Ltd., China is substantially equivalent to the IMC Piston syringe with Hypodermic Lumen Needle manufactured by IMC and cleared under K102969. The device consists of a metal tube that is sharpened at one end and the end joined to a female connector (hub) designated to mate with a male connector ( nozzle ) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Shifeng Piston Syringe with or without needle:
Summary of Device Acceptance Criteria and Performance
The Shifeng Disposable Syringe with or without needle demonstrates substantial equivalence to a predicate device (IMC Piston Syringe with Hypodermic Lumen Needle, K102969) by meeting various performance standards outlined in ISO 7886-1:1993/Cor. 1: 1995 and ISO 10993 for biocompatibility and ISO 11135 for sterilization.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ISO Standard/Aspect) | Reported Device Performance (Compliance/Details) |
|---|---|
| ISO 7886-1:1993/Cor. 1: 1995 (General) | |
| Cleanliness (Clause 5) | Tests performed according to standard |
| Limits for acidity or alkalinity (Clause 6) | Tests performed according to standard |
| Limits for extractable metals (Clause 7) | Tests performed according to standard |
| Lubricant (Clause 8) | Tests performed according to standard |
| Tolerance on graduated capacity (Clause 9) | Tests performed according to standard |
| Scale (Clause 10.1) | Tests performed according to standard |
| Numbering of scale (Clause 10.2) | Tests performed according to standard |
| Overall length of scale to nominal capacity line (Clause 10.3) | Tests performed according to standard |
| Position of scale (Clause 10.4) | Tests performed according to standard |
| Dimensions (Clause 11.1) | Complying with ISO 7886-1 |
| Finger grips (Clause 11.2) | Tests performed according to standard |
| Design (Clause 12.1) | Tests performed according to standard |
| Fit of piston in barrel (Clause 12.2) | Tests performed according to standard |
| Fiducial line (Clause 12.3) | Tests performed according to standard |
| Conical fitting (Clause 13.1) | Tests performed according to standard |
| Position of nozzle on end of barrel (Clause 13.2) | Tests performed according to standard |
| Nozzle lumen (Clause 13.3) | Tests performed according to standard |
| Dead space (Clause 14.1) | Tests performed according to standard |
| Freedom from air and liquid leakage past piston (Clause 14.2) | Tests performed according to standard |
| Primary container (Clause 15.1) | Tests performed according to standard |
| Secondary container (Clause 15.2) | Tests performed according to standard |
| Storage container (Clause 16.3) | Tests performed according to standard |
| Transport wrapping (Clause 16.4) | Tests performed according to standard |
| Barrel Diameter | 1ml: 4.65-4.70mm; 2ml: 8.85-8.90mm; 3ml: 9.00-9.05mm; 5ml: 12.40-12.45mm; 10ml: 14.95-15.00mm (Similar to predicate) |
| Barrel Marking Specs | Complying with ISO7886-1 |
| Gradations legibility | Legible |
| Lubricant amount / cm2 | Not exceed 0.25mg |
| Barrel Transparency | Transparent |
| Delivery Accuracy | Complying with ISO 7886-1, 10.1 ~10.4 |
| Reuse Durability | Not applicable, single use device |
| Labeling | Complying with ISO7886-1: 1993 |
| ISO 10993 (Biocompatibility) | |
| Biocompatibility | Complying with ISO 10993 (blood contacting materials are biocompatible) |
| Ethylene Oxide Residual Levels | Not exceed maximum daily dose levels proposed (1.501ug/device for Lot 20100301; 10.9ug/device for Lot 20110926) |
| Ethylene Chlorohydrin (ECH) Residual Levels | 10.9ug/device (Lot 20110926) |
| ISO 11135 (Sterilization) | |
| Sterilization | ETO, ISO 11135 compliance |
| Sterility Assurance Level (SAL) | 10^-6 (validated according to ISO 11135-1:2007 to provide SAL of 10^-8 mentioned, but typically 10^-6 for devices) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the various tests conducted. It only lists the test items performed in accordance with the specified ISO standards.
The data provenance is retrospective, as the tests were performed on the device "manufactured by Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd., China," implying that the devices already existed. The manufacturer is based in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing appears to be based on adherence to international standards (ISO), which typically involve standardized test methods rather than expert consensus on a "ground truth" for each specific test item in the way one might see for diagnostic image interpretation.
4. Adjudication Method for the Test Set
This information is not provided. Given that the tests are based on ISO standards with specific pass/fail criteria, an adjudication method for reconciling expert disagreements is unlikely to be relevant in the traditional sense. The results would be objectively measured against the standard's requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a piston syringe, a physical medical instrument, and not a diagnostic AI system where human reader performance (with or without AI assistance) would be a relevant metric.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a physical instrument, not an algorithm or AI. The performance refers to its physical and material properties, rather than algorithmic output.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests conducted on the Shifeng Disposable Syringe is based on established international standards (ISO 7886-1, ISO 10993, ISO 11135). This means that the device's physical properties and functionalities are measured against the predefined specifications and acceptable ranges set forth by these standards. It's not "expert consensus" in the diagnostic sense, nor pathology or outcomes data, but rather objective compliance with engineering and quality standards.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. This is a physical, non-AI medical device; therefore, there is no algorithm or model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this physical device, this question is not applicable.
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