(295 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a "microprocessor-controlled, blower-based system" with "basic functionality and performance characteristics... unchanged from the predicate device". There is no mention of AI/ML in the intended use, device description, or performance studies.
Yes
The device is intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea, which is a medical condition.
No
The device delivers positive pressure for the treatment of Obstructive Sleep Apnea and is not described as being used for diagnosis.
No
The device description clearly states it is a "microprocessor-controlled, blower-based system" and mentions a "redesigned enclosure" and "electrical circuit," indicating it is a hardware device with integrated software, not a software-only medical device.
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 body.
- Device Description: The device is a blower-based system that generates positive airway pressure. This describes a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is a defining characteristic of IVD devices.
Therefore, the 3B Luna CPAP and Auto CPAP Systems are medical devices used for therapy, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The 3B Luna 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. 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 Luna CPAP and Auto CPAP System is a microprocessor-controlled, blower-based system that generates positive airway pressure from 4 to 20 cm H20. The device is intended for use with a patient interface (mask). The device has been modified to include a color LCD, menu driven user interface, and a redesigned enclosure. The electrical circuit was redesigned to incorporate the color LCD. The basic functionality and performance characteristics of the Luna CPAP and Auto CPAP are unchanged from the predicate device RESmart CPAP and Auto CPAP (K132967).
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
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)
Extensive non-clinical testing was conducted according to ISO 17510-1:2007, Sleep Apnea Breathing Therapy-Part 1: Sleep Apnea Breathing Therapy Equipment. Side by side Performance Testing Bench equivalence with the predicated device. Testing for particulate matter and volatiles also demonstrated compliance to EPA requirements in K132967. The Luna CPAP has been tested to appropriate standards and other applicable requirements. The Luna CPAP with integrated heated humidifier was designed and tested according to: IEC equipment - Part 1: General Requirements for safety Medical electrical equipment - General requirements for basic safety and essential performance IEC 60601-1-2:2007, medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.
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
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 22, 2015
3B™ Medical, Inc Mr. Alex Lucio Vice President 21301 Highway 27 N. Lake Wales, FL 33859
Re: K141770
Trade/Device Name: Luna CPAP and Auto-CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 6, 2015 Received: March 23, 2015
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.
1
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/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,
Teiashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number: K141770 Luna CPAP and Auto CPAP System
Indications for Use:
The 3B Luna 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. These devices are intended for single patient use by prescription in the home or hospital / institutional environment on adult patients.
| Prescription Use: X | AND/OR | Over-The-Counter Use: |
|---|---|---|
| (Part 21 CFR 801 Subpar D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) Summary
| Device Trade Name | Luna CPAP and Auto-CPAP |
|---|---|
| Systems with Integrated Heated Humidifier | |
| Common/Usual Name | CPAP System, Auto-CPAP system |
| Date Prepared | April 16, 2015 |
| Sponsor Identification | 3B Medical, Inc. |
| 21301 Highway 27 N. | |
| Lake Wales, FL 33859 | |
| Phone | 863-226-6285 |
| Fax | 863-226-6284 |
| alucio@3bproducts.com | |
| Submission Correspondent | Alex Lucio |
| 3B Medical, Inc. | |
| 21301 Highway 27 N. | |
| Lake Wales, FL 33859 | |
| Phone | 863-226-6285 |
| Fax | 863-226-6284 |
4
| Establishment Registration # | 3008566132 |
|---|---|
| BMC Medical CO., LTD | |
| 5/f Main Building No.19 | |
| Gucheng Street West, Shinjingshan | |
| Beijing, CHINA 100043 | |
| Classification | Class II Device |
| Classification Name | Non-continuous ventilator |
| Classification Panel | Medical Device |
| Classification Reference | 21 CFR 878.5905 |
| Products Code | BZD |
| Medical Specialties | Anesthesiology |
| Predicate Device(s) | RESmart® CPAP and Auto-CPAP Systems |
| (K132967) | |
| Reason for Submission: | Device Modification |
| Intended Use | The 3B Luna 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. These devices are intended for single | |
| patient use by prescription in the home or | |
| hospital / institutional environment on adult | |
| patients. | |
| Device Description | The Luna CPAP and Auto CPAP System is a |
| microprocessor-controlled, blower-based system | |
| that generates positive airway pressure from 4 to | |
| 20 cm H20. The device is intended for |
2
5
use with a patient interface (mask). The device has been modified to include a color LCD, menu driven user interface, and a redesigned enclosure. The electrical circuit was redesigned to incorporate the color LCD. The basic functionality and performance characteristics of the Luna CPAP and Auto CPAP are unchanged from the predicate device RESmart CPAP and Auto CPAP (K132967).
