(223 days)
The Babylog 8000 plus is a long term ventilator to be used in intensive care of premature and newborn babies and of infants up to 10 kg (22 lbs).
The device provides the following ventilation modes:
CMV Continuous Mandatory Ventilation
AIC Assist Control Ventilation
SIMV Synchronized Intermittent Mandatory Ventilation
Pressure Support Ventilation (available option) PSV
CPAP Continuous Positive Airway Pressure
Ventilation mode extension:
VG Volume Guarantee (available option), Volume controlled ventilation
VIVE Variable Inspiratory, Variable Expiratory Flow
The Babylog 8000 plus is an enhanced version of its predecessor Babylog 8000. It is a long-term, microprocessor-controlled, intensive care ventilator for premature and newborn babies, as well as for infants weighing up to about 10 kg.
The Babylog 8000 plus ventilates according to the continuous-flow principle with either time control or volume control, depending on the ventilation mode, and pressure limitation. Oxygen is metered out by the integrated air/O2 mixer.
A variety of the device functions are monitored in operation to make sure that safety-relevant failures are detected and safety for the patient is maintained.
The analog and digital interface is optionally available for connecting the Babylog 8000 plus to a device like a patient monitor or computer so that measured values and settings can be transferred to such equipment.
The ventilator can also be combined with a medicament nebulizer.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dräger Babylog 8000 plus ventilator.
The document is a 510(k) Summary of Safety and Effectiveness for the Dräger Babylog 8000 plus. It focuses on demonstrating substantial equivalence to predicate devices (Babylog 8000 and Servo 300), rather than outlining specific, quantitative 'acceptance criteria' in the typical sense of a clinical trial or performance study with numerical thresholds and associated statistical proof.
Instead, the "acceptance criteria" here are implicitly defined by the characteristics of the predicate devices. The study's aim is to show the new device meets or exceeds the safety and effectiveness of these predicates.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, explicit numerical acceptance criteria are not presented in a traditional "pass/fail" format. The "acceptance criteria" are the functional specifications and performance characteristics of the legally marketed predicate devices (Babylog 8000 and Siemens Servo 300). The "reported device performance" is the claim of substantial equivalence for the Babylog 8000 plus to these characteristics.
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Babylog 8000 plus) |
|---|---|---|
| Ventilator Type | Intensive Care Ventilator (21 CFR 868.5895) | Intensive Care Ventilator (21 CFR 868.5895) |
| Intended Use | Long-term ventilation for premature/newborn babies and infants up to 10 kg. | Long-term ventilation for premature/newborn babies and infants up to 10 kg (22lbs). |
| Control Principle | Servo 300: pressure-controlled or volume-controlled, time-cycled or flow-cycled, pressure-limited. | |
| Babylog 8000: time-controlled, time-cycled, pressure-limited. | Time-controlled or volume-controlled; time-cycled or flow-cycled; pressure-limited. (Claimed substantially equivalent to Servo 300 where enhanced). | |
| Software controlled | Yes (both predicates) | Yes |
| Ventilation modes: | ||
| CPAP | Yes (both predicates) | Yes |
| CMV | Yes (both predicates) | Yes |
| Assist Control | Yes (both predicates) | Yes (AIC Assist Control Ventilation - time-controlled, volume triggered, time-cycled, pressure-limited continuous flow ventilation, synchronized with each spontaneous patient breath) |
| SIMV | Yes (both predicates) | Yes (Synchronized Intermittent Mandatory Ventilation - time-controlled, volume triggered, flow cycled, pressure-limited continuous flow ventilation, synchronized with patient's spontaneous breathing at the set ventilation rate) |
| PSV | Yes (Servo 300), No (Babylog 8000) | Substantially equivalent to Servo 300. (Pressure Support Ventilation - Time-controlled, volume triggered, flow cycled, pressure-limited ventilation synchronized with each spontaneous patient breath). |
| VG (Volume Guarantee) | No (both predicates) | Available option. Volume controlled ventilation. Ventilator controls inspiratory pressure to deliver preset tidal volume. May be combined with AIC, SIMV and PSV. (This is an enhancement, not a direct equivalence). |
| VIVE (Variable Insp. Exp. Flow) | No (both predicates) | Available option. Separate continuous flow during expiration in mandatory ventilation modes. (This is an enhancement, not a direct equivalence). |
| Method of Triggering | Flow or pressure (Servo 300); Volume (Babylog 8000) | Like Babylog 8000 (Volume triggering) where applicable, with flow triggering available for new modes (e.g., PSV). |
| O2 Concentration | 21 to 100 Vol% ±3 Vol% (both predicates) | Like Babylog 8000 (21 to 100 Vol% ±3 Vol%) |
| Pinsp | 10 to 120 cmH2O (Servo 300); 10 to 80 cmH2O (Babylog 8000) | 5 to 80 cmH2O (This range partially overlaps with both predicates, with enhanced lower limit compared to Babylog 8000 and a more restricted upper limit than Servo 300, but still within a clinically appropriate range for intended population). |
| PEEP | 0 to 50 cmH2O (Servo 300); 0 to 25 cmH2O (Babylog 8000) | Like Babylog 8000 (0 to 25 cmH2O) |
| Tidal Volume | Servo 300: adult: 2 to 4000 mL, pediatric: 0 to 400 mL, neonate: 0 to 40 mL. | |
