(235 days)
No
The description focuses on the mechanical operation of a jet nebulizer and aerosol characterization, with no mention of AI or ML.
Yes
The device is used to administer aerosol treatments to patients, indicating a direct therapeutic purpose.
No
Explanation: The device is described as a nebulizer used to administer aerosol treatments and medications. Its function is to convert liquid medicine into an aerosol for inhalation, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly outlines a physical, hardware-based nebulizer that converts liquid medicine into an aerosol using compressed air and a baffle. It is a disposable, single-patient-use device.
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 for inhalation. This is a therapeutic use, not a diagnostic one.
- Device Description: The device description details how it converts liquid medicine into an aerosol for inhalation. This process is related to drug delivery, not testing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to gain information about a person's health status. This nebulizer's function is to deliver medication directly to the respiratory system.
N/A
Intended Use / Indications for Use
The ILI nebulizer is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and healthcare 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 is disposable, single-patient-use and intended for use with pediatric (5 years and older) and adult patient.
Product codes
CAF
Device Description
The JLI nebulizer is a small volume jet nebulizer designed to deliver aerosolized medications for inhalation to the respiratory system, the compressed air is forced into the nebulizer through a nozzle cover, where it accelerates and emerges at a high velocity, creating a vacuum (Venturi effect), in the process the liquid medicine is converted into small droplets called aerosol by impacting upon a rigid baffle, the aerosol may be used for inhalation treatment of a physician's prescription. The JLI nebulizer is disposable, single-patient-use.
The JLI nebulizer may replace the BESMED Jet Nebulizer Bottle (Besmed; Model PN-1128E; K091272), and connects to the accessories in K091272, which include Mouthpiece, T-piece, Corrugate tube and Air tube.
The JLI nebulizer is powered by air compressor, which is legally marketed on the USA (Manufacturer: HOMED; Model: JLN-2301AS, K161586).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth
Indicated Patient Age Range
pediatric (5 years and older) and adult patient.
Intended User / Care Setting
Homecare and healthcare settings, physician or healthcare professional
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
Aerosol characterization tests for the subject devices and predicate devices were conducted in accordance with the relevant sections of the CDRH Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH-1993), USP 40 Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers. For each device, three drugs: Albuterol sulfate (10mg/2ml), Ipratropium bromide (0.25mg/2ml), Budesonide (0.5mg/2ml) were tested respectively. The comparison items include Mass Median Aerodynamic Diameter (MMAD), Geometric Standard Deviation (GSD), Respirable mass, Respirable Fraction and Total Mass. Also, the variability of intra-sample and inter-sample was tested for the subject devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests were performed.
Aerosol characterization tests for the subject devices and predicate devices were conducted. For each device, three drugs: Albuterol sulfate (10mg/2ml), Ipratropium bromide (0.25mg/2ml), Budesonide (0.5mg/2ml) were tested respectively. The comparison items include Mass Median Aerodynamic Diameter (MMAD), Geometric Standard Deviation (GSD), Respirable mass, Respirable Fraction and Total Mass. The variability of intra-sample and inter-sample was also tested for the subject devices.
Key results show:
- Aerosol particulate performance were tested in the modes of adult and pediatric, then parameters of Total Mass, MMAD, GSD, Respirable fraction and Respirable mass were substantially equivalent to the predicate device in a confidence level of 95%.
