(266 days)
Not Found
No
The summary describes a standard pulmonary function testing device that measures airflow and volume to calculate standard respiratory parameters. There is no mention of AI, ML, or any advanced algorithms beyond standard physiological calculations.
No.
This device is a diagnostic device used to measure and collect data on lung function parameters, not to treat any condition.
Yes
The device is intended for measurement and data collection of lung function parameters, which is a type of diagnostic testing to assess the condition of the lungs.
No
The device description explicitly states that the device is comprised of a "main unit (display screen, sensor and communication module), USB cable, application software (computer software, mobile software), and a power supply." This indicates the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The Pulmonary Function Tester (Model: A9) measures lung function parameters by analyzing the air flow and volume of a patient's exhaled or inhaled air. This is a direct measurement of a physiological process within the body, not an examination of a specimen taken from the body.
- Intended Use: The intended use describes the device as being used for "measurement and data collection of lung function parameters" and performing "cooperation-dependent flow-volume measurements." This aligns with in vivo testing (testing within a living organism), not in vitro testing (testing outside of a living organism).
Therefore, the Pulmonary Function Tester (Model: A9) is a medical device used for in vivo pulmonary function testing, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Pulmonary Function Tester (Model: A9) is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow-volume measurements. Measurements shall be performed under the direction of a physician in the clinic, doctors' office or hospital. The Pulmonary Function Tester (Model: A9) is intended for use in patients from 4 years of age and older who can understand and perform instructions of the physician.
Product codes
BTY
Device Description
The Pulmonary Function Tester (Model: A9) is a hand-held pulmonary function testing device which can be used by patients older than 4 years old under the direction of a physician in the clinic, doctors' office or hospital. The Pulmonary Function Tester (Model: A9) is comprised of the main unit (display screen, sensor and communication module), USB cable, application software (computer software, mobile software), and a power supply. The device use is very simple, it adopts mouth blowing method. The device uses a flow sensor to measure the air flow and volume of the patient's exhaled or inhaled air. According to the volume-time curve and the flow-volume curve, the pulmonary ventilation indicators of human respiratory physiology, such as slow vital capacity, maximum minute ventilation and forced vital capacity, are estimated and reported on the LCD screen and computer/mobile software. The pulmonary Function Tester is powered by lithium battery (DC 3.7V, 1500mAh) or tablet/computer USB port, or the equipped power supply.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
from 4 years of age and older
Intended User / Care Setting
physician in the clinic, doctors' office or hospital.
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
Non-clinical tests were conducted to verify that the Pulmonary Function Tester (Model: A9) meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device.
Summary of Performance Studies
Non-clinical tests were conducted to verify that the Pulmonary Function Tester (Model: A9) meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results also demonstrate that the device complies with the following standards and guidance:
- IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- FDA's Guidance Document: Guidance Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff - 2013.
- The FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices- Guidance for Industry and Food and Drug Administration Staff issued 2023". The software documentation for this device was considered as Basic Documentation Level.
- The FDA "Cybersecurity in Medical Devices: Quality System Considerations and Content of A Premarket Submissions- Guidance for Industry and Food and Drug Administration Staff 2023.
- Standardization of Spirometry 2019 Update; An Official American Thoracic Society and European Respiratory Society: Technical Statement
- ISO 26782, Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans; 2009.
- ISO 23747, Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans; 2015.
Biocompatibility:
The body-contacting components of this device have been demonstrated conformance to the following standards: - ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5, Biological Evaluation of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity
- ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
Particulate and volatile organic compounds emission have been tested. The testing results demonstrate that the targeted device complies with the following standards: - ISO 18562-1, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
- ISO 18562-2, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
- ISO 18562-3, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
- ISO 18562-4, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate.
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
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 21, 2024
Guangzhou Homesun Medical Technology Co., Ltd % Tracy Che Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China
Re: K231561
Trade/Device Name: Pulmonary Function Tester, Model: A9 Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: BTY Dated: January 17, 2024 Received: January 17, 2024
Dear Tracy Che:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices
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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) K231561
Device Name Pulmonary Function Tester, Model: A9
Indications for Use (Describe)
The Pulmonary Function Tester (Model: A9) is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow-volume measurements shall be performed under the direction of a physician in the clinic, doctors' office or hospital. The Pulmonary Function Tester (Model: A9) is intended for use in patients from 4 years of age and older who can understand and perform instructions of the physician.
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
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information
| 510 (k) owner's name: | Guangzhou Homesun Medical Technology Co., Ltd |
|---|---|
| Address: | Floor 7th, Tianxiang Business Building, No.28, Li Fu Road |
| Haizhu District, Guangzhou, GD. China | |
| Contact person: | Suijie Huang |
| Phone number: | +86 13826204942 |
| Email: | hsj@huxijia.com |
| Date of summary prepared: | February 20, 2024 |
(2) Proprietary name of the device
| Trade name/Model: | Pulmonary Function Tester, model: A9 |
|---|---|
| Regulation name: | Predictive Pulmonary Function Value Calculator |
| Regulation number: | 21 CFR 868.1890 |
| Product code | BTY |
| Review panel: | Anesthesiology |
| Regulation class: | Class II |
(3) Predicate device
| Sponsor | VIASYS HEALTHCARE GMBH |
|---|---|
| Device Name and Model | MASTERSCREEN PNEUMO & MASTERSCOPE |
| 510(k) Number | K071753 |
| Product Code | BTY |
| Regulation Number | 21 CFR 868.1890 |
| Regulation Class | II |
(4) Description/ Design of device
The Pulmonary Function Tester (Model: A9) is a hand-held pulmonary function testing device which can be used by patients older than 4 years old under the direction of a physician in the clinic, doctors' office or hospital. The Pulmonary Function Tester (Model: A9) is comprised of the main unit (display screen, sensor and communication module), USB cable, application software (computer software, mobile software), and a power supply. The device use is very simple, it adopts mouth blowing method. The device uses a flow sensor to measure the air flow and volume of the
5
patient's exhaled or inhaled air. According to the volume-time curve and the flow-volume curve, the pulmonary ventilation indicators of human respiratory physiology, such as slow vital capacity, maximum minute ventilation and forced vital capacity, are estimated and reported on the LCD screen and computer/mobile software. The pulmonary Function Tester is powered by lithium battery (DC 3.7V, 1500mAh) or tablet/computer USB port, or the equipped power supply.
