IOB Temperature Management System

K231596 · Iob Medical, Inc. · DWJ · Jun 30, 2023 · Cardiovascular

Device Facts

• Record ID: K231596
• Device Name: IOB Temperature Management System
• Applicant: Iob Medical, Inc.
• Product Code: DWJ · Cardiovascular
• Decision Date: Jun 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The IOB Temperature Management System Model IOB-507 is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated.

Device Story

System comprises IOB Warming Unit (IOB-507) and single-use disposable warming blankets. Unit draws ambient air through 0.2-micron filter, warms it to selected temperature (32°C, 38°C, 43°C, or ambient), and delivers it via hose to blanket distribution channels. Perforations in blanket disperse air over patient. Servo-controlled via thermistor at hose-blanket interface; secondary safety thermistor triggers alarm and independent analog shutoff if temperature exceeds set point. Used in clinical settings; operated by healthcare professionals. Output is controlled thermal air flow; assists in maintaining patient normothermia or inducing hyperthermia, potentially improving clinical outcomes during surgery or recovery.

Clinical Evidence

No clinical data. Bench testing only: electrical safety, EMC, usability, alarm system testing, air velocity, software validation, temperature uniformity, shelf-life (3 years), simulated transport (ASTM D4169), bubble testing (ASTM F2096), and biocompatibility (ISO 10993).

Technological Characteristics

Materials: non-woven polypropylene fabric coated with polyethylene. Sensing: thermistor-based servo-control. Energy: 110-120V AC, 14A. Dimensions: 29.5 x 22 x 22 cm. Connectivity: standalone. Sterilization: non-sterile and sterile options. Software: embedded control logic with independent analog safety circuit.

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)
• IOB Warming Blankets (K190221)
• IOB Warming Blankets (K221669)

Submission Summary (Full Text)

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June 30, 2023

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

Re: K231596

Trade/Device Name: IOB Temperature Management System Model IOB-507 Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II Product Code: DWJ Dated: May 29, 2023 Received: June 1, 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 (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.

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

Sincerely.

Eric E. Richardson -S

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) K231596

Device Name

IOB Temperature Management System Model IOB-507

Indications for Use (Describe)

The IOB Temperature Management System Model IOB-507 is 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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# 510(k) Summary

### I. SUBMITTER

IOB Medical Inc. 504 E Diamond Avenue, Suite I Gaithersburg, MD 20877 USA

Tel: [phone] Fax: [phone]

Contact Person: Joe Shia Email: [e-mail]

Date: 29 May, 2023

# II. DEVICE

Name of Device: IOB Temperature Management System Model IOB-507 Common or Usual Name: Temperature Management System Classification Name: Thermal Regulating System (21 CFR 870.5900) Regulatory Class: II Product Code: DWJ

# III. PREDICATE DEVICE

K162679 IOB Temperature Management System K190221 IOB Warming Blankets K221669 IOB Warming Blankets

# IV. DEVICE DESCRIPTION

The IOB Temperature Management System Model IOB-507 consists of the IOB Warming Unit and the IOB Warming Blankets. The IOB Warming Unit, model IOB-507, 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

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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℃, 38℃, and 43℃. These temperature settings are servo-controlled by a thermistor placed at the end of the hose where the hose connects to the blanket. The unit can also deliver ambient-temperature air. The temperature indicated on the control panel is the temperature of air being delivered to the average contact surface temperature of the blanket. A control thermistor in the warming unit adjusts the power applied to the heater to maintain the selected temperature. This enables the unit to maintain the selected temperature under variations in ambient temperature. Besides, the warming unit has high and low air flow options.

A safety thermistor provides a signal to a separate high-temperature analog circuit. The safety thermistor activates and produces an alarm if the temperature exceeds the set point. The analog safety circuit provides an independent means of shutoff, which discontinues power to the heater and motor. This prevents patient exposure to excessive temperatures.

