(155 days)
Not Found
No
The description focuses on the mechanical and ultrasonic principles of operation, with no mention of AI or ML.
Yes
The device is intended for use in the treatment of medical conditions (asthma, COPD, and other respiratory ailments) by aerosolizing medication for therapy.
No
The device is described as an ultrasonic nebulizer intended for delivering aerosolized medication for the treatment of respiratory ailments, not for diagnosing conditions.
No
The device description clearly outlines physical components like a piezoelectric crystal, medication cap, and various attachments (mouthpiece, masks, tubes), indicating it is a hardware device with a physical mechanism for generating aerosolized medication.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for delivering aerosolized medication for the treatment of respiratory ailments. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details how the device converts liquid medication into an aerosol for inhalation. This process is focused on drug delivery, not on analyzing biological samples to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health status or to diagnose a disease.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This nebulizer's function is to administer medication, which is a treatment, not a diagnostic activity.
N/A
Intended Use / Indications for Use
The GUAN HONG Model# AC103/DR 103 Ultrasonic Nebulizer is an ultrasonic nebulizer that is intended for use in the treatment of asthma, COPD and other respiratory allments in which an aerosolized medication is required during therapy. The GUAN HONG Model# AC103/DR 103 Ultrasonic Nebulizer is not intended for use with Pentamidine. It is intended for single patient use.
Product codes
CAF
Device Description
GUAN HONG Ultrasonic Nebulizer (Model MH-AC 103 & MH-DR 103) is designed to spray liquids in aerosol form into gases directly to the patient for use by the adult and pediatric population.
The Ultrasonic Nebulizer units contains a piezoelectric crystal that generate ultrasonic waves which are transmitted through buffer water to medication cap and convert the liquid medication into an aerosol. The Nebulizer medication cap is designed for single-patient use and holds up to 5ml of medication for Model # AC 103 , 8 ml for Model # DR 103.
Inhalation can be made through nose or mouth. Attachments that are used during the nebulization process include MOUTHPIECE, ADULT MASK; PEDIATRIC MASK, NOSE FORK , CONNECTOR, CORRUGATED TUBE.
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
adult and pediatric population
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)
In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included IEC 60601-1 , IEC 60601-1-2 and NEBULIZER CHARACTERIZATION STUDY , ISO 10993 requirements. A comparison study with device that use auscultatory method was performed to validate the performance of the GUAN HONG Model# MH-AC103 / MH-DR 103 Ultrasonic Nebulizer. The comparison study demonstrated that the clinical repeatability of GUAN HONG Model# MH-AC103 / MH-DR 103 Ultrasonic Nebulizer is statistically and clinically acceptable.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2004
Guan Hong Enterprise Company Limited C/O Ms. Jennifer Reich 3892 South America West Trail Flaggstaff, Arizona 86001
Re: K041079
Trade/Device Name: Guan Hong Model #AC103/DR 103 Ultrasonic Nebulizer Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: August 30, 2004 Received: August 7, 2004
Dear Ms. Reich:
This letter corrects our substantially equivalent letter of September 28, 2004 regarding the company name.
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 (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.
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.
1
Page 2 - Ms. Reich
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); 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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
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): ____________________________________________________________________________________________________________________________________________________
GUAN HONG Model # AC103 / DR 103 Ultrasonic Nebulizer Device Name: GUAN HONG ENTERPRISE CO.,LTD.
Indications For Use:
The GUAN HONG Model# AC103/DR 103 Ultrasonic Nebulizer is an ultrasonic nebulizer that is intended for use in the treatment of asthma, COPD and other respiratory allments in which an aerosolized medication is required during therapy. The GUAN HONG Model# AC103/DR 103 Ultrasonic Nebulizer is not intended for use with Pentamidine. It is intended for single patient use.
Aurymtelem
eneral Hospital. ion Control Den
510(k) Number:
Prescription Use _____________________________________________________________________________________________________________________________________________________________ V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Image /page/3/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be a combination of letters and numbers. The string starts with the letters 'K' and 'O', followed by the numbers '4', '1', '0', '7', and '9'. The handwriting is somewhat stylized, with some characters slightly distorted or connected.
510(K) SUM
SEP 2 8
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
| 1.0 Submitter's Name: | GUAN HONG ENTERPRISE CO.,LTD. |
|---|---|
| Address: | No.17 Hsin Ren Rd.,An-Ping Industrial District, Tainan, Taiwan, R.O.C. |
| Phone: | 001-886-6-2614191 |
| Fax: | 001-886-2-2637008 |
| Contact: | Mr. James Lin, General Manager |
| 2.0 Device Name: | GUAN HONG Ultrasonic Nebulizer |
| Model No.: | |
| MH-AC 103 (/or AC 103) Portable Ultrasonic Nebulizer | |
| MH-DR 103 (/or DR 103) Ultrasonic Nebulizer | |
| 3.0 Classification: | Class II |
| 4.0 Predicate Device: | GUAN HONG Model# MH-AC103 / MH-DR 103 Ultrasonic Nebulizer has similar general design with Mabis NB-02 Ultrasonic Nebulizer (K990506) marketed by MABIS HEALTHCARE, INC. |
| 5.0 Device Description: | GUAN HONG Ultrasonic Nebulizer (Model MH-AC 103 & MH-DR 103) is designed to spray liquids in aerosol form into gases directly to the patient for use by the adult and pediatric population. |
The Ultrasonic Nebulizer units contains a piezoelectric crystal that generate ultrasonic waves which are transmitted through buffer water to medication cap and convert the liquid medication into an aerosol. The Nebulizer medication cap is designed for single-patient use and holds up to 5ml of medication for Model # AC 103 , 8 ml for Model # DR 103.
Inhalation can be made through nose or mouth. Attachments that are used during the nebulization process include MOUTHPIECE, ADULT MASK; PEDIATRIC MASK, NOSE FORK , CONNECTOR, CORRUGATED TUBE. |
FDA 510(K) SUMMARY
4
The GUAN HONG Model# AC103/DR 103 Ultrasonic Nebulizer 6.0 Indication for Use: is an ultrasonic nebulizer that is intended for use in the treatment of asthma, COPD and other respiratory ailments in which an aerosolized medication is required during therapy. The GUAN HONG Model# AC103/DR 103 Ultrasonic Nebulizer is not intended for use with Pentamidine. It is intended for single patient use.
In terms of operating specification, Safety & EMC requirements, 7.0 Performance the device conforms to applicable standards included IEC Summary: 60601-1 , IEC 60601-1-2 and NEBULIZER CHARACTERIZATION STUDY , ISO 10993 requirements. A comparison study with device that use auscultatory method was performed to validate the performance of the GUAN HONG Model# MH-AC103 / MH-DR 103 Ultrasonic Nebulizer. The comparison study demonstrated that the clinical repeatability of GUAN HONG Model# MH-AC103 / MH-DR 103 Ultrasonic Nebulizer is statistically and clinically acceptable.
r Conclusions:
i he GUAN HONG Model# MH-AC103 / MH-DR 103 Ultrasonic Nebulizer have the same intended use and similar technological characteristics as Mabis NB-02 Ultrasonic Nebulizer (K990506) marketed by MABIS HEALTHCARE, INC.. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the GUAN HONG Model# MH-AC103 / MH-DR 103 Ultrasonic Nebulizer is substantially equivalent to the predicate devices.
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