(566 days)
LTV2 model 2200 and 2150 ventilators are intended to provide continuous or intermittent ventilator support for the care of the individuals who require mechanical ventilation. The use environment is for institutional use. Institutional use includes ICU or other hospital environments including intra-hospital transport. The model 2200 can operate with high pressure O2. The model 2150 operates with low pressure oxygen.
TheLTV2 Series Ventilators are intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following types of ventilatory support:
- . Positive Pressure Ventilation, delivered invasively or non-invasively (via mask).
- . Assist/Control, SIMV, CPAP, and NPPV modes of ventilation.
The ventilator is suitable for use in professional healthcare facilities, including during intrahospital transport.
The LTV2 Series ventilator supports adult and pediatric patients weighing at least 10 kg (22 lb) in professional healthcare facilities response with invasive or noninvasive ventilation presets. These settings can be easily refined using the touch-turn-touch interface on the LED display. The ventilator also provides a wide range of ventilation therapies to meet demanding patient needs, including volume control, pressure control, pressure support and spontaneous breath types. Combined with the spontaneous breathing trial function, the ultra-sensitive flow trigger facilitates weaning patients weighing at least 10 kg (22lb).
The provided document is an FDA 510(k) premarket notification for the LTV2 Series Ventilators. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a study with a test set, expert ground truth, and statistical analysis as would be done for a novel AI/ML device.
Therefore, the information typically requested in your prompt regarding acceptance criteria, study design for performance metrics (like sensitivity, specificity, F1 score), sample sizes for test and training sets, expert adjudication, MRMC studies, and ground truth establishment is not present in this document because it's not relevant to a 510(k) submission for a non-AI/ML medical device like a ventilator.
The document describes the device's technical specifications and compares them to predicate devices, along with listing applicable performance standards and verification testing (e.g., waveform, alarms, endurance). The conclusion explicitly states: "Based on the similarities in the safety and effectiveness profiles of the subject, predicate and reference devices, no clinical studies were deemed to needed to support this submission."
To address your request, I will explain why your specific questions are not applicable to this document and provide the information that is available.
Reasoning for Inapplicability of AI/ML-focused Questions:
The LTV2 Series Ventilator is a mechanical device, not an AI/ML diagnostic or prognostic tool. Therefore, the regulatory pathway (510(k)) and the evidence required to demonstrate safety and effectiveness for this type of device differ significantly from what would be expected for an AI/ML device.
- Acceptance Criteria & Reported Performance (Table A): For a mechanical device, performance is evaluated against engineering specifications, industry standards (e.g., IEC 60601 series, ISO 80601-2-12 for ventilators), and comparison with predicate devices. There isn't a "test set" in the sense of a dataset of medical images or patient records, or metrics like sensitivity/specificity for a diagnosis. Performance is about meeting physical parameters (e.g., tidal volume range, breath rate range, pressure control range, alarm specifications, electrical safety).
- Sample Sizes, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth (Questions 2-7): These questions are highly specific to the validation of AI/ML algorithms, particularly in medical imaging or diagnostic contexts. They relate to how a model's output is compared against a clinical "truth" established by human experts or other definitive sources. For a ventilator, "performance" is demonstrated through non-clinical testing (e.g., mechanical testing, software V&V, endurance testing) confirming it adheres to its design specifications and relevant safety/performance standards.
- Training Set & Ground Truth Establishment (Questions 8-9): These apply to the development and training of machine learning models. A mechanical ventilator does not have "training data" in this sense. Its design and functionality are based on engineering principles and verified through physical testing.
Information Available from the Document (Addressing Relevant Aspects):
The document demonstrates the device's safety and effectiveness by showing substantial equivalence to existing predicate devices and compliance with recognized performance standards.
1. Table of "Acceptance Criteria" (derived from technical specifications and standards) and "Reported Device Performance" (implied by meeting standards and equivalence to predicates):
For a mechanical ventilator, "acceptance criteria" are typically defined by engineering specifications and compliance with relevant international standards. "Reported device performance" is confirmed through design verification and validation testing, ensuring these specifications and standards are met. The document states:
"Successful test results (electrical safety testing, mechanical testing, software V&V, and waveform verification tests) ensured the proposed ventilator does not raise any different questions of safety and effectiveness."
