(343 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on the mechanical process of nebulization.
Yes
The device is a nebulizer set used to administer aerosol treatments, which are therapeutic in nature for adult patients in hospital environments.
No
The text describes a disposable nebulizer set used to administer aerosol treatments, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical nebulizer set made of PVC, including a hollow tube, nebulizer jar/bottle, and relies on a compressed gas source. This indicates it is a hardware device, not software-only.
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 (medications) to patients. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details how the device converts liquid medication into an aerosol for inhalation. This is a drug delivery mechanism.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a patient's health status, which is the core function of an IVD.
IVD devices are used to perform tests in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions. This nebulizer set operates in vivo (within the body) by delivering medication.
N/A
Intended Use / Indications for Use
The disposable nebulizer set is used to administer various aerosol treatments to adult patients in hospital environments. It is not intended for transport use. The Disposable Nebulizer Set is for less than 24 hours cumulative use. The disposal nebulizer set is used to administer various aerosol treatments to adult patients in hospital environments. It is not intended for transport use. It is intended for adult patients consistent with the indications for the aerosol medication The Disposable Nebulizer Set is for single use for less than 24 hours cumulative use
Product codes
CAF
Device Description
The disposal nebulizer set is designed and manufactured by SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD. The disposal nebulizer sets are made of PVC; they are supplied as sterile. It is for single use for less than 24 hours cumulative use. The nebulizer set consists of a hollow tube connected to a nebulizer jar/bottle, which holds the liquid medication; a compressed gas source respiratory size aerosolized liquids into gasses that are delivered directly to the patient for breathing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth
Indicated Patient Age Range
adult patients
Intended User / Care Setting
hospital environments.
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)
Summary of Non-Clinical studies: The nebulizer complies with voluntary standards as following: 1. ISO 10993-1 Fourth Edition: 2009 Biological evaluation of medical devices Part 1: Evaluation and testing within the risk management process 2. ISO 10993-5 Third Edition: 2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity 3. ISO 10993-10 Third Edition: 2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization 4. ISO 11135-1 Second Edition: 2007 Sterilization of health care products —Ethylene oxide —Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices 5. ISO 10993-7 Second Edition 2008-10-15, Biological Evaluation Of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals Summary of Clinical Tests: The subject of this premarket submission, disposal nebulizer set, did not require clinical studies to support substantial equivalence. The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the subject device is determined as safe and effectiveness.
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
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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure with three faces in profile, suggesting a sense of community and care.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8, 2015
Suzhou Weikang Medical Apparatus Co., Ltd. c/o Mr. Mike Gu Regulatory Affairs Manager OSMUNDA Medical Device Consulting Co., Ltd. 7th Floor, Jingui Business Building N0. 982 Congyun Rd., Baiyun District Guangzhou, Guangdong CHINA 510420
Re: K140237 Trade/Device Name: Disposable Nebulizer Set Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: Class II Product Code: CAF Dated: December 4, 2014 Received: December 8, 2014
Dear Mr. Gu:
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.
1
Page 2 - Mr. Gu
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 (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.
