(214 days)
No
The device description details a servo-controlled system using a thermistor to maintain a selected temperature, which is a standard control mechanism and does not indicate the use of AI or ML. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes.
The device is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated, which describes a therapeutic purpose.
No
The device is a temperature management system designed to warm patients, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines hardware components including a warming unit, air filter, heater, thermistor, hose, and warming blankets. The software mentioned is for controlling the temperature and airflow of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for managing patient body temperature (hypothermia or induced hyperthermia). This is a therapeutic and physiological intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a system for warming air and delivering it to a patient via blankets. This is a physical therapy/warming device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic purpose.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The IOB Temperature Management system is indicated for hypothermic patients or normothermic for whom induced hyperthermia or localized increase in temperature is clinically indicated.
Product codes
DWJ
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: 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-001, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Temperature uniformity tests show equivalence between the IOB warming blankets and the predicate.
- Accelerated stability tests show three years shelf-life of the IOB warming blankets.
- Electrical safety/EMC testing, and software validation show that the device meets its design specifications, performs as intended.
- 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.
- Clinical Studies Not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection.
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
1
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
2
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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3
510(k) SUMMARY
| 1. Date: | April 28, 2017 |
|---|---|
| 2. Submitter: | IOB Medical Inc |
| 504E Diamond Ave., Suite I | |
| Gaithersburg, MD 20877 | |
| 3. Contact person: | Joe Shia |
| LSI International Inc. | |
| 504 East Diamond Ave., Suite F | |
| Gaithersburg, MD 20877 | |
| Telephone: 240-505-7880 | |
| Fax: 301-916-6213 | |
| Email: shiajl@yahoo.com |
-
- Device Name: IOB Temperature Management System
-
- Classification: Class:
Class II
| Product Code | CFR # | Product Name |
|---|---|---|
| DWJ | 870.5900 | Thermal Regulating System |
-
- Predicate Devices: K021473 Bair Hugger Temperature Management System
-
- 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.
-
- 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.
- Device Description
The IOB Warming Blankets in this submission are the following:
4
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.
-
- Substantial Equivalence Information
A summary comparison of features of the IOB Temperature Management system and the predicate devices is provided in following Tables.
- Substantial Equivalence Information
| Parameters | Predicate devices K021473 | Proposed devices |
|---|---|---|
| Bair Hugger blankets (models | ||
| 540,525,522,300,555,635,310,610,550,575, | ||
| 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-010 | ||
| IOB-011, IOB-012,IOB-014,IOB-15,IOB-16 | ||
| IOB-17, IOB-18, IOB-019,IOB-020,IOB-021, | ||
| IOB-022,IOB-023) |
| Table 1: Comparison between IOB Warming Blankets and predicate devices. | ||||
|---|---|---|---|---|
5
| INDICATIONS
FOR USE | The Bair Hugger temperature management
system is indicated for hyper- or hypothermic
patients or normothermic patients for whom
induced hyper- or hypothermia or localized
temperature therapy is clinically indicated. In
addition, the Bair Hugger temperature
management system can be used to provide
patient thermal comfort when conditions exist
that may cause patients to become too warm or
too cold. The Bair Hugger temperature
management system can be used with adult and
pediatric patients. | 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. |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MATERIAL
DESIGN | Consists of two layers of non- woven
polypropylene fabric bonded to a fusion layer of
polyethylene.
The layers are bonded together to form a
distribution network of air delivery channels
The warm air is distributed around the patient's
body through the delivery channels and exits the
blanket through a specially designed series of
perforations in the patient side layer of the
blanket.
The distribution of air is designed to minimize
temperature differences of delivered air at
different blanket locations. | SAME |
| Shelf Life | 3 years | SAME |
| Sterility | Non-sterile except 645 and 630 | Non-sterile except IOB-14, IOB-16, IOB-020 and
IOB-023 |
| Blanket
Dimensions
(approximate) | 540 107×91cm
525 152×91cm
522 188×61cm
300 213×91cm
635 221×91cm
610 183×91cm
575 188×91cm
585 188×91cm
560 23×335cm
570 213×91cm
305 183×91cm
315 213×91cm
542 107×91cm
523 213×91cm
110 213×91cm
310 152×91cm
555 91×84cm
550 152×81cm
537 89×61cm
530 188×21cm
645 23x274cm
630 152x91cm | IOB-001 142×120cm
IOB-002 142×120cm
IOB-003 195×80cm
IOB-004 210×120cm
IOB-006 215×100cm
IOB-008 210×120cm
IOB-010 215×100cm
IOB-011 170×100cm
IOB-015 17x180cm
IOB-016 210×120cm
IOB-017 180×120cm
IOB-018 210×120cm
IOB-019 142×120cm
IOB-021 215×80cm
IOB-022 210×120cm
IOB-007 170×100cm
IOB-005 91×80cm
IOB-009 160×80cm
IOB-012 142×100cm
IOB-014 110×17cm
IOB-020 17x150cm
IOB-023 142x120cm |
| Air Velocity | 28-30cfm | Same |
| Air
Temperature | Hose End Temperature
43°C +/- 3.0°C
38°C +/- 3.0°C
32°C +/- 3.0°C
Ambient | Hose End Temperature
43°C +/- 3.0°C
38°C +/- 3.0°C
32°C +/- 3.0°C
Ambient |
| System
Power | 110-120VAC,60Hz,10A
220-240VAC,50Hz,4.5A | 110-120V, 60 Hz, 12A
230V, 50/60 Hz, 8A |
| Heater
Power | 850 Watts | 1000 W |
| Dimensions | 33X 25 X 28cm | 28 X 22X 22cm |
| Weight | 5.2kg | 4.5kg |
| EMI/EMC
Compliant | IEC60601-1, IEC 60601-1-2 | IEC60601-1, IEC 60601-1-2 |
| Forced air
Over
Temperature | Auto-shuts heater off at 47°C +/- 2°C | Auto-shuts heater off at 47°C +/- 2°C. |
| Hose with
Secure
Locking | Yes | Yes |
| Air Filter | Replaceable 0.2 micron | Replaceable 0.2 micron |
| Temperature
Display | Front panel LCD display | Front panel digital display |
6
7
- Safety and Performance Characteristics
- Temperature uniformity tests show equivalence between the IOB warming blankets and the 1. predicate.
-
- Accelerated stability tests show three years shelf-life of the IOB warming blankets.
-
- Electrical safety/EMC testing, and software validation show that the device meets its design specifications, performs as intended.
-
- 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.
-
- 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.