(73 days)
The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilation is a restricted medical device intension of individuals who require incomment venture direction of a physician. Specifically, the ventilator is applicable for adult and petiative weighing at least 5 kg (1 1 lbs), who require the following types of ventilatory support:
- Positive Pressure Yentilation, delivered invasively (via ET tube) or non-invasively (via mask).
Assist/Control, SIMV, CPAP, or NPPV modes of ventilation.
The ventilator is suitable for use in institutional, home, or transport settings.
The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support:
- Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask).
- Assist/Control, SIMV, CPAP, or NPPV modes of ventilation. .
- Breath types including Volume, Pressure Control and Pressure Support. .
The modifications intended to be cleared by this submission are: - Incorporation of optional internal PEEP control, replacing the optional external 록 mechanical PEEP valve used with the previously cleared LTV 1000 Ventilator.
- 해 The addition of a Low PEEP alarm.
- The addition of optional Patient Setting Control Presets to assist clinicians in initially setting patient ventilation set parameters.
- I The addition of NPPV mode setting enhancements to assist the clinician in setting up NPPV mode ventilation.
- I The addition of externally accessibility to the device internal battery for trained service personnel battery replacement.
- g The designation of the modified LTV 1000 Ventilator as the VIASYS LTV 1200 Ventilator. (Note: The previously cleared Pulmonetic Systems LTV 1000 will continue to be marketed without the modifications listed in this submission).
The LTV 1000 Ventilator, previously cleared for homecare, institutional and transport use is now being submitted for clearance with the listed modifications.
This 510(k) premarket notification (K060647) is for the Pulmonetic Systems, Inc. LTV 1200 Ventilator. The submission describes modifications to the previously cleared LTV 1000 Ventilator. However, the document does not contain information regarding specific acceptance criteria for performance metrics or a detailed study proving the device meets those criteria, as one would typically find for AI/ML-based medical devices.
Instead, this submission is a typical medical device 510(k) for a hardware device with software components, focusing on demonstrating substantial equivalence to predicate devices and adherence to general controls and good manufacturing practices. The "acceptance criteria" discussed are implicitly related to the device functioning as intended for ventilation, meeting safety standards, and performing comparably to the predicate LTV 1000 and other listed ventilators (iVent 201 Portable Ventilator, AVEA Ventilator).
Here's a breakdown of the requested information based on the provided document, with notes on what is not applicable or not present in a traditional hardware device submission like this:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from Modifications and Equivalence) |
|---|---|
| Functional Equivalence to Predicate Devices: Device performs its intended ventilatory support functions comparably to the LTV 1000, iVent 201, and AVEA Ventilators. | The LTV 1200 Ventilator is stated to be "substantially equivalent" to predicate devices, including the LTV 1000, iVent 201, and AVEA Ventilators. This implies that its overall performance in delivering ventilatory support (e.g., breath types, modes, pressure/volume delivery) meets similar standards. Specific performance metrics are not quantitative stated in this summary. |
| Proper function of new features/modifications: |
- Optional internal PEEP control
- Low PEEP alarm
- Optional Patient Setting Control Presets
- NPPV mode setting enhancements
- Externally accessibility to the device internal battery | The modifications are listed, and the 510(k) clearance implies that the FDA found these modifications do not raise new questions of safety or effectiveness and function as intended. However, specific quantitative performance data for these new features (e.g., alarm accuracy, preset efficacy) is not provided in this summary. |
| Safety and Effectiveness: Device meets general safety and effectiveness requirements for ventilators for adult and pediatric patients (>5 kg) in institutional, home, and transport settings. | The FDA's clearance (K060647) indicates that after review, the device is deemed substantially equivalent, which includes an implicit determination of sufficient safety and effectiveness for its stated indications for use. Compliance with general controls and GMP is also required. |
Note: For a hardware device like a ventilator, acceptance criteria typically involve detailed engineering specifications, performance against recognized standards (e.g., ISO 80601-2-12 for critical care ventilators), and verification/validation testing covering aspects like:
- Pressure/volume/flow accuracy and stability
- Alarm performance (accuracy, response time)
- Battery life and management
- Durability and environmental testing
- Electromagnetic compatibility (EMC)
- Biocompatibility (if applicable to patient contact parts)
- Software validation (for embedded software)
This 510(k) summary does not include such detailed technical specifications or test results. It focuses on the regulatory aspect of demonstrating substantial equivalence.
The following information is not present in the provided 510(k) summary, as it is typically relevant for AI/ML-based medical devices or more specific clinical trials, which are not the focus of this hardware device submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided: This type of information is generally for studies involving data analysis, particularly for AI/ML models. For a ventilator, testing involves engineering verification and validation testing, not typically a "test set" in the context of data-driven models.
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/Not Provided: This is specific to establishing ground truth for diagnostic or prognostic AI/ML applications. For a ventilator, "ground truth" is established by physical measurements and engineering standards, not expert consensus on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided: This relates to expert review processes for ground truth establishment in data-driven studies.
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/Not Provided: MRMC studies are used for evaluating diagnostic performance of AI-assisted human readers, which is not relevant for a ventilator's functional clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Provided: This also pertains to AI/ML algorithm performance. The LTV 1200 is a device operated by a human, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Provided, but inferred through engineering standards: For a ventilator, the "ground truth" for its performance is derived from physical laws of gas exchange, pressure/flow measurements, and established medical standards for ventilatory support. This is verified through engineering tests, rather than expert consensus on data labels, pathology, or outcomes data in the traditional sense of AI/ML studies.
8. The sample size for the training set
- Not Applicable/Not Provided: This refers to data used to train AI/ML models.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided: This also refers to AI/ML model training data.
Summary of the Study (as described in the 510(k) summary):
The "study" for the LTV 1200 Ventilator, as presented in this 510(k) summary, is not a clinical trial or a data-driven performance study in the AI/ML context. Instead, it is a regulatory submission process aimed at demonstrating substantial equivalence to legally marketed predicate devices (LTV 1000, iVent 201 Portable Ventilator, AVEA Ventilator).
- Evidence for Equivalence: The submission implicitly relies on:
- Description of modifications: The document details the changes from the LTV 1000, which are primarily related to convenience, alarms, and internal components, not fundamental changes to the core ventilation mechanism.
- Intended Use comparison: The intended use of the LTV 1200 is identical to the LTV 1000 (continuous or intermittent ventilatory support for adults and pediatric patients >5kg in various settings).
- Technological Characteristics Comparison (implied): While not explicitly detailed in the summary, a full 510(k) submission would include a comparison of technological characteristics between the new device and the predicates, demonstrating that any differences do not raise new questions of safety and effectiveness. This often involves engineering verification and validation testing, which is assumed to have been performed even if not detailed in the public summary.
The FDA's clearance (K060647) signifies that they reviewed the provided information and concluded that the LTV 1200 Ventilator, with its modifications, is substantially equivalent to the predicate devices and can therefore be marketed without requiring a premarket approval application (PMA) or more extensive clinical trials typical for novel devices.
§ 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).