(113 days)
The CAREO 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 Safety Syringe aids in the prevention of needlestick injuries. In addition, when the user breaks the plunger, the CAREO Safety Syringe reduces the possibility of syringe reuse.
The Life-Shield Products, Inc., CAREO Safety Syringe is a sterile, single use and disposable, 3, 5, 10 mL piston syringe, provided with a permanently attached needle in twelve product configurations. The CAREO Safety Syringe is similar in appearance, size, materials, operation, and purpose to the cited predicate device and other conventional single use, sterile, disposable syringes.
The provided 510(k) summary for the CAREO Safety Syringe describes several aspects of the device and its testing but does not explicitly state specific acceptance criteria or an overarching study designed to prove the device meets those criteria in the typical format of a clinical trial for AI/software devices. This document is from 2005, predating the widespread use and regulatory frameworks for AI-driven medical devices.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various tests and conformity to standards.
Here's an attempt to extract and interpret the information based on the provided text, acknowledging that many requested fields may not be directly applicable or explicitly stated in this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit numerical acceptance criteria for performance metrics are not stated in the provided document, we infer them from the nature of the tests conducted and the claim of substantial equivalence. The "reported device performance" is a general statement about meeting specifications rather than specific metrics.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Physiochemical Compatibility (Equivalent to predicates) | CAREO Safety Syringe, SafePro*, SECUREGARD®, and CAREO Retractable Safety Syringe are equivalent. |
| Biocompatibility (As per applicable standards) | Device meets biocompatibility requirements (implied by "biocompatibility testing"). |
| Standard Conformity (Meets applicable medical device standards) | Device conforms to relevant standards (implied by "standard conformity testing"). |
| Simulated Use Performance (Performs according to specification) | Simulated use testing has demonstrated that the CAREO Safety Syringe performs according to specification. |
| Indications for Use Support (Testing supports claimed indications) | Testing supports the claimed Indications for Use, including prevention of needlestick injuries and reduction of syringe reuse. |
| Substantial Equivalence (Similar intended use, design, technological/operational characteristics to predicates) | Demonstrated substantial equivalence to SafePro* (K012726), SECUREGARD® (K012121), and CAREO Retractable Safety Syringe (K030976) based on similarities in intended use, design, technological and operational characteristics. |
| Sterility (Provided sterile) | Syringe is provided sterile, single-use, and disposable. |
| Prevention of Needlestick Injuries (Aids in prevention) | Aids in the prevention of needlestick injuries. |
| Reduction of Syringe Reuse (Reduces possibility when plunger is broken) | Reduces the possibility of syringe reuse when the user breaks the plunger. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for any of the described tests (physiochemical, biocompatibility, standard conformity, simulated use). It only mentions "Testing provided in this premarket notification includes..." The data provenance (country of origin, retrospective/prospective) is also not specified for these tests. Given the nature of a 510(k) for a physical medical device like a syringe, these tests would typically be laboratory or bench tests rather than clinical studies with human patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This concept is not relevant or applicable to the type of device (a safety syringe) and the testing described in this 510(k) submission. "Ground truth" established by experts is typically associated with diagnostic AI/imaging devices.
4. Adjudication Method for the Test Set
Not applicable. The tests described are laboratory/bench tests, not clinical studies requiring expert adjudication methods like 2+1 or 3+1.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is specifically for evaluating the effectiveness of AI with human readers, typically in image interpretation. The device is a physical safety syringe, not an AI or imaging device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, this is not an AI or software algorithm. The "performance" relates to the physical and functional aspects of the syringe itself.
7. Type of Ground Truth Used
The "ground truth" for the tests mentioned (physiochemical, biocompatibility, standard conformity, simulated use) would be based on:
- Scientific principles and material properties for physiochemical compatibility.
- Established biological safety standards for biocompatibility.
- Recognized industry standards (e.g., ISO for medical devices) for standard conformity.
- Pre-defined performance specifications for simulated use testing.
It is not based on expert consensus, pathology, or outcomes data in a clinical sense for this device.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device 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 physical 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).