(189 days)
Ohmeda Excel Series Anesthesia Machines Class II 21CFR868.5160, Ohmeda APAC (Advanced Portable Anesthesia Care) System Class II 21 2. CFR868.5160, Ohmeda 7900 Anesthesia Ventilator - Class II - 21CFR868.5895
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No
The provided text describes a standard anesthesia gas system with mechanical and electronic components for gas delivery and safety features. There is no mention of AI or ML in the intended use, device description, or performance studies summary. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as an "Anesthesia Gas System" and "gas machine that supplies set flows of medical gases to the breathing system," which is a device used to administer anesthesia. Anesthesia administration falls under the domain of controlling or supporting a physiological process, not directly treating a disease or condition.
No
The device is described as an "Anesthesia Gas System" that "supplies set flows of medical gases to the breathing system" and "accept integral monitors for vital signs and respiratory gases," indicating its role in patient support during anesthesia, not in diagnosing medical conditions.
No
The device description clearly outlines a physical anesthesia gas system with various hardware components such as frames, gases, vaporizers, ventilators, cylinder connections, and trolleys. It is not solely software.
Based on the provided information, the Ohmeda Excel 3000 Anesthesia Gas System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use/Indications for Use: The description clearly states its purpose is to "supply set flows of medical gases to the breathing system" for anesthesia. This is a direct therapeutic and life-support function, not a diagnostic test performed on samples outside the body.
- Device Description: The description focuses on the mechanical and gas delivery aspects of the system, including gas types, vaporizer positions, and ventilator compatibility. This aligns with an anesthesia machine, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Excel 3000's function is to deliver gases to a patient during a medical procedure, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The Excel 3000 Anesthesia Gas System is a gas machine that supplies set flows of medical gases to the breathing system. A large selection of frames, gases, vaporizers and ventilators, give full control of the system configuration. The Excel 3000 is available in wide or narrow trolley and pendant models. The narrow trolley and pendant come with two or three gases, two vaporizer positions and up to four cylinder connections. The wide trolley comes with two, three or four gases, three vaporizer positions and up to five cylinder connections. All models have O2 and N2O. The Excel 3000 comes with up to two optional gases (air, CO2, heliox). All Excel systems accept Tec 4, Tec 5 and Tec 6 vaporizers. Excel 3000 systems use either the 7900 Ventilator, 7800 Ventilator, or the 7000 Ventilator, along with being able to accept integral monitors for vital signs and respiratory gases. Safety features and devices within the Excel 3000 decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.
Product codes
73 BSZ
Device Description
The Excel 3000 Anesthesia Gas System is a gas machine that supplies set flows of medical gases to the breathing system. A large selection of frames, gases, vaporizers and ventilators, give full control of the system configuration. The Excel 3000 is available in wide or narrow trolley and pendant models. The narrow trolley and pendant come with two or three gases, two vaporizer positions and up to four cylinder connections. The wide trolley comes with two, three or four gases, three vaporizer positions and up to five cylinder connections. All models have O2 and N2O. The Excel 3000 comes with up to two optional gases (air, CO2, heliox). All Excel systems accept Tec 4, Tec 5 and Tec 6 vaporizers. Excel 3000 systems use either the 7900 Ventilator, 7800 Ventilator, or the 7000 Ventilator, along with being able to accept integral monitors for vital signs and respiratory gases. Safety features and devices within the Excel 3000 decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.
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
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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
The Ohmeda Excel 3000 Anesthesia Gas System has been validated through rigorous testing that, in part, support the compliance of the Ohmeda Excel 3000 Anesthesia Gas System to the above mentioned standards.
Key Metrics
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Predicate Device(s)
Ohmeda Excel Series Anesthesia Machines Class II 21CFR868.5160, Ohmeda APAC (Advanced Portable Anesthesia Care) System Class II 21 2. CFR868.5160, Ohmeda 7900 Anesthesia Ventilator - Class II - 21CFR868.5895
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
APR 2 1 1998
Memorandum
January 23rd, 1998
| Subject: | 510(k) Summary of Safety and Effectiveness Information for the Ohmeda Excel 3000 Anesthesia Gas System |
|---|---|
| Proprietary: | Ohmeda Excel 3000 Anesthesia Gas System |
| Common: | Gas Machine, Anesthesia |
| Classification: | Anesthesiology, 73BSZ, 21CFR868.5160 |
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.
