The Clever TD-7001 Nebulizer is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize physician-prescribed solution for inhalation by the patient, except for Pentamidine. The Clever TD-7001 Nebulizer is for use with children and adult patients in the homecare environment.

Device Description

Clever TD-7001 Nebulizer is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize physician-prescribed solution for inhalation by the patient. It is for use with children and adult patients in the homecare environment. Clever TD-7001 Nebulizer consists of a Nebulizer unit, a medication cap and a Jand Medication cup are single medication cup. The Nebulizer unit, me patient re-usable. The Nebulizer unit trol circuitry and is powered by using 2 AA alkaline batteries organ A onnects to electrical outlets. The patient interface comprises a mouthpiê medication cap contains the metal alloy mesh. When the device is turne ultrasonic piezoelectric element vibrate to cause the mesh vibrate. ation solution tin the reservoir of medication cup is aerosolized by the vibrating the aerosols can be inhaled through the mouthpiece or mask.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Clever TD-7001 Nebulizer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Aerosol Characterization Testing (Particle Size Distribution)
Equivalent performance to predicate device (K062263) for 3 drugs (Ipratropium bromide, Ventolin, Cromolyn sodium) with no significant difference (p > 0.035).	The test "has shown Clever TD-7001 Nebulizer consistent in repeatabil for each three classes of drug, and demonstrated equivalent performance? ate device K062263 that no significant difference (p>0.035) in the Clever TD-7001 Nebulizerst as the ame performance characteristics as the predicate device and meets its product specification as well."
Airpath Testing (Gas Sample Analysis)
Device does not emit potential toxic gases (carbon monoxide, carbon dioxide, ozone, volatile organic compounds).	"Gas sample analysis of Clever TD-7001 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)."
Output of particulate matter conforms to EPA PM2.5 standard.	"The output of particulate matter conformed to EPA requirements of the PM2.5 standard."
Materials (Biocompatibility)
Meet ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation), ISO 10993-10 (sensitization), ISO 10993-6 (implantation), and ISO 10993-3 (genotoxicity) for gas path contact materials.	"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." (Implies meeting the standards.)
Safety and EMC (Electrical Safety and Electromagnetic Compatibility)
Meet EN 60601-1:1988+A1:1991+A2:1995 and EN 60601-1-1-2:2001+A1:2006, CISPR 11:2003.	"The electromagnetic compatibility and electric safety of the proposed device are tested to meet the following standards: - EN 60601-1:1988+ A1:1991+ A2:1995 - EN 60601-1-1-2:2001+A1:2006, CISPR 11: 2003" (Implies meeting the standards.)

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

The document does not explicitly state the specific sample sizes for the test sets in the performance characteristic studies. It mentions "three drugs (Ipratropium bromide, Ventolin, and Cromolyn sodium)" were used for the aerosol characterization testing, implying at least three distinct test cases.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It is, however, implied to be generated specifically for the submission of this device, suggesting prospective testing conducted by the manufacturer, TaiDoc Technology Corporation (Taiwan).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the given text. For device performance testing of a nebulizer, "ground truth" would typically refer to objective measurements obtained from controlled laboratory conditions, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of the described performance testing. The studies are objective measurements (e.g., particle size distribution, gas analysis) rather than subjective assessments requiring adjudication.

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

An MRMC comparative effectiveness study was not conducted. This type of study is typically relevant for AI-powered diagnostic imaging devices, not for a medical device like a nebulizer.

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

This concept is not applicable as the device is a nebulizer and does not involve an algorithm or AI. The performance tests described (aerosol characterization, airpath, materials, safety/EMC) are inherently "standalone" in the sense that they measure the device's physical and functional properties directly.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

Objective Measurement Standards:
- For Aerosol Characterization: Comparison to the performance of a legally marketed predicate device (K062263) using established methods like Cascade Impactor, with statistical significance testing (p > 0.035).
- For Airpath Testing: Compliance with EPA requirements (PM2.5 standard) and general toxic gas emission limits.
- For Materials: Adherence to international biocompatibility standards (ISO 10993 series).
- For Safety and EMC: Compliance with international electrical safety and electromagnetic compatibility standards (EN 60601 series, CISPR 11).

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI/ML algorithm requiring a training set.

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

This information is not applicable as the device is not an AI/ML algorithm requiring a training set.

Summary

{0}------------------------------------------------

Re:K122060

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.

