(158 days)
The Terumo® Pen Injector Needle 34 is intended for use with a pen injector device for the subcutaneous injection of drugs, including insulin.
The Terumo® Pen Injector Needle 34 is comprised of a double-tapered stainless steel needle cannula that is pointed at both the cartridge interface end, to puncture the cartridge for drug delivery, and the patient interface end, for injection into the patient's body tissue. The patient interface end features a 3-bevel, asymmetrical needle edge.
The cannula tapers from a 29G (0.33 mm) outer diameter at the cartridge interface end to a 34G (0.18 mm) outer diameter at the needle tip (patient interface end). It is normal-walled (min. 0.089 mm inner diameter) at the needle tip, and the internal diameter tapers like the outer diameter (wall thickness is uniform throughout the needle length). The double-pointed needle is attached to a plastic hub which screws on to a compatible pen injector (not supplied with this device).
The needle insertion length (from the glue mount on the hub to the tip of the patient interface end) is 4 mm (5/32"). The length of the needle cartridge side is 6.5 mm (1/4"). The patient interface end (needle tip) is covered by a white plastic needle protector cap (inner needle cap) which is then covered by a clear plastic outer case (outer needle case). The cartridge interface end is then covered with a sealing film.
Just prior to use, the outer needle case is removed and retained for recapping once the injection is completed. The inner needle cap is then removed to expose the needle and the injection administered. After the injection, the user inserts the used needle into the open end of the outer needle case so it can be safely removed from the pen injector and disposed of immediately.
This pen needle device is individually packaged and sterilized by electron beam. It is a manually operated, disposable device intended for single use only.
The provided document is a 510(k) summary for the Terumo® Pen Injector Needle 34. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results of the device meeting specific acceptance criteria in the way an AI/ML device submission would.
Therefore, the information requested in your prompt regarding acceptance criteria and studies (as they relate to AI/ML device performance, such as sample sizes for test sets, ground truth establishment, MRMC studies, standalone performance, etc.) is not present in this document. This document details non-clinical performance and biocompatibility testing for a medical needle, which are distinct from the types of studies typically conducted for AI/ML devices.
However, I can extract the available information regarding the non-clinical tests performed and their general results as presented in the document.
Here's a summary of the available information and a notation on what is not present:
1. A table of acceptance criteria and the reported device performance
The document provides a table of non-clinical tests performed and states whether the device meets the standard or acceptance criteria. Specific numerical acceptance criteria are generally not explicitly stated but are implied by adherence to ISO standards or established criteria based on predicate devices.
| Test | Standard | Reported Device Performance |
|---|---|---|
| Surface finish | ISO 11608-2: 2012, ISO 9626: 1991, A1 2001 | Meets standard |
| Cleanliness | ISO 11608-2: 2012, ISO 9626: 1991, A1 2001 | Meets standard |
| Limits for acidity and alkalinity | ISO 11608-2: 2012, ISO 9626: 1991, A1 2001 | Meets standard |
| Dimensions | ISO 11608-2: 2012, ISO 9626: 1991, A1 2001 | Meets standard |
| Stiffness | ISO 11608-2: 2012, ISO 9626: 1991, A1 2001 | Meets standard |
| Resistance to breakage | ISO 11608-2: 2012, ISO 9626: 1991, A1 2001 | Meets standard |
| Resistance to corrosion | ISO 11608-2: 2012, ISO 9626: 1991, A1 2001 | Meets standard |
| Dimensions for needles | ISO 11608-2: 2012 | Meets standard |
| Determination of flow rate through the needle | ISO 11608-2: 2012 | Meets standard |
| Bond between hub and needle tube | ISO 11608-2: 2012 | Meets standard |
| Needle points | ISO 11608-2: 2012 | Meets standard |
| Freedom from defects | ISO 11608-2: 2012 | Meets standard |
| Lubrication | ISO 11608-2: 2012 | Meets standard |
| Dislocation of measuring point at patient end | ISO 11608-2: 2012 | Meets standard |
| Determination of functional compatibility with needle-based injection systems | ISO 11608-2: 2012 | Meets standard |
| Ease of assembly and disassembly | ISO 11608-2: 2012 | Meets standard |
| Sterility | ISO 11608-2: 2012, ISO 11137-1: 2006 | Meets standard |
| Penetration resistance | Acceptance criteria established based on predicates | Meets acceptance criteria |
| Seal film fitting strength | Acceptance criteria established based on predicates | Meets acceptance criteria |
| Cap-hub fitting strength | Acceptance criteria established based on predicates | Meets acceptance criteria |
Regarding Biocompatibility Testing:
The device underwent biocompatibility testing in accordance with ISO 10993-1 and FDA guidance. All listed tests (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity, Pyrogenicity, Hemolysis, Physicochemical Profile) for non-aged and accelerated-aged devices demonstrated that the device is biocompatible.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes non-clinical performance and biocompatibility tests on the device itself, not on patient data.
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 information is not applicable/provided. The tests are based on conformity to ISO standards and established engineering criteria, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for the non-clinical device performance tests described here.
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
This information is not applicable/provided. MRMC studies are used for evaluating diagnostic or treatment interpretation, often involving AI systems. This submission is for a physical medical device (pen injector needle) and does not involve AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This device is a physical needle and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is based on International Organization for Standardization (ISO) standards and established internal acceptance criteria derived from predicate devices. For biocompatibility, it's based on ISO 10993-1 and FDA guidance.
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable/provided. There is no "training set" for this device.
§ 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).