(107 days)
Promisemed Covered Safety Pen Needle is intended for subcutaneous injection of insulin in the treatment of diabetes.
Promisemed Covered Safety 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 Covered Safety Pen Needle consists of needle tube, trigger shield, spring, fixer, needle hub, needle container, 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 Covered Safety Pen Needle is the modification of Verifine Safety Type Insulin Pen Needle cleared in K161950. The baseline location of trigger shield is adjusted to allow the needle tube be covered by trigger shield thoroughly before use. This modification prevents accidental needle sticks before inserting the needle into the skin while the needle container is removed. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle aqain and lock in place. Once the Covered Safety Insulin Pen Needle is in the locked mode, it can no longer be used.
Promisemed Covered Safety 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 distinquished by needle gauge and length.
This document is a 510(k) Pre-market Notification for a medical device called "Promisemed Covered Safety Pen Needle". It focuses on establishing substantial equivalence to a predicate device, not on presenting a standalone study of the device's performance against specific acceptance criteria in a clinical or AI context. Therefore, much of the requested information regarding AI/clinical studies, expert ground truth, sample sizes for test/training sets, and MRMC studies is not applicable or not provided in this regulatory document.
However, based on the provided text, I can extract information related to non-clinical testing and the acceptance criteria established by adherence to recognized international standards.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is demonstrated by compliance with international standards. The acceptance criteria are implicit in the requirements of these standards.
| Acceptance Criteria (Defined by Standard) | Reported Device Performance |
|---|---|
| ISO 9626:2016 (Needle material) | Complied |
| ISO 11608-2:2012 | Complied |
| Needle Dimensions | Complied |
| Flow rate | Complied |
| Bond between hub and needle tube | Complied |
| Needle points | Complied |
| Freedom from defects | Complied |
| Lubrication | Complied |
| Dislocation of measuring point patient end | Complied |
| Functional compatibility with needle-based injected systems | Complied |
| Ease of assembly and disassembly | Complied |
| ISO 7864:2016 (Pierce Force) | Complied |
| ISO 23908:2011 | Complied |
| Accidental access to a sharp once in safe mode | Complied |
| Safety mechanism activation | Complied |
| Safety overriding and unlocking force after activation | Complied |
| ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2013, ISO 10993-11:2006, ISO 10993-11:2017 & ASTM F756-13 (Biocompatibility) | Complied |
| Cytotoxicity | No cytotoxicity |
| Sensitization | No evidence of sensitization |
| Irritation | No evidence of skin irritation |
| Acute Systemic Toxicity | No systemic toxicity |
| Material Mediated Pyrogenicity | No pyrogenic |
| Hemocompatibility | No evidence of hemolysis |
| ISO 11135:2014, ISO 11737-1:2018, ISO 11737-2:2009 & ISO 10993-7:2008 (Sterilization) | Complied |
| Sterility Assurance Level (SAL) | 10^-6 |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each non-clinical test. The testing was conducted to verify compliance with various ISO standards, which typically involve specific sample size requirements for each test. The data provenance is presumed to be from tests performed by the manufacturer, Promisemed Hangzhou Meditech Co., Ltd., in China, as they are the submitter. The tests are non-clinical (bench testing), not derived from patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical device safety and performance evaluation based on adherence to engineering and biological safety standards, not a study requiring expert ground truth for diagnostic purposes.
4. Adjudication method for the test set
Not applicable. The tests are based on objective measurements and compliance with standard specifications, not subjective expert judgment or adjudication.
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 a pen needle for insulin injection; it does not involve human readers, AI, or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is defined by the objective metrics and specifications outlined in the referenced ISO and ASTM standards (e.g., specific dimensions, force thresholds, biological response, sterility levels).
8. The sample size for the training set
Not applicable. This is a medical device approval based on non-clinical testing against standards, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).