MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE

K072420 · Oceanic Medical Products, Inc. · BSZ · Jan 22, 2008 · Anesthesiology

Device Facts

• Record ID: K072420
• Device Name: MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE
• Applicant: Oceanic Medical Products, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Jan 22, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Magellan-2200, Model-3 Anesthesia Machine is intended for spontaneous or manually assisted ventilation of patients during anesthesia. It may be used for the delivery of gases and anesthetic vapor. It is capable of monitor/alarm functions for oxygen concentration, breathing pressure and source oxygen pressure.

Device Story

Magellan-2200, Model-3 is an anesthesia gas machine; modification of Model-1. Device delivers gases and anesthetic vapor for spontaneous or manually assisted patient ventilation. Components include inlet gas manifold (oxygen/air), pressure gauges, low-pressure alarm, oxygen analyzer/monitor, oxygen flow selector (nasal cannula/mask), oxygen flush button, flowmeters, agent-specific vaporizer, common gas outlet, CO2 absorber with one-way valves, and reservoir bag/pressure relief arm. Used in clinical settings by healthcare providers to manage patient ventilation and anesthesia delivery. Output includes gas/vapor delivery and real-time monitoring of oxygen concentration and breathing pressure; alerts provider to pressure/concentration changes to support clinical decision-making and patient safety during anesthesia.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Gas machine for anesthesia/analgesia. Components: inlet gas manifold, pressure gauges, low-pressure alarm, oxygen analyzer/monitor, oxygen flow selector, oxygen flush button, flowmeters, agent-specific vaporizer, common gas outlet, CO2 absorber with one-way valves, reservoir bag, pressure relief/scavenger arm. Mechanical/pneumatic operation.

Indications for Use

Indicated for spontaneous or manually assisted ventilation of patients during anesthesia, including delivery of gases and anesthetic vapor, with monitoring/alarm functions for oxygen concentration, breathing pressure, and source oxygen pressure.

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

• Magellan-2200, Model-1 Anesthesia Machine (K010613)
• Cardinal Medical Specialties OBA-1 Anesthesia Machine (K000859)

Submission Summary (Full Text)

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510(k) SUMMARY

# K072420 21 : 1 2

# Oceanic Medical Products, Inc.'s Magellan-2200, Model-3 Anesthesia Machine

#### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

William M. Gates Vice President, Innovation and Development Oceanic Medical Products, Inc. 8005 Shannon Industrial Park Lane Atchison, Kansas 66002 Telephone: [phone] Facsimile: [phone]

JAN 22 2008

# OR

Howard M. Holstein, Esq. Hogan and Hartson, LLP 555 Thirteenth Street, NW Washington, DC, 20004 Telephone: [phone] Facsimile: [phone]

Date Prepared: December 26, 2007

#### Name of Device and Name/Address of Sponsor

Magellan-2200, Model-3 Anesthesia Machine

Oceanic Medical Products, Inc. 8005 Shannon Industrial Park Lane Atchison, Kansas 66002 Telephone: [phone] Facsimile: [phone]

#### Common or Usual Name

Anesthesia Gas Machine

#### Classification Name

Gas Machine, Anesthesia

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## Product Code

BSZ

### Regulation Number

21 C.F.R. § 868.5160

### Predicate Devices

Oceanic Medical Products, Inc.'s Magellan-2200, Model-1 Anesthesia Machine (K010613) Cardinal Medical Specialties OBA-1 Anesthesia Machine (K000859)

# Purpose of the Special 510(k) Notice

The Magellan-2200, Model-3 Anesthesia Machine is a modification to the Magellan-2200, Model-1 Anesthesia Machine.

## Intended Use

The Magellan-2200, Model-3 Anesthesia Machine is intended for spontaneous or manually assisted ventilation of patients during anesthesia. It may be used for the delivery of gases and anesthetic vapor. It is capable of monitor/alarm functions for oxygen concentration, breathing pressure and source oxygen pressure.

#### Technological Characteristics

The Model-3 is a gas machine for anesthesia or analgesia. The device consists of the following components: an inlet gas manifold for oxygen and air; pressure gauges for oxygen and air; a low-pressure alarm for inlet oxygen surveillance; an oxygen analyzer and monitor; an oxygen flow selector for nasal cannula or oxygen mask for pre- and post-anesthesia use; an oxygen flush button; oxygen and air flowmeters; an agent-specific vaporizer; a common gas outlet; a carbon dioxide absorber with one way valves; and a reservoir bag/pressure gauge/pressure relief/scavenger outlet arm.

#### Substantial Equivalence

The Model-3 has the same intended use and similar indications, principles of operation, and technological characteristics as the predicate devices. Thus, the Model-3 is substantially equivalent to its predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 22 2008

Oceanic Medical Products, Incorporated C/O Mr. Howard M. Holstein Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, NW Washington, DC 20004

Re: K072420

Trade/Device Name: Magellan-2200, Model-3 Anesthesia Machine Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: December 26, 2007 Received: December 26, 2007

Dear Mr. Holstein:

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 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) 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 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Holstein

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sutte Jr. Michaudavis.

Chip 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

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# Attachment 8

#### Indications for Use Statement

Device Name: Magellan-2200, Model-3 Anesthesia Machine

Indications for Use:

The Magellan-2200, Model-3 Anesthesia Machine is intended/indicated for spontaneous or manually assisted ventilation of patients during anesthesia. It may be used for the delivery of gases and anesthetic vapor. It is capable of monitor/alarm functions for oxygen concentration, breathing pressure and source oxygen pressure.

Prescription Use X (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K072420

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