Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the device description focuses on traditional anesthesia system components and functionalities.

Therapeutic

Yes
The device is intended to provide general inhalational anesthesia and ventilation support to patients, which are therapeutic interventions.

Diagnostic

No

Explanation: The device is an anesthesia system intended to provide general inhalational anesthesia and ventilation support. It does not perform diagnostic functions but rather provides therapeutic and life-support functions during surgical procedures.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as an Electronic Gas Mixer, anesthesia ventilator, Integrated Breathing System, and optional multigas module.

IVD (In Vitro Diagnostic)

Based on the provided information, the Intellisave AX700 Anesthesia System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to "provide general inhalational anesthesia and ventilation support to neonatal, pediatric and adult patients." This describes a device used directly on a patient for treatment and life support, not for testing samples taken from the body.
Device Description: The description details components like a gas mixer, ventilator, and breathing system, all of which are involved in delivering gases and supporting respiration in a living patient.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.

IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The Intellisave AX700 operates directly on the patient's respiratory system.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

BSZ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

neonatal, pediatric and adult patients

Intended User / Care Setting

Prescriptive device restricted to use by, or on the order of, a physician.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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. Clinical performance data was not required to demonstrate conformance to specifications and standards or substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K112722

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K102182

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

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
Islevdalvej 211
2610 Rødovre, Denmark | AUG 0 2 2013 |
|----------------------|------------------------------------------------------------------------------------------------------|--------------|
| | Contact Person: Mr. Neil Battiste
Email Address: neil.battiste@philips.com
Phone: 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 Control
Pressure Control
SIMV
Pressure Support

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 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 30cmH2O	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	GE Avance	AX700	Comments
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

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 flows1 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

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
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

7

510(k) Summary, page 8 of 9

| Pneumatic

Specifications	GE Avance	AX700	Comments
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

Specifications	GE Avance	AX700	Comments
Operation
Temperature	10° to 40°C	10° to 40°C	Equivalent
Humidity	15 to 95% relative
humidity	10 to 90% relative
humidity	Equivalent
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
Humidity	10 to 95% RH	10 to 90% relative
humidity	Equivalent

Dimensions	GE Avance	AX700
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

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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.

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