(228 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on microprocessor-controlled pressure delivery, not AI/ML algorithms.
Yes
The device is intended for the treatment of Obstructive Sleep Apnea (OSA), which is a medical condition, making it a therapeutic device.
No
The device is described as a treatment device for Obstructive Sleep Apnea (OSA), delivering positive airway pressure. There is no mention of it diagnosing OSA or any other condition.
No
The device description explicitly states it is a "microprocessor controlled, blower-based system that generates bi-level positive airway pressure," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the Luna® G3 BPAP 25A is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The Luna® G3 BPAP 25A is a therapeutic device that delivers positive airway pressure to treat Obstructive Sleep Apnea.
- The intended use clearly states it's for the treatment of adult Obstructive Sleep Apnea. This is a therapeutic purpose, not a diagnostic one based on analyzing biological samples.
- The device description focuses on generating and delivering air pressure. There is no mention of collecting or analyzing biological specimens.
Therefore, the Luna® G3 BPAP 25A falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Luna® G3 BPAP 25A is a Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The integrated 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. If 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The Luna® G3 BPAP 25A is a microprocessor controlled, blower-based system that generates bi-level positive airway pressure (IPAP/EPAP) to support treatment of obstructive sleep apnea. The system provides fixed or auto-adjust pressure from 4 to 25 cmH2O above the ambient atmospheric pressure to a patient's oral/nasal airway.
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. It is to be used on patients >66lbs/30kg
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 Performance Data:
- Biocompatibility Assessment: Evaluation and testing conducted in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 18562-1, ISO 18562-2, ISO 18562-3, ISO 18562-4, and FDA Guidance documents.
- Electrical Safety and Electromagnetic Compatibility: Testing conducted on the subject device complies with AAMI ANSI ES 60601-1:2005/(R)2012 And A1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-1-11:2015, ISO 80601-2-70:2015, and ISO 80601-2-74:2017.
- Software Verification and Validation: Testing and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", and "Guidance-Radio Frequency Wireless Technology in Medical Devices".
- Mechanical Testing: Mechanical shock test, Sine vibration test, Drop test, Damp heat test, Dielectric voltage withstand test, Leakage current test.
Key results: Results of tests and assessments did not raise new safety or effectiveness questions.
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® BPAP 25A (K133769), DreamStation Auto BiPAP (K131982)
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.
Luna® CPAP and Auto CPAP System (K153387)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 29, 2021
3B Medical, Inc. Yasser Estafanous Director of RA/OA 203 Avenue A NW. Suite 300 Winter Haven, Florida 33881
Re: K201620
Trade/Device Name: Luna® G3 BPAP 25A Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 17, 2020 Received: December 18, 2020
Dear Yasser Estafanous:
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,
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of ENT, 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
2
Indications for Use
510(k) Number (if known) K201620
Device Name Luna® G3 BPAP 25A
Indications for Use (Describe)
The Luna® G3 BPAP 25A is a Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The integrated 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. If 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)
Prescription Use (Part 21 CFR 801 Subpart D) |
---|
Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Device Trade Name | Luna® G3 BPAP 25A |
---|---|
Model | LG3700 |
Common/Usual Name | BPAP System |
Date Prepared | January 29, 2021 |
Sponsor Identification | 3B Medical, Inc. |
203 Avenue A NW, Suite 300, | |
Submission Correspondent | Yasser Estafanous |
3B Medical, Inc. | |
203 Avenue A NW, Suite 300, | |
Winter Haven, FL 33881 | |
Phone | 863-226-6285 |
Fax | 863-226-6284 |
yestafanous@3bproducts.com | |
Establishment Registration # | 3008566132 |
BMC Medical CO., LTD. | |
Room 901, Building 1, No.28 Pingguoyuan | |
Road, Shijingshan, Beijing 100041, CHINA | |
Classification | Class II Device (21 CFR 868.5905) |
Classification Name | Noncontinuous ventilator |
Classification Panel | Medical Device |
Products Code | BZD |
Medical Specialties | Anesthesiology |
Predicate Device(s) | RESmart® BPAP 25A (K133769) |
DreamStation Auto BiPAP (K131982) | |
Reference Device | Luna® CPAP and Auto CPAP System |
(K153387) | |
Reason for Submission: | New Device |
Intended Use | The Luna® G3 BPAP 25A is a Bi-level PAP (Bi- |
level Positive Airway Pressure) device designed | |
for the treatment of adult Obstructive Sleep Apnea | |
(OSA). The 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. It is to be used on patients >66lbs/30kg | |
for whom CPAP therapy has been prescribed. The | |
system can deliver bi-level therapy or auto bi-level | |
therapy. | |
Device Description | The Luna® G3 BPAP 25A is a microprocessor |
controlled, blower-based system that generates bi- | |
level positive airway pressure (IPAP/EPAP) to | |
support treatment of obstructive sleep apnea. The | |
system provides fixed or auto-adjust pressure from |
4
4 to 25 cmH2O above the ambient atmospheric
pressure to a patient's oral/nasal airway.
