(221 days)
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.
GUS831 Compressor Nebulizer is a portable aerosol nebulizer electronically powered by an external power 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.
Here's a breakdown of the acceptance criteria and study information for the GUS831 Compressor Nebulizer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device (U-RIGHT Compressor Nebulizer, K121969) rather than explicitly stating pre-defined acceptance criteria with pass/fail thresholds against a specific standard for all performance parameters. However, the aerosol characterization section presents quantitative data for both the subject and predicate devices, implying those values serve as comparative criteria.
Note: The "acceptance criteria" here are implicitly defined by the predicate device's performance, with the goal being "statistically identical" or "substantially equivalent" performance.
| Performance Parameter | Test Condition | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (GUS831) | Conclusion on Meeting Acceptance Criteria |
|---|---|---|---|---|
| Aerosol Characterization (Adult Conditions @ 28 LPM) | ||||
| Particle Size (MMAD) Albuterol Sulfate (2.5 mg/3 ml) | Adult @ 28 LPM | 3.87±0.31 µm | 2.64±0.35 µm | Substantially Equivalent (implicitly) |
| Particle Size (MMAD) Ipratropium Bromide (0.5 mg/2.5 ml) | Adult @ 28 LPM | 3.37±0.46 µm | 2.51±0.36 µm | Substantially Equivalent (implicitly) |
| Particle Size (MMAD) Cromolyn Sodium (20 mg/2.0 ml) | Adult @ 28 LPM | 2.87±0.15 µm | 2.64±0.34 µm | Substantially Equivalent (implicitly) |
| Geometric Standard Deviation Albuterol Sulfate (2.5 mg/3 ml) | Adult @ 28 LPM | 3.77±0.48 | 3.32±0.57 | Substantially Equivalent (implicitly) |
| Geometric Standard Deviation Ipratropium Bromide (0.5 mg/2.5 ml) | Adult @ 28 LPM | 4.14±0.25 | 3.59±0.48 | Substantially Equivalent (implicitly) |
| Geometric Standard Deviation Cromolyn Sodium (20 mg/2.0 ml) | Adult @ 28 LPM | 3.70±0.55 | 3.37±0.70 | Substantially Equivalent (implicitly) |
| Total Dose Delivered Albuterol Sulfate (2.5 mg/3 ml) | Adult @ 28 LPM | 514±55 µg | 471±45 µg | Substantially Equivalent (implicitly) |
| Total Dose Delivered Ipratropium Bromide (0.5 mg/2.5 ml) | Adult @ 28 LPM | 89±12 µg | 91±9 µg | Substantially Equivalent (implicitly) |
| Total Dose Delivered Cromolyn Sodium (20 mg/2.0 ml) | Adult @ 28 LPM | 2772±441 µg | 3286±383 µg | Substantially Equivalent (implicitly) |
| Total Respirable Dose (0.5-5 um) Albuterol Sulfate | Adult @ 28 LPM | 259±37 µg | 263±38 µg | Substantially Equivalent (implicitly) |
| Total Respirable Dose (0.5-5 um) Ipratropium Bromide | Adult @ 28 LPM | 42±5 µg | 50±8 µg | Substantially Equivalent (implicitly) |
| Total Respirable Dose (0.5-5 um) Cromolyn Sodium | Adult @ 28 LPM | 1448±312 µg | 1913±328 µg | Substantially Equivalent (implicitly) |
| Coarse Particle Dose (>4.7 um) Albuterol Sulfate | Adult @ 28 LPM | 253±38 µg | 178±23 µg | Substantially Equivalent (implicitly) |
| Coarse Particle Dose (>4.7 um) Ipratropium Bromide | Adult @ 28 LPM | 41±8 µg | 35±6 µg | Substantially Equivalent (implicitly) |
| Coarse Particle Dose (>4.7 um) Cromolyn Sodium | Adult @ 28 LPM | 1143±106 µg | 1268±316 µg | Substantially Equivalent (implicitly) |
| Fine Particle Dose (<4.7 um) Albuterol Sulfate | Adult @ 28 LPM | 261±17 µg | 293±45 µg | Substantially Equivalent (implicitly) |
| Fine Particle Dose (<4.7 um) Ipratropium Bromide | Adult @ 28 LPM | 48±4 µg | 56±7 µg | Substantially Equivalent (implicitly) |
| Fine Particle Dose (<4.7 um) Cromolyn Sodium | Adult @ 28 LPM | 1628±338 µg | 2018±430 µg | Substantially Equivalent (implicitly) |
