(257 days)
The 3B and BMC RESmart® BPAP system is a Bi-level PAP (Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The optional integrated humidifier is indicated for the humidification and warming of air from the flow generator device. These devices are intended for single-patient use by prescription in the home or hospital/intuitional environment on adult patients. It is to be used on patients (>66lbs/30kg) for whom positive airway pressure therapy has been prescribed. The system can deliver bi-level therapy or auto bi-level therapy.
The RESmart BPAP is a microprocessor controlled blower based bilevel positive pressure system that delivers two different positive pressure levels (IPAP/EPAP) from 4 to 25 cmH₂O. The dual pressure levels provide a more natural means of delivering pressure support therapy to the patient resulting in improved patient comfort. Two operation modes are being introduced, including the Auto Bi-Level mode and Spontaneous Bi-Level mode. Bi-Level therapy with automatically adjusting IPAP and EPAP levels is delivered in the Auto Bi-Level mode at the prescribed pressure range. The Spontaneous Bi-Level mode delivers fixed prescribed inspiratory and expiratory pressure. The BPAP device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask).
This document is a 510(k) summary for the RESmart® BPAP 25A device, which is a Bi-level Positive Airway Pressure (BPAP) device. The purpose of this submission is to demonstrate substantial equivalence to predicate devices, not to establish new acceptance criteria through clinical trials. Therefore, much of the requested information about acceptance criteria and study details for proving a device meets them is not present in this type of document.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document states that "Extensive testing was conducted in accordance with ISO 17510-1:2007, Sleep Apnea Breathing Therapy-Part I: Sleep Apnea Breathing Therapy Equipment." and mentions several performance aspects. It also states, "Design verification tests were performed on the RESmart BPAP to ensure product requirements and evaluate risk analysis. All tests were verified to meet the required acceptance criteria." However, the specific quantitative acceptance criteria and their corresponding reported performance values are not explicitly listed in a table format in this summary.
Based on the text, we can infer some general performance aspects that met their acceptance criteria, likely established by the ISO standard and internal design verification:
| Performance Aspect | Acceptance Criteria (Inferred from ISO 17510-1:2007 and general safety/performance standards) | Reported Device Performance |
|---|---|---|
| Max Flow Rate | Meets requirements for patient ventilation (specific value not provided) | Substantially equivalent to predicate device |
| Static Pressure | Within acceptable limits for therapy delivery (specific value not provided) | Substantially equivalent to predicate device |
| Dynamic Pressure | Within acceptable limits for therapy delivery (specific value not provided) | Substantially equivalent to predicate device |
| Sound Pressure | Within acceptable limits for patient comfort (specific value not provided) | Substantially equivalent to predicate device |
| Air Quality | Meets safety and quality standards (specific metrics not provided) | Substantially equivalent to predicate device |
| Electrical Safety | Meets all requirements of IEC 60601-1 | Meets all requirements of IEC 60601-1 |
| EMC | Meets all requirements of IEC 60601-1 | Meets all requirements of IEC 60601-1 |
| Bi-level Functionality | Achieves dual pressure delivery of IPAP and EPAP as intended (specific metrics not provided) | Functionally equivalent to predicate device (Respironics BiPAP Auto) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify a "test set" in the context of human subjects or clinical data for performance evaluation. The testing described appears to be primarily bench testing and engineering verification. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since the document describes bench testing and engineering verification rather than a clinical study with a "ground truth" derived from expert diagnosis, this information is not applicable and therefore not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As no clinical test set requiring expert adjudication is described, this information is not applicable and therefore not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This document describes a medical device (BPAP system) for the treatment of Obstructive Sleep Apnea, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and not mentioned in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone medical device that delivers therapy. The "algorithm" mentioned refers to the software controlling the bi-level functionality. The performance testing outlined (max flow rate, static pressure, dynamic pressure, sound pressure, air quality, electrical safety, EMC) inherently evaluates the device's standalone performance, including its embedded algorithms, against engineering and safety standards. There is no mention of a separate "standalone algorithm only" performance study in the context of a human-in-the-loop comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the engineering and performance testing described, the "ground truth" would be established by the specified engineering standards (e.g., ISO 17510-1:2007, IEC 60601-1) and the performance characteristics of the predicate device. For example, the ground truth for electrical safety is defined by the IEC 60601-1 standard. For functional equivalence, the performance of the predicate device (Respironics BiPAP Auto) serves as the reference.
8. The sample size for the training set:
The term "training set" is typically used in the context of machine learning. While the device contains a microprocessor and software with an algorithm for bi-level functionality, this document does not describe the development or training of a machine learning model. Therefore, a "training set" in that sense is not applicable and not mentioned.