- There is not significant statistical difference in aerosol particles characteristics between subject device and predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MMAD (Mass Median Aerodynamic Diameter), GSD (Geometric Standard Deviation), Respirable fraction (%), Respirable mass (mg), Total dose (mg)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shenzhen Homed Medical Device Co., Ltd. Shi Shengming Regulatory manager 3rd Floor, Block 1, Longquan Industrial Zone, Huarong Road. Dalang Street Shenzhen, Guangdong 518109 China
Re: K212395
Trade/Device Name: Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: January 25, 2022 Received: February 18, 2022
Dear Shi Shengming:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brandon Blakely, PhD Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212395
Device Name
JLI nebulizer
Indications for Use (Describe)
The ILI nebulizer is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and healthcare 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 is disposable, single-patient-use and intended for use with pediatric (5 years and older) and adult patient.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92 on March 24, 2022
1. Submitter
| Submitter's Name | Shenzhen Homed Medical Device Co., Ltd. |
|---|---|
| Contact Person | Shi Shengming |
| Address | 3rd Floor, Block 1, Longquan Industrial Zone, Huarong Road, Dalang Street. Longhua New District, Shenzhen City, Guangdong, China |
| Telephone | +86-755-29821671 |
| Fax number | +86-755-29821673 |
| shifei@homedgroup.com |
2. Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | JLI Nebulizer |
| Classification name: | Nebulizer |
| Classification: | |
| Review Panel: | Anesthesiology |
| Product Code: | CAF |
| Regulation Number: | 868.5630 |
3. Predicate Device Information
| Trade Name | BESMED Jet Nebulizer Bottle Set |
|---|---|
| 510(k) Number | K091272 |
| Classification name | Nebulizer |
| Classification: | II |
| Review Panel: | Anesthesiology |
| Product code | CAF |
| Regulation No. | 868.5630 |
4. Device Descriptions
The JLI nebulizer is a small volume jet nebulizer designed to deliver aerosolized medications for inhalation to the respiratory system, the compressed air is forced into the nebulizer through a nozzle cover, where it accelerates and emerges at a high velocity, creating a vacuum (Venturi effect), in the process the liquid medicine is converted into small droplets called aerosol by impacting upon a rigid baffle, the aerosol may be used for inhalation treatment of a physician's prescription. The JLI nebulizer is disposable, single-patient-use.
4
The JLI nebulizer may replace the BESMED Jet Nebulizer Bottle (Besmed; Model PN-1128E; K091272), and connects to the accessories in K091272, which include Mouthpiece, T-piece, Corrugate tube and Air tube.
The JLI nebulizer is powered by air compressor, which is legally marketed on the USA (Manufacturer: HOMED; Model: JLN-2301AS, K161586).
5. Intended Use and Indications for Use
The JLI nebulizer is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and healthcare 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 is disposable, single-patient-use and intended for use with pediatric (5 years and older) and adult patient.
6. Comparisons of technological characteristics with the predicate device
The JLI nebulizer and Besmed Nebulizer (K091272) are similar in purpose, composition, function, scientific technology and method of operation, the following table provides a comparison of the devices.
| Items | Subject Device
(JLI nebulizer, K212395) | Predicate Device
(Besmed nebulizer, K091272) | Remark |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Intended
use/Indicat
i on for
Use | The JLI nebulizer is used to
administer various aerosol
treatments to adult and pediatric
patients in both the homecare
and healthcare 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.
The JLI nebulizer is disposable,
single- patient-use and intended
for use with pediatric (5 years
and older)
and adult patient. | 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. | Same |
| Technolog
y | Pneumatic Jet Nebulizer | Pneumatic Jet Nebulizer | Same |
| Operatio
n
principle | Venturi | Venturi | Same |
| Environm
e nt of
use | Clinic, homecare | Clinic, homecare | Same |
| Patient
Populatio
n | Intended for use with pediatric (5
years and older) and adult
patient | Intended for use with pediatric
and adult patient | Similar |
| Single
patient use
only | Yes | Yes | Same |
| OTC or Rx | Rx | Rx | Same |
| Anatomi
c. Site | Mouth | Mouth | Same |
5
| Compositi | Nebulizer and accessories
(mouthpiece, T-piece, corrugate | Nebulizer and accessories
(mouthpiece, T-piece, corrugate | Same |
|-----------|--------------------------------------------------------------|--------------------------------------------------------------|------|
| o n | | | |
6
| Items | Subject Device
(JLI
nebulizer,K21239
5) | Predicate Device
(Besmed nebulizer,
K091272) | Remark |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------|
| | tube, air tube) | tube, air tube) | |
