The IOB Warming Blankets are indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated.

Device Description

The IOB warming blankets are used with the IOB Temperature Management System (previously cleared K162679) that draws ambient- temperature air through a 0.2 micron particulate 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 IOB Warming Blankets in this submission are the following:

Jackson Warming Blanket IOB-024
Infant Full Body/Under Body Blanket IOB-025
Large Half Body Blanket IOB-026
Large Full Body Blanket IOB-027
Infant Under Body Blanket IOB-028
Lithotomy/Orthopedic Under Body Blanket IOB-029
Small Size Warming Suit IOB-301
Medium Size Warming Suit IOB-302
Large Size Warming Suit IOB-303
Extra Large Size Warming Suit IOB-304

These blankets are single-use and disposable. Each blanket consists of two layers of non-woven polypropylene fabric coated with a layer of polyethylene. The layers 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 Warming Blankets (K190221). It describes the device, its intended use, and its substantial equivalence to a predicate device (K162679 IOB Temperature Management System).

However, the information requested about acceptance criteria and the study that proves the device meets the acceptance criteria, particularly regarding details like sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/Machine Learning-based medical devices, is not present in this document.

This document pertains to a Class II medical device (Thermal Regulating System), which falls under a different regulatory pathway than AI-powered diagnostic or predictive tools. The approval here is based on substantial equivalence to a predicate, not necessarily on a de novo clinical performance study against specific acceptance criteria for AI model performance.

The document states:

"Clinical Studies Not applicable" (Section 10, point 4)
The safety and performance characteristics mentioned are related to:
- Temperature uniformity tests: "show equivalence between the IOB warming blankets and the predicate." (This implies a comparison, but not detailed acceptance criteria or methodology for an AI-based system).
- Accelerated stability tests: "show three years shelf-life of the IOB warming blankets." (This is a physical product test, not AI performance).
- Biocompatibility tests: "were reported in the previously cleared K162679." (Again, physical product testing).

Therefore, I cannot provide the requested table and detailed information as the provided text does not contain data related to the performance evaluation of an AI/ML-based medical device against acceptance criteria.

The prompt's questions are highly specific to the evaluation of AI/ML algorithms, which is not the subject of this 510(k) submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 25, 2019

IOB Medical Inc % Joe Shia Director LSI International Inc 504E Diamond Ave., Suite J Gaithersburg, Maryland 20877

Re: K190221

Trade/Device Name: IOB Warming Blankets Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: September 22, 2019 Received: September 24, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190221

Device Name IOB Warming Blankes

Indications for Use (Describe)

The IOB Warming Blankets are indicated for hypothermic patients or normothermic patients 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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K190221 510(k) SUMMARY

1. Date:	October 15, 2019
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 Warming Blankets
1. Classification:

Class:

Class II

ProductCode	CFR #	Product Name
DWJ	870.5900	Thermal Regulating System

1. Predicate Devices: K162679 IOB Temperature Management System
1. Indications for Use

The IOB Warming Blankets are indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated.

1. Device Description
  The IOB warming blankets are used with the IOB Temperature Management System (previously cleared K162679) that draws ambient- temperature air through a 0.2 micron particulate 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 IOB Warming Blankets in this submission are the following:

Jackson Warming Blanket IOB-024 Infant Full Body/Under Body Blanket IOB-025 Large Half Body Blanket IOB-026 Large Full Body Blanket IOB-027 Infant Under Body Blanket IOB-028

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Lithotomy/Orthopedic Under Body Blanket IOB-029 Small Size Warming Suit IOB-301 Medium Size Warming Suit IOB-302 Large Size Warming Suit IOB-303 Extra Large Size Warming Suit IOB-304

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

Parameters	Predicate devices K162679	Proposed devices
	IOB Warming Blankets (modelsIOB-004, IOB-005, IOB-002, IOB-005,IOB-011, IOB-007)	IOB Warming Blankets(IOB-024, IOB-025, IOB-026, IOB-027, IOB-028, IOB-029, IOB-301, IOB-302, IOB-303,IOB-304)
INDICATIONSFOR USE	The IOB Temperature Management system isindicated for hypothermic patients ornormothermic patients for whom inducedhyperthermia or localized increase intemperature is clinically indicated.	The IOB Warming Blankets are indicated forhypothermic patients or normothermic patientsfor whom induced hyperthermia or localizedincrease in temperature 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

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

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Shelf Life	3 years	SAME
Sterility	Sterile and Non-sterile	SAME
BlanketDimensions(approximate)	IOB-004IOB-005IOB-002IOB-004IOB-005IOB-011IOB-002IOB-007	210×120cm90cm ×80cm142cm×120cm210×120cm90cm×80cm170cm×100cm142cm×120cm170cm×100cm	IOB-024IOB-025IOB-026IOB-027IOB-028IOB-029IOB-301IOB-302	240cm×150cm120cm× 80cm150cm×120cm220cm×120cm100cm×100cm200cm×100cm170cm×100cm170cm×100cm
	IOB-004IOB-004	210cm×120cm210cm×120cm	IOB-303IOB-304	180cm×120cm182cm×120cm

Safety and Performance Characteristics

1. Temperature uniformity tests show equivalence between the IOB warming blankets and the predicate.
1. Accelerated stability tests show three years shelf-life of the IOB warming blankets.
1. Biocompatibility tests were reported in the previously cleared K162679.
1. Clinical Studies

Not applicable

11.Conclusion

Based on the information presented in this 510K premarket notification, the IOB Warming Blanket 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).