(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: ±15mL, < 60 mL: ±10 mL | 250-1500mL: ± 5%, min. 25mL, 20-250mL: ±10%, min. 10 mL | Equivalent |
| Pressure delivery | ±10% or ±3 cm H2O | ±1 cm H2O | Equivalent |
| PEEP delivery | ±1.5 cm H2O | ±1 cm H2O | Equivalent |
| Tidal volume monitoring | > 210 mL = ±9%, < 210 mL = ±18 mL, < 60 mL = ±10 mL | Adult sensor: 500- 1500ml = ±10%, 200- 500ml = ±50ml, Pediatric sensor: 100- 300ml = ±10%, <100ml = ±10ml | Equivalent |
| Pressure monitoring | -20 -100 cmH2O ±5% or ±2 cm H2O | -20 -100 cmH2O ±2 cm H2O | Equivalent |
| Gas Monitor | |||
| Carbon dioxide | Range: 0-15% (0-113mmHg), Accuracy: ±0.2 vol% + 2% of reading | Range: 0-10%, 0-1%: ±0.1 vol%, 1-5%: ±0.2 vol%, 5-7%: ±0.3 vol%, 7-10%: ±0.5 vol% | Equivalent |
| Oxygen | Range: 0-100%, Accuracy: ±1 vol% + 2% of reading | Range: 0-100%, 0-25%: ±1 vol%, 25-80%: ±2 vol%, 80-100%: ±3 vol% | Equivalent |
| Nitrous oxide | Range: 0-100%, Accuracy: ±2 vol% + 2% of reading | Range: 0-100%, 0-20%: ±2 vol%, 20-100%: ±3 vol% | Equivalent |
| Respiration rate | Range: 4 to 60 BPM | Range: 0 to 100 BPM | Equivalent |
| Halothane | Range: 0 to 6%, Accuracy: ±0.15 vol% + 5 % of reading | Range: 0 to 7.5%, 0-1%: ±0.15 vol%, 1-5%: ±0.2 vol% | Maximum vaporizer setting is 5% (implies AX700 exceeds needed range) |
| Enflurane | Range: 0 to 6%, Accuracy: ±0.15 vol% + 5 % of reading | Range: 0 to 7.5%, 0-1%: ±0.15 vol%, 1-5%: ±0.2 vol% | Maximum vaporizer setting is 5% |
| Isoflurane | Range: 0 to 6%, Accuracy: ±0.15 vol% + 5 % of reading | Range: 0 to 7.5%, 0-1%: ±0.15 vol%, 1-5%: ±0.2 vol% | Maximum vaporizer setting is 5% |
| Sevoflurane | Range: 0 to 8%, Accuracy: ±0.15 vol% + 5 % of reading | Range: 0 to 9%, 0-1%: ±0.15 vol%, 1-5%: ±0.2 vol%, 5-8%: ±0.4 vol% | Maximum vaporizer setting is 8% |
| Desflurane | Range: 0 to 20%, 0 to 5%: ±0.2 vol %, 5 to 10% ±0.5 vol %, 10 to 20% ±1 vol % | Range: 0 to 20%, 0-1%: ±0.15 vol%, 1-5%: ±0.2 vol%, 5-10%: ±0.4 vol%, 10-15%: ±0.6 vol%, 15-18%: ±1 vol% | Equivalent |
| Alarms | |||
| Low Tidal Volume | OFF, 0 to 1500 mL | N/A | Minute Volume alarms, pressure alarms provide the same information. |
| High Tidal Volume | 20 to 1600 mL, OFF | N/A | Minute Volume alarms, pressure alarms provide the same information. |
| Low Minute Volume | OFF, 0 to 10 L/min | 0.1-79.9 L and OFF | Both within range required for application. |
| High Minute Volume | 0.5 to 30 L/min, OFF | 0.1-80.0 L and OFF | Both within range required for application. |
| Low Inspired oxygen | 18 to 99% | 18-100% | Equivalent |
| High Inspired oxygen | 19 to 100%, OFF | 19-100% and OFF | Equivalent |
| Low Expired CO2 | 0.0 to 14.9 % | 0.0 to 15.0 %, OFF | Equivalent |
| High Expired CO2 | 0.1 to 15 %, OFF | 0.0 to 15.0 %, OFF | Equivalent |
| High Inspired AA | 0.1 to 20%, OFF | 0.0 to 30.0 % | Equivalent |
| Low Resp. Rate | 0 to 99 BPM, OFF | 4 to 80 BPM, OFF | Equivalent |
| High Resp. Rate | 2 to 100, OFF | 4 to 80 BPM. OFF | Equivalent |
| Apnea alarm, information | 30 seconds | 20 seconds, automatic ventilation | Equivalent |
| Apnea alarm, high priority | 120 seconds | 60 seconds, manual and automatic ventilation | Equivalent |
| Low airway pressure | Below PEEP+4 cm H2O for 20 sec. | Below PEEP+2 cm H2O for 15 sec. (Disconnection alarm) | Disconnection alarm (functional equivalence) |
| High airway pressure | 12 to 100 cmH2O | 10-82 cmH2O | Functionally equivalent; ranges overlap and are within clinical needs |
| Sustained airway pressure | Pmax <30 cmH2O: 6cmH2O; Pmax 30-60 cmH2O: 20% of Pmax; Pmax >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 <1LPM; ± 2.5% setting; 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."
