The IOB Temperature Management system is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated.

Device Description

The IOB Temperature Management System consists of the IOB warming unit and the IOB warming blankets. The IOB warming unit draws ambient- temperature air through a 0.2 micron air filter. The filtered air is warmed to a selected temperature. The warmed air enters the IOB Warming Blanket through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the warming blanket gently disperse the warmed air over and around the patient. The warming unit has three temperature settings of 32°C, 38°C, and 43°C. These temperature settings are servo-controlled by a thermistor placed at the end of hose where the hose connects to the blanket. The unit can also delivers ambient-temperature air. The temperature indicated on the control panel is the temperature of air being delivered to the blanket at the end of the hose. A control thermistor in the warming unit adjusts the power applied to the heater to maintain the selected temperature. This enables the system to maintain the selected temperature under variations in ambient temperature. Besides, the warming unit has high and low air flow for choose.

The IOB Warming Blankets in this submission are the following:
Torso IOB-001 Lower Body IOB-002 Upper Body IOB-003 Full Body IOB-004 Pediatric Underbody IOB-005 Adult Underbody IOB-006 Pediatric Full Body IOB-007 Full Body Surgical IOB-008 Large Pediatric Underbody IOB-009 Spinal Underbody IOB-010 Lithotomy Underbody IOB-011 Pediatric Lower Body IOB-012 Pediatric Long IOB-014 Cath Lab IOB-015 Surgical Access IOB-016 Chest Access IOB-017 Multi-Access IOB-018 Dual Port Torso IOB-019 Cardiac Access IOB-020 XL Upper Body IOB-021 Outpatient Care IOB-022 Cardiac IOB-023
These blankets are single-use and disposable. Each blanket consists of two lavers of non-woven polypropylene fabric coated with a layer of polyethylene. The lavers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket.

AI/ML Overview

The provided text is a 510(k) summary for the IOB Temperature Management System, which is a medical device for warming patients. It addresses substantial equivalence to a predicate device (Bair Hugger Temperature Management System) rather than outlining acceptance criteria and a study proving device performance in the context of an AI/ML powered device.

Therefore, the specific information requested about acceptance criteria and studies demonstrating performance as would be expected for an AI/ML driven diagnostic or assistive technology (e.g., sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) is not present in the provided document.

The document focuses on the physical and functional characteristics of a thermal regulating system and its blankets, demonstrating its equivalence to a legally marketed predicate device.

However, I can extract the safety and performance characteristics mentioned in the document, which serve a similar purpose of demonstrating the device's suitability for its intended use, even if they are for a physical device rather than an AI/ML algorithm.

Here's the information that can be extracted, framed to best fit your request:

Acceptance Criteria and Study for the IOB Temperature Management System (as applicable to a physical thermal regulating device)

Since the IOB Temperature Management System is a physical device (a thermal regulating system) and not an AI/ML powered diagnostic or assistive technology, the typical "acceptance criteria" and "study" framework for AI/ML performance metrics (like sensitivity, specificity, AUC, etc.) and related study design details (sample size for test/training, ground truth methods, expert adjudication, MRMC) does not apply.

Instead, the provided document outlines the general "Safety and Performance Characteristics" and their verification methods to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Characteristic)	Reported Device Performance (Verification Method)
Temperature Uniformity	"Temperature uniformity tests show equivalence between the IOB warming blankets and the predicate."
Shelf-Life	"Accelerated stability tests show three years shelf-life of the IOB warming blankets."
Electrical Safety / EMC	"Electrical safety/EMC testing... show that the device meets its design specifications, performs as intended."
Software Validation	"Software validation show that the device meets its design specifications, performs as intended."
Biocompatibility	"Biocompatibility testing (cytotoxicity, irritation and sensitivity) according to ISO 10993 for a limited contact device was demonstrated to be suitable for the intended use of the product."

2. Sample size used for the test set and the data provenance

Not applicable / Not specified in the provided document for the types of tests described (temperature uniformity, accelerated stability, electrical safety, software validation, biocompatibility). These tests typically involve a defined number of units or samples under specific conditions rather than patient "test sets" as understood for AI/ML evaluation.

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

Not applicable / Information not provided. The ground truth for these device performance tests is based on objective measurements and established standards (e.g., precise temperature readings, material degradation, electrical standards, ISO biocompatibility standards) rather than expert consensus on diagnostic interpretations.

