(343 days)
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
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.
The Weikang Disposable Nebulizer Set is a light weight 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.
This FDA 510(k) summary describes the Suzhou Weikang Medical Apparatus Co., Ltd Disposable Nebulizer Set (K140237). It is a premarket notification for a medical device, which means the device is being compared to existing legally marketed predicate devices to show "substantial equivalence."
Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document establishes substantial equivalence by comparing the proposed device's performance attributes to two predicate devices: Headstar Medical Small Volume Jet Nebulizer (K121770) and Miller (VixOne) (K926055). The acceptance criteria are implicit in the performance characteristics of the predicate devices. The proposed device aims to meet or be comparable to these established performance levels.
| Attribute | Predicate Device (Miller - K926055) | Proposed Device (Suzhou Weikang - K140237) | Acceptance Criteria (Implied) | Does it meet? |
|---|---|---|---|---|
| Intended 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. | Similar intended use for administering aerosol treatments. | Yes (for adult patients in hospital settings) |
| Mechanism | Pneumatic (gas powered) jet nebulizer | Air compressor | Similar mechanism for aerosol generation. | Yes (both use compressed air) |
| Raw materials | Unknown | Nebulizer Bottle: PP, Mouth Piece: PP, Oxygen Tubing: PVC, Corrugated Tubing: PVC, CPA: PP | Biocompatible materials, suitable for medical use. | Yes (material specifications provided) |
| Sterilization | EO | EO | Sterilization method is equivalent. | Yes |
| Population | Adult and pediatric patients | Asthma Patient, adult patient | Subset of predicate population (adult patients). | Yes (meets for adult patients) |
| Anatomic site | Mouth | Mouth | Same route of administration. | Yes |
| Environment of Use | Home or hospital | Hospital | Subset of predicate environment. | Yes (meets hospital environment) |
| Flow rate | 6-8 l/min | 4-8 l/min | Overlap in flow rate range. | Yes |
| Air pressure (Kpa) | Unknown | 700 | Comparable if within acceptable therapeutic range. | Yes (value provided and presumably acceptable) |
| Total dose delivered by device (µg) | Albuterol sulfate: 1557±113; Ipratropium bromide: 276±5; Cromolyn sodium: 6227±945 | Albuterol sulfate: 1483±46; Ipratropium bromide: 284±8; Cromolyn sodium: 6387±361 | Values are similar and within acceptable manufacturing/therapeutic variation. | Yes |
| Particle size (MMAD) (µm) | 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 | Values are similar and within acceptable therapeutic range for aerosol delivery. | Yes |
| Geometric standard deviation | 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 | Values are similar. | Yes |
| Total respirable dose (0.5-5 µm) (µg) | Albuterol sulfate: 786±63; Ipratropium bromide: 146±9; Cromolyn sodium: 4001±506 | Albuterol sulfate: 737±22; Ipratropium bromide: 141±13; Cromolyn sodium: 4075±320 | Values are similar and within acceptable therapeutic range. | Yes |
| Biocompatibility | ISO 10993-5 and ISO 10993-10 | ISO 10993-5 and ISO 10993-10 | Meets specified international standards for biocompatibility. | Yes |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state a "test set" in the context of an AI/algorithm study. Instead, the "testing" involves a series of non-clinical studies (performance bench testing and biocompatibility testing) to demonstrate that the new device has "similar performance characteristics and technological characteristics" to the predicate devices.
- Sample Size for performance testing (Total Dose, Particle Size, Respirable Dose): Not explicitly stated in terms of number of runs or units tested, but numerical results with standard deviations are provided, implying multiple measurements were taken for each parameter.
- Data Provenance: The data appears to be prospective in the sense that it was generated by Suzhou Weikang Medical Apparatus Co., Ltd specifically for this 510(k) submission, comparing their new device's performance to the predicate devices. The country of origin for the testing itself is not explicitly stated, but the manufacturer is based in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable to this document. The device is a medical apparatus (a nebulizer), not an AI algorithm. Therefore, there's no "ground truth" established by experts in the context of diagnostic interpretation or AI model validation. The ground truth for performance measures (e.g., total dose, particle size) is physical measurement against established laboratory standards.
4. Adjudication method for the test set:
This is not applicable as there is no diagnostic image/data interpretation by experts that would require an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a nebulizer, a physical medical apparatus, not an AI-powered diagnostic tool requiring human-in-the-loop performance studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is not an algorithm.
7. The type of ground truth used:
For the performance characteristics (e.g., total dose, particle size, respirable dose), the "ground truth" is established through physical measurements and adherence to recognized scientific and engineering principles for nebulizer performance testing. For biocompatibility and sterilization, the ground truth is established by compliance with international standards (ISO 10993 series and ISO 11135-1).
8. The sample size for the training set:
This is not applicable. There is no AI/machine learning model, and thus no "training set."
9. How the ground truth for the training set was established:
This is not applicable as there is no AI/machine learning model.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a series of non-clinical bench tests and compliance assessments described under "Summary of Non-Clinical studies". These studies evaluate the physical and material characteristics of the Suzhou Weikang Disposable Nebulizer Set.
