(75 days)
Not Found
No
The summary describes a standard anesthesia machine with basic monitoring and alarm functions, and there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device is used for ventilation of patients during anesthesia and delivery of gases and anesthetic vapor, which are direct medical interventions.
No
The device is an anesthesia machine intended for ventilation and gas delivery, with monitoring and alarm functions for operational parameters, not for diagnosing patient conditions.
No
The device description explicitly lists hardware components such as a Gas Manifold, Pressure Gauges, Flowmeters, and an Oxygen Auxiliary Flow Selector, indicating it is not solely software.
Based on the provided information, the Magellan-2200 Model-2 Anesthesia Machine is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "ventilation of patients during anesthesia" and "delivery of gases and anesthetic vapor." This describes a device used directly on a patient for life support and drug delivery, not for testing samples taken from the body.
- Device Description: The components listed (Gas Manifold, Alarms, Gauges, Flowmeters) are all related to delivering and monitoring gases and pressure within a breathing circuit connected to a patient. They are not components typically found in an IVD device used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes related to in vitro testing.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The Magellan-2200 Model-2 Anesthesia Machine is a medical device used for patient care during surgery, not for in vitro testing.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BSZ
Device Description
The Magellan-2200 Model-2 consists of the following components:
Gas Manifold with Safety Connections
Low Pressure Oxygen Alarm
Oxygen and Air Pressure Gauges
Oxygen Auxiliary Flow Selector
Oxygen and Air Flowmeters
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Magellan-2200 Model-2 Anesthesia Machine was tested according to the same protocols used for its predicate, the Magellan-2200 Model-1 in order to ascertain if the system worked as designed with the replacement ventilator and its electrically-powered air compressor source. All recommended mechanical and electrical testing was completed simultaneously by the manufacturers of the anesthesia machine and/or the ventilator. In all instances, the Magellan-2200 Model-2 functioned as intended and the bench testing and electrical testing results observed were as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Magellan-2200 Model-1 Anesthesia Machine (K010613)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
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: 913 874 2000 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: 202 637 5600 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 |
| 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. | |
| Indicated 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. | |
| Technological | |
| Characteristics: | The Magellan-2200 Model-2 consists of the following components: |
Gas Manifold with Safety Connections
Low Pressure Oxygen Alarm
Oxygen and Air Pressure Gauges
Oxygen Auxiliary Flow Selector
Oxygen and Air Flowmeters
|
| Performance Data: | The Magellan-2200 Model-2 Anesthesia Machine was tested
according to the same protocols used for its predicate, the
Magellan-2200 Model-1 in order to ascertain if the system worked
as designed with the replacement ventilator and its electrically-
powered air compressor source. All recommended mechanical
and electrical testing was completed simultaneously by the
manufacturers of the anesthesia machine and/or the ventilator.
In all instances, the Magellan-2200 Model-2 functioned as
intended and the bench testing and electrical testing results
observed were as expected. |
| Substantial Equivalence: | The Magellan-2200 Model-2 Anesthesia Machine is as safe and
effective as the Magellan-2200 Model-1 Anesthesia Machine. The
Magellan-2200 Model-2 Anesthesia Machine as the same
intended uses and same indications, technological characteristics
and principles of operation as its predicate device. The minor
technological difference between the Magellan-2200 Model-2
Anesthesia Machine and it predicate device raise no new issues
of safety or effectiveness. Thus, the Magellan-2200 Model-2
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.
3
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
4
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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