(618 days)
FEELject LDV(Low dead volume) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.
A Disposable Syringe with Needle 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 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 manually operated. This is a single-use device. This product is packed by sterile paper and sterilized by E.O gas.
The provided text describes the 510(k) summary for the FEELject LDV (Low dead volume) Syringe, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new medical device meets specific acceptance criteria through a clinical study or AI performance evaluation.
Therefore, the information required to answer your specific questions about acceptance criteria, AI performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies for an AI/device is not available in this document.
The document discusses bench testing and biocompatibility testing to show that the device performs in a substantially equivalent manner to the predicate device. These tests demonstrate the physical and biological properties of the syringe, not the performance of an AI algorithm or a diagnostic device.
Here's a breakdown of what can be extracted from the document, and why the other requested information is absent:
Information Available from the Document:
This document is a 510(k) summary for a medical device (syringe), not an AI algorithm. Therefore, the requested information about AI-related acceptance criteria, study design (MRMC, standalone), ground truth establishment for AI, and sample sizes for AI training/test sets is not applicable and not found in this text.
The closest equivalent to "acceptance criteria" here is compliance with ISO standards and passing various bench tests and biocompatibility tests to show substantial equivalence to the predicate device.
1. A table of acceptance criteria and the reported device performance
While not "AI performance" criteria, the document lists various requirements/tests for the syringe and their results (Pass). These serve as the "acceptance criteria" for the syringe's physical and biological properties.
| Requirement - Test (ISO 7886-1) | Reported Device Performance (Result) |
|---|---|
| Limits for extractable metals | Pass |
| General | Pass |
| Limits for acidity or alkalinity | Pass |
| Conical fitting | Pass |
| Position of nozzle on end of barrel | Pass |
| Tolerance on graduated capacity | Pass |
| Scale | Pass |
| Numbering of scales | Pass |
| Overall length of scale to nominal capacity line | Pass |
| Position of scale | Pass |
| Barrel flanges | Pass |
| Plunger stopper/plunger assembly | Pass |
| Dead space | Pass |
| Freedom from air and liquid leakage past plunger stopper | Pass |
| Force to operate the piston | Pass |
| Fit of plunger stopper/plunger in barrel | Pass |
| Unit packaging and self-contained syringe units | Pass |
| Quantity of silicone oil | Pass |
| Requirement - Test (ISO 7864) | Reported Device Performance (Result) |
|---|---|
| Cleanliness | Pass |
| Tolerances on length | Pass |
| Needle Point, needles with sharp tip only | Pass |
| Bond between hub and needle tube | Pass |
| Patency lumen | Pass |
| Requirement – Test (ISO 9626) | Reported Device Performance (Result) |
|---|---|
| Stiffness | Pass |
| Resistance to breakage | Pass |
| Resistance to corrosion | Pass |
| Requirement - Test (USP 788) | Reported Device Performance (Result) |
|---|---|
| Particulate matter injections | Pass |
| Biocompatibility Test Item | Test Method / Test Criteria | Reported Device Performance (Result) |
|---|---|---|
| Cytotoxicity | ISO 10993-5 Tests for in vitro cytotoxicity | Pass |
| Skin Sensitization Test | ISO 10993-10 irritation and skin sensitization | Pass |
| Intracutaneous Reactivity Test | ISO 10993-10 Test for irritation and skin sensitization, maximization test for delayed hypersensitivity | Pass |
| Acute Systemic Toxicity Test | ISO 10993-11 Test for systemic toxicity - Acute Systemic Toxicity | Pass |
| Pyrogen Test | ISO 10993-11 Tests for systemic toxicity, Annex(F) Information on material-mediated pyrogens. | Pass |
| Hemolysis Test | ISO 10993-4 Selection of tests for interactions with blood | Pass |
| Sterility and LAL Test Item | Test Standard | Reported Device Performance (Result) |
|---|---|---|
| LAL test (Bacterial Endotoxins) | USP39 (Unit : EU/Device) | Pass |
| Sterility test | According to ISO 11737-2 | Pass |
| E.O Residual | Under the conditions of ISO 10993-7:2008, Ethylene oxide sterilization residuals | Pass |
Information Not Applicable or Not Present:
The following information is specifically requested for AI/Software as a Medical Device (SaMD) performance studies, which are not described in this 510(k) summary for a physical medical device (syringe). Therefore, the answers are "Not Applicable" or "Not Provided" in this context.
- 2. Sample sized used for the test set and the data provenance: Not applicable. The tests are bench tests of physical characteristics, not data-driven AI test sets with specific sample sizes from a clinical population.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established for a physical syringe.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is for AI performance evaluation.
- 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 for AI performance evaluation.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI performance evaluation. The device is a physical syringe.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. This is for AI performance evaluation. The "ground truth" for the syringe is its compliance with specified physical and biological standards.
- 8. The sample size for the training set: Not applicable. There is no AI training set for a syringe.
- 9. How the ground truth for the training set was established: Not applicable. There is no AI training set for a 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).