INTELLISAVE AX700 ANESTHESIA SYSTEM

K122063 · Philips Anesthesia Care · BSZ · Aug 2, 2013 · Anesthesiology

Device Facts

• Record ID: K122063
• Device Name: INTELLISAVE AX700 ANESTHESIA SYSTEM
• Applicant: Philips Anesthesia Care
• Product Code: BSZ · Anesthesiology
• Decision Date: Aug 2, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

Intellisave AX700 is an anesthesia system for inhalation anesthesia and ventilation support. Inputs: O2, N2O, or Air from centralized supply or cylinders. Electronic Gas Mixer (EGM) controls gas flow (0-20 L/min); Integrated Breathing System (IBS) manages patient rebreathing circuit and bag-in-bottle. Ventilator supports multiple modes: Volume Controlled, Pressure Controlled, SIMV, Pressure Supported, PRVT, and Volume Supported. Optional multigas module measures respiration rate, N2O, CO2, and anesthetic agents with auto-identification. Used in OR by physicians/clinicians. Output: delivered gas mixtures and ventilation parameters displayed for clinician monitoring. Clinicians use real-time data to adjust anesthesia delivery and ventilation settings, ensuring patient stability during surgery.

Clinical Evidence

No clinical data was required. Substantial equivalence was demonstrated through bench testing, software validation, and verification of performance specifications against recognized international standards (IEC 60601-1, 60601-1-2, 60601-1-4, 60601-1-6, 60601-1-8, 60601-2-13, ISO 10079-3, ISO 21647).

Technological Characteristics

Software-controlled electromechanical anesthesia system. Features Electronic Gas Mixer (EGM), Integrated Breathing System (IBS), and optional multigas module. Ventilation modes: Volume/Pressure Controlled, SIMV, Pressure/Volume Supported, PRVT. Connectivity: Standalone. Power: 100-120 Vac. Standards: IEC 60601-1, 60601-1-2, 60601-1-4, 60601-1-6, 60601-1-8, 60601-2-13, ISO 10079-3, ISO 21647.

Indications for Use

Indicated for neonatal, pediatric, and adult patients requiring general inhalational anesthesia and ventilation support (volume or pressure controlled).

Regulatory Classification

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. 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).

Predicate Devices

• GE Avance Anesthesia Breathing Machine (K112722)

Reference Devices

• Maquet Flow-i Anesthesia Gas Machine (K102182)

Submission Summary (Full Text)

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K122063

PHILIPS

# Philips Healthcare

Islevdalvej 211 2610 Roedovre Denmark

Anesthesia Care

# 510 (k) Summary of IntelliSave AX700 Anesthesia System

| 510(k) Owner: | Philips Anesthesia Care<br>Islevdalvej 211<br>2610 Rødovre, Denmark | AUG 0 2 2013 |
|----------------------|------------------------------------------------------------------------------------------------------|--------------|
| | Contact Person: Mr. Neil Battiste<br>Email Address: [e-mail]<br>Phone: [phone] | |
| Trade Name: | Intellisave AX700 Anesthesia System | |
| Common Name: | Anesthesia System | |
| Classification Name: | Anesthesia Breathing Machine per 21 CFR §868.5160,<br>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 [phone] Fax [phone] [e-mail] www.philips.com/anesthesia www.dameca.dk

August 2, 2013

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#### 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.

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#### 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 Control<br>Pressure Control<br>SIMV<br>Pressure Support<br><br>PCV-VG<br>Cardiac Bypass Mode | Volume Controlled<br>Ventilation<br>Pressure Controlled<br>Ventilation SIMV<br>Pressure Supported<br>Ventilation<br>Volume Supported<br>Ventilation<br>PRVT<br>Heart-Lung Mode | Equivalent |
| Intended Use | The GE Avance<br>Anesthesia System is<br>intended to provide<br>general inhalation<br>anesthesia and<br>ventilatory support to a<br>wide range of patients<br>(neonatal, pediatric,<br>adult). The device is<br>intended for volume or<br>pressure control<br>ventilation. | The Intellisave AX700<br>Anesthesia System is<br>intended to provide general<br>inhalational anesthesia and<br>ventilation support to<br>neonatal, pediatric and<br>adult patients. The device<br>is intended to provide<br>volume or pressure<br>controlled 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,<br>inspired: | 5 to 60 cmH2O | 4 to 67 cmH2O | Equivalent |
| Pressure limit: | 12 to 100 cmH2O | 10 to 80 cmH2O | Equivalent |
| Pressure<br>Support: | Off, 2 to 40 cmH2O | 4 to 50 cmH2O | Equivalent |

