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510(k) Data Aggregation
(364 days)
Jeil Tech Co., Ltd.
STERILE SINGLE USE LDV SYRINGE/CHOICARE STERILE SINGLE USE LDV SYRINGE is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection 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. This is a single-use device. This product is packed by sterile paper and sterilized by E.O gas.
This document is an FDA 510(k) Premarket Notification for a medical device (Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe). The provided text describes the device, its intended use, performance data, and a comparison to a predicate device to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
Important Note: The provided document is a 510(k) submission for a syringe, which is a relatively low-risk medical device. The types of acceptance criteria and studies are primarily focused on bench testing and adherence to existing international standards, rather than complex clinical studies or AI/software performance evaluations. Therefore, many of the requested points related to AI, MRMC studies, and expert ground truth establishment for complex image analysis are not applicable or detailed in this document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to various ISO standards and specific quantitative thresholds for certain tests. The reported device performance is consistently "Pass" for all tested criteria, indicating the device met the acceptance criteria.
| Requirement – Test (Standard) | Acceptance Criteria (Implicit for "Pass") | Reported Device Performance |
|---|---|---|
| ISO 7886-1:2017 (Syringe Performance) | Conformance to standard requirements for manual use syringes (e.g., proper dimensions, tightness, piston/plunger assembly) | Pass |
| Visual check | N/A (Visual inspection, implied to be defect-free) | Pass |
| Dimension (out diameter of the needle tube) | N/A (Within specified tolerance per standard) | Pass |
| Length of the needle tube | N/A (Within specified tolerance per standard) | Pass |
| Nozzle | N/A (Conforms to design and standard) | Pass |
| Tightness | N/A (No leakage at specified pressures) | Pass |
| Piston/Plunger Assembly | N/A (Smooth movement, no binding) | Pass |
| ISO 7864:2016 (Hypodermic Needle Performance) | Conformance to standard requirements (e.g., elasticity, flexural strength, pullout) | Pass |
| Elasticity | N/A (Meets specified flexibility) | Pass |
| Flexural strength | N/A (Withstands specified bending force) | Pass |
| Pullout | N/A (Withstands specified pullout force) | Pass |
| ISO 9626:2016 (Stainless Steel Needle Tubing) | Conformance to standard requirements (e.g., stiffness, resistance to breakage/corrosion) | Pass |
| Stiffness | N/A (Meets specified rigidity) | Pass |
| Resistance to breakage | N/A (Withstands specified forces without breaking) | Pass |
| Resistance to corrosion | N/A (Shows no significant corrosion after specified tests) | Pass |
| Dead Volume | ) | Satisfy the requirements for bacterial endotoxins |
| Particulate Matter Injection (USP ) | Satisfy the requirements for particulate matter | Pass |
| Sterility & EO Residuals | Conformance to standard requirements (e.g., SAL of 10^-6, low EO residuals) | Pass (for all listed tests) |
| LAL test (USP39 ) | Satisfy the requirements for bacterial endotoxins | Pass |
| E.O sterilization validation (ISO 11135:2014) | Process validated to achieve sterility | Pass |
| Sterility test (ISO 11737-2) | No microbial growth | Pass |
| E.O Residual test (ISO 10993-7:2008) | Meets test requirements for ethylene oxide sterilization residuals | Pass |
| Needle Injury Test (ISO 23908:2011 Sharps Injury Protection) | Conformance to standard requirements for sharps injury protection (e.g., acceptable penetration, pull-out, cap removal, activation/locking, unlocking forces) | Pass (for all listed tests) |
| Needle penetration force | N/A (Within specified range) | Pass |
| Pull-out force | N/A (Within specified range) | Pass |
| Needle cap removal force | N/A (Within specified range) | Pass |
| Activation (locking) force (for safety feature) | N/A (Within specified range) | Pass |
| Unlocking force (for safety feature) | N/A (Within specified range) | Pass |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample sizes for each bench test conducted. However, for a 510(k) submission, testing is typically performed on a statistically relevant number of units as required by the referenced ISO standards.
- Data Provenance: The document indicates that the tests were performed by Jeil Tech Co., Ltd. (Republic of Korea). The studies are "bench tests," which are laboratory tests, not clinical studies involving human patients. The nature is prospective in the sense that the tests were performed specifically for this submission to verify the device's adherence to standards and safety.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. Bench testing for a syringe relies on objective measurements against engineering specifications and international standards (e.g., ISO, USP). There isn't "ground truth" to be established by human experts in the context of diagnostic interpretation or clinical outcomes. The "experts" involved would be qualified lab technicians and engineers performing and verifying the tests.
4. Adjudication Method for the Test Set
This is not applicable. Since the tests are objective bench measurements against quantitative or qualitative (Pass/Fail based on standard adherence) criteria, there is no need for an adjudication method. The results are either within specification or not.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This is not applicable. This submission is for a physical medical device (syringe), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC comparative effectiveness study was performed or required.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable. As stated above, this is not an AI/algorithm device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is the adherence to established international standards (ISO 7886-1, ISO 7864, ISO 9626, ISO 23908, ISO 10993 series, ISO 11135, ISO 11737-2) and specific quantitative requirements (e.g., dead volume, endotoxin limits). This is an engineering specification and regulatory standard conformance type of ground truth.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI or machine learning device. The device is manufactured based on design specifications, and tested to ensure it meets those specifications and relevant standards.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for this device.
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