| Babylog 8000: No (result of settings/system characteristics). | 2 to 100 mL (when VG option is activated). This is an enhancement providing volume control, which was not directly available on the Babylog 8000 but was available on the predicate Servo 300 for neonates (0 to 40 mL, the Babylog 8000 plus range includes and extends this). | |
| Alarm Functionality | Airway pressure, O2 concentration, Expired minute volume, Apnea, Gas supply, Power failure (common to both predicates). | Yes, for all common alarms. |
| Breathing frequency low/high: Yes (upper alarm limit only) - improved over both predicates (which had none). | ||
| Monitoring Parameters | Peak airway pressure, Mean airway pressure, PEEP, Expired tidal volume, Expired minute volume, Breathing frequency, FiO2, Supply pressures (common to both predicates). | Yes, for all common monitoring parameters. |
| New monitoring parameters: compliance, resistance, rate-volume-ratio (not on predicates). These are deemed "not essential for safety and effectiveness". | ||
| Physical Characteristics | Similar dimensions/weight, Gas supply pressure, Gas delivery system, Mains voltage range, Power consumption, Internal battery (where applicable to specific predicate). | Like Babylog 8000 for physical characteristics, gas supply, power supply (where comparable). Similar communication interface to predicates, medicament nebulizer capability. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a test set or a clinical study with patients or patient data. This 510(k) summary focuses on demonstrating substantial equivalence through comparison of technological characteristics with predicate devices and adherence to technical standards. It is a "bench study" style comparison, implicitly relying on the design, function, and testing against standards rather than patient-specific performance data.
Therefore:
- Sample size for the test set: Not applicable (no test set of patient data described).
- Data provenance: Not applicable (no patient data described).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no test set with patient data is described, this section is not applicable. The assessment relies on engineering and regulatory experts to compare specifications and confirm adherence to standards. Dr. Klaus Freudenstein, Project Manager, is listed as having compared device performances, implying an engineering/technical background.
4. Adjudication Method for the Test Set
Not applicable, as no test set requiring ground truth adjudication is described.
5. 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
Not applicable. This is a medical device for ventilation, not an AI or imaging diagnostic device. No human reader studies are mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm, and its performance is assessed against established device characteristics and standards.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the established safety and effectiveness of the predicate devices as determined by their prior FDA clearance and general clinical use, along with conformity to recognized technical standards (e.g., for ventilators). The comparison table on pages 2-3 serves as the primary evidence.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No AI model or training set is described.
Summary of the Study for Demonstrating Acceptance:
The "study" presented here is a comparison of the technological characteristics and intended use of the Dräger Babylog 8000 plus against two predicate devices: the Dräger Babylog 8000 (already marketed by the applicant) and the Siemens Servo 300.
The core of the study is a side-by-side tabular comparison (pages 2-3) of various features including:
- Control Principle
- Ventilation modes (CPAP, CMV, Assist Control, SIMV, PSV, VSV, PRVC, Manual inspiration, VG, VIVE)
- Ventilator settings (Tin, Tex, CMV rate, SIMV rate, I:E ratio, O2 concentration, Pinsp, PEEP, Insp. Flow, Tidal Volume, Minute Volume, Trigger sensitivity, Trigger response time, Rise time)
- Front panel controls and display technology
- Alarm functionalities (Airway pressure, O2 concentration, Expired minute volume, Apnea, Gas supply, Power failure, Breathing frequency, Battery supply, O2 cell disconnect, flow/pressure sensor errors, Ventilator inop)
- Monitoring Parameters (peak/mean airway pressure, PEEP, inspired/expired tidal volume, expired minute volume, spontaneous fraction of expired minute volume, percent leakage, breathing frequency, rate-volume-ratio, compliance, resistance, FiO2, supply pressures)
- Physical Characteristics (dimensions, weight, gas supply, power supply, internal battery)
- Special functions (communications interface, medicament nebulizer)
The study concludes that:
- The Babylog 8000 plus is an "enhanced version" of the Babylog 8000.
- New ventilation modes in the Babylog 8000 plus (not in Babylog 8000 software 3.0) are "substantially equivalent to ventilation modes of the Servo 300 ventilator of Siemens."
- Additional monitoring features (compliance, resistance, rate volume ratio) are provided, but are "not essential for the safety and effectiveness" concerning the intended use.
- The device "fulfills at least the same technical standards" as the predicate Dräger device and has been tested according to these standards.
- Therefore, the device is "as safe and effective as the predicate devices."
This is a regulatory submission study, not a clinical trial or performance study requiring patient data within this document. The "proof" is based on technical specifications, established standards, and a direct comparison to legally marketed predicate devices, demonstrating that the design and function are equivalent or superior without raising new questions of safety or effectiveness.
§ 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).