(339 days)
No reference devices were used in this submission
No
The device description and performance studies focus on mechanical components (flapper valve, blade design) and standard medical device testing (biocompatibility, mechanical, risk assessment, human factors). There is no mention of AI, ML, data processing, or algorithms.
Yes.
The device is intended for use with a manual resuscitator to provide flow-controlled ventilation to non-breathing patients, with the goal of minimizing gastric inflation, which directly addresses a physiological issue and supports patient care.
No
The device is described as a "universal safety accessory device" intended for "flow controlled ventilation" and to "minimize gastric inflation during manual ventilation," which are therapeutic functions, not diagnostic.
No
The device description clearly states it is a "universal safety accessory device" that uses a "flapper valve with a blade design to limit the flow rate." This describes a physical, mechanical component, not software. The performance studies also focus on mechanical and material properties.
Based on the provided information, the Sotair™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for use with a manual resuscitator to provide flow-controlled ventilation to non-breathing patients. This is a therapeutic and life-support function, not a diagnostic one.
- Device Description: The description details a mechanical device with a flow-limiting valve. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The Sotair device is a medical device used for ventilation, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Sotair™ device is intended for use with a manual resuscitator with air-tight connections, in non-breathing patients that require flow controlled ventilation using ambient air or a supplemental oxygen source. The Sotair device is a single use, disposable device added to a manual resuscitator and can be used for in-hospital, emergency, and transport care. The adult Sotair device comprises a flow-limiting valve that limits the inspiratory flow enabling providers to ventilate approximately 55 liters-per-minute (LPM). The flow-limiting valve is intended to minimize gastric inflation during manual ventilation. The Sotair device can be disabled by removing the manual resuscitator to its conventional operation. The Sotair device is intended for adult use only.
Product codes
BTM
Device Description
The Sotair™ device is a universal safety accessory device that is compatible with all manual resuscitators and airway interfaces that have standard ISO 5356-1:2015 15/22 mm connections. The Sotair device's flow-limiting function has been tested with the following bag resuscitators: Ambu Spur II, adult; Curaplex Resuscitation Bags, adult premium BVM; Curaplex® VentiSure2™ BVM Manual Resuscitator, Adult; AirLife Adult Manual Resuscitator; Sunmed/ventlab AirFlow Standard, Size 5; Mercury Medical CPR 2 - Small Adult Bag; Adult CPR-2 Bag; 1st Response Adult Manual Resuscitator with Oxygen Reservoir Bag; The BAG II Resuscitator Adult w/ Mask #5; Adult BagEasy Resuscitator w/ Mask; Disposable Bag Mask Resuscitator; RUSCH, Manual Pulmonary Resuscitator with oxygen reservoir bag, Adult. The Sotair device is not compatible with manual resuscitators that have a built-in flow limiting device.
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
Intended User / Care Setting
in-hospital, emergency, and transport care
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)
Biocompatibility Testing:
Biological safety testing on the final, finished Sotair device was conducted in accordance with ISO 10993 and ISO 18562. The Sotair device has contact with the humidified breathing gas pathway for a limited duration (
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Safe BVM Corporation % Sara Toyloy President Fabrica Consulting, LLC 73 Lincoln Drive Sausalito, California 94965
Re: K212905
Trade/Device Name: Sotair™ Device Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: Class II Product Code: BTM Dated: July 14, 2022 Received: July 18, 2022
Dear Sara Toyloy:
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,
Brandon Blakely, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory, and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K212905
Device Name Sotair™ Device
Indications for Use (Describe)
The Sotair™ device is intended for use with a manual resuscitator with air-tight connections, in non-breathing patients that require flow controlled ventilation using ambient air or a supplemental oxygen source. The Sotair device is a single use, disposable device added to a manual resuscitator and can be used for in-hospital, emergency, and transport care. The adult Sotair device comprises a flow-limiting valve that limits the inspiratory flow enabling providers to ventilate approximately 55 liters-per-minute (LPM). The flow-limiting valve is intended to minimize gastric inflation during manual ventilation. The Sotair device can be disabled by removing the manual resuscitator to its conventional operation. The Sotair device is intended for adult use only.