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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Ranges | GE Avance | AX700 | Comments |
|-----------------------------------|-----------------------------------------------------------------|----------------------------------------------|---------------------------------------------------|
| Respiration Rate: | 4 - 100 BPM (VCV,<br>PCV, PCV-VG)<br>2 to 60 BPM (SIMV,<br>PSV) | 4 to 80 BPM | Both within range<br>required for<br>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<br>termination: | 5 to 50% | 10 to 80% (expiratory<br>triggering) | Both within range<br>required for<br>application. |
| Inspiratory<br>Pause: | 0-60% | 0 to 70% | Equivalent |
| PEEP: | OFF, 4 to 30cmH2O | OFF, 4 to 20 cmH2O | Both within range<br>required for<br>application. |
| Ventilator gas<br>flow: | Continuous: Max. 80 L/min<br>Peak: 120 L/min | Continuous: Max. 80 L/min<br>Peak: 120 L/min | Equivalent |
| (fresh gas) Flow<br>compensation: | 200 mL/min to 15<br>L/min | 200 mL/min to 20 L/min | Equivalent |

| Accuracy | GE Avance | AX700 | Comments |
|----------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------|
| Tidal volume<br>delivery | > 210 mL: ±7%<br>< 210 mL: ±15mL<br>< 60 mL: ±10 mL | 250-1500mL:± 5%, min.<br>25mL<br>20-250mL: ±10%, min. 10<br>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<br>monitoring | > 210 mL = ±9%<br>< 210 mL = ±18 mL<br>< 60 mL = ±10 mL | Adult sensor:<br>500- 1500ml = ±10%<br>200- 500ml = ±50ml<br>Pediatric sensor:<br>100- 300ml = ±10%<br><100ml = ±10ml | Equivalent |
| Pressure<br>monitoring | -20 -100 cmH2O<br>±5% or ±2 cm H2O | -20 -100 cmH2O<br>±2 cm H2O | Equivalent |

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| Gas Monitor | GE Avance | AX700 | Comments |
|------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Carbon dioxide | Range:0-15%(0-<br>113mmHg)<br>Accuracy: ±0.2 vol% +<br>2% of reading | Range: 0-10%<br>0-1%: ±0.1 vol%<br>1-5%: ±0.2 vol%<br>5-7%: ±0.3 vol%<br>7-10%: ±0.5 vol% | Equivalent |
| Oxygen | Range: 0-100%<br>Accuracy: ±1 vol% + 2<br>% of reading | Range: 0-100%<br>0-25%: ±1 vol%<br>25-80%: ±2 vol%<br>80-100%: ±3 vol% | Equivalent |
| Nitrous oxide | Range: 0-100%<br>Accuracy: ±2 vol% + 2<br>% of reading | Range: 0-100%<br>0-20%: ±2 vol%<br>20-100%: ±3 vol% | Equivalent |
| Respiration rate | range: 4 to 60 BPM | Range: 0 to 100 BPM | Equivalent |
| Halothane | range: 0 to 6%<br>accuracy: ±0.15 vol%<br>+ 5 % of reading | range: 0 to 7.5%<br>0-1%: ±0.15 vol%<br>1-5%: ±0.2 vol% | Maximum vaporizer<br>setting is 5% |
| Enflurane | range: 0 to 6%<br>accuracy: ±0.15 vol%<br>+ 5 % of reading | range: 0 to 7.5%<br>0-1%: ±0.15 vol%<br>1-5%: ±0.2 vol% | Maximum vaporizer<br>setting is 5% |
| Isoflurane | range: 0 to 6%<br>accuracy: ±0.15 vol%<br>+ 5 % of reading | range: 0 to 7.5%<br>0-1%: ±0.15 vol%<br>1-5%: ±0.2 vol% | Maximum vaporizer<br>setting is 5% |
| Sevoflurane | range: 0 to 8%<br>accuracy: ±0.15 vol%<br>+ 5 % of reading | range: 0 to 9%<br>0-1%: ±0.15 vol%<br>1-5%: ±0.2 vol%<br>5-8%: ±0.4 vol% | Maximum vaporizer<br>setting is 8% |
| Desflurane | range: 0 to 20%<br>0 to 5%: ±0.2 vol %*<br>5 to 10% ±0.5 vol %<br>10 to 20% ±1 vol %* | range: 0 to 20%<br>0-1%: ±0.15 vol%<br>1-5%: ±0.2 vol%<br>5-10%: ±0.4 vol%<br>10-15%: ±0.6 vol%<br>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).