4. Adjudication method for the test set

Not applicable / Information not provided. Adjudication methods are not relevant for these types of engineering and material performance tests.

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 physical device, not an AI/ML diagnostic. A MRMC study is not relevant here.

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

No. This is a physical device, not an AI/ML algorithm.

7. The type of ground truth used

For Temperature Uniformity: Objective physical measurements against a standard for thermal performance (implied).
For Shelf-Life: Objective laboratory testing for material degradation and functional integrity over time (accelerated aging).
For Electrical Safety/EMC: Compliance with international safety standards (IEC60601-1, IEC 60601-1-2) through objective measurements.
For Software Validation: Verification against design specifications and functional requirements.
For Biocompatibility: Adherence to ISO 10993 standards (cytotoxicity, irritation, sensitivity) through laboratory testing.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device.

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

Not applicable. There is no "training set" or corresponding ground truth establishment mentioned for this device.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 28, 2017

IOB Medical, Inc. % Joe Shia Regulatory Consultant LSI International, Inc. 504 East Diamond Ave., Suite F Gaithersburg, Maryland 20877

Re: K162679

Trade/Device Name: IOB Temperature Management System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: March 10, 2017 Received: March 20, 2017

Dear Joe Shia:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Fernando
Aguel-S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162679

Device Name

IOB Temperature Management System

Indications for Use (Describe)

The IOB Temperature Management system is indicated for hypothermic patients or normothermic for whom induced hyperthermia or localized increase in temperature is clinically indicated.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

1. Date:	April 28, 2017
2. Submitter:	IOB Medical Inc504E Diamond Ave., Suite IGaithersburg, MD 20877
3. Contact person:	Joe ShiaLSI International Inc.504 East Diamond Ave., Suite FGaithersburg, MD 20877Telephone: 240-505-7880Fax: 301-916-6213Email: shiajl@yahoo.com

1. Device Name: IOB Temperature Management System
1. Classification: Class:

Class II

Product Code	CFR #	Product Name
DWJ	870.5900	Thermal Regulating System

1. Predicate Devices: K021473 Bair Hugger Temperature Management System
1. Intended Use

The IOB Temperature Management system is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated.

1. Device Description
  The IOB Temperature Management System consists of the IOB warming unit and the IOB warming The IOB warming unit draws ambient- temperature air through a 0.2 micron air filter. The blankets. filtered air is warmed to a selected temperature. The warmed air enters the IOB Warming Blanket through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the warming blanket gently disperse the warmed air over and around the patient. The warming unit has three temperature settings of 32°C, 38°C, and 43°C. These temperature settings are servo-controlled by a thermistor placed at the end of hose where the hose connects to the blanket. The unit can also delivers ambient-temperature air. The temperature indicated on the control panel is the temperature of air being delivered to the blanket at the end of the hose. A control thermistor in the warming unit adjusts the power applied to the heater to maintain the selected temperature. This enables the system to maintain the selected temperature under variations in ambient temperature. Besides, the warming unit has high and low air flow for choose.

The IOB Warming Blankets in this submission are the following:

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Torso IOB-001 Lower Body IOB-002 Upper Body IOB-003 Full Body IOB-004 Pediatric Underbody IOB-005 Adult Underbody IOB-006 Pediatric Full Body IOB-007 Full Body Surgical IOB-008 Large Pediatric Underbody IOB-009 Spinal Underbody IOB-010 Lithotomy Underbody IOB-011 Pediatric Lower Body IOB-012 Pediatric Long IOB-014 Cath Lab IOB-015 Surgical Access IOB-016 Chest Access IOB-017 Multi-Access IOB-018 Dual Port Torso IOB-019 Cardiac Access IOB-020 XL Upper Body IOB-021 Outpatient Care IOB-022 Cardiac IOB-023

These blankets are single-use and disposable. Each blanket consists of two lavers of non-woven polypropylene fabric coated with a layer of polyethylene. The lavers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket.

1. Substantial Equivalence Information
  A summary comparison of features of the IOB Temperature Management system and the predicate devices is provided in following Tables.

Parameters	Predicate devices K021473	Proposed devices
	Bair Hugger blankets (models540,525,522,300,555,635,310,610,550,575,585,537,530,560,570,305,315,542,645,523,110,630)	IOB Warming Blankets(IOB-001,IOB-002,IOB-003,IOB-004,IOB-005,IOB-006,IOB-007,IOB-008,IOB-009,IOB-010IOB-011, IOB-012,IOB-014,IOB-15,IOB-16IOB-17, IOB-18, IOB-019,IOB-020,IOB-021,IOB-022,IOB-023)

		Table 1: Comparison between IOB Warming Blankets and predicate devices.

