The BESMED Jet Nebulizer Bottle Set is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

Device Description

The MAXHEALTH Air Nebulizer is intended to spray liquid medications in aerosol fonn into gases that re directly delivered to the patient.

AI/ML Overview

The information provided describes the acceptance criteria and a study to demonstrate substantial equivalence for the BESMED Jet Nebulizer Bottle Set, Model PN-1128E, as part of a 510(k) submission.

This is a device for administering aerosol treatments. The studies conducted are primarily performance and biocompatibility tests, rather than studies involving human readers or AI algorithms for diagnostic purposes. Therefore, some of the requested information (like MRMC studies, effect size of AI, number of experts for ground truth, adjudication methods, and sample sizes for training/test sets in the context of AI) is not applicable to this type of device and submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" in a quantitative table format for performance beyond what's compared with the predicate device. However, it indicates conformity to relevant standards and a comparative analysis.

Aspect	Acceptance Criteria (Implied by equivalence to predicate & standards)	Reported Device Performance
Intended Use	Administer aerosol treatments to adult/pediatric patients; home/hospital. Used with FDA approved drugs as prescribed.	SAME as predicate device (HSINER Jet Nebulizer, K052811)
Principle	Aerosolizes liquid into aerosol form by compressing air.	SAME as predicate device
Capacity of Medication Cup	6 ml	SAME as predicate device (6 ml)
Particle Size	< 5 micron (as per predicate device)	SAME as predicate device (< 5 micron)
Accessories	Mouthpiece, T-piece, Corrugate tube, Air tube	SAME as predicate device (1 piece of each)
Nebulizer Characterization	USFDA 21CFR part 58	Study conducted. (Results not detailed beyond "Study conducted")
Biocompatibility	ISO 10993-5 (Cytotoxicity) & ISO 10993-10 (Skin irritation & sensitization)	Studies conducted. (Results not detailed beyond "Study conducted")
Dimensions	Not explicitly stated as acceptance criteria, but compared.	7.8 x 4.5 (Tall x Diameter cm)
Features	Novel appearance, compact structure, cabinet bulk, simple operation, convenient carrying.	As above, plus non-oil lubrication single-cylinder piston pump for air pressure.

Self-correction: The document explicitly states "Particle size < 5 micron" for both the predicate and new device under "Comparison Areas" as a "Similar" characteristic. This serves as an acceptance criterion implicitly met by the new device.

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

Sample Size for Test Set: Not applicable in the context of diagnostic AI algorithms. The studies mentioned (Nebulizer Characterization, Biocompatibility) would have their own sample sizes for parts or materials, but these are not specified in the summary.
Data Provenance: Not applicable in the context of diagnostic AI algorithms as no "data" in that sense is being analyzed. The device is manufactured by Besmed Health Business Corp. in Taiwan. The testing would likely be performed in a controlled laboratory setting.

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

Not applicable. This device is a medical accessory, not a diagnostic AI intended to interpret medical images or data requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for the performance and biocompatibility testing of a nebulizer.

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

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the performance of diagnostic systems (often AI-assisted) and human readers. The BESMED Jet Nebulizer is a device for drug delivery, not diagnosis.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study (in the context of an AI algorithm) was not done. An AI algorithm is not part of this device. The studies mentioned are performance tests of the physical nebulizer.

7. Type of Ground Truth Used

The "ground truth" for this device's performance would be established through objective measurements against defined engineering specifications and regulatory standards. For example:

Nebulizer Characterization: Measurements of aerosol particle size distribution, nebulization rate, and drug output, compared to the requirements of USFDA 21CFR part 58 and, implicitly, demonstrating equivalence to the predicate device.
Biocompatibility: Laboratory testing (cytotoxicity, skin irritation, sensitization) following ISO 10993 standards, where the "ground truth" is the biological response observed in the test systems against acceptance limits defined by the standard.

There's no clinical "ground truth" in terms of disease presence/absence or medical condition for this type of device.

8. Sample Size for the Training Set

Not applicable. There is no AI algorithm involved, so no training set is used.

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

Not applicable, as no training set is involved.

