GUS831 Compressor Nebulizer

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below. May 1, 2020 Globalcare Medical Technology Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, Nanshan Medical device industrial park, Nanshan District Shenzhen, 518067 Cn Re: K192633 Trade/Device Name: GUS831 Compressor Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: April 22, 2020 Received: April 27, 2020 Dear Kevin Wang: 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 {1}------------------------------------------------ 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 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 (QS) 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 medical devices and radiation-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, James J. Lee Ph.D. Assistant Director DHT1C: Division of ENT, 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) K192633 Device Name GUS831 Compressor Nebulizer GUS831 compressor nebulizer is designed for the production of compressed air to operate a nebulizer kit for the production of medical aerosol for respiratory disorders. The nebulizer kit is intended for multiple use by single patient for single medication. GUS831 compressor nebulizer is intended for domestic use with children from 5 years old, adolescent and adult patients and requires the order of a physician for medical use. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> □ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | **CONTINUE ON A SEPARATE PAGE IF NEEDED.** 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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ # 510(K) Summary ### Prepared in accordance with the requirements of 21 CFR Part 807.92 Prepared Date: 2020/02/02 ## 1. Submission sponsor Name: Globalcare Medical Technology Co., Ltd. Address: 7th Building, 39 Middle Industrial Main Road, European Industrial Zone, Xiaolan Town, Zhongshan City, Guangdong Province, P.R. China Contact person: Janice Deng Title: Regulatory Officer E-mail: janice@globalcare.com.cn Tel: +86 760 22589901-608 #### 2. Submission correspondent Name: Chonconn Medical Device Consulting Co., Ltd. Address: No. A415, Block A, NanShan Medical devices Industrial Park Nanshan District, Shenzhen, Guangdong, P.R. China 518067 Contact person: Kevin Wang E-mail: kevin@chonconn.com Tel: +86-755 33941160 | Trade/Device Name | Compressor Nebulizer | |-------------------|-----------------------------------| | Model | GUS831 | | Common Name | Compressor Nebulizer | | Regulatory Class | Class II | | Classification | 21CFR §868.5630 / Nebulizer / CAF | | Submission type | Traditional 510(K) | #### Subject Device Information 3. #### 4. Predicate Device By submission of the Traditional 510(k), Globalcare Medical Technology Co., Ltd. is requesting clearance for Compressor Nebulizer. It is comparable to the following legally marketed system: 1. TaiDoc Technology Corporation, U-RIGHT Compressor Nebulizer under K121969. The subject device has same intended use, same target patient population, same performance effectiveness, performance safety as the predicate devices and no question is raised regarding to effectiveness and safety. So, the conclusion is that the subject device is substantial equivalent to the predicate. #### 5. Intended use & Indication for use GUS831 compressor nebulizer is designed for the production of compressed air to operate a nebulizer kit for the production of medical aerosol for respiratory disorders. The nebulizer kit is intended for multiple use by single patient for single medication. GUS831 compressor nebulizer is intended for domestic use with children from 5 years old, adolescent and adult patients and requires the order of a physician for medical use. #### Device Description 6. GUS831 Compressor Nebulizer is a portable aerosol nebulizer electronically powered by an external power {4}------------------------------------------------ adapter and by an internal rechargeable lithium polymer battery. The compressed air, created by the membrane pump of the device, flows into the nebulizer container kit. The air pressure forced the liquid through the nozzle where it is atomized against a plate within the container. The device is equipped with a mouthpiece to easily delivery the medical aerosol. #### 7. Principle of Operation This device operates on the Venturi principle. Compressed