U-RIGHT Compressor Nebulizer, model TD-7013/ TD-7012, is designed to provide a compressed air source to aerosolize physician-prescribed liquid medication when used in combination with the packaged Nebulizer kit, except for Pentamidine. The packaged Nebulizer kit is intended for single use by single patient. U-RIGHT Compressor Nebulizer, model TD-7013/ TD-7012, is intended for use with children, adolescents ( 2 years to 18 years old), and adult patients in the homecare settings.

Device Description

U-RIGHT Compressor Nebulizer is a light weight portable aerosol nebulizer, which uses a pneumatic piston that compresses air, forcing it to flow into the nebulizer container. And the force of the air flowing into the nebulizer container disperses the liquid medicine into aerosol particles for inhalation treatment of a physician's prescription medicine.

The only difference between model TD-7012 and TD-7013 is the outer casing design. The operating principle, the compressor type, working mechanism, and the accessories Nebulizer kit are all the same in these two models.

AI/ML Overview

The submission describes the acceptance criteria and study for the U-RIGHT Compressor Nebulizer (model TD-7013/TD-7012).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test	Acceptance Criteria	Reported Device Performance
Aerosol Characterization	Particle Size Distribution via Cascade Impactor	Equivalent performance to predicate device (K990435) with no significant difference (p>0.05) in particle distributions for Ipratropium bromide, Ventolin, and Cromolyn sodium. Consistent repeatability across drug classes.	Shown to be consistent in repeatability tests for three classes of drugs and demonstrated equivalent performance to the predicate device K990435 with no significant difference (p>0.05) in particle distributions. Meets product specifications.
Airpath Testing	Gas Sample Analysis	Device does not emit potential toxic gases (carbon monoxide, carbon dioxide, ozone, VOCs). Output of particulate matter conforms to EPA PM2.5 standard.	Device does not emit potential toxic gases. Output of particulate matter conformed to EPA requirements of the PM2.5 standard.
Biocompatibility	Cytotoxicity (ISO 10993-5)	Bio-compatible	Tests conducted and results are assumed to have met standards, classified as "Biocompatibility evaluations... have been conducted for the gas path contact materials."
	Irritation (ISO 10993-10)	Bio-compatible	Tests conducted and results are assumed to have met standards.
	Sensitization (ISO 10993-10)	Bio-compatible	Tests conducted and results are assumed to have met standards.
	Implantation (ISO 10993-6)	Bio-compatible	Tests conducted and results are assumed to have met standards.
	Genotoxicity (ISO 10993-3)	Bio-compatible	Tests conducted and results are assumed to have met standards.
Safety and EMC	Electrical Safety (EN 60601-1:2006)	Compliance with standard	Tested to meet the standard.
	Electromagnetic Compatibility (EN 60601-1-1-2:2007, CISPR 11:2009+A1:2010)	Compliance with standards	Tested to meet the standards.

2. Sample Size Used for the Test Set and the Data Provenance

The provided text describes performance testing comparing the U-RIGHT Compressor Nebulizer to a predicate device. For the Aerosol Characterization Testing, the test involved comparing aerosol particle distributions with three specific drugs (Ipratropium bromide, Ventolin, and Cromolyn sodium) to the predicate device. The sample size for this comparative testing is not explicitly stated as a number of devices or number of tests per device, but the comparison was made across these three drugs.

Data provenance: The testing was conducted by TaiDoc Technology Corporation as part of their 510(k) submission. The location of the testing facility is not specified, but the applicant is based in Taiwan. The study appears to be prospective as it involves performance testing of the newly developed device against an existing predicate.

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 submission. The "ground truth" in this context is referring to measurable physical properties and compliance with engineering standards, not expert interpretations of medical images or conditions. The "ground truth" for the aerosol characterization would be the measured particle size distribution from the predicate device and the specified statistical equivalence, while for other tests it's compliance with safety and environmental standards.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are focused on objective performance measurements and compliance with technical standards, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study described is a technical performance comparison between a new device and a predicate device (device-to-device comparison), not a reader study involving human interpretation of data/images.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device. The "Aerosol Characterization Testing" assessed the particle size distribution of the U-RIGHT Compressor Nebulizer with different drugs and demonstrated its performance characteristics and repeatability. The "Airpath Testing" and "Materials" testing (biocompatibility) also assessed the device's standalone performance regarding air quality output and material safety. The "Safety and EMC" testing specifically evaluated the device's adherence to relevant electrical safety and electromagnetic compatibility standards. While these tests had a comparative element to a predicate where applicable, they fundamentally assessed the device's inherent performance and compliance.

7. Type of Ground Truth Used

The ground truth used in these studies is primarily based on:

Predicate Device Performance: For aerosol characterization, the performance of the legally marketed predicate device (Bestneb Portable Aerosol Therapy Unit, Model AP-10010, K990435) served as the reference point for equivalence (statistical significance p>0.05).
Regulatory and Engineering Standards: For airpath testing, biocompatibility, electrical safety, and EMC, the ground truth is defined by compliance with established international standards (e.g., ISO 10993 series, EN 60601 series, CISPR 11) and EPA requirements (PM2.5 standard).
Product Specifications: The device's own product specifications were also used as a benchmark for performance.

