(194 days)
Not Found
No
The document describes a standard nebulizer and does not mention any AI or ML components or functionalities.
No
The device is described as administering aerosol treatments and spraying liquid medications, fitting the definition of a therapeutic device rather than a diagnostic one.
No
Explanation: This device is a nebulizer, which is used to administer medication, not to diagnose a condition.
No
The device description explicitly states it is a "Nebulizer Bottle Set" and "intended to spray liquid medications in aerosol form," indicating a physical hardware component for drug delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer aerosol treatments to patients. This is a therapeutic function, delivering medication directly to the patient's respiratory system.
- Device Description: The device sprays liquid medications into gases for direct delivery to the patient. This describes a drug delivery system, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) from the human body to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are specifically designed to perform tests on biological specimens outside the body to provide diagnostic information. This device's function is to deliver medication into the body.
N/A
Intended Use / Indications for Use
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.
Product codes
CAF
Device Description
The MAXHEALTH Air Nebulizer is intended to spray liquid medications in aerosol fonn into gases that re directly delivered to the patient.
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 patients
Intended User / Care Setting
physician or healthcare professional / homecare and hospital settings
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Nebulizer Characterization Study: USFDA 21CFR part 58
- Biocompatibility Test:
- Cytotoxicity study ISO 10993 - 5
- Skin irritation study ISO 10993-10
- Skin sensitization study ISO 10993.10
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
" ■ 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:
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.
Performance Testing:
- Nebulizer Characterization Study: USFDA 21CFR part 58
-
- 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 )
1
" & 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 to | |
| administer various aerosol treatments | ||
| to adult and pediatric patients in both | ||
| the homecare and hospital settings. | ||
| This device is intended for use only | ||
| with FDA approved drugs upon the | ||
| specific direction by a physician. | ||
| Its use is indicated whenever a | ||
| physician or healthcare professional | ||
| administers or prescribes medical | ||
| aerosol products to a patient using a | ||
| Small Volume Nebulizer. | SAME | |
| Principle | Aerosolizes liquid into aerosol | |
| form by compressing air | SAME | |
| Capacity of | ||
| medication cup | 6 ml | SAME |
| Particle size |