(136 days)
The Vyntus BODY is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. The test results can be saved for future reference or report generation purposes.
The products can be utilized with patients aged 4 years and older as long as they can cooperate in the performance - no special limit to patient's sex or height exists.
Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities).
A qualified physician has to reassess all Vyntus BODY measurements. An interpretation by SentrySuite is only significant if it is considered in connection with other clinical findings.
The Vyntus BODY is a whole-bodyplethysmograph and consists of the Vyntus BODY cabin, an ultrasonic flow sensor (USS), and a shutter. The Vyntus BODY system allows the determination of a subjects' pulmonary function status. It includes the determination of the subjects' ventilatory flows and volume by means of the USS. The measurement of the lung diffusion by the DLCO technique is accomplished with the supply of test gas and the gas analyzers for methane (CH4) and carbone monoxide (CO).
All variants are stationary and not battery operated. The sensor data is sent to a host computer system via cable connection for processing, storage, and reporting. The host computer can be networked via LAN, WLAN, or Internet.
All measurements are performed with the use of the Windows based operating software SentrySuite (SeS). The SeS software also stores the measurement results and provides output capabilities.
The host computer, monitor, and printer are mounted on the Vyntus Cart. Use of the cart is optional; computing equipment may be placed on other furniture.
The provided text is a 510(k) summary for the Vyntus BODY, a pulmonary-function data calculator. It outlines the device's characteristics, its comparison to predicate devices, and the performance data submitted to support its substantial equivalence. However, it does not contain a detailed study report that proves the device meets specific acceptance criteria with reported device performance metrics and specific sample sizes for test sets.
The document focuses on demonstrating substantial equivalence to predicate devices, rather than an independent performance study against predefined criteria.
Therefore, many of the requested details about acceptance criteria, reported performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not explicitly provided in this document.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
The document mentions "Accuracy testing" as one of the performance data provided. In the "Patient User Interface Specifications" table (Page 7-8), it lists performance specifications for flow and volume accuracy which can be considered acceptance criteria. However, it does not explicitly provide the reported device performance against these criteria in a clear table format. The table below presents the acceptance criteria as listed:
| Parameter | Acceptance Criteria (Vyntus BODY) | Reported Device Performance |
|---|---|---|
| Flow Accuracy (exhalation) | 0 - 14 L/S: 1.5% or 0.05 L/S (whichever is greater) | Not explicitly reported |
| Flow Accuracy (inhalation) | 0 to 14 L/S: 2.5% or 0.05 L/S (whichever is greater) | Not explicitly reported |
| Flow Range | 0 - 18 L/S bidirectional | Not explicitly reported |
| Flow Resolution | 1mL/s | Not explicitly reported |
| Volume Accuracy (exhalation) | 0 to 14L: 1.5% or 0.05L (whichever is greater) | Not explicitly reported |
| Volume Accuracy (inhalation) | 0 to 14L: 2.5% or 0.05L (whichever is greater) | Not explicitly reported |
| Volume Range | +/- 30 L (software limited) | Not explicitly reported |
| Volume Resolution | 1 mL | Not explicitly reported |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size for the test set: Not mentioned.
- Data provenance: Not mentioned. The document primarily refers to "Accuracy testing" as a type of performance data provided, but without details on the studies or datasets used for this testing.
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):
This information is not provided. The device is a "Pulmonary-function data calculator," suggesting that its accuracy would likely be evaluated against established physiological measurement standards, not necessarily against expert human interpretation in the same way an AI diagnostic imaging tool would be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable or not mentioned. The device's primary function is to measure and calculate lung function parameters; its performance would likely be validated against metrological standards or established calibration methods, rather than through an adjudication process of expert interpretations.
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:
Not applicable. The Vyntus BODY is a pulmonary function data calculator, not an AI-assisted diagnostic tool that aids human readers in interpreting complex medical images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function or validation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone system for measurements, data collection, and analysis. It is designed to perform these functions "without human-in-the-loop performance" in terms of its direct measurement and calculation capabilities. The document states, "A qualified physician has to reassess all Vyntus BODY measurements. An interpretation by SentrySuite is only significant if it is considered in connection with other clinical findings." This indicates that while the device performs its analytical function standalone, ultimate clinical interpretation requires a physician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "Accuracy testing" mentioned would typically use calibrated instruments or known physical standards as ground truth for flow and volume measurements. The document references "ATS/ERS Task Force: Standardization of Lung Function Testing," implying that the device's performance is likely measured against these established international standards for pulmonary function testing.
8. The sample size for the training set:
Not applicable or not mentioned. The device appears to be a measurement and calculation system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its functionality is based on known physiological principles and instrumentation, likely calibrated against standard references.
9. How the ground truth for the training set was established:
Not applicable, as there's no indication of a "training set" for an AI/ML algorithm.
