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510(k) Data Aggregation
(175 days)
The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non-invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications.
The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively.
The VOCSN unified respiratory support system is a mechanical ventilator which combines additional conventional therapies into a single device. Additional therapies include oxygen, cough assist, and suction.
The device description will be broken down by therapy; i.e., ventilation, oxygen concentration and delivery, cough assist, and suction.
The provided text describes a medical device, the VOCSN Unified Respiratory System, and its various components, along with comparisons to predicate devices and adherence to performance standards. However, it does not describe a study involving an AI algorithm's performance or human reader improvements. Therefore, I cannot provide details on sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC studies, as these elements are not present in the document.
Instead, the document focuses on the VOCSN Unified Respiratory System's regulatory submission (510(k)) to the FDA, demonstrating its substantial equivalence to previously cleared medical devices. This involves non-clinical performance testing against user and product requirements and compliance with international standards.
I will structure the answer based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance (as derived from the text):
The acceptance criteria are generally framed as compliance with specific international and FDA guidance standards, as well as meeting internal User Requirements and Product Requirements Specifications. The "reported device performance" is essentially the statement that the device is compliant with these standards and requirements, and that verification/validation testing was successfully completed. Specific quantitative performance targets are not always explicitly stated in the summary but are implied by compliance with the referenced standards.
Ventilation Component:
| Acceptance Criteria (Standards/Requirements) | Reported Device Performance |
|---|---|
| ISO 80601-2-12 (Critical care ventilators) | Compliant |
| ASTM F1246 (Home care ventilators) | Compliant |
| ISO 5356-1 (Conical connectors) | Compliant |
| ISO 80601-2-55 (Respiratory gas monitors) | Compliant |
| ISO 27427 (Nebulizing system) | Compliant |
| ISO 5367 (Breathing sets and connectors) | Compliant |
| IEC 60601-1 (Medical electrical equipment) | Compliant |
| IEC 60601-1-2 (Electromagnetic compatibility) | Compliant |
| IEC 60601-1-11 (Medical devices for home use) | Compliant |
| IEC 60601-1-8 (Alarm system) | Compliant |
| Biocompatibility (VOC analysis, particulate matter, CO2, CO, Ozone) | Compliant |
| Biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, bacterial reverse mutation genotoxicity, chemical characterization with risk assessment for gas pathway with humidification/aerosolized meds) | Compliant |
| User Requirements Document | Performance validated |
| Product Requirements Specification | System performance verified |
Oxygen Concentrator Component:
| Acceptance Criteria (Standards/Requirements) | Reported Device Performance |
|---|---|
| ISO 80601-2-69 (Oxygen concentrators) | Compliant |
| ISO 80601-2-67 (Oxygen conserving equipment) | Compliant |
| IEC 60601-1 (Medical electrical equipment) | Compliant |
| IEC 60601-1-2 (Electromagnetic compatibility) | Compliant |
| IEC 60601-1-11 (Medical devices for home use) | Compliant |
| IEC 60601-1-8 (Alarm system) | Compliant |
| Biocompatibility (as listed in Ventilation section) | Compliant |
| User Requirements Document | Performance validated |
| Product Requirements Specification | System performance verified |
Cough Assist Component:
| Acceptance Criteria (Standards/Requirements) | Reported Device Performance |
|---|---|
| IEC 60601-1 (Medical electrical equipment) | Compliant |
| IEC 60601-1-11 (Medical devices for home use) | Compliant |
| IEC 60601-1-8 (Alarm system) | Compliant |
| Biocompatibility (as listed in Ventilation section) | Compliant |
| User Requirements Document | Performance validated |
| Product Requirements Specification | System performance verified |
Suction Component:
| Acceptance Criteria (Standards/Requirements) | Reported Device Performance |
|---|---|
| FDA Guidance Document for Powered Suction Pump 510(k)s | Compliant |
| ISO 10079-1 (Electrically powered suction equipment) | Compliant |
| IEC 60601-1 (Medical electrical equipment) | Compliant |
| IEC 60601-1-11 (Medical devices for home use) | Compliant |
| IEC 60601-1-8 (Alarm system) | Compliant |
| User Requirements Document | Performance validated |
| Product Requirements Specification | System performance verified |
Heated Wire Patient Circuit Accessory:
| Acceptance Criteria (Standards/Requirements) | Reported Device Performance |
|---|---|
| ISO 10993-1 (Biological Evaluation) | Compliant |
| ISO 8185 (Respiratory tract humidifiers for medical use) | Compliant |
| ISO 5356-1 (Conical connectors) | Compliant |
| ISO 5367 (Breathing sets and connectors) | Compliant |
| IEC 60601-1 (Medical Electrical Equipment) | Complies with applicable parts |
| Condensate control over wide range | Demonstrated |
| Resistance to airflow (ISO 8185 / ISO 5367) | Compliant |
| Patient leakage current (IEC 60601-1) | Compliant |
| Biocompatibility (as listed in Ventilation section) | Compliant |
| User Requirements Document | Performance validated |
| Product Requirements Specification | System performance verified |
Bacteria Filter Accessory:
| Acceptance Criteria (Standards/Requirements) | Reported Device Performance |
|---|---|
| ISO 5356-1 (Conical connectors) | Compliant |
| 99.99% BFE & VFE Filtration efficiency | Achieved |
| Resistance @ 30 lpm (0.4 cmH2O) | Achieved |
| Biocompatibility (as listed in Ventilation section) | Compliant |
| User Requirements Document | Performance validated |
| Product Requirements Specification | System performance verified |
Regarding AI-specific questions:
The provided document describes a physical medical device (VOCSN Unified Respiratory System), not an AI algorithm. Therefore, the following information is not present in the text:
- Sample size used for the test set and the data provenance: Not applicable as no AI test set is described. The device performance was validated and verified through simulated use conditions and testing against various standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Device validation and verification typically involve engineering and clinical experts during the design and testing phases, but not specifically for establishing "ground truth" in the context of an AI model's performance.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is relevant for AI-assisted human reading tasks, which is not the subject of this document.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable. The "ground truth" here is compliance with engineering specifications and regulatory standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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