Search Results
Found 1 results
510(k) Data Aggregation
(29 days)
The Smart Syringe is to be used with the DyeVert™ Plus Contrast Reduction System or the Contrast Monitoring System. The DyeVert™ Plus Contrast Reduction System is to be used for contrast volume reduction and for the monitoring of radiopaque contrast media during angiographic or CT procedures with the following agents: Iodixanol 270 or 320 mg/l mL, Iohexol 300 or 350 mgl/mL and Iopamidol 370 mg/mL. The Contrast Monitoring System is to be used during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.
The Smart Syringe is a component to the DyeVert™ Plus Contrast Reduction System and Contrast Monitoring System. The Smart Syringe is not intended to be used independently. The Smart Syringe is a control syringe with wireless communication capability to the Osprey Medical DyeVert Plus and Contrast Monitoring Display.
The provided text describes the 510(k) premarket notification for the "Smart Syringe." However, it states that no clinical testing was performed to support this 510(k) Premarket Notification. Therefore, a study proving the device meets acceptance criteria, as typically understood in the context of clinical or standalone algorithm performance, is not available in the provided document.
Instead, the submission relies on non-clinical bench testing and a demonstration of substantial equivalence to a previously cleared predicate device. The acceptance criteria and performance are therefore related to these non-clinical tests.
Here's an analysis based on the provided text, addressing your points where possible, and indicating where information is not available due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance |
|---|---|---|
| Device Performance | Confirmatory device performance testing: flow rate, peak pressure, contrast diversion, monitoring accuracy, fluid ingress, durability testing (cycling), visual verifications to design specifications. Compliance to IEC 60601-1 3.1 edition (electrical safety), IEC 60601-1-2 (2007) (emissions and immunity). | All testing passed and demonstrated product performance met all prior established acceptance criteria. |
| Sterilization | Sterilization validation in accordance with ISO 11135-1:2014, achieving a Sterility Assurance Level of 10⁻⁶. | All testing passed. Sterilization conditions have been validated. |
| Software | Software development process in accordance with IEC 62304:2006. Verification of all software requirement specifications. | All testing passed. |
| Simulated Use (Bench) | Priming, disposable wireless pairing, ease of use (usability), system set-up, device priming ability. Injection pressure, contrast diversion, image analysis testing. | Testing demonstrated no new or different question of safety or effectiveness. |
| Packaging & Shelf Life | Distribution testing per ASTM D4169:2016 (visual inspection, cycle testing, dye leak/penetration test, seal strength test, functional testing). Compliance with ISO 11607 part 1 and 2:2006 (packaging for terminally sterilized medical devices). | All testing passed and demonstrated product performance met all prior established acceptance criteria. Packaging was deemed to be in compliance with ISO 11607 part 1 and 2:2006. |
| Biocompatibility | Testing in accordance with ISO 10993-1:2009: cytotoxicity, sensitization, irritation, acute systemic toxicity, hemocompatibility. | All testing passed and met prior established acceptance criteria. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify the sample sizes for the individual non-clinical tests (e.g., how many syringes were tested for flow rate or durability). It refers to "testing" in a general sense.
- Data Provenance: Not applicable in the context of clinical data. The non-clinical tests were performed by the manufacturer, Osprey Medical, Inc., or leveraged from previous submissions for the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not applicable as no clinical test set requiring expert-established ground truth was used for this 510(k) submission.
4. Adjudication Method for the Test Set
- Not applicable, as no clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical testing was performed to support this 510(k) Premarket Notification."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. The "Smart Syringe" is a physical medical device, a component of a contrast reduction/monitoring system, not an AI algorithm. Its performance is related to its mechanical and electrical functions and its interaction within the larger system.
7. The Type of Ground Truth Used
- For the non-clinical tests, the "ground truth" was established by engineering and quality standards, defined by "prior established acceptance criteria" and adherence to various international standards (e.g., IEC 60601-1, ISO 11135-1, IEC 62304, ASTM D4169, ISO 11607, ISO 10993-1). These standards and internal specifications effectively serve as the "ground truth" for the device's physical, electrical, and biocompatibility performance.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device is not an AI algorithm that requires a "training set."
Summary:
The K171698 submission for the Smart Syringe relied entirely on non-clinical bench testing and adherence to established engineering and regulatory standards to demonstrate substantial equivalence to its predicate device. No clinical data or AI algorithm performance was part of this particular submission. The "acceptance criteria" and "performance" described are related to these non-clinical, quantifiable metrics such as flow rate, pressure, sterilization efficacy, and biocompatibility, as verified against pre-defined specifications and international standards.
Ask a specific question about this device
Page 1 of 1