(72 days)
Not Found
Yes
The device description mentions "optical character recognition" which is a form of AI/ML used for extracting text from images.
Yes
The device is intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea, which is a therapeutic purpose.
No
The device is described as delivering positive pressure for the treatment of Obstructive Sleep Apnea, which is a therapeutic function, not a diagnostic one. While it processes data (iCode software), its primary stated purpose is treatment.
No
The device description clearly states it is a "microprocessorcontrolled, blower-based system that generates positive airway pressure". This indicates a hardware component is central to the device's function, even though it includes a software modification (porting the iCode software to a web-based application).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver positive pressure for the treatment of Obstructive Sleep Apnea." This is a therapeutic intervention, not a diagnostic test performed on samples taken from the human body.
- Device Description: The device is a "blower-based system that generates positive airway pressure." This describes a mechanical device for delivering air pressure, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The description 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 prognosis of a disease or condition based on sample analysis.
The mention of "optical character recognition" and "iCode Report Generator" relates to processing data generated by the CPAP device itself (likely related to usage data or settings), not to analyzing biological samples.
No
The input letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked 'Not Found'.
Intended Use / Indications for Use
The 3B and BMC RESmart CPAP and Auto CPAP Systems are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. 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/institutional environment on adult patients.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The RESmart CPAP and Auto CPAP System is a microprocessorcontrolled, blower-based system that generates positive airway pressure from 4 to 20 cm H2O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask). The RESmart CPAP and Auto CPAP device has been modified to include porting the iCode software to a web-based application. The basic functional and performance characteristic of the RESmart CPAP and Auto CPAP is unchanged from the predicate device RESmart CPAP and Auto CPAP (K110629).
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 patients
Intended User / Care Setting
single patient use by prescription in the home or hospital/institutional environment
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)
Non-clinical testing includes software verification and validation of the iCode Report Generator and iCode Smartphone application.
Verification and validation activities were conducted based on risk analysis and demonstrated substantial equivalence to the predicate.
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.
RESmart CPAP and Auto CPAP System (K110629)
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
§ 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).
0
510(k) Summary (K131707)
רשK13170
.
RESmart CPAP/Auto CPAP
.
510(k) Summary
| Device Trade Name | RESmart CPAP and Auto CPAP | |
|---|---|---|
| Common/ Usual Name | CPAP System, Auto CPAP System | |
| Date Prepared | 31 May, 2013 | |
| Sponsor Identification: | 3B Medical, Inc. | |
| 21301 Highway 27 N. | ||
| Lake Wales, FL 33859 | AUG 2 2 2013 | |
| Phone: | 863-226-6285 | |
| Fax: | 863-226-6284 | |
| Submission Correspondent | Alex Lucio | |
| Vice President | ||
| 3B Medical, Inc. | ||
| 21301 Highway 27 N. | ||
| Lake Wales, FL 33859 | ||
| 863-226-6285 | ||
| 863-226-6284 | ||
| alucio@3bproducts.com | ||
| Establishment Registration # | 3008566132 | |
| BMC MEDICAL CO., LTD | ||
| 5/f Main Building No. 19 | ||
| Gucheng Street West, Shijingshan | ||
| Beijing, CHINA 100043 | ||
| Classification | Class II Device | |
| Classification Panel | Medical Device | |
| Classification Reference | 21 CFR 868.5905 | |
| Product Code | BZD - Non-continuous Ventilator (Respirator) | |
| Medical Specialties | Anesthesiology | |
| Predicate Device(s) | RESmart CPAP and Auto CPAP System (K110629) |
1
Intended Use
Device Description:
The 3B and BMC RESmart CPAP and Auto CPAP Systems are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. 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/institutional environment on adult patients.
Please see the Indications for Use Statement in Attachment 5.
The RESmart CPAP and Auto CPAP System is a microprocessorcontrolled, blower-based system that generates positive airway pressure from 4 to 20 cm H2O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask). The RESmart CPAP and Auto CPAP device has been modified to include porting the iCode software to a web-based application. The basic functional and performance characteristic of the RESmart CPAP and Auto CPAP is unchanged from the predicate device RESmart CPAP and Auto СРАР (К110629).
