(414 days)
TK Safety Needle device is intended for use in the aspiration and injection of fluids for medical purposes. The TK Safety Needle is compatible for use with standard luer lock syringes. Additionally, after withdrawal of the needle from the body the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle-stick.
The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with one-hand operation by pressing the sheath either with the finger or thumb, or by surface activation. The locking mechanism is positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner the flexibility to adjust the sheath to its desired position for use.
The provided text describes a 510(k) submission for the "TK Safety Needle," which is a single lumen hypodermic needle with a safety shield. The submission aims to demonstrate substantial equivalence to a predicate device, the "TM Safety Needle" (K142765).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided document details non-clinical testing performed against recognized ISO standards. These standards implicitly contain the acceptance criteria for various functional and safety aspects of a hypodermic needle. The report states that the device was "demonstrated to be in conformance" with these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Functional Performance Testing (ISO 7864:2016) | Conforms to ISO 7864 |
| Fragmentation test | Conforms |
| Determination of flow rate | Conforms |
| Penetration force and drag force | Conforms |
| Bonding strength | Conforms |
| Small-bore Connectors (ISO 80369-7:2016) | Conforms to ISO 80369-7 |
| Leakage by pressure decay | Conforms |
| Falling drop positive-pressure liquid leakage | Conforms |
| Subatmospheric-pressure air leakage | Conforms |
| Stress cracking | Conforms |
| Resistance to separation from axial load | Conforms |
| Resistance to separation from unscrewing | Conforms |
| Resistance to overriding | Conforms |
| Needle Tubing (ISO 9626) | Conforms to ISO 9626 |
| Sharps Injury Protection (ISO 23908) | Conforms to ISO 23908 |
| Sharps injury testing per FDA guidance | Conforms |
| Sterility (ISO 11135:2014, ISO 11607-1:2006, ISO 11607:2006, ISO 10993-7:2008) | EO sterilization testing conducted |
| Biocompatibility Testing (ISO 10993-1:2018) | Conforms to ISO 10993-1 |
| Cytotoxicity (ISO 10993-5:2017) | Conforms |
| Sensitization (ISO 10993-10:2017) | Conforms |
| Irritation (ISO 10993-10:2017) | Conforms |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Conforms |
| Pyrogenicity (ISO 10993-4:2017) | Conforms |
| Hemocompatibility (ISO 10993-4:2017) | Conforms |
| Particulate matter testing (USP) | Conforms |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for the functional, sterility, or biocompatibility tests. It only indicates that "the sterile, single lumen hypodermic needles described in this summary were tested." The data provenance is implied to be from Anhui Tiankang Medical Technology Co., Ltd. in China, as they are the submitter and manufacturer. The testing described is prospective, as it was conducted specifically for this submission to demonstrate conformance.
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)
This type of device (hypodermic needle) does not typically involve human expert interpretation for "ground truth" in the way an AI diagnostic device would. The "ground truth" for the tests performed is based on the objective measurements and pass/fail criteria defined by the cited ISO standards and USP. Therefore, no experts in the sense of medical diagnosticians were used to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the assessment of these types of medical devices against performance standards involves objective measurements and predefined pass/fail criteria, not subjective interpretation requiring an adjudication method.
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
No. The TK Safety Needle is a physical medical device, not an AI-powered diagnostic tool, and therefore an MRMC comparative effectiveness study is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As a physical medical device, this question is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the defined specifications and limits set by the referenced international standards (e.g., ISO 7864, ISO 80369-7, ISO 10993, USP). For example, the fragmentation test would have a specific maximum allowable fragmentation, and the flow rate test would have a specified range of acceptable flow rates. The device's performance is measured against these objective, predefined criteria.
8. The sample size for the training set
Not applicable. This device is a physical product and does not utilize a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
§ 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).