{0}------------------------------------------------
PHILIPS
Philips Healthcare
Islevdalvej 211 2610 Roedovre Denmark
Anesthesia Care
510 (k) Summary of IntelliSave AX700 Anesthesia System
| 510(k) Owner: | Philips Anesthesia CareIslevdalvej 2112610 Rødovre, Denmark | AUG 0 2 2013 |
|---|---|---|
| Contact Person: Mr. Neil BattisteEmail Address: neil.battiste@philips.comPhone: 407-754-4813 | ||
| Trade Name: | Intellisave AX700 Anesthesia System | |
| Common Name: | Anesthesia System | |
| Classification Name: | Anesthesia Breathing Machine per 21 CFR §868.5160,product code BSZ. |
Predicate Device:
This device is substantially equivalent to the GE Avance Anesthesia Breathing Machine, which was cleared to market on December 11, 2011 via 510(k) K112722.
Philips Anesthesia Care lslevdalvej 211 2610 Roedovre Denmark CVR 28 64 30 12
Phone +45 4450 9990 Fax +45 4450 9999 info@dameca.dk www.philips.com/anesthesia www.dameca.dk
August 2, 2013
{1}------------------------------------------------
510(k) Summary, page 2 of 9
Device Description:
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) that allows the operator to choose a fresh gas flow between O2/N2O or O2/Air in the range 0-20 L/min. If N2O is selected as a carrier gas, the N2O percentage is limited to 75% (minimum 25% 02). Both a real-time clock and stopwatch are integrated into the electronic gas mixer.
- An anesthesia ventilator with the following ventilation modes: .
- Volume Controlled Ventilation ●
- . Pressure Controlled Ventilation
- Synchronized Intermittent Mandatory Ventilation
- 트 Pressure Supported Ventilation
- . Pressure Regulated Volume Target
- 트 Volume Supported Ventilation
- An Integrated Breathing System (IBS) that integrates a bag-in-bottle and patient rebreathing . circuit (including an absorber) into the same block. Thus, there are only two hoses (inspiratory and expiratory) from the breathing system to the V-piece. An APL (Adjustable Pressure Limiting) valve integrated into the breathing system allows the operator to choose between manual ventilation or spontaneous respiration.
- An optional multigas module that measures respiration rate, inspired and expired . concentrations of N20. CO2 and anesthetic agents. The multigas module has automatic identification of primary and secondary anesthetic agents.
Intended Use:
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.
{2}------------------------------------------------
510(k) Summary, page 3 of 9
Summary Of Technological Characteristics:
The Intellisave 'AX700 Anesthesia Breathing Machine uses has the same technological characteristics as the predicate device. Both are software controlled electromechanical devices designed to deliver inhalation anesthesia during surgery
Comparison between predicate and proposed device:
The Intellisave AX700 Anesthesia Breathing Machine uses equivalent technology as the GE Avance Anesthesia Breathing Machine (K112722). The following table compares these two devices to confirm substantial equivalence.
