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510(k) Data Aggregation
(26 days)
Cary is indicated for removal of fluids from the upper airway. The device creates a negative pressure (vacuum) that draws fluids through disposable suction tube that is connected to a disposable collection canister. The fluids are captured in the collection canister for proper disposal. Cary is for use only on the order of a physician or other licensed practitioner (e.g. Emergency Medical Technician in field use).
[Cary] is a handheld, electrically powered medical suction device used to clear the upper airway during emergency care. It consists of a reusable drive unit and disposable collection container (pumpister) and tubing. The drive unit powers a piston pump, creating negative pressure (vacuum) in the disposable collection container. The vacuum draws fluids and other matter through a disposable tubing connected to the container, where they are collected for disposal. The size and shape of the device enable use by one hand, and a rechargeable lithium-ion battery allows field and transport use of the device.
The provided FDA 510(k) clearance letter and summary for the "Cary" device ([K251111](https://510k.innolitics.com/search/K251111)) primarily discuss non-clinical performance testing to demonstrate substantial equivalence to a predicate device. This document does not describe a clinical study (e.g., MRMC or standalone human-in-the-loop study) involving human readers or expert panels for establishing ground truth, as would typically be seen for AI/ML-driven diagnostic devices. Instead, the testing focuses on the physical and functional performance of the suction pump itself against recognized consensus standards.
Therefore, many of the requested points regarding clinical study design, expert panels, ground truth, and MRMC studies are not applicable based on the provided text.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several non-clinical tests with implied or explicit acceptance criteria based on industry standards and comparison to the predicate device.
| Test Category | Acceptance Criteria (Implied/Explicit from Standards/Predicate) | Reported Device Performance |
|---|---|---|
| Operating Position | Ability to operate in any spatial orientation. | Confirmed. |
| Protection Devices | Compliance with overfill protection and reverse flow protection. | Results within acceptance criteria. |
| Noise Level | Unspecified standard, implied safe/acceptable level. | 70.5 dB. "Within the acceptance criteria apart from 0.5dB excess when the suction tip was blocked. This is considered as an acceptable deviation from the standard requirement as it does not decrease the safety or effectiveness of the subject device when compared to the predicate device." |
| Air Leakage | As per standard requirements for general use suction equipment. | Results within acceptance criteria. |
| Vacuum Levels & Free Air Flow | Within acceptance criteria for High vacuum/high flow and Low vacuum/low flow (similar to predicate: High vacuum <600 mmHg vs <550 mmHg; Low vacuum ≤100 mmHg vs 50 mmHg; High flow ≥ 20 l/min vs 30 l/m). | Results within acceptance criteria. Suction performance "similar to LCSU 4". |
| Pharyngeal Suction Equipment | Ability to evacuate ≥ 200 ml of simulated vomitus in ≤ 10 s. | Results within acceptance criteria. |
| Reprocessing Validation | Appropriateness of manual reprocessing process; user ability to carry out instructions. | Outcome within acceptance criteria. |
| Biocompatibility | Compliance with ISO 10993 standards for cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyrogenicity. | Confirmed for direct-contact materials. |
| Software | Compliance with IEC 62304 and FDA guidance for software functions, classified as Class B. | Verification and validation conducted, documentation provided as recommended. (Specific performance metrics are not applicable here as it's about compliance, not a clinical outcome). |
| EMC and Electrical Safety | Compliance with IEC 60601-1-2 and IEC 60601-1 series. | Confirmed. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical, laboratory-based testing of the device's physical and functional performance, not a clinical study involving a dataset of patient cases. Therefore, "sample size for the test set" and "data provenance" in the context of patient data are not applicable. The tests were performed on the device prototypes/production samples in controlled laboratory environments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of device performance testing for a suction pump, refers to established engineering specifications, physical laws, and recognized standards (e.g., ISO 10079-1). There are no "experts" in the sense of medical professionals interpreting patient data to establish ground truth for this type of device.
4. Adjudication Method for the Test Set
Not applicable. As this is non-clinical performance testing against engineering standards, an adjudication method for conflicting interpretations of medical data is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly describes non-clinical testing and comparison to a predicate device based on device performance metrics (e.g., vacuum levels, flow rates, noise), not on human reader performance with or without AI assistance. This device is a powered suction pump, not an AI diagnostic/imaging device that would typically undergo MRMC studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The device is a mechanical suction pump, not an AI algorithm. Its performance is inherent to its physical design and operation, not an output from an algorithm in the typical AI sense.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical tests is based on:
- Recognized Consensus Standards: e.g., ISO 10079-1, ISO 10079-4, IEC 62304, ISO 10993, IEC 60601 series.
- Engineering Specifications: Explicit performance requirements (e.g., ≥ 20 l/min flow rate, < 1 kPa air leakage).
- Comparison to Predicate Device Performance: Establishing equivalence or superiority in key performance areas.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/ML device that requires machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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