8. Sample Size for the Training Set

This information is not applicable. This device is a medical nebulizer, not an AI/machine learning algorithm, and therefore does not have a "training set" in the computational sense. The product development likely involved design iterations and internal testing, but not a formal 'training set' as used in AI validation.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reason stated in point 8.

Summary

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B2. 510(k) Summary

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

K121969 The Assigned 510(k) number is:

1. Submitter's Identification: TaiDoc Technology Corporation 3F,5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 24888, Taiwan
  Correspondence: Pinjung Chen Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1176 Fax: +886-2-6625-0288 Email: pinjung.chen(@taidoc.com.tw

Date of submission: June 30th, 2012

1. Device name:
  Proprietary name: U-RIGHT Compressor Nebulizer, model TD-7013/ TD-7012

Regulatory information:

A. Regulation section: 21 CFR § 868.5630
B. Classification: Class II
C. Product Code: CAF, nebulizer (direct patient interface)
D. Panel: Anesthesiology
1. Intended Use:
1. U-RIGHT Compressor Nebulizer, model TD-7013/ TD-7012, is designed to provide a compressed air source to aerosolize physician-prescribed liquid medication when used in combination with the packaged Nebulizer kit, except for Pentamidine. The packaged Nebulizer kit is intended for single use by single patient. U-RIGHT

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Compressor Nebulizer, model TD-7013/ TD-7012, is intended for use with children, adolescents ( 2 years to 18 years old), and adult patients in the homecare settings.

5. Device Description:

6. Substantial Equivalence Information:

A. Predicate device name: Bestneb Portable Aerosol Therapy Unit.

Model AP-10010

B. Predicate K number: K990435
C. Comparison with predicate:

The modified U-RIGHT Compressor Nebulizer has the following similarities to the predicate device:

. Same intended use

■ Same patient population and same environment of use

1 Same operating principle

Same working mechanism 1
Same fundamental scientific technology 트

The differences encompass:

트 Physical appearance of unit and components
. Slight difference in storage condition
Device weight 1
Power requirement and power consumption

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1. Summary of Performance Testing:

1) Aerosol Characterization Testing

The particle size distribution test via Cascade Impactor of U-RIGHT Compressor Nebulizer was performed in comparison to the predicate device K990435 with three drugs (Ipratropium bromide, Ventolin, and Cromolyn sodium). The test has shown U-RIGHT Compressor Nebulizer consistent in repeatability tests for each three classes of drug, and demonstrated equivalent performance to the predicate device K990435 that no significant difference (p>0.05) in the particle distributions.

U-RIGHT Compressor Nebulizer has the same performance characteristics as the predicate device and meets its product specification as well.

2) Airpath Testing

Gas sample analysis of U-RIGHT Compressor Nebulizer has performed and shown the device does not emit potential toxic gases that may cause harmful influences to human, including carbon monoxide, carbon dioxide, ozone, or volatile organic compounds (VOCs). The output of particulate matter conformed to EPA requirements of the PM2.5 standard.

3) Materials

FDA authority considers the gas path contact components the external communicating components with tissue contact. Biocompatibility evaluations of cytotoxicity (ISO 10993-5), irritation (ISO 10993-10), sensitization (ISO 10993-10), implantation (ISO 10993-6) and genotoxicity (ISO 10993-3) tests have been conducted for the gas path contact materials.

4) Safety and EMC

The electromagnetic compatibility and electric safety of the proposed device are tested to meet the following standards:

트 EN 60601-1:2006
EN 60601-1-1-2:2007, CISPR 11: 2009+A1:2010

8. Conclusion:

Based on the information provided in this submission, U-RIGHT Compressor

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Nebulizer is substantially equivalent to the predicate device in safety and effectiveness. :

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three overlapping, curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 28, 2013

Ms. Pinjung Chen Regulatory Affairs Specialist TaiDoc Technology Corporation 3F,5F, No.127, Wugong 2nd Road Wugu District New Taipei City, Taiwan 24888

Re: K121969

Trade/Device Name: U-RIGHT Compressor Nebulizer, Model TD-7013/ TD-7012 Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: January 15, 2013 Received: January 22, 2013

Dear Mr. Chen:

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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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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Kwame O. Ulmer for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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B1. Indications for Use Statement

Indications for Use

510(k) Number:

Device Name: U-RIGHT Compressor Nebulizer, Model TD-7013/ TD-7012

Indications for Use:

Prescription Use _ X

(21 CFR Part 801 Subpart D)

And/Or Over the Counter Use (21 CFR Part 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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heslotogy, General Hospital

510(k) Number: K121969

BI- Page 1 of 1

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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B1. Indications for Use Statement

Indications for Use

510(k) Number: x | 21969

Device Name: U-RIGHT Compressor Nebulizer, Model TD-7013/ TD-7012

Indications for Use:

Prescription Use __ X (21 CFR Part 801 Subpart D)

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number: K121969

B1- Page 1 of 1

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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).