(201 days)
Not Found
No
The description focuses on the mechanical and material aspects of a warming blanket and its interaction with a temperature management system. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is used for induced hyperthermia or localized temperature increase, which are therapeutic interventions.
No
The device, IOB Warming Blankets, is indicated for warming patients, not for diagnosing medical conditions. It functions by distributing warmed air, which is a therapeutic action, not a diagnostic one.
No
The device description clearly outlines physical components (blankets made of fabric and polyethylene, a hose, air delivery channels, perforations) and their function in delivering warmed air. This indicates a hardware-based device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The IOB Warming Blankets are used externally on the patient's body to manage temperature. They do not involve testing samples taken from the body.
- Intended Use: The intended use is for warming patients, not for diagnostic testing.
- Device Description: The description details a system for delivering warmed air to the patient's surface.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the IOB Warming Blankets fall under the category of therapeutic or supportive medical devices, not In Vitro Diagnostics.
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 (comma separated list FDA assigned to the subject device)
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:
Torso IOB-001S Lower Body IOB-002S Upper Body IOB-003S Full Body IOB-004S 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.
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)
Nonclinical Tests:
- 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 IOB warming blankets and the predicate.
- Real time stability tests show three years shelf-life of the IOB warming blankets.
- Simulated transport testing was performed according to ASTM D4169. No package damage was observed. All product hold integrity after the transport testing.
- Bubble testing was carried out according to the ASTM F2096. No leakage was found.
- Biocompatibility tests were reported in the previously cleared K162679.
Clinical Studies: Not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
510(k) SUMMARY K221669
| 1. Date: | November 27, 2022 |
|---|---|
| 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 J | |
| 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:
Torso IOB-001S Lower Body IOB-002S Upper Body IOB-003S Full Body IOB-004S
4
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.
-
- Substantial Equivalence Information
A summary comparison of features of the IOB Warming Blankets and the predicate devices is provided in following Tables.
- Substantial Equivalence Information
| Parameters | Predicate devices K162679 | Proposed devices |
|---|---|---|
| IOB Warming Blankets (models | ||
| 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-015, IOB-017, IOB-018, IOB-019, | ||
| IOB-021, IOB-022) | IOB Warming Blankets (models IOB-001S, | |
| IOB-002S, IOB-003S, IOB-004S, IOB-005S, | ||
| IOB-006S, IOB-007S, IOB-008S, IOB-009S, | ||
| IOB-010S, IOB-011S, IOB-012S, IOB-015S, | ||
| IOB-017S, IOB-018S, IOB-019S, IOB-021S, | ||
| IOB-022S) | ||
| 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 | SAME |
Table 1: Comparison between IOB Warming Blankets and predicate devices.
5
| | 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. | |
|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Shelf Life | 3 years | SAME |
| Sterility | Non-sterile | Sterile |
| Parameters | Predicate devices K162679 | Proposed devices |
|---|---|---|
| IOB Warming Blankets (models | ||
| IOB-021, IOB-003) | IOB Warming Blankets (models IOB-030/IOB- | |
| 030S, IOB-034/IOB-034S) | ||
| 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 | |
| Shelf Life | 3 years | SAME |
| Sterility | Sterile and Non-sterile | SAME |
| Blanket | ||
| Dimensions | ||
| (approximate) | IOB-021 230cm×100cm | |
| IOB-003 202cm×64cm | IOB-30/IOB-30S 198cm×80cm | |
| IOB-34/IOB-34S 140cm×64cm |
10. Safety and Performance Characteristics
-
- Nonclinical Tests
6
- 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.
-
- 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.