The FilteredFlo Warming Blanket is intended to be used with the IOB-507 patient warming system. The IOB-507 Temperature Management system is indicated for hypothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. These blankets are intended for adult and pediatric use.

Device Description

The FilteredFlo warming blankets are used with the IOB Temperature Management System (previously cleared K231596) 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 FilteredFlo 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 FilteredFlo warming blankets in the submission are the following:

FF-243 ADULT/PACU BLANKET
FF-244 PEDIATRIC BLANKET
FF-246 INFANT UNDERBODY BLANKET
FF-247 LARGE PEDIATRIC UNDERBODY BLANKET
FF-248 ADULT UNDERBODY BLANKET
FF-443 UPPER BODY BLANKET
FF-442 LOWER BODY BLANKET
FF-344 TORSO BLANKET
FF-145 WARMING TUBE BLANKET

These blankets are single-use and disposable. Each blanket consists of two layers of nonwoven 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 document is a 510(k) summary for a medical device called "FilteredFlo Warming Blankets." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information related to software, artificial intelligence (AI), diagnostic performance, or extensive clinical studies that would typically have the requested details about acceptance criteria for AI models, human reader studies, ground truth establishment, or training/test set sizes.

The "studies" mentioned are primarily non-clinical tests to demonstrate that the new warming blankets perform equivalently to existing ones in terms of physical characteristics and safety, not diagnostic accuracy or AI performance.

Therefore, I cannot provide the requested information for acceptance criteria and studies related to AI or diagnostic performance, as these are not relevant to the "FilteredFlo Warming Blankets" device as described in this 510(k) submission.

Here's a breakdown of what can be extracted from the document, tailored as much as possible to your request, but highlighting the absence of AI/diagnostic-specific details:

Device: FilteredFlo Warming Blankets (models FF-243, FF-244, FF-246, FF-247, FF-248, FF-443, FF-442, FF-344, FF-145)

Intended Use: "The FilteredFlo Warming Blanket is intended to be used with the IOB-507 patient warming system. The IOB-507 Temperature Management system is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. These blankets are intended for adult and pediatric use."

A table of acceptance criteria and the reported device performance

Since this is a thermal regulating system and not an AI or diagnostic device, the "acceptance criteria" are related to physical and functional equivalence to a predicate device, specifically in terms of temperature uniformity, package integrity, and lack of leaks.

Acceptance Criteria	Reported Device Performance
Temperature Uniformity	All test results show temperature uniformity "equivalence" between the FilteredFlo Warming Blankets and the predicate at different IOB Warmer settings.
Simulated Transport Testing (ASTM D4169)	No package damage was observed. All products held integrity after the transport testing.
Bubble Testing (ASTM F2096) (Leakage)	No leakage was found.
Biocompatibility	Tests for biocompatibility were reported in the previously cleared K231596 (predicate device's clearance). The proposed device is implicitly accepted as biocompatible based on previous clearance.
Material Design and Indication for Use Equivalence	The proposed device's material design and Indications for Use are deemed "Substantially Equivalent" to the predicate device.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each test, but implied to be a representative sample of the different blanket models. These are physical product tests, not data-driven studies with "test sets" in the AI sense.
- Data Provenance: Not specified, but these are laboratory/bench tests performed by the manufacturer or their contractors.
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)

Not applicable. "Ground truth" in this context refers to established engineering standards and physical measurements, rather than expert diagnostic consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. These are engineering and physical product tests, not qualitative assessments requiring adjudication. The results are based on objective measurements against defined criteria.
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

Not applicable. This device is a warming blanket, not an AI or diagnostic tool. No MRMC study was performed or is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for demonstrating performance is derived from established engineering standards (e.g., ASTM standards for transport and bubble testing) and physical measurements (e.g., temperature measurements for uniformity). Comparison to the predicate device's cleared performance serves as the benchmark for "equivalence."
The sample size for the training set

Not applicable. This device does not involve a "training set" for an algorithm.
How the ground truth for the training set was established

Not applicable.

Summary

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October 24, 2023

IOB Medical Inc % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K232638

Trade/Device Name: FilteredFlo Warming Blankets Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II Product Code: DWJ Dated: October 10, 2023 Received: October 11, 2023

Dear Dave Yungvirt:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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,

Nicole M. Gillette -S

Nicole Gillette 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

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Indications for Use

510(k) Number (if known) K232638

Device Name FilteredFlo Warming Blankets

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K232638

I. SUBMITTER

IOB Medical Inc. 12011 Mosteller Rd. Cincinnati, OH 45241 IOB Medical is a part of Gentherm Medical.

