(266 days)
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.
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.
The provided text is a 510(k) Summary for a Pulmonary Function Tester. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria for specific performance metrics nor the results of a specific clinical study used to prove the device meets those criteria.
Instead, the document states that "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." It then lists the standards the device complies with. While these standards define acceptable performance ranges and test methods, the actual acceptance criteria and the device's reported performance against these criteria for each specific lung function parameter are not explicitly detailed in a table or narrative form in the provided text.
Therefore, I cannot populate the requested table and answer questions 2-9 with specific information from the provided document, as that level of detail is not present. The document focuses on demonstrating compliance with recognized standards rather than presenting a detailed study report of the device's performance against specific, pre-defined acceptance criteria.
Key Missing Information for Your Request:
- Specific Acceptance Criteria: While compliance with standards like ISO 26782 and ISO 23747 implies certain performance expectations, the document does not list explicit numerical acceptance criteria for parameters like FVC accuracy, FEV1 accuracy, PEF accuracy, etc., for the subject device itself.
- Reported Device Performance: Relatedly, the document does not provide a table or narrative of the subject device's measured performance (e.g., "FVC accuracy achieved X%") against these (unspecified) acceptance criteria.
- Detailed Study Design: There is no description of a clinical or non-clinical study with details about sample size, ground truth establishment, expert involvement, or adjudication methods. The "non-clinical tests" are mentioned as being conducted to verify design specifications and compliance with standards, but the specifics of these tests are not provided beyond the standards themselves.
Based on the provided text, here is what can and cannot be stated:
1. A table of acceptance criteria and the reported device performance
Cannot be fully provided as the specific acceptance criteria and reported device performance (e.g., FVC accuracy = X%, PEF accuracy = Y%) are not explicitly stated in a table or narrative form in the provided text.
The document references standards that contain performance requirements. For example, under "Flow (PEF) Accuracy" it states for the subject device: "<============================================================================================================================================================= Similar, conforms to ISO 23747". For "Volume (FEV1, FEV6 and FVC) Accuracy" it states for the subject device: "< ± 2.5% Similar, conforms to ATS 2019 and ISO 26782."
This suggests that the acceptance criteria for these parameters are derived from the referenced standards, and the device's performance is stated to conform to these standards, but the exact numerical reading from a specific test showing "X% accuracy was achieved" is missing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available in the provided text. The document mentions "Non-clinical tests were conducted," but offers no details about sample size (if applicable to non-clinical tests in this context, which often involves equipment calibration/verification rather than biological samples), data provenance, or study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not available in the provided text. The document describes non-clinical tests for device performance verification against standards. There is no mention of human experts establishing ground truth for a test set, as would be common in diagnostic AI studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not available in the provided text. As there's no mention of a test set with human-established ground truth, an adjudication method is irrelevant here.
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
No. This device is a "Pulmonary Function Tester" (a medical device for measuring lung function), not an AI-powered diagnostic imaging tool or a system designed to assist human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this device's function and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence. The "non-clinical tests" described are essentially standalone performance evaluations of the device's ability to measure physiological parameters according to engineering specifications and international standards like ISO 26782 and ISO 23747. The device itself performs the measurements and calculates the parameters. Performance is assessed on its ability to accurately and precisely perform these measurements, not on an algorithm's diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "non-clinical tests," the ground truth would be established by reference standards and calibrated instruments used to generate known flow and volume inputs for the device. For example, precisely controlled flow generators and volume syringes would be used, and the device's measurements would be compared against these known inputs to determine accuracy. The specific methods are implied by the referenced ISO standards.
8. The sample size for the training set
Not applicable/Not available in the provided text. This device is a hardware-based pulmonary function tester with associated software; it is not presented as an AI/ML device requiring a training set in the conventional sense of machine learning for pattern recognition or prediction. Its fundamental operation relies on physical principles of flow and volume measurement described under "Technology."
9. How the ground truth for the training set was established
Not applicable/Not available in the provided text. See answer to #8.
