(251 days)
No
The description focuses on the mechanical and electrical components of an ultrasonic nebulizer and performance testing related to aerosol characteristics, airpath, materials, safety, and EMC. There is no mention of AI, ML, image processing, or data sets for training or testing algorithms.
Yes
The device is designed to aerosolize physician-prescribed solutions for inhalation, specifically for therapeutic purposes (e.g., administering medication for respiratory conditions).
No
Explanation: The device is described as a nebulizer system designed to aerosolize physician-prescribed solutions for inhalation, which is a treatment delivery function, not a diagnostic one.
No
The device description clearly outlines physical hardware components (Nebulizer unit, medication cap, medication cup, mouthpiece, mask, ultrasonic piezoelectric element, batteries) and describes their physical function in aerosolizing medication. Performance studies also focus on hardware characteristics like particle size distribution, airpath testing, materials, safety, and EMC.
Based on the provided information, the Clever TD-7001 Nebulizer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to aerosolize physician-prescribed solutions for inhalation by the patient. This is a therapeutic delivery method, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a device that creates an aerosol for inhalation. It does not mention any components or processes related to 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 screening of diseases
The performance studies described focus on the device's ability to aerosolize medication effectively and safely, which is consistent with a therapeutic device, not an IVD.
N/A
Intended Use / 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. The Clever TD-7001 Nebulizer is for use with children and adult patients in the homecare environment.
Product codes
CAF
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.
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
children and adult patients
Intended User / Care Setting
Not Found
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)
- 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.
-
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. -
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. -
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
- EN 60601-1-1-2:2001+A1:2006, CISPR 11: 2003
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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:
-
- 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
-
- 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.
-
- 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 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.
- 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
-
- 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 ■
-
- 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 Hospital
Infection Control, Dental Devices | |
| | 1.100 mln | |
3-page lof 1
510(k) Number:_K122060