| Criteria/Element of Comparison | Acceptance/Target Performance (as per standards/predicates) | Reported Device Performance (as demonstrated by testing and equivalence) |
|---|---|---|
| Intended Use | Continuous or intermittent ventilator support for individuals requiring mechanical ventilation. Institutional use (ICU, hospital, intra-hospital transport). | Meets: Same as predicate devices. |
| Indications for Use (Patient Population) | Adult and pediatric patients weighing at least 10 kg (22 lbs.) (Proposed Device). Predicates were for 5 kg (11 lbs.). | Meets (within specified range): Targeted for adult and pediatric patients weighing at least 10 kg (22 lbs.). Discussion notes: "Substantial equivalent, increase in lower weight limit." Implies the device functions safely and effectively for this patient group. |
| Principles of Operation | Positive pressure mechanical ventilator. | Meets: Same as predicate. |
| Environment of Use | Healthcare institutional settings (Proposed Device). Predicates included home/transport. | Meets: Suitable for use in healthcare institutional settings. Discussion notes: "Substantial equivalent for healthcare institutional settings." |
| Compatibility (Temperature, Humidity, EMC, Sound) | Storage Temp: -20 to +60 C. Operating Temp: +5 to +40 C. Humidity: 10-95% non-condensing. EMC: IEC 60601-1-2. Sound: Not exceed 55 dBA (RMS) at one meter (proposed); 50 dBA (predicates). | Meets: Designed and tested to latest EMC standards (IEC 60601-1-2 Ed 3/4). Storage/Operating temps & humidity are consistent. Sound level of 55 dBA is within acceptable limits for the environment. Discussion notes: "Substantial equivalent, designed and tested to latest EMC standards." |
| Electrical Safety | Class II Type BF (IEC 60601-1-2). | Meets: Same as predicate. |
| Internal PEEP/PEEP Compensation | Range: 0-20 cmH2O ± 1 cmH2O or 10%, whichever is greater, within 3 breaths. (Mechanical/pneumatic control). | Meets: Same as predicate. |
| Bias Flow | Off or 5 to 15 LPM. Predicates were Off or 10 LPM ± 10% or 1 LPM. | Meets: Off or 5 to 15 LPM. Discussion notes: "Substantially Equivalent (Reference device K032451, K070594)" |
| Ventilation Mode & Breath Types | Control Mode, Assist/Control Mode, SIMV Mode, CPAP, NPPV, Apnea Backup. Breath types: Pressure Control, Volume Control, Pressure Support, Spontaneous. | Meets: Same as predicate. |
| Breath Rate | 0-80 BPM. | Meets: Same as predicate. |
| Tidal Volume | 50-2,000 mL. | Meets: Same as predicate. |
| Inspiratory Time | 0.3 - 9.9 seconds. | Meets: Same as predicate. |
| Pressure Control (for applicable modes) | 4 – 98 cmH20 (Assist/Control & SIMV/CPAP); Off - 60 cmH2O (NPPV). Predicate was 1-99 cmH2O. | Meets: Range specified. Discussion notes: "Substantially equivalent." |
| Pressure Support | 1-60 cmH2O. | Meets: Same as predicate. |
| Sensitivity | Off, 1-9 LPM. | Meets: Same as predicate. |
| O2% | 21–100%; oxygen bleed flow (for LTV 2150 and LTV 2200). | Meets: Same as predicate. |
| O2 Flush | 1-3 min (LTV 2200 only). | Meets: Same as predicate. |
| PEEP/CPAP | 0 – 20 cmH2O. | Meets: Same as predicate. |
| Blender | LTV2 2200: High and low oxygen inlet pressure. LTV2 2150: Low oxygen inlet pressure. | Meets: Same as predicate. |
| Software Functionality (VOXP) | VOXP (VENTILATOR OPEN XML PROTOCOL) present (Proposed Device). Not present in predicates. | Meets: Present. Discussion notes: "Substantially equivalent," implying this added feature does not raise new safety/effectiveness questions and has been validated. |
| Compliance with Standards | Adherence to a range of relevant medical device standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 62304, ISO 80601-2-12, ISO 14971). | Meets: "The LTV2 Series Ventilators was designed and tested in accordance with the following and FDA guidance documents and international standards." Implies successful testing against all listed standards. |
| Verification Testing | Successful completion of design verification tests. | Meets: Design Verification included: Waveform, Alarms, Ventilation Controls, Ventilation Displays, Endurance, Patient Circuit Testing. "Successful test results... ensured the proposed ventilator does not raise any different questions of safety and effectiveness." |
2. Sample Sized used for the test set and the data provenance:
- Not Applicable in the AI/ML sense. For this mechanical device, performance is evaluated through design verification and validation testing, and compliance with standards. There is no "test set" of patient data or images. Performance is based on physical property testing, software validation, and electrical safety testing.
- The data provenance for such tests are typically in-house lab reports and compliance certificates from testing bodies, not clinical data from specific countries or retrospective/prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. "Ground truth" established by experts is a concept for AI/ML diagnostic or prognostic devices. For a ventilator, the "truth" is whether the device meets its engineered specifications and performs reliably according to intended use and recognized standards. This is assessed by engineers, quality control personnel, and regulatory specialists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used in studies involving human interpretation or labeling of data, typically for AI/ML validation. This is a mechanical device.
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. MRMC studies are for evaluating the impact of AI assistance on human performance in diagnostic tasks. This is a mechanical ventilator.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This refers to the performance of an AI algorithm on its own. While the ventilator has internal algorithms for control, its "performance" is inherently tied to its mechanical function, and its safety/effectiveness is not evaluated as a standalone AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the AI/ML sense. The "ground truth" for a mechanical ventilator's performance is its adherence to its design specifications, established engineering principles, and compliance with international performance and safety standards for ventilators. This is verified through objective measurements, calibrations, and stress tests.
8. The sample size for the training set:
- Not Applicable. A mechanical ventilator does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. As there's no training set, this question is not relevant.
§ 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).