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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the Quality Life Technologies Compressor Nebulizer, comparing it to predicate devices. The submission focuses on demonstrating substantial equivalence rather than presenting an exhaustive study of acceptance criteria and performance against those criteria as would be done for a novel device.

However, based on the non-clinical tests mentioned, we can infer some "acceptance criteria" and the reported performance.

Here's an analysis of the requested information:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission, the "acceptance criteria" are implied by the performance of the predicate devices and general medical device safety and efficacy standards. The "reported device performance" is largely presented as meeting these standards or being substantially equivalent to the predicates.

Acceptance Criterion (Implied)	Reported Device Performance (Quality Life Technologies Compressor Nebulizer)
Biocompatibility: Meet requirements of ISO 10993 Part-1.	Biocompatible: "The patient contact components of the Quality Life Technologies Compressor Nebulizer met the requirements of ISO 10993 Part-1, Biological Evaluation of Medical Devices."
Electrical Safety: Meet requirements of IEC 60601-1.	Met Electrical Safety Standards: "Quality Life Technologies Compressor Nebulizer met the requirements of IEC 60601-1."
Electromagnetic Compatibility (EMC): Meet requirements of IEC 60601-1-2.	Met EMC Standards: "Quality Life Technologies Compressor Nebulizer met the requirements of IEC 60601-1-2."
Functional Performance (Substantial Equivalence to Predicate K870027 - SALTER LABS):
- MMAD (Mean Mass Aerodynamic Diameter) for Albuterol Sulfate (<5 micron, Predicate: 3.13)	- MMAD for Albuterol Sulfate: 2.21 (within <5 micron, better than predicate)
- MMAD (Mean Mass Aerodynamic Diameter) for Ipratropium Bromide (<5 micron, Predicate: 3.10)	- MMAD for Ipratropium Bromide: 3.04 (within <5 micron, better than predicate)
- MMAD (Mean Mass Aerodynamic Diameter) for Cromolyn Sodium (<5 micron, Predicate: 2.40)	- MMAD for Cromolyn Sodium: 2.87 (within <5 micron)
- Percent of drug delivered in respirable fraction for Albuterol Sulfate (Predicate: 53.5%)	- Percent of drug delivered in respirable fraction for Albuterol Sulfate: 24.5% (Lower than predicate in this specific comparison, but the overall conclusion is still substantial equivalence to predicates, which might have other varying performance metrics or the difference is deemed acceptable for the intended use.)
- Percent of drug delivered in respirable fraction for Ipratropium Bromide (Predicate: 48.0%)	- Percent of drug delivered in respirable fraction for Ipratropium Bromide: 47.7% (Similar to predicate)
- Percent of drug delivered in respirable fraction for Cromolyn Sodium (Predicate: 29.5%)	- Percent of drug delivered in respirable fraction for Cromolyn Sodium: 18.1% (Lower than predicate, similar rationale as Albuterol Sulfate)
- Max. flow rate of compressor (Predicate: 10.0 l/min)	- Max. flow rate of compressor: 9.9 l/min (Similar to predicate)
- Max. pressure (Predicate: 40.0 psig)	- Max. pressure: 40.0 psig (Identical to predicate)
Overall Performance: Substantial equivalence to predicate device.	"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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in terms of patient data or a specific number of units tested for performance. The non-clinical tests mentioned are likely standard engineering and laboratory tests performed on a representative sample of the manufactured device. The data provenance is not explicitly stated beyond "third party lab," which suggests an external accredited testing facility. It's not retrospective or prospective study data in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The device is a compressor nebulizer, and the testing described is primarily engineering performance testing, not clinical studies requiring expert interpretation of ground truth in areas like medical imaging or pathology.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study that would involve expert adjudication of results.

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

Not applicable. This device is a compressor nebulizer, not an AI-powered diagnostic tool, and therefore no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a hardware compressor nebulizer, not an algorithm or AI system.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the performance metrics (MMAD, respirable fraction, flow rate, pressure), the "ground truth" would be established by validated measurement techniques and equipment within the testing laboratory, adhering to relevant standards (e.g., pharmacopeial methods for aerosol characterization). For biocompatibility, the ground truth is defined by the adherence to ISO 10993 standards, demonstrated through specific tests (e.g., cytotoxicity, sensitization). For electrical safety and EMC, the ground truth is adherence to IEC 60601 series standards, demonstrated through specific electrical and electromagnetic compatibility tests.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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

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K052438, EMG Technology Co., Ltd . EMG Handle Nebulizer NB02 Series

Device Description:

Intended Use:

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.

