(119 days)
Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient' s vascular system through the needle inserted into the vein.
Safelock Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein, and the safety sheath is designed to prevent accidental needlesticks.
The proposed devices are intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein. The device contains a conical fitting provides a standard female luer lock connector which may connect to an I.V. administration set with a male conical fitting. And the infusion needle is inserted patient's vein. Then the solution will be administered from the I.V. administration set through the infusion needle into patient vascular by gravity.
The provided document is a 510(k) summary for injection needles. Medical devices like this generally do not have specific "acceptance criteria" in the same way an AI/ML diagnostic device would for performance metrics such as sensitivity, specificity, or AUC. Instead, they are evaluated against established performance standards and guidelines for similar predicate devices.
However, I can extract information related to the device's testing and compliance, which serves a similar purpose to demonstrating that the device "meets acceptance criteria" for its type.
Here’s a summary based on the provided text, structured to align with your request as much as possible for a medical device of this nature:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of medical device (Disposable Infusion Needle), the "acceptance criteria" are mainly conformance to recognized international and industry standards, and demonstration of equivalency to predicate devices. Performance is reported through successful compliance with these standards and a simulated clinical study.
| Acceptance Criteria (Standards/Tests) | Reported Device Performance |
|---|---|
| Material & Physical Properties | |
| ISO 9626:1991+AMENDMENT 1 2001 (Stainless steel needle tubing) | Complied (Non-clinical tests demonstrated compliance.) |
| ISO 7864:1993 (Sterile hypodermic needles for single use) | Complied (Non-clinical tests demonstrated compliance.) |
| ASTM F 88/F88M-09 (Seal strength of flexible barrier materials) | Complied (Non-clinical tests demonstrated compliance.) |
| ASTM F1140/F1140M-13 (Internal pressurization failure resistance of packages) | Complied (Non-clinical tests demonstrated compliance.) |
| Biocompatibility | |
| ISO 10993 (Series) | Conformed (General statement of conformance with ISO 10993 within the comparison table; specific tests listed below also demonstrate compliance.) |
| ISO 10993-1:2009 (Evaluation and testing within a risk management process) | Complied (Non-clinical tests demonstrated compliance.) |
| ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Complied (Non-clinical tests demonstrated compliance.) |
| ISO 10993-10:2010 (Test for irritation and delayed-type hypersensitivity) | Complied (Non-clinical tests demonstrated compliance.) |
| ISO 10993-11:2006 (Tests for systemic toxicity) | Complied (Non-clinical tests demonstrated compliance.) |
| ASTM F 756-13 (Assessment of hemolytic properties of materials) | Complied (Non-clinical tests demonstrated compliance.) |
| Sterilization & Packaging | |
| USP37-NF32 (Bacterial Endotoxins Limit) | Complied (Non-clinical tests demonstrated compliance.) |
| ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Complied (Non-clinical tests demonstrated compliance.) |
| ISO 11135-1:2007 (Ethylene oxide sterilization - Requirements) | Complied (Non-clinical tests demonstrated compliance.) |
| ISO 11737-2:2009 (Sterility tests in definition, validation, maintenance) | Complied (Non-clinical tests demonstrated compliance.) |
| Safety Feature Performance | |
| FDA Guidance: Medical Devices with Sharps Injury Prevention Feature (August 9, 2005) | Successful (A simulated clinical study was performed to evaluate the safety mechanism and "The results demonstrated that the proposed device met the pre-established criteria.") |
2. Sample Size for the Test Set and Data Provenance
- Sample Size (for simulated clinical study): Not explicitly stated. The document only mentions "A simulated clinical study was performed..." without specifying the number of devices or trials.
- Data Provenance: The study was a "simulated clinical study" performed by the manufacturer (Jiangyin Caina Technology Co., Ltd. in China) in accordance with FDA guidance. The data is retrospective in the sense that it was generated for the 510(k) submission, not as a prospective clinical trial on human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. For a simulated clinical study evaluating a safety mechanism, "ground truth" would typically be established based on engineering specifications and successful activation/functionality of the safety feature as observed by study personnel, rather than expert consensus on medical imaging or diagnoses.
4. Adjudication Method for the Test Set
This information is not provided. Given it's a simulated clinical study for a mechanical safety feature, a formal adjudication panel as found in diagnostic studies is unlikely. Performance would be assessed objectively against pre-established pass/fail criteria.
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
There was no MRMC comparative effectiveness study done. This device is a physical medical instrument (infusion needle), not an AI/ML-based diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There was no standalone algorithm performance study done. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the simulated clinical study of the safety mechanism, the "ground truth" would be the functional performance of the safety sheath as designed and measured against predetermined engineering and safety specifications (e.g., successful locking, prevention of needlesticks in a simulated environment). This is based on objective, repeatable tests rather than clinical outcomes or diagnostic interpretations.
8. The sample size for the training set
There is no training set for this type of medical device. The device is not an AI/ML model that requires training data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.