(247 days)
The Carecube is a patient isolation unit (PIU) designed for the temporary isolation of patients within a hospital setting to prevent particulate (biological) cross-contamination between user and patient, while enclosing the contaminated patient from the external environment. Device should only be used in a hospital setting. This is for temporary housing of a patient prior to transfer to an appropriate hospital destination. Transfer to a more permanent hospital setting should occur as soon as possible. The Carecube is designed with features that enable low-moderate complexity medical interventions. This includes the following procedures: blood draw, medication administration, palpating abdomen, cardiac auscultation, and connection to IV line/monitoring cables.
The Carecube Negative Pressure Isolation Chamber is a modular, negative pressure, isolation patient care system with both reusable and disposable components that can rapidly augment capacity to care for airborne infectious diseases and other biological threats for common patient care protocols with features built into the unit to allow ease of execution. The device is intended to be used indoors, in a hospital setting, as a temporary isolation of patients with suspected or confirmed diagnosis of infectious disease to prevent Healthcare Practitioners (HCP) exposure to pathogenic biological airborne particulates and is designed with features that enable low-moderate complexity medical interventions.
This document describes the Carecube Negative Pressure Isolation Chamber, a patient isolation unit (PIU), and its assessment for substantial equivalence to a predicate device. This device is not an AI/ML powered device, so an analysis of acceptance criteria relative to an AI/ML device is not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/ML device, the acceptance criteria are based on various performance and safety tests rather than metrics like sensitivity, specificity, or AUC. The document lists the following performance tests and their results:
| Performance Criterion | Standard/Test Method | Proposed Device Result |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| Sensitization | ISO 10993-10 | Non-sensitizing |
| Intracutaneous Reactivity | ISO 10993-23 | Non-irritant |
| Acute Systemic Toxicity | ISO 10993-11 | Non-toxic |
| Volatile Organic Compounds; Particulates | Toxicological Risk Assessment | Non-toxic |
| EMC and Electrical Safety | ||
| IEC 60601-1 | Pass | |
| IEC 60601-1-2 | Pass | |
| IEC 60601-1-6 | Pass | |
| Usability / Human Factors | ||
| IEC 62366-1 | Pass | |
| Packaging Testing | ||
| ASTM D4169 | Pass | |
| ASTM D4332 | Pass | |
| Shelf-life Testing | ||
| ASTM F1980 | 12 months | |
| Functional Performance Testing | ||
| Canopy Robustness | Internal | Pass |
| Airflow and Smoke Testing | Internal | Pass |
| Differential Pressure | Internal | Pass |
| Tagged particle Clearance | Internal | Pass |
| Tagged particle Containment | Internal | Pass |
| Noise | Internal | Pass |
| Viral Penetration | ASTM F1671 | Pass |
| Cleaning Resiliency | Internal | Pass |
| Cleaning Validation | AAMI TIR30, AAMI ST98 | Pass |
| Disinfection Validation | AAMI TIR30, AAMI ST98 | Pass |
| Flammability | 16 CFR Part 1610.7 | Pass |
| Repeat Use Testing | Internal | Pass |
| Usage Life Testing | ||
| System Usage Life | Internal | Pass |
| Filter Usage Life | Internal | Pass |
| Clinical Testing | ||
| Human Use Comfort | Internal | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The clinical study conducted for the Carecube Negative Pressure Isolation Chamber was a prospective, single-center, non-blinded study.
- Sample Size: A minimum of ten (10) subjects were included.
- Data Provenance: The study used normal, healthy volunteers aged 21-47 years old, comprising a cross-section of males and females. This indicates prospective data collection from a single, unspecified center (presumably in the US given FDA submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is not an AI/ML device, the concept of "ground truth" as established by experts (e.g., radiologists) for a test set is not directly applicable. The clinical study focused on patient safety and comfort, assessed through routine monitoring of vital signs, STAID evaluation (for anxiety), and environmental monitoring (temperature, humidity, CO2, O2). The determination of "Pass" likely relies on established medical norms for vital signs and comfort levels, and environmental safety standards, interpreted by the study's clinical team, rather than a panel of independent expert adjudicators for a "ground truth" diagnosis.
4. Adjudication Method
Not applicable for this type of device and study. The study assessed physiological parameters and environmental conditions, not diagnostic outcomes requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-powered device, and the study was designed to assess safety and comfort, not diagnostic performance with or without AI assistance.
6. Standalone Performance Study
Not applicable. This device is not an algorithm; it is a physical patient isolation unit. The performance studies detailed are for the physical device's characteristics and its interaction with a human patient (comfort, safety).
7. Type of Ground Truth Used
As mentioned above, the "ground truth" in the clinical study related to:
- Physiological measurements: Vital signs (blood pressure, body temperature, pulse, oxygen saturation), which have objective measurements.
- Patient-reported outcomes: Level of anxiety using the STAID evaluation, which is a standardized psychological assessment.
- Environmental measurements: Temperature, relative humidity, carbon dioxide (CO2), and atmospheric oxygen (O2) within the Carecube, which are objective measurements.
These measurements were used to determine if the device provided a safe and comfortable environment, not to establish a diagnostic ground truth.
8. Sample Size for the Training Set
Not applicable. This device does not use an AI/ML algorithm, so there is no training set as understood in the context of AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 880.5450 Patient care reverse isolation chamber.
(a)
Identification. A patient care reverse isolation chamber is a device consisting of a roomlike enclosure designed to prevent the entry of harmful airborne material. This device protects a patient who is undergoing treatment for burns or is lacking a normal immunosuppressive defense due to therapy or congenital abnormality. The device includes fans and air filters which maintain an atmosphere of clean air at a pressure greater than the air pressure outside the enclosure.(b)
Classification. Class II (performance standards).