| GE Avance | AX700 | Comments | |
|---|---|---|---|
| Modes | Volume ControlPressure ControlSIMVPressure SupportPCV-VGCardiac Bypass Mode | Volume ControlledVentilationPressure ControlledVentilation SIMVPressure SupportedVentilationVolume SupportedVentilationPRVTHeart-Lung Mode | Equivalent |
| Intended Use | The GE AvanceAnesthesia System isintended to providegeneral inhalationanesthesia andventilatory support to awide range of patients(neonatal, pediatric,adult). The device isintended for volume orpressure controlventilation. | The Intellisave AX700Anesthesia System isintended to provide generalinhalational anesthesia andventilation support toneonatal, pediatric andadult patients. The deviceis intended to providevolume or pressurecontrolled ventilation. | Equivalent |
| Ranges | GE Avance | AX700 | Comments |
| 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 |
| PressureSupport: | Off, 2 to 40 cmH2O | 4 to 50 cmH2O | Equivalent |
{3}------------------------------------------------
| Ranges | GE Avance | AX700 | Comments |
|---|---|---|---|
| Respiration Rate: | 4 - 100 BPM (VCV,PCV, PCV-VG)2 to 60 BPM (SIMV,PSV) | 4 to 80 BPM | Both within rangerequired forapplication. |
| 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 |
| Inspirationtermination: | 5 to 50% | 10 to 80% (expiratorytriggering) | Both within rangerequired forapplication. |
| InspiratoryPause: | 0-60% | 0 to 70% | Equivalent |
| PEEP: | OFF, 4 to 30cmH2O | OFF, 4 to 20 cmH2O | Both within rangerequired forapplication. |
| Ventilator gasflow: | Continuous: Max. 80 L/minPeak: 120 L/min | Continuous: Max. 80 L/minPeak: 120 L/min | Equivalent |
| (fresh gas) Flowcompensation: | 200 mL/min to 15L/min | 200 mL/min to 20 L/min | Equivalent |
| Accuracy | GE Avance | AX700 | Comments |
|---|---|---|---|
| Tidal volumedelivery | > 210 mL: ±7%< 210 mL: ±15mL< 60 mL: ±10 mL | 250-1500mL:± 5%, min.25mL20-250mL: ±10%, min. 10mL | Equivalent |
| Pressure delivery | ±10% or ±3 cm H2O | ±1 cm H2O | Equivalent |
| PEEP delivery | ±1.5 cm H2O | ±1 cm H2O | Equivalent |
| Tidal volumemonitoring | > 210 mL = ±9%< 210 mL = ±18 mL< 60 mL = ±10 mL | Adult sensor:500- 1500ml = ±10%200- 500ml = ±50mlPediatric sensor:100- 300ml = ±10%<100ml = ±10ml | Equivalent |
| Pressuremonitoring | -20 -100 cmH2O±5% or ±2 cm H2O | -20 -100 cmH2O±2 cm H2O | Equivalent |
{4}------------------------------------------------
| Gas Monitor | GE Avance | AX700 | Comments |
|---|---|---|---|
| Carbon dioxide | Range:0-15%(0-113mmHg)Accuracy: ±0.2 vol% +2% of reading | Range: 0-10%0-1%: ±0.1 vol%1-5%: ±0.2 vol%5-7%: ±0.3 vol%7-10%: ±0.5 vol% | Equivalent |
| Oxygen | Range: 0-100%Accuracy: ±1 vol% + 2% of reading | Range: 0-100%0-25%: ±1 vol%25-80%: ±2 vol%80-100%: ±3 vol% | Equivalent |
| Nitrous oxide | Range: 0-100%Accuracy: ±2 vol% + 2% of reading | Range: 0-100%0-20%: ±2 vol%20-100%: ±3 vol% | Equivalent |
| Respiration rate | range: 4 to 60 BPM | Range: 0 to 100 BPM | Equivalent |
| Halothane | range: 0 to 6%accuracy: ±0.15 vol%+ 5 % of reading | range: 0 to 7.5%0-1%: ±0.15 vol%1-5%: ±0.2 vol% | Maximum vaporizersetting is 5% |
| Enflurane | range: 0 to 6%accuracy: ±0.15 vol%+ 5 % of reading | range: 0 to 7.5%0-1%: ±0.15 vol%1-5%: ±0.2 vol% | Maximum vaporizersetting is 5% |
| Isoflurane | range: 0 to 6%accuracy: ±0.15 vol%+ 5 % of reading | range: 0 to 7.5%0-1%: ±0.15 vol%1-5%: ±0.2 vol% | Maximum vaporizersetting is 5% |
| Sevoflurane | range: 0 to 8%accuracy: ±0.15 vol%+ 5 % of reading | range: 0 to 9%0-1%: ±0.15 vol%1-5%: ±0.2 vol%5-8%: ±0.4 vol% | Maximum vaporizersetting is 8% |
| Desflurane | range: 0 to 20%0 to 5%: ±0.2 vol %5 to 10% ±0.5 vol %10 to 20% ±1 vol % | range: 0 to 20%0-1%: ±0.15 vol%1-5%: ±0.2 vol%5-10%: ±0.4 vol%10-15%: ±0.6 vol%15-18%: ±1 vol% | Equivalent |
In addition to being equivalent to the GE Avance, the gas monitor is exactly the same as that used in the Maquet Flow-i Anesthesia Gas Machine (K102182).
