(65 days)
Not Found
No
The description focuses on standard radiant warming technology with servo control based on skin temperature, and optional features like pulse oximetry and oxygen delivery. There is no mention of AI or ML algorithms for control, analysis, or prediction.
Yes
The device is intended to treat neonates by regulating their temperature and providing an optimal clinical environment, which are therapeutic functions.
No
The device is described as an infant warmer for temperature regulation and management of neonates, and while it has optional functions like pulse oximetry and oxygen delivery, its primary purpose is not to diagnose a disease or condition.
No
The device description clearly outlines hardware components such as a heater, mattress, pulse oximeter, oxygen delivery system, suction unit, timer, lamps, and physical structures like a canopy, mattress platform, and support column rails. This indicates it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the V-505 Atom Infa Warmer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing an optimum clinical environment for observation, examination, temperature regulation, and management of neonates. This involves direct interaction with the patient's body (radiant warming, monitoring skin temperature).
- Device Description: The description details features related to patient care and monitoring (radiant heat, temperature control, pulse oximetry, oxygen delivery, suction). These are all functions performed on or around the patient, not on samples taken from the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVD devices are specifically designed for testing samples outside of the body to diagnose diseases or conditions.
Therefore, the V-505 Atom Infa Warmer is a medical device used for patient care and support, not an IVD.
N/A
Intended Use / Indications for Use
The V-505 Atom Infa Warmer is a radiant warming, open type incubator intended to provide an optimum clinical environment for observation, examination, temperature regulation, and management of neonates. Optional functions include pulse oximetry and oxygen delivery.
This device is not intended for home use.
This is a prescription device.
Product codes (comma separated list FDA assigned to the subject device)
FMT
Device Description
The Atom Infa Warmer V-505 is designed to maintain an infants body temperature by means of infrared radiant heat emitted from a heater located above the mattress. Temperature control is achieved either by manual adjustment of the heater output or by servo control based on changes in the infants skin temperature. All models of the V-505 may also be purchased with the following optional functions: a pulse oximeter that measures the infant's SpO2 and pulse rate, an oxygen delivery system consisting of either an oxygen blender or an oxygen flowmeter, and a suction unit. Other device features (depending on the model) include a timer, illumination lamps, an RS232 connector for communication with an external computer, a rotating/tilting canopy, a tilting mattress platform, baby quards, and support column rails for attaching an optional tray set or IV pole.
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
neonates
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.
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
§ 880.5130 Infant radiant warmer.
(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.
0
Ko60461 P. 1. Pr
と言われる。 1972
Section I 510(k) Summary of Safety and Effectiveness
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 3135 Commerce Drive Doylestown, Pa. 18901
Mary Staniewicz Ph 215-794-0495 Fax 215-794-0495
Device trade/proprietary name:
V-505 Infa Warmer
Device common/usual/classification name:
Infant Radiant Warmer
Classification:
General Hospital 21 CFR 880.5130 Infant Radiant Warmer, FMT, Class II
Performance Standards:
None applicable
Predicate Device:
K940951 Resuscitaire Infant Radiant Warmer K002355 V-505 Infa Warmer
Device Description
The Atom Infa Warmer V-505 is designed to maintain an infants body temperature by means of infrared radiant heat emitted from a heater located
1
above the mattress. Temperature control is achieved either by manual adjustment of the heater output or by servo control based on changes in the infants skin temperature. All models of the V-505 may also be purchased with the following optional functions: a pulse oximeter that measures the infant's SpO2 and pulse rate, an oxygen delivery system consisting of either an oxygen blender or an oxygen flowmeter, and a suction unit. Other device features (depending on the model) include a timer, illumination lamps, an RS232 connector for communication with an external computer, a rotating/tilting canopy, a tilting mattress platform, baby quards, and support column rails for attaching an optional tray set or IV pole.
Intended Use
The V-505 Atom Infa Warmer is a radiant warming, open type incubator intended to provide an optimum clinical environment for observation, examination, temperature regulation, and management of neonates. Optional functions include pulse oximetry and oxygen delivery.
Description of Modifications
The differences between the V-505 original submission and the V-505 modifications include label clarifications and changes to overlays for English product, compliance to the current International EMI standards, minor software modifications to improve display clarity and ease of use for the US market and compliance to International particular standard for Radiant Warmers.
Substantial Equivalence
The Atom Infa Warmer V-505 is believed to be substantially equivalent, based on intended use, design, operational and technological characteristics, and principles of operation, to the Draeger Medical Resuscitaire Radiant Warmer and to the Atom Infa Warmer V-505 cleared in the original submission K002355. Atom Medical believes that the information provided demonstrates that the modifications to the original V-505 are precise enough to demonstrate this equivalence. The V-505 and predicates are all intended to maintain a newborns body temperature by radiant heat and to provide a controlled environment for the observation, examination and management of newboms. The V-505 and the predicate devices all operate in both the manual and servo modes for temperature control. All devices also offer a variety of features including oxygen flowmeter and/or blender , suction control, Apgar timer, tilting mattress, tilting/rotating canopy, illumination lights, and an RS232 communications module. All devices have similar displays, alarms, and user controls.
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 curved lines representing its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2006
Atom Medical, Incorporated C/O Ms. Mary Staniewicz Chief Financial Officer NeoForce Group, Incorporated 35 Commerce Drive Ivyland, Pennsylvania 18974
Re: K060461
Trade/Device Name: V-505 Infa Warmer Regulation Number: 21 CFR 880.5130 Regulation Name: Infant radiant warmer Regulatory Class: II Product Code: FMT Dated: April 7, 2006 Received: April 10, 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.
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
3
Page 2 - Ms. Mary Staniewicz
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.
Sincerely vours.
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
4
Indications for Use
510(k) Number (if known): K060461
Device Name: V-505 Atom Infa Warmer
Indications for Use:
The V-505 Atom Infa Warmer is a radiant warming, open type incubator intended to provide an optimum clinical environment for observation, examination, temperature regulation, and management of neonates. Optional functions include pulse oximetry and oxygen delivery.
This device is not intended for home use.
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)
Antonin V. Martin
logy, General Hospital
ical Dental Devices
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