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510(k) Data Aggregation
(385 days)
The Intellisave AX700 Anesthesia System is intended to provide general inhalational anesthesia and ventilation support to neonatal, pediatric and adult patients. The device is intended to provide volume or pressure controlled ventilation.
The Intellisave AX700 suitable for most types of inhalation anesthesia. O2 and N2O or O2 and Air can be administered, and anesthesia vaporizer(s) can be connected to a back bar. The gasses can be supplied from a centralized supply or cylinders. The Intellisave AX 700 is a prescriptive device restricted to use by, or on the order of, a physician. The Intellisave AX700 includes the following: An Electronic Gas Mixer (EGM), an anesthesia ventilator with various ventilation modes, an Integrated Breathing System (IBS), and an optional multigas module.
The Philips Intellisave AX700 Anesthesia System is an anesthesia breathing machine, which is a medical device and therefore its performance is compared to a similar predicate device already on the market rather than having explicit acceptance criteria set. The study conducted to demonstrate equivalence is a non-clinical performance assessment which shows how the AX700 is substantially equivalent to the GE Avance Anesthesia Breathing Machine (K112722).
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for a medical device (anesthesia system), direct "acceptance criteria" are not explicitly defined as pass/fail thresholds for an AI algorithm's performance. Instead, the "acceptance criteria" can be interpreted as demonstrating that the Philips Intellisave AX700 Anesthesia System performs equivalently to the predicate device, the GE Avance Anesthesia Breathing Machine (K112722), across various technical and functional specifications. The table below summarizes the comparison presented in the 510(k) summary, effectively acting as the reported device performance against the predicate's established performance.
| Category | Predicate Device (GE Avance) Performance | Proposed Device (AX700) Performance | Equivalence Assessment (Comments) |
|---|---|---|---|
| Ventilation Modes | Volume Control, Pressure Control, SIMV, Pressure Support, PCV-VG, Cardiac Bypass Mode | Volume Controlled Ventilation, Pressure Controlled Ventilation, SIMV, Pressure Supported Ventilation, Volume Supported Ventilation, PRVT, Heart-Lung Mode | Equivalent |
| Intended Use | General inhalation anesthesia and ventilatory support to neonatal, pediatric, adult patients; volume or pressure control ventilation. | General inhalational anesthesia and ventilation support to neonatal, pediatric, and adult patients; volume or pressure controlled ventilation. | Equivalent |
| Ranges (Ventilation) | |||
| Tidal volume | 20 to 1500 mL | 20 to 1500 mL | Equivalent |
| Minute volume | 0 to 99.9 L/min | 0.2 to 60.0 L/min | Equivalent |
| Pressure, inspired | 5 to 60 cmH2O | 4 to 67 cmH2O | Equivalent |
| Pressure limit | 12 to 100 cmH2O | 10 to 80 cmH2O | Equivalent |
| Pressure Support | Off, 2 to 40 cmH2O | 4 to 50 cmH2O | Equivalent |
| Respiration Rate | 4 - 100 BPM (VCV, PCV, PCV-VG), 2 to 60 BPM (SIMV, PSV) | 4 to 80 BPM | Both within range required for application. |
| I:E Ratio | 2:1 to 1:8 | 3:1 to 1:9.9 | Equivalent |
| Flow trigger | 1 to 10 L/min | 1 to 10 LPM | Equivalent |
| Inspiration termination | 5 to 50% | 10 to 80% (expiratory triggering) | Both within range required for application. |
| Inspiratory Pause | 0-60% | 0 to 70% | Equivalent |
| PEEP | OFF, 4 to 30 cmH2O | OFF, 4 to 20 cmH2O | Both within range required for application. |
| Ventilator gas flow | Continuous: Max. 80 L/min, Peak: 120 L/min | Continuous: Max. 80 L/min, Peak: 120 L/min | Equivalent |
| (Fresh gas) Flow compensation | 200 mL/min to 15 L/min | 200 mL/min to 20 L/min | Equivalent |
| Accuracy (Ventilation) | |||
| Tidal volume delivery | > 210 mL: ±7%, 210 mL = ±9%, 60 cmH2O: 12 cm H2O for 15 seconds (+PEEP-2cmH2O with PEEP on) | PEEP + 5 cmH2O for 15 sec | Equivalent |
| Alarm silence | 120 seconds | 120 seconds | Equivalent |
| Fresh Gas | |||
| Flow range (per gas) | OFF, 100 mL/min-15 L/min | OFF, 100 mL/min to 10 LPM | Both within range required for application. |
