(50 days)
The V-2200 Infant Incubator is a device to keep premature infants or neonatal infants in a warm environment which is covered by a hood and isolated from ambient air and of which internal air temperature and humidity, are controlled. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.
This device is not intended for home use.
This device is not intended as a transport incubator.
This is a prescription device.
This product consists of a hood, a sensor module, a mattress platform, a middle deck section, a conditioning chamber, a humidity chamber, an operation control section, a power source, a relay box, an oxygen supply/filter box, an oxygen controller and a weight monitor. It is equipped with an incubator air temperature control function to circulate the air containing the heat energy generated by the heater attached to the conditioning chamber inside the hood by means of a fan in order to maintain the incubator air temperature at a fixed level. The device is also equipped with a skin temperature control function to maintain the infant's skin temperature at a fixed level in response to the patients temperature as measured by the skin probe. There is a humidity control function to adjust the amount of vapor generated in the humidity chamber. The following additional features can be installed into the incubator: an oxygen control function to draw oxygen and outside air and control the oxygen concentration delivered to the patient compartment to the desired level; and a weight monitor to facilitate taking the infants weight without moving them from the incubator. This device is designed to be used in treatment, procedures and observation of low-birth-weight and sick neonates, providing heat to the neonate when the body temperature is low and also to provide humidity if desired
The provided document does not contain the information requested for acceptance criteria and a study proving device performance.
The document is a 510(k) summary for the V-2200 Infant Incubator, focusing on its substantial equivalence to predicate devices due to a user interface display modification. It describes the device, its intended use, and the regulatory approval process.
Specifically, the document does not include:
- A table of acceptance criteria or reported device performance metrics.
- Details about a study conducted to demonstrate the device meets any specific performance criteria.
- Information on sample sizes, data provenance, expert qualifications, adjudication methods, or ground truth establishment for any such study.
- Any mention of AI, MRMC comparative effectiveness studies, or standalone algorithm performance.
The document is a regulatory submission for a medical device (infant incubator), and while it mentions "performance standards: none applicable," it does not include performance data or studies that would fall under the categories requested. The "description of modifications" section explicitly states the difference between the V2200 and the V2100G is solely the user interface display (an independent component, multicolor LCD). This suggests the core therapeutic functions (temperature and humidity control) were likely considered equivalent to the predicate without requiring new performance studies for those aspects.
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La61280
JUN 2 7 2006
Page 17 of 18
510(k) Supplement
NeoForce Group, Inc V-2200 Infant Incubator
P. 1 SF2
Attachment 5.0
Updated 510(k) Summary of Safety and Effectiveness
Applicant:
Atom Medical Inc lwakata Bldg 3d Floor 3-18-15, Hungo Tokoyo, Bunkyo-ku 1130033 Japan Registration No: In process
Contact Person:
Neoforce Group 5985 Honey Hollow Road Doylestown, Pa. 18901
Mary Staniewicz Ph 215-794-0495 Fax 215-794-0495
Device trade/proprietary name:
V2200 Infant Incubator
Device common/usual/classification name:
infant Incubator
Classification:
General Hospital 21 CFR 880.5400 Infant Incubator, FMZ, Class II
Performance Standards:
None applicable
Predicate Device:
K001242 C2000 Isolette Infant Incubator K021809 V2100G Infant Incubator
Device Description
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NeoForce Group, Inc V-2200 Infant Incubator
Page 18 of 18
K$61284 p.2.52
This product consists of a hood, a sensor module, a mattress platform, a middle deck section, a conditioning chamber, a humidity chamber, an operation control section, a power source, a relay box, an oxygen supply/filter box, an oxygen controller and a weight monitor. It is equipped with an incubator air temperature control function to circulate the air containing the heat energy generated by the heater attached to the conditioning chamber inside the hood by means of a fan in order to maintain the incubator air temperature at a fixed level. The device is also equipped with a skin temperature control function to maintain the infant's skin temperature at a fixed level in response to the patients temperature as measured by the skin probe. There is a humidity control function to adjust the amount of vapor generated in the humidity chamber. The following additional features can be installed into the incubator: an oxygen control function to draw oxygen and outside air and control the oxygen concentration delivered to the patient compartment to the desired level; and a weight monitor to facilitate taking the infants weight without moving them from the incubator. This device is designed to be used in treatment, procedures and observation of low-birth-weight and sick neonates, providing heat to the neonate when the body temperature is low and also to provide humidity if desired
Intended Use
The V2200 Infant Incubator is a device to keep premature infants or neonatal infants in a warm environment which is covered by a hood and isolated from ambient air and of which internal air temperature and humidity, are controlled. It is intended for inpatient use in maternity nursenes, and neonatal care environments of hospitals or other healthcare facilities.
Description of Modifications
The difference between the V2200 and the V2100G is the user interface display. The user interface display in the V2100G is housed in the main body of the device and is a monochrome LED display of parameters. The new user interface display is an independent component that is mounted on a moveable arm to allow more convenient positioning by the caregiver. In addition, the display is a multicolor LCD display providing a more flexible user interface.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 27 2006
Atom Medical, Incorporated C/O Ms. Laura Danielson Responsible Third Party Official TÜV Products Service 1775 Old Highway 8 New Brighton, Minnesota 55112-1891
Re: K061280 Trade/Device Name: V-2200 Infant Incubator Regulation Number: 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ Dated: June 1, 2006 Received: June 12, 2006
Dear Ms. Danielson:
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 premarke 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 -Ms. Danielson
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) 276-0115. 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/industry/support/index.html.
Sincercly 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
Enclosure
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Indications for Use
510(k) Number (if known): K061280
Device Name: V-2200 Infant Incubator
Indications for Use:
The V-2200 Infant Incubator is a device to keep premature infants or neonatal infants in a warm environment which is covered by a hood and isolated from ambient air and of which internal air temperature and humidity, are controlled. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.
This device is not intended for home use.
This device is not intended as a transport incubator.
This is a prescription device.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chilin W < ========================================================================================================================================================================== ・・( ・) Cology, General Hospital, will Cori. and only Sevices
Kubiak
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 880.5400 Neonatal incubator.
(a)
Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.(b)
Classification. Class II (performance standards).