(55 days)
No
The description focuses on the mechanical function of a warming blanket and its interaction with a temperature management system, with no mention of AI or ML.
Yes
The device is described as "intended for hypothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated," which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
This device is a warming blanket intended for therapeutic use (patient warming) rather than diagnosis. It does not collect or interpret physiological data for the purpose of identifying a disease or condition.
No
The device described is a physical warming blanket made of fabric and polyethylene, designed to be used with a separate warming system. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The FilteredFlo Warming Blanket is a patient warming system accessory. It uses warmed air to directly heat the patient's body.
- Intended Use: The intended use is for warming hypothermic patients or those requiring localized temperature increase. This is a therapeutic/supportive function, not a diagnostic one based on analyzing biological specimens.
- Device Description: The description details the physical construction and how it delivers warmed air to the patient's surface. There is no mention of analyzing biological samples.
- Performance Studies: The performance studies focus on physical characteristics like temperature uniformity, package integrity, and leakage, which are relevant to a warming device, not an IVD.
The device's function and intended use clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications 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 for whom induced hyperthermia or localized increase in temperature is clinically indicated. These blankets are intended for adult and pediatric use.
Product codes
DWJ
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.
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
Adult and pediatric
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
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.
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.
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, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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)
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.
| 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 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:
4
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.
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 (models | ||
| IOB-004, IOB-007, IOB-028, IOB- | ||
| 009, IOB-006, IOB-003, IOB-002, | ||
| IOB-001, IOB-015) | FilteredFlo Warming Blankets (models | |
| FF-243, FF-244, FF-246, FF-247, FF- | ||
| 248, FF-443, FF-442, FF-344, FF-145) | ||
| Indications For | ||
| Use | IOB Temperature Management | |
| system is indicated for hypothermic | ||
| patients or normothermic patients | ||
| for whom induced hyperthermia or | The FilteredFlo Warming Blanket is | |
| intended to be used with the IOB-507 | ||
| patient warming system. The IOB-507 | ||
| Temperature Management system is |
Table 1: Comparison between the FilteredFlo Warming Blankets and the predicate device
5
| | localized increase in temperature is
clinically indicated. | | 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. | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 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 | |
| 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 |
| Blanket
Dimensions | 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.
6
- 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.
-
- 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.