| Total Flow range | OFF, 150 mL/min-15 L/min | OFF, 200 mL/min to 20 LPM | Both within range required for application. |
| O2 flow accuracy | ± 5% or ± 20 mL/min | ± 10% or ± 50 mL/min | Both within range required for application. |
| Balance gas flow accuracy | ± 5% or ± 20 mL/min (larger of) Air/N2O | ± 10% or ± 50 mL/min | Both within range required for application. |
| Total flow accuracy | ± 10% or ± 40 mL/min | ± 10% or ± 50 mL/min | Equivalent |
| O2 concentration range (Air) | 21%, 25 to 100% (Air); 25 to 100% (N2O) | 21 to 100% (balance gas Air); 25 to 100% (balance gas N2O) | Equivalent |
| O2 concentration accuracy | ± 5% V/V for flows 1 LPM | ± 5% V/V | Equivalent |
| Compensation | to 20℃ and 101.3 kPa | to 20℃ and 101.3 kPa | Equivalent |
| Alternate O2 flow | 500 mL/min – 10 L/min | 5 L/min - 15 L/min | Both within range required for application. |
| Electrical Specs | |||
| Power input | 100-120 Vac, 50/60 Hz | 100-120 Vac, 50/60 Hz | Equivalent |
| Rating | 10A@220Vac/15A@120Vac | 10A@220Vac/15A@120 Vac | Equivalent |
| Outlets | 3 outlets on back with 2A fuses, and one 3A fuse (120 V), breakers, isolation transformer | 3 outlets on back with 3.15A fuse (120 V) and one 1 outlet in front (vaporizer) with 3.15 A fuse. Isolation transformer | Equivalent |
| Pneumatic Specs | |||
| Aux. Fresh gas Outlet | ISO 22 mm OD / 15 mm ID | ISO 22 mm OD / 15 mm ID | Equivalent |
| Gas supply input | 35 to 100 psi | 58 to 87 psi | Both within range for Operating Room application. |
| Adjustable Pressure Limiting valve | 0.8 to 70 cm H2O | Spontaneous, 5 to 75 cmH2O | Equivalent |
| Environmental Specs | |||
| Operation Temperature | 10° to 40°C | 10° to 40°C | Equivalent |
| Operation Humidity | 15 to 95% relative humidity | 10 to 90% relative humidity | Equivalent |
| Operation Altitude | -440 to 3565 m | -100 to 3000 m | Both within range required for application. |
| Storage Temperature | -25° to 60°C / -13° to 140°F | -20° to 60°C | Equivalent |
| Storage Humidity | 10 to 95% RH | 10 to 90% relative humidity | Equivalent |
2. Sample Size Used for the Test Set and Data Provenance
This submission is for a traditional medical device (anesthesia system), not an AI/ML-driven device that relies on a test set of data samples for algorithmic performance evaluation.
Therefore, there is no "test set" sample size in the context of data (e.g., images, patient records) or any mention of data provenance (e.g., country of origin, retrospective/prospective).
The "testing" mentioned refers to engineering verification and validation testing of the physical and software components of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and their Qualifications
As there is no "test set" of data samples in the sense of AI/ML, there were no experts used to establish ground truth for such a test set. This device is evaluated based on its functional specifications and compliance with established medical device standards.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the context of data requiring adjudication. The evaluation is based on engineering tests and comparison to a predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size with AI vs. without AI assistance
No MRMC comparative effectiveness study was done as this is not an AI/ML-enabled diagnostic or assistive device. The submission describes a standalone anesthesia system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
This question is not directly applicable in the context of this device. The device is an anesthesia system, a piece of medical equipment, not an algorithm being evaluated for its standalone performance. The "standalone" performance is the intrinsic technical and functional performance of the system as measured during bench testing and detailed in the comparison table. The device itself is designed for human-in-the-loop operation by a physician.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through engineering specifications, compliance with recognized industry standards (e.g., IEC, ISO), and direct measurement of physical and software outputs during verification and validation testing. The predicate device's established performance serves as the benchmark against which the proposed device's "truth" (its actual performance characteristics) is compared.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set."