- Biocompatibility: The device was tested for biocompatibility according to ISO 10993-5 (In vitro cytotoxicity) and ISO 10993-10 (Irritation and skin sensitization), and also complies generally with ISO 10993-1.
- Sterilization: The sterilization process (Ethylene Oxide) complies with ISO 11135-1, and residual ethylene oxide levels comply with ISO 10993-7.
- Performance Testing: The device's performance characteristics, such as total dose delivered, particle size (MMAD), geometric standard deviation, and total respirable dose for specific medications (Albuterol sulfate, Ipratropium bromide, Cromolyn sodium), were measured and compared to the values reported for the predicate device (Miller/VixOne K926055). The results showed comparable performance, demonstrating substantial equivalence in key therapeutic delivery metrics.
- Other characteristics: Manufacturing materials, intended use, mechanism, target population, anatomic site, environment of use, flow rate, and air pressure were also compared to the predicate devices and found to be sufficiently similar or equivalent.
The conclusion is that based on these non-clinical studies and comparisons, the proposed device is "Substantially Equivalent" (SE) to the legally marketed predicate devices, implying it is as safe and effective. No clinical studies were required to support this claim of substantial equivalence.
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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.
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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
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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)
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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., LtdAdd: No. 89, Wangmi Street, Jianlin Road, Suzhou New District,Suzhou, 215129 CHINA |
| Primary Contact Person: | Mike GuRegulatory ManagerGuangzhou Osmunda Medical Device Consulting Co., LtdTel: +86-20-62321333Fax: +86-20-86330253 |
| Secondary Contact Person: | Wu WenheQuality DirectorSuzhou Weikang Medical Apparatus Co., LtdTel: + 86-512-66627328Fax: +86-512-66650996 |
| Device Trade Name: | Disposable Nebulizer Set |
| Common/Usual Name: | Nebulizer |
| Classification Name:Product Code: | Nebulizer 21CFR 868.5630CAF |
| Predicate Device(s): | Headstar Medical Small Volume Jet Nebulizer K121770;Miller (VixOne) K926055 |
| Device Description: | The disposal nebulizer set is designed and manufactured bySUZHOU WEIKANG MEDICAL APPARATUS CO., LTD. Thedisposal nebulizer sets are made of PVC; they are suppliedas sterile. It is for single use for less than 24 hourscumulative use. The nebulizer set consists of a hollow tubeconnected to a nebulizer jar/bottle, which holds the liquidmedication; a compressed gas source respiratory sizeaerosolized liquids into gasses that are delivered directly tothe patient for breathing. |
| Intended Use: | The disposal nebulizer set is used to administer variousaerosol treatments to adult patients in hospitalenvironments. It is not intended for transport use. It isintended for adult patients consistent with the indicationsfor the aerosol medication The Disposable Nebulizer Set is |
for single use for less than 24 hours cumulative use
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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 MEDICALPRODUCTS CO., LTD | WARREN C.MILLER | SUZHOUWEIKANGMEDICALAPPARATUS CO.,LTD |
| Product | Headstar Medical SmallVolume Jet Nebulizer | Miller (VixOne) | DisposableNebulizer Set |
| 510(k) Number | K121770 | K926055 | / |
| Intended use | The Headstar medicalSmallVolumeJetnebulizercreatesrespiratory mist out ofthe drug and is used toadministervariousaerosol treatments toadult andpediatricpatients in homecareandhospitalenvironments. It is notintended for transportuse. | Ahandheld,pneumaticnebulizer designedtoaerosolizeprescription drugsfor inhalation by apatient. Its use isindicatedwheneverahealthcareprofessionaladministersorprescribes medicalaerosol productsto a patient using asmallvolumenebulizer | Thedisposalnebulizer set isusedtoadministervarious aerosoltreatmentstoadult patients inhospitalenvironments. Itis not intendedfor transport use. |
| Mechanism | Air compressor | Pneumatic (gaspowered) jetnebulizer | Air compressor |
| Raw materials | Nebulizer Bottle: PSMouth Piece: PPOxygen Tubing: PVCCorrugated Tubing: EVACPA: PP | Unknown | Nebulizer Bottle:PPMouth Piece: PPOxygen Tubing:PVCCorrugatedTubing: PVCСРА: РР |
| Sterilization | EO | EO | EO |
| Population | Asthma Patient, adultand pediatric patients | Adult and pediatricpatients | 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:
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| Applicablestandard | ||
|---|---|---|
| ISO 10993-1ISO 10993-5ISO 10993-10ISO 11135-1ISO 10993-7 | ISO 10993-1Fourth Edition:2009 ISO 10993-5Third Edition:2009 ISO 10993-10 Third Edition:2010ISO 11135-1Second Edition:2007 Part 1ISO 10993-7Second Edition2008-10-15 | |
| Guidance | ||
| REVIEWER GUIDANCE FORNEBULIZER,METERED DOSEINHALERS, SPACERSAND ACTUATORS | REVIEWERGUIDANCE FORNEBULIZER,METERED DOSEINHALERS,SPACERS ANDACTUATORS | REVIEWER GUIDANCE FORNEBULIZER,METERED DOSEINHALERS,SPACERS ANDACTUATORS |
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.
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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).
§ 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).