| Ultra-Fine Particle Dose (<1.0 um) Albuterol Sulfate | Adult @ 28 LPM | 56±33 µg | 87±23 µg | Substantially Equivalent (implicitly) |
| Ultra-Fine Particle Dose (<1.0 um) Ipratropium Bromide | Adult @ 28 LPM | 17±3 µg | 20±3 µg | Substantially Equivalent (implicitly) |
| Ultra-Fine Particle Dose (<1.0 um) Cromolyn Sodium | Adult @ 28 LPM | 540±80 µg | 687±133 µg | Substantially Equivalent (implicitly) |
| Aerosol Characterization (Pediatric Conditions @ 12 LPM) | ||||
| Particle Size (MMAD) Albuterol Sulfate (2.5 mg/3 ml) | Pediatric @ 12 LPM | 5.57±0.45 µm | 5.00±0.95 µm | Substantially Equivalent (implicitly) |
| Particle Size (MMAD) Ipratropium Bromide (0.5 mg/2.5 ml) | Pediatric @ 12 LPM | 6.80±0.61 µm | 4.57±1.12 µm | Substantially Equivalent (implicitly) |
| Particle Size (MMAD) Cromolyn Sodium (20 mg/2.0 ml) | Pediatric @ 12 LPM | 7.23±0.49 µm | 4.93±0.47 µm | Substantially Equivalent (implicitly) |
| Geometric Standard Deviation Albuterol Sulfate (2.5 mg/3 ml) | Pediatric @ 12 LPM | 3.90±0.29 | 3.00±0.07 | Substantially Equivalent (implicitly) |
| Geometric Standard Deviation Ipratropium Bromide (0.5 mg/2.5 ml) | Pediatric @ 12 LPM | 3.74±0.24 | 3.42±0.09 | Substantially Equivalent (implicitly) |
| Geometric Standard Deviation Cromolyn Sodium (20 mg/2.0 ml) | Pediatric @ 12 LPM | 3.63±0.79 | 4.35±0.62 | Substantially Equivalent (implicitly) |
| Total Dose Delivered Albuterol Sulfate (2.5 mg/3 ml) | Pediatric @ 12 LPM | 1148±69 µg | 1106±53 µg | Substantially Equivalent (implicitly) |
| Total Dose Delivered Ipratropium Bromide (0.5 mg/2.5 ml) | Pediatric @ 12 LPM | 232±11 µg | 221±26 µg | Substantially Equivalent (implicitly) |
| Total Dose Delivered Cromolyn Sodium (20 mg/2.0 ml) | Pediatric @ 12 LPM | 6633±595 µg | 5523±154 µg | Substantially Equivalent (implicitly) |
| Total Respirable Dose (0.5-5 um) Albuterol Sulfate | Pediatric @ 12 LPM | 423±15 µg | 541±93 µg | Substantially Equivalent (implicitly) |
| Total Respirable Dose (0.5-5 um) Ipratropium Bromide | Pediatric @ 12 LPM | 79±5 µg | 103±19 µg | Substantially Equivalent (implicitly) |
| Total Respirable Dose (0.5-5 um) Cromolyn Sodium | Pediatric @ 12 LPM | 2263±207 µg | 2370±132 µg | Substantially Equivalent (implicitly) |
| Coarse Particle Dose (>4.7 um) Albuterol Sulfate | Pediatric @ 12 LPM | 701±107 µg | 576±36 µg | Substantially Equivalent (implicitly) |
| Coarse Particle Dose (>4.7 um) Ipratropium Bromide | Pediatric @ 12 LPM | 152±8 µg | 113±27 µg | Substantially Equivalent (implicitly) |
| Coarse Particle Dose (>4.7 um) Cromolyn Sodium | Pediatric @ 12 LPM | 4343±426 µg | 2920±113 µg | Substantially Equivalent (implicitly) |
| Fine Particle Dose (<4.7 um) Albuterol Sulfate | Pediatric @ 12 LPM | 447±39 µg | 531±88 µg | Substantially Equivalent (implicitly) |
| Fine Particle Dose (<4.7 um) Ipratropium Bromide | Pediatric @ 12 LPM | 80±2 µg | 108±32 µg | Substantially Equivalent (implicitly) |
| Fine Particle Dose (<4.7 um) Cromolyn Sodium | Pediatric @ 12 LPM | 2290±478 µg | 2603±111 µg | Substantially Equivalent (implicitly) |
| Ultra-Fine Particle Dose (<1.0 um) Albuterol Sulfate | Pediatric @ 12 LPM | 51±4 µg | 80±26 µg | Substantially Equivalent (implicitly) |
| Ultra-Fine Particle Dose (<1.0 um) Ipratropium Bromide | Pediatric @ 12 LPM | 17±3 µg | 17±5 µg | Substantially Equivalent (implicitly) |
| Ultra-Fine Particle Dose (<1.0 um) Cromolyn Sodium | Pediatric @ 12 LPM | 571±161 µg | 737±51 µg | Substantially Equivalent (implicitly) |
Overall Conclusion: The document states that "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."
