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510(k) Data Aggregation
(63 days)
BD Hypodermic Syringe is intended for general aspiration and injection of fluids.
The BD Hypodermic Syringe operates on the same fundamental scientific technology as the predicate cleared under K980580. The subject device consists of a: graduated barrel, plunger rod and needle/hub assembly. The device is offered with an attached 27G x 16mm cannula integrated with a 1mL syringe barrel capacity. The subject device is offered in self-contained (with a plunger cap) configuration. It is a single-use disposable device that is provided sterile. The BD Hypodermic Syringe is non-toxic and non-pyrogenic.
This document describes the non-clinical testing performed to demonstrate the substantial equivalence of the BD Hypodermic Syringe (the subject device) to its predicate device (K980580: Becton Dickinson Syringes).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Standard/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | ||
| Syringe Functionality | ISO 7886-1: 2017 Sterile hypodermic syringes for single use – Part 1: Syringes for manual use (This standard specifies requirements for sterile hypodermic syringes for single use, including dimensional characteristics, freedom from particles, lubrication, plunger force, fluid leakage, and dead space.) | The subject device met the requirements of ISO 7886-1:2017. |
| Needle Requirements | ISO 7864: 2016 Sterile hypodermic needles for single use – Requirements and test methods (This standard specifies requirements for sterile hypodermic needles for single use, including needle dimensions, sterility, corrosion resistance, and penetration force.) | The subject device met the requirements of ISO 7864:2016. |
| Needle Tubing Requirements | ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods (This standard specifies requirements for stainless steel needle tubing used in the manufacture of medical devices, including mechanical properties, surface finish, and freedom from defects.) | The subject device met the requirements of ISO 9626:2016. |
| Biocompatibility | ||
| Overall Biological Evaluation | ISO 10993-1:2018 Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process (Since the device is an externally communicating device with prolonged contact duration (>24 hours to 30 days), specific endpoints as outlined in the standard were required.) | All material modifications met the requirements per ISO 10993-1:2018. |
| Cytotoxicity | As per ISO 10993-1:2018 guidelines for externally communicating devices with prolonged contact. (Specific cell culture tests to evaluate the potential for the device materials to cause cell lysis or inhibition of cell growth.) | Met the requirements. |
| Sensitization | As per ISO 10993-1:2018 guidelines. (Tests to assess the potential for the device materials to induce an allergic reaction.) | Met the requirements. |
| Irritation or Intracutaneous reactivity | As per ISO 10993-1:2018 guidelines. (Tests to evaluate local irritation effects in tissue from direct or intracutaneous contact with device materials or extracts.) | Met the requirements. |
| Acute Systemic Toxicity | As per ISO 10993-1:2018 guidelines. (Tests to detect harmful effects from a single exposure to device extracts.) | Met the requirements. |
| Material Mediated Pyrogenicity | As per ISO 10993-1:2018 guidelines. (Tests to detect pyrogenic substances released from the device materials.) | Met the requirements. |
| Subacute/Subchronic Toxicity | As per ISO 10993-1:2018 guidelines. (Tests to detect adverse effects from repeated or continuous exposure to device extracts over a period longer than acute, but less than chronic.) | Met the requirements. |
| Indirect Hemolysis | As per ISO 10993-1:2018 guidelines. (Tests to evaluate the potential of device extracts to cause rupture of red blood cells.) | Met the requirements. |
| Particulate Matter | USP Particulate Matter In Injections. (This standard specifies limits for subvisible particulate matter in parenteral preparations, which is critical for injectable devices to prevent adverse patient reactions.) | Met the requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test within the functional performance and biocompatibility sections. However, it indicates that testing was performed per current ISO and USP standards. These standards typically outline minimum sample size requirements for the tests they prescribe to ensure statistical validity.
The data provenance is not explicitly stated in terms of country of origin. The study is retrospective as it involves validation of design changes for a device for which substantial equivalence is being claimed to a previously cleared predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission (510(k) for a medical device) typically relies on objective laboratory testing against recognized consensus standards rather than expert consensus for individual test results. Therefore, there is no mention of experts establishing ground truth in the context of radiologists or similar clinical experts. The "ground truth" for these non-clinical tests is established by the specifications and methodologies outlined in the referenced ISO and USP standards. The validation is performed by engineers and scientists, whose qualifications would implicitly align with the requirements of design verification and validation in medical device manufacturing.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation of the test set is based on objective conformity to established international standards, not on subjective expert assessment that would require an adjudication method like 2+1 or 3+1.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a non-clinical medical device (hypodermic syringe), not an AI-powered diagnostic or imaging device. Therefore, a study comparing human reader performance with and without AI assistance is not relevant to this type of device.
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 (syringe), not an algorithm or software requiring standalone performance testing in this context.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for the non-clinical tests (functional performance and biocompatibility) is defined by the specifications and acceptance criteria outlined in the referenced ISO and USP international consensus standards. For example:
- Functional Performance: Ground truth is defined by the quantitative limits (e.g., maximum plunger force, fluid leakage limits, dimensional tolerances) specified in ISO 7886-1, ISO 7864, and ISO 9626.
- Biocompatibility: Ground truth is defined by the qualitative and quantitative endpoints (e.g., absence of cytotoxicity, sensitization, irritation) and methodologies specified in ISO 10993-1.
8. The Sample Size for the Training Set
Not Applicable. This is a non-clinical evaluation of a physical medical device. There is no "training set" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for this type of device submission, the concept of establishing ground truth for a training set does not apply.
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