DescriptiveInformation	Proposed Device	Predicate Device
510(k) Number	NONE	K931015
Manufacturer	Quality Life Technologies Co., Ltd	DEVILBISS HEALTH CARE, INC
Proprietary orModel Name	Quality Life TechnologiesCompressor Nebulizer, ModelsNBA02-XXX	DEVILBISS MODEL 4650COMPRESSOR NEUBULIZER
Indication for Use	The Quality Life TechnologiesCompressor Nebulizer is an ACpowered air compressor thatprovides a source of compressedair for home health care use. Theproduct is used in conjunction witha jet (pneumatic) nebulizer toconvert liquid medication into anaerosol form with particles smallerthan 5 microns diameter for	The DeVilbiss compressor/nebulizer is anAC powered air compressor that providesa source of compressed air for homehealth care use. The product is used inconjunction with a jet (pneumatic)nebulizer to convert liquid medication intoan aerosol form with particles smallerthan 5 microns diameter for inhalation intothe patient's respiratory tract for thetreatment of respiratory disorders.

Comparison to Predicate Devices:

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inhalation into the patient'srespiratory tract for the treatment ofrespiratory disorders.	The target population for this deviceconsists of adult patients suffering from,but not limited to asthma, cystic fibrosis,
The target population for this deviceconsists of adult patients sufferingfrom, but not limited to asthma,cystic fibrosis, and chronicobstructive pulmonary disease.Further, additional applications foraerosolized medication areconstantly under investigation andthis device may be deemed suitablefor such applications as prescribed.	and chronic obstructive pulmonarydisease. Further, additional applicationsfor aerosolized medication are constantlyunder investigation and this device maybe deemed suitable for such applicationsas prescribed.The intended environment for use of theproduct is in the patient's home on theorder of a physician.
The intended environment for useof the product is in the patient'shome on the order of a physician.

・

・・

・

DescriptiveInformation	Proposed Device	Predicate Device
510(k) Number	NONE	K870027
Manufacturer	Quality Life Technologies Co., Ltd	SALTER LABS
Proprietary orModel Name	Quality Life Technologies CompressorNebulizer, Models NBA02-XXX	HAND HELD PHEUMATICPOWERED (DISPOSABLE)NEBULIZER
Indication for Use	The Quality Life TechnologiesCompressor Nebulizer is an ACpowered air compressor that providesa source of compressed air for homehealth care use. The product is used inconjunction with a jet (pneumatic)nebulizer to convert liquid medicationinto an aerosol form with particlessmaller than 5 microns diameter forinhalation into the patient's respiratorytract for the treatment of respiratorydisorders.	Hand Held Pheumatic Powered(Disposable) Nebulizer is to convertliquid medication into an aerosol formwith particles smaller than 5 micronsdiameter for inhalation into thepatient's respiratory tract for thetreatment of respiratory disorders
	The target population for this deviceconsists of adult patients sufferingfrom, but not limited to asthma, cysticfibrosis, and chronic obstructivepulmonary disease. Further, additionalapplications for aerosolized medicationare constantly under investigation andthis device may be deemed suitable forsuch applications as prescribed.
	The intended environment for use ofthe product is in the patient's home onthe order of a physician.
Principle	Aerosolizes liquid into aerosol form bycompressing air.	Aerosolizes liquid into aerosol form bycompressing air
MMAD	<5 micronAlbuterol Sulfate (2.5 mg/3.0ml): 2.21	<5 micronAlbuterol Sulfate (2.5 mg/3.0ml): 3.13

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	Ipratropium Bromide (0.5 mg/2.5ml):3.04	Ipratropium Bromide (0.5 mg/2.5ml):3.10
	Cromolyn Sodium (20mg/2.0ml): 2.87	Cromolyn Sodium (20mg/2.0ml): 2.40
Accessories	Tubing, Nebulizer Cup, NebulizerInsert, Nebulizer Cap, Mouthpiece	Mouthpiece, T-piece, Cap, MedicationCup, Nebulizer Air-Inlet Connector,Baffle, Tubing
Target population	Adult patients	Both adult and pediatric patients
Environment use	In the patient's home on the order of aphysician.	In the patient's home on the order of aphysician.
Design	Medication Cup Volumes: Max.5.0mlDevice features: handy	Medication Cup Volumes: Max.5.0mlDevice features: handy
Performance	Flow rate of compressor:Max. flow rate of compressor is 9.9(l/min)Max. pressure is 40.0 (psig)	Flow rate of compressor:Max. flow rate of compressor is 10.0(l/min)Max. pressure is 40.0 (psig)
	Percent of drug does deliveredwhich falls in the respirablefraction:	Percent of drug does deliveredwhich falls in the respirablefraction:
	Albuterol Sulfate (2.5mg/3ml): 24.5%Ipratropium Bromide (0.5mg/2.5ml):47.7%Cromolyn Sodium (20mg/2.0ml):18.1%	Albuterol Sulfate (2.5mg/3ml): 53.5%Ipratropium Bromide (0.5mg/2.5ml):48.0%Cromolyn Sodium (20mg/2.0ml):29.5%
Biocompatibility	Biocompatible	Biocompatible

DescriptiveInformation	Proposed Device	Predicate Device
510(k) Number	NONE	K052438
Manufacturer	Quality Life Technologies Co., Ltd	EMG Technology Co., Ltd
Proprietary orModel Name	Quality Life TechnologiesCompressor Nebulizer, ModelsNBA02-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.

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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.

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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.

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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

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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

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).