(80 days)
The Clip-On Spacer is designed for use with Rebit® prefilled syringes containing The Clip-On Spacer is designed for use with Rebile pro mode of may and therapy.
The Clip-On Spacer is designed to aid the user in injecting the appropriate The Clip-On Spacer Is designed to "Blu" the "Boo" in "Myoung" when less than the full volume of the syringe is prescribed.
The Clip-On Spacer is designed to clip around the plunger rod of the Rebit® pre-filled syringe. It is held in place using a hook-hole closure which resists opening, once closed, under axial compression of 28N. When the plunger rod is depressed into the syringe barrel, the Clip-On Spacer limits the volume of solution delivered from the syringe to within ± 1.5% of the syringe volume (1 mL) ± 2% of the expelled volume according to EN ISO 7886-1:1997 "Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use"..
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
Device: Clip-On Spacer (for Rebif® pre-filled syringes)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Volume Delivery Accuracy: Limitations of delivered solution volume | Within ± 1.5% of the syringe volume (1 mL) ± 2% of the expelled volume according to EN ISO 7886-1:1997 "Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use". The product passed this test. |
| Axial Compression Resistance: Clip-On Spacer resists opening under axial compression | Able to bear axial compression of 28N (14N x 2) without deforming or opening the hook-hole closure. |
| Drop Test Resistance: Rigidity and sturdiness of the closing system post-impact | Strong enough to take a fall of 1 meter on hard ground without any impact on the safety of the closing system. |
| Risk Analysis: No inherent risk or additional hazards compared to manual titration | A risk analysis performed according to ISO/EN 1441 indicated that there is no risk inherent in using the Clip-On Spacer and there are no additional hazards induced with the injection of Rebif® with the spacers compared to manual titration. |
| Facilitate injection of less than full volume of pre-filled syringe (Intended Use comparison) | Yes (The Clip-On Spacer stops the plunger rod at the correct titration volume, assisting in delivering a partial dose. This is a design feature/intended use, not a performance metric with numerical limits, but rather a functional comparison to manual injection where the user visually controls the dose.) |
| Plunger rod limitation to pre-determined depth within syringe barrel (Design comparison) | Yes (The Clip-On Spacer stops the plunger rod at the correct titration volume. This is a design feature, not a performance metric with numerical limits, but rather a functional comparison to manual injection where the plumger is not limited.) |
| Appropriate materials for degree of patient contact (Materials comparison) | Yes (Compared to manual injection and Rebiject II™, this is a material suitability assessment, not a specific performance metric.) |
Study Details
The provided document describes non-clinical performance data for the Clip-On Spacer. There is no mention of a clinical study to prove the device meets acceptance criteria.
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Sample size used for the test set and the data provenance:
- The document does not specify the sample size for any of the non-clinical tests (e.g., number of spacers tested for volume accuracy, axial compression, or drop testing).
- Data Provenance: The tests appear to be conducted by the manufacturer (Serono, Inc.) as part of their premarket notification. The country of origin of the data is not explicitly stated but is inferred to be related to the manufacturer's location (Rockland, MA, USA). The data is retrospective in the context of this submission, as the tests would have been completed prior to the 510(k) filing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is not an AI/diagnostic device that relies on expert interpretation of results to establish ground truth. The acceptance criteria are based on physical and functional performance, assessed through laboratory testing.
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Adjudication method for the test set:
- Not applicable. See point 2. The tests are objective measurements against defined standards (e.g., EN ISO 7886-1:1997, ISO/EN 1441) and physical criteria (28N compression, 1m drop).
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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/diagnostic device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/diagnostic device.
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The type of ground truth used:
- Objective Engineering/Performance Standards: The ground truth for the non-clinical tests are established by industry standards (EN ISO 7886-1:1997, ISO/EN 1441) and specific physical criteria (e.g., ±1.5% accuracy, 28N resistance, 1m drop). The "truth" is whether the device meets these quantitatively defined thresholds or procedural requirements for risk analysis.
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The sample size for the training set:
- Not applicable. This is not a machine learning/AI device, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 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).