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(172 days)
The indication for FLOW-i Anaesthesia System is administering inhalation Anaesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anaesthesia administration.
FLOW-i (K102182 SE5/9/2011) is a high-performance Anaesthesia system designed to meet the many ventilatory challenges within Anaesthesia, as well as to provide inhalation Anaesthesia. It is intended to serve a wide range of patients from neonatal to adult.
FLOW-i is a software-controlled semi-closed system for inhalation Anaesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide).
The most important performance features of the FLOW-i Anaesthesia system are:
- o a ventilator whose functionality is based on ICU-ventilator technology,
- o the volume reflector technology,
- o the electronically controlled injector vaporizers and
- o the ergonomic design.
The proposed modification (K112114) includes two additional ventilation modes and a backup function:
- o PRVC, Pressure Regulated Volume Control
- O SIMV (VC and PC), Synchronized Intermittent Mandatory Ventilation
- o Pressure Support with Backup
In addition to the new ventilation modes the proposed modification includes a number of minor changes.
PRVC is a controlled mode of ventilation which combines the advantages of volume controlled and pressure controlled ventilation. FLOW-i assures that the preset tidal volume is delivered at the lowest possible pressure in order to protect the lungs. The flow during inspiration is decelerating and patient can trigger extra breaths.
SIMV is designed to improve synchronization of breaths which can decrease patient's tendency to fight against the Anaesthesia ventilator.
Backup functionality has been added to Pressure Support to add safety for the patient and improve the work flow for the users by minimizing apnea alarms.
The provided text describes modifications to the MAQUET FLOW-i Anaesthesia System (K112114) and claims substantial equivalence to a previously cleared version of the FLOW-i (K102182) and the GE Datex-Ohmeda, Aisys Anaesthesia System (K090233). Rather than outlining specific acceptance criteria and a detailed study proving performance against them, the document focuses on demonstrating that the updated device performs within its specifications and applied performance standards through various non-clinical tests.
Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it lists areas where performance testing was conducted to ensure the device performs "within its specifications and within the limits of the applied performance standards."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technical data specifications | Performs within specifications |
| Measurement ranges | Performs within specified ranges |
| Measurement accuracy | Accuracy verified |
| Delivery accuracy | Accuracy verified |
| Construction | Verified |
| Features | Verified |
| Interfaces | Verified |
| Handling | Verified |
| Critical situations | Verified |
| Interventions | Verified |
| Electrical safety | Covered in evaluation |
| Mechanical safety | Covered in evaluation |
| Electromagnetic Compatibility | Covered in evaluation |
| Software Validation | Covered in evaluation |
| Usability | Covered in evaluation |
| Tightness | Covered in evaluation |
| Verification of Alarms | Covered in evaluation |
| Packaging | Covered in evaluation |
| Verification of Operating Data | Covered in evaluation |
| Biocompatibility | Covered in evaluation |
| Vaporizer filling system | Covered in evaluation |
| New Ventilation Modes (PRVC, SIMV) | Functionality equivalent to predicate device (Aisys) |
| Backup Functionality (Pressure Support) | Assessed for safety and workflow improvement |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of a patient cohort or a dataset with a defined sample size for clinical evaluation. The testing described is non-clinical, focusing on device performance characteristics. Therefore, information on data provenance (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study described is a non-clinical device performance and verification study, not a clinical study involving expert assessment of medical data.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned. The study is a non-clinical verification and validation of device performance against specifications and standards, not a comparison of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an anaesthesia system, which is inherently a human-in-the-loop system controlled by healthcare professionals. The concept of "standalone algorithm performance" as typically applied to AI/ML software is not relevant here. The performance testing focuses on the system's ability to deliver ventilation and anaesthesia as specified.
7. The Type of Ground Truth Used
For the non-clinical performance and verification testing, the "ground truth" would be established by the engineering and design specifications for the device, and compliance with recognized standards (e.g., electrical safety, EMC). It relies on objective measurements against these predefined acceptable ranges and behaviors. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of non-clinical evaluation.
8. The Sample Size for the Training Set
No training set is mentioned as this device is not an AI/ML algorithm that undergoes a "training" phase. The system is software-controlled, but the "validation" described is for the software's functionality and performance against design requirements, not statistical learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned.
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