(135 days)
The transport incubator is intended for use by personnel trained in neonatal care to facilitate the movements of neonates by air or ambulance.
The Aviator Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to ar uc 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 interes of a rece 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; axygen analyzers; air and oxygen cylinders; air compressors; etc. The integrate pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board or of Wiest cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.
This document describes the Aviator Transport Incubator with PulseOx, a medical device, and its conformance to established performance standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| IEC 60601-1 (Medical Electrical Equipment, Part 1: General Requirements for Safety) | In compliance. Functional and design verification and validation testing conducted indicate compliance. |
| IEC 60601-1-2 (Medical Electrical Equipment, Part 1: General Requirements for Safety, Electromagnetic Compatibility-Requirements and Tests) | In compliance. Functional and design verification and validation testing conducted indicate compliance. |
| IEC 60601-2-20 (Medical Electrical Equipment, Part 2: Particular Requirements for Safety of Transport Incubators) | In compliance. Functional and design verification and validation testing conducted indicate compliance. |
| ISO 9919 (Medical Electrical Equipment Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use) | In compliance. Functional and design verification and validation testing conducted indicate compliance. |
| ISO 21647 (Medical Electrical Equipment Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors) | In compliance. Functional and design verification and validation testing conducted indicate compliance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the context of clinical or observational data. The testing mentioned is related to engineering and safety standards compliance. Therefore, no information on data provenance (country of origin, retrospective/prospective) is available because the document describes device safety and performance testing against industry standards, not a clinical study involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. The "ground truth" for the device's performance in this context is defined by the technical specifications and requirements outlined in the listed international consensus standards (IEC, ISO). Device performance is measured against these technical specifications, not against expert human consensus on clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods are typically used in studies involving expert review of clinical cases. The testing described here is focused on engineering validation and verification against predefined technical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this submission. The document focuses on the technical safety and performance of the device itself, not on how human readers or operators interact with or are augmented by the device's specific new feature (PulseOx).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a physical medical instrument (transport incubator) with integrated features, not a standalone AI algorithm. The performance testing described is for the device's functional and design verification and validation. Therefore, the concept of a "standalone algorithm" performance is not applicable. The PulseOx feature is integrated into the device and its performance would be assessed as part of the overall system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by conformance to recognized international consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-20, ISO 9919, ISO 21647). These standards specify safety, essential performance, and electromagnetic compatibility requirements for medical electrical equipment, particularly transport incubators and pulse oximeters/respiratory gas monitors.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a hardware product with integrated sensors (PulseOx). It is not described as utilizing a machine learning algorithm that requires a "training set" of data in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the reasons outlined in point 8. The device's functionality is based on established engineering principles and sensor technology, not on a machine learning model trained on a specific dataset.
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Special 510(k): Device Modification Aviator Incubator with PulseOx November 22, 2010
1
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: Aviator Transport Incubator with PulseOx Common Name: Transport Incubator Classification Name: Neonatal Transport Incubator (FPL)
Predicate Device:
Aviator Transport Incubator (K081399)
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.
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Special 510(k): Device Modification Aviator Incubator with PulseOx November 22, 2010
Functional Description and Technological Characteristics:
The Aviator Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to ar uc 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 interes of a rece 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; axygen analyzers; air and oxygen cylinders; air compressors; etc.
The integrate pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board or of Wiest cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.
Substantial Equivalence:
In summary, the Aviator 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 Aviator 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 seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Amy Piener Director of Regulatory Affairs Internation Biomedical, Limited 8508 Cross Park Drive Austin, Texas 78754
APR 1 5 2011
Re: K103527
Trade/Device Name: Aviator 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.
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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/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.
Sincerely yours,
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
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Special 510(k): . Aviator Transport Incubator with PulseOx November 22, 2010
INDICATIONS FOR USE
K103527 510(k) Number (if known):
Device Name: Aviator 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.
ং
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)
Mih C. Chape Y/15/11
(Division Sign-Off) (Division Sigir-On)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
Page 1 of
510(k) Number: K103527
§ 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).