Comparison of Technological Characteristics with the Predicate Devices.
The Luna® G3 BPAP 25A utilizes the same blower and the same algorithm as the primary predicate device RESmart® BPAP 25A (K133769) for respiratory event detection and therapy for sleep disordered breathing events. The subject device and the primary predicate device share the same intended use, same operating principal, and are manufactured and packaged with similar processes. The basic functionality and performance characteristics of the subject device are the same as
5
the primary predicate device. Compared with the primary predicate device, the subject device includes the following main modifications:
- The humidifier is integrated into the BPAP device, which makes the physical size of the subject device smaller and does not affect the safety or effectiveness of the subject device.
- An optional heated tubing (LH1) is intended to provide warmed and/or ● humidified breathing gases before entering the patient's airway. The purpose of the heated tubing is to maintain or raise the gas temperature to or above the dew point (of the air exiting the humidifier) reducing or eliminating water condensation and/or pooling of water in the breathing circuit. The biocompatibility of the heated tubing has been tested, and there is no risks of safety or effectiveness.
- The subject device includes an integrated cellular module, which enables the . device to upload therapy data to the software iCodeConnect (K160127) managed by the healthcare provider, and the therapy parameters of the device can be adjusted by the healthcare provider through the cellular module. The EMC and wireless coexistence of the cellular module and the cybersecurity of its software are tested and assessed, and there is no risks of safety or effectiveness.
- The subject device provides an AutoCPAP mode in addition to the three therapy modes of the primary predicate device RESmart® BPAP 25A (K133769). The AutoCPAP mode delivers CPAP therapy and provides an air pressure no less than the prescribed one based on the patient's needs. The auto adjusting CPAP algorithm of the AutoCPAP mode is identical to that of the reference device Luna® CPAP and Auto CPAP System (K153387). It did not raise new safety or effectiveness questions.
The predicate device DreamStation Auto BiPAP (K131982) comprises an optional heated tubing and an optional cellular modem. The basic functionality and performance characteristics of the two components of the subject device Luna® G3 BPAP 25A are the same as those of those of of the predicate device
6
DreamStation Auto BiPAP (K131982). Testings and assessments were conducted on the subject device and they did not raise new safety or effectiveness questions.
The substantial equivalence comparison is provided below.
7
Subject Device | Primary Predicate Device | Predicate Device | Reference Device | |||
---|---|---|---|---|---|---|
Luna® G3 BPAP 25A | ||||||
(K201620) | RESmart® BPAP 25A | |||||
(K133769) | DreamStation Auto BiP | |||||
AP (K131982) | Luna® CPAP and Auto | |||||
CPAP System | ||||||
(K153387) | Comparison | |||||
Classification | ||||||
Device | ||||||
Classification | Class II Device | Class II Device | Class II Device | Class II Device | Identical to primary | |
predicate | ||||||
Product Code | BZD | BZD | BZD | BZD | Identical to primary | |
predicate | ||||||
Classification | ||||||
Panel | Anesthesiology | Anesthesiology | Anesthesiology | Anesthesiology | Identical to primary | |
predicate | ||||||
Regulation | ||||||
Number | 21 CFR 868.5905 | 21 CFR 868.5905 | 21 CFR 868.5905 | 21 CFR 868.5905 | Identical to primary | |
predicate | ||||||
Regulation | ||||||
Name | Noncontinuous ventilator | Noncontinuous ventilator | Noncontinuous ventilator | Noncontinuous ventilator | Identical to primary | |
predicate | ||||||
Intended Use and Indications for Use | ||||||
Subject Device | Primary Predicate | |||||
Device | Predicate Device | Reference Device | ||||
Luna® G3 BPAP 25A | ||||||
(K201620) | RESmart® BPAP 25A | |||||
(K133769) | DreamStation Auto BiP | |||||
AP (K131982) | Luna® CPAP and Auto | |||||
CPAP System | ||||||
(K153387) | Comparison | |||||
Indications | ||||||
For Use | The Luna® G3 BPAP | |||||
25A is a Bi-level PAP | ||||||
(Bi-level Positive Airway | ||||||
Pressure) device designed | ||||||
for the treatment of adult | ||||||
Obstructive Sleep Apnea | ||||||
(OSA). The 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. It is to be used | ||||||