Non-Clinical Testing Extensive non-clinical testing was conducted according to ISO 17510-1:2007, Sleep Apnea Breathing Therapy-Part I: Sleep Apnea Breathing Therapy Equipment. Side by side Performance Testing Bench equivalence with the predicated device.
- Biocompatibility The materials in the predicate device are identical and manufactured with the same manufacturing processes as the predicate device K132967; hence biocompatibility testing is not required.
Materials used in the construction of components that contact the heated humidified gas pathway permanent are classified communicating devices" (with tissue/bone/dentin).
The appropriate biological tests conducted and passed for these components, in accordance with FDA guidance #G95-1- were performed in K132967:
- ISO 10993-3 Genotoxicity, .
- ISO 10993-5 Cytotoxicity ●
- ISO 10993-6 Implantation and ●
- ISO 10993-10 Sensitization and Irritation ●
6
Testing for particulate matter and volatiles also demonstrated compliance to EPA requirements in K132967.
The Luna CPAP has been tested to appropriate standards and other applicable requirements. The Luna CPAP with integrated heated humidifier was designed and tested according to:
- IEC equipment - Part 1: General Requirements for safety Medical electrical equipment - General requirements for basic safety and essential performance
- IEC 60601-1-2:2007, medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
The proposed and predicate devices have identical materials, indications for use, and operating principles. Testing and validation of component part upgrades establish substantial equivalence between predicate and proposed devices.
Substantial Equivalence The proposed Luna CPAP and Auto CPAP System remain substantially equivalent to the RESmart II CPAP and AutoCPAP/Luna CPAP and AutoCPAP System (K132967) in that they have the same intended use, same operating principle, technology, identical materials, and manufacturing process. Designed validation and verification
7
tests were performed on the Luna CPAP and Auto-CPAP System because of the risk analysis and product requirements.
Comparative Summary of Technological Characteristics
| Features/
Function | Proposed Device (K141770)
Luna CPAP and Auto CPAP Systems | Predicate Device (K132967)
RESmart CPAP/APAP
(Private labeled as 3B CPAP/APAP) |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Therapy
Delivered | CPAP,
Auto CPAP | CPAP,
Auto CPAP |
| Operation
Temperature | 5 to 35° C
(41 to | 5 to 30° C
(41 to 86 F) |
| Storage/Transport
Temperature | -25 to 70° C | -20 to 55° C |
| Humidity | 15% to 93% Non-condensing | ≤ 80% Non-condensing |
| Atmospheric
Pressure | 76 to 106 kPa | 86 to 106 kPa |
| Standards
Compliance | IEC 60601-1 General Requirements for Safety of
Medical Electrical Equipment
IEC60601-1-11 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-2 Electromagnetic Compatibility | IEC 60601-1 General Requirements for Safety of
Medical Electrical Equipment
IEC 60601-1-2 Electromagnetic Compatibility
ISO 8185 General Requirements for Humidification Systems |
| Mode of
Operation | Continuous | Continuous |
| AC Power
Consumption | 100-240VAC, 50/60Hz,
2.0A max | 100-240VAC, 50/60Hz,
1.0A max |
| Software | Microprocessor controlled | Microprocessor controlled |
| System
Contents | Air blower, pressure-flow monitoring, pressure
controlling, user interface, heated humidifier,
power cord, carrying case, user manual. | Air blower, pressure-flow monitoring, pressure
controlling, user interface, heated humidifier,
power cord, carrying case, user manual. |
| Type of
Protection
Against Electric
Shock | Class II Equipment | Class II Equipment |
| Degree of
Protection
Against Electric
Shock | Type BF Vertical Applied Part | Type BF Vertical Applied Part |
| Degree of
Protection
Against Ingress
of Water | IP22 | IPX1-Drip- Proof, Vertical |
| Pressure Range | 4-20 cmH20 (in 0.5 cmH20 increments) | 4-20 cmH20 (in 0.5 cmH2) increments) |
| Sound Pressure
Level | 350 ml |
| | Heater Settings: 1 to 5 (95 to 167 °F) | Heater Settings: 1 to 5 (104 to 149 °F) |
| | Pressure Drop with Humidifier: 10mg/L | Humidity Range: 10 to 40 mg H2O/L |
8
9
Conclusions There have been no changes in the material composition, intended use, or or operating principles. Performance bench testing and device validation and verification demonstrate that the proposed device is substantially equivalent to the predicate device.