Summary

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" ■ BESMED HE ALTH BUSINESS CORP. 【091272

NO. 5. LANE 116, WU-KONG 2nd RD., WU-KU INDUSTRIAL PARK, TAIWAN

TFL: +886 2 2290 3959 FAX : + 886 2 2299 9076 = n www.bestied.com

" 510k SUMMARY"

NOV 1 0 2009

Submitter's Name: Besmed Health Business Corp.

No.5, Lane 116, Wu-Kong 2nd Road, Wu-Ku Industrial Park, Taipei Hsien, 24890, Taiwan

Date summary prepared:

April 10, 2009

Device Name:

Proprietary Name: BESMED Jet Nebulizer Bottle Set, Model PN-1128E

Common or Usual Name: Jet Nebulizer Classification Name: CAF, Class II 21 CFR 868.5630

Indications for Use:

Device Description:

The MAXHEALTH Air Nebulizer is intended to spray liquid medications in aerosol fonn into gases that re directly delivered to the patient.

Performance Testing:

Nebulizer Characterization Study: USFDA 21CFR part 58

1. Biocompatibility Test:
Cytotoxicity study ISO 10993 · 5
· Skin irritation study ISO 10993-10
· Skin sensitization study ISO 10993.10

Legally marketed device for substantial equivalence comparison:

HSINER Jet Nebulizer, ( K052811 )

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" & BESMED HEALTH BUSINESS CORP.

NO. 5. LANE 116. WU-KONG 2nd RD., WU-KU INDUSTRIAL PARK, TAIPEI. TAIWAN

TEL: +886 2 2290 3959 FAX: + 886 2 2299 9076 www.besmed.com

Comparison Areas	Predicate Device	New Device
Manufacturer	Hsiner Co., Ltd.	Besmed Health Business Corp.
510K number	K052811	TBA
Device name	Jet Nebulizer	Jet Nebulizer Bottle Set
Model	HS-31100	PN-1128
Similar:
Intended for Use	The Jet Nebulizer is used toadminister various aerosol treatmentsto adult and pediatric patients in boththe homecare and hospital settings.This device is intended for use onlywith FDA approved drugs upon thespecific direction by a physician.Its use is indicated whenever aphysician or healthcare professionaladministers or prescribes medicalaerosol products to a patient using aSmall Volume Nebulizer.	SAME
Principle	Aerosolizes liquid into aerosolform by compressing air	SAME
Capacity ofmedication cup	6 ml	SAME
Particle size	< 5 micron	SAME
Accessories	Mouthpiece - 1 pieceT-piece - 1 pieceCorrugate tube - 1 pieceAir tube -- 1 piece	SAME

Comparison Table

(continued)

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8 8 BESMED HEALTH BUSINESS CORP.

NO. 5. LANE 116, WU-KONG 2nd RD., WU-KU INDUSTRIAL PARK, TAIPEL TAIWAN

TEL: +886 2 2290 3959 FAX: + 886 2 2299 9076 www.besmed.com

Different:
Dimension	7.9 x 4.1(Tall x Diameter cm)	7.8 x 4.5(Tall x Diameter cm)
Features	Novel appearance, compactstructure, cabinet bulk, simpleoperation, convenient carrying	1. Provide non-oillubrication single-cylinderpiston pump for air pressure2. Novel appearance,compact structure, cabinet bulksimple operation, convenientcarrying

Differences between the Legally Marketed Predicate Devices:

The BESMED Jet Nebulizer Bottle Set, PN-1128E is viewed as substantially equivalent to the predicate device: HSINER Jet Nebulizer, ( K052811 )
Except the different specifications, there are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Dr. Ke-Min-Jen Besmed Health Business 58 Fu-Chiun Street Hsin Chu City China (Taiwan) 300

NOV 1 0 2009

Re: K091272

Trade/Device Name: BESMED Jet Nebulizer Bottle Set, PN-1128E Regulation Number: 21CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: October 28, 2009 Received: October 28, 2009

Dear Dr. Jen:

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.

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 (OS) 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,

for

Susan Runner, D.D.S., M.A. Acting 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 :

Device Name: BESMED Jet Nebulizer Bottle Set, PN-1128E

Indications for Use:

Prescription Use V

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schulthess

Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) K091272

Page_1 of 1

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).