9. How the ground truth for the training set was established:
As there is no mention of a machine learning training set, this information is not applicable. The "ground truth" for the device's design and performance is based on engineering principles, safety standards, and the performance characteristics of the predicate device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2014
BMC Medical Co., Ltd. Alex Lucio, Vice President 3B Medical, Inc. 21301 US Highway 27 N Lake Wales. FL 33859
Re: K133769
Trade/Device Name: RESmart® BPAP 25A Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: Class II Product Code: BZD Dated: July 23, 2014 Received: July 25, 2014
Dear Mr. Lucio,
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
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Erin - Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K133769
Device Name RESmart BPAP 25A
Indications for Use (Describe)
The 3B and BMC RESmart BPAP system is a Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The optional integrated for the humidification and warming of air from the flow generator device. These devices are intended for single-patient use by prescription in the home or hospital/institutional environment on adult patients. It is to be used on patients >661bs/30kg for whom CPAP therapy has been prescribed. The system can deliver bi-level therapy or auto bi-level therapy.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
| Device Trade Name | RESmart BPAP 25A |
|---|---|
| Common/ Usual Name | BPAP System |
| Date Prepared | 19 November 2013 |
| Sponsor Identification: | 3B Medical, Inc.21301 Highway 27 N.Lake Wales, FL 33859 |
| Submission Correspondent | Alex LucioVice President3B Medical, Inc.21301 Highway 27 N.Lake Wales, FL 33859T: (863)226-6285 ext. 101F: (863)226-6284alucio@3bproducts.com |
| Establishment Registration # | 3008566132 |
| BMC MEDICAL CO., LTD5/f Main Building No. 19Gucheng Street West, ShijingshanBeijing, CHINA 100043 | |
| Classification | Class II Device |
| Classification Panel | Anesthesiology |
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD - Non-continuous Ventilator (Respirator) |
| Predicate Device(s) | Predicate Respironics BiPAP Auto (K050759) |
| Predicate RESmart® Auto-CPAP (K131707) | |
| Indications for Use | The 3B and BMC RESmart® BPAP system is a Bi-level PAP (Bi-level Positive Airway Pressure) device designed for thetreatment of adult Obstructive Sleep Apnea (OSA). The optionalintegrated humidifier is indicated for the humidification andwarming of air from the flow generator device. These devicesare intended for single-patient use by prescription in the homeor hospital/intuitional environment on adult patients. It is to be |
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RESmart BPAP
used on patients (>66lbs/30kg) for whom positive airway pressure therapy has been prescribed. The system can deliver bi-level therapy or auto bi-level therapy.
Device Description The RESmart BPAP is a microprocessor controlled blower based bilevel positive pressure system that delivers two different positive pressure levels (IPAP/EPAP) from 4 to 25 cmH₂O. The dual pressure levels provide a more natural means of delivering pressure support therapy to the patient resulting in improved patient comfort. Two operation modes are being introduced, including the Auto Bi-Level mode and Spontaneous Bi-Level mode. Bi-Level therapy with automatically adjusting IPAP and EPAP levels is delivered in the Auto Bi-Level mode at the prescribed pressure range. The Spontaneous Bi-Level mode delivers fixed prescribed inspiratory and expiratory pressure. The BPAP device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask). Purpose of Submission Modified design to the RESmart System software to achieve bilevel functionality in order to provide a bi-level device as an alternate device for patients who reject standard CPAP therapy. Performance Testing Extensive testing was conducted in accordance with ISO 17510-1:2007, Sleep Apnea Breathing Therapy-Part I: Sleep Apnea Breathing Therapy Equipment. Clinical Testing and Performance Contrast Testing demonstrated substantial equivalence with the predicate device in terms of max flow rate, static pressure, dynamic pressure, and sound pressure. The air quality testing determined the device is substantially equivalent to the predicate device. The device was tested according to IEC 60601-1 with the result that the device meets all requirements for electrical safety and electromagnetic compatibility and is otherwise substantially equivalent with the predicate device. Testing and validation of component part upgrades establish substantial equivalence between predicate and proposed devices.
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Substantial Equivalence The RESmart BPAP remains substantially equivalent to the predicate RESmart CPAP and Auto-CPAP System (K131707) in that they share the same intended use, operating principle, and manufacturing process. The RESmart BPAP remains substantially equivalent to the predicate Respironics BiPAP Auto (K050759) in that they share the same intended use, operating principle, and performance. Design modifications were made to the RESmart system software to achieve bi-level functionality to provide a bi-level device as an alternate device for patients who reject standard CPAP therapy. Design verification tests were performed on the RESmart BPAP to ensure product requirements and evaluate risk analysis. All tests were verified to meet the required acceptance criteria. The RESmart BPAP is mechanically identical to the RESmart CPAP/Auto-CPAP System. The modification to the software involves change to algorithm to produce dual pressure delivery of IPAP and EPAP substantially equivalent to the same function in the Respironics BiPAP Auto. In summary, the device described in this submission is substantially equivalent to the predicates. Truthful & Accuracy A certification of truthfulness and accuracy of the RESmart BPAP as described in this submission is provided in Section 9. Conclusion The 3B and BMC RESmart BPAP is substantially equivalent to the predicate devices already approved by the FDA.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).