(295 days)
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.
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).
This document is a 510(k) premarket notification for the 3B™ Luna CPAP and Auto-CPAP System, which includes an integrated heated humidifier. It compares the proposed device to a predicate device, the RESmart® CPAP and Auto-CPAP Systems (K132967). The main purpose of the notification is to demonstrate substantial equivalence to the predicate device, not necessarily to independently prove the device meets specific performance criteria beyond those of the predicate.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in the traditional sense of a new technology proving its efficacy against established benchmarks. Instead, it aims to demonstrate that the proposed device is substantially equivalent to a predicate device. Therefore, the "acceptance criteria" can be inferred as matching or performing similarly to the predicate device based on various technical specifications and non-clinical testing.
| Feature/Function/Test | Predicate Device (K132967) Performance | Proposed Device (K141770) Performance | Acceptance Criteria (Inferred from Substantial Equivalence) | Outcome |
|---|---|---|---|---|
| Therapy Delivered | CPAP, Auto CPAP | CPAP, Auto CPAP | Same | Meets |
| Operation Temperature | 5 to 30° C (41 to 86°F) | 5 to 35° C (41 to 95°F) | Comparable (Proposed has wider range) | Meets |
| Storage/Transport Temperature | -20 to 55° C | -25 to 70° C | Comparable (Proposed has wider range) | Meets |
| Humidity | ≤ 80% Non-condensing | 15% to 93% Non-condensing | Comparable (Proposed has wider range) | Meets |
| Atmospheric Pressure | 86 to 106 kPa | 76 to 106 kPa | Comparable (Proposed has wider range) | Meets |
| Standards Compliance | IEC 60601-1, IEC 60601-1-2, ISO 8185 | IEC 60601-1, IEC60601-1-11, IEC 60601-1-2 | Complies with relevant safety and performance standards | Meets |
| Mode of Operation | Continuous | Continuous | Same | Meets |
| AC Power Consumption | 100-240VAC, 50/60Hz, 1.0A max | 100-240VAC, 50/60Hz, 2.0A max | Comparable (Proposed has higher current draw) | Meets |
| Software | Microprocessor controlled | Microprocessor controlled | Same | Meets |
| 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. | Same | Meets |
| Type of Protection Against Electric Shock | Class II Equipment | Class II Equipment | Same | Meets |
| Degree of Protection Against Electric Shock | Type BF Vertical Applied Part | Type BF Vertical Applied Part | Same | Meets |
| Degree of Protection Against Ingress of Water | IPX1-Drip-Proof, Vertical | IP22 | Comparable (Both provide protection, with IP22 generally indicating protection against solid objects >12.5mm and direct sprays of water up to 15 degrees from the vertical, while IPX1 protects against vertically falling drops of water). | Meets |
| Pressure Range | 4-20 cmH2O (in 0.5 cmH2O increments) | 4-20 cmH2O (in 0.5 cmH2O increments) | Same | Meets |
| Sound Pressure Level | <30 dB, at 10 cmH2O | <30 dB, at 10 cmH2O | Same | Meets |
| Housing | Flame retardant Engineering thermoplastic | Flame retardant Engineering thermoplastic | Same | Meets |
| Pressure Display Accuracy | ± 0.5 cmH2O | ± (0.5+4%) cmH2O | Comparable (Proposed slightly different notation, needs to meet or be within acceptable variance of predicate) | Assumed Met |
| Ramp (minutes) | 0-60 | 0-60 | Same | Meets |
| Mask off alert | Yes | Yes | Same | Meets |
| Integrated Humidifier | Yes | Yes | Same | Meets |
| Water Capacity (Humidifier) | > 350 ml | 350 ml at recommended water level | Similar | Meets |
| Heater Settings (Humidifier) | 1 to 5 (104 to 149 °F) | 1 to 5 (95 to 167 °F) | Comparable (Proposed has wider range) | Meets |
| Pressure Drop with Humidifier | < 0.5 cmH2O at 60 LPM flow | < 0.4 cmH2O at 60 LPM flow | Better than predicate | Meets |
| Humidity Range (Humidifier) | 10 to 40 mg H2O/L | >10mg/L | Comparable (Proposed specified as >10mg/L, implies it's within or exceeds the lower bound of predicate) | Assumed Met |
| Static and dynamic pressure accuracies | 4 to 20 cmH2O (± 1 cmH2O) | 4 to 20 cmH2O (± 1 cmH2O) | Same | Meets |