(5) Indications for Use
The Pulmonary Function Tester (Model: A9) is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow-volume measurements. Measurements shall be performed under the direction of a physician in the clinic, doctors' office or hospital. The pulmonary Function Tester (Model: A9) is intended for use in patients from 4 years of age and older who can understand and perform instructions of the physician.
| Item | Subject device | Predicate device | Remark | |
|---|---|---|---|---|
| Trade name | Pulmonary Function Tester | |||
| (Model A9) | MASTERSCREEN PNEUMO | |||
| & MASTERSCOPE | ||||
| 510 (k) number | K231561 | K071753 | ||
| Regulation number | 21 CFR 868.1890 | 21 CFR 868.1890 | Same | |
| Regulation description | Predictive Pulmonary Function Value Calculator | Predictive Pulmonary Function Value Calculator | Same | |
| Product code | BTY | BTY | Same | |
| Class | II | II | Same | |
| Indications for use/ Intended use | The Pulmonary Function Tester (Model: A9) is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow-volume measurements. Measurements shall be performed under the direction of a physician in the clinic, doctors' office or hospital. The Pulmonary Function Tester (Model: A9) is intended for use in patients from 4 years of age and older | The Master Screen Pneumo & Masterscope is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow volume measurements. Mostly it will be used for COPD and Asthma patients. Measurements will be performed under the direction of a physician in the clinic, doctors office or hospital. It can be utilized for patients from 4 years of age and older | Similar | |
| Item | Subject device | Predicate device | Remark | |
| can understand | ||||
| who | ||||
| and | as long as they can cooperate | |||
| perform instructions of the | in the performance. | |||
| physician. | The Master Screen Pneumo is | |||
| powered from 100 - 240 V / 50 | ||||
| - 60 Hz wall outlets. No energy | ||||
| is transferred to the patient. | ||||
| Patient population | The device can be utilized for | The device can be utilized for | Same | |
| patients from 4 years of age | patients from 4 years of age | |||
| and older as long as they can | and older as long as they can | |||
| cooperate in the performance. | cooperate in the performance. | |||
| Environment of use | Clinic, doctors' office | |||
| or | Clinic. | |||
| doctors' | ||||
| office | ||||
| or | Same | |||
| hospital | hospital | |||
| Prescription or OTC | Prescription | Prescription | Same | |
| Basic unit specification | ||||
| Power supply | Internal | |||
| battery: | ||||
| 3.7V, | 100 - 240 V / 50 - 60 Hz | Different | ||
| 1500mAh | ||||
| DC input: 5V, 1.2A | ||||
| Power supply: input : | ||||
| 100-240V~,50-60Hz,0.3A ; | ||||
| output: 5V===1.2A | ||||
| Dimensions | 2137828mm | 292 * 198 * 64 mm | Different | |
| Components | Mainly composed of main | Mainly composed of Handle | Similar | |
| unit, USB cable application | with pneumotach and shutter, | |||
| software, and power supply. | power unit and notebook | |||
| (software). | ||||
| Performance specification | ||||
| Technology | for | Same | ||
| measure | ||||
| volume | flow | |||
| and | Differential pressure sensor | Differential pressure | ||
| Flow | Type | High Quality Pneumotach | High Quality Pneumotach | Same |
| (PEF) | Range | 0 – 16 L/s | 士 20 L/s | Same |
| Accuracy | FDA's Guidance Document: Guidance Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff - 2013. |
- A The FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices- Guidance for Industry and Food and Drug Administration Staff issued 2023". The software documentation for this device was considered as Basic Documentation Level.
- The FDA "Cybersecurity in Medical Devices: Quality System Considerations and Content of A Premarket Submissions- Guidance for Industry and Food and Drug Administration Staff 2023.
- A Standardization of Spirometry 2019 Update; An Official American Thoracic Society and European Respiratory Society: Technical Statement
- ハ ISO 26782, Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans; 2009.
- ハ ISO 23747, Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans; 2015.
| Component of
Device Requiring
Biocompatibility | Material of
Component | Body Contact Category
(ISO 10993-1) | Contact Duration
(ISO 10993-1) |
|------------------------------------------------------|--------------------------|-------------------------------------------|-----------------------------------|
| Pulmonary Function
Tester main unit | ABS | Surface-contacting device:
Intact skin | ISO 10993-5, Biological Evaluation of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity
-
ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
Particulate and volatile organic compounds emission have been tested. The testing results demonstrate that the targeted device complies with the following standards:
- A ISO 18562-1, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
-
ISO 18562-2, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
- A ISO 18562-3, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
- A ISO 18562-4, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate.
(8) Conclusion
Based on the above analyses and tests, it can be concluded that the Pulmonary Function Tester (Model: A9) is substantially equivalent to MASTERSCREEN PNEUMO & MASTERSCOPE and the noted differences do not raise different questions of safety and effectiveness.