(84 days)
The CAREO Safety Syringe for U-100 Insulin is a sterile, single-use, disposable, retractable safety syringe which is intended to provide a safe and reliable method for injection of insulin into a patient.
The CAREO Safety Syringe for U-100 Insulin is also intended to prevent needlestick injuries. In addition, when the user breaks the plunger, reuse of the syringe is prevented.
The Life-Shield Products, Inc., CAREO Safety Syringe for U-100 Insulin is a sterile, single use and disposable, 1cc/mL piston syringe, provided with a permanently attached needle in nine product configurations. The CAREO Safety Syringe for U-100 Insulin is similar in appearance, size, materials operation, and purpose to the cited predicate device and other conventional single use, sterile, disposable syringes.
The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria. Instead, it describes a medical device (CAREO Safety Syringe for U-100 Insulin) and its substantial equivalence to predicate devices. The document explicitly states that "Therefore, no new tests are necessary." because the materials, safety features, and functional/performance characteristics are identical to those already verified and validated for other CAREO Safety Syringes in previous 510(k) premarket notifications.
Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.
Here's an attempt to populate the table and answer the questions based on the available information:
Acceptance Criteria and Device Performance
Since the document states "no new tests are necessary" due to substantial equivalence, specific numerical acceptance criteria for the CAREO Safety Syringe for U-100 Insulin are not presented in this 510(k) submission. The acceptance criteria would likely be implied to be "equivalent to the predicate devices" which have already met their respective criteria.
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Material Safety | Equivalent to predicate devices (K030976, K052397, K060208) | Verified and Validated (as per predicate device findings) |
| Biocompatibility | Equivalent to predicate devices (K030976, K052397, K060208) | Verified and Validated (as per predicate device findings) |
| Safety Feature Functionality (Needlestick Prevention) | Equivalent to predicate devices (K030976, K052397, K060208) | Verified and Validated (as per predicate device findings) |
| Safety Feature Functionality (Reuse Prevention - Plunger Break) | Equivalent to predicate devices (K030976, K052397, K060208) | Verified and Validated (as per predicate device findings) |
| Other Functional & Performance Characteristics | Equivalent to predicate devices (K030976, K052397, K060208) | Verified and Validated (as per predicate device findings) |
Study Details:
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Sample size used for the test set and the data provenance:
- No new test set was used for this specific 510(k) submission because "no new tests are necessary." The device's performance is asserted based on its identical characteristics to previously cleared devices. Data provenance for the original predicate devices' testing is not provided in this document.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no new test set was used for this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no new test set was used for this submission.
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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 manual safety syringe, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual safety syringe, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the predicate devices, the ground truth for performance characteristics would have been established through physical testing (e.g., force required for needle retraction, plunger break functionality, material strength, biocompatibility assays). The specific details are not in this document.
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The sample size for the training set:
- Not applicable, as no new training was performed for this 510(k). The basis is substantial equivalence to predicate devices.
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How the ground truth for the training set was established:
- Not applicable, as no new training was performed for this 510(k). The basis is substantial equivalence to predicate devices, implying their ground truth was established through standard testing for medical devices of this type.
§ 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).