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| Alarms | GE Avance | AX700 | Comments |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------------|
| Low Tidal<br>Volume | OFF, 0 to 1500 mL | N/A | Minute Volume<br>alarms, pressure<br>alarms provide the<br>same information. |
| High Tidal<br>Volume | 20 to 1600 mL, OFF | N/A | Minute Volume<br>alarms, pressure<br>alarms provide the<br>same information. |
| Low Minute<br>Volume | OFF, 0 to 10 L/min | 0.1-79.9 L and OFF | Both within range<br>required for<br>application. |
| High Minute<br>Volume | 0.5 to 30 L/min, OFF | 0.1-80.0 L and OFF | Both within range<br>required for<br>application. |
| Low Inspired<br>oxygen | 18 to 99% | 18-100% | Equivalent |
| High Inspired<br>oxygen | 19 to 100%, OFF | 19-100% and OFF | Equivalent |
| Low Expired<br>CO2 | 0.0 to 14.9 % | 0.0 to 15.0 %, OFF | Equivalent |
| High Expired<br>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 BMP, OFF | 4 to 80 BPM, OFF | Equivalent |
| High Resp. Rate | 2 to 100, OFF | 4 to 80 BPM. OFF | Equivalent |
| Apnea alarm,<br>information | 30 seconds | 20 seconds, automatic<br>ventilation | Equivalent |
| Apnea alarm,<br>high priority | 120 seconds | 60 seconds, manual<br>and automatic<br>ventilation | Equivalent |
| Low airway<br>pressure | Below PEEP+4 cm H2O<br>for 20 sec. | Below PEEP+2 cm<br>H2O for 15 sec.<br>(Disconnection alarm) | disconnection alarm |
| High airway<br>pressure | 12 to 100 cmH2O | 10-82 cmH2O | |
| Sustained airway<br>pressure<br>(automatic<br>ventilation) | Pmax <30 cmH2O:6cmH2O<br>Pmax30-60 cmH2O: 20%<br>of Pmax<br>Pmax>60 cmH2O: 12 cm<br>H2O for 15 seconds<br>(+PEEP-2cmH2O with<br>PEEP on) | PEEP + 5 cmH2O for<br>15 sec | Equivalent |
| Alarm silence | 120 seconds | 120 seconds | Equivalent |

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| 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)<br>25 to 100% (N2O) | 21 to 100% (balance gas Air)<br>25 to 100% (balance gas N2O) | Equivalent |
| O2 concentration accuracy | $\pm$ 5% V/V for flows<1LPM<br>$\pm$ 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. |

| Electrical<br>Specifications | 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 with<br>2A fuses, and one 3A<br>fuse (120 V), breakers,<br>isolation transformer | 3 outlets on back with<br>3.15A fuse (120 V) and<br>one 1 outlet in front<br>(vaporizer) with 3.15 A<br>fuse. Isolation<br>transformer | Equivalent |

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#### 510(k) Summary, page 8 of 9

| Pneumatic<br>Specifications | GE Avance | AX700 | Comments |
|------------------------------------------|----------------------------|-------------------------------|--------------------------------------------------------|
| Aux. Fresh gas<br>Outlet | ISO 22 mm OD / 15<br>mm ID | ISO 22 mm OD / 15 mm<br>ID | Equivalent |
| Gas supply input | 35 to 100 psi | 58 to 87 psi | Both within range for<br>Operating Room<br>application |
| Adjustable<br>Pressure Limiting<br>valve | 0.8 to 70 cm H2O | Spontaneous, 5 to 75<br>cmH2O | Equivalent |

| Environmental<br>Specifications | GE Avance | AX700 | Comments |
|---------------------------------|--------------------------------|--------------------------------|---------------------------------------------------|
| Operation | | | |
| Temperature | 10° to 40°C | 10° to 40°C | Equivalent |
| Humidity | 15 to 95% relative<br>humidity | 10 to 90% relative<br>humidity | Equivalent |
| Altitude | -440 to 3565 m | -100 to 3000 m | Both within range<br>required for<br>application. |
| Storage | | | |
| Temperature | -25° to 60°C/-13° to<br>140°F | -20° to 60°C | Equivalent |
| Humidity | 10 to 95% RH | 10 to 90% relative<br>humidity | 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.

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#### 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.

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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