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify the exact numerical sample size for the aerosol characterization testing (e.g., number of nebulizers tested, number of runs per condition). It reports mean and standard deviation, implying replicate measurements were performed.
- Data Provenance: The testing was conducted by an "independent source" according to the relevant CDRH Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH – 1993). The country of origin of the data is not explicitly stated. The study appears to be prospective for the device testing itself, as it was performed to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device and study. The testing for a compressor nebulizer involves objective physical and chemical measurements (e.g., particle size, dose delivery) rather than expert interpretation of images or patient data. The ground truth is established by the standardized measurement methods themselves.
4. Adjudication Method for the Test Set
This information is not applicable for this type of device and study, as it did not involve expert review or consensus for establishing ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical cases, sometimes with and without AI assistance. The GUS831 Compressor Nebulizer is a therapeutic device (drug delivery), not a diagnostic one.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance evaluation was done. The aerosol characterization and biocompatibility testing were conducted directly on the device (GUS831 Compressor Nebulizer) and compared to the predicate device, without involving human users in a clinical setting for performance assessment.
7. The Type of Ground Truth Used
The ground truth for the aerosol characterization was established through objective physical and chemical measurements obtained using a cascade impactor, following the methodology outlined in the CDRH Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH – 1993). This is a form of objective measurement data, not expert consensus, pathology, or outcomes data typically associated with diagnostic AI.
The ground truth for biocompatibility was established by testing against recognized international standards (ISO 10993-1, ISO 18562 family).
8. The Sample Size for the Training Set
This information is not applicable. The GUS831 Compressor Nebulizer is a physical medical device; it is not an AI/ML algorithm that requires a training set. The "testing" referred to in the document is for the physical performance and biocompatibility of the device compared to a predicate, not for training a model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as the device is not an AI/ML algorithm requiring a training set.
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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
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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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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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 DeviceGUS831 Compressor Nebulizer | Predicate DeviceU-RIGHT Compressor Nebulizer | Comment |
|---|---|---|---|
| K number | K192633 | K121969 | / |
| Indication for use | GUS831 compressor nebulizer isdesigned for the production ofcompressed air to operate anebulizer kit for the production ofmedical aerosol for respiratorydisorders. The nebulizer kit isintended for multiple use by singlepatient for single medication.GUS831 compressor nebulizer isintended for domestic use withchildren from 5 years old,adolescent and adult patients andrequires the order of a physician formedical use. | U-RIGHT Compressor Nebulizer,model TD-7013/TD-7012, isdesigned to provide a compressedair source to aerosolizephysician-prescribed liquidmedication when used incombination with the packagedNebulizer kit, except forPentamidine. The packagedNebulizer kit is intended for singleuse by single patient. U-RIGHTCompressor Nebulizer, modelTD-7013/TD-7012, is intended foruse with children, adolescents (5years to 18 years old), and adultpatients in the homecare settings. | Substantiallyequivalent |
| Product Code | CAF | CAF | Same |
| Regulationnumber | 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 DeviceGUS831 Compressor Nebulizer | Predicate DeviceU-RIGHT Compressor Nebulizer | Comment |
