(180 days)
The V60 Ventilator with Proportional Pressure Ventilation and Auto-Trak+ Software Options is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional setting under the direction of a physician.
The ventilator is intended to support pediatric patients weighing 20 kg (44 lbs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. The ventilator is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
The ventilator is intended to be used only with various combinations of Respironics recommended patient circuits, interfaces (masks), humidifiers and other accessories.
The V60 Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.
The modifications to the currently marketed V60 Ventilator are two-fold; addition of PPV and Auto-Trak+ Software Options.
PPV is an assist mode of ventilation. It combines patient- triggered breaths that deliver pressure in proportion to patient effort. PPV provides ventilation support similar to that of the V60 Ventilator, specifically the S/T mode.
Auto-Trak+ is a Software Option that provides the clinician the means to adjust the trieger and cycle thresholds while retaining the functionality of Auto-Trak Sensitivity.
The provided document, K102985, describes a 510(k) premarket notification for the V60 Ventilator with Proportional Pressure Ventilation (PPV) and Auto-Trak+ Software Options. The document focuses on demonstrating substantial equivalence to a predicate device (V60 Ventilator) and outlines verification and validation activities.
However, the submission does not contain explicit acceptance criteria or a detailed study report that directly describes the device meeting specific quantitative or qualitative acceptance criteria with a statistical analysis based on human or algorithm performance data.
Here's a breakdown of what can be extracted and what information is missing based on your requested format:
1. Table of Acceptance Criteria and Reported Device Performance
Observation: This document does not explicitly state specific, quantifiable acceptance criteria for the performance of the PPV and Auto-Trak+ software options, nor does it present device performance data in a detailed table format to demonstrate compliance against such criteria.
The document generally states:
- "All software activities, including verification and validation have been successfully completed in accordance with Respironics California, Inc. policies and procedures and the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices dated May 11, 2005."
- "Bench testing has been successfully completed and waveform data, performed to ASTM F1100-90, comparing the V60 Ventilator with PPV and Auto-Trak+ Software Options with the currently marketed V60 Ventilator are contained in the submission."
- "In addition to the software verification and validation activities and performance testing, a comparison of performance characteristics has been conducted and documented in this submission."
Without the full submission, the specific "waveform data" and "comparison of performance characteristics" are not detailed here. Therefore, a table of acceptance criteria and reported performance cannot be generated from the provided text.
2. Sample Size Used for the Test Set and Data Provenance
Observation: The document does not specify a sample size for a "test set" in the context of clinical or human-in-the-loop performance evaluation. It mentions "bench testing" and "waveform data" but does not describe a test set in terms of patient data or clinical scenarios, nor does it mention data provenance (country of origin, retrospective/prospective). This submission primarily focuses on engineering verification and validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Observation: This information is not provided because the document does not describe a study involving expert-established ground truth for a test set. The validation appears to be engineering-focused.
4. Adjudication Method for the Test Set
Observation: This information is not provided as no "test set" with expert review is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Observation: No MRMC comparative effectiveness study is mentioned or implied. The submission addresses the addition of new features (PPV and Auto-Trak+software options) to an existing cleared device (V60 Ventilator) by demonstrating that these additions do not alter the fundamental scientific technology or raise new safety/effectiveness questions. The primary evidence presented is engineering verification and validation, along with bench testing comparing the modified device to the predicate device.
6. Standalone (Algorithm Only) Performance Study
Observation: While "software verification and validation activities" were conducted, the document does not provide details of a standalone (algorithm only) performance study in terms of specific metrics like sensitivity, specificity, or accuracy that would typically be associated with AI algorithms or complex decision-support systems. The PPV and Auto-Trak+ are described as "software options" that enhance ventilation modes and sensitivity adjustments, not as standalone diagnostic or treatment algorithms that would typically undergo such standalone performance evaluation in the way AI models are tested today. The evaluation seems to be integrated into the overall device performance through bench testing.
7. Type of Ground Truth Used
Observation: The term "ground truth" as typically understood in AI/algorithm performance studies (e.g., pathology, outcomes data, expert consensus) is not applicable or not explicitly discussed in this submission. The validation relies on technical specifications, engineering principles, and comparison to existing validated device performance through bench testing (e.g., waveform data conforming to ASTM F1100-90).
8. Sample Size for the Training Set
Observation: This document does not mention a "training set" as the device's software options are not described as machine learning or AI models that require data training. The software modifications enhance existing ventilation functionality.
9. How the Ground Truth for the Training Set Was Established
Observation: This information is not applicable as no training set or machine learning model is described.
Summary of Findings:
The K102985 submission for the V60 Ventilator with PPV and Auto-Trak+ Software Options is a premarket notification primarily focused on demonstrating substantial equivalence through mechanical and software verification and validation, and bench testing, rather than a clinical performance study with defined acceptance criteria for AI or human performance. It asserts that the modifications do not alter the fundamental technology or raise new safety/effectiveness questions, making it substantially equivalent to the predicate device. The information requested (especially regarding clinical study design, expert review, and AI performance metrics) is largely absent from this particular document, which is typical for 510(k)s focusing on modifications to established device types where extensive de novo clinical trials are not required.
§ 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).