(245 days)
The "Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH" is a hypodermic syringe with fixed needle intended for manual aspiration of GONAL-f Multi-Dose and for the solution into parts of the body below the surface of the skin.
The syringes designed for manual use are intended for use soon after filling, as they are not suitable for containing GONAL-f Multi-Dose over extended periods of time.
The "Syringe with fixed needle – For use only with GONAL-f Multi-Dose 600 IU/mL FSH" is comprised of a standard piston syringe with a permanently attached (fixed) hypodermic single lumen needle designed for the manual aspiration and injection of GONAL-f Multi-Dose. The needle is covered by a protective cap. The graduated scale is specifically designed for GONAL-f Multi-Dose. This syringe is a 1 ml syringe with 27G x 12" fixed needle. This is a single use syringe.
The provided text is a U.S. FDA 510(k) Premarket Notification for a medical device (a syringe). It details the device's characteristics, intended use, and comparison to a predicate device, along with summaries of verification and validation activities.
However, the request asks for information relevant to the acceptance criteria and study proving a device meets acceptance criteria for an AI/ML-driven medical device. The furnished document does not describe an AI/ML device. It describes a physical medical device (syringe) and its physical, mechanical, and biological performance characteristics. Therefore, many of the specific questions regarding AI/ML device testing (e.g., sample size for test/training sets, data provenance, number/qualifications of experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to the content provided.
The document focuses on:
- Physical performance tests: Cleanliness, visual appearance, gasket position, needle length, blister dimensions, peel behavior, integrity of sterile barrier, seal strength, package burst, air/liquid leakage, mobility force, graduated capacity tolerance, dead space volume, plunger-gasket assembly, stopper function strength, barrel printing resistance, protector fitting strength, bonding strength of cannula, needle penetration resistance, and transport simulation tests.
- Biocompatibility tests: Cytotoxicity, hemolysis, systemic (acute) toxicity, intracutaneous reactivity, sensitization, pyrogenicity, and LAL testing.
- Sterilization validation: Ethylene oxide sterilization to SAL 10-6, and residuals compliance.
- Shelf life: 5 years.
Assuming the request is a general template for AI/ML devices and I must derive the closest equivalent answers from the provided syringe document:
Here's an interpretation based on the provided document, although it explicitly does not relate to an AI/ML device:
1. Table of acceptance criteria and the reported device performance:
The document provides a table of "Verification Activities" with "STANDARD OR INTERNAL ACCEPTANCE CRITERIA." While specific "reported device performance" values are not listed for each test (only that the tests were performed and the device met the criteria), the acceptance criteria themselves are explicitly stated.
| TEST | STANDARD OR INTERNAL ACCEPTANCE CRITERIA | Reported Device Performance (Implied) |
|---|---|---|
| 1. Cleanliness and visual appearance | Cleanliness and visual appearance in accordance with EN ISO 8537. | Met criteria |
| 2. Position of gasket | The gasket is assembled so that the fiducial line is positioned at 3 mm +1/-3 mm from the zero-line of the graduation in accordance with internal acceptance criteria. | Met criteria |
| 3. Effective needle length | Effective needle length needs to be between 10 and 14 mm in accordance with internal acceptance criteria. | Met criteria |
| 4. Blister dimension + seal width | The dimension of the blister pack is in accordance with the technical drawing (LxW: 150 x 34.3 mm). The seal width of the blister pack is minimum 2 mm. This is in accordance with internal acceptance criteria. | Met criteria |
| 5. Peel behavior | Peel behavior in accordance with EN ISO 11607-1. | Met criteria |
| 6. Sterile barrier system integrity | Sterile barrier system integrity in accordance with EN ISO 11607-1. | Met criteria |
| 7. Peel strength | Peel strength in accordance with EN ISO 11607-1. | Met criteria |
| 8. Seal strength | Seal strength in accordance with EN ISO 11607-1. | Met criteria |
| 9. Package burst | Package burst test in accordance with EN ISO 11607-1. | Met criteria |
| 10. Air leakage past gasket and needle/barrel connection | No leakage of air past the gasket and needle/barrel connection in accordance with EN ISO 8537. | Met criteria |
