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510(k) Data Aggregation
(63 days)
The CAREO Retractable Safety Syringe is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection.
The CAREO Retractable Safety Syringe aids in the prevention of needlestick injuries. In addition, when the user breaks the plunger, the CAREO Retractable Safety Syringe reduces the possibility of syringe reuse.
The Life-Shield Products, Inc., CAREO Retractable Safety Syringe is a sterile, single-use and disposable, 3 mL piston syringe, provided with a permanently attached needle in eight product configurations. The CAREO Retractable Safety Syringe is similar in appearance, size, materials, operation, and purpose to the cited predicate device and other conventional single-use, sterile, disposable syringes.
Here's a breakdown of the acceptance criteria and study information for the Life-Shield Products, Inc. CAREO Ret retractable Safety Syringe, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it refers to "specifications" for the simulated use testing. However, it does provide a statement of performance against these implied criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performs according to specification (for simulated use) | "Simulated use testing using 500 syringes demonstrates that the CAREO Retractable Safety Syringe performs according to specification." |
| Equivalence to predicate device (side-by-side testing) | "Side-by-side testing of the CAREO Retractable Safety Syringe and the SECUREGARD® Ret retractable Safety Syringe shows that the two products are equivalent." |
| Biocompatibility | Testing provided in this premarket notification includes biocompatibility. (No specific performance data given, but implies successful testing against relevant standards). |
| Packaging Integrity | Testing provided in this premarket notification includes packaging integrity. (No specific performance data given, but implies successful testing against relevant standards). |
| Standards Conformity | Testing provided in this premarket notification includes standards conformity. (No specific performance data given, but implies successful testing against relevant standards). |
| Supports Claimed Indications for Use (e.g., prevention of needlestick injuries, reduction of syringe reuse) | "Testing also supports the claimed Indications for Use." (No specific quantitative data, but implies successful demonstration of these functionalities through testing). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): 500 syringes were used for the "Simulated use testing."
- Data Provenance: The document states the sponsor is "Life-Shield Products, Inc. 3F, No. 10, Wuchiuan 7th Rd Wugu Shiang Taipei 248 Taiwan, ROC". This suggests the data originates from Taiwan. The study is implicitly prospective as it involves new testing of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish a ground truth for the simulated use testing. The "ground truth" for this type of device likely relies on engineering specifications and direct observation of the device's mechanical function, rather than expert interpretation of data.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned, as the study described is a performance test against specifications, not a comparative study with subjective outcomes.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation is a key factor. This device is a medical instrument where performance is largely objective and mechanical.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The concept of "standalone" performance (algorithm only) is not applicable here as the device is a physical syringe, not an algorithm or AI. The simulated use testing can be considered a standalone performance assessment of the device itself (without human-in-the-loop in a comparative sense, but of course with a human operating the syringe in the simulation).
7. The Type of Ground Truth Used:
For the "Simulated use testing," the "ground truth" would be the engineering specifications and functional requirements for the syringe. The testing observed whether the syringe performed its intended actions (e.g., needle retraction, plunger breakage) correctly and consistently, as defined by its design specifications. For the "Side-by-side testing," the ground truth was the performance of the predicate device (SECUREGARD® Ret retractable Safety Syringe) against which the CAREO syringe was compared for equivalence.
8. The Sample Size for the Training Set:
The document does not mention a "training set" in the context of device development or testing. This term is typically used in machine learning or AI development. The testing described is for a physical medical device.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" in the context of this device's testing, how its ground truth was established is not applicable.
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