IOB Warming Blankets

K221669 · Iob Medical, Inc. · DWJ · Dec 27, 2022 · Cardiovascular

Device Facts

• Record ID: K221669
• Device Name: IOB Warming Blankets
• Applicant: Iob Medical, Inc.
• Product Code: DWJ · Cardiovascular
• Decision Date: Dec 27, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

IOB Warming Blankets are single-use, disposable convective warming accessories used with the IOB Temperature Management System. The system draws ambient air through a 0.2-micron particulate filter, warms it to a selected temperature, and delivers it via a hose to the blanket. The blanket, constructed of non-woven polypropylene and polyethylene, distributes air through internal channels and releases it onto the patient via perforations. Used in clinical settings to manage patient body temperature; helps prevent or treat hypothermia and provides localized warming. Healthcare providers operate the system to maintain patient thermal regulation.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including temperature uniformity, real-time stability (3-year shelf life), simulated transport testing (ASTM D4169), and bubble leak testing (ASTM F2096). Biocompatibility was established via the predicate device.

Technological Characteristics

Materials: two layers of non-woven polypropylene fabric coated with polyethylene. Principle: convective air warming via distribution channels and perforations. Connectivity: connects to IOB Temperature Management System. Sterility: sterile and non-sterile options. Standards: ASTM D4169 (transport), ASTM F2096 (leak testing).

Indications for Use

Indicated for hypothermic or normothermic patients requiring induced hyperthermia or localized temperature increase.

Regulatory Classification

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.

Predicate Devices

• IOB Temperature Management System (K162679)

Submission Summary (Full Text)

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December 27, 2022

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

Re: K221669

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: November 27, 2022 Received: November 28, 2022

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

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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 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 (QS) 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Eric E. Richardson -S == 2022.12.27 09:05:58 -05'00'

for 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

Enclosure

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# Indications for Use

510(k) Number (if known) K221669

Device Name IOB Warming Blankets

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.

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) SUMMARY K221669

| 1. Date: | November 27, 2022 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Submitter: | IOB Medical Inc<br>504E Diamond Ave., Suite I<br>Gaithersburg, MD 20877 |
| 3. Contact person: | Joe Shia<br>LSI International Inc.<br>504 East Diamond Ave., Suite J<br>Gaithersburg, MD 20877<br>Telephone: [phone]<br>Fax: [phone]<br>Email:[e-mail] |

- 4. Device Name: IOB Warming Blankets
- 5. Classification: Class:

Class II

| Product<br>Code | CFR # | Product Name |
|-----------------|----------|---------------------------|
| DWJ | 870.5900 | Thermal Regulating System |

- 6. Predicate Devices: K162679 IOB Temperature Management System
- 7. 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.

- 8. 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:

Torso IOB-001S Lower Body IOB-002S Upper Body IOB-003S Full Body IOB-004S

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Pediatric Underbody IOB-005S Adult Underbody IOB-006S Pediatric Full Body IOB-007S Full Body Surgical IOB-008S Large Pediatric Underbody IOB-009S Spinal Underbody IOB-010S Lithotomy Underbody IOB-011S Pediatric Lower Body IOB-012S Cath Lab IOB-015S Chest Access IOB-017S Multi-Access IOB-018S Dual Port Torso IOB-019S XL Upper Body IOB-021S Outpatient Care IOB-022S Multi-position Upper Body Warming Blanket IOB-030/IOB-030S Arms-in Upper Body Warming Blanket IOB-034/IOB-034S

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.

- 9. 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 (models<br>IOB-001, IOB-002, IOB-003, IOB-004,<br>IOB-005, IOB-006, IOB-007, IOB-008,<br>IOB-009, IOB-010, IOB-011, IOB-012,<br>IOB-015, IOB-017, IOB-018, IOB-019,<br>IOB-021, IOB-022) | IOB Warming Blankets (models IOB-001S,<br>IOB-002S, IOB-003S, IOB-004S, IOB-005S,<br>IOB-006S, IOB-007S, IOB-008S, IOB-009S,<br>IOB-010S, IOB-011S, IOB-012S, IOB-015S,<br>IOB-017S, IOB-018S, IOB-019S, IOB-021S,<br>IOB-022S) |
| INDICATIONS<br>FOR USE | The IOB Temperature Management system is<br>indicated for hypothermic patients or<br>normothermic patients for whom induced<br>hyperthermia or localized increase in<br>temperature is clinically indicated. | The IOB Warming Blankets are indicated for<br>hypothermic patients or normothermic patients<br>for whom induced hyperthermia or localized<br>increase in temperature is clinically indicated. |
| MATERIAL<br>DESIGN | Consists of two layers of non- woven<br>polypropylene fabric bonded to a fusion layer of<br>polyethylene.<br>The layers are bonded together to form a | SAME |

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

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| | distribution network of air delivery channels<br>The warm air is distributed around the patient's<br>body through the delivery channels and exits the<br>blanket through a specially designed series of<br>perforations in the patient side layer of the<br>blanket.<br>The distribution of air is designed to minimize<br>temperature differences of delivered air at<br>different blanket locations. | |
|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Shelf Life | 3 years | SAME |
| Sterility | Non-sterile | Sterile |

| Parameters | Predicate devices K162679 | Proposed devices |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | IOB Warming Blankets (models<br>IOB-021, IOB-003) | IOB Warming Blankets (models IOB-030/IOB-<br>030S, IOB-034/IOB-034S) |
| INDICATIONS<br>FOR USE | The IOB Temperature Management system is<br>indicated for hypothermic patients or<br>normothermic patients for whom induced<br>hyperthermia or localized increase in<br>temperature is clinically indicated. | The IOB Warming Blankets are indicated for<br>hypothermic patients or normothermic patients<br>for whom induced hyperthermia or localized<br>increase in temperature is clinically indicated. |
| MATERIAL<br>DESIGN | Consists of two layers of non- woven<br>polypropylene fabric bonded to a fusion layer of<br>polyethylene.<br>The layers are bonded together to form a<br>distribution network of air delivery channels<br>The warm air is distributed around the patient's<br>body through the delivery channels and exits the<br>blanket through a specially designed series of<br>perforations in the patient side layer of the<br>blanket.<br>The distribution of air is designed to minimize<br>temperature differences of delivered air at<br>different blanket locations. | SAME |
| Shelf Life | 3 years | SAME |
| Sterility | Sterile and Non-sterile | SAME |
| Blanket<br>Dimensions<br>(approximate) | IOB-021 230cm×100cm<br>IOB-003 202cm×64cm | IOB-30/IOB-30S 198cm×80cm<br>IOB-34/IOB-34S 140cm×64cm |

## 10. Safety and Performance Characteristics

- 1. Nonclinical Tests

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- Temperature uniformity tests were performed by measuring five testing points on blanket a. surface at different IOB Warmer settings. All test results show temperature uniformity equivalence between the IOB warming blankets and the predicate.
- Real time stability tests show three years shelf-life of the IOB warming blankets. b.
- Simulated transport testing was performed according to ASTM D4169. No package C. 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 k162679.
- 2. Clinical Studies

Not applicable

## 11. Conclusion

Based on the information presented in this 510K premarket notification including nonclinical tests of temperature uniformity, real time stability, transport testing and biocompatibility, the IOB Warming Blanket is substantially equivalent to the predicate.