(161 days)
Not Found
No
The description focuses on thermal regulation, power management, and integration of standard monitoring technologies (pulse oximetry, oxygen monitoring) without mentioning any AI/ML capabilities for data analysis, prediction, or control.
No
The device is a transport incubator that provides a thermally regulated environment and monitoring capabilities, but it does not directly treat a disease or condition. It is for support and transport, not therapy.
Yes
The device integrates pulse oximetry and oxygen monitoring, which are diagnostic capabilities as they provide information about the infant's physiological status (oxygen saturation, pulse). It is also designed to carry patient monitors indicating blood pressure, respiration, electrocardiogram, oxygen saturation, and pulse.
No
The device description clearly outlines a physical transport incubator with integrated hardware components like a heating element, battery, display panel, and connections for pulse oximetry and oxygen monitoring. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states the device is a "transport incubator" that provides a "thermally regulated environment" for neonatal infants during transport. It also includes integrated pulse oximetry and oxygen monitoring, which are physiological measurements taken directly from the patient.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples (blood, urine, tissue, etc.) taken from the infant. Its function is to maintain the infant's environment and monitor physiological parameters in vivo.
Therefore, the device's function falls under the category of medical equipment used for patient care and monitoring, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The transport incubator is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment. The system is to be operated by trained medical technical personnel.
Product codes
FPL
Device Description
The A750i 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
Intended User / Care Setting
trained medical technical personnel
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)
Performance testing of the A750i. 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 (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
§ 880.5410 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).
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Special 510(k): Device Modification A750i Incubator with PulseOx November 22, 2010
MAY 1 1 2011
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: A750i Transport Incubator with PulseOx Common Name: Transport Incubator Classification Name: Neonatal Transport Incubator (FPL)
Predicate Device:
Transport Incubator 185A (K031096)
Intended Use:
The transport incubator is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment. The system is to be operated by trained medical technical personnel.
1
Special 510(k): Device Modification A750i Incubator with PulseOx November 22, 2010
Functional Description and Technological Characteristics:
The A750i 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 A750i 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 A750i. 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines that suggest wings or feathers. The bird is positioned within a circular border, and 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
MAY 1 1 2011
Ms. Amy Pieper Director of Regulatory Affairs International Biomedical, Limited 8508 Cross Park Drive Austin, Texas 78754
Re: K103525
Trade/Device Name: A750i Transport Incubator with PulseOx Regulation Number: 21 CFR 880.5410 Regulation Name: Neonatal Transport Incubator Regulatory Class: II Product Code: FPL Dated: April 12, 2011 Received: April 14, 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 Eederal Register.
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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/CDRHOffices/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.
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Sincerely yours,
hn for
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
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Special 510(k): A750i Transport Incubator with PulseOx November 22, 2010
INDICATIONS FOR USE
510(k) Number (if known): K/03525
Device Name: A750i Transport Incubator with PulseOx
Indications For Use:
The transport incubator is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment. The system is to be operated by trained medical technical personnel.
Prescription Use X (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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dentola
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