(209 days)
The Disposable 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 can be used by the patient at home or healthcare professionals at medical/health care centers.
The Disposable Insulin Pen Needle consists of a needle tube, a needle hub, a needle container, a needle shield and a seal. The needle tube is a double-ended needle that can be assembled into the needle hub using UV glue. The needle hub has the means of needle assembly attachment to allow it to be screwed onto the pen-injector device. This allows the Non-Patient (NP) end of the needle to penetrate through the rubber septum of the pen injector cartridge. The Patient and NP ends of the needle are lubricated using silicon oil for ease of injection and rubber septum penetration. The needle shield is assembled over the Patient end of the needle to protect the point from damage and accidental needle sticks. This needle assembly is inserted into a needle container and sealed with a peel-away label to provide a sterile barrier and tamper evidence. The peelaway label is pre-printed with information, which includes the lot number and needle gauge / length. It is supplied with several models. Different models are distinguished by needle gauge and length. The Disposable Insulin Pen Needle is a single-use disposable device and is provided sterile (EO sterilization). It is non-toxic and nonpyrogenic.
Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the Hantech Medical Device Co., Ltd. Disposable Insulin Pen Needle (K222739).
It's important to note that this document is a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device, rather than a full study proving a device meets novel acceptance criteria. Therefore, many of the typical AI/ML study components (like expert consensus, adjudication, MRMC studies, training set details) are not applicable here. This submission focuses on demonstrating that the new device performs similarly to an already approved device through established engineering and biocompatibility testing.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" are generally derived from recognized international and national standards, and "reported device performance" indicates conformity to these standards.
| Acceptance Criteria Category | Specific Criteria (from referenced standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Absence of cytotoxicity (ISO 10993-5:2009) | No cytotoxicity |
| Absence of skin sensitization (ISO 10993-10:2010) | No evidence of sensitization | |
| Absence of hemolysis (ISO 10993-4:2017) | No evidence of hemolysis | |
| Acceptable intradermal reactivity (ISO 10993-10:2010) | Not explicitly detailed as "acceptable" but implied by conformity. "No evidence of skin irritation" is noted. | |
| Absence of acute systemic toxicity (ISO 10993-11:2017) | No systemic toxicity | |
| Non-pyrogenic (ISO 10993-11:2017) | Non-pyrogenic | |
| Absence of subacute systemic toxicity (ISO 10993-11:2017) | No Subacute Systemic Toxicity | |
| Acceptable particulate levels (USP 788) | Implied by conformity, no specific value given. | |
| Sterilization | Sterility Assurance Level (SAL) of $10^{-6}$ (ISO 11135:2014) | Sterilized by ethylene oxide gas SAL = $10^{-6}$ |
| Compliance with ethylene oxide sterilization residuals (ISO 10993-7:2008) | Implied by conformity to ISO 10993-7. | |
| Packaging integrity and sterile barrier system requirements (ISO 11607-1:2019, ISO 11607-2:2019) | Implied by conformity to these standards. | |
| Shelf life stability (based on stability study and accelerated aging - ASTM F1980-16) | 5 years shelf life | |
| Performance | Requirements for hypodermic needles (ISO 7864:2016) | Complied with ISO 7864 |
| Requirements for stainless steel needle tubing (ISO 9626:2016) | Complied with ISO 9626 | |
| Requirements for needle-based injection systems (ISO 11608-2:2012) | Complied with ISO 11608-2 | |
| Labeling | Compliance with 21 CFR Part 801 | Meet the requirements of 21 CFR Part 801 |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of clinical data or AI model evaluation. Instead, testing refers to product compliance with international standards for medical devices. The sample sizes for these specific engineering and biocompatibility tests are not detailed in this summary, but would typically be defined by the relevant ISO standards (e.g., a certain number of units for sterility testing or mechanical strength tests).
- Data Provenance: The tests were conducted by the manufacturer, Hantech Medical Device Co., Ltd., which is located in Ningbo, Zhejiang, China. The testing would be prospective in the sense that physical devices were manufactured and then tested to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. For this type of medical device 510(k) submission, "ground truth" is not established by human experts interpreting clinical data. Instead, it's established by objective measurements against predefined engineering standards and biocompatibility requirements. The "experts" involved would be qualified laboratory technicians, engineers, and biocompatibility specialists carrying out the specified tests following established protocols.
4. Adjudication Method for the Test Set
Not applicable. There is no qualitative assessment by human readers that would require an adjudication method. Test results are quantitative measurements or assessments against scientific 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
Not applicable. This device is a physical medical product (insulin pen needle), not an AI/ML diagnostic or assistive technology. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. As noted above, this is a physical medical device, not an algorithm or software.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this substantially equivalent device is the demonstrated compliance with recognized international and national standards for mechanical performance, sterility, and biocompatibility, as well as comparison to the characteristics of a legally marketed predicate device. This is based on objective laboratory and quality control testing, not clinical outcomes data, pathology, or expert consensus on interpretations.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device, so no training set or its associated ground truth establishment is relevant.
§ 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).