{5}------------------------------------------------
| Alarms | GE Avance | AX700 | Comments |
|---|---|---|---|
| Low TidalVolume | OFF, 0 to 1500 mL | N/A | Minute Volumealarms, pressurealarms provide thesame information. |
| High TidalVolume | 20 to 1600 mL, OFF | N/A | Minute Volumealarms, pressurealarms provide thesame information. |
| Low MinuteVolume | OFF, 0 to 10 L/min | 0.1-79.9 L and OFF | Both within rangerequired forapplication. |
| High MinuteVolume | 0.5 to 30 L/min, OFF | 0.1-80.0 L and OFF | Both within rangerequired forapplication. |
| Low Inspiredoxygen | 18 to 99% | 18-100% | Equivalent |
| High Inspiredoxygen | 19 to 100%, OFF | 19-100% and OFF | Equivalent |
| Low ExpiredCO2 | 0.0 to 14.9 % | 0.0 to 15.0 %, OFF | Equivalent |
| High ExpiredCO2 | 0.1 to 15 %, OFF | 0.0 to 15.0 %, OFF | Equivalent |
| High Inspired AA | 0.1 to 20%, OFF | 0.0 to 30.0 % | Equivalent |
| Low Resp. Rate | 0 to 99 BMP, OFF | 4 to 80 BPM, OFF | Equivalent |
| High Resp. Rate | 2 to 100, OFF | 4 to 80 BPM. OFF | Equivalent |
| Apnea alarm,information | 30 seconds | 20 seconds, automaticventilation | Equivalent |
| Apnea alarm,high priority | 120 seconds | 60 seconds, manualand automaticventilation | Equivalent |
| Low airwaypressure | Below PEEP+4 cm H2Ofor 20 sec. | Below PEEP+2 cmH2O for 15 sec.(Disconnection alarm) | disconnection alarm |
| High airwaypressure | 12 to 100 cmH2O | 10-82 cmH2O | |
| Sustained airwaypressure(automaticventilation) | Pmax <30 cmH2O:6cmH2OPmax30-60 cmH2O: 20%of PmaxPmax>60 cmH2O: 12 cmH2O for 15 seconds(+PEEP-2cmH2O withPEEP on) | PEEP + 5 cmH2O for15 sec | Equivalent |
| Alarm silence | 120 seconds | 120 seconds | Equivalent |
{6}------------------------------------------------
| Fresh gas | GE Avance | AX700 | Comments |
|---|---|---|---|
| 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 | $\pm$ 5% or $\pm$ 20 mL/min | $\pm$ 10% or $\pm$ 50 mL/min | Both within range required for application. |
| Balance gas flow accuracy | $\pm$ 5% or $\pm$ 20 mL/min (larger of) Air/N2O | $\pm$ 10% or $\pm$ 50 mL/min | Both within range required for application. |
| Total flow accuracy | $\pm$ 10% or $\pm$ 40 mL/min | $\pm$ 10% or $\pm$ 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 | $\pm$ 5% V/V for flows<1LPM$\pm$ 2.5%setting;flows>1 LPM | $\pm$ 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. |
| ElectricalSpecifications | GE Avance | AX700 | Comments |
|---|---|---|---|
| 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 with2A fuses, and one 3Afuse (120 V), breakers,isolation transformer | 3 outlets on back with3.15A fuse (120 V) andone 1 outlet in front(vaporizer) with 3.15 Afuse. Isolationtransformer | Equivalent |
{7}------------------------------------------------
510(k) Summary, page 8 of 9
| PneumaticSpecifications | GE Avance | AX700 | Comments |
|---|---|---|---|
| Aux. Fresh gasOutlet | ISO 22 mm OD / 15mm ID | ISO 22 mm OD / 15 mmID | Equivalent |
| Gas supply input | 35 to 100 psi | 58 to 87 psi | Both within range forOperating Roomapplication |
| AdjustablePressure Limitingvalve | 0.8 to 70 cm H2O | Spontaneous, 5 to 75cmH2O | Equivalent |
| EnvironmentalSpecifications | GE Avance | AX700 | Comments |
|---|---|---|---|
| Operation | |||
| Temperature | 10° to 40°C | 10° to 40°C | Equivalent |
| Humidity | 15 to 95% relativehumidity | 10 to 90% relativehumidity | Equivalent |
| Altitude | -440 to 3565 m | -100 to 3000 m | Both within rangerequired forapplication. |
