(330 days)
The Breathe Technologies Life2000 Ventilation System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult patients who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). - Assist/Control mode of ventilation. The ventilator is suitable for use in home and institutional settings.
The Breathe Technologies Life2000 Ventilation System is a portable, battery powered, critical care ventilator. The Ventilator administers the physician-prescribed volume to the patient via the attached Breathe Technologies Patient Universal Connector which connects into the patient's tracheostomy tube, endotracheal tube, or any off the shelf non-invasive mask. It can also be used with the Breath Technologies NIOV Pillows Interface, a type of nasal mask. The ventilator is small and light enough to be worn on a patient's belt, or slung over their shoulder. It is connected to a separate, third party, gas supply. The Ventilator is intended for Institutional or Home Use. It is not intended for use during emergency/medical transportation.
The Breathe Technologies Life2000 Ventilation System is a portable, battery-powered critical care ventilator for adult patients requiring continuous or intermittent ventilatory support.
Here's an analysis of its acceptance criteria and supporting studies:
- Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Predicate Device (LTV-1200, K060647) Acceptance Criteria | Application Device (Life2000 Ventilation System) Performance | Evaluation / Difference Status |
|---|---|---|---|
| Indications for Use | Continuous/intermittent ventilatory support, adult & pediatric (>5kg), invasive/non-invasive, A/C, SIMV, CPAP, NPPV modes, institutional, home & transport settings | Continuous/intermittent ventilatory support, adult patients only, invasive/non-invasive, Assist/Control mode, institutional & home settings | Difference: Application device's indications are a subset of the predicate (adults only, fewer modes, no transport). This is considered acceptable as it's a narrower use case. |
| Product Classification Code | CBK | CBK | Identical |
| CFR Citation | 21 CFR 868.5895 | 21 CFR 868.5895 | Identical |
| Principal Operator | Trained personnel under direction of a physician | Trained personnel under direction of a physician | Identical |
| Environment of Use | Institution, Home, and Transport | Institution & Home | Difference: Application device not validated for transport. This is an accepted difference as it narrows the intended use. |
| Patient Interface | Invasive (ET tube) or non-invasive (mask) | Invasive (ET tube) or non-invasive (mask) | Identical |
| Power Source | Battery Powered, run while charging | Battery Powered, run while charging | Identical |
| Operational Modes | Volume Control, Volume Assist/Control, Volume Assist, Pressure Control, Pressure Support, SIMV, CPAP, NPPV | Volume Control, Volume Assist/Control, Volume Assist | Difference: Application device modes are a subset of the predicate. This is an accepted difference as fewer documented modes are presented. |
| Active Exhalation Valve? | Yes, Mechanical | Yes, Mechanical/Pneumatic | Clinically Equivalent |
| Design Designation | Portable Critical Care | Portable Critical Care | Identical |
| Size WxLxH (in) | 3 x 10 x 12 | 3.2 x 7.7 x 1.0 | Difference: Application device is much smaller. Considered an improvement potentially making it easier for patients to handle, with no new safety/effectiveness issues raised. |
| Weight | 13.4 lbs | 1.1 lbs | Difference: Application device is much lighter. Considered an improvement potentially making it easier for patients to handle, with no new safety/effectiveness issues raised. |
| Volume Setting Range | 50 - 2000 ml/breath | 50 - 750 ml/breath | Difference: Application device range is a subset of the predicate. This is an accepted difference as it's a narrower range. |
| Resultant Tidal Volume | 50 - 2000 ml/breath | 50 - Up to 2000 ml/breath due to venturi effect | Identical |
| PEEP Setting | 0 – 20 cmH2O | 0 - 10 cmH2O | Difference: Application device range is a subset of the predicate. This is an accepted difference as it's a narrower range. |
| PIP Alarms & Monitoring | Yes | Yes | Identical |
| Adjustable Inspiration Time | 0.3 - 9.9 seconds | 0.15 to 3 seconds | Difference: I-time of application device is a subset of predicate. Only clinically relevant times are used. This is an accepted difference. |
| Supply Gas | Oxygen, Air | Oxygen, Air | Identical |
| Method of supply gas pressurization | Internal turbine for Air, Compressed Source for O2 | Compressed source for Air, Compressed source for O2 | Clinically Equivalent |
| Sterilized? | Ventilator: No, Patient Circuit: No | Ventilator: No, Patient Circuit: No | Identical |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for specific performance tests (e.g., comparative waveform testing, human factors).
- The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, beyond general statements of compliance with international and US standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The document identifies general "qualified, trained personnel under the direction of a physician" as the intended operators for the device. However, it does not specify the number or qualifications of experts used to establish ground truth or conduct specific performance assessments for the testing mentioned (e.g., comparative waveform testing, human factors).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not specify any adjudication methods for the test sets.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study is mentioned, as this device is a mechanical ventilator, not an AI-assisted diagnostic tool. The "comparative effectiveness" studies mentioned are related to device performance compared to a predicate, not human reader performance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable to a mechanical ventilator device. The device's performance is inherently standalone in its function, but its operation always involves a human user (qualified personnel under a physician's direction).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "Summary of Supporting Data," the ground truth for device performance is established through compliance with recognized standards such as ISO 10993-1, FDA Draft Reviewer Guide for Ventilators, ASTM F1246-91, IEC 60601-1, IEC 60601-1-2, and ISO 80601-2-12. This implies engineering and clinical performance metrics defined by these standards serve as the "ground truth" for the device's functional and safety capabilities.
- Specific tests mentioned like "Ventilator Cleaning validation," "Risk characterization of VOC's," "Static Analysis Tool verification of software," "Comparative Waveform Testing," and "Human Factors and Usability Testing" would have their own defined ground truths based on established protocols for those types of evaluations (e.g., cleanliness standards, toxicology limits, software quality metrics, physiological waveform accuracy, human-computer interaction success rates).
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The sample size for the training set
- This is not applicable for a mechanical ventilator. Training sets are typically associated with machine learning or AI models, which are not described as integral to this device's function.
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How the ground truth for the training set was established
- This is not applicable for a mechanical ventilator.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).