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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 RoadHaizhu 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
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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 understandwhoand | 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' officeor | Clinic.doctors'officeor | Same | |
| hospital | hospital | |||
| Prescription or OTC | Prescription | Prescription | Same | |
| Basic unit specification | ||||
| Power supply | Internalbattery: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 | ||
| measurevolume | flowand | 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 | <============================================================================================================================================================================= | 0.1 to 14 L/s: ± 5% or ± | Similar, | |
| 0.2 L/s (whichever is greater) | conformsto | |||
| ISO 23747 | ||||
| Linearity | ≤5% | Not known | Different but | |
| conformsto | ||||
| ISO 23747 | ||||
| Frequency | ±0.25L/s士12%or | Not known | Different but | |
| response | (whichever is greater) | conformsto | ||
| ISO 23747 | ||||
| Resolution | 0.01 L/s | 0.01 L/s | Same | |
| < 0.15 kPa/(L/s) (not | <0.05kPa/L/s (<0.5cm H2O/ | Different but | ||
| Resistance | including filter) | L/s) at 10 L/s | conformsto | |
| ISO 23747 | ||||
| Item | Subject device | Predicate device | Remark | |
| Type | Volume calculation throughintegration, from flowmeasurements | Volume calculation throughintegration, from flowmeasurements | Same | |
| Range | 0 -10 L | $\pm$ 20 L | Different butconforms toISO 26782 | |
| Accuracy | < $\pm$ 2.5% | 0.5 to 8 L: $\pm$ 3% or $\pm$ 0.05 L(whichever is greater) | Similar,conforms toATS 2019and ISO26782 | |
| Volume(FEV1,FEV6andFVC) | < 2.5% | Not known | Different butconforms toATS 2019and ISO26782 | |
| Linearity | < 2.5% | Not known | Different butconforms toATS 2019and ISO26782 | |
| Repeatability | <2.5% | Not known | Different butconforms toATS 2019and ISO26782 | |
| Resolution | 1 mL | 1 mL | Same | |
| Operating mode | Spot checking | Spot checking | Same | |
| Data transmission | Bluetooth/ USB | USB | Similar | |
| Coaching | Display of volume-time andflow-volume curves | Display of volume-time andflow-volume curves | Same | |
| Measurementparameters | FVC: VC、FEV0.5、FEV1、FEV3、FEV6、V backextrapol.ex、FIVC(FVC IN)、FIV1、PEF 、FEF25%、FEF50%、FEF75%、FEF25%-75%(MMEF)、PIF、FIF50%、FET100%、FEV1/FVC、FEV3/FVC、FEV1/VC max、Vbackextrapol.ex% FVCFEF50%/FIF50%、FEV1/FIV1SVC: VC max、VC in、VC ex、IC、IRV、VT、ERV、MV、BFMVV: VT MVV、MVV、TIMEMVV、BF MVV | FVC: VC、 FEV1、FEV1、FEV3 、 FEV6 、PEF 、FEF25%、FEF50%、FEF75%、FEF25%-75% ( MMEF )、PIF、FEV1/FVC、FEV1/VCmax、SVC: VC max、VC in、VCex、 IC、IRV、VT、ERV、MV、 BFMVV :VT MVV 、MVV 、TIMEMVV、BF MVVRocc: ROCC、Palv、GOCC | Similar | |
| Temperature: +10 - +34 °C, | Temperature: +10°C - +34°C(+50° F to 93.2° F), | Same | ||
| Working conditions | Humidity: 15 -95% RH, | Humidity: 15 - 95%RH, non-condensing, | ||
| Atmospheric pressure: 700 -1060 hPa | Atmospheric pressure: 700 - | |||
| Item | Subject device | Predicate device | Remark | |
| 1060 hPa (525 to 795mmHg) | ||||
| Storage conditions | Temperature: -20 - +50 °C,Humidity: 15 - 95% RH,Atmospheric pressure: 600 - 1200 hPa | Temperature: -20 - +50 °C(-4° F to 122° F),Humidity: 15 - 95% RH, non-condensing,Atmospheric pressure: 600 - 1200 hPa (450 to 900mmHg) | Same |
(6) Technological characteristics and substantial equivalence
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(7) Non-clinical studies and tests
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:
- A IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- ハ 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.
- 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 ofDevice RequiringBiocompatibility | Material ofComponent | Body Contact Category(ISO 10993-1) | Contact Duration(ISO 10993-1) |
|---|---|---|---|
| Pulmonary FunctionTester main unit | ABS | Surface-contacting device:Intact skin | < 24hours |
Biocompatibility
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| Flow sensor head | ABS, 304 | Externally communicating tissue/bone/dentin | |
|---|---|---|---|
| stainless steel | < 24hours |
The body-contacting components of this device have been demonstrated conformance to the following standards:
- A 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:
- 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.
§ 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).