| 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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5. 510(k) Summary
| 1. Submitter: | SafeBVM, Corporation
Chesterfield, MO 63017 USA |
|------------------|---------------------------------------------------------------------------------------------------------|
| Phone Number: | +1 (314) 973-6606 |
| Sponsor Contact: | Haris Shekhani, MD
President, SafeBVM
Email: haris@safebvm.com
Phone: +1 (314) 973-6606 |
| Correspondent: | Sara Toyloy
Fabrica Consulting, LLC
Email: sara@fabricaconsulting.com
Phone: +1 (415) 297-8826 |
| Date Prepared: | August 17, 2022 |
-
- Device:
| Proprietary Name: | Sotair™ Device |
|---|---|
| Common Name: | Flow-Limiting Valve |
| Regulation: | 21 CFR § 868.5915 |
| Classification: | Manual emergency ventilator |
| Device Class: | Class 2 |
| Device Code: | BTM |
| Review Panel: | Anesthesiology |
3. Predicate Device:
Smart Bag MO (K021328), O-Two Systems International, Inc. No reference devices were used in this submission
4. Device Description:
The Sotair™ device is a universal safety accessory device that is compatible with all manual resuscitators and airway interfaces that have standard ISO 5356-1:2015 15/22 mm connections. The Sotair device's flow-limiting function has been tested with the following bag resuscitators:
| Model Number | Description/Brand Name | Manufacturer |
|---|---|---|
| 520 211 00X, 520 211 00XX | Ambu Spur II, adult | Ambu |
| 2442-BVMPAD | Curaplex Resuscitation Bags, adult premium | |
| BVM | Curaplex |
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| Model Number | Description/Brand Name | Manufacturer |
|---|---|---|
| 301-558XEA | Curaplex® VentiSure2™ BVM Manual Resuscitator, Adult | Curaplex |
| 04-2K80XX | AirLife Adult Manual Resuscitator | Vyaire Medical/Carefusion |
| AF5140MBX, AF5140MBXX | Sunmed/ventlab AirFlow Standard, Size 5 | Sunmed/Ventlab |
| 10564XX, 10585XX | Mercury Medical CPR 2 - Small Adult Bag | Mercury Medical |
| 1056XXX, 10582XX | Adult CPR-2 Bag | Mercury Medical |
| 850XX | 1st Response Adult Manual Resuscitator with Oxygen Reservoir Bag | Smith's Medical |
| 8451X1 | The BAG II Resuscitator Adult w/ Mask #5 | Laerdal |
| 562013 | Adult BagEasy Resuscitator w/ Mask | Westmed |
| L670-0X0XX | Disposable Bag Mask Resuscitator | Allied Healthcare Products |
| 53710X | RUSCH, Manual Pulmonary Resuscitator with oxygen reservoir bag, Adult | Teleflex |
The Sotair device is not compatible with manual resuscitators that have a built-in flow limiting device.
5. Indications for Use:
The Sotair device is intended for use with a manual resuscitator with air-tight connections, in nonbreathing patients that require flow-controlled ventilation using ambient air or a supplemental oxygen source. The Sotair device is a single use, disposable device added to a manual resuscitator and can be used for in-hospital, emergency, and transport care. The adult Sotair device comprises a flow-limiting valve that limits the inspiratory flow enabling user to ventilate approximately 55 liters-per-minute (LPM). The flow-limiting valve is intended to minimize gastric inflation during manual yentilation. The Sotair device can be disabled by removing the device, thereby returning the manual resuscitator to its conventional operation. The Sotair device is for adult use only.
6. Comparison of Indications for Use and Technological Characteristics with the Predicate Device:
Comparison of Indications for Use:
The Sotair device is a flow-limiting valve with the primary function of minimizing gastric inflation during manual ventilation. This intended use statement is the same as the predicate device with regard to the Smart Bag MO's flow-limiting-valve which provides the same primary function of minimizing gastric inflation during manual ventilation. Small differences exist between the two intended uses wherein the Sotair device has a statement indicating that "the device is intended for
5
use in conjunction with a manual resuscitator which does not have a flow-limiting valve" whereas the predicate Smart Bag MO indicates that "the Smart Bag MO includes a flow-limiting valve that limits the inspiratory flow". Additional differences exist between the two devices including the maximum ventilation rate of ~55 LPM and the targeted patient population (adult use only) for Sotair, however, these differences do not impact the substantial equivalence of the Sotair device as compared to the predicate device.
Comparison of Technological Characteristics:
The Sotair device (subject device) differs from the predicate device with regard to the actual mechanism that is used to limit the flow rate. Specifically, the Sotair device uses a flapper valve with a blade design whereas the Smart Bag MO (predicate device) uses a t-shaped piston with spring design. While the actual morphology differs between the two devices, the mechanism of action is the same for both devices, i.e., the flow-limiting valve becomes activated when the provider squeezes the bag forcefully (i.e., too hard). The Sotair device and the Smart Bag MO mechanisms are both actuated with excessive force and enable the provider to limit inspiratory flows delivered to the patient. When activated, the flow-limiting valve mechanisms of both devices move within their respective housing to limit flow. Both valves are brightly colored to aid in visualization, and their plastic components consist of similar medical-grade polycarbonate material.
7. Performance Data:
To demonstrate that the differences in technological characteristics specific to the flow-limiting valve mechanism do not impact the substantial equivalence of the Sotair device (subject device) to the Smart Bag MO device (predicate device), performance testing was completed to support the determination of substantial equivalence as follows:
Biocompatibility Testing:
Biological safety testing on the final, finished Sotair device was conducted in accordance with ISO 10993 and ISO 18562. The Sotair device has contact with the humidified breathing gas pathway for a limited duration (