| Dimensions | Height: 75.42mm | Height: about 75.9mm | Similar |
| | External diameter of aerosol outlet: 18.59mm | External diameter of aerosol outlet: about 18.0mm | |
| | Internal diameter of aerosol outlet:
17.79mm | Internal diameter of aerosol outlet: about 17.2mm | |
| | Diameter of air inlet: 5.73mm | Diameter of air inlet: about
5.8mm | |
| Aerosolization | Continuous during inhalation and exhalation | Continuous during inhalation and exhalation | Same |
| Maximum
Fill Volume | 6 mL | 6 mL | Same |
| Materials | Polypropylene (PP) | Not publicly available | Different |
| Type of gas
source | Compressed air | Compressed air | Same |
| Biocompatibility | Conform to FDA guidance of
biological evaluation of medical
devices | Conform to FDA guidance of
biological evaluation of
medical devices | Same |
| Aerosol
characterization | Aerosol particulate performance were tested in the modes of adult
and pediatric, then parameters of Total Mass, MMAD, GSD,
Respirable fraction and Respirable mass were substantially
equivalent to the predicate device in a confidence level of 95%. | | Similar |
The subject device of JLI nebulizer and the predicated device of Besmed nebulizer are similar in purpose, composition, function, scientific technology and method of operation, both the subject device and predicated device have the similar patient population, type of gas source, biocompatibility performance, and there is not significant statistical difference in aerosol particles characteristics between subject device and predicate device. Only minor differences exist between the subject device and predicate device, which will not raise any new issue on safety and effectiveness of the subject device.
7. Brief discussions of the nonclinical tests
The subject device conforms to the following standards:
7.1 Biocompatibility evaluation
The biocompatibility evaluations of the subject device were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" and FDA biocompatibility guidance, the subject devices will be classified as external communication devices-tissue contact, and considering the cumulative exposure, the contact time will be permanent, the biocompatibility tests should consider the Cytotoxicity test, Sensitization test, Pyrogen test, Systemic toxicity test, Implantation test, Genotoxicity test and Toxicological risk assessment. The testing standards include the following:
| Standard | Descriptions |
|---|---|
| ---------- | -------------- |
7
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process |
|------------------|---------------------------------------------------------------------------------------------------------------|
| ISO 10993-5:2009 | Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro |
8
| Cytotoxicity | |
|---|---|
| ISO 10993-10:2010 | Biological Evaluation of Medical Devices- Part 10: Tests for Irritation |
| and Skin Sensitization | |
| ISO 10993-11:2017 | Biological evaluation of medical devices - Part 11: Tests for systemic |
| toxicity | |
| ISO 10993-3: 2014 | Biological evaluation of medical devices-Part 3: tests for genotoxicity, |
| carcinogenicity and reproductive toxicity | |
| ISO 10993-6: 2016 | Biological evaluation of medical devices - Part 6: Tests for local effects |
| after implantation | |
| ISO 10993-17-2002 | Biological evaluation of medical devices-Part 17: Establishment of |
| allowable limits for leachable substances | |
| ISO 10993-18: | |
| 2020 | Biological evaluation of medical devices-Part 18: Chemical |
| characterization of medical device materials within a risk management | |
| process |
7.2 Dry Gas Pathway Testing
Testing pertaining to the dry gas pathway and associated risk assessments/conclusions were conducted by an independent source. Testing included the assessments of Emissions of volatile organic compounds (VOCs), Fine particles (particulate matter PM2.5&10). The testing standards include the following:
| Standard | Descriptions |
|---|---|
| ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare |
| applications - Part 1: Evaluation and testing within a risk management | |
| process | |
| ISO 18562-2:2017 | Tests for emissions of volatile Biocompatibility evaluation of breathing |
| gas pathways in healthcare applications - Part 2: Tests for emissions | |
| of particulate matter | |
| ISO 18562-3:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare |
| applications - Part 3: Tests for emissions of volatile organic | |
| compounds (VOCs) |
7.3 Performance data
Aerosol characterization tests for the subject devices and predicate devices were conducted in accordance with the relevant sections of the CDRH Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH-1993), USP 40 Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers. For each device, three drugs: Albuterol sulfate (10mg/2ml), Ipratropium bromide (0.25mg/2ml), Budesonide (0.5mg/2ml) were tested respectively. The comparison items include Mass Median Aerodynamic Diameter (MMAD), Geometric Standard Deviation (GSD), Respirable mass, Respirable Fraction and Total Mass. Also, the variability of intra-sample and inter-sample was tested for the subject devices.
