(455 days)
No
The device description and performance studies focus on the mechanical and electrical aspects of a piston compressor nebulizer, with no mention of AI or ML.
Yes
The device is described as an air compressor used with a jet nebulizer to convert inhalable drugs into an aerosol form for inhalation by a patient for the treatment of various respiratory disorders, indicating a therapeutic purpose.
No
Explanation: The device is a nebulizer that converts liquid medication into an aerosol form for inhalation to treat respiratory disorders. It does not diagnose any conditions or diseases.
No
The device description explicitly states it is a "small, piston-type air compressor" and mentions "electrical and mechanical safety standards," indicating it is a hardware 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 convert inhalable drugs into an aerosol form for inhalation by a patient for the treatment of respiratory disorders. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as an air compressor used to power a nebulizer. Its function is mechanical (generating compressed air) and physical (creating an aerosol). It does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any substance in a biological sample for diagnostic purposes.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (on the body) by delivering medication.
N/A
Intended Use / Indications for Use
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) include an AC powered air compressor that provides a source of compressed air for home health care use. The compressor is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatic patients (4 years and older).
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) is designed and manufactured by Shenzhen Homed Medical Device Co., Ltd.
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS. JLN-2301AS, JLN-2317AS and JLN-2320AS) is a small, piston-type air compressor, sized to provide the proper flow and pressure sufficient to power jet (pneumatic) nebulizers. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device.
When the compressor is used in conjunction with a therapeutic nebulizer set, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter.
The Besmed Nebulizer Set (Model No. PN-1128E) - (K091272) which has been under FDA clearance will be used with JLN-23XX Series Piston Compress Nebulizer.
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 or pediatric patients (4 years and older)
Intended User / Care Setting
home health care
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)
Discussion of Non-Clinical Tests Performed:
The performance requirements for the JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) were verified according to the following tests to make sure to be substantial Equivalent to the predicate device.
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) met the requirements of IEC 60601-1 and IEC 60601-1-2. These testes demonstrate the electrical safety and EMC protection of proposed devices meet the same standard as predicate device.
Laboratory testing, include noise tests, pressure tests and flowrate tests, were conducted to validate and verify that the JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) met all design specifications in various environments and was substantially equivalent to the predicate device.
The biocompatibility test were conducted on the JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) along to make sure the proposed device substantially equivalent to the predicate device in biological aspect.
Regard to product performance, the particle size distribution test via Cascade Impactor (conducted according EN13544-1) of the JLN-23XX Series Piston Compress Nebulizer (with models JLN-2317AS) with the nebulizer set (K091272) was performed in comparison to the predicate device (K020932) with three drugs (Ipratropium bromide, Ventolin, and Pulmicort). The test has shown the proposed device consistent regard to repeatability tests for each three classes of drug, and also demonstrated equivalent performance ability as the predicate device (K020932) that no significant difference in the particle distributions. The Proposed devices have same performance characteristics as the predicate device (K020932) and also meet its product specification as well.
Discussion of Clinical Tests Performed:
Not Applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol that resembles a stylized caduceus or a series of human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2017
Shenzhen Homed Medical Device Co., Ltd Shengming Shi Manager Of Technical Regulation Department No.2 Building, Longgu Industrial Zone, Longhua Town Shenzhen, 518109 CN
Re: K161586
Trade/Device Name: The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: August 4, 2017 Received: August 7, 2017
Dear Shengming Shi:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161586
Device Name
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2301AS, JLN-2317AS and JLN-2320AS)
Indications for Use (Describe)
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) include an AC powered air compressor that provides a source of compressed air for home health care use. The compressor is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatic patients (4 years and older).
| 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
K161586
510(K) SUMMARY
Submitter:
Shenzhen Homed Medical Device Co., Ltd. No.2 Building, Longgu Industrial Zone, Longhua Town, Shenzhen, Guangdong, 518109, CHINA
Contact Person: ●
Shengming Shi Manager of Technical Regulation Department Tel: 86-755-29821675-8011 Fax: 86-755-29821953 Email: shifei@homedgroup.com
Date Prepared: ●
Aug 30, 2017
Name of the Devices:
- Device Common Name: Nebulizer (direct patient interface)
- Device Proprietary Name: JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)
- Classification Name: Nebulizer (Direct Patient Interface)
- Regulation Number: 21CFR 868.5630 ●
- Product Code: CAF
- Review Panel: Anesthesiology
Legally Marketed Predicate Device(s):
K020932 Devilbiss Model 3655 Compressor/Nebulize
Indications for Use:
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS,
4
JLN-2301AS, JLN-2317AS and JLN-2320AS) include an AC powered air compressor that provides a source of compressed air for home health care use. The compressor is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients (4 years and older).
Reference Guidance:
- Guidance for Industry and FDA Staff Format for Traditional and Abbreviated ● 510(k)s
- Guidance for Industry and FDA Staff - The 510(k) Program Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
- Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators
Recognized Consensus Standard used
ISO 10993-1 : 2009
Biological evaluation of medical devices
IEC 60601-1: 2005 + A1: 2012
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2 : 2014
Medical electrical equipment - - Part 1-2: General requirements for basic safety and essential performance -Standard: Electromagnetic disturbances - -Collateral Requirements and tests
IEC 60601-1-11: 2010 + CORR.1: 2011
Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance --Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Device Description:
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) is designed and manufactured by Shenzhen Homed Medical Device Co., Ltd.
