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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Guan Hong Model #AC103/DR 103 Ultrasonic Nebulizer:

Based on the provided 510(k) summary, the information regarding specific acceptance criteria and detailed study results is very limited. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive clinical performance study as might be seen for novel or high-risk devices.

Therefore, for many of the requested points, the answer will be "Not found in the provided text."

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

Acceptance Criteria	Reported Device Performance
Not explicit (implied equivalence to predicate)	"Statistically and clinically acceptable" repeatability (comparison study with a device using an auscultatory method).
Applicable Standards Conformance (implied acceptance)	Conforms to IEC 60601-1, IEC 60601-1-2, NEBULIZER CHARACTERIZATION STUDY, and ISO 10993 requirements.

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

Sample Size for Test Set: Not found in the provided text.
Data Provenance: Not found in the provided text. The device is manufactured in Taiwan, R.O.C., but the location of the comparison study is not specified. It is likely a prospective study, but this is not explicitly stated.

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)

Not found in the provided text. The study mentioned is a "comparison study with a device that uses an auscultatory method" to validate repeatability, implying a technical or clinical measurement of output rather than expert interpretation of images or symptoms which would typically require "ground truth" established by experts.

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

Not applicable as no expert adjudication for ground truth is mentioned or implied for this type of device and study.

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

No, an MRMC comparative effectiveness study was not done. This device is an ultrasonic nebulizer, not an AI-powered diagnostic tool. The "comparison study" mentioned is likely focused on the device's physical performance characteristics (e.g., aerosol output, particle size distribution) against a reference or predicate device, not on human reader performance with or without AI.

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

Yes, a standalone study was done, though not in the AI sense. The term "standalone" here would apply to the device's own performance characteristics (e.g., nebulization rate, particle size) being evaluated. The document states a "comparison study with a device that use auscultatory method was performed to validate the performance of the GUAN HONG Model# MH-AC103 / MH-DR 103 Ultrasonic Nebulizer." This is a standalone evaluation of the device itself.

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

Not explicitly stated, but inferred to be technical or clinical measurements. For a nebulizer, "ground truth" in a comparison study would likely refer to objective measurements of aerosol output parameters (e.g., Mass Median Aerodynamic Diameter (MMAD), Fine Particle Fraction (FPF), nebulization rate) obtained through standardized characterization methods, and possibly clinical indicators of medication delivery if a clinical study was performed (which is only vaguely alluded to).

8. The sample size for the training set

Not applicable. This device does not involve AI or machine learning models that require a "training set."

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

Not applicable. This device does not involve AI or machine learning models that require a "training set" or ground truth for such a set.

Summary

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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.

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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:

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)

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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 NebulizerModel No.:MH-AC 103 (/or AC 103) Portable Ultrasonic NebulizerMH-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

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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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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).