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/Resourcesfor You/Industry/default.htm. 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 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,
Teiashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Denuty Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140237
Device Name Disposal nebulizer set
Indications for Use (Describe)
The disposable nebulizer set is used to administer various aerosol treatments to adult patients in hospital environments. It is not intended for transport use. The Disposable Nebulizer Set is for less than 24 hours cumulative use.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | Jan 21,2014 |
|---|---|
| Submitter: | Suzhou Weikang Medical Apparatus Co., Ltd |
| Add: No. 89, Wangmi Street, Jianlin Road, Suzhou New District, | |
| Suzhou, 215129 CHINA | |
| Primary Contact Person: | Mike Gu |
| Regulatory Manager | |
| Guangzhou Osmunda Medical Device Consulting Co., Ltd | |
| Tel: +86-20-62321333 | |
| Fax: +86-20-86330253 | |
| Secondary Contact Person: | Wu Wenhe |
| Quality Director | |
| Suzhou Weikang Medical Apparatus Co., Ltd | |
| Tel: + 86-512-66627328 | |
| Fax: +86-512-66650996 | |
| Device Trade Name: | Disposable Nebulizer Set |
| Common/Usual Name: | Nebulizer |
| Classification Name: | |
| Product Code: | Nebulizer 21CFR 868.5630 |
| CAF | |
| Predicate Device(s): | Headstar Medical Small Volume Jet Nebulizer K121770; |
| Miller (VixOne) K926055 | |
| Device Description: | The disposal nebulizer set is designed and manufactured by |
| SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD. The | |
| disposal nebulizer sets are made of PVC; they are supplied | |
| as sterile. It is for single use for less than 24 hours | |
| cumulative use. The nebulizer set consists of a hollow tube | |
| connected to a nebulizer jar/bottle, which holds the liquid | |
| medication; a compressed gas source respiratory size | |
| aerosolized liquids into gasses that are delivered directly to | |
| the patient for breathing. | |
| Intended Use: | The disposal nebulizer set is used to administer various |
| aerosol treatments to adult patients in hospital | |
| environments. It is not intended for transport use. It is | |
| intended for adult patients consistent with the indications | |
| for the aerosol medication The Disposable Nebulizer Set is |
for single use for less than 24 hours cumulative use
4
The Weikang Disposable Nebulizer Set is a light weight Technology: portable aerosol Nebulizer which uses a compressor that causes compressed air to flow at high velocity through a liquid medicine to turn it into an aerosol which is inhaled by the patient.
| Attributes | Predicate Device | Predicate Device | Proposed Device |
|---|---|---|---|
| Manufacturer | HEADSTAR MEDICAL | ||
| PRODUCTS CO., LTD | WARREN C. | ||
| MILLER | SUZHOU | ||
| WEIKANG | |||
| MEDICAL | |||
| APPARATUS CO., | |||
| LTD | |||
| Product | Headstar Medical Small | ||
| Volume Jet Nebulizer | Miller (VixOne) | Disposable | |
| Nebulizer Set | |||
| 510(k) Number | K121770 | K926055 | / |
| Intended use | The Headstar medical | ||
| Small | |||
| Volume | |||
| Jet | |||
| nebulizer | |||
| creates | |||
| respiratory mist out of | |||
| the drug and is used to | |||
| administer | |||
| various | |||
| aerosol treatments to | |||
| adult and | |||
| pediatric | |||
| patients in homecare | |||
| and | |||
| hospital | |||
| environments. It is not | |||
| intended for transport | |||
| use. | A | ||
| handheld, | |||
| pneumatic | |||
| nebulizer designed | |||
| to | |||
| aerosolize | |||
| prescription drugs | |||
| for inhalation by a | |||
| patient. Its use is | |||
| indicated | |||
| whenever | |||
| a | |||
| healthcare | |||
| professional | |||
| administers | |||
| or | |||
| prescribes medical | |||
| aerosol products | |||
| to a patient using a | |||
| small | |||
| volume | |||
| nebulizer | The | ||
| disposal | |||
| nebulizer set is | |||
| used | |||
| to | |||
| administer | |||
| various aerosol | |||