The Assigned 510(k) number is:

1. Submitter's Identification: TaiDoc Technology Corporation 3F,5F, No.127, Wugong 2nd Rd. City, 24888, Taiwan Correspondence: Pinjung Chen Regulatory Affairs S Tel: +886-2-6625-8 Fax: +886-2-6625-02 Email: pinjung.chen@taidoo Prepared date: Junes
1. Device name: Proprietary name: Clever TD-7001 Nebulizer
- Regulatory information:
- Regulation section: 21 CFR § 868.5630 A.
- B. Classification: Class II
- CAF, nebulizer (direct patient interface) C. Product Code:
- Panel: Anesthesiology D.
1. Indication for Use:

The Clever TD-7001·Nebulizer is an ultrasonic (vibrating mesh) nebulizer system

4- page lof 4

{1}------------------------------------------------

designed to aerosolize physician-prescribed solution for inhalation by the patient, except for Pentamidine.

The Clever TD-7001 Nebulizer is for use with children and adult patients in the homecare environment.

4. Device Description:

Clever TD-7001 Nebulizer consists of a Nebulizer unit, a medication cap and a Jand Medication cup are single medication cup. The Nebulizer unit, me patient re-usable. The Nebulizer unit trol circuitry and is powered by using 2 AA alkaline batteries organ A onnects to electrical outlets. The patient interface comprises a mouthpiê medication cap contains the metal alloy mesh. When the device is turne ultrasonic piezoelectric element vibrate to cause the mesh vibrate. ation solution tin the reservoir of medication cup is aerosolized by the vibrating the aerosols can be inhaled through the mouthpiece or mask.

Substantial Equivalence Information:

Predicate device name: Omron Micro Air Vibrating mesh nebulizer NE-U22 A.
Predicate K number: K062263 B.
C. Comparison with predicate:

The proposed Clever TD-7001 Nebulizer has the following similarities to the predicate device which make substantially equivalence:

. Same intended use
. Same patient population
Same operating principle and working mechanism
Same performance efficacy
Same fundamental scientific technology

The differences encompass:

4- page 2of 4

{2}------------------------------------------------

Physical appearance change 1
Mesh cap and medication cup/bottle assemble method 1
. The connection of electrode from the main unit to the transducer/vibrator
D The material in fluid pathway
Power requirement and power consumption
1. Performance Characteristics:

1) Aerosol Characterization Testing

The particle size distribution test via Cascade Impactor of Clever TD-7001 Nebulizer was performed in comparison to the predicate device, K062263 with three drugs (Ipratropium bromide, Ventolin, and Cromolyn sodium). The test has shown Clever TD-7001 Nebulizer consistent in repeatabil for each three classes of drug, and demonstrated equivalent performance? ate device K062263 that no significant difference (p>0.035) in the

Clever TD-7001 Nebulizerst as the ame performance characteristics as the predicate device and meets its product specification as well.

2) Airpath Testing

of Clever TD-7001 Nebulizer has performed and shown the Gas sample analysis 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- page 3of 4

{3}------------------------------------------------

4) Safety and EMC

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

EN 60601-1:1988+ A1:1991+ A2:1995 트
EN 60601-1-1-2:2001+A1:2006, CISPR 11: 2003 ■
1. Conclusion:

Based on the information provided in this submission, Clever TD-7001 Nebulizer is substantially equivalent to the predicate device in safety and effectiveness.

Property of TaiD,
Confidential material
Duplication and copying prohibited
Without consent of TaiDoc

4- page 4of 4

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, rendered in black.

Public Health Service

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

March 21, 2013

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

Re: K122060

Trade/Device Name: Clever TD-7001 Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: January 31, 2013 Received: February 8, 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.

{5}------------------------------------------------

Page 2 - Mr. Chen

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.

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.

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

{6}------------------------------------------------

Re:K122060

Attachment 3. Indications for Use Statement

Indications for Use

510(k) Number: K122060

Device Name: Clever TD-7001 Nebulizer

Indications for Use:

The Clever TD-7001 Nebulizer is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize physician-prescribed solution for inhalation by the patient, . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... " except for Pentamidine. .:

ensepy. I chamburn.
The Clever TD-7001 Nebulizer is for use with children and adult patients in the : homecare environment.

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

Over the Counter Use And/Or (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)

	Albert E. Moyal=c=US, o=U.S. Govemment, ou=HHS.100.1 1=13000593331.	for LS
(Division Sign-Off)	Division of Anesthesiology, General HospitalInfection Control, Dental Devices
	1.100 mln

3-page lof 1

510(k) Number:_K122060

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).