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510(k) Data Aggregation
(268 days)
ARTIGLASS L. O.R. GLASS SYRINGE
The Artiglass LOR Glass Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard medical textbooks. These syringes are not intended for injection or aspiration.
Artiglass L.O.R. Glass Syringe is glass syringe similar to that of a standard piston syringe. It is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique. The Artiglass L.O.R. Glass Syringe is provided not sterile, in bulk form to other manufacturers as part of an epidural insertion trays as a component to the epidural kit. The syringe may be sterilized before use and it can be re-sterilized via Autoclave. Artiglass L.O.R. Glass Syringe is intended to be used only by qualified personnel. This syringe is not intended for injection or aspiration. The Artiglass L.O.R. Glass Syringe is available in volume of 5ml and 10 ml.
The Artiglass L.O.R. Glass Syringe is a medical device designed to verify needle tip placement in the epidural space using the Loss of Resistance technique.
1. Acceptance Criteria and Reported Device Performance:
| Item# | Performance Specification | Reported Device Performance (Status of Artiglass L.O.R. Glass Syringes) |
|---|---|---|
| 1 | ISO 594/1 Conical fitting with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements | Complying |
| 2 | ISO 595/1 Reusable all-glass or metal-and-glass syringes for medical use - Part 1: Dimensions | Complying |
| 3 | ISO 594-2 Second edition 1998-09-01 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings | Complying |
| 4 | ISO 595-2 First Edition 1987-12-15 Reusable all-glass or metal-and-glass syringes for medical use - Part 2: Design, performance requirements tests | Complying |
| N/A | Operating principle similar to predicate device | Operates under the same operating principle as the predicate device. |
| N/A | Dimensions and component characteristics similar to predicate device | Is similar in dimension and component characteristics to the predicate device. |
| N/A | Glass luer tip and metal luer tip similar to predicate device | Has similar glass luer tip and metal luer tip of the predicate device. |
| N/A | Luer lock connector similar to predicate device | Has a similar luer lock connector as the predicate device. |
| N/A | Supplied non-sterile as predicate device | Is supplied not sterile as the predicate device. |
| N/A | Meets the requirements of ISO 14971:2009 (Risk management for medical devices) | Meets the requirements of ISO 14971:2009, as applicable to the intended use of the device. |
| N/A | Meets the requirements of ISO 10993 (Biological evaluation of medical devices) | Meets the requirements of ISO 10993 as applicable to the intended use, description and technological characteristics of the device. |
| N/A | Equivalent performance to the predicate device during design verification testing | Demonstrates equivalent performance to the predicate device during design verification testing. |
Study Details Proving Device Meets Acceptance Criteria:
The device's performance was evaluated through Design Verification tests, which included bench and animal testing. The study was designed to assess the safety and effectiveness of the Artiglass L.O.R. Glass Syringes for their stated indications for use.
2. Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly stated in the provided text. The document mentions "Design Verification tests" and "bench and animal testing" but does not quantify the sample sizes for these tests.
- Data Provenance: Not explicitly stated. The manufacturer is Artiglass S.r.l. in Italy, suggesting the study likely originated there, but this is not confirmed. The study appears to be prospective in nature, as it involved performing new tests ("Design Verification tests were performed").
3. Number of Experts and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The study discusses compliance with international standards (ISO), which implies review by qualified personnel, but individual expert qualifications are not detailed.
4. Adjudication Method:
- Adjudication Method: Not applicable or not specified. This type of device (syringe) undergoes compliance testing against technical standards and direct performance assessment rather than a human-driven subjective assessment requiring adjudication (like image interpretation).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No. This is not an AI-assisted diagnostic device, but rather a physical medical instrument. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. Standalone Performance (Algorithm Only):
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm, so a standalone algorithm performance evaluation would not be relevant.
7. Type of Ground Truth Used:
- Type of Ground Truth: The ground truth for this device is based on compliance with established international standards (ISO standards) for syringes and medical equipment, as well as direct performance assessment through bench and animal testing to ensure the device functions as intended and safely. This is not a diagnostic device relying on expert consensus or pathology for ground truth.
8. Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This is a physical medical device, not a machine learning algorithm, so there is no "training set."
9. How Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.
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