(266 days)
TopFine® LDS (Low Dead Space) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.
The TopFine® LDS (Low Dead Space) 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 hypodermic single lumen needle which is a permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. It is made of plastic and silicone materials that allows for smooth plunger movement, and is manually operated. This is a single-use device. This product is packed by sterile paper and sterilized by Ethylene Oxide gas.
The proposed device has 2 models depending on the diameter of the needle.
The provided document is a 510(k) premarket notification for a medical device, specifically a syringe. It does not contain information about an Artificial Intelligence/Machine Learning (AI/ML) device. Therefore, it is not possible to describe acceptance criteria or a study related to AI/ML device performance.
The document focuses on demonstrating substantial equivalence of the "TopFine® LDS (Low Dead Space) Syringe" to a predicate syringe through various performance tests and material comparisons.
Here's an analysis based on the information provided, specifically addressing the technical performance of the syringe, not AI/ML:
Acceptance Criteria and Reported Device Performance (Non-AI/ML Syringe)
The document details various performance criteria for the syringe. There isn't a single table explicitly labeled "Acceptance Criteria and Reported Device Performance" with detailed numerical results for each criterion. However, the "Comparison of technological characteristics with the predicate device" section (page 5) and "Performance data" section (page 7) implicitly define the acceptance criteria by stating compliance with recognized standards and providing general results.
Here's an attempt to construct a table based on the provided information, focusing on criteria where reported performance is available, even if only generally stated as "Same" or "Complies."
| Acceptance Criteria Category | Specific Criteria / Standard | Acceptance Criteria (Expected/Reference) | Reported Device Performance (TopFine® LDS Syringe) |
|---|---|---|---|
| General Characteristics | Regulation Number | 21 CFR 880.5860 | Same (21 CFR 880.5860) |
| Product Code | QNQ | Same (QNQ) | |
| Indications for Use | Intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin. | Same | |
| Type of use | Prescription Use | Same | |
| Mechanism of action | Plunger can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel fluids through the connector to the patient. | Same | |
| Number of uses | Single Use Only | Same | |
| Material (Needle) | SUS 304 | Same (SUS 304) | |
| Material (Cap) | Polypropylene | Same (Polypropylene) | |
| Material (Barrel) | Polypropylene | Same (Polypropylene) | |
| Material (Plunger) | Polypropylene | Same (Polypropylene) | |
| Material (Gasket) | Polyisoprene | Same (Polyisoprene) | |
| Needle Gauge | 23G, 25G | Same (23G, 25G) | |
| Needle OD (23G) | 0.600 ~ 0.673 mm | Same (0.600 ~ 0.673 mm) | |
| Needle OD (25G) | 0.500 ~ 0.530 mm | Same (0.500 ~ 0.530 mm) | |
| Syringe nozzle type | Permanently attached | Same | |
| Syringe capacity | 1 ml | Same (1 ml) | |
| Performance - Biocompatibility | ISO 10993-1 Classification | Externally Communicating Device, Blood Path Indirect, Limited Contact ( acceptance criteria | Met USP acceptance criteria. |
| Performance - Physical | Needle Length (23G, 25G) | Predicate: 25.0 mm, 25.4 mm, 38.1 mm | Proposed: 26.5 mm (+1.5 / -2.5 mm) - Different, but performance verified. |
| Hub/needle bond strength (23G) | ≥ 34 N (ISO 7864) | Same (≥ 34 N) | |
| Hub/needle bond strength (25G) | ≥ 22 N (ISO 7864) | Same (≥ 22 N) | |
| Dead space | ≤ 0.03 ml | Same (≤ 0.03 ml) | |
| Performance Needle Standard | ISO 7864:2016 | Same (ISO 7864:2016) | |
| Needle Tubing Standard | ISO 9626:2016 | Same (ISO 9626:2016) | |
| Syringe Standard | ISO 7886-1:2017 | Same (ISO 7886-1:2017) | |
| Performance - Sterility | Sterilization Method | EO Gas, SAL=10-6 | Same (EO Gas, SAL=10-6) |
| EO Residue | Not detected (LOD: 0.001) | EO not detected. | |
| ECH Residue | Not detected (LOD: 0.02) | ECH not detected. | |
| Pyrogen Test | Bacterial endotoxin USP , USP | Testing conducted and met criteria. | |
| Package Integrity (ASTM D4169-22) | Acceptable for protection and sterility maintenance after environmental conditioning and simulated transportation. | All packaging is acceptable. | |
| Seal Peel Test | Complies with ASTM F88/F88 -15 | Performed. | |
| Dye Migration | Complies with ASTM F1929-15 | Performed. | |
| Shelf Life | 3 years (validated using ASTM F1980-21) | 3 years validated. | |
| Labeling | Compliance | Complies with 21 CFR part 801 | Same (Complies with 21 CFR part 801) |
Since this is concerning a non-AI/ML medical device, the following points are not applicable or cannot be answered from the provided text:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify exact sample sizes for each physical or biological test. It only mentions that tests were "conducted."
- Data provenance (country of origin, retrospective/prospective) is not mentioned for the testing data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is not an AI/ML device requiring expert ground truth for image/data interpretation. This refers to standard performance testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for clinical studies involving human interpretation or AI/ML output.
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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
- Not applicable. This is not an AI/ML device. "Clinical studies were not required to support substantial equivalence."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the syringe, "ground truth" would be established by direct physical measurements, chemical analyses, and biological assays according to the specified international and national standards (e.g., ISO, USP, ASTM). For example, the "dead space" measurement itself would be the ground truth for that specific characteristic, and the acceptance criterion is a predefined maximum value (≤ 0.03 ml).
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The sample size for the training set
- Not applicable. This is not an AI/ML device with a training set.
-
How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
In summary, the document addresses a traditional medical device (syringe) and demonstrates its substantial equivalence to a predicate device through adherence to manufacturing standards, material comparisons, and performance testing against established physical, chemical, and biological criteria, rather than through AI/ML performance metrics.
§ 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).