(134 days)
Not Found
No
The summary describes a standard neonatal transport incubator with temperature control, oxygen monitoring, and pulse oximetry. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
Yes.
The device description states its functions are "intended to be used in treatment, procedures and observation of low-birth-weight and sick neonates, allowing provision of heat to the neonate when the body temperature is low," which aligns with the definition of a therapeutic device as it provides care and aims to alleviate or cure a condition.
No
The V-808 Atom Transcapsule is a neonatal transport incubator. While it monitors vital signs like oxygen saturation and pulse rate, these are for facilitating the safe transport and stable environment of the infant, not for diagnosing specific diseases or conditions. The device description explicitly states these functions are for "treatment, procedures and observation," not diagnosis.
No
The device description clearly outlines multiple hardware components including a hood, mattress platform, conditioning chamber, heater, fan, oxygen supply, and integrated pulse oximetry capability. It is a physical transport incubator with embedded functions, not a standalone software application.
Based on the provided information, the V-808 Atom Transcapsule is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- V-808 Function: The V-808 Atom Transcapsule is a transport incubator designed to provide a controlled environment for premature and neonatal infants during transport. Its functions include temperature control, oxygen supply and monitoring, and non-invasive pulse oximetry (measuring oxygen saturation and pulse rate through the skin).
- No Specimen Analysis: The description of the V-808 does not mention the collection or analysis of any specimens from the infant. All its functions are related to providing environmental support and non-invasive monitoring of the infant's physiological state.
Therefore, the V-808 Atom Transcapsule falls under the category of a medical device that provides life support and monitoring, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The V-808 Atom Transcapsule is a neonatal transport incubator. The incubator is a device with a transparent hood intended to contain a premature infant or a neonatal infant within the compartment covered by said hood and intended to safely convey the infant accommodated in that compartment, providing the infant with isolated environment from ambient air where temperature - controlled air is supplied. The V-808 also provides oxygen monitoring and supply as well as an integrated pulse oximetry capability.
Product codes (comma separated list FDA assigned to the subject device)
FPL, DQA
Device Description
This product consists of a hood section, a mattress platform section, a middle deck section, a conditioning chamber section, an operation section and a pedestal section. 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, an oxygen supply function to deliver oxygen into the inner hood from outside, and a function to determine and display the oxygen concentration of the endosed compartment covered by the hood. It is further equipped with a function to measure and display the skin temperature of the neonate, as well as a pulse oximeter function to determine oxygen saturation and pulse rate non-invasively.
It is a transport incubator, wherein said functions are intended to be used in treatment, procedures and observation of low-birth-weight and sick neonates, allowing provision of heat to the neonate when the body temperature is low.
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
premature infant or a neonatal infant
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): 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.
K941106 T1500 Transport Incubator, K990966 Masimo Set Pulse Oximeter
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
§ 880.5410 Neonatal transport incubator.
(a)
Identification. A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.(b)
Classification. Class II (performance standards).
0
1082
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 35 Commerce Drive lvyland, Pa 18974
Mary Staniewicz Ph 215-672-6800 Fax 215-672-1123
Device trade/proprietary name:
V-808 Atom Transcapsule
Device common/usual/classification name:
Neonatal Transport Incubator
Classification:
General Hospital 21 CFR 880.5410 Infant Incubator, FPL, Class II
Anesthesiology 21 CFR 870.2700 Oximeter, DQA, Class II
Performance Standards:
None applicable
Predicate Device:
K941106 T1500 Transport Incubator K990966 Masimo Set Pulse Oximeter
1
Device Description
This product consists of a hood section, a mattress platform section, a middle deck section, a conditioning chamber section, an operation section and a pedestal section. 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, an oxygen supply function to deliver oxygen into the inner hood from outside, and a function to determine and display the oxygen concentration of the endosed compartment covered by the hood. It is further equipped with a function to measure and display the skin temperature of the neonate, as well as a pulse oximeter function to determine oxygen saturation and pulse rate non-invasively.
It is a transport incubator, wherein said functions are intended to be used in treatment, procedures and observation of low-birth-weight and sick neonates, allowing provision of heat to the neonate when the body temperature is low.
Intended Use
The V-808 Atom Transcapsule is a neonatal transport incubator. The incubator is a device with a transparent hood intended to contain a premature infant or a neonatal infant within the compartment covered by said hood and intended to safely convey the infant accommodated in that compartment, providing the infant with isolated environment from ambient air where temperature - controlled air is supplied. The V-808 also provides oxygen monitoring and supply as well as an integrated pulse oximetry capability.
Description of Modifications
The difference between the V-808 and the T1500 predicate device is the SpO2 feature. The Pulse Oximetry SpO2 is provided by Masimo and is also a currently marketed device. The V-808 combines two medical device technologies on to one platform, the neonatal transport incubator and pulse oximeter.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2006
Atom Medical Incorporated C/O Ms. Mary Staniewicz Chief Financial Officer NeoForce Group Incorporated 35 Commerce Drive Ivyland, Pennsylvania 18974
Re: K061071
Trade/Device Name: V-808 Atom Transcapsule Regulation Number: 880.5410 Regulation Name: Neonatal Transport Incubator Regulatory Class: II Product Code: FPL Dated: August 11, 2006 Received: August 14, 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.
3
Page 2 - Ms. Stanwiecz
Please be advised that FDA's issuance of a substantial equivalence determination does not I Toast that FDA has made a determination that your device complies with other requirements mean that i Dri nas made a dotes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements, including, but not limited to: registration 1 ou into confire (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF rear 007), adality systems (QS) regulation (21 CFR Part 820); and if requirence as between a 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) This letter wifi anon yourse bogan to and stantial equivalence of your device to a premarket notification. - The wice 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), 11 you donto 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 maj overni 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,
Clue
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
4
Section A SMDA Requirements
A.1 Indication for Use Statement
510(k) Number:
Device Name: V-808 Atom Transcapsule
Indications for Use:
The V-808 Atom Transcapsule is a neonatal transport incubator. The incubator is a device with a transparent hood intended to contain a premature infant or a neonatal infant within the compartment covered by said hood and intended to safely convey the infant accommodated in that compartment, providing the infant with isolated environment from ambient air where temperature - controlled air is supplied. The V-808 also provides oxygen monitoring and supply as well as an integrated pulse oximetry capability.
This device is not intended for home use.
This is a prescription device.
Anthen D, 1-K
Sion Sign-Off) . cion of Anesthesiology, General Hospital, Chion Control, Dental Devices
个6/47 () Number:_
Prescription Use X (Per 21 CFR 801.109) OR
Over-the-Counter Use
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(Please do not write below this line continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)