(153 days)
The V200 Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients as prescribed by a physician. The ventilator is intended for use in either invasive or non-invasive applications.
The intended use is identical to that of the predicate the currently marketed Esprit Ventilator.
The V200 Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients as prescribed by a physician. The V200 Ventilator is intended for use in either invasive or noninvasive applications and contains the following modes of ventilation:
- . Assist/Control (A/C)
- Synchronized Intermittent Mandatory Ventilation (SIMV) .
- Continuous Positive Airway Pressure (CPAP)
- Spontaneous (Spont) .
- . Spontaneous/Timed (Spont/T)
- Apnea (Backup Mode) .
The V200 Ventilator is a hardware modification to the currently marketed Esprit that upgrades the look of the Esprit through minor changes to some of the external hardware components, as follows:
- The position of the encoder knob changed, as well as the attachment method .
- Material changes were made to the top and bottom enclosure .
- Dimensional, material, and attachment method changes were made to the bezel . assembly
- The resins and color of the Heated Filter Assembly were changed ●
- Dimensional changes were made to the Overlay, as well as positioning of the hard . keys, indicator lights, and icons
Ventilators with this updated look are sold under the brand name of the V200 Ventilator.
All electrical components, internal hardware components, firmware, and software are physically and functionally identical to those on the currently marketed Esprit Ventilator.
The V200 Ventilator technological characteristics with respect to the control mechanism, operating principle, energy type, ergonomics of the patient interface, firmware, software, environmental specifications, and performance specifications are identical to that of the currently marketed Esprit Ventilator.
The V200 ventilator contains the identical software as the currently marketed Esprit Ventilator. The software options are enabled by downloading the operational software and installing the software option. They are integrated into the V200 Ventilator in the same manner as they are on the currently marketed Esprit Ventilator. The options can be installed either in the factory or in the field as an upgrade to existing V200 Ventilators.
All available options on the Esprit cleared subsequent to the original 510(k) (K981072) are also available on the V200 Ventilator.
This 510(k) summary explains that the V200 Ventilator is a hardware modification of the already-marketed Esprit Ventilator. The submission focuses on demonstrating substantial equivalence rather than presenting new performance data against specific acceptance criteria for a novel device. Therefore, many standard elements of acceptance criteria and a study proving those criteria are not explicitly present in the provided text.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance:
Since the V200 Ventilator is presented as a hardware modification of an existing device (Esprit Ventilator) with identical technological characteristics, the acceptance criteria are implicitly that the V200 Ventilator performs identically to the Esprit Ventilator in all functional and safety aspects.
| Acceptance Criteria Category | Reported Device Performance (V200 Ventilator) |
|---|---|
| Intended Use | Identical to the predicate (Esprit Ventilator): providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients by qualified medical personnel, in invasive or non-invasive applications. |
| Technological Characteristics | Identical to the predicate (Esprit Ventilator) with respect to control mechanism, operating principle, energy type, ergonomics of the patient interface, firmware, software, environmental specifications, and performance specifications. |
| Hardware Components | External hardware components changed (encoder knob position, enclosure materials, bezel, heated filter assembly, overlay dimensions and positioning of keys/lights/icons). Internal hardware components are physically and functionally identical. |
| Electrical Components | Physically and functionally identical to the predicate (Esprit Ventilator). |
| Firmware/Software | Physically and functionally identical to the predicate (Esprit Ventilator), including all available options cleared for the Esprit. |
| Safety & Effectiveness | "These changes do not raise any new questions regarding safety and effectiveness." (Implies no degradation from predicate). |
| Electromagnetic Compatibility (EMC) | Test data provided to support substantial equivalence. |
| Safety Testing | Test data provided to support substantial equivalence. |
| Shock and Vibration Testing | Test data provided to support substantial equivalence. |
2. 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 a "sample size" for a clinical test set in the traditional sense, nor does it mention data provenance (country, retrospective/prospective). This is because the submission primarily relies on demonstrating that the hardware modifications did not alter the performance of the existing, cleared device. The testing mentioned in "Substantial Equivalence/Performance Testing" relates to engineering and regulatory compliance testing rather than clinical performance testing with patient data.
3. 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):
Not applicable. This submission concerns hardware changes to a medical device, not a diagnostic algorithm that requires expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This submission concerns hardware changes to a medical device, not a diagnostic algorithm that requires expert adjudication for a test set.
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. The V200 Ventilator is a mechanical ventilator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The V200 Ventilator is a mechanical ventilator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the typical sense for a diagnostic device. For the V200 Ventilator, "ground truth" likely refers to the established performance specifications and safety profile of the predicate Esprit Ventilator. The "study" (testing) aims to show that the V200 maintains this "ground truth" and that the hardware changes did not introduce deviations.
8. The sample size for the training set:
Not applicable. The V200 Ventilator is a mechanical ventilator with identical firmware and software to its predicate. There is no mention of a "training set" as would be relevant for machine learning algorithms.
9. How the ground truth for the training set was established:
Not applicable, as there is no mention of a training set.
§ 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).