| TargetPopulation | >5years old | >2 years old | Same |
| EnvironmentalUse | Home use | Homecare setting | Same |
| Principle ofOperation | Compressor Air | Compressor Air | Same |
| Power source | DC adaptor: 5Vd.c.,Internal lithium polymer (Li-Pol)battery: 3.7Vd.c., 2570 mAh | DC adaptor: 6Vd.c. | Substantiallyequivalent |
| Powerconsumption | 10W | 6W | Difference has noeffect on safety oreffectiveness |
| Compressorpressure range(only compressor) | 13 ~ 17 psi | 15 ~ 17 psi | Difference has noeffect on safety oreffectiveness |
| Operatingpressure range(with nebulizingchamber) | 5.1 ~ 8 psi | 6 ~ 8 psi | Difference has noeffect on safety oreffectiveness |
| Flow Rate | 4 ~ 6 LPM | 4 LPM Max. | Substantiallyequivalent |
| Noise Level | 45 dBA | 60 dBA | Difference has noeffect on safety oreffectiveness |
| Mode ofoperation | 30 mins on/ 30 mins off | 30 mins on/ 30 mins off | Same |
| NebulizationRate (avg) | 0.25 ml/min | 0.25ml/min | Same |
| Medicationcapacity | 2ml ~ 6ml | 2ml ~ 6ml | Same |
| User interface | On/Off switchLED indicators | On/Off switch | Difference has noeffect on safety oreffectiveness |
| Standards met | IEC 60601-1IEC 60601-1-2IEC 60601-1-11 | IEC 60601-1IEC 60601-1-2 | Subject devicecomplies withmore recentstandards |
| Patient contact /anatomical site | Mouth | Mouth | Same |
| Contact materialsperISO 10993-1 | External communicatingcomponents with tissue contact | External communicatingcomponents with tissue contact | Same |
| Features | Subject DeviceGUS831 Compressor Nebulizer | Predicate DeviceU-RIGHT Compressor Nebulizer | Comment |
| Biocompatibilitytesting | Cytotoxicity (ISO 10993-5)Irritation (ISO 10993-10)Sensitization (ISO 10993-10)Implantation (ISO 10993-6)Genotoxicity (ISO 10993-3)Gas pathways ISO 18562 | Cytotoxicity (ISO 10993-5)Irritation (ISO 10993-10)Sensitization (ISO 10993-10)Implantation (ISO 10993-6)Genotoxicity (ISO 10993-3) | Subject devicecomplies withmore recentstandards |
| Dimensions (mm) | 68x45x110 | 125x115x46 | Difference has noeffect on safety oreffectiveness |
| Weight (Kg) | 0.250 | 0.290 | Difference has noeffect on safety oreffectiveness |
| Operatingconditions | 10-40°C10-95% RH700-1060 hPa | 10-40°C30-85% RH700-1060 hPa | Difference has noeffect on safety oreffectiveness |
| Storageconditions | -20-60°C10-95% RH700-1060 hPa | -25-70°C10-95% RH700-1060 hPa | Difference has noeffect on safety oreffectiveness |
| Materials | Case: ABSMedicine chamber: PCNozzle: PPMouthpiece: HDPEAir tube: PVC | Case: ABSMedicine chamber: PCNozzle: PPMouthpiece: HDPEAir tube: PVC | Same |
| Sterility | No | No | Same |
| Reusable parts | Nebulizing chamber andmouthpieceCompressor and air tube | Compressor and air tube | Difference has noeffect on safety oreffectiveness |
| Device Cleaning | Compressor: Soft dry cloth andnon-abrasive cleaners for the outercase of the compressorKit: wash with soap and hot waterafter each treatment | Compressor: Alcohol cotton swabsfor the outer casing of the compressorKit: wash with running water or soakin warm water | Difference has noeffect on safety oreffectiveness |
| Contraindications | None | Pentamidine | Difference has noeffect on safety oreffectiveness |
| Device lifetime | 400 hours running time | 3 years | Difference has noeffect on safety oreffectiveness |
| Features | Drug | Subject DeviceGUS831 | Predicate DeviceU-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
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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
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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:
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| (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 DeviceGUS831 | Predicate DeviceU-RIGHT |
|---|---|---|---|
| Particle Characterization per Cascade Impactor @ 12 LPM | |||
| Particle Size (MMAD)(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(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)(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)(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)(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)(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.
§ 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).