Tel: 1(301)250-0831 Fax: 1(301)916-6213

Contact Person: Joe Shia Email: shiajl@yahoo.com

Date: October 21, 2023

II. DEVICE

Name of Device: FilteredFlo Warming Blankets Common or Usual Name: Warming Blanket Classification Name: Thermal Regulating System (21 CFR 870.5900) Regulatory Class: II Product Code: DWJ

III. PREDICATE DEVICE

K231596 IOB Temperature Management System Model IOB-507

IV. DEVICE DESCRIPTION

The FilteredFlo warming blankets in the submission are the following:

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FF-243 ADULT/PACU BLANKET FF-244 PEDIATRIC BLANKET FF-246 INFANT UNDERBODY BLANKET FF-247 LARGE PEDIATRIC UNDERBODY BLANKET FF-248 ADULT UNDERBODY BLANKET FF-443 UPPER BODY BLANKET FF-442 LOWER BODY BLANKET FF-344 TORSO BLANKET FF-145 WARMING TUBE BLANKET

V. INTENDED FOR USE

The FilteredFlo Warming Blanket is intended to be used with the IOB-507 patient warming system. The IOB-507 Temperature Management system is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. These blankets are intended for adult and pediatric use.

VI. SUBSTANTIAL EQUIVALENCE INFORMATION

A summary comparison of features of the FilteredFlo Warming Blankets and the predicate device is provided in following Table 1.

Parameters	Predicate Device K231596	Proposed Device
	IOB Warming Blankets (modelsIOB-004, IOB-007, IOB-028, IOB-009, IOB-006, IOB-003, IOB-002,IOB-001, IOB-015)	FilteredFlo Warming Blankets (modelsFF-243, FF-244, FF-246, FF-247, FF-248, FF-443, FF-442, FF-344, FF-145)
Indications ForUse	IOB Temperature Managementsystem is indicated for hypothermicpatients or normothermic patientsfor whom induced hyperthermia or	The FilteredFlo Warming Blanket isintended to be used with the IOB-507patient warming system. The IOB-507Temperature Management system is

Table 1: Comparison between the FilteredFlo Warming Blankets and the predicate device

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	localized increase in temperature isclinically indicated.		indicated for hypothermic patients ornormothermic patients for whom inducedhyperthermia or localized increase intemperature is clinically indicated.These blankets are intended for adult andpediatric use.
Material Design	Consists of two layers of non-woven polypropylene fabricbonded to a fusion layer ofpolyethylene.The layers are bonded together toform a distribution network of airdelivery channels.The warm air is distributed aroundthe patient's body through thedelivery channels and exits theblanket through a speciallydesigned series of perforations inthe patient side layer of the blanket.The distribution of air is designed tominimize temperature differences ofdelivered air at different blanketlocations.		SAME
Sterility	Sterile and Non-sterile		Non-sterile
	IOB-004	210 x 120 cm	FF-243	235 x 125 cm
	IOB-007	170 x 100 cm	FF-244	142 x 100 cm
	IOB-028	100 x 100 cm	FF-246	100 x 80 cm
	IOB-009	160 x 80 cm	FF-247	160 x 80 cm
BlanketDimensions	IOB-006	215 x 100 cm	FF-248	215 x 100 cm
	IOB-003	202 x 64 cm	FF-443	220 x 80 cm
	IOB-002	142 x 120 cm	FF-442	135 x 100 cm
	IOB-001	142 x 120 cm	FF-344	110 x 100 cm
	IOB-015	180 x 74 cm	FF-145	180 x 74 cm

VII. SAFETY AND PERFORMANCE CHARACTERISTICS

1. Nonclinical Tests

a. Temperature uniformity tests were performed by measuring five testing points on blanket surface at different IOB Warmer settings. All test results show temperature uniformity equivalence between the FilteredFlo Warming Blankets and the predicate.

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b. Simulated transport testing was performed according to ASTM D4169. No package damage was observed. All product hold integrity after the transport testing.
d. Bubble testing was carried out according to the ASTM F2096. No leakage was found.
e. Biocompatibility tests were reported in the previously cleared K231596.
1. Clinical Studies

Not applicable.

VIII. CONCLUSION

Based on the information presented in this 510K premarket notification including nonclinical tests of temperature uniformity tests, transport testing, bubble testing and biocompatibility testing, the FilteredFlo Warming Blankets are substantially equivalent to the predicates.

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).