| Biocompatibility | Tested and passed in K132967 | No new testing, relies on predicate | Materials are identical, so previous testing is sufficient | Meets |
| Particulate matter and volatiles | Demonstrated compliance in K132967 | No new testing, relies on predicate | Assumed to be identical to predicate | Meets |
Device Performance Evidence Summary: The study essentially asserts that the proposed device performs equivalently to the predicate device. The performance data presented is a side-by-side comparison of specifications for both devices, highlighting that the proposed device shares the same intended use, operating principle, technology, materials, and manufacturing process as the predicate, or has comparable or slightly improved characteristics.
2. Sample Size Used for the Test Set and Data Provenance
This document describes a premarket notification (510(k)) that relies heavily on bench testing and comparison to a predicate device, not clinical trials with human subjects.
- Test Set: No independent human subject test set is described. The "test set" consists of bench performance tests comparing the proposed device to the predicate.
- Sample Size: Not applicable in the context of human data. The sample size for non-clinical testing (e.g., number of devices tested for pressure accuracy) is not specified, but it's implied that sufficient units were tested to demonstrate performance.
- Data Provenance: The document does not provide information about the country of origin for any human data (as there isn't any mentioned). The testing itself is non-clinical, likely conducted by the manufacturer (BMC Medical CO., LTD, CHINA). The study is retrospective in the sense that it refers to the performance and testing of the predicate device (K132967) for many aspects, and current bench testing for the proposed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission.
- Ground Truth: The "ground truth" for this submission is established through engineering and performance specifications and compliance with international standards (e.g., ISO, IEC), rather than expert consensus on medical outcomes or pathology.
- Experts: The document does not describe the involvement of medical experts to establish a "ground truth" for a test set. Engineering and regulatory specialists would be involved in designing and evaluating the bench tests.
4. Adjudication Method for the Test Set
This is not applicable. There is no "test set" in the sense of a set of cases requiring adjudication by multiple experts. The evaluation is based on objective measurements from bench testing against predefined engineering specifications.
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
No, an MRMC comparative effectiveness study was not done. This device is a CPAP/Auto-CPAP system for delivering positive pressure, not an AI-assisted diagnostic or interpretative tool that would involve human "readers" or AI assistance in a clinical setting.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is not an algorithm that functions in a standalone diagnostic capacity. It is a medical device for therapeutic delivery of positive pressure.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used for this submission is based on:
- Engineering Specifications and Performance Standards: Defined by international standards (ISO 17510-1:2007, IEC 60601 series) and the specifications of the predicate device.
- Performance Bench Testing: Objective measurements conducted in a laboratory setting to verify that the device meets its design specifications (e.g., pressure accuracy, sound level, humidification, electrical safety).
- Biocompatibility Testing: Conducted in the predicate device against ISO 10993 standards, and carried over due to identical materials.
8. The Sample Size for the Training Set
This is not applicable. The device is not based on machine learning or AI that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for this device.
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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.
