Search Results
Found 1 results
510(k) Data Aggregation
(109 days)
Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle
Sterile Hypodermic Syringe with/without needle: The Sterile Hypodermic Syringe with/without needle is intended for use in the aspiration and injection of fluids for medical purposes.
Sterile Hypodermic Needle: The Sterile Hypodermic Needle is intended to be used with a syringe for fluids aspiration and injection for medical purposes.
The Sterile Hypodermic Syringe with/without needle is intended for use in the aspiration and injection of fluids for medical purposes. The Sterile Hypodermic Needle is intended to be used with a syringe for fluids aspiration and injection for medical purposes. It is intended for the patient population, including adults, transitional adolescents, adolescents, and children. The device is intended for use in a professional healthcare facility. The device is a disposable syringe made of the following components: Needle cap, Needle tube, Needle hub, Barrel, Plunger, Plunger stopper.
The provided submission describes a medical device, a Sterile Hypodermic Syringe with/without Needle and a Sterile Hypodermic Needle, and does not involve AI/ML. Therefore, the requested information regarding acceptance criteria and studies that prove the device meets these criteria in the context of AI/ML, human readers, ground truth, and sample sizes for training/test sets is not applicable to this document.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing, biocompatibility testing, sterilization validation, and package/shelf-life testing. No clinical data was submitted.
However, based on the non-clinical performance testing sections, I can extract the acceptance criteria and the studies performed to meet them as they relate to the physical device properties.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Test | Reported Device Performance |
|---|---|---|
| Performance | ISO 7886-1 (Sterile hypodermic syringes for single use - Part 1: Syringes for manual use) | Complied with standard requirements |
| ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods) | Complied with standard requirements | |
| ISO 7864 (Sterile hypodermic needles for single use -- Requirements and test methods) | Complied with standard requirements | |
| ISO 80369-7 (Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications) | Complied with standard requirements | |
| ISO 80369-20 (Small-bore connectors for liquids and gases in healthcare applications part 20: standard test methods) | Complied with standard requirements | |
| ISO 6009 (Hypodermic needles for single use Colour coding for identification) | Complied with standard requirements | |
| Biocompatibility | ISO 10993-5: 2009 (In Vitro Cytotoxicity) | Conforms to standard |
| ISO 10993-10: 2010 (Sensitization) | Conforms to standard | |
| ISO 10993-10: 2010 (Intracutaneous Reactivity) | Conforms to standard | |
| ISO 10993-11: 2017 (Acute Systemic Toxicity) | Conforms to standard | |
| ISO 10993-4:2017 (Coagulation) | Conforms to standard | |
| ISO 10993-4: 2017 (Complement activity) | Conforms to standard | |
| ISO 10993-4: 2017 & ASTM F756-17 (Hemolytic Properties) | Conforms to standard | |
| Sterilization Validation | ISO 11135-1 (Sterilization of health care products - ethylene oxide - part 1) | Complied with standard requirements |
| ISO 11737-1 (Sterilization of medical devices-Microbiological methods-Part 1) | Complied with standard requirements | |
| ISO 11737-2 (Sterilization of medical devices -- Microbiological methods -- Part 2) | Complied with standard requirements | |
| ISO 10993-7 (Biological evaluation of medical devices - Part 7: Test of Ethylene Oxide Residuals) | Complied with standard requirements | |
| AAMI / ANSI ST72 (Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing) | Complied with standard requirements | |
| Package and Shelf Life | AAMI/ANSI/ISO 11137-1 (Sterilization of health care products - Radiation - Part 1) | Complied with standard requirements |
| AAMI/ANSI/ISO 11737-2 (Sterilization of medical devices - Microbiological methods - Part 2) | Complied with standard requirements | |
| AAMI/ANSI/ISO 11607-1 (Packaging for terminally sterilized medical devices - Part 1) | Complied with standard requirements | |
| ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration) | Complied with standard requirements | |
| ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems for Medical Devices) | Complied with standard requirements | |
| ASTM D3078-02 (2021) (Determination of Leaks in Flexible Packaging by Bubble Emission) | Complied with standard requirements | |
| DIN58953-6: 2016 (Microbial barrier testing of packaging materials) | Complied with standard requirements | |
| ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials) | Complied with standard requirements | |
| Package Integrity Tests | Accelerated Aging Test | Conducted |
| Simulated shipping distribution testing | Conducted | |
| Visual inspection | Conducted | |
| Performance Inspection (Chemical and Physical) | Conducted | |
| Sterile Test | Conducted | |
| Vacuum Leak Test | Conducted | |
| Dye penetration test | Conducted | |
| Agar Contact-Attack Test | Conducted | |
| Tensile Seal Strength Test | Conducted |
The remaining requested information is not applicable to this document as it pertains to AI/ML device studies, which this submission is not.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as this is a traditional medical device (syringe/needle) and not an AI/ML device. Performance testing for traditional devices typically involves testing physical samples defined by the relevant standards, not a "test set" of data in the AI/ML sense. No specific country of origin or retrospective/prospective nature of data for these tests is mentioned beyond the manufacturing location (China).
3. 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 study. Ground truth in this context would refer to the validated methods and accepted performance limits defined by the referenced international standards, rather than expert consensus on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not an AI/ML device study.
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 as this is not an AI/ML device study. No human reader studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is not an AI/ML device study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical performance, biocompatibility, sterilization, and packaging tests, the "ground truth" is defined by the objective pass/fail criteria and methodologies outlined in the referenced international and national consensus standards (e.g., ISO, ASTM, AAMI/ANSI). These standards represent established scientific and engineering principles for evaluating medical device safety and performance.
8. The sample size for the training set
- Not applicable as this is not an AI/ML device study.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/ML device study.
Ask a specific question about this device
Page 1 of 1