on patients >66lbs/30kg | ||||||
for whom CPAP therapy | ||||||
has been prescribed. The | ||||||
system can deliver bi- | ||||||
level therapy or auto bi- | ||||||
level therapy. | The RESmart® BPAP | |||||
25A 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/institutional | ||||||
environment on adult | ||||||
patients. It is to be used | ||||||
on patients >66lbs/30kg | ||||||
for whom CPAP therapy | ||||||
has been prescribed. The | ||||||
system can deliver bi- | ||||||
level therapy or auto bi- | ||||||
level therapy. | The DreamStation Auto | |||||
BiPAP device delivers | ||||||
positive airway pressure | ||||||
therapy for the treatment | ||||||
of Obstructive Sleep | ||||||
Apnea (OSA) in | ||||||
spontaneously breathing | ||||||
patients weighing over | ||||||
30kg (66 lbs). It is for use | ||||||
in the home or | ||||||
hospital/institutional | ||||||
environment. | The Luna® CPAP and | |||||
Auto CPAP Systems are | ||||||
intended to deliver | ||||||
positive pressure for the | ||||||
treatment of Obstructive | ||||||
Sleep Apnea (OSA). The | ||||||
optional integrated heated | ||||||
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. | Identical to primary | |||||
predicate | ||||||
Subject Device | Primary Predicate | |||||
Device | Predicate Device | Reference Device | ||||
Luna® G3 BPAP 25A | ||||||
(K201620) | RESmart® BPAP 25A | |||||
(K133769) | DreamStation Auto BiP | |||||
AP (K131982) | Luna® CPAP and Auto | |||||
CPAP System | ||||||
(K153387) | Comparison | |||||
Therapy | ||||||
Delivered | S, | |||||
Auto S, | ||||||
CPAP, | ||||||
AutoCPAP | S, | |||||
Auto S, | ||||||
CPAP | S, | |||||
Auto S, | ||||||
CPAP | CPAP, | |||||
AutoCPAP | Similar to primary | |||||
predicate. Adding the | ||||||
AutoCPAP mode of the | ||||||
reference device does | ||||||
not affect safety or | ||||||
effectiveness. | ||||||
Pressure Range | For CPAP and | |||||
AutoCPAP mode: 4.0– | ||||||
20.0 cmH2O | ||||||
For Auto S and S mode: | ||||||
4.0-25.0 cmH2O | For CPAP mode: 4.0– | |||||
20.0 cmH2O | ||||||
For Auto S and S mode: | ||||||
4.0-25.0 cmH2O | For CPAP mode: 4.0– | |||||
20.0 cmH2O | ||||||
For Auto Bi-level mode: | ||||||
4.0-25.0 cmH2O | 4.0–20.0 cmH2O | Similar to primary | ||||
predicate. Pressure | ||||||
range of the AutoCPAP | ||||||
mode is added, which | ||||||
does not affect safety or | ||||||
effectiveness. | ||||||
Pressure | ||||||
Regulation | $\pm$ 0.5 cmH2O | $\pm$ 0.5 cmH2O | $\pm$ 0.5 cmH2O | $\pm$ 0.5 cmH2O | Identical to primary | |
predicate | ||||||
Pressure | ||||||
Display | ||||||
Accuracy (hPa) | $\pm$ (0.8cmH2O+4%) | $\pm$ 0.5 cmH2O | $\pm$ (0.3cmH2O+3.7%) | $\pm$ (0.5 cmH2O+4%) | Similar to primary | |
predicate. Change does | ||||||
not impact safety or | ||||||
effectiveness. | ||||||
Algorithm | ||||||
Automatic | ||||||
adjusting | ||||||
CPAP | ||||||
algorithm | Yes | No | No | Yes | Identical to reference | |
device | ||||||
Ramp | ||||||
(minutes) | 0-60 | 0-60 | 0-60 | 0-60 | Identical to primary | |
predicate | ||||||
Expiratory | ||||||
Pressure Relief | Reslex® function | |||||
Level 1-3 | Reslex® function | |||||
Level 1-3 | Flex® function | |||||
Level 1-3 | Reslex® function | |||||
Level 1-3 | Identical to primary | |||||
predicate | ||||||
Humidifier | ||||||
Subject Device | Primary Predicate | |||||
Device | Predicate Device | Reference Device | ||||
Luna® G3 BPAP 25A | ||||||
(K201620) | RESmart® BPAP 25A | |||||
(K133769) | DreamStation Auto BiP | |||||
AP (K131982) | Luna® CPAP and Auto | |||||
CPAP System | ||||||
(K153387) | Comparison | |||||
Integrated | Yes | No | No | No | Both subject and | |
primary predicate | ||||||
devices have a method | ||||||
to attach a | ||||||
humidification system. | ||||||
Change does not impact | ||||||
safety or effectiveness. | ||||||
Humidity | ||||||
Output | ≥15 mg/L, as required by | |||||
ISO80601-2-74 | ≥10 mg/L, as required | |||||
by ISO8185 | ≥10 mg/L, as required by | |||||
ISO8185 | ≥10 mg/L, as required by | |||||
ISO8185 | Similar to primary | |||||
predicate. Change does | ||||||
not impact safety or | ||||||
effectiveness. | ||||||
Humidifier | ||||||
Settings | 1-5 (95 to 154.4°F/35 to | |||||
68°C) | 1-5 (104 to 149°F/40 to | |||||
65°C) | 1 to 5 (95 to 149°F/35 to | |||||
65°C) | 1-5 (95 to 167°F/35 to | |||||
75°C) | Similar to primary | |||||
predicate. Change does | ||||||
not impact safety or | ||||||
effectiveness. | ||||||