| 11. Liquid leakage past gasket and needle/barrel connection | No leakage of water past the gasket and needle/barrel connection in accordance with EN ISO 8537. | Met criteria |
| 12. Mobility Force | The Initial Force is maximum 10 N and the Emptying Force is maximum 1.0 N in accordance with internal acceptance criteria. | Met criteria |
| 13. Tolerance on graduated capacity | Tolerance on graduated capacity is in accordance with EN ISO 8537. | Met criteria |
| 14. Dead space volume | Dead space volume in accordance with EN ISO 8537. | Met criteria |
| 15. Plunger-gasket assembly fitting | The gasket-plunger does not separate in accordance with internal acceptance criteria. | Met criteria |
| 16. Stopper function strength | The stopper function strength is more than 10 N in accordance with internal acceptance criteria. | Met criteria |
| 17. Barrel printing resistance | To check the readability of the graduated printing of syringes after contact with water, ethanol, oil, antiseptic solution or tension-active solution, or after pencil scratching or dry rubbing with finger. This is in accordance with internal acceptance criteria. | Met criteria |
| 18. Protector fitting strength | The protector fitting strength is between 2 N and 12 N in accordance with internal acceptance criteria. | Met criteria |
| 19. Bonding strength cannula | Bonding strength of the cannula in accordance with EN ISO 8537. | Met criteria |
| 20. Needle penetration resistance | The penetration resistance of cannula point and drag complies with the limits specified as follow: Point Value ≤ 0.12 N and Drag Value ≤ 0.04 N. This is in accordance with internal acceptance criteria. | Met criteria |
| 21. Transport simulation test | There is no damage of the sterile barrier after vibration test (in accordance with EN ISO 2247), roll test (in accordance with EN ISO 2876) and vertical impact test (in accordance with drop test) (in accordance with EN ISO 2248). | Met criteria |
| Biocompatibility Tests | All performed tests (cytotoxicity, haemolysis, systemic (acute) toxicity, intracutaneous reactivity, sensitization, pyrogenicity, LAL Testing) demonstrated that the blood contacting materials are biocompatible in accordance with relevant ISO standards and FDA guidance. | Met criteria |
| Sterility | Sterility assured by validated EtO sterilization to a Sterility Assurance Level (SAL) of 10-6 in accordance with EN ISO 11135. Ethylene oxide and ethylene chlorohydrin residual levels comply with EN ISO 10993-7. | Met criteria |
| Shelf life | Established at 5 years. | Established |
2. Sample size used for the test set and the data provenance:
- The document states, "All necessary verification and validation tests have been performed by testing the "Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH"." It does not specify the sample size for each test.
- Data provenance: Not explicitly stated, but as the company is Terumo Europe N.V. (Belgium), the testing would likely have been conducted within their quality system, potentially in Belgium or at their manufacturing sites. It's a "prospective" test in the sense that the new device was manufactured and then subjected to these validation tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is irrelevant to the type of device described. Ground truth for a physical syringe's performance is established by objective measurements against engineering specifications and international standards, not by expert consensus on, for example, diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is irrelevant to the type of device described. No adjudication methods are mentioned as it's not applicable to the physical/mechanical and biological testing of a syringe.
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:
- This question is irrelevant as the device is a physical syringe, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is irrelevant as the device is a physical syringe, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device's performance is based on International Standards (EN ISO) and internal acceptance criteria derived from engineering specifications and regulatory requirements. For example, ISO 8537 for "Syringes for insulin" and ISO 11607-1 for "Sterilization of health care products - Packaging for terminally sterilized medical devices." Biocompatibility is against ISO 10993 series.
8. The sample size for the training set:
- This concept is not applicable as the device is not an AI/ML model that requires training data.
9. How the ground truth for the training set was established:
- Not applicable as there is no training set for a physical syringe.
§ 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).