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS. JLN-2301AS, JLN-2317AS and JLN-2320AS) is a small, piston-type air compressor, sized to provide the proper flow and pressure sufficient to power jet (pneumatic)
5
nebulizers. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device.
When the compressor is used in conjunction with a therapeutic nebulizer set, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter.
The Besmed Nebulizer Set (Model No. PN-1128E) - (K091272) which has been under FDA clearance will be used with JLN-23XX Series Piston Compress Nebulizer.
Comparison to Predicate Devices:
The Substantial Equivalence Comparison Chat is provided as follows:
| Table1: Substantial Equivalence Comparison Chat | ||
|---|---|---|
| Descriptive Information | Proposed Device | Predicate Device |
| 510(K) Number | None | K020932 |
| Proprietary or Model Name | The JLN-23XX Series | |
| Piston Compress | ||
| Nebulizer (with models | ||
| JLN-2300AS, | ||
| JLN-2301AS, | ||
| JLN-2317AS and | ||
| JLN-2320AS) | Devilbiss Model 3655 | |
| Compressor/Nebulize | ||
| Indication for Use | The JLN-23XX Series | |
| Piston Compress | ||
| Nebulizer (with models | ||
| JLN-2300AS, | ||
| JLN-2301AS, | ||
| JLN-2317AS and | ||
| JLN-2320AS) include an | ||
| AC powered air | ||
| compressor that provides | ||
| a source of compressed | ||
| air for home health care | ||
| use. The compressor is | ||
| used in conjunction with a | ||
| jet (pneumatic) nebulizer | ||
| to convert certain | The DeVilbiss | |
| compressor / nebulizer | ||
| Model 3655 includes an | ||
| AC powered air | ||
| compressor that provides | ||
| a source of compressed | ||
| air for home health care | ||
| use. The compressor is | ||
| used in conjunction with a | ||
| jet (pneumatic) nebulizer | ||
| to convert certain | ||
| inhalable drugs into an | ||
| aerosol form for | ||
| inhalation by a patient. | ||
| The device can be used |
Table1: Substantial Equivalence Comparison Chat
6
| inhalable drugs into an | with adult or pediatric | |
|---|---|---|
| aerosol form for | patients. | |
| inhalation by a patient. | ||
| The device can be used | ||
| with adult or pediatric | ||
| patients (4 years and | ||
| older). | ||
| Compressor Type | Piston | Piston |
| Electrical Requirements | 120VAC, 60Hz | 115 VAC (±10%) 60 Hz |
| Power Consumption | 200VA | 140 watts maximum |
| Storage/Transport | ||
| Temperature Range | -25 to 70°C (-13 to 158°F) | -40° to +158°F (-40° to |
| +70°C) | ||
| Storage/Transport | ||
| Humidity | 10 - 95% | up to 95% |
| non-condensing | ||
| Operating Humidity | 10 - 95% non-condensing | up to 95% |
| non-condensing | ||
| Operating Temperature | ||
| Range | 10 to 40°C (50 to 104°F) | +40° to +104°F (+5 to |
| +40°C) | ||
| Compressor Flow (Free | ||
| flow) | 8LPM | 8 lpm |
| Max Pressure | 30 psig or greater / 206 | |
| Kpa | 35 psig (241 kPa) | |
| Operating Pressure Range | 30 psig or greater | / |
| Noise Level | below 63dBA | 58-62 dBA |
| Biocompatibility | Biocompatible | Biocompatible |
| Guidance | Reviewer Guidance for | |
| Nebulizers, Metered Dose | ||
| Inhalers, Spacers and | ||
| Actuators | Reviewer Guidance for | |
| Nebulizers, Metered Dose | ||
| Inhalers, Spacers and | ||
| Actuators |
Discussion of Non-Clinical Tests Performed:
The performance requirements for the JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) were verified according to the following tests to make sure to be substantial Equivalent to the predicate device.
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) met the requirements of IEC 60601-1 and IEC 60601-1-2. These testes demonstrate the electrical safety and EMC protection of proposed devices meet the same standard as predicate device.
7
Laboratory testing, include noise tests, pressure tests and flowrate tests, were conducted to validate and verify that the JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) met all design specifications in various environments and was substantially equivalent to the predicate device.
The biocompatibility test were conducted on the JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) along to make sure the proposed device substantially equivalent to the predicate device in biological aspect.
Regard to product performance, the particle size distribution test via Cascade Impactor (conducted according EN13544-1) of the JLN-23XX Series Piston Compress Nebulizer (with models JLN-2317AS) with the nebulizer set (K091272) was performed in comparison to the predicate device (K020932) with three drugs (Ipratropium bromide, Ventolin, and Pulmicort). The test has shown the proposed device consistent regard to repeatability tests for each three classes of drug, and also demonstrated equivalent performance ability as the predicate device (K020932) that no significant difference in the particle distributions. The Proposed devices have same performance characteristics as the predicate device (K020932) and also meet its product specification as well.
Discussion of Clinical Tests Performed:
Not Applicable.
Conclusions:
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) has the same intended use and similar characteristics as the predicate device. Moreover, bench testing contained in this submission demonstrates that the JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) is substantially equivalent to the predicate devices.