(113 days)
The UltiCare Safety Insulin Syringe is intended to inject U-100 insulin into the body. The safety mechanism aids in the prevention of needle stick injuries.
The UltiCare Safety Insulin Syringe is a standard piston type syringe with permanently attached (uni-body) needle and protective shield. These syringes are sterile, single-use, disposable piston syringes consisting of a syringe barrel calibrated in units of insulin (U-100), plunger rod with gasket, permanently attached single lumen needle, needle cap, and protective shield. The UltiCare Safety Insulin Syringes are non-toxic and non-pyrogenic, and will be available in numerous sizes and combinations between the smallest (0.3 ml x 31G x 5/16 ") and the largest (1 ml x 29G x 1/2 ").
The UltiCare™ Safety Insulin Syringe is a traditional 510(k) premarket notification for a medical device. As such, the submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a rigorous study proving that the device meets specific acceptance criteria in the manner of a clinical trial for a novel drug or a complex diagnostic AI.
Here's an analysis of the provided information based on your requested criteria, highlighting why some information is absent due to the nature of a 510(k) for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device (UltiCare™ Safety Insulin Syringe), the "acceptance criteria" are not reported as specific performance metrics in a clinical context (e.g., sensitivity, specificity for a diagnostic AI). Instead, they are compliance with recognized voluntary standards and FDA guidance documents, along with equivalence to predicate devices. The "reported device performance" is the successful testing against these standards and the assertion of substantial equivalence.
| Acceptance Criteria (Standards/Guidance) | Reported Device Performance |
|---|---|
| ISO 7864: Sterile hypodermic needles for single use. | Designed and successfully tested to meet applicable requirements. |
| ISO 8537: Sterile single-use syringes, with or without needle, for insulin. | Designed and successfully tested to meet applicable requirements. |
| ISO 9626: Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods. | Designed and successfully tested to meet applicable requirements. |
| Voluntary Standards and FDA Guidance Documents applicable to subject and predicate devices. | Results of non-clinical testing support substantial equivalence. |
| Biocompatibility: (based on material equivalence) | Uses same materials, dyes/inks, manufacturing process, adhesives, and sterilization process/cycle as previously cleared device (K080600), excluding orange colorant of needle cap, thus additional testing not required. |
| Sterilization: ISO 11135 (Sterilization of health care products – Ethylene oxide) | Validated using the Half Cycle method. |
| Residue Levels (Ethylene Oxide/Ethylene Chlorohydrin): ISO 10993-7 | Maximum levels will not exceed limits in standard. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific tests (e.g., how many syringes were tested for each ISO standard). This detail is typically found in the full test reports, not a 510(k) summary. For physical devices like syringes, testing generally involves a representative sample size to ensure statistical validity, as specified by the testing standards themselves.
- Data Provenance: The data appears to be pre-market, non-clinical bench testing data conducted by the manufacturer (UltiMed Inc.) or its designated testing facilities in the United States (based on company location and communication with the FDA).
- Retrospective or Prospective: This would be considered prospective in the sense that the testing was specifically performed to support this 510(k) submission for the new device configuration. However, it's not a clinical study on human subjects, so "prospective" here refers to the testing being planned and executed for this regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable (N/A) in the context of this 510(k) submission. "Ground truth" established by experts (e.g., radiologists, pathologists) is relevant for diagnostic devices or AI, where human interpretation is the gold standard. For a physical device like a safety syringe, compliance with engineering standards and functionality is often assessed through mechanical and physical testing performed by technicians and engineers, rather than expert clinical consensus as a "ground truth." The "ground truth" here is the performance specifications defined by the ISO standards.
4. Adjudication Method for the Test Set
- This information is not applicable (N/A) for this type of device and submission. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert review processes, particularly for diagnostic devices or endpoint determination. The performance of the syringe against ISO standards is determined by objective measurements and technical assessment, not expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable (N/A). An MRMC study is relevant for diagnostic interpretation, typically involving multiple human readers interpreting cases (e.g., medical images) to assess accuracy and inter-reader variability, often in the context of AI assistance. This device is a physical medical instrument (syringe), not a diagnostic tool, so an MRMC study would not be performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable (N/A). This concept is specific to AI/algorithm performance. The UltiCare Safety Insulin Syringe is a mechanical device, not an algorithm.
7. Type of Ground Truth Used
- The "ground truth" for this device's performance is compliance with international voluntary standards (ISO 7864, ISO 8537, ISO 9626) and FDA guidance documents. These standards define the expected performance characteristics, materials, and safety features for syringes. The testing performed verifies that the device meets these pre-defined, objectively measurable criteria.
8. Sample Size for the Training Set
- Not applicable (N/A). "Training set" refers to data used to train an AI algorithm. This device does not involve an AI algorithm; its design and manufacturing are based on established engineering principles and material science.
9. How the Ground Truth for the Training Set Was Established
- Not applicable (N/A). As there is no AI algorithm, there is no training set and therefore no ground truth establishment for a training set. The design of the syringe and its safety features are based on engineering specifications and the requirements outlined in the relevant ISO standards, which have been established through consensus and research over time by international standards organizations.
In summary: The UltiCare™ Safety Insulin Syringe 510(k) submission effectively demonstrates substantial equivalence by showing that its design, function, and materials are similar to predicate devices, and that it successfully meets the requirements of applicable recognized industry standards for safety and performance through non-clinical testing. The concepts of "acceptance criteria," "ground truth," and various study methodologies like MRMC or standalone performance are applied differently or are not directly relevant when evaluating a physical medical device for 510(k) substantial equivalence.
§ 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).