air is driven through a converging nozzle, where it accelerates and emerges at a high velocity, creating a vacuum (Venturi effect). The vacuum draws a liquid residing in a reservoir up through a cylindrical channel and into the emerging airstream formed by the nozzle, to mix with air and impact upon a rigid surface. This process uses energy from the airstream to convert liquid into small droplets called aerosol. Upon reaching the user aerosol is suitably refined to enter the lungs effectively. #### Comparison to the Predicate Device 8. The GUS831 Compressor Nebulizer and U-RIGHT Compressor Nebulizer (K121969), are identical in purpose, function, core technology and method of operation. Only minor differences exist between the GUS831 Compressor Nebulizer and predicate, which do not affect the safety or effectiveness of the subject device. Table 1 provides a comparison of the subject and predicate devices. | Features | Subject Device<br>GUS831 Compressor Nebulizer | Predicate Device<br>U-RIGHT Compressor Nebulizer | Comment | |-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | K number | K192633 | K121969 | / | | Indication for use | GUS831 compressor nebulizer is<br>designed for the production of<br>compressed air to operate a<br>nebulizer kit for the production of<br>medical aerosol for respiratory<br>disorders. The nebulizer kit is<br>intended for multiple use by single<br>patient for single medication.<br>GUS831 compressor nebulizer is<br>intended for domestic use with<br>children from 5 years old,<br>adolescent and adult patients and<br>requires the order of a physician for<br>medical use. | U-RIGHT Compressor Nebulizer,<br>model TD-7013/TD-7012, is<br>designed to provide a compressed<br>air source to aerosolize<br>physician-prescribed liquid<br>medication when used in<br>combination with the packaged<br>Nebulizer kit, except for<br>Pentamidine. The packaged<br>Nebulizer kit is intended for single<br>use by single patient. U-RIGHT<br>Compressor Nebulizer, model<br>TD-7013/TD-7012, is intended for<br>use with children, adolescents (5<br>years to 18 years old), and adult<br>patients in the homecare settings. | Substantially<br>equivalent | | Product Code | CAF | CAF | Same | | Regulation<br>number | 21 CFR §868.5630 | 21 CFR §868.5630 | Same | | Panel | Anesthesiology | Anesthesiology | Same | | Class | Class II | Class II | Same | | Use | Prescription Use | Prescription Use | Same | | Features | Subject Device<br>GUS831 Compressor Nebulizer | Predicate Device<br>U-RIGHT Compressor Nebulizer | Comment | | Target<br>Population | >5<br>years old | >2 years old | Same | | Environmental<br>Use | Home use | Homecare setting | Same | | Principle of<br>Operation | Compressor Air | Compressor Air | Same | | Power source | DC adaptor: 5Vd.c.,<br>Internal lithium polymer (Li-Pol)<br>battery: 3.7Vd.c., 2570 mAh | DC adaptor: 6Vd.c. | Substantially<br>equivalent | | Power<br>consumption | 10W | 6W | Difference has no<br>effect on safety or<br>effectiveness | | Compressor<br>pressure range<br>(only compressor) | 13 ~ 17 psi | 15 ~ 17 psi | Difference has no<br>effect on safety or<br>effectiveness | | Operating<br>pressure range<br>(with nebulizing<br>chamber) | 5.1 ~ 8 psi | 6 ~ 8 psi | Difference has no<br>effect on safety or<br>effectiveness | | Flow Rate | 4 ~ 6 LPM | 4 LPM Max. | Substantially<br>equivalent | | Noise Level | 45 dBA | 60 dBA | Difference has no<br>effect on safety or<br>effectiveness | | Mode of<br>operation | 30 mins on/ 30 mins off | 30 mins on/ 30 mins off | Same | | Nebulization<br>Rate (avg) | 0.25 ml/min | 0.25ml/min | Same | | Medication<br>capacity | 2ml ~ 6ml | 2ml ~ 6ml | Same | | User interface | On/Off switch<br>LED indicators | On/Off switch | Difference has no<br>effect on safety or<br>effectiveness | | Standards met | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11 | IEC 60601-1<br>IEC 60601-1-2 | Subject device<br>complies with<br>more recent<br>standards | | Patient contact /<br>anatomical site | Mouth | Mouth | Same | | Contact materials<br>per<br>ISO 10993-1 | External communicating<br>components with tissue contact | External communicating<br>components with tissue contact | Same | | Features | Subject Device<br>GUS831 Compressor Nebulizer | Predicate Device<br>U-RIGHT Compressor Nebulizer | Comment | | Biocompatibility<br>testing | Cytotoxicity (ISO 10993-5)<br>Irritation (ISO 10993-10)<br>Sensitization (ISO 10993-10)<br>Implantation (ISO 10993-6)<br>Genotoxicity (ISO 10993-3)<br>Gas pathways ISO 18562 | Cytotoxicity (ISO 10993-5)<br>Irritation (ISO 10993-10)<br>Sensitization (ISO 10993-10)<br>Implantation (ISO 10993-6)<br>Genotoxicity (ISO 10993-3) | Subject device<br>complies with<br>more recent<br>standards | | Dimensions (mm) | 68x45x110 | 125x115x46 | Difference has no<br>effect on safety or<br>effectiveness | | Weight (Kg) | 0.250 | 0.290 | Difference has no<br>effect on safety or<br>effectiveness | | Operating<br>conditions | 10-40°C<br>10-95% RH<br>700-1060 hPa | 10-40°C<br>30-85% RH<br>700-1060 hPa | Difference has no<br>effect on safety or<br>effectiveness | | Storage<br>conditions | -20-60°C<br>10-95% RH<br>700-1060 hPa | -25-70°C<br>10-95% RH<br>700-1060 hPa | Difference has no<br>effect on safety or<br>effectiveness | | Materials | Case: ABS<br>Medicine chamber: PC<br>Nozzle: PP<br>Mouthpiece: HDPE<br>Air tube: PVC | Case: ABS<br>Medicine chamber: PC<br>Nozzle: PP<br>Mouthpiece: HDPE<br>Air tube: PVC | Same | | Sterility | No | No | Same | | Reusable parts | Nebulizing chamber and<br>mouthpiece<br>Compressor and air tube | Compressor and air tube | Difference has no<br>effect on safety or<br>effectiveness | | Device Cleaning | Compressor: Soft dry cloth and<br>non-abrasive cleaners for the outer<br>case of the compressor<br>Kit: wash with soap and hot water<br>after each treatment | Compressor: Alcohol cotton swabs<br>for the outer casing of the compressor<br>Kit: wash with running water or soak<br>in warm water | Difference has no<br>effect on safety or<br>effectiveness | | Contraindications | None | Pentamidine | Difference has no<br>effect on safety or<br>effectiveness | | Device lifetime | 400 hours running time | 3 years | Difference has no<br>effect on safety or<br>effectiveness | | Features | Drug | Subject Device<br>GUS831 | Predicate Device<br>U-RIGHT | | Particle Characterization per Cascade Impactor @ 28 LPM | | | | | Particle Size (MMAD) | Albuterol Sulfate (2.5 mg/3 ml) | 2.64±0.35 | 3.87±0.31 | Table 1: Comparison to Predicate Device {5}------------------------------------------------ {6}------------------------------------------------ # 9. Device Testing Testing and equivalence analysis were performed to support the substantial equivalence determination. ## 9.1 Biocompatibility testing The biocompatibility evaluation for the GUS831 compressor nebulizer was conducted in accordance with the FDA Biocompatibility guidance, 2016 (Use of International Standard ISO 10993-1, "Biological {7}------------------------------------------------ evaluation of medical devices - Part 1: Evaluation and testing within a risk management process") and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. All the patient-contacting parts of the GUS831 compressor nebulizer are: Device: External Communicating (Indirect gas pathway) Tissue / Bone / Dentin communicating Duration of Use - permanent (> 30 days) Mouthpiece: Surface Contact Mucosal membrane Duration of Use - permanent (> 30 days) The GUS compressor nebulizer use an identical nebulizing kit to U-RIGHT TD-7013, which is already cleared under K121969. Mouthpiece and nebulizing bottle have same formulation and processing, and no other chemicals have been added (e.g., plasticizers, fillers, cleaning agents, mold, release agents etc.) so new issue regarding biological safety are not raised. Mouthpiece and nebulizer bottle tests were performed for K121969 clearance as external communicating components with tissue contact: - Cytotoxicity (ISO 10993-5) . - . Sensitization (ISO 10993-10) - . Irritation (ISO 10993-10) - . Genotoxicity (ISO 10993-3) - Implantation (ISO 10993-6) . ### 9.2 Biocompatibility evaluation of breathing gas pathways Additional testing pertaining to the gas pathway and associated risk assessments/conclusions were conducted according to the ISO 18562 family of standard by an independent source. Testing included the following assessments: - . Volatile Organic Compound Analysis (VOCs) - Emitted Particulate Gas Analysis (EPA PM2.5) . - . Leachables in condensate (metal ions and organic impurities) ### 9.3 Aerosol Characterization Aerosol characterization testing for the subject device and predicate device was 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). The particle size distribution