(147 days)
Not Found
No
The device description and intended use focus on traditional anesthesia machine components and functions, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is used for patient ventilation during anesthesia, which is a therapeutic intervention.
No
The device is described as an "Anesthesia Machine" used for "ventilation of patients during anesthesia" and "delivery of gases and anesthetic vapor." While it has monitoring and alarm functions for oxygen and pressure, these are for ensuring the safe operation of the anesthesia delivery, not for diagnosing a patient's medical condition.
No
The device description clearly lists multiple hardware components, including gas manifolds, pressure gauges, flowmeters, a vaporizer, and a carbon dioxide absorber.
Based on the provided information, the Magellan-2200, Model-3 Anesthesia Machine is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "spontaneous or manually assisted ventilation of patients during anesthesia" and for the "delivery of gases and anesthetic vapor." This describes a device used directly on a patient for life support and anesthesia delivery, which is an in vivo (within a living organism) application.
- Device Description: The components listed are all related to the delivery and monitoring of gases and anesthetic agents to a patient's respiratory system. There are no components or functions described that involve testing samples of human origin (like blood, urine, tissue, etc.) outside of the body, which is the hallmark of an IVD.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or analytical processes that are typical of IVD devices.
In summary, the Magellan-2200, Model-3 Anesthesia Machine is a medical device used for patient care during anesthesia, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for 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.
Product codes
BSZ
Device Description
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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Oceanic Medical Products, Inc.'s Magellan-2200, Model-1 Anesthesia Machine (K010613), Cardinal Medical Specialties OBA-1 Anesthesia Machine (K000859)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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: (913) 874-2000 Facsimile: (913) 874-2005
JAN 22 2008
OR
Howard M. Holstein, Esq. Hogan and Hartson, LLP 555 Thirteenth Street, NW Washington, DC, 20004 Telephone: (202) 637-5813 Facsimile: (202) 637-5910
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: (913) 874-2000 Facsimile: (913) 874-2005
Common or Usual Name
Anesthesia Gas Machine
Classification Name
Gas Machine, Anesthesia
1
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.
2
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.
3
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 (240) 276-0120. 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/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
4
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)
inh Nhh
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072420
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