(286 days)
The Vitalograph Model 6600 COMPACT is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on adults and paediatrics, 5 years and older. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC or connected to compatible Vitalograph or third party devices to acquire, view, store and print the device output.
Vitalograph Model 6600 Compact, running Vitalograph Model 7000 Spirotrac software, ref 510(k) K141546, shall provide a mains-powered desktop spirometer for creating, adding and recalling subjects and performing Spirometry testing on those subjects to aid in the measuring the effect of lung disease on pulmonary function. Model 6600 Compact will also, via the Spirotrac software, connect to compatible third party devices to read and display the output from these devices to allow the information to be retained with the subject. All connected compatible third party devices are those cleared via Model 7000 510(k) K141546. The intended use of the Compact is in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry. Its primary functions are: 1. Interaction will be via the touch Screen interface. 2. Running the Spirotrac software, as cleared in K141546, The model 6600 Compact performs spirometric measurements using the established fleisch Pneumotachograph, using single breath and multiple-breath testing techniques, to display and record lung volumes and flow rates (including FVC, FEV1, FEV6, PEF, MVV and VC) and their sub-divisions to aid in the measuring the effect of lung disease on pulmonary function 3. Record subject demographic data. 4. Produce printed reports to external printers.
This document describes a 510(k) premarket notification for the Vitalograph Model 6600 Compact, a diagnostic spirometer. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy, as might be seen for AI/ML devices. Instead, the acceptance criteria for this spirometer are based on adherence to established international performance and safety standards, and equivalency to predicate devices.
| Acceptance Criteria (Standards Adherence & Equivalency) | Reported Device Performance |
|---|---|
| Performance Standards: |
- ISO 26782 (Anaesthetic and respiratory equipment -- Spirometers intended for the measurement of time forced expired volumes in humans)
- ATS/ERS 2005 (ATS/ERS Task Force: Standardisation of Lung Function Testing)
- ISO 23747 (Anaesthetic and respiratory equipment -- Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans)
- EN13826:2003 (for PEF, now ISO 23747:2009)
- EN ISO 26782:2009 | "All tests and validations demonstrated satisfactory results."
"The Model 6600 Compact successfully passed the performance requirements of these tests." |
| Safety Standards: - IEC / EN 60601 (inclusive of EN 60601-1-1 and EN 60601-1-2) | "Yes" (in comparison table) for Model 6600 and predicate Model 2120.
"Yes, for connected compatible devices" for predicate Spirotrac Model 7000. (Implies Model 6600, using Spirotrac software, also meets this). |
| Mechanical Shock Testing: - Drop test of packaged device (specified height, all corners/edges)
- Random Vibration, Sinusoidal Vibration, and Bump Tests
- Storage conditions testing
- Operating temperature limits testing | "All tests and validations demonstrated satisfactory results."
"Evidence of successful completion of tests and validations has been provided with this submission." |
| Equivalence to Predicate Devices (Model 7000 Spirotrac, K141546 and Model 2120, K100687): - Identical user interface and software
- Same indications for use (including pediatric population clarification)
- Same operating principle and flow measurement principles
- Same parameters calculation
- Same method of use
- Same performance (bench tested)
- Same patient interface accessories
- "No new issues of safety or effectiveness have been introduced" | The document asserts "The characteristics of the Model 6600 Compact are similar to those of the predicate devices listed." The detailed comparison table throughout pages 7-10 highlights these similarities. |
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "performance testing against international standards" (ISO 26782, ATS/ERS 2005, ISO 23747) and "Mechanical shock testing". However, it does not specify the sample size (e.g., number of spirometry maneuvers, number of devices tested for mechanical shock) used for these tests.
The data provenance is internal testing performed by Vitalograph Ireland Ltd. It implies prospective testing conducted for regulatory submission, rather than retrospective analysis of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For a diagnostic spirometer, "ground truth" typically refers to accurately generated airflow and volume signals from a calibration syringe or a mechanical lung simulator, which are then compared to the device's measurements. The document mentions "bench tested against performance standards," suggesting such methods were used, but details on expert involvement in setting these "ground truths" or validating the testing methodology are absent.
4. Adjudication Method for the Test Set:
This information is not provided. Given that the testing involves adherence to objective performance standards for measuring physiological parameters (airflow, volume), typical "adjudication" in the sense of resolving discrepancies between human readers or algorithm outputs is not directly applicable. The device's measurements are compared against the known, controlled inputs from the test equipment.
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:
A MRMC comparative effectiveness study is not applicable to this device. This is a standalone diagnostic spirometer, not an AI/ML-driven interpretive system that would assist human readers in, for example, image interpretation. The device's function is to objectively measure lung parameters, not to provide interpretations that human readers would then review or augment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance assessment was done. The entire submission focuses on the device's (Vitalograph Model 6600 Compact) ability to accurately measure respiratory parameters (FVC, FEV1, FEV6, PEF, MVV and VC) independently, against international performance standards described in point 1. The device itself performs the measurements; it's not described as having an AI algorithm requiring human interaction for its primary function.
7. The Type of Ground Truth Used:
The ground truth used for performance testing (bench testing) would have been precisely known, controlled flow and volume inputs generated by calibration equipment (e.g., a calibration syringe, flow generator, or mechanical lung simulator) that comply with the requirements of the mentioned ISO and ATS/ERS standards. This is an objective, physical ground truth.
8. The Sample Size for the Training Set:
This information is not applicable as the Vitalograph Model 6600 Compact is a hardware device based on established physical measurement principles (Fleisch Pneumotachograph) and software logic, not a machine learning or AI algorithm that typically requires a "training set." The software (Spirotrac Model 7000) was previously cleared (K141546), implying its development and validation occurred prior, but no training set for an AI model is mentioned for this device.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).