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August 16, 2019
Vyaire Medical Inc. Colleen Watson Director, Regulatory Affairs 26125 N. Riverwoods Blvd. Mettawa, Illinois 60045
Re: K190853
Trade/Device Name: Vyntus BODY Regulation Number: 21 CFR 868.1880 Regulation Name: Pulmonary-function data calculator Regulatory Class: Class II Product Code: BZC, JEH, BTY Dated: July 15, 2019 Received: July 17, 2019
Dear Colleen Watson:
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 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) K190853
Device Name Vyntus BODY
Indications for Use (Describe)
The Vyntus BODY is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. The test results can be saved for future reference or report generation purposes.
The products can be utilized with patients aged 4 years and older as long as they can cooperate in the performance - no special limit to patient's sex or height exists.
Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities).
A qualified physician has to reassess all Vyntus BODY measurements. An interpretation by SentrySuite is only significant if it is considered in connection with other clinical findings.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is in a dark blue, sans-serif font, with the "TM" symbol in the upper right corner. Below "Vyaire" is the word "MEDICAL" in a smaller, light blue, sans-serif font.
510(k) Summary
I. Submitter
Vyaire Medical, Inc. 26125 N. Riverwoods Blvd. Mettawa, IL 60045
Contact Person: Colleen Watson Phone: + 847-786-5998 x110070 Date Prepared: August 14, 2019
II. Device
| Device Proprietary Name: | Vyntus BODY |
|---|---|
| Common or Usual Name: | Pulmonary-function data calculator |
| Volume Plethysmograph | |
| Predictive Pulmonary Function Value Calculator | |
| Classification Name: | Pulmonary-function data calculator |
| Volume Plethysmograph | |
| Predictive Pulmonary Function Value Calculator | |
| Regulation Number: | 21 CFR 868.1880 |
| 21 CFR 868.1760 | |
| 21 CFR 868.1890 | |
| Product Code: | BZC, JEH, BTY |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
- Primary Predicate: SentrySuite Product Line, K122699, CareFusion Germany 234 GmbH ●
- Secondary Predicate: Vyntus ONE, K181524, Vyaire Medical Inc.
IV. Device Description
The Vyntus BODY is a whole-bodyplethysmograph and consists of the Vyntus BODY cabin, an ultrasonic flow sensor (USS), and a shutter. The Vyntus BODY system allows the determination of a subjects' pulmonary function status. It includes the determination of the subjects' ventilatory flows and volume by means of the USS. The measurement of the lung diffusion by the DLCO technique is accomplished with the supply of test gas and the gas analyzers for methane (CH4) and carbone monoxide (CO).
Vyaire Medical, Inc 26125 N. Riverwoods Blvd. Mettawa. IL 60045 IISA
vaire Medical. Inc 2745 Savi Ranch Pkw Yorba Linda, CA 92887 USA
Vvaire Medical Or Kuortaneenkatu 2 FI-00510 Helsinki Finland
Vyaire Medical GmbH Leibnizstrasse 7 97204 Hoechberg Germany
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All variants are stationary and not battery operated. The sensor data is sent to a host computer system via cable connection for processing, storage, and reporting. The host computer can be networked via LAN, WLAN, or Internet.
All measurements are performed with the use of the Windows based operating software SentrySuite (SeS). The SeS software also stores the measurement results and provides output capabilities.
The host computer, monitor, and printer are mounted on the Vyntus Cart. Use of the cart is optional; computing equipment may be placed on other furniture.
V. Indications for Use
The Vyntus BODY is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. The test results can be saved for further referral or report generation purposes.
The products can be utilized for patients from 4 years on and older as long as they can cooperate in the performance - no special limit to patient's sex or height.
Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar settings (professional healthcare facilities).
A qualified physician has to reassess all Vyntus BODY measurements. An interpretation by SentrySuite is only significant by confirmation of other clinical findings.
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VI. Comparison of Technological Characteristics
The subject device and predicate devices share the following technological characteristics:
- software network options; .
- measuring programs; .
- patient user interface and associated specification; ●
- patient direct contacting parts;
- gases used; ●
- sensor technologies; ●
- environmental operating conditions; and ●
- accessories.
The subject body and predicate devices are technologically different as follows:
- . minor differences in hardware components including cabin design, trolley, and diffusion option; and
- . use of different software version.
A comparison of the Vyntus BODY to the predicate devices is provided below.