The IOB Warming Blankets in this submission are the following: IOB-001/IOB-001S Torso Warming Blanket IOB-002/IOB-002S Lower Body Warming Blanket IOB-003/IOB-003S Upper Body Warming Blanket IOB-004/IOB-004S Full Body Warming Blanket IOB-005/IOB-005S Pediatric Under Body Warming Blanket IOB-006/IOB-006S Adult Under Body Warming Blanket IOB-007/IOB-007S Pediatric Full Body Warming Blanket IOB-008/IOB-008S Full Body Surgical Warming Blanket IOB-009/IOB-009S Large Pediatric Under Body Warming Blanket IOB-010/IOB-010S Spinal Under Body Warming Blanket IOB-011/IOB-011S Lithotomy Under Body Warming Blanket IOB-012/IOB-012S Pediatric Lower Body Warming Blanket IOB-014/IOB-014S Pediatric Long Warming Blanket IOB-015/IOB-015S Cath Lab Warming Blanket IOB-016/IOB-016S Surgical Access Warming Blanket IOB-017/IOB-017S Chest Access Warming Blanket IOB-018/IOB-018S Multi-Access Warming Blanket IOB-019/IOB-019S Dual Port Torso Warming Blanket IOB-020/IOB-020S Cardiac Access Warming Blanket IOB-021/IOB-021S XL Upper Body Warming Blanket IOB-022/IOB-022S Outpatient Care Warming Blanket IOB-023/IOB-023S Cardiac Warming Blanket IOB-024/IOB-024S Jackson Warming Blanket

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IOB-025/IOB-025S Infant Full Body & Under Body Warming Blanket IOB-026/IOB-026S Large Half Body Warming Blanket IOB-027/IOB-027S Large Full Body Warming Blanket IOB-028/IOB-028S Infant Under Body Warming Blanket IOB-029/IOB-029S Lithotomy & Orthopedic Under Body Warming Blanket IOB-030/IOB-030S Multi-position Upper Body Warming Blanket IOB-034/IOB-034S Arms-in Upper Body Warming Blanket IOB-301/IOB-301S Small Size Warming Suit IOB-302/IOB-302S Medium Size Warming Suit IOB-303/IOB-303S Large Size Warming Suit IOB-304/IOB-304S Extra Large Size Warming Suit

IOB warming 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.

No product in the IOB Warming Blanket contains latex, DEHP or BPA.

# V. INTENDED FOR USE

The IOB Temperature Management System Model IOB-507 is indicated for hypothermic patients or normothermic for whom induced hyperthermia or localized increase in temperature is clinically indicated.

# VI. SUBSTANTIAL EQUIVALENCE INFORMATION

A summary comparison of features of the IOB Warming Unit Model IOB-507 and the predicate device is provided in following Table 1.

| Parameters | Predicate Device K162679<br>IOB Warming Unit Model IOB-505 | Proposed Device<br>IOB Warming Unit Model IOB-507 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Indications For<br>Use | IOB Temperature Management<br>system is indicated for hypothermic<br>patients or normothermic patients<br>for whom induced hyperthermia or<br>localized increase in temperature is<br>clinically indicated. | Same |

### Table 1: Comparison between the IOB Warming Unit and the predicate device

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| Parameters | Predicate Device K162679<br>IOB Warming Unit Model IOB-505 | Proposed Device<br>IOB Warming Unit Model IOB-507 |
|--------------------------------|------------------------------------------------------------|---------------------------------------------------|
| Air Velocity | 28-30cfm | 30-45cfm |
| Temperature<br>Settings | 43°C+/-3°C<br>38°C+/-3°C<br>32°C+/-3°C<br>Ambient | 43°C+/-2°C<br>38°C+/-2°C<br>32°C+/-2°C<br>Ambient |
| System Power | 110-120 V, 60 Hz, 12 A<br>220-240 V, 50/60 Hz, 8 A | 110-120 V, 60 Hz, 14 A |
| Heater Power | 1000 W | 950 W |
| Dimensions | 28 X 22X 22cm | 29.5 x 22 x 22 cm |
| Weight | 4.5 kg | 5.4 kg |
| EMI/EMC<br>Compliant | IEC 60601-1, IEC 60601-1-2 | Same |
| Forced Air Over<br>Temperature | Auto-shuts heater off at 47°C+/-<br>2°C | Same |
| Hose with Secure<br>Locking | Yes | Same |
| Air Filter | Replaceable 0.2 micron | Same |
| Temperature<br>Display | Front panel digital display | Front panel LCD display |

A summary comparison of features of the IOB Warming Blankets and the predicate devices is provided in following Table 2.

