QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER

{0}------------------------------------------------ # 510(k) Summary k / 12824 JUN 2 1 2012 ## Summary Prepared Date: 04/12/2012 ### Submission Sponsor: #### Quality Life Technologies Co., Ltd No.5 Lao Fu Wu Road, Huang Wu Industrial District, Dong Keng Town, Dongguan, Guangdong, P.R.China 523447 ### Submission Correspondent: Mr. Leon Lu Director of Quality and Requlatory Affairs ## MEDevice Services, LLC 3500 South Dupont Highway Dover, Delaware 19901 USA Phone: 1-877-202-1588 Fax: 1-888-202-8884 Email: info@medeviceservices.com Website: www.medeviceservices.com #### Trade/Device Name: Quality Life Technologies Compressor Nebulizer, Models NBA02-XXX Common or Usual Name: Nebulizer (direct patient interface) Device Class: II Classification Name: Nebulizer (direct patient interface) Regulation Number: 21 CFR 868.5630 Product Code: CAF Review Panel: Anesthesiology ### Predicate Device: - K931015, DEVILBISS HEALTH CARE, INC. THUNGER TIGER CORP. . � DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER - K870027, SALTER LABS . HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER {1}------------------------------------------------ - K052438, EMG Technology Co., Ltd . EMG Handle Nebulizer NB02 Series ## Device Description: Our Quality Life Technologies Compressor Nebulizer works to convert the medication to a high-quality mist of fine particles and spray liquid medications in aerosol form into gases that are directly delivered to the patient. ## Intended Use: The Quality Life Technologies Compressor Nebulizer is an AC powered air compressor that provides a source of compressed air for home health care use. The product is used in conjunction with a jet (pneumatic) nebulizer to convert liquid medication into an aerosol form with particles smaller than 5 microns diameter for inhalation into the patient's respiratory tract for the treatment of respiratory disorders. The target population for this device consists of adult patients suffering from, but not limited to asthma, cystic fibrosis, and chronic obstructive pulmonary disease. Further, additional applications for aerosolized medication are constantly under, investigation and this device may be deemed suitable for such applications as prescribed. The intended environment for use of the product is in the patient's home on the order of a physician. | Descriptive<br>Information | Proposed Device | Predicate Device | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | NONE | K931015 | | Manufacturer | Quality Life Technologies Co., Ltd | DEVILBISS HEALTH CARE, INC | | Proprietary or<br>Model Name | Quality Life Technologies<br>Compressor Nebulizer, Models<br>NBA02-XXX | DEVILBISS MODEL 4650<br>COMPRESSOR NEUBULIZER | | Indication for Use | The Quality Life Technologies<br>Compressor Nebulizer is an AC<br>powered air compressor that<br>provides a source of compressed<br>air for home health care use. The<br>product is used in conjunction with<br>a jet (pneumatic) nebulizer to<br>convert liquid medication into an<br>aerosol form with particles smaller<br>than 5 microns diameter for | The DeVilbiss compressor/nebulizer is an<br>AC powered air compressor that provides<br>a source of compressed air for home<br>health care use. The product is used in<br>conjunction with a jet (pneumatic)<br>nebulizer to convert liquid medication into<br>an aerosol form with particles smaller<br>than 5 microns diameter for inhalation into<br>the patient's respiratory tract for the<br>treatment of respiratory disorders. | ## Comparison to Predicate Devices: {2}------------------------------------------------ | inhalation into the patient's<br>respiratory tract for the treatment of<br>respiratory disorders. | The target population for this device<br>consists of adult patients suffering from,<br>but not limited to asthma, cystic fibrosis, | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The target population for this device<br>consists of adult patients suffering<br>from, but not limited to asthma,<br>cystic fibrosis, and chronic<br>obstructive pulmonary disease.<br>Further, additional applications for<br>aerosolized medication are<br>constantly under investigation and<br>this device may be deemed suitable<br>for such applications as prescribed. | and chronic obstructive pulmonary<br>disease. Further, additional applications<br>for aerosolized medication are constantly<br>under investigation and this device may<br>be deemed suitable for such applications<br>as prescribed.<br>The intended environment for use of the<br>product is in the patient's home on the<br>order of a physician. | | The intended environment for use<br>of the product is in the patient's<br>home on the order of a physician. | | . ・ : t . : . ・・ ・ · | Descriptive<br>Information | Proposed Device | Predicate Device | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | NONE | K870027 | | Manufacturer | Quality Life Technologies Co., Ltd | SALTER LABS | | Proprietary or<br>Model Name | Quality Life Technologies Compressor<br>Nebulizer, Models NBA02-XXX | HAND HELD PHEUMATIC<br>POWERED (DISPOSABLE)<br>NEBULIZER | | Indication for Use | The Quality Life Technologies<br>Compressor Nebulizer is an AC<br>powered air compressor that provides<br>a source of compressed air for home<br>health care use. The product is used in<br>conjunction with a jet (pneumatic)<br>nebulizer to convert liquid medication<br>into an aerosol form with particles<br>smaller than 5 microns diameter for<br>inhalation into the patient's respiratory<br>tract for the treatment of respiratory<br>disorders. | Hand Held Pheumatic Powered<br>(Disposable) Nebulizer is to convert<br>liquid medication into an aerosol form<br>with particles smaller than 5 microns<br>diameter for inhalation into the<br>patient's respiratory tract for the<br>treatment of respiratory disorders | | | The target population for this device<br>consists of adult patients suffering<br>from, but not limited to asthma, cystic<br>fibrosis, and chronic obstructive<br>pulmonary