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 185A+ 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

This document describes a Special 510(k) for a device modification, specifically the addition of PulseOx functionality to an existing transport incubator. The provided text, however, focuses on regulatory compliance and functional description rather than detailed performance studies with acceptance criteria, sample sizes, and ground truth establishment for a device leveraging AI/ML.

Therefore, many of the requested sections about acceptance criteria and study details cannot be fully populated as the document does not contain this type of information. It primarily indicates that performance testing for functional and design verification and validation was conducted in compliance with recognized consensus standards for medical electrical equipment and pulse oximetry.

Here's an attempt to extract and describe what information is available based on the request:

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

The document does not provide specific acceptance criteria or reported device performance metrics in a tabular format for the integrated PulseOx functionality. It states that "The testing indicates the incubator is in compliance with the following recognized consensus standards," implying that meeting the requirements of these standards serves as the acceptance criteria.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with IEC 60601-1 (General Safety)	Testing indicates compliance.
Compliance with IEC 60601-1-2 (EMC)	Testing indicates compliance.
Compliance with IEC 60601-2-20 (Transport Incubators)	Testing indicates compliance.
Compliance with ISO 9919 (Pulse Oximeter Equipment)	Testing indicates compliance.
Compliance with ISO 21647 (Respiratory Gas Monitors - though PulseOx is for oxygen saturation, not respiratory gas monitoring, this may be a typo or an overarching standard for respiratory-related measurements)	Testing indicates compliance.
Functional and design verification and validation	Conducted, indicating compliance with standards.

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

This information is not provided in the document. The submission focuses on regulatory compliance through standard adherence rather than a clinical performance study with defined test sets and data provenance for the PulseOx enhancement.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as the document does not describe the establishment of a ground truth for a test set in the context of a clinical study or AI/ML evaluation. The evaluation is based on adherence to recognized engineering and safety standards.

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

This information is not provided. An adjudication method is typically relevant for studies involving human interpretation or subjective assessment, which is not described here for the PulseOx integration.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable here. The device is a hardware modification (adding PulseOx) to an incubator, not an AI/ML-driven diagnostic tool intended to assist human readers.

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

This information is not provided and is not directly applicable. The PulseOx is an integrated measurement device, not an algorithm in the sense of AI/ML. Its performance would be evaluated as a standalone sensor system, which is implicitly covered by adherence to ISO 9919.

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

The concept of "ground truth" as typically applied to image analysis, pathology, or outcomes data is not directly relevant or described in the context of this device modification. The "ground truth" for the PulseOx functionality would be established by reference to a gold standard measurement technique for oxygen saturation (e.g., arterial blood gas analysis in a clinical setting, or calibrated test equipment in a lab setting) as part of the validation for ISO 9919. However, the document does not detail how this was performed.

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" as this device does not utilize machine learning or AI that would require such a set.

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

This information is not provided and is not applicable, as there is no mention of a training set for machine learning.

Summary

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K1@3523

Special 510(k): Device Modification 185A+ Incubator with PulseQx 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:	185A+ Transport Incubator with PulseO
Common Name:	Transport Incubator
Classification Name:	Neonatal Transport Incubator (FPL)

Predicate Device:

Transport Incubator 185A Incubator (K031096)

Intended Use:

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Special 510(k): Device Modification 185A+ Incubator with PulseOx November 22, 2010

Functional Description and Technological Characteristics:

Substantial Equivalence:

In summary, the 185A+ 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 185A+ 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The bird is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol.

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 International Biomedical, Limited 8508 Cross Park Drive Austin, Texas 78754

MAY 1 1 2011

Re: K103523

Trade/Device Name: 185A+ 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 Federal 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 /ucm115809.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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Wh far

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): 185A+ Transport Incubator with PulseOx November 22, 2010

INDICATIONS FOR USE

510(k) Number (if known): < 10 352 3

Device Name: 185A+ 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 Dental Devices
$10(k) Number:

K103523

Page 1 of

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).