(42 days)
The CAREO Safety Syringe 1cc/mL 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 CARFO Safety Syringe 1cc/mL 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 1cc/mL is a sterile, single use and disposable, 1cc/mL piston syringe, provided with a permanently attached needle in fifteen product configurations. The CAREO Safety Syringe 1cc/mL 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 describes a medical device (CAREO Safety Syringe 1cc/mL) seeking 510(k) premarket notification. The filing focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study. Therefore, much of the requested information about acceptance criteria, study details, and AI-specific aspects (MRMC, standalone algorithm) is not applicable or cannot be extracted from this document.
Here's a breakdown of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a formal table of acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it is equivalent to the legally marketed predicate devices.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device materials are biocompatible (e.g., non-toxic, non-irritating, non-sensitizing). | Testing provided in the premarket notification includes biocompatibility. (Specific results not detailed in this excerpt). |
| Packaging Integrity | Packaging maintains sterility and integrity until use. | Testing provided in the premarket notification includes packaging integrity. (Specific results not detailed in this excerpt). |
| Standards Conformity | Device conforms to relevant industry standards (not specified, but implicit for medical devices). | Testing provided in the premarket notification includes standards conformity. (Specific results not detailed in this excerpt). |
| Simulated Use Performance (Safety Syringe Functionality) | Device performs its intended functions for intramuscular and subcutaneous injection, prevents needlestick injuries, and prevents reuse after plunger breakage, similar to predicate devices. | "Simulated use testing has demonstrates that the CAREO Safety Syringe performs according to specification." |
| Equivalence to Predicate | The CAREO Safety Syringe 1cc/mL exhibits similar performance, safety, and effectiveness to its predicate devices for its stated intended use. | "Side-by-side testing of the CAREO Safety Syringe 1cc/mL and the 1cc SafePro* Safety Syringe shows that the two products are equivalent." |
| Indications for Use Support | Testing supports the claimed indications for use. | "Testing also supports the claimed Indications for Use." |
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not explicitly stated. The document mentions "Side-by-side testing of the CAREO Safety Syringe Icc/mL and the 1cc SafePro* Safety Syringe" and "Simulated use testing," but does not specify the number of syringes or tests conducted.
- Data provenance: Not explicitly stated. It is implied that the testing was conducted by or for Life-Shield Products, Inc. (Taiwan, R.O.C.). The nature of the testing (simulated use, side-by-side comparison) suggests it would be prospective data collection for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable. This type of device (a syringe) typically does not involve expert-reviewed "ground truth" in the way an imaging diagnostic device would. Performance is assessed through engineering tests and simulated use.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication method: Not applicable. As there are no "experts" establishing a subjective ground truth, there is no need for an adjudication method like 2+1 or 3+1. Performance is based on objective measurements and observations during testing.
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:
- MRMC study: No. This is a physical medical device (syringe), not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone algorithm performance: No. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Type of ground truth: Not applicable in the context of expert consensus or pathology for diagnostic interpretation. For this device, the "ground truth" for performance is established by objective engineering specifications, observed mechanical functionality in simulated use, and compliance with relevant standards. The primary "ground truth" for regulatory approval is the performance and characteristics of the legally marketed predicate devices, against which substantial equivalence is claimed.
8. The sample size for the training set:
- Sample size for the training set: Not applicable. This document does not describe the development or training of an AI algorithm; it is for a physical medical device.
9. How the ground truth for the training set was established:
- Ground truth for the training set: Not applicable.
§ 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).