| Parameters | Drugs | JLI nebulizer | Besmed nebulizer |
|---|---|---|---|
| Total dose | |||
| (mg) | Albuterol sulfate | 7.4990±0.5384 | 7.5360±0.7936 |
| Ipratropium bromide | 0.1863±0.0248 | 0.1963±0.0150 | |
| Budesonide | 0.3873±0.0285 | 0.3953±0.0252 | |
| MMAD (μm) | Albuterol sulfate | 3.1233±0.2113 | 3.2233±0.1301 |
7.3.1 Aerosol particle characteristics (the sampling rate is 28 L/min)
9
| Ipratropium bromide | $2.7300\pm0.1389$ | $2.6167\pm0.1604$ | |
|---|---|---|---|
| Budesonide | $3.3333\pm0.1365$ | $3.4733\pm0.1474$ | |
| GSD | Albuterol sulfate | $2.1100\pm0.0781$ | $2.2267\pm0.0551$ |
| Ipratropium bromide | $2.7400\pm0.0173$ | $2.7600\pm0.1179$ | |
| Budesonide | $2.7733\pm0.0569$ | $2.7867\pm0.0929$ | |
| Respirable | |||
| fraction (%) | Albuterol sulfate | $72.84\pm2.30$ | $69.83\pm1.46$ |
| Ipratropium bromide | $68.68\pm1.28$ | $68.64\pm1.25$ | |
| Budesonide | $62.25\pm0.65$ | $60.92\pm1.15$ | |
| Respirable | |||
| mass (mg) | Albuterol sulfate | $5.4701\pm0.5632$ | $5.2694\pm0.6474$ |
| Ipratropium bromide | $0.1280\pm0.0175$ | $0.1349\pm0.0126$ | |
| Budesonide | $0.2411\pm0.0178$ | $0.2408\pm0.0142$ |
7.3.2 Aerosol particle characteristics (the sampling rate is 12 L/min)
| Parameters | Drugs | JLI nebulizer | Besmed nebulizer |
|---|---|---|---|
| Total dose | |||
| (mg) | Albuterol sulfate | 6.9057±0.3856 | 6.5897±0.5465 |
| Ipratropium bromide | 0.1513±0.0178 | 0.1527±0.0259 | |
| Budesonide | 0.3160±0.0288 | 0.3213±0.0326 | |
| MMAD (μm) | Albuterol sulfate | 3.3033±0.1415 | 3.1933±0.1002 |
| Ipratropium bromide | 2.8667±0.2237 | 2.7100±0.1587 | |
| Budesonide | 3.3700±0.2193 | 3.5533±0.1858 | |
| GSD | Albuterol sulfate | 2.1333±0.1060 | 2.2133±0.0702 |
| Ipratropium bromide | 2.5600±0.0361 | 2.7567±0.2053 | |
| Budesonide | 2.6133±0.0058 | 2.6700±0.1136 | |
| Respirable | |||
| fraction (%) | Albuterol sulfate | 69.99±1.06 | 70.40±0.50 |
| Ipratropium bromide | 69.22±1.99 | 67.92±2.26 | |
| Budesonide | 63.43±1.92 | 61.37±12.59 | |
| Respirable | |||
| mass (mg) | Albuterol sulfate | 4.8332±0.2848 | 4.6375±0.3511 |
| Ipratropium bromide | 0.1045±0.0096 | 0.1035±0.0158 | |
| Budesonide | 0.2006±0.0218 | 0.1971±0.0212 |
8. Clinical Testing
Substantial equivalence does not depend on clinical test data.
9. Conclusions
Based on device comparison information and performance data, the differences in technological characteristics between the subject devise and predicate device do not raise any new safety and effectiveness issue. Therefore, the subject device is substantially equivalent to the predicate device.