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510(k) Data Aggregation
(209 days)
Insulin Syringes without needle
The Insulin Syringes without needle is intended for medical purpose in conjunction with sterile needle for the manual aspiration and injection of U100 insulin into subcutaneous tissues.
The Insulin Syringes without needle is a sterile and single use syringe intended for injection of U-100 insulin into the body, in conjunction with a sterile needle. The proposed device is available in 1 ml. The proposed device is sterilized by Ethylene Oxide to achieve a SAL of 10-6 and supplied in immediate package to maintain the sterility of the device during the shelf life of 5 years.
This document is a 510(k) Summary for a medical device called "Insulin Syringes without needle" (K221045) from Berpu Medical Technology Co., Ltd. It compares the proposed device to a predicate device (K162180) to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and supporting studies as presented in the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a table format with corresponding reported device performance for a specific study. Instead, it describes adherence to recognized standards and successful completion of various tests. For the purpose of this request, I will synthesize the information into a table based on the non-clinical testing performed and the standards referenced.
| Acceptance Criteria (Inferred from Standards) | Reported Device Performance |
|---|---|
| Material Performance | |
| Compliance with ISO 8537:2016 for insulin syringes (performance, dimensions, etc.) | Complied with ISO 8537:2016 |
| Compliance with ISO 80369-7:2021 for small-bore connectors (Luer lock performance) | Complied with ISO 80369-7:2021 (performance test conducted with proposed device) |
| Biocompatibility (as per ISO 10993-1 for prolonged contact) | |
| Absence of Cytotoxicity | Addressed |
| Absence of Sensitization | Addressed |
| Absence of Intracutaneous Reactivity | Addressed |
| Absence of Acute Systemic Toxicity | Addressed |
| Absence of Material-Mediated Pyrogenicity | Addressed |
| Absence of Subchronic/Subacute Toxicity | Addressed |
| Hemocompatibility | Addressed |
| Particulate Matter in Injections (USP ) | Met the USP acceptance criteria |
| Sterility & Shelf Life | |
| Sterilization validated per ISO 11135:2014 (Ethylene Oxide) | Validated to achieve a SAL of 10^-6^ |
| Shelf life of 5 years (validated per ASTM F1980-16) | 5 years shelf life determined based on stability studies (accelerated aging and simulated shipping) |
| EO and ECH residuals within limits (ISO 10993-7:2008) | Complied |
| Bacterial Endotoxin Limit (USP ) | Complied |
| Packaging Integrity (after accelerated aging, environmental conditioning, transport) | |
| Visual Inspection (ASTM F1886 / F1886M-16) | Performed |
| Seal Strength (ASTM F88/F88M-15) | Performed |
| Dye Penetration (ASTM F1929-15) | Performed. "All packaging deemed acceptable for protection of product and sterility maintenance." This implies passing criteria for these tests, although specific numerical results/criteria are not provided in this summary. |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for "test sets" in the context of clinical studies, as it explicitly states "No clinical study is included in this submission."
For non-clinical tests (e.g., performance, biocompatibility, sterilization validation, shelf-life, packaging), specific sample sizes used for testing are not provided in this summary. The data provenance would be from the manufacturer's internal testing or contracted laboratories performing tests according to the cited ISO and ASTM standards. This testing is typically prospective, performed on manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical studies were conducted, and therefore, no expert-established ground truth for a clinical test set is relevant to this submission.
4. Adjudication method for the test set
Not applicable. No clinical studies were conducted, and therefore, no adjudication method for a clinical test set is relevant to this submission.
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 device is an insulin syringe, not an AI-powered diagnostic or assistive tool. No MRMC study was mentioned or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an insulin syringe, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is established by the specified international (ISO) and national (ASTM, USP) standards. The device is tested against these standards, and its performance is compared to the requirements outlined in those standards. For example, for particulate matter, the ground truth is the maximum particle count allowed by USP . For sterility, the ground truth is a SAL of 10^-6^ as per ISO 11135.
8. The sample size for the training set
Not applicable. No AI/machine learning component is involved, so there is no training set in this context.
9. How the ground truth for the training set was established
Not applicable. No AI/machine learning component is involved, so there is no training set or corresponding ground truth establishment in this context.
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