| Storage | |||
| Temperature | -25° to 60°C/-13° to140°F | -20° to 60°C | Equivalent |
| Humidity | 10 to 95% RH | 10 to 90% relativehumidity | Equivalent |
| Dimensions | GE Avance | AX700 | Comments |
|---|---|---|---|
| Height: | 136 cm | 155 cm | |
| Width: | 76 cm | 81 cm | |
| Depth: | 76 cm | 79 cm | |
| Weight: | Appx 135 kg/298lb | Appx. 150 kg/331 lb |
Based on the above assessment, we confirm that the Intellisave AX700 Anesthesia Breathing Machine is substantially equivalent to the GE Avance Anesthesia Breathing Machine.
{8}------------------------------------------------
Assessment Of Non-Clinical Performance Data:
The Intellisave AX700 has been thoroughly tested through verification and validation, including software validation, in bench testing under simulated use conditions. Compliance with applicable voluntary standards has also been demonstrated as follows:.
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, . 1988; with Amendments
- IEC 60601-1-1:2000, Medical electrical equipment -- Part 1-1: Safety requirements for . medical electrical systems.
- IEC 60601-1-2:2001.Medical electrical equipment-Part 1-2:Electromagnetic . Compatibility-Requirements & Tests w Amendments.
- 1EC 60601-1-4; 2000,Medical electrical equipment-Part 1-1-4: Programmable Electrical . Medical Systems
- IEC 60601-1-6:2006,Medical electrical equipment-Part 1-1-6: Usability .
- IEC 60601-1-8: 2003, Medical electrical equipment Part 1-8: Alarm systems in medical . equipment
- IEC 60601-2-13 Edition 3.1 2009-08, Medical electrical equipment Part 2-13: Particular . requirements for anaesthetic systems.
- ISO 10079-3:1999, Suction equipment powered from a vacuum or pressure source .
- 1SO 21647:2004, Medical electrical equipment Particular requirements for respiratory . gas monitors.
Assessment Of Non-Clinical Testing:
Clinical performance data was not required to demonstrate conformance to specifications and standards or substantial equivalence.
Conclusion:
The Intellisave AX700 Anesthesia System has been found to be substantially equivalent to the predicate device.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centered horizontally. The words are all capitalized and evenly spaced.
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration
10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 2, 2013
Philips Anesthesia Care C/O Mr. Neil Battiste lslevdalvej 211 Roedovre. Denmark 2610
Re: K122063
Trade/Device Name: Intellisave AX700 Anesthesia System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas machine for anesthesia or analgesia Regulatory Class: II Product Code: BSZ Dated: July 24, 2013 Received: July 26, 2013
Dear Mr. Battiste:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
{10}------------------------------------------------
Page 2 - Mr. Battiste
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID FOR
Sincerely yours,
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{11}------------------------------------------------
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Intellisave AX700 Anesthesia System
Indications for Use:
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.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﺍﻟﻤﻨﺘﺨﺐ - - Maria Jison
2013.08.02 15:09:44 -04:00 (Dir istou Sign Off) Division of Anesthesiology, General Hospital Respiratory. Infection Cantiol and Dental Devices 510(k) Number: K122063
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).