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510(k) Data Aggregation
(191 days)
Promisemed Insulin Pen Needle
Promisemed Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. It is sterile and for single use only. It is suitable for all age groups including neonate, infant, children and adult, and can be used by the patient at home or healthcare professionals at medical/health care centers.
Promisemed Insulin Pen Needle is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. The user proceeds with inserting the needle into the skin manually.
The Promisemed Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. Promisemed Insulin Pen Needle is the modification of the Verifine Common Type Insulin Pen Needle cleared in K161950 in extension of the range of gauge and needle length as well as change in material of needle shield. Promisemed Insulin Pen Needle is sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. It is supplied with several models. Different models are distinguished by needle gauge and length.
This is a 510(k) premarket notification for a medical device, the Promisemed Insulin Pen Needle. These documents typically focus on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and study reports for novel AI algorithms.
Therefore, the requested information for an AI/ML powered device, such as acceptance criteria in the form of performance metrics (sensitivity, specificity), descriptions of test sets (sample size, provenance), expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable to this submission.
This submission focuses on engineering and biocompatibility testing to demonstrate that the Promisemed Insulin Pen Needle performs as safely and effectively as a previously cleared insulin pen needle (K161950), despite minor changes in gauge range, needle length, and material of the needle shield.
Here's a summary of what is available in the document regarding performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of acceptance criteria with specific performance metrics like sensitivity, specificity, accuracy, etc., as these are not relevant for a mechanical device like an insulin pen needle. Instead, it refers to compliance with established international standards for such devices.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Compliance Statement) |
|---|---|
| ISO 9626 | "Complied with ISO 7864, ISO 9626, ISO 11608-2" (implied for both subject and predicate device, indicating the subject device also complies) |
| ISO 11608-2 | "Complied with ISO 7864, ISO 9626, ISO 11608-2" (implied for both subject and predicate device, indicating the subject device also complies). Specifically mentioned that 3.5mm needle length meets the "requirement of ISO 11608-2 to a 95%/95% C/R" (Confidence/Reliability, a statistical measure often used for medical device performance validation). |
| ISO 7864 | "Complied with ISO 7864, ISO 9626, ISO 11608-2" (implied for both subject and predicate device, indicating the subject device also complies) |
| Biocompatibility (ISO 10993 series) | Complied with ISO10993 series standards. Tests performed: |
| - Cytotoxicity | No cytotoxicity |
| - Skin Irritation | No evidence of skin irritation |
| - Skin Sensitization | No evidence of sensitization |
| - Acute Systemic Toxicity | No systemic toxicity |
| - Hemolysis (ASTM F756-13) | No evidence of hemolysis |
| - Pyrogenicity (ISO 10993-11) | Non-pyrogenic |
| Particulate Matter (USP ) | Met the USP acceptance criteria. |
| Package Integrity (ISTA 3A, ASTM F88, ASTM F1929) | All packaging deemed acceptable for protection of product and sterility maintenance. |
| Shelf Life (ASTM F1980-16) | 5 years validated. |
| Sterility Assurance Level (SAL) | 10⁻⁶ (Same as predicate) |
2. Sample size used for the test set and the data provenance:
Not applicable for this type of device submission. Performance is assessed through compliance with engineering standards and biocompatibility testing on material samples and device prototypes. The data provenance would be from laboratory testing conducted in China (Promisemed Hangzhou Meditech Co., Ltd. is based in China). The document indicates the testing was "bench testing."
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 a mechanical device is established by compliance with engineering specifications and recognized consensus standards, not by expert consensus on clinical output.
4. Adjudication method for the test set:
Not applicable.
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 not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used:
For the engineering performance tests (e.g., needle strength, flow rate), the ground truth is defined by the acceptance limits specified within the referenced international standards (ISO 9626, ISO 11608-2, ISO 7864). For biocompatibility, the ground truth is the absence of adverse biological reactions as per ISO 10993 series. For sterility, it's achieving an SAL of 10⁻⁶.
8. The sample size for the training set:
Not applicable as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
Not applicable.
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