(150 days)
The syringe, as supplied, is a device with a small barrel, plunger and fixed needle, calibrated in units of insulin (U-100), to be used to administer (infuse) insulin subcutaneously. It incorporates features that include reuse prevention and sharps injury prevention.
The 1mL Unitract® Insulin Syringe is a sterile, fixed needle, single use, syringe, consisting of a barrel and plunger assembly. The syringe is supplied in two needle sizes, being 27G x ½" and 29G x ½".
The devices function in a manner similar to standard syringes for filling and mixing insulin and subcutaneous injection, but also incorporates a sharps injury prevention (automatic needle retraction) and reuse prevention (auto disable) feature.
The syringe, as supplied, is a device with a small barrel, plunger and fixed needle, calibrated in units of insulin (U-100), to be used to administer (infuse) insulin subcutaneously. It incorporates features that include reuse prevention and sharps injury prevention.
The sharps injury prevention feature allows for automatic and full retraction of the needle into the syringe barrel immediately after the full dose has been expelled; where the rate of retraction may be controlled by the user. The reuse prevention feature also engages immediately after retraction, which prevents further movement of the plunger in either direction.
The provided text describes a Special 510(k) Summary for the 1mL Unitract® Insulin Syringe. It outlines the device's characteristics, indications for use, and a summary of performance tests conducted to establish substantial equivalence to a predicate device.
However, the document does not provide the detailed acceptance criteria or the specific results of a study in a tabular format as requested. Instead, it offers a general statement about mechanical performance, chemical testing, biocompatibility testing, and sterilization validation.
Therefore, I cannot fully complete the requested table or answer all direct questions about study specifics (like sample sizes, ground truth establishment, or expert involvement) as this information is not present in the provided text.
Here is an attempt to structure the available information regarding acceptance criteria and reported device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Aspect | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Meets design specifications based on the requirements of the FDA Consensus Standard and voluntary standards. This would encompass aspects like plunger force, needle security, leak prevention, etc., though specific numerical criteria are not detailed. | "Mechanical performance tests were conducted to verify the device meets design specifications based on the requirements of the FDA Consensus Standard and the voluntary standards." (General statement of compliance, no specific values or thresholds reported). |
| Safety Features | Specific criteria for peak activation forces of the retraction mechanism, spring reaction forces, and forces to override the auto-disable feature. (Specific numerical criteria are not detailed). | "Additional performance testing was conducted on the safety features relating to peak activation forces of the retraction mechanism, spring reaction forces and forces to override the auto disable feature." (General statement of testing, no specific values or thresholds reported, but implies these aspects were evaluated and found acceptable). |
| Biocompatibility | Materials in the fluid path meet USP Class VI requirements. Cytotoxicity and pyrogenicity levels must be acceptable. | "Biocompatibility testing of the finished devices included Cytotoxicity and Pyrogens; with all materials in the fluid path meeting USP Class VI requirements." (All materials met USP Class VI, suggesting acceptable cytotoxicity and pyrogenicity). |
| Chemical Residues | Acceptable levels for Reducing (Oxidisable) Matter, Extractable Trace Metals, Non-Volatile Residue, pH, and chemical residues (EO Sterilization). (Specific numerical criteria are not detailed). | "Chemical testing included Reducing (Oxidisable) Matter, Extractable Trace Metals, Non-Volatile Residue, pH and chemical residues (EO Sterilisation)." (General statement of testing, no specific values or thresholds reported, but implies these aspects were evaluated and found acceptable). |
| Sterilization Assurance | Sterilization processes validated to European Standard DIN EN 550:1994, Sterilisation of medical devices - Validation and routine control of ethylene oxide sterilisation to achieve a sterility assurance level (SAL) of 10⁻⁶. | "Sterilisation processes are validated to European Standard DIN EN 550:1994, Sterilisation of medical devices - Validation and routine control of ethylene oxide sterilisation to a sterility assurance level (SAL) of 10⁻⁶." (Successfully validated to the specified standard and SAL). |
| Manufacturing Control | Functional, chemical, and biological tests performed on each production lot number. | "Manufacturing process control requires functional, chemical and biological tests be performed on each production lot number." (Indicates adherence to process controls throughout manufacturing). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text for any of the performance tests.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests were conducted internally by Unilife Medical Solutions Limited, based in Lewisberry, PA, USA.
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 information is generally not applicable to the performance testing of a physical medical device like a syringe, which relies on objective measurements against engineering and biological standards, rather than expert interpretation of data like in an AI/imaging study. No experts are mentioned in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable; adjudication methods are typically used for subjective assessments (e.g., in clinical trials or AI studies) where consensus among experts is needed for ground truth. The tests described are objective, physical, chemical, and biological measurements.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study applies to diagnostic imaging or AI-assisted diagnostic tools, not to the performance validation of a medical syringe. The device described does not involve "human readers" interpreting data or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done. This concept is relevant to AI algorithms, which is not what this submission is about. The device is a physical syringe, and its performance is evaluated through material, mechanical, and biological testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance tests would be defined by established engineering standards, FDA Consensus Standards, voluntary industry standards (e.g., DIN EN 550:1994 for sterilization), and USP Class VI requirements for biocompatibility. For mechanical tests, the "ground truth" is whether the device meets specified force, dimension, or functional parameters. For chemical and biological tests, it's whether results fall within acceptable limits defined by regulatory and material science standards.
8. The sample size for the training set
- Not applicable. The submission describes a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this device.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).