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| Vyntus BODY(Subject Device) | SentrySuite Product Line(K122699) | Vyntus ONE(K181524) | Comparison | ||
|---|---|---|---|---|---|
| Use setting | Healthcare setting | Healthcare setting | Healthcare setting | Identical | |
| Patient population | Patients > 4 years old | Patients > 4 years old | Patients > 4 years old | Identical | |
| HardwareComponents | Cabin | Frame: aluminumWindows: glassVolume: 1110 LLocking Mechanism:electromagneticElectronics: built into the cabinceiling | Frame: aluminumWindows: acrylic glassVolume: 830 LLocking Mechanism: mechanicalElectronics: built into the cabinfloor | N/A | Different |
| PatientUserInterface | Ultrasonic flow sensor(ultrasonic signal)Flow Path Valve | Pneumotach (pressure differenceto detect flow)Cross adapterShutter | Ultrasonic flow sensor(ultrasonic signal)Flow Path Valve | Identical toK181524 | |
| Trolley | Vyntus CART 3b | Trolley E | Vyntus CART 3.0NVyntus CART 3.1N | Different | |
| DiffusionOption | Diffusion Real Time unit(covered in the cabin ceiling) | Diffusion Real Time unit(mounted in the box frame) | Diffusion Real Time unit(covered in the Vyntus ONEunit) | Different | |
| Demand Valve (to supply gas) | Demand Valve (to supply gas) | Electronic demand valve (tosupply gas) | Identical toK122699 | ||
| Software | SentrySuite Version 2.19 | SentrySuite Version 2.7 | SentrySuite 2.21 | Different | |
| Software Network Options | Use as Workstation•Use as Server•Online connection•Vlink connection•GDT connection•Sentry.NET•Data integration•Database handling•JINET server | Use as Workstation•Use as Server•Online connection•Vlink connection•GDT connection•Sentry.NET•Data integration•Database handling•JINET server | Use as Workstation•Use as Server•Online connection•Vlink connection•GDT connection•Sentry.NET•Data integration•Database handling•JINET server | Identical | |
| Performance (Measuringprograms) | Slow Spirometry(ERV, IC, VCin, VCex)•Incentive Spirometry(animation) | Slow Spirometry(ERV, IC, VCin, VCex)•Incentive Spirometry(animation) | Slow Spirometry(ERV, IC, VCin, VCex)•Incentive Spirometry(animation) | Identical toK122699 | |
| Vyntus BODY(Subject Device) | SentrySuite Product Line(K122699) | Vyntus ONE(K181524) | Comparison | ||
| • Forced Spirometry(FVC, FEF1, PEF, MEF50, etc.)• MVV(MVV)• Bodyplethysmography(FRCpleth, TLC, RV, sRaw)• Diffusion SB Realtime(Vin, VA, TLC, FICO, FICH4,TLC-SB, FRC-SB, RV-SBDLCLO)• Diffusion SB Intrabreath(Vin, VA, TLC, FECO, FECH4)• R Occlusion(ROCC)• Respiratory Drive P0.1(P0.1)• MIP / MEP(maximum mouth pressure in-expiratory in kPa)• Bronchoprovocation test | • Forced Spirometry(FVC, FEF1, PEF, MEF50, etc.)• MVV(MVV)• Bodyplethysmography(FRCpleth, TLC, RV, sRaw)• Diffusion SB Realtime(Vin, VA, TLC, FICO, FICH4,TLC-SB, FRC-SB, RV-SBDLCLO)• Diffusion SB Intrabreath(Vin, VA, TLC, FECO, FECH4)• R Occlusion(ROCC)• Respiratory Drive P0.1(P0.1)• MIP / MEP(maximum mouth pressure in-expiratory in kPa)• Bronchoprovocation test | • Forced Spirometry(FVC, FEF1, PEF, MEF50, etc.)• MVV(MVV)• Diffusion SB Realtime(Vin, VA, TLC, FICO, FICH4,TLC-SB, FRC-SB, RV-SBDLCLO)• Diffusion SB Intrabreath(Vin, VA, TLC, FECO, FECH4)• R Occlusion(ROCC)• Respiratory Drive P0.1(P0.1)• MIP / MEP(maximum mouth pressure in-expiratory in kPa) | |||
| Patient User InterfaceSpecifications | • Flow Accuracy (exhalation):0 - 14 L/S: 1.5% or 0.05 L/S(whichever is greater)• Flow Accuracy (inhalation):0 to 14 L/S: 2.5% or 0.05L/S (whichever is greater)• Flow Range: 0 - 18 L/Sbidirectional• Flow Resolution: 1mL/s• Volume Accuracy(exhalation): 0 to 14L: 1.5%or 0.05L (whichever isgreater)• Volume Accuracy(inhalation): 0 to 14L: 2.5%or 0.05L (whichever isgreater)• Volume Range: +/- 30 L(software limited) | • Flow Accuracy (exhalation):0.2 - 12 L/S: +/- 2% or +/-0.2 L/S (whichever isgreater)• Flow Accuracy (inhalation):0.1 - 14 L/S: +/- 5% or +/-0.2 L/S (whichever isgreater)• Flow Range: 0 - +/- 20 L/S• Flow Resolution: 10 mL/s• Volume Accuracy (in/ex):0.5 to 8L: +/- 3% or +/-0.05L (whichever is greater)• Volume Range: +/- 20 L• Volume Resolution: 1 mL | • Flow Accuracy (exhalation):0 - 14 L/S: 1.5% or 0.05 L/S(whichever is greater)• Flow Accuracy (inhalation):0 to 14 L/S: 2.5% or 0.05L/S (whichