V-2200 INFANT INCUBATOR
Device Facts
| Record ID | K061856 |
|---|---|
| Device Name | V-2200 INFANT INCUBATOR |
| Applicant | Atom Medical, Inc. |
| Product Code | FMZ · General Hospital |
| Decision Date | Sep 28, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5400 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
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.
Device Story
V-2200 Infant Incubator provides controlled thermal/humidified environment for premature/sick neonates; isolates infant from ambient air via hood. Components: hood, mattress platform, conditioning/humidity chambers, heater, fan, oxygen supply/filter, pulse oximeter, oxygen controller, weight monitor. Operation: air temperature control via heater/fan; skin temperature control via skin probe; humidity control via vapor generation. Optional pulse oximetry (Masimo technology) monitors SpO2/pulse rate non-invasively; oxygen controller regulates O2 concentration; weight monitor facilitates weighing without moving infant. Used in hospital maternity nurseries/neonatal care units by clinicians. Output: thermal/humidity regulation, SpO2/pulse data, O2 concentration, infant weight. Benefits: maintains stable physiological environment for vulnerable neonates; facilitates clinical observation/treatment.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Incubator with hood, conditioning/humidity chambers, heater, fan, and sensors. Optional integrated Masimo pulse oximeter, oxygen controller, and weight monitor. Connectivity: standalone. Sterilization: not specified. Software: embedded control logic for temperature, humidity, and O2 regulation.
Indications for Use
Indicated for premature or neonatal infants requiring a controlled thermal and humidified environment. Intended for inpatient use in hospital maternity nurseries and neonatal care units. Not for home use or transport. Prescription only.
Regulatory Classification
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.
Predicate Devices
- V-2100G Infant Incubator (K021809)
- V-505 Atom Infa Warmer (K002355)
- Masimo Set Pulse Oximeter (K990966)
Submission Summary (Full Text)
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#### 510(k) Summary of Safety and Effectiveness Section I
Applicant:
Atom Medical Inc lwakata Bldg 3rd Floor 3-18-15, Hungo Tokoyo, Bunkyo-ku 1130033 Japan Registration No: In process
Contact Person:
Neoforce Group, Inc 35 Commerce Drive lvyland, Pa. 18974
Mary Staniewicz Ph 215-672-6800 Fax 215-672-1123
Device trade/proprietary name:
V-2200 Infant Incubator
Device common/usual/classification name:
Infant Incubator
Classification:
General Hospital 21 CFR 880.5400 Infant Incubator, FMZ, Class II
Anesthesiology 21 CFR 870.2700 Oximeter, DQA, Class II
Performance Standards:
None applicable
Predicate Device:
10 10
. 8
:
K021809 V-2100G Infant Incubator K002355 V-505 Atom Infa Warmer K990966 Masimo Set Pulse Oximeter
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## Device Description
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, a pulse oximeter, 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: a pulse oximeter function to monitor Sp02 concentration and pulse rate non-invasively; 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 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.
### Description of Modifications
The V-2200 Infant Incubator now incorporates an optional pulse oximeter which was not the subject of the original V-2200 submission. The Pulse Oximetry SpO2 is provided by Masimo and is also a currently marketed device. The V-2100G Infant Incubator and the V-505 Infa Warmer are both currently marketed devices which incorporate this pulse oximetry technology from Masimo.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 2006
Atom Medical, Incorporated C/O Ms. Mary Staniewicz Neoforce Group, Incorporated 35 Commerce Drive Ivyland, Pennsylvania 18974
Re: K061856
Trade/Device Name: V-2200 Infant Incubator Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ, DQA Dated: June 5, 2006 Received: June 30, 2006
Dear Ms. Staniewicz:
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 - Ms. Staniewicz
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clare
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):
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 rne v-2200 miant modbated is a active tand isolated from ambient air and of which internal air temperature and humidity, are controlled. It is intended for inpatient use in maternity nurseries, temperature and hamilaty, are other healthcare facilities. Optional functions include pulse oximetry and oxygen delivery.
This device is not intended for home use.
This device is not intended as a transport incubator.
This is a prescription device.
Prescription Use X (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)
in Birnis
Jon Sign-Off) on of Anesthesiology, General Hospital, ction Control, Dental Devices
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