(90 days)
The BD Plastipak™ Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
The BD Plastipak™ Syringe is a three-piece, single use, sterile, hypodermic syringe with a 6% (Luer) male connector in 20 mL and 50 mL eccentric luer slip tip configurations. The BD Plastipak™ Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The syringe barrel incorporates a male 6% (Luer) connector which is connectable to a compatible female 6% (Luer) connector. The BD Plastipak™ Syringe is provided sterile by Ethylene Oxide Gas (ETO) sterilization method.
The provided text is a 510(k) Clearance Letter for a medical device (BD Plastipak™ Syringe). It details the device's characteristics, intended use, and comparison to a predicate device. However, it does not describe an AI/ML-driven medical device or a study involving human readers or expert consensus for ground truth establishment.
The document discusses bench performance testing and biocompatibility tests for a physical device (syringe), not a software or AI-based diagnostic tool. Therefore, many of the requested criteria (like sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types) are not applicable to this specific submission.
Despite the irrelevance of some questions to the provided document, I will structure the answer based on the questions asked, indicating "Not Applicable" or providing the information that is present in the document.
Here's an analysis of the provided 510(k) clearance letter in the context of the requested information about acceptance criteria and study data:
This 510(k) clearance letter pertains to a physical medical device, the BD Plastipak™ Syringe, not an AI/ML-driven diagnostic or image analysis tool. As such, many of the typical acceptance criteria and study methodologies applicable to AI models (e.g., ground truth established by experts, MRMC studies, training/test set sizes for algorithms, human reader improvement with AI assistance) are not relevant or described in this document.
The "study" referenced in the document primarily consists of non-clinical performance and biocompatibility testing to demonstrate the substantial equivalence of the new syringe (with a changed barrel resin) to a previously cleared predicate syringe.
1. Table of Acceptance Criteria and Reported Device Performance
The document states, "The subject device met all the predetermined acceptance criteria for the above listed performance and biocompatibility tests." However, it does not explicitly list the quantitative acceptance criteria or the specific numerical performance results for each test. It only lists the tests performed and the standards they adhere to.
| Test Category | Test | Purpose (as described) | Acceptance Criteria (Not Explicitly Stated Quantitatively) | Reported Performance (Not Explicitly Stated Quantitatively) |
|---|---|---|---|---|
| Performance Testing | Breakout Force | ISO 7886-1:2017- Performance evaluation of force to operate the piston. | Met predetermined criteria (implied by "met all") | Subject device performed equivalent to predicate (implied) |
| Sustaining Force | ISO 7886-1:2017- Evaluation of force to operate the piston. | Met predetermined criteria (implied by "met all") | Subject device performed equivalent to predicate (implied) | |
| Leakage Past Stopper | ISO 7886-1:2017- Evaluation of Freedom from air and liquid leakage past plunger stopper. | Met predetermined criteria (implied by "met all") | Subject device performed equivalent to predicate (implied) | |
| Volumetric Accuracy | ISO 7886-1:2017- Evaluation of Volumetric Accuracy | Met predetermined criteria (implied by "met all") | Subject device performed equivalent to predicate (implied) | |
| Dead Space | ISO 7886-1:2017- Evaluation of residual volume | Met predetermined criteria (implied by "met all") | Subject device performed equivalent to predicate (implied) | |
| Luer Leakage | ISO 80369-7:2021 - Evaluation of the luer fittings for leakage | Met predetermined criteria (implied by "met all") | Subject device performed equivalent to predicate (implied) | |
| Stress Cracking | ISO 80369-7:2021- Evaluation of the luer fittings for stress cracking | Met predetermined criteria (implied by "met all") | Subject device performed equivalent to predicate (implied) | |
| Resistance to separation from axial load | ISO 80369-7:2021- Evaluation of the luer fitting for separation when subjected to axial force. | Met predetermined criteria (implied by "met all") | Subject device performed equivalent to predicate (implied) | |
| Biocompatibility Testing | Cytotoxicity | ISO 10993-5:2009- Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Met predetermined criteria (implied by "met all") | Subject device performed equivalent to predicate (implied) |
| Sensitization | ISO 10993-10:2021- Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization | Met predetermined criteria (implied by "met all") | Subject device performed equivalent to predicate (implied) | |
| Intracutaneous Reactivity | ISO 10993-23:2021- Biological evaluation of medical devices- Test for Irritation | Met predetermined criteria (implied by "met all") | Subject device performed equivalent to predicate (implied) | |
| Acute Systemic Toxicity | ISO 10993-11:2017- Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | Met predetermined criteria (implied by "met all") | Subject device performed equivalent to predicate (implied) | |
| Material Mediated Pyrogenicity | ISO 10993-11:2017- Biological evaluation of medical devices — Part 11: Tests for systemic toxicity USP43-NF38 Pyrogen Test (USP Rabbit Test) | Met predetermined criteria (implied by "met all") | Subject device performed equivalent to predicate (implied) | |
| Hemocompatibility | ISO 10993-4:2017- Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood ASTM F756-17- Standard Practice for Hemolytic Properties of Materials | Met predetermined criteria (implied by "met all") | Subject device performed equivalent to predicate (implied) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The tests are "bench performance testing" on various syringe units.
- Data Provenance: Not specified, but generally, bench testing for physical devices is conducted in a controlled lab environment by the manufacturer. It is non-clinical.
- Retrospective or Prospective: Not applicable for this type of physical device testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. Ground truth for this physical device testing is established through standardized laboratory test methods and measurements against international or internal specifications, not by human experts interpreting clinical data.
4. Adjudication Method for the Test Set
- Not Applicable. (See point 3)
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI/ML device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an AI/ML device. Therefore, no standalone algorithm performance was assessed. The performance tests are for the physical syringe itself.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on measurements against established engineering specifications and international standards (e.g., ISO, ASTM, USP) for physical and material properties (e.g., force, leakage, volume accuracy, biocompatibility reactions). It is not based on expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device. There is no concept of a "training set" in the context of the reported non-clinical bench testing for a physical syringe.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. (See point 8)
§ 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).