OHMEDA EXCEL 3000 ANESTHESIA SYSTEM

K973896 · Ohmeda Medical · BSZ · Apr 21, 1998 · Anesthesiology

Device Facts

• Record ID: K973896
• Device Name: OHMEDA EXCEL 3000 ANESTHESIA SYSTEM
• Applicant: Ohmeda Medical
• Product Code: BSZ · Anesthesiology
• Decision Date: Apr 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Anesthesia gas machine; supplies controlled flows of medical gases (O2, N2O, air, CO2, heliox) to breathing circuits. Configurable via various frames (wide/narrow trolley, pendant), vaporizers (Tec 4, 5, 6), and ventilators (7000, 7800, 7900). Integrates vital signs and respiratory gas monitors. Used in clinical environments by anesthesia providers. Safety mechanisms mitigate risks of hypoxic mixtures, agent cross-contamination, and gas/power supply failure. Benefits patient by ensuring precise, safe delivery of anesthetic gases and ventilation support during surgical procedures.

Clinical Evidence

Bench testing only. Validation performed against voluntary standards including ASTM F1208-94 (Anesthesia Breathing Circuit), IEC 601-1 (Medical Electrical Equipment), and IEC 601-1-4 (Programmable Medical Electrical Equipment).

Technological Characteristics

Gas anesthesia delivery system; trolley or pendant form factor. Supports 2-4 gas inputs. Compatible with Tec 4, 5, 6 vaporizers and 7000/7800/7900 ventilators. Includes integrated monitoring for vital signs and respiratory gases. Complies with ASTM F1208-94, IEC 601-1, and IEC 601-1-4. Safety features include hypoxic guard and power/gas failure protection.

Indications for Use

Indicated for the delivery of medical gases to a breathing system for anesthesia. Used in clinical settings by anesthesia professionals. Prescription use only.

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

• Ohmeda Excel Series Anesthesia Machines
• Ohmeda APAC (Advanced Portable Anesthesia Care) System
• Ohmeda 7900 Anesthesia Ventilator

Submission Summary (Full Text)

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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
- 3. 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;

- 1. ASTM F1208-94 Anesthesia Breathing Circuit Standard
- 2. EN 60601-1. IEC 601-1: 1988 Medical Electrical Equipment
- 3. Draft ISO DIS 7767 Oxygen monitors for monitoring patient breathing mixtures
- 4. CEN 475 Electrically generated alarm signals
- 5. 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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.

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Concurrence of CDRH. Office of Device Evaluation (ODE)

M. Ruz

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number: _

K913896

Use

Prescription Use (Per 21CFR801.109) OR

Over-The-Counter Use_ (Optional Format 1-2-96)