MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2

K060193 · Oceanic Medical Products, Inc. · BSZ · Apr 10, 2006 · Anesthesiology

Device Facts

• Record ID: K060193
• Device Name: MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2
• Applicant: Oceanic Medical Products, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Apr 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Magellan-2200 Model-2 Anesthesia Machine is intended for spontaneous, manually assisted or automatic 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 respiratory volumes.

Device Story

Magellan-2200 Model-2 is an anesthesia machine for spontaneous, manually assisted, or automatic patient ventilation. Device delivers gases and anesthetic vapor; provides monitoring and alarm functions for oxygen concentration, breathing pressure, and respiratory volumes. System includes gas manifold with safety connections, low-pressure oxygen alarm, oxygen/air pressure gauges, oxygen auxiliary flow selector, and oxygen/air flowmeters. Used in clinical settings by healthcare providers to manage patient ventilation during anesthesia. Output allows clinicians to adjust gas delivery and monitor patient respiratory status, facilitating safe anesthesia administration.

Clinical Evidence

Bench testing only. System performance was verified using protocols identical to the predicate device (Magellan-2200 Model-1) to confirm functionality of the replacement ventilator and electrically-powered air compressor. All mechanical and electrical testing results were as expected.

Technological Characteristics

Components: Gas manifold with safety connections, low-pressure oxygen alarm, oxygen/air pressure gauges, oxygen auxiliary flow selector, oxygen/air flowmeters. Electrically-powered air compressor source. Ventilator integration.

Indications for Use

Indicated for patients requiring spontaneous, manually assisted, or automatic ventilation during anesthesia; includes delivery of gases and anesthetic vapor, and monitoring/alarm functions for oxygen concentration, breathing pressure, and respiratory volumes.

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)

Submission Summary (Full Text)

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Kobo193

#### 510(k) SUMMARY

# Oceanic Medical Products, Inc. Magellan-2200 Model-2 Anesthesia Machine

Oceanic Medical Products, Inc. 8005 Shannon Industrial Park Lane Atchison, KS 66002

Telephone: [phone] Facsimile: 913 874 2005

William M. Gates, VP Innovation and Development

### Date Prepared: March 24, 2006

Howard M. Holstein Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street N.W. Washington, DC 20004-1109

Telephone: [phone] Facsimile: 202 637 5910

| Trade Name: | Magellan-2200 Model-2 Anesthesia Machine |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Anesthesia Machine |
| Classification Name: | Gas Machine, Anesthesia |
| C.F.R. Section: | 21 C.F.R. § 868.5160 |
| Product Code : | BSZ |
| Predicate Device: | Magellan-2200 Model-1 Anesthesia Machine (K010613) |
| Manufacturer: | Oceanic Medical Products, Inc. |
| Intended Use: | The Magellan-2200 Model-2 Anesthesia Machine is intended for<br>spontaneous, manually assisted or automatic ventilation of<br>patients during anesthesia. It may be used for the delivery of<br>gases and anesthetic vapor. It is capable of monitor/alarm<br>functions for oxygen concentration, breathing pressure and<br>respiratory volumes. |
| Indicated Use: | The Magellan-2200 Model-2 Anesthesia Machine is intended for<br>spontaneous, manually assisted or automatic ventilation of |
| | patients during anesthesia. It may be used for the delivery of<br>gases and anesthetic vapor. It is capable of monitor/alarm<br>functions for oxygen concentration, breathing pressure and<br>respiratory volumes. |
| Technological<br>Characteristics: | The Magellan-2200 Model-2 consists of the following components:<br><br>Gas Manifold with Safety Connections<br>Low Pressure Oxygen Alarm<br>Oxygen and Air Pressure Gauges<br>Oxygen Auxiliary Flow Selector<br>Oxygen and Air Flowmeters<br> |
| Performance Data: | The Magellan-2200 Model-2 Anesthesia Machine was tested<br>according to the same protocols used for its predicate, the<br>Magellan-2200 Model-1 in order to ascertain if the system worked<br>as designed with the replacement ventilator and its electrically-<br>powered air compressor source. All recommended mechanical<br>and electrical testing was completed simultaneously by the<br>manufacturers of the anesthesia machine and/or the ventilator.<br><br>In all instances, the Magellan-2200 Model-2 functioned as<br>intended and the bench testing and electrical testing results<br>observed were as expected. |
| Substantial Equivalence: | The Magellan-2200 Model-2 Anesthesia Machine is as safe and<br>effective as the Magellan-2200 Model-1 Anesthesia Machine. The<br>Magellan-2200 Model-2 Anesthesia Machine as the same<br>intended uses and same indications, technological characteristics<br>and principles of operation as its predicate device. The minor<br>technological difference between the Magellan-2200 Model-2<br>Anesthesia Machine and it predicate device raise no new issues<br>of safety or effectiveness. Thus, the Magellan-2200 Model-2<br>Anesthesia Machine is substantially equivalent. |

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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 depiction of an eagle or bird-like figure, with three curved lines forming the body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Oceanic Medical Products, Incorporated C/O Mr. Howard M. Holstein Hogan & Hartson, Limited Liability Partnership 555 Thirteenth Street, NW Washington DC 20004

Re: K060193

Trade/Device Name: Magellan-2200 Model-2 Anesthesia Machine Regulation Number: 868.5160 Regulation Name: Gas machine for anesthesia or analgesia Regulatory Class: II Product Code: BSZ Dated: January 25, 2006 Received: January 25, 2006

APR 1 0 2006

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 (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 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.

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.

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## Page 2 – Mr. Howard M. Holstein

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 continue 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/dsma/dsmamain.html

Sincerely yours,

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

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#### Indications for Use

510(k) Number (if known):

Device Name: Magellan-2200 Model-2 Anesthesia Machine

Indications for Use:

The Magellan-2200 Model-2 Anesthesia Machine is intended for spontaneous, manually assisted or automatic 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 respiratory volumes.

The Magellan-2200 Model-2 Anesthesia Machine in indicated for use with spontaneous, manually assisted or automatic 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 respiratory volumes.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aun Syhom

...ology, General Hospital,
...ontrol, Dental Devices
K060193

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