(160 days)
The MEDT Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
The proposed device, MEDT Pen Needle, is a single-use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. It consist of three components, which are (1) needle, (2) hub and (3) inner sheath; it is sealed in a package consists of (1) a outer sheath and (2) Tyvek Paper.
The provided text describes the 510(k) summary for the MEDT Pen Needle, focusing on its substantial equivalence to a predicate device rather than a study proving the device meets acceptance criteria in the context of an AI/ML medical device. The document outlines non-clinical tests conducted to demonstrate the device meets design specifications and complies with relevant standards.
Therefore, many of the requested categories for AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this submission, as it pertains to a physical medical device (hypodermic needle) and not an AI/ML algorithm.
However, I can extract the acceptance criteria and reported performance based on the non-clinical tests mentioned.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Item | Reported Device Performance | Relevant Standard |
|---|---|---|
| Physical, Mechanical, and Chemical Tests | ||
| Materials, Surface finish, Cleanliness | Complies with relevant ISO standards | ISO 7864:1993, ISO 9626:1991 AMD 2001, ISO 11608-2:2012 |
| Limits for acidity and alkalinity | Complies with relevant ISO standards | ISO 7864:1993 |
| Size designation, Dimensions | Complies with relevant ISO standards (Needle gauges: 29G, 30G, 31G, 32G; 12 different needle dimensions) | ISO 7864:1993, ISO 9626:1991 AMD 2001, ISO 11608-2:2012 |
| Stiffness, Resistance to breakage | Complies with relevant ISO standards | ISO 7864:1993, ISO 9626:1991 AMD 2001 |
| Resistance to corrosion | Complies with relevant ISO standards | ISO 7864:1993 |
| Limits for extractable metals | Complies with relevant ISO standards | ISO 9626:1991 AMD 2001 |
| Colour coding, Needle hub, Sheath | Complies with relevant ISO standards | ISO 11608-2:2012 |
| Needle tube, Needle point, Performance | Complies with relevant ISO standards | ISO 7864:1993, ISO 11608-2:2012 |
| Determination of flow rate through the needle | Complies with relevant ISO standards | ISO 7864:1993 |
| Bond between hub and needle tube | Complies with relevant ISO standards | ISO 7864:1993 |
| Freedom from defects, Lubrication | Complies with relevant ISO standards | ISO 7864:1993 |
| Dislocation of measuring point at patient end | Complies with relevant ISO standards | ISO 11608-2:2012 |
| Functional compatibility with pen injectors | Compatible with NovoPen Echo, HumaPen Luxura (Same as predicate) | ISO 11608-2:2012 |
| Ease of assembly and disassembly | Complies with relevant ISO standards | ISO 11608-2:2012 |
| Sterile Barrier Packaging Testing | ||
| Seal Strength | Complies with ASTM F88/F88M-09 | ASTM F88/F88M-09 |
| Sterilization and Shelf Life Testing | ||
| EO residue, ECH residue | Complies with ISO 10993-7:2008 | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | Complies with USP 37-NF 32 , 20 EU per product | USP 37-NF 32 |
| Shelf Life Evaluation | Verified claimed shelf life through accelerated aging; Physical, Mechanical, Chemical, Package tests | |
| Sterility Test | Performed per USP 38-NF 33 , SAL: 10-6 | USP 38-NF 33 |
| Biocompatibility Testing | ||
| Cytotoxicity test | No cytotoxicity | ISO 10993-5:2009 |
| Intracutaneous Reactivity test | No Intracutaneous reactivity | ISO 10993-10:2010 |
| Skin Sensitization Test | No significant evidence of sensitization | ISO 10993-10:2010 |
| Acute Systemic Toxicity Test | No systemic toxicity | ISO 10993-11:2006 |
| Hemolysis Test | No evidence of hemolysis | ASTM F 756-13 |
| Pyrogen Test | No pyrogen | USP 38-NF 33 |
| Labeling | Conforms with 21 CFR 801 | 21 CFR 801 |
Inapplicability to AI/ML Device Study Criteria:
The provided document is a 510(k) summary for a physical medical device (hypodermic pen needle), not an AI/ML medical device. Therefore, the following requested information related to AI/ML device studies is not applicable and not found within the document:
- Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical samples of the device undergoing laboratory testing, not a dataset for algorithm evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through compliance with engineering standards and laboratory measurements.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML. The "ground truth" for this device is based on established engineering and biocompatibility standards, and physical measurements.
- The sample size for the training set: Not applicable.
- 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).