(262 days)
No
The description focuses on the physical components and function of warming blankets used with a previously cleared temperature management system. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is indicated for directly treating hypothermia and inducing localized hyperthermia, which are therapeutic actions.
No
The device, IOB Warming Blankets, is indicated for warming patients (hypothermic or normothermic for induced hyperthermia) by dispersing warmed air. It is a therapeutic device, not one that measures or analyzes data to diagnose a condition.
No
The device description clearly details physical components (blankets made of fabric and polyethylene) and their interaction with a separate hardware system (IOB Temperature Management System) to deliver warmed air. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for warming patients (hypothermic or normothermic) to induce hyperthermia or increase localized temperature. This is a therapeutic/supportive function, not a diagnostic one.
- Device Description: The device is a warming blanket that uses warmed air to heat the patient's body. This is a physical intervention, not a test performed on biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for diagnosis.
- Performance Studies: The performance studies focus on temperature uniformity, stability, and biocompatibility, which are relevant to a warming device, not a diagnostic test.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
DWJ
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.
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
- 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.
- Biocompatibility tests were reported in the previously cleared K162679.
- Clinical Studies: Not applicable
Key Metrics
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/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
1
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
2
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 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 Warming Blankets
-
- Classification:
Class:
Class II
| Product
| Code | CFR # | Product Name |
|---|---|---|
| DWJ | 870.5900 | Thermal Regulating System |
-
- Predicate Devices: K162679 IOB Temperature Management System
-
- 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.
-
- 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..
- Device Description
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
4
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.
-
- 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 | ||
| IOB-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) | ||
| INDICATIONS | ||
| FOR 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. | The IOB Warming Blankets are 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 |
Table 1: Comparison between IOB Warming Blankets and predicate devices.
5
| Shelf Life | 3 years | SAME | ||
|---|---|---|---|---|
| Sterility | Sterile and Non-sterile | SAME | ||
| Blanket | ||||
| Dimensions | ||||
| (approximate) | IOB-004 | |||
| IOB-005 | ||||
| IOB-002 | ||||
| IOB-004 | ||||
| IOB-005 | ||||
| IOB-011 | ||||
| IOB-002 | ||||
| IOB-007 | 210×120cm | |||
| 90cm ×80cm | ||||
| 142cm×120cm | ||||
| 210×120cm | ||||
| 90cm×80cm | ||||
| 170cm×100cm | ||||
| 142cm×120cm | ||||
| 170cm×100cm | IOB-024 | |||
| IOB-025 | ||||
| IOB-026 | ||||
| IOB-027 | ||||
| IOB-028 | ||||
| IOB-029 | ||||
| IOB-301 | ||||
| IOB-302 | 240cm×150cm | |||
| 120cm× 80cm | ||||
| 150cm×120cm | ||||
| 220cm×120cm | ||||
| 100cm×100cm | ||||
| 200cm×100cm | ||||
| 170cm×100cm | ||||
| 170cm×100cm | ||||
| IOB-004 | ||||
| IOB-004 | 210cm×120cm | |||
| 210cm×120cm | IOB-303 | |||
| IOB-304 | 180cm×120cm | |||
| 182cm×120cm |
- Safety and Performance Characteristics
-
- 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.
-
- Biocompatibility tests were reported in the previously cleared K162679.
-
- 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.