(142 days)
Intraosseous Infusion Needles are sterile, disposable devices used primarily during pediatric emergencies as an alternative to unsuccessful intravenous access to allow for effective infusion of resuscitative drugs or fluids.
The Intraosseous Infusion Needles are intended for use as an alternative to intravenous access during pediatric emergencies, permitting infusion of drugs and fluids. Intraosseous Infusion Needles consist of two basic components - the needle (composed of a knob, a stylet luer-lock, and a beveled stylet) and the cannula (comprised of a hub, a base plate, and a cannula shaft). The cannula attaches to the needle by the stylet luer-lock and is supplied attached and ready to use. The Intraosseous Infusion Needles are available in the following configurations:
Intraosseous Infusion Needle (with Dieckmann Modification – Standard Hub Design)
Cannula Gauge: 14, 16, 18
Cannula/Stylet Length (cm): 14 Gauge: 3.0; 16 Gauge: 2.5, 3.0, 4.0; 18 Gauge: 2.5, 3.0
Stylet Length (cm): 14 Gauge: 4.6; 16 Gauge: 4.2 (for 2.5cm cannula), 4.65 (for 3.0cm cannula), 5.65 (for 4.0cm cannula); 18 Gauge: 4.2 (for 2.5cm cannula), 4.65 (for 3.0cm cannula)
Stylet Bevel Style: Trocar
Hub Material: Clear Polycarbonate (for 14 and 16 Gauge), Pink Polycarbonate (for 18 Gauge)
The provided FDA 510(k) clearance letter and summary for the Intraosseous Infusion Needles does not contain the detailed information necessary to answer most of the questions you've posed regarding acceptance criteria and study particulars.
This document focuses on justifying "substantial equivalence" to a predicate device, primarily by demonstrating that changes to the sterilization process do not negatively impact safety or effectiveness. It explicitly states that "No additional performance testing was conducted because the design of the subject device is identical to the predicate, K160887."
Therefore, I can only provide limited information based on the text.
Here's what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or performance metrics for the device's primary function (intraosseous infusion). The "performance testing" described is related only to the sterilization process.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Sterilization Efficacy | Sterility Assurance Level (SAL) of $10^{-6}$ | Not explicitly stated as "met" an acceptance criterion, but the Ethylene Oxide Sterilization Performance Qualification was conducted to validate changes to the sterilization cycle parameters. This implies the SAL of $10^{-6}$ was achieved with the new process. |
| Residuals | Compliance with ISO 10993-7 for Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals | Evaluation of EO and ECH residuals was conducted, implying compliance. |
| Biocompatibility | Identical to predicate in formulation, processing, sterilization method, geometry, and no other chemicals added. | Device is identical to the predicate in these aspects, addressing biocompatibility by proxy with the predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified for any performance testing related to the device's functional use or even for the sterilization validation beyond general statements of "performance testing was conducted."
- Data Provenance: Not specified.
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)
Not applicable. The document does not describe studies requiring expert ground truth for device performance related to patient outcomes or imaging. The testing focuses on sterilization process validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe studies requiring 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 physical medical needle, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical needle, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the sterilization validation, the "ground truth" would be objective laboratory measurements and adherence to international standards (e.g., ANSI/AAMI/ISO 11135 and ISO 10993-7) for sterility and residuals. It's not related to clinical "ground truth" like pathology or outcomes.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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).