| treatments | |||
| to | |||
| adult patients in | |||
| hospital | |||
| environments. It | |||
| is not intended | |||
| for transport use. | |||
| Mechanism | Air compressor | Pneumatic (gas | |
| powered) jet | |||
| nebulizer | Air compressor | ||
| Raw materials | Nebulizer Bottle: PS | ||
| Mouth Piece: PP | |||
| Oxygen Tubing: PVC | |||
| Corrugated Tubing: EVA | |||
| CPA: PP | Unknown | Nebulizer Bottle: | |
| PP | |||
| Mouth Piece: PP | |||
| Oxygen Tubing: | |||
| PVC | |||
| Corrugated | |||
| Tubing: PVC | |||
| СРА: РР | |||
| Sterilization | EO | EO | EO |
| Population | Asthma Patient, adult | ||
| and pediatric patients | Adult and pediatric | ||
| patients | Asthma Patient, | ||
| adult patient | |||
| Anatomic site | Mouth | Mouth | Mouth |
| Environment of Use | Home or hospital | Home or hospital | hospital |
| Flow rate | 4-8 l/min | 6-8 l/min | 4-8 l/min |
| Air pressure (Kpa) | 700 | Unknown | 700 |
| Total dose delivered by device (µg) | Unknown | Albuterol sulfate: | |
| 1557±113; | |||
| Ipratropium bromide: 276±5; | |||
| Cromolyn sodium: 6227±945 | Albuterol sulfate: | ||
| 1483±46; | |||
| Ipratropium bromide: 284±8; | |||
| Cromolyn sodium: 6387±361 | |||
| Particle size (MMAD) (µm) | Unknown | Albuterol sulfate: 2.1; | |
| Ipratropium bromide: 1.53±0.06; | |||
| Cromolyn sodium: 1.97±0.06 | Albuterol sulfate: 2±0.1; | ||
| Ipratropium bromide: 1.5±0.13; | |||
| Cromolyn sodium: 2.2±0.33 | |||
| Geometric standard deviation | Unknown | Albuterol sulfate: 3.33±0.48; | |
| Ipratropium bromide: 3.45±1.23; | |||
| Cromolyn sodium: 2.88±0.33 | Albuterol sulfate: 3.28±0.28; | ||
| Ipratropium bromide: 3.13±0.3; | |||
| Cromolyn sodium: 2.59±0.58 | |||
| Total respirable dose (0.5-5 µm) (µg) | Unknown | Albuterol sulfate: 786±63; | |
| Ipratropium bromide: 146±9; | |||
| Cromolyn sodium: 4001±506 | Albuterol sulfate: 737±22; | ||
| Ipratropium bromide: 141±13; | |||
| Cromolyn sodium: 4075±320 | |||
| Biocompatibility | ISO 10993-5 and ISO 10993-10 | Unknown | ISO 10993-5 and ISO 10993-10 |
Summary of Non-Clinical studies:
Determination of
Substantial Equivalence:
5
6
| Applicable
| standard | ||
|---|---|---|
| ISO 10993-1 | ||
| ISO 10993-5 | ||
| ISO 10993-10 | ||
| ISO 11135-1 | ||
| ISO 10993-7 | ISO 10993-1 | |
| Fourth Edition: | ||
| 2009 ISO 10993-5 | ||
| Third Edition: | ||
| 2009 ISO 10993- | ||
| 10 Third Edition: | ||
| 2010 | ||
| ISO 11135-1 | ||
| Second Edition: | ||
| 2007 Part 1 | ||
| ISO 10993-7 | ||
| Second Edition | ||
| 2008-10-15 | ||
| Guidance | ||
| REVIEWER GUIDANCE FOR | ||
| NEBULIZER, | ||
| METERED DOSE | ||
| INHALERS, SPACERS | ||
| AND ACTUATORS | REVIEWER | |
| GUIDANCE FOR | ||
| NEBULIZER, | ||
| METERED DOSE | ||
| INHALERS, | ||
| SPACERS AND | ||
| ACTUATORS | REVIEWER GUIDANCE FOR | |
| NEBULIZER, | ||
| METERED DOSE | ||
| INHALERS, | ||
| SPACERS AND | ||
| ACTUATORS |
The nebulizer complies with voluntary standards as following:
-
- ISO 10993-1 Fourth Edition: 2009 Biological evaluation of medical devices Part 1: Evaluation and testing within the risk management process
-
- ISO 10993-5 Third Edition: 2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
-
- ISO 10993-10 Third Edition: 2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
-
- ISO 11135-1 Second Edition: 2007 Sterilization of health care products —Ethylene oxide —Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
-
- ISO 10993-7 Second Edition 2008-10-15, Biological Evaluation Of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
Summary of Clinical Tests:
The subject of this premarket submission, disposal nebulizer set, did not require clinical studies to support substantial equivalence.
The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device.
Therefore, the subject device is determined as safe and effectiveness.
7
Refer to the section 12 for further information.
- Conclusion: Suzhou Weikang Medical Apparatus Co., Ltd Considers the Disposable Nebulizer Set to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).