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| | Predicate Devices K162679 | Predicate Devices K190221 | Predicate Devices K221669 | Proposed Devices |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameters | IOB Warming Blankets | IOB Warming Blankets | IOB Warming Blankets | IOB Warming Blankets |
| Models | IOB-001, IOB-002, IOB-<br>003, IOB-004, IOB-005,<br>IOB-006, IOB-007, IOB-<br>008, IOB-009, IOB-010,<br>IOB-011, IOB-012, IOB-<br>014, IOB-015, IOB-016,<br>IOB-017, IOB-018, IOB-<br>019, IOB-020, IOB-021,<br>IOB-022, IOB-023 | IOB-024, IOB-025, IOB-026,<br>IOB-027, IOB-028, IOB-029,<br>IOB-301, IOB-302, IOB-303,<br>IOB-304 | IOB-001S, IOB-002S, IOB-<br>003S, IOB-004S, IOB-005S,<br>IOB-006S, IOB-007S, IOB-<br>008S, IOB-009S, IOB-010S,<br>IOB-011S, IOB-012S, IOB-<br>015S, IOB-017S, IOB-018S,<br>IOB-019S, IOB-021S, IOB-<br>022S, IOB-030/IOB-030S,<br>IOB-034/IOB-034S | IOB-001, IOB-002 IOB-003, IOB-<br>004, IOB-005, IOB-006, IOB-007,<br>IOB-008, IOB-009, IOB-010, IOB-<br>011, IOB-012, IOB-014, IOB-015,<br>IOB-016, IOB-017, IOB-018, IOB-<br>019, IOB-020, IOB-021, IOB-022,<br>IOB-023, IOB-024, IOB-025, IOB-<br>026, IOB-027, IOB-028, IOB-029,<br>IOB-030, IOB-034, IOB-301, IOB-<br>302, IOB-303, IOB-304, IOB-001S,<br>IOB-002S, IOB-003S, IOB-004S,<br>IOB-005S, IOB-006S, IOB-007S,<br>IOB-008S, IOB-009S, IOB-010S,<br>IOB-011S, IOB-012S, IOB-014S,<br>IOB-015S, IOB-016S, IOB-017S,<br>IOB-018S, IOB-019S, IOB-020S,<br>IOB-021S, IOB-022S, IOB-023S,<br>IOB-024S, IOB-025S, IOB-026S,<br>IOB-027S, IOB-028S, IOB-029S,<br>IOB-030S, IOB-034S, IOB-301S,<br>IOB-302S, IOB-303S, IOB-304S |
| Indications For<br>Use | The IOB Warming Blankets<br>are indicated for<br>hypothermic patients or<br>normothermic patients for<br>whom induced hyperthermia<br>or localized increase in<br>temperature is clinically<br>indicated. | The IOB Warming Blankets<br>are indicated for hypothermic<br>patients or normothermic<br>patients for whom induced<br>hyperthermia or localized<br>increase in temperature is<br>clinically indicated. | The IOB Warming Blankets<br>are indicated for hypothermic<br>patients or normothermic<br>patients for whom induced<br>hyperthermia or localized<br>increase in temperature is<br>clinically indicated. | Same |

