(183 days)
Not Found
No
The summary describes a standard anesthesia system and ventilator, focusing on its intended use, device description, and comparison to predicate devices. There is no mention of AI, ML, or related technologies in the provided text.
Yes
The device is intended to provide general inhalation anesthesia and ventilatory support to patients, which are therapeutic functions.
No
The device is an anesthesia system intended to provide general inhalation anesthesia and ventilatory support, not to diagnose a condition.
No
The device description explicitly refers to an "Anesthesia System" and mentions compliance with standards for "Medical Electrical Equipment" and "Anesthetic Work Stations," indicating it is a physical hardware device with integrated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general inhalation anesthesia and ventilatory support." This describes a device used directly on a patient for medical treatment and support, not for testing samples taken from the body.
- Device Description: The description details an "Anesthesia System" and mentions components like a "Ventilator" and "Anesthesia Delivery Unit." These are all consistent with devices used in a clinical setting for patient care.
- 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.
Therefore, the Datex-Ohmeda S/5 Avance Anesthesia System is a medical device used for anesthesia and ventilation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Datex-Ohmeda S/5 Avance Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The S/5 Avance is not suitable for use in a MRI environment.
Product codes (comma separated list FDA assigned to the subject device)
BSZ
Device Description
The Datex-Ohmeda S/5 Avance Anesthesia System and the currently marketed device are The Datest of Interious in design concepts, technologies and materials. The Datex-Ohmeda S/5 Substance Anesthesia System has been validated through rigorous testing that, in part, supports the I compliance of S/5 Avance Anesthesia System to the standards listed above.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
a wide range of patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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).
0
MAR 1 0 2004
| Date: | January 7th, 2004 |
|---|---|
| Subject: | 510(k) Summary of Safety and Effectiveness Information |
| for the Datex-Ohmeda S/5 Avance Anesthesia System | |
| Proprietary: | Datex-Ohmeda S/5 Avance Anesthesia System |
| Common: | Gas Machine, Anesthesia |
| Classification: | Anesthesiology, 73 BSZ, 21 CFR 868.5160 |
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.
The Datex-Ohmeda S/5 Avance Anesthesia System is substantially equivalent to the following currently marketed device:
Datex-Ohmeda Aestiva/5, with 7100 Ventilator, Anesthesia System - Class II -21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K000706
Datex-Ohmeda Excel 3000 (Aestiva), with 7900 Ventilator, Anesthesia System -Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K973896
Datex-Ohmeda AS/3 Anesthesia Delivery Unit (ADU) - Class II -- 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K973985
The Datex-Ohmeda S/5 Avance Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The S/5 Avance is not suitable for use in a MRI environment.
The Datex-Ohmeda S/5 Avance Anesthesia System was designed to comply with the applicable portions of the following voluntary standards;
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- UL 2601 General requirements for Medical Electrical Equipment
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- EN 740 Anesthetic Work Stations
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- EN/IEC 60601-1: General requirements for Medical Electrical Equipment
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- EN/IEC 60601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatibility
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- EN 475 Electrically Generated Alarm Signals
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- ASTM F1463-93 Standard Specification for Alarm Signals
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- ASTM F1208-94 Anesthesia Breathing Circuit Standard
1
-
- ASTM F1101-90 -- Standard Specification for Ventilators Intended for Use During Anesthesia
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- ISO 5358 Anesthetic Gas Machines
The Datex-Ohmeda S/5 Avance Anesthesia System and the currently marketed device are The Datest of Interious in design concepts, technologies and materials. The Datex-Ohmeda S/5 Substance Anesthesia System has been validated through rigorous testing that, in part, supports the I compliance of S/5 Avance Anesthesia System to the standards listed above.
Dan Kosednar, RAC Contact: Manager, Regulatory Planning and Submissions
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2994
Mr. Dan Kosednar Regulatory Planning and Submissions Manager Datex-Ohmeda, Incorporated P.O. Box 7550 Madison, Wisconsin 53707
Rc: K032803
Trade/Device Name: Datex-Ohmeda S/5 Avance Anesthesia System Regulation Number: 868.5160 Regulation Name: Gas Machine, Anesthesia Regulatory Class: II Product Code: BSZ Dated: January 8, 2004 Received: January 9, 2004
Dear Mr. Kosednar:
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 for ass stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered provision 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your de rice to such additional controls. Existing major regulations affecting your device can may of subject to one, when was and Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that i Dri has made a and regulations administered by other Federal agencies. You must
3
Page 2 – Mr. Dan Kosednar
comply with all the Act's requirements, including, but not limited to: registration and listing (21 compry with an the Act 31equirements, with and 01); good manufacturing practice requirements as set CITY art 6077, adomig (21 CFR Part 820); and if applicable, the electronic 101111 the quality systems (20) regarations 531-542 of the Act); 21 CFR 1000-1050. This production comes pro rasketing your device as described in your Section 510(k) icutification. The FDA finding of substantial equivalence of your device to a legally premailted notification: "The First mailing for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at 100 101 594-4646. Also, please note the regulation entitled, Connact the Office of Oremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general intermational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html.
Sincerely vours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 510(k) Number (if known): K032803 Device Name: Datex-Ohmeda S/5 Avance Anesthesia System Indications For Use: The Datex-Ohmeda S/5 Avance Anesthesia System is intended to provide general I he Datex-Olinieda Sr 7 Availed Anosulesand Joteswide range of patients. The device is
inhalation anesthesia and ventilatory support to a wide range of patiently for for intended for volume or pressure control ventilation. The S/5 Avance is not suitable for use in a MRI environment. Over-The-Counter Use AND/OR Prescription Use XXX (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of __ 1
CAurich
nesthesi Seneral Hospital.
510(k) Number: K03280