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INDICATIONSFOR USE	The Bair Hugger temperature managementsystem is indicated for hyper- or hypothermicpatients or normothermic patients for whominduced hyper- or hypothermia or localizedtemperature therapy is clinically indicated. Inaddition, the Bair Hugger temperaturemanagement system can be used to providepatient thermal comfort when conditions existthat may cause patients to become too warm ortoo cold. The Bair Hugger temperaturemanagement system can be used with adult andpediatric patients.	The IOB Temperature Management system isindicated for hypothermic patients ornormothermic patients for whom inducedhyperthermia or localized increase intemperature is clinically indicated.
MATERIALDESIGN	Consists of two layers of non- wovenpolypropylene fabric bonded to a fusion layer ofpolyethylene.The layers are bonded together to form adistribution network of air delivery channelsThe warm air is distributed around the patient'sbody through the delivery channels and exits theblanket through a specially designed series ofperforations in the patient side layer of theblanket.The distribution of air is designed to minimizetemperature differences of delivered air atdifferent blanket locations.	SAME
Shelf Life	3 years	SAME
Sterility	Non-sterile except 645 and 630	Non-sterile except IOB-14, IOB-16, IOB-020 andIOB-023
BlanketDimensions(approximate)	540 107×91cm525 152×91cm522 188×61cm300 213×91cm635 221×91cm610 183×91cm575 188×91cm585 188×91cm560 23×335cm570 213×91cm305 183×91cm315 213×91cm542 107×91cm523 213×91cm110 213×91cm310 152×91cm555 91×84cm550 152×81cm537 89×61cm530 188×21cm645 23x274cm630 152x91cm	IOB-001 142×120cmIOB-002 142×120cmIOB-003 195×80cmIOB-004 210×120cmIOB-006 215×100cmIOB-008 210×120cmIOB-010 215×100cmIOB-011 170×100cmIOB-015 17x180cmIOB-016 210×120cmIOB-017 180×120cmIOB-018 210×120cmIOB-019 142×120cmIOB-021 215×80cmIOB-022 210×120cmIOB-007 170×100cmIOB-005 91×80cmIOB-009 160×80cmIOB-012 142×100cmIOB-014 110×17cmIOB-020 17x150cmIOB-023 142x120cm
Air Velocity	28-30cfm	Same
AirTemperature	Hose End Temperature43°C +/- 3.0°C38°C +/- 3.0°C32°C +/- 3.0°CAmbient	Hose End Temperature43°C +/- 3.0°C38°C +/- 3.0°C32°C +/- 3.0°CAmbient
SystemPower	110-120VAC,60Hz,10A220-240VAC,50Hz,4.5A	110-120V, 60 Hz, 12A230V, 50/60 Hz, 8A
HeaterPower	850 Watts	1000 W
Dimensions	33X 25 X 28cm	28 X 22X 22cm
Weight	5.2kg	4.5kg
EMI/EMCCompliant	IEC60601-1, IEC 60601-1-2	IEC60601-1, IEC 60601-1-2
Forced airOverTemperature	Auto-shuts heater off at 47°C +/- 2°C	Auto-shuts heater off at 47°C +/- 2°C.
Hose withSecureLocking	Yes	Yes
Air Filter	Replaceable 0.2 micron	Replaceable 0.2 micron
TemperatureDisplay	Front panel LCD display	Front panel digital display

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Safety and Performance Characteristics

Temperature uniformity tests show equivalence between the IOB warming blankets and the 1. predicate.
1. Accelerated stability tests show three years shelf-life of the IOB warming blankets.
1. Electrical safety/EMC testing, and software validation show that the device meets its design specifications, performs as intended.
1. Biocompatibility testing (cytotoxicity, irritation and sensitivity) according to ISO 10993 for a limited contact device was demonstrated to be suitable for the intended use of the product.
1. Clinical Studies Not applicable

11.Conclusion

Based on the information presented in this 510K premarket notification, the IOB Temperature Management System is substantially equivalent to the predicate.

Regulation Number and Section

§ 870.5900 Thermal regulating system.

(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).