(183 days)
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 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 was designed to comply with the applicable portions of the following voluntary standards; - 1. UL 2601 General requirements for Medical Electrical Equipment - 2. EN 740 Anesthetic Work Stations - 3. EN/IEC 60601-1: General requirements for Medical Electrical Equipment - 4. EN/IEC 60601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatibility - 5. EN 475 Electrically Generated Alarm Signals - 6. ASTM F1463-93 Standard Specification for Alarm Signals - 7. ASTM F1208-94 Anesthesia Breathing Circuit Standard - 8. ASTM F1101-90 -- Standard Specification for Ventilators Intended for Use During Anesthesia - 9. 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.
This 510(k) premarket notification describes the Datex-Ohmeda S/5 Avance Anesthesia System. The submission establishes substantial equivalence to previously cleared devices rather than presenting a de novo study with explicit acceptance criteria for performance. Therefore, the information requested regarding a standalone study, multi-reader multi-case study, and detailed ground truth provenance is not explicitly available in this document.
Here's an analysis based on the provided text, focusing on how the device meets applicable standards rather than specific quantifiable acceptance criteria within a clinical performance study.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are primarily established by compliance with recognized voluntary standards and the performance of predicate devices. The document does not provide specific numerical performance metrics for the S/5 Avance Anesthesia System that would typically be found in a clinical study report. Instead, performance is implied by its adherence to these standards.
| Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance (Implied by Standards Compliance) |
|---|---|
| Safe electrical operation (UL 2601, EN/IEC 60601-1) | Device designed to comply with these standards. |
| Anesthetic workstation functionality (EN 740) | Device designed to comply with this standard. |
| Electromagnetic compatibility (EN/IEC 60601-1-2) | Device designed to comply with this standard. |
| Alarm signal generation (EN 475, ASTM F1463-93) | Device designed to comply with these standards. |
| Anesthesia breathing circuit standards (ASTM F1208-94) | Device designed to comply with this standard. |
| Ventilator standards for anesthesia (ASTM F1101-90) | Device designed to comply with this standard. |
| Anesthetic gas machine standards (ISO 5358) | Device designed to comply with this standard. |
| General inhalation anesthesia and ventilatory support (Indications for Use) | Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients for volume or pressure control ventilation. |
| Substantial equivalence to predicate devices (Datex-Ohmeda Aestiva/5, Excel 3000, AS/3 ADU) | Stated as substantially equivalent in design concepts, technologies, and materials to the listed predicate devices. Validated through rigorous testing to support compliance. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This 510(k) submission does not describe a clinical test set in the traditional sense with patient data. The "testing" mentioned is primarily related to engineering and system verification for compliance with voluntary standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The submission focuses on device design and compliance with standards, not on establishing ground truth for a clinical dataset. Expert review would have been part of the regulatory body's assessment rather than part of the manufacturer's testing described here.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is an anesthesia system, not an AI-assisted diagnostic or treatment planning tool that would typically involve an MRMC study.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This is a medical device (anesthesia system), not an algorithm or AI product. Its performance is integrated into its physical and functional operation, demonstrated through compliance with engineering and safety standards.
7. Type of Ground Truth Used
The "ground truth" in this context is the fulfillment of requirements outlined in recognized national and international voluntary standards (e.g., UL, EN, IEC, ASTM, ISO) for electrical safety, performance, and functionality of anesthesia systems and ventilators. This is not clinical ground truth in terms of diagnoses or outcomes but rather engineering and safety compliance.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See above.
{0}------------------------------------------------
MAR 1 0 2004
| Date: | January 7th, 2004 |
|---|---|
| Subject: | 510(k) Summary of Safety and Effectiveness Informationfor 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;
-
- UL 2601 General requirements for Medical Electrical Equipment
-
- EN 740 Anesthetic Work Stations
-
- EN/IEC 60601-1: General requirements for Medical Electrical Equipment
-
- EN/IEC 60601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatibility
-
- EN 475 Electrically Generated Alarm Signals
-
- ASTM F1463-93 Standard Specification for Alarm Signals
-
- ASTM F1208-94 Anesthesia Breathing Circuit Standard
{1}------------------------------------------------
-
- ASTM F1101-90 -- Standard Specification for Ventilators Intended for Use During Anesthesia
-
- 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
§ 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).