(135 days)
Not Found
No
The summary describes a transport incubator with integrated monitoring capabilities (pulse oximetry, oxygen monitoring). There is no mention of AI, ML, or any algorithms that would suggest intelligent data processing or decision-making beyond standard medical device functionality. The performance studies focus on safety and essential performance standards, not AI/ML validation.
No.
The device maintains a thermally regulated environment to prevent heat loss and facilitates transport; it does not directly treat a disease or condition.
No
The device is primarily a transport incubator to maintain a thermally regulated environment for neonates. While it integrates pulse oximetry and oxygen monitoring, these are for monitoring the neonatal infant's status during transport, not for diagnosing a specific condition. Its purpose is to facilitate the movement of neonates, not to diagnose a disease or condition.
No
The device description clearly outlines a physical transport incubator with integrated hardware components for thermal regulation, power, and pulse oximetry/oxygen monitoring. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The description clearly states the device is a "transport incubator" intended to maintain a thermally regulated environment for neonates during transport. It also integrates features for monitoring vital signs (pulse oximetry, oxygen monitoring) and carrying life support equipment.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples from the infant. Its primary function is environmental control and physiological monitoring.
The integrated pulse oximetry and oxygen monitoring features are considered patient monitoring devices, not IVDs. While they provide information about the infant's physiological status, they do not involve the analysis of in vitro samples.
N/A
Intended Use / Indications for Use
The transport incubator is intended for use by personnel trained in neonatal care to facilitate the movements of neonates by air or ambulance. The transport incubator circulates warmed air at an operator selected and controlled temperature when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator is also intended to carry equipment designed for airway management and monitoring of the neonatal infant's status.
Product codes
FPL
Device Description
The Voyager Infant Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to prevent infant heat loss when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator maintains a thermally regulated environment with either externally supplied power or internal power supplied by a rechargeable battery. The transport incubator is also designed to offer integrated pulse oximetry and oxygen monitoring capability on the display panel. The transport incubator is also designed to carry equipment designed for life support and monitoring of the neonatal infant's status. The equipment includes but is not restricted to: hand and mechanical operated ventilator's; ventilator monitors: infusion pumps; patient monitors indicating blood pressure, respiration, electrocardiogram, oxygen saturation, pulse, etc .; suction pumps; oxygen analyzers; air and oxygen cylinders; air compressors; etc.
The integrated pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board and patient cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.
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
neonatal infants / neonates
Intended User / Care Setting
personnel trained in neonatal care
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
Performance testing of the Voyager Infant Transport Incubator with PulseOx has been conducted for functional and design verification and validation. The testing indicates the incubator is in compliance with the following recognized consensus standards:
- IEC 60601-1 Medical Electrical Equipment, Part 1 : General . Requirements for Safety
- . IEC 60601-1-2 Medical Electrical Equipment, Part 1: General Requirements for Safety, Electromagnetic Compatibility-Requirements and Tests
- IEC 60601-2-20 Medical Electrical Equipment, Part 2: Particular . Requirements for Safety of Transport Incubators
- ISO 9919 Medical Electrical Equipment -- Particular Requirements for the Basic . Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use
- ISO 21647 Medical Electrical Equipment Particular Requirements for the Basic . Safety and Essential Performance of Respiratory Gas Monitors
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Special 510(k): Device Modification Voyager Transport Incubator with PulseOx November 22, 2010
APR 1 5 2011
사
510(k) SUMMARY
Submitter Information: International Biomedical 8508 Cross Park Drive Austin, TX 78754 U.S.A.
Regulatory Affairs Contact:
Amy Pieper Director of Regulatory Affairs (512) 873-0033 - phone (512) 873-9090 - fax
Date Summary Prepared: November 22, 2010
Device Identification:
Trade Name: Voyager Transport Incubator with PulseOx Common Name: Transport Incubator Classification Name: Neonatal Transport Incubator (FPL)
Predicate Device:
Infant Life Support Module - 20 (K022876)
Intended Use:
The transport incubator is intended for use by personnel trained in neonatal care to facilitate the movements of neonates by air or ambulance. The transport incubator circulates warmed air at an operator selected and controlled temperature when
transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator is also intended to carry equipment designed for airway management and monitoring of the neonatal infant's status.
1
Special 510(k): Device Modification Voyager Transport Incubator with PulseOx November 22, 2010
Functional Description and Technological Characteristics:
The Voyager Infant Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to prevent infant heat loss when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator maintains a thermally regulated environment with either externally supplied power or internal power supplied by a rechargeable battery. The transport incubator is also designed to offer integrated pulse oximetry and oxygen monitoring capability on the display panel. The transport incubator is also designed to carry equipment designed for life support and monitoring of the neonatal infant's status. The equipment includes but is not restricted to: hand and mechanical operated ventilator's; ventilator monitors: infusion pumps; patient monitors indicating blood pressure, respiration, electrocardiogram, oxygen saturation, pulse, etc .; suction pumps; oxygen analyzers; air and oxygen cylinders; air compressors; etc.
The integrated pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board and patient cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.
Substantial Equivalence:
In summary, the Voyager Infant Transport Incubator with PulseOx described in this submission are, in our opinion, substantially equivalent to the predicate device, in regards to intended use and safety and effectiveness.
Performance Testing:
Performance testing of the Voyager Infant Transport Incubator with PulseOx has been conducted for functional and design verification and validation. The testing indicates the incubator is in compliance with the following recognized consensus standards:
- IEC 60601-1 Medical Electrical Equipment, Part 1 : General . Requirements for Safety
- . IEC 60601-1-2 Medical Electrical Equipment, Part 1: General Requirements for Safety, Electromagnetic Compatibility-Requirements and Tests
- IEC 60601-2-20 Medical Electrical Equipment, Part 2: Particular . Requirements for Safety of Transport Incubators
- ISO 9919 Medical Electrical Equipment -- Particular Requirements for the Basic . Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use
- ISO 21647 Medical Electrical Equipment Particular Requirements for the Basic . Safety and Essential Performance of Respiratory Gas Monitors
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2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three curved lines representing its body and wings. The eagle faces right and is positioned in the center of a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Amy Pieper Director of Regulatory Affairs Internation Biomedical, Limited 8508 Cross Park Drive Austin, Texas 78754
APR 1 5 2011
Re: K103524
Trade/Device Name: Voyager Transport Incubator with PulseOx Regulation Number: 21 CFR 880.5410 Regulation Name: Neonatal Transport Incubator Regulatory Class: II Product Code: FPL Dated: March 17, 2011 Received: March 17, 2011
Dear Ms. Pieper:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Pieper
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
ncerely vours.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
4
Special 510(k): Device Modification Voyager Transport Incubator with PulseOx November 22, 2010
INDICATIONS FOR USE
510(k) Number (if known): K403524
Device Name: Voyager Transport Incubator with PulseOx
Indications For Use:
The transport incubator is intended for use by personnel trained in neonatal care to facilitate the movements of neonates by air or ambulance. The transport incubator circulates warmed air at an operator selected and controlled temperature when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator is also intended to carry equipment designed for airway management and monitoring of the neonatal infant's status.
Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rill C. Chym
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
510(k) Number: K103524
FDA Submission - Voyager w/PulseOx International Biomedical
Attachment 2