Delay | Yes | Yes | No | Yes | Identical to primary | |
predicate | ||||||
Physical Characteristics | ||||||
Dimensions | 265 × 145 × 114 mm | |||||
(with integrated | ||||||
humidifier) | 220 x 194 x 112 mm, | |||||
313 x 194 x 112 mm | ||||||
(with humidifier) | 157 × 193 × 84 mm, | |||||
297 × 193 × 84 mm (with | ||||||
humidifier) | 170 x 180 x 118 mm, | |||||
290 × 180 × 134 mm (with | ||||||
humidifier) | Dimensions are smaller | |||||
than primary predicate. | ||||||
No impact on safety | ||||||
and effectiveness. | ||||||
Weight | 1.7kg (with integrated | |||||
humidifier) | 2.2 kg, | |||||
3 kg (with humidifier) | 1.33kg, | |||||
1.98kg (with humidifier) | 1.5kg, | |||||
2.5kg (with humidifier) | Weight is less than | |||||
primary predicate. No | ||||||
impact on safety and | ||||||
effectiveness. | ||||||
AC Power | ||||||
Consumption | 100-240V, 50/60Hz, 2.0A | 100-240V AC, 50/60Hz, | ||||
1.0A max | 100-240V AC, 50/60 Hz, | |||||
2.0-1.0 A | 100-240 V AC, 50/60 Hz, | |||||
2.0 A max | Similar to primary | |||||
predicate | ||||||
Subject Device | Primary Predicate | |||||
Device | Predicate Device | Reference Device | Comparison | |||
Luna® G3 BPAP 25A | ||||||
(K201620) | RESmart® BPAP 25A | |||||
(K133769) | DreamStation Auto BiP | |||||
AP (K131982) | Luna® CPAP and Auto | |||||
CPAP System | ||||||
(K153387) | ||||||
IEC 60601 | ||||||
Classification | Class II, Type BF | Class II, Type BF | Class II, Type BF | Class II, Type BF | Identical to primary | |
predicate | ||||||
Degree of | ||||||
Protection | ||||||
Against Water | ||||||
Ingress | IP22 | IPX1-Drip-Proof, | ||||
Vertical | IP22 | IP22 | IP22 is a more rigorous | |||
test than IPX1. Change | ||||||
does not impact safety | ||||||
or effectiveness. | ||||||
Sound Pressure | ||||||
Level | 30 days) with dry and humidified gas pathways. Evaluation and testing were conducted in accordance with the following standards and guidance documents: |
- · ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
· FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 16, 2016
· ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
•ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process
· ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter
15
• ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic compounds (VOCs)
• ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Texts for leachables in condensate
Electrical Safety and Electromagnetic Compatibility:
Testing was conducted on the subject device Luna® G3 BPAP 25A. The system complies with the following standards for electrical safety and EMC:
· AAMI ANSI ES 60601-1:2005/(R)2012 And A1:2012. Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
· IEC 60601-1-2:2014. Medical electrical equipments for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - requirements and tests
· IEC 60601-1-6:2013. Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Usability
• IEC 60601-1-11:2015. Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance
- Collateral Standard: Requirements For Medical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment
· ISO 80601-2-70:2015. Medical electrical equipments for basic safety and essential performance of sleep apnoea breathing therapy equipment
• ISO 80601-2-74:2017. Medical electrical equipments for basic safety and essential performance of respiratory humidifying equipment
Software Verification and Validation:
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff:
- · "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- · "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"
- · "Guidance-Radio Frequency Wireless Technology in Medical Devices"
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Luna® G3 BPAP 25A
Mechanical Testing:
Mechanical shock test, Sine vibration test, Drop test, Damp heat test, Dielectric voltage withstand test, Leakage current test.
Results of tests and assessments did not raise new safety or effectiveness questions.
Conclusion
The subject and predicate devices are used for the treatment of obstructive sleep apnea (OSA). They are substantially equivalent in terms of technology and intended use. Risk assessments, biocompatibility evaluation, electromagnetic compatibility and electrical safety, as well as mechanical that any differences do not raise new questions of safety or effectiveness. The subject device Luna® G3 BPAP 25A is, therefore, substantially equivalent to the predicate device.