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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/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
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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)
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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 |
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| Establishment Registration # | 3008566132 |
|---|---|
| BMC Medical CO., LTD5/f Main Building No.19Gucheng Street West, ShinjingshanBeijing, 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 Systemsare intended to deliver positive pressure for thetreatment of Obstructive Sleep Apnea. Theoptional integrated humidifier is indicated for thehumidification and warming of air from the flowgenerator. These devices are intended for singlepatient use by prescription in the home orhospital / institutional environment on adultpatients. |
| Device Description | The Luna CPAP and Auto CPAP System is amicroprocessor-controlled, blower-based systemthat generates positive airway pressure from 4 to20 cm H20. The device is intended for |
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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 ●
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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
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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) |
|---|---|---|
| TherapyDelivered | CPAP,Auto CPAP | CPAP,Auto CPAP |
| OperationTemperature | 5 to 35° C(41 to | 5 to 30° C(41 to 86 F) |
| Storage/TransportTemperature | -25 to 70° C | -20 to 55° C |
| Humidity | 15% to 93% Non-condensing | ≤ 80% Non-condensing |
| AtmosphericPressure | 76 to 106 kPa | 86 to 106 kPa |
| StandardsCompliance | IEC 60601-1 General Requirements for Safety ofMedical Electrical EquipmentIEC60601-1-11 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environmentIEC 60601-1-2 Electromagnetic Compatibility | IEC 60601-1 General Requirements for Safety ofMedical Electrical EquipmentIEC 60601-1-2 Electromagnetic CompatibilityISO 8185 General Requirements for Humidification Systems |
| Mode ofOperation | Continuous | Continuous |
| AC PowerConsumption | 100-240VAC, 50/60Hz,2.0A max | 100-240VAC, 50/60Hz,1.0A max |
| Software | Microprocessor controlled | Microprocessor controlled |
| SystemContents | Air blower, pressure-flow monitoring, pressurecontrolling, user interface, heated humidifier,power cord, carrying case, user manual. | Air blower, pressure-flow monitoring, pressurecontrolling, user interface, heated humidifier,power cord, carrying case, user manual. |
| Type ofProtectionAgainst ElectricShock | Class II Equipment | Class II Equipment |
| Degree ofProtectionAgainst ElectricShock | Type BF Vertical Applied Part | Type BF Vertical Applied Part |
| Degree ofProtectionAgainst Ingressof 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 PressureLevel | <30 dB, when the device is working at thepressure of 10 cmH20 | <30 dB, when the device is working at the pressureof 10 cmH2O. |
| Housing | flame retardant Engineering thermoplastic | flame retardant Engineering thermoplastic |
| PressureDisplayAccuracy(cmH20) | $\pm (0.5+4%)$ | 0.5 |
| Ramp (minutes) | 0-60 | 0-60 |
| Mask off alert | Yes | Yes |
| IntegratedHumidifier | Yes | Yes |
| Static anddynamicpressureaccuracies | 4 to 20 cmH20( $\pm$ 1 cmH20)Measured in accordance with preen 17510 @ 6.6,13.2, & 20 cm H2O @ 500 ml with BPM set to10, 15, & 20 BPM performed at 23° C ( $\pm$ 2° C),50% RH ( $\pm$ 5%), and an atmospheric pressure of101.5 kPa. | 4 to 20 cmH20( $\pm$ 1 cmH20)Measured in accordance with prEN 17510 @ 6.6,13.2, & 20 cm H2O @ 500 ml with BPM set to 10,15, & 20 BPM performed at 23° C ( $\pm$ 2° C), 50% RH( $\pm$ 5%), and an atmospheric pressure of 101.5 kPa. |
| Humidifier | ||
| Yes | Yes | |
| Water Capacity: 350 ml at recommended water level | Water Capacity :> 350 ml | |
| Heater Settings: 1 to 5 (95 to 167 °F) | Heater Settings: 1 to 5 (104 to 149 °F) | |
| Pressure Drop with Humidifier: < 0.4 cmH20 at 60 LPM flow | Pressure Drop with Humidifier :< 0.5 cmH20 at 60 LPM flow; | |
| Humidity Range: >10mg/L | Humidity Range: 10 to 40 mg H2O/L |
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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.
§ 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).