disease. Further, additional<br>applications for aerosolized medication<br>are constantly under investigation and<br>this device may be deemed suitable for<br>such applications as prescribed. | | | | The intended environment for use of<br>the product is in the patient's home on<br>the order of a physician. | | | Principle | Aerosolizes liquid into aerosol form by<br>compressing air. | Aerosolizes liquid into aerosol form by<br>compressing air | | MMAD | <5 micron<br>Albuterol Sulfate (2.5 mg/3.0ml): 2.21 | <5 micron<br>Albuterol Sulfate (2.5 mg/3.0ml): 3.13 | · {3}------------------------------------------------ | | Ipratropium Bromide (0.5 mg/2.5ml):<br>3.04 | Ipratropium Bromide (0.5 mg/2.5ml):<br>3.10 | |-------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | | Cromolyn Sodium (20mg/2.0ml): 2.87 | Cromolyn Sodium (20mg/2.0ml): 2.40 | | Accessories | Tubing, Nebulizer Cup, Nebulizer<br>Insert, Nebulizer Cap, Mouthpiece | Mouthpiece, T-piece, Cap, Medication<br>Cup, Nebulizer Air-Inlet Connector,<br>Baffle, Tubing | | Target population | Adult patients | Both adult and pediatric patients | | Environment use | In the patient's home on the order of a<br>physician. | In the patient's home on the order of a<br>physician. | | Design | Medication Cup Volumes: Max.<br>5.0ml<br>Device features: handy | Medication Cup Volumes: Max.<br>5.0ml<br>Device features: handy | | Performance | Flow rate of compressor:<br>Max. flow rate of compressor is 9.9<br>(l/min)<br>Max. pressure is 40.0 (psig) | Flow rate of compressor:<br>Max. flow rate of compressor is 10.0<br>(l/min)<br>Max. pressure is 40.0 (psig) | | | Percent of drug does delivered<br>which falls in the respirable<br>fraction: | Percent of drug does delivered<br>which falls in the respirable<br>fraction: | | | Albuterol Sulfate (2.5mg/3ml): 24.5%<br>Ipratropium Bromide (0.5mg/2.5ml):<br>47.7%<br>Cromolyn Sodium (20mg/2.0ml):<br>18.1% | Albuterol Sulfate (2.5mg/3ml): 53.5%<br>Ipratropium Bromide (0.5mg/2.5ml):<br>48.0%<br>Cromolyn Sodium (20mg/2.0ml):<br>29.5% | | Biocompatibility | Biocompatible | Biocompatible | | Descriptive<br>Information | Proposed Device | Predicate Device | |------------------------------|------------------------------------------------------------------------|----------------------------------| | 510(k) Number | NONE | K052438 | | Manufacturer | Quality Life Technologies Co., Ltd | EMG Technology Co., Ltd | | Proprietary or<br>Model Name | Quality Life Technologies<br>Compressor Nebulizer, Models<br>NBA02-XXX | EMG Handle Nebulizer NB02 Series | | Materials | Same | Same | ## Discussion of Non-Clinical Tests Performed: The performance requirements for Quality Life Technologies Compressor Nebulizer were met: The patient contact components of the Quality Life Technologies Compressor Nebulizer met the requirements of ISO 10993 Part-1, "Biological Evaluation of Medical Devices". Quality Life Technologies Compressor Nebulizer met the requirements of IEC 60601-1 and IEC 60601-1-2. {4}------------------------------------------------ The performance of the Quality Life Technologies Compressor Nebulizer was tested by third party lab and demonstrated substantially equivalent to that of the predicate device. Therefore, we conclude that the Quality Life Technologies Compressor Nebulizer is both safe and effective for its intended use. ## Discussion of Clinical Tests Performed: None ### Conclusion: The proposed device is as safe and effective as the predicate devices. The proposed device has the same intended uses and indications, similar technological characteristics, and principles of operation as its predicate device. The minor differences between the proposed device and its predicate devices raise no new issues of safety or effectiveness. Thus, Quality Life Technologies Compressor Nebulizer, Models NBA02-XXX are substantially equivalent to its predicate devices. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three legs, representing the department's mission to protect the health of all Americans and provide essential human services. The seal is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Quality Life Technologies Company, Limited C/O Mr. Leon Lu Director, of Quality and Regulatory Affairs MEDevice Services, LLC 3500 South Dupont Highway Dover, Delaware 19901 ·JUN 2 1 2012 Re: K112824 Trade/Device Name: Quality Life Technologies Nebulizer Compressor, Models NBA02-XXX Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: June 12, 2012 Received: June 15, 2012 Dear Mr. Lu: 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. {6}------------------------------------------------ #### Page 2- Mr. Lu 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm. Sincerely yours. Nh for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health #### Enclosure {7}------------------------------------------------ # Indications for Use #### 510(k) Number (if known): Device Name: Quality Life Technologies Nebulizer Compressor, Models NBA02-XXX #### Indications for Use: The Quality Life Technologies Compressor Nebulizer is an AC powered air compressor that rnovides a source of compressed air for home health care use. The product is used in provided a ooutro of compatic) nebulizer to convert liquid medication into an aerosol form with particles smaller than 5 microns diameter for inhalation into the patient's respiratory fract for the treatment of respiratory disorders. The target population for this device consists of adult patients suffering from, but not limited to asthma, cystic fibrosis, and chronic obstructive pulmonary disease. Further, additional assilind, oyotto librools) in medication are constantly under investigation and this device may be deemed suitable for such applications as prescribed. The intended environment for use of the product is in the patient's home on the order of a physician. Over-The-Counter Use AND/OR Prescription Use × (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) L. Schultheis Division of Anesthestology, General Hospital Infection Control, Dental Devices 510(k) Number: KC.172824