| | | | Table 2: Comparison between the IOB Warming Blankets and the predicate devices. | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | |
| Parameters | Predicate Devices K162679 | Predicate Devices K190221 | Predicate Devices K221669 | Proposed Devices |
| | IOB Warming Blankets | IOB Warming Blankets | IOB Warming Blankets | IOB Warming Blankets |
| Material<br>Design | Consists of two layers of<br>non- woven polypropylene<br>fabric bonded to a fusion<br>layer of polyethylene.<br>The layers are bonded<br>together to form a<br>distribution network of air<br>delivery channels.<br>The warm air is distributed<br>around the patient's body<br>through the delivery<br>channels and exits the<br>blanket through a specially<br>designed series of<br>perforations in the patient<br>side layer of the blanket.<br>The distribution of air is<br>designed to minimize<br>temperature differences of<br>delivered air at different<br>blanket locations. | Consists of two layers of non-<br>woven polypropylene fabric<br>bonded to a fusion layer of<br>polyethylene.<br>The layers are bonded<br>together to form a distribution<br>network of air delivery<br>channels.<br>The warm air is distributed<br>around the patient's body<br>through the delivery channels<br>and exits the blanket through a<br>specially designed series of<br>perforations in the patient side<br>layer of the blanket.<br>The distribution of air is<br>designed to minimize<br>temperature differences of<br>delivered air at different<br>blanket locations. | Consists of two layers of non-<br>woven polypropylene fabric<br>bonded to a fusion layer of<br>polyethylene.<br>The layers are bonded<br>together to form a distribution<br>network of air delivery<br>channels.<br>The warm air is distributed<br>around the patient's body<br>through the delivery channels<br>and exits the blanket through a<br>specially designed series of<br>perforations in the patient side<br>layer of the blanket.<br>The distribution of air is<br>designed to minimize<br>temperature differences of<br>delivered air at different<br>blanket locations. | Same |
| Shelf Life | 3 years | 3 years | 3 years | Same |
| Sterility | Non-sterile except IOB-014,<br>IOB-016, IOB-020 andIOB-<br>023 | Non-sterile and sterile | Non-sterile and sterile | Non-sterile and sterile |
| Parameters | Predicate Devices K162679<br>IOB Warming Blankets | Predicate Devices K190221<br>IOB Warming Blankets | Predicate Devices K221669<br>IOB Warming Blankets | Proposed Devices<br>IOB Warming Blankets |
| Blanket<br>Dimensions<br>(approximate) | IOB-001 142×120cm | IOB-024 240cm×150cm | IOB-001S 142×120cm | IOB-001/IOB-001S 142×120cm |
| | IOB-002 142×120cm | IOB-025 120cm×80cm | IOB-002S 142×120cm | IOB-002/IOB-002S 142×120cm |
| | IOB-003 195×80cm | IOB-026 150cm×120cm | IOB-003S 195×80cm | IOB-003/IOB-003S 202×64cm |
| | IOB-004 210×120cm | IOB-027 220cm×120cm | IOB-004S 210×120cm | IOB-004/IOB-004S 210×120cm |
| | IOB-006 215×100cm | IOB-028 100cm×100cm | IOB-006S 215×100cm | IOB-005/IOB-005S 100×80cm |
| | IOB-008 210×120cm | IOB-029 200cm×100cm | IOB-008S 210×120cm | IOB-006/IOB-006S 215×100cm |
| | IOB-010 215×100cm | IOB-301 170cm×100cm | IOB-010S 215×100cm | IOB-007/IOB-007S 170×100cm |
| | IOB-011 170×100cm | IOB-302 170cm×100cm | IOB-011S 170×100cm | IOB-008/IOB-008S 210×120cm |
| | IOB-015 17×180cm | IOB-303 180cm×120cm | IOB-015S 17×180cm | IOB-009/IOB-009S 160×80cm |
| | IOB-016 210×120cm | IOB-304 182cm×120cm | IOB-017S 180×120cm | IOB-010/IOB-010S 215×100cm |
| | IOB-017 180×120cm | | IOB-018S 210×120cm | IOB-011/IOB-011S 200×100cm |
| | IOB-018 210×120cm | | IOB-019S 142×120cm | IOB-012/IOB-012S 142×100cm |
| | IOB-019 142×120cm | | IOB-021S 215×80cm | IOB-014/IOB-014S 122×64cm |
| | IOB-021 215×80cm | | IOB-022S 210×120cm | IOB-015/IOB-015S 192×74cm |
| | IOB-022 210×120cm | | IOB-007S 170×100cm | IOB-016/IOB-016S 210×120cm |
| | IOB-007 170×100cm | | IOB-005S 91×80cm | IOB-017/IOB-017S 215×100cm |
| | IOB-005 91×80cm | | IOB-009S 160×80cm | IOB-018/IOB-018S 210×120cm |
| | IOB-009 160×80cm | | IOB-012S 142×100cm | IOB-019/IOB-019S 109×102cm |
| | IOB-012 142×100cm |…