(31 days)
The Terumo Allergy Syringe is intended for the preparation/mixing of allergenic extracts/prescribed substances, the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. This syringe is designed for manual use.
The Terumo Allergy Syringe with fixed hypodermic single lumen needle is a sterile, single use, standard piston syringe, designed for manual use. The syringe is available in Icc volumes with 23G, 26G and 27G, 1/2" and 3/8" fixed hypodermic single lumen needles. These needles have either a regular or intradermal bevel.
This document is a 510(k) summary for a medical device, specifically the Terumo Allergy Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than defining new acceptance criteria and conducting a study against them in the traditional sense of a novel AI/software product. Therefore, many of the requested categories are not applicable or cannot be fully answered from the provided text.
However, I can extract information related to the device's performance and the comparison to its predicate.
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k), the "acceptance criteria" is demonstrating substantial equivalence in performance to the predicate device, the B-D® Allergy Syringe (K941657). The reported device performance is that it is substantially equivalent. Specific numerical acceptance criteria are not provided in this summary.
| Performance Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Volume | Substantially equivalent to predicate B-D® Allergy Syringe | Demonstrated substantial equivalence through testing |
| Cannula/barrel adherence | Substantially equivalent to predicate B-D® Allergy Syringe | Demonstrated substantial equivalence through testing |
| Maximum penetration force | Substantially equivalent to predicate B-D® Allergy Syringe | Demonstrated substantial equivalence through testing |
| Leakage | Substantially equivalent to predicate B-D® Allergy Syringe | Demonstrated substantial equivalence through testing |
| Aspiration initial | Substantially equivalent to predicate B-D® Allergy Syringe | Demonstrated substantial equivalence through testing |
| breakaway force | ||
| Aspiration | Substantially equivalent to predicate B-D® Allergy Syringe | Demonstrated substantial equivalence through testing |
| Injection force | Substantially equivalent to predicate B-D® Allergy Syringe | Demonstrated substantial equivalence through testing |
| Residual volume | Substantially equivalent to predicate B-D® Allergy Syringe | Demonstrated substantial equivalence through testing |
| Sterility | Sterility Assurance Level (SAL) of 10-6 (ISO 11137 validated) | Achieved SAL of 10-6, monitored with dosimeters |
| Biocompatibility | Compliance with ISO-10993 (External Communicating, Blood Path Indirect, Limited Duration) | Blood contacting materials found to be biocompatible |
| Expiration Dating | Establish a viable expiration date | Established to be 5 years (60 months) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes used for each performance test (e.g., number of syringes tested for volume, leakage, etc.). It only states that "The following tests were performed demonstrating the substantial equivalence..."
Data provenance (country of origin, retrospective/prospective) is not mentioned. These are likely prospective tests conducted on manufactured devices in a lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a physical medical device. Ground truth for its performance characteristics (like leakage or force) would be established by direct physical measurement, not by expert consensus on observational data.
4. Adjudication Method for the Test Set
Not applicable. As above, performance is measured objectively.
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
Not applicable. This is not an AI/software device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an AI/software device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance tests mentioned (Volume, Cannula/barrel adherence, Maximum penetration force, Leakage, Aspiration initial breakaway force, Aspiration, Injection force, Residual volume, Sterility, Biocompatibility, Expiration Dating) would be based on:
- Direct Physical Measurement: Using calibrated equipment to measure forces, volumes, and integrity.
- Standardized Sterility Testing Methods: Following ISO 11137 protocols.
- Biological Testing: As per ISO 10993 for biocompatibility.
- Stability Testing: To establish expiration dating.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. (See #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).