(290 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on material changes, not functional changes related to AI/ML.
Yes
The device "deliver[s] pressure for the treatment of Obstructive Sleep Apnea," which is an explicit therapeutic action.
No
The device is described as a CPAP and Auto CPAP System "intended to deliver pressure for the treatment of Obstructive Sleep Apnea." This indicates a therapeutic, rather than a diagnostic, purpose.
No
The device description explicitly states it is a "CPAP and Auto CPAP System" and mentions changes to the "materials of water chamber," indicating it is a physical hardware device with components like a water chamber.
Based on the provided information, the Luna® CPAP and Auto CPAP System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to deliver pressure for the treatment of Obstructive Sleep Apnea. This is a therapeutic function, not a diagnostic one performed on in vitro samples.
- Device Description: The description focuses on the physical components and their function in delivering air pressure. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The document 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 in vitro analysis.
The device is clearly described as a therapeutic device for treating a respiratory condition.
N/A
Intended Use / Indications for Use
The Luna® CPAP and Auto CPAP System are intended to deliver pressure for the treatment of Obstructive Sleep Apnea. The optional integrated hunidifier 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 materials of water chamber of Luna® CPAF and Auto CPAP device were changed. The suppliers of Polycarbonate and silicone were changed. The basic functional and performance characteristics of the Luna® CPAP and Auto CPAF devices are unchanged from the predicate devices (K141770).
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)
Extensive non-clinical testing was conducted in according with ISO 10993 series standards.
The appropriate biological tests conducted and passed for these components, in accordance with FDA guidance #G95-1- were:
- I ISO 10993-3 Genotoxicity,
- ISO 10993-5 Cytotoxicity
- 1 ISO 10993-6 Implantation and
- I ISO 10993-10 Sensitization and Irritation
Series mechanical tests were also conducted to demonstrate the mechanical performance of the water chamber, including: drop test, leak test, and humidity performance test.
These test reports demonstrated substantial equivalence between the proposed and predicate devices. - Biocompatibility The materials used in the chamber have been changed. In order to prove the new materials have no effect on safety, BMC conducted a series of tests on finished water chamber, including Intracutaneous Reactivity test, Ames test, In vitro Mammalian Cell Gene Mutation Test, Skin Sensitization Mammalian Test, In vitro Test. Chromosome Aberration In Vitro Cytotoxicity Test and Muscle Implantation Test.
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 is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2016
3B Medical, Inc. Alex Lucio Vice President 799 Overlook Drive Winter Haven, FL 33884
Re: K153387
Trade/Device Name: Luna® CPAP and Auto CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: July 28, 2016 Received: August 8, 2016
Dear Alex 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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) :
K153387
Device Name
Luna& CPAP and Auto CPAP System
Indications for Use (Describe)
The Luna® CPAP and Auto CPAP System are intended to deliver pressure for the treatment of Obstructive Sleep Apnea. The optional integrated hunidifier 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
| Department of Health and Human Services |
|---|
| Food and Drug Administration |
| Office of Chief Information Officer |
| Paperwork Reduction Act (PRA) Staff |
| PRAStaff@fda.hhs.gov |
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Device Trade Name | Luna® CPAP and Auto CPAP System |
|---|---|
| Common/Usual Name | CPAP System, Auto CPAP system |
| Date Prepared | September 8, 2016 |
| Sponsor Identification | 3B Medical, Inc. |
| 799 Overlook Drive | |
| Winter Haven, FL 33884 | |
| Phone | |
| Fax | |
| 863-226-6285 | |
| 863-226-6284 | |
| alucio@3bproducts.com | |
| Submission Correspondent | Alex Lucio |
| 3B Medical, Inc. | |
| 799 Overlook Drive | |
| Winter Haven, FL 33884 | |
| Phone | |
| Fax | |
| 863-226-6285 | |
| 863-226-6284 | |
| alucio@3bproducts.com |
4
| 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 Name | Non-continuous ventilator |
| Classification Panel | Medical Device |
| Classification Reference | 21 CFR 868.5905 |
| Products Code | BZD |
| Medical Specialties | Anesthesiology |
| Predicate Device(s) | Luna® CPAP and Auto-CPAP Systems |
| (K141770) | |
| Reason for Submission: | Device Modification |
| Intended Use | The Luna® CPAP and Auto CPAP Systems are |
| intended to deliver positive pressure for the | |
| treatment of Obstructive Sleep Apnea. 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. | |
| Device Description | The materials of water chamber of Luna® CPAF |
| and Auto CPAP device were changed. The | |
| suppliers of Polycarbonate and silicone were | |
| changed. | |
| The basic functional and performance | |
| characteristics of the Luna® CPAP and Auto CPAF | |
| devices are unchanged from the predicate devices | |
| 2 |
5
(K141770).
The modification of the device just changed in the Non-Clinical Testing materials, it did not refer to the modification of specification and performance. Biological tests about the change of materials have been done. Extensive non-clinical testing was conducted in according with ISO 10993 series standards.
Materials used in the construction of components that contact the heated humidified gas pathway are classified as permanent "external communicating devices" (with tissue/ bone/ dentin).
The appropriate biological tests conducted and passed for these components, in accordance with FDA guidance #G95-1- were:
- I ISO 10993-3 Genotoxicity,
- ISO 10993-5 Cytotoxicity
- 1 ISO 10993-6 Implantation and
- I ISO 10993-10 Sensitization and Irritation
Series mechanical tests were also conducted to demonstrate the mechanical performance of the water chamber, including: drop test, leak test, and humidity performance test.
These test reports demonstrated substantial equivalence between the proposed and predicate devices.
- Biocompatibility The materials used in the chamber have been changed. In order to prove the new materials have no effect on safety, BMC conducted a series of tests on finished water chamber, including Intracutaneous Reactivity test, Ames test, In vitro Mammalian Cell Gene Mutation Test, Skin Sensitization Mammalian Test, In vitro
6
Test. Chromosome Aberration In Vitro Cytotoxicity Test and Muscle Implantation Test.
Substantial Equivalence
The Luna® CPAP and Auto CPAP System (K141770) remain substantially equivalent to the proposed Luna® CPAP and Auto CPAP System in that they have the same intended use, same operating principle, same technology, and same manufacturing process. Biological tests were performed on the Luna® CPAP and Auto-CPAP System to prove the change of material does not affect the safety and effectiveness.
Conclusions
There have been no changes in the intended use, or operating principles. Biological testing demonstrated that the proposed device is substantially equivalent to the predicate device.