OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM

K965041 · Ohmeda Medical · BSZ · Jun 17, 1997 · Anesthesiology

Device Facts

• Record ID: K965041
• Device Name: OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM
• Applicant: Ohmeda Medical
• Product Code: BSZ · Anesthesiology
• Decision Date: Jun 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The APAC is a self-contained, portable and lightweight anesthesia machine that includes the components and accessories necessary to deliver anesthesia. Gases and vaporizers; The APAC System delivers three breathing circuit gases: O₂ (cylinder or pipeline), N₂O (pipeline only), air (pipeline only). The APAC System includes a Tec 5 Vaporizer. Ventilators; The APAC System uses a 7800 Ventilator changed to use O₂ or air as the pneumatic power source. Patient Safety; Safety devices decrease the risk of: Hypoxic Mixtures; A flow control proportioning system keeps the O₂ concentration higher than 23% at the fresh gas outlet for O₂ and N₂O mixtures. N₂O flow decreases proportionally as the O₂ supply decreases. N₂O and air flow stops completely in case of total O₂ supply failure. Complete power or sudden gas supply failures: Batteries continue 7800 Ventilator operation during a power failure. Ohmeda ventilators have power failure alarms. Ohmeda ventilators have alarms for low gas supply pressure. The APAC System has an alarm for O₂ supply pressures less than 27 to 33 psig (186 to 228 kPa).

Device Story

Self-contained, portable anesthesia machine; delivers O2, N2O, and air via Tec 5 vaporizer. Integrates 7800 Ventilator using O2 or air as pneumatic power source. Used by clinicians in clinical settings. Safety features include flow control proportioning system to maintain O2 concentration >23%; automatic N2O reduction/stoppage upon O2 supply failure; battery backup for ventilator; alarms for power failure, low gas supply pressure, and low O2 supply pressure. Output consists of controlled gas/anesthetic delivery to patient; monitored by clinician via integrated alarms and pressure indicators to ensure patient safety during anesthesia administration.

Clinical Evidence

Bench testing only; no clinical data provided. Validation performed against voluntary standards including ASTM F1161-88, EN 60601-1-2, IEC 601-1-2, EN 60601-1, IEC 601-1, IEC 601-2-13, and DIN 13252.

Technological Characteristics

Portable anesthesia machine; includes Tec 5 vaporizer and 7800 Ventilator. Pneumatic power source (O2/air). Safety systems: mechanical flow control proportioning, battery backup, pressure-based alarm systems. Standards: ASTM F1161-88, EN 60601-1-2, IEC 601-1-2, EN 60601-1, IEC 601-1, IEC 601-2-13, DIN 13252.

Indications for Use

Indicated for use as a self-contained, portable anesthesia delivery system for patients requiring anesthesia administration.

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 (Class II)

Submission Summary (Full Text)

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K965041

17 1997

THE BOC GROUP

JUN 17 1997

Ohmeda Inc
Ohmeda Drive
PO Box 7550
Madison WI 53707-7550
608 221 1551

December 6, 1996

Subject: 510(k) Summary of Safety and Effectiveness Information for the Ohmeda APAC (Advanced Portable Anesthesia Care) System
Proprietary: Ohmeda APAC (Advanced Portable Anesthesia Care) System
Common: Gas Machine, Anesthesia
Classification: Anesthesiology, 73BSZ, 21CFR868.5160

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.

The Ohmeda APAC System is substantially equivalent to the following currently marketed device:

1. Ohmeda Excel Series Anesthesia Machines - Class II - 21CFR868.5160

The APAC is a self-contained, portable and lightweight anesthesia machine that includes the components and accessories necessary to deliver anesthesia. Gases and vaporizers; The APAC System delivers three breathing circuit gases: O₂ (cylinder or pipeline), N₂O (pipeline only), air (pipeline only). The APAC System includes a Tec 5 Vaporizer. Ventilators; The APAC System uses a 7800 Ventilator changed to use O₂ or air as the pneumatic power source. Patient Safety; Safety devices decrease the risk of: Hypoxic Mixtures; A flow control proportioning system keeps the O₂ concentration higher than 23% at the fresh gas outlet for O₂ and N₂O mixtures. N₂O flow decreases proportionally as the O₂ supply decreases. N₂O and air flow stops completely in case of total O₂ supply failure. Complete power or sudden gas supply failures: Batteries continue 7800 Ventilator operation during a power failure. Ohmeda ventilators have power failure alarms. Ohmeda ventilators have alarms for low gas supply pressure. The APAC System has an alarm for O₂ supply pressures less than 27 to 33 psig (186 to 228 kPa).

The Ohmeda APAC System was designed to comply with the applicable portions of the following voluntary standards;

1. ASTM F1161-88 for the Anesthesia Machine System
2. EN 60601-1-2, IEC 601-1-2 for the 7800 Ventilator
3. EN 60601-1, IEC 601-1 and IEC 601-2-13 for the 7800 Ventilator
4. DIN 13252 for the Tec 5 Sevotec 8%
5. DIN 13252 for the Tec 5 Fluotec 5%
6. DIN 13252 for the Tec 5 Enfluratec5%
7. DIN 13252 for the Tec 5 Isotec5%

The Ohmeda APAC System and the currently marketed devices are substantially equivalent in design concepts, technologies and materials. The Ohmeda APAC System has been validated through rigorous testing that, in part, support the compliance of the APAC to the above mentioned standards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 17 1997

Mr. Chuck Morreale
Ohmeda Inc.
Ohmeda Drive
P.O. Box 7550
Madison, Wisconsin 53707-7550

Re: K965041
Ohmeda Advanced Portable Anesthesia Care (APAC) System
Regulatory Class: II (two)
Product Code: 73 BSZ
Dated: March 17, 1997
Received: March 19, 1997

Dear Mr. Morreale:

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, Drug, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. Chuck Morreale

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. 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): K965041

Device Name: Ohmeda APAC System

Indications For Use:

The APAC is a self-contained, portable and lightweight anesthesia machine that includes the components and accessories necessary to deliver anesthesia.

## Gases and vaporizers

The APAC System delivers three breathing circuit gases:

- O₂ (cylinder or pipeline)
- N₂O (pipeline only)
- air (pipeline only)

The APAC System includes a Tec 5 Vaporizer

## Ventilators

The APAC System uses a 7800 Ventilator changed to use O₂ or air as the pneumatic power source.

## Patient Safety

Safety devices decrease the risk of:

### Hypoxic Mixtures

- A flow control proportioning system keeps the O₂ concentration higher than 23% at the fresh gas outlet for O₂ and N₂O mixtures.
- N₂O flow decreases proportionally as the O₂ supply decreases.
- N₂O and air flow stops completely in case of total O₂ supply failure.

### Complete power or sudden gas supply failures

- Batteries continue 7800 Ventilator operation during a power failure.
- Ohmeda ventilators have power failure alarms.
- Ohmeda ventilators have alarms for low gas supply pressure.
- The APAC System has an alarm for O₂ supply pressures less than 27 to 33 psig (186 to 228 kPa).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number: K965041

Prescription Use ☑ (Per 21CFR801.109)

OR

Over-The-Counter Use ☐ (Optional Format 1-2-96)