test via Cascade Impactor of GUS831 Compressor Nebulizer was performed in comparison to the predicate device K121969 with three drugs (Albuterol sulfate, Ipratropium bromide, Cromolyn sodium). The test has shown almost all the performance parameters of the two different nebulizers were statistically identical for adult conditions and substantially equivalent in the therapeutic amount of medication delivered for pediatric conditions. The measured differences raise no new safety and efficacy issues; therefore, device equivalence is proved. ### ADULT CONDITIONS: {8}------------------------------------------------ | (μm) | Ipratropium Bromide (0.5 mg/2.5 ml) | 2.51±0.36 | 3.37±0.46 | |------------------------------------|-------------------------------------|-----------|-----------| | | Cromolyn Sodium (20 mg/2.0 ml) | 2.64±0.34 | 2.87±0.15 | | Geometric Standard Deviation | Albuterol Sulfate (2.5 mg/3 ml) | 3.32±0.57 | 3.77±0.48 | | | Ipratropium Bromide (0.5 mg/2.5 ml) | 3.59±0.48 | 4.14±0.25 | | | Cromolyn Sodium (20 mg/2.0 ml) | 3.37±0.70 | 3.70±0.55 | | Total Dose Delivered | Albuterol Sulfate (2.5 mg/3 ml) | 471±45 | 514±55 | | (µg) | Ipratropium Bromide (0.5 mg/2.5 ml) | 91±9 | 89±12 | | | Cromolyn Sodium (20 mg/2.0 ml) | 3286±383 | 2772±441 | | Total Respirable Dose (0.5-5 um) | Albuterol Sulfate (2.5 mg/3 ml) | 263±38 | 259±37 | | (µg) | Ipratropium Bromide (0.5 mg/2.5 ml) | 50±8 | 42±5 | | | Cromolyn Sodium (20 mg/2.0 ml) | 1913±328 | 1448±312 | | Coarse Particle Dose (>4.7 um) | Albuterol Sulfate (2.5 mg/3 ml) | 178±23 | 253±38 | | (µg) | Ipratropium Bromide (0.5 mg/2.5 ml) | 35±6 | 41±8 | | | Cromolyn Sodium (20 mg/2.0 ml) | 1268±316 | 1143±106 | | Fine Particle Dose (<4.7 um) | Albuterol Sulfate (2.5 mg/3 ml) | 293±45 | 261±17 | | (µg) | Ipratropium Bromide (0.5 mg/2.5 ml) | 56±7 | 48±4 | | | Cromolyn Sodium (20 mg/2.0 ml) | 2018±430 | 1628±338 | | Ultra-Fine Particle Dose (<1.0 um) | Albuterol Sulfate (2.5 mg/3 ml) | 87±23 | 56±33 | | (µg) | Ipratropium Bromide (0.5 mg/2.5 ml) | 20±3 | 17±3 | | | Cromolyn Sodium (20 mg/2.0 ml) | 687±133 | 540±80 | {9}------------------------------------------------ ## PEDIATRIC CONDITIONS: | Features | Drug | Subject Device<br>GUS831 | Predicate Device<br>U-RIGHT | |---------------------------------------------------------|-------------------------------------|--------------------------|-----------------------------| | Particle Characterization per Cascade Impactor @ 12 LPM | | | | | Particle Size (MMAD)<br>(μm) | Albuterol Sulfate (2.5 mg/3 ml) | 5.00±0.95 | 5.57±0.45 | | | Ipratropium Bromide (0.5 mg/2.5 ml) | 4.57±1.12 | 6.80±0.61 | | | Cromolyn Sodium (20 mg/2.0 ml) | 4.93±0.47 | 7.23±0.49 | | Geometric Standard Deviation | Albuterol Sulfate (2.5 mg/3 ml) | 3.00±0.07 | 3.90±0.29 | | | Ipratropium Bromide (0.5 mg/2.5 ml) | 3.42±0.09 | 3.74±0.24 | | | Cromolyn Sodium (20 mg/2.0 ml) | 4.35±0.62 | 3.63±0.79 | | Total Dose Delivered<br>(µg) | Albuterol Sulfate (2.5 mg/3 ml) | 1106±53 | 1148±69 | | | Ipratropium Bromide (0.5 mg/2.5 ml) | 221±26 | 232±11 | | | Cromolyn Sodium (20 mg/2.0 ml) | 5523±154 | 6633±595 | | Total Respirable Dose (0.5-5 um)<br>(µg) | Albuterol Sulfate (2.5 mg/3 ml) | 541±93 | 423±15 | | | Ipratropium Bromide (0.5 mg/2.5 ml) | 103±19 | 79±5 | | | Cromolyn Sodium (20 mg/2.0 ml) | 2370±132 | 2263±207 | | Coarse Particle Dose (>4.7 um)<br>(µg) | Albuterol Sulfate (2.5 mg/3 ml) | 576±36 | 701±107 | | | Ipratropium Bromide (0.5 mg/2.5 ml) | 113±27 | 152±8 | | | Cromolyn Sodium (20 mg/2.0 ml) | 2920±113 | 4343±426 | | Fine Particle Dose (<4.7 um)<br>(µg) | Albuterol Sulfate (2.5 mg/3 ml) | 531±88 | 447±39 | | | Ipratropium Bromide (0.5 mg/2.5 ml) | 108±32 | 80±2 | | | Cromolyn Sodium (20 mg/2.0 ml) | 2603±111 | 2290±478 | | Ultra-Fine Particle Dose (<1.0 um)<br>(µg) | Albuterol Sulfate (2.5 mg/3 ml) | 80±26 | 51±4 | | | Ipratropium Bromide (0.5 mg/2.5 ml) | 17±5 | 17±3 | | | Cromolyn Sodium (20 mg/2.0 ml) | 737±51 | 571±161 | ### 10. Conclusion It has been shown in this 510(k) submission that the difference between the proposed devices and the predicate devices do not raise any questions regarding safety and effectiveness. Performance testing and compliance with voluntary standards demonstrate that the proposed are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, of operation, biocompatibility, performance characteristics, and intended use.