The Ohmeda Excel 3000 Anesthesia Gas System is substantially equivalent to the following currently marketed device:
- Ohmeda Excel Series Anesthesia Machines Class II 21CFR868.5160 ﮩﻨﮯ
- Ohmeda APAC (Advanced Portable Anesthesia Care) System Class II 21 2.
- CFR868.5160
-
- Ohmeda 7900 Anesthesia Ventilator - Class II - 21CFR868.5895
The Excel 3000 Anesthesia Gas System is a gas machine that supplies set flows of medical gases to the breathing system. A large selection of frames, gases, vaporizers and ventilators, give full control of the system configuration. The Excel 3000 is available in wide or narrow trolley and pendant models. The narrow trolley and pendant come with two or three gases, two vaporizer positions and up to four cylinder connections. The wide trolley comes with two, three or four gases, three vaporizer positions and up to five cylinder connections. All models have O2 and N2O. The Excel 3000 comes with up to two optional gases (air, CO2, heliox). All Excel systems accept Tec 4, Tec 5 and Tec 6 vaporizers. Excel 3000 systems use either the 7900 Ventilator, 7800 Ventilator, or the 7000 Ventilator, along with being able to accept integral monitors for vital signs and respiratory gases. Safety features and devices within the Excel 3000 decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.
The Ohmeda Excel 3000 Anesthesia Gas System was designed to comply with the applicable portions of the following voluntary standards;
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- ASTM F1208-94 Anesthesia Breathing Circuit Standard
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- EN 60601-1. IEC 601-1: 1988 Medical Electrical Equipment
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- Draft ISO DIS 7767 Oxygen monitors for monitoring patient breathing mixtures
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- CEN 475 Electrically generated alarm signals
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- IEC 601-1-4:1996 Collateral Standard for Programmable Medical Electrical Equipment
The Ohmeda Excel 3000 Anesthesia Gas System and the currently marketed devices are substantially equivalent in design concepts, technologies and materials. The Ohmeda Excel 3000 Anesthesia Gas System has been validated through rigorous testing that, in part, support the compliance of the Ohmeda Excel 3000 Anesthesia Gas System to the above mentioned standards.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head facing to the left. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 21 1998
Mr. Daniel Kosednar Ohmeda Inc. Ohmeda Drive P.O. Box 7550 Madison, WI 53707-7550
K973896 Re : Ohmeda Excel 3000 Anesthesia System Requlatory Class: II (two) Product Code: 73 BSZ January 23, 1998 Dated: Received: January 26, 1998
Dear Mr. Kosednar:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Daniel Kosednar
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K973896
Device Name: Ohmeda Excel 3000 Anesthesia Gas System
Indications For Use:
The Excel 3000 Anesthesia Gas System is a gas machine that supplies set flows of medical gases to the breathing system. A large selection of frames, gases, vaporizers and ventilators, give full control of the system configuration. The Excel 3000 is available in wide or narrow trolley and pendant models. The narrow trolley and pendant come with two or three gases, two vaporizer positions and up to four cylinder connections. The wide trolley comes with two, three or four gases, three vaporizer positions and up to five cylinder connections. All models have O2 and N2O. The Excel 3000 comes with up to two optional gases (air, CO2, heliox). All Excel systems accept Tec 4, Tec 5 and Tec 6 vaporizers. Excel 3000 systems use either the 7900 Ventilator, 7800 Ventilator, or the 7000 Ventilator, along with being able to accept integral monitors for vital signs and respiratory gases. Safety features and devices within the Excel 3000 decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
M. Ruz
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number: _
Use
Prescription Use (Per 21CFR801.109) OR
Over-The-Counter Use_ (Optional Format 1-2-96)