Purpose of the Modifications: The purpose of this modification is to port the iCode feature, used to report compliance data for insurance reimbursement, to a web based program. There are no changes in logic, Rather the extent of the device algorithm, or function. modification is a simple change from a desktop environment to a web server based environment.
For those modifications involving a software change, all software has been verified and code reviewed using the methods provided in our internal procedures. The following paragraphs provide a summary of the modifications:
-
- Modification is the porting of the iCode feature to a web based application, which is referred to as the "iCode Report Generator."
- . The purpose of the modification is to accommodate the needs of a fast changing marketplace, and is preferable
2
to most homecare providers because it is web based, requires no software installation, and may also be used to empower patients by allowing patients to review their sleep data. The entire scheme of iCode is based on reading the device LCD display and recording the character string displayed. There is no software that directly connects, interfaces, or otherwise interacts with the RESmart device. The device modification consists only of porting the feature to a web based version.
- Modification for using iCode, for Andriod and iPhone 2. devices, which is referred to as an application.
- The purpose of the modification was developed to . allow users to access the iCode Report Generator using their smartphone. The smartphone application allow manual entry of the iCode string displayed on the RESmart LCD display on the user's cell phone. The smartphone app interfaces with iCode Report Generator and forwards the iCode string in the URL call. The application promps the user to take a photograph, point and click. Using optical character recognition, the character string is extracted from the photograph, and then the string is passed to the iCode Report Generator.
(K110629) in that they have the same intended use, same
| Non-clinical Testing | Non-clinical testing includes software verification and validation
of the iCode Report Generator and iCode Smartphone
application. See Software Requirement Specifications of iCode
Report Generator, App. A; System Test Report of iCode Report
Generator, App. B; Software Requirements Specification for
3B/BMC iCode Smartphone Applications, App. C; System Test
Report of iCode Smartphone Application, App. D; and the
Software Summary of iCode Report Generator, App.E. |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence | The RESmart CPAP and Auto CPAP System remain substantially
equivalent to the RESmart CPAP and Auto CPAP System |
3
| Section 7 | 510(k) Summary (K131707) | RESmart CPAP/Auto CPAP |
|---|---|---|
| operating principle, and same manufacturing process. Design | ||
| verification tests were performed on the RESmart CPAP and | ||
| Auto CPAP system because of the risk analysis and product | ||
| requirements. The modifications described within have been | ||
| evaluated in terms of both safety and effectiveness. All tests | ||
| were verified to meet the required acceptance criteria. In | ||
| summary, the device described in this submission is | ||
| substantially equivalent to the predicate device. | ||
| Truthful & Accuracy | A certification of truthfulness and accuracy of the RESmart CPAP | |
| and Auto CPAP System as described in this submission is | ||
| provided in Attachment 8. | ||
| Conclusions | There have been no changes in: | |
| Intended use Operating principle Manufacturing process All other packaging labels and labeling | ||
| (instructions for use, package insert, and | ||
| operator's manual) for the device are | ||
| unchanged from the previously cleared version. |
Verification and validation activities were conducted based on risk analysis and demonstrated substantial equivalence to the predicate.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2013
3B Medical, Incorporated Mr. Alex Lucio Vice President 21301 Highway 27 North LAKE WALES FL 33859
Re: K131707
Trade/Device Name: BMC RESmart™ CPAP/Auto CPAP Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 18, 2013 Received: July 23, 2013
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.
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Page 2 - Mr. Lucio
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 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/ResourcesforYou/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,
Image /page/5/Picture/6 description: The image shows the text "Mary S. Runner - S". The text is in black font and is centered in the image. The letters "FDA" are in the middle of the text, but they are outlined and not filled in with color. The text is easy to read and is well-lit.
Kwame Ulmer M.S. Acting Division 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: K131707
BMC RESmart™ CPAP/Auto CPAP
Indications for Use:
The 3B and BMC RESmart CPAP and Auto CPAP Systems are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. 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.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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· Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: _
CONFIDENTIAL