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.

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.

AI/ML Overview

The provided text describes a Special 510(k) for a device modification: A750i Transport Incubator with PulseOx. This document focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized consensus standards for safety and performance, rather than presenting a study specifically designed to establish "acceptance criteria" and subsequent "device performance" in the way one might for an AI/CADe device.

Therefore, many of the requested fields related to AI/CADe study design (like sample size for test sets, data provenance, expert ground truthing, MRMC studies, standalone performance, training sets) are not applicable to this type of submission. This document highlights compliance with engineering and safety standards for a modified medical device.

However, I can extract the relevant information from the provided text as best as possible, interpreting "acceptance criteria" as compliance with recognized standards.

Here's the breakdown of the information that is available or can be inferred from the provided text:

1. A table of acceptance criteria and the reported device performance

For a device modification like this, acceptance criteria primarily refer to compliance with established medical device safety and performance standards. The "reported device performance" is the statement that the testing indicates compliance.

Acceptance Criteria (Standards Met)	Reported Device Performance (Compliance Statement)
IEC 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety	"The testing indicates the incubator is in compliance with..." this standard.
IEC 60601-1-2 Medical Electrical Equipment, Part 1: General Requirements for Safety, Electromagnetic Compatibility-Requirements and Tests	"The testing indicates the incubator is in compliance with..." this standard.
IEC 60601-2-20 Medical Electrical Equipment, Part 2: Particular Requirements for Safety of Transport Incubators	"The testing indicates the incubator is in compliance with..." this standard.
ISO 9919 Medical Electrical Equipment - Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use	"The testing indicates the incubator is in compliance with..." this standard.
ISO 21647 Medical Electrical Equipment Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors	"The testing indicates the incubator is in compliance with..." this standard.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: This information is not provided in the document. The performance testing mentioned is for "functional and design verification and validation," which typically involves engineering tests on the device itself, rather than a clinical "test set" in the context of an AI/CADe device.
Data Provenance: Not applicable in the sense of clinical data. The testing is likely internal to the manufacturer (International Biomedical, based in Austin, TX, U.S.A.). It's functional testing of a physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This type of information is relevant for studies involving human interpretation or diagnostic accuracy, which is not the primary focus of this device modification submission. The "ground truth" for this device would be its conformance to engineering specifications and safety standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a device modification for a transport incubator with integrated pulse oximetry, not an AI/CADe device.
Effect Size: Not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This is not an algorithm-only device. The pulse oximetry is an integrated feature, and its performance would be assessed against the ISO 9919 standard.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" here is the established specifications and requirements of the recognized consensus standards (IEC and ISO standards listed above). The device's performance is measured against these technical and safety requirements.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device that would require a "training set."

9. How the ground truth for the training set was established

Not Applicable. See point 8.

In summary, this 510(k) submission demonstrates that a modified medical device (an incubator with integrated pulse oximetry) meets its design and safety objectives by complying with relevant international standards. It is not an AI/CADe device submission, and as such, many of the typical questions for such studies do not apply.

Summary

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K103525

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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:

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Special 510(k): Device Modification A750i Incubator with PulseOx November 22, 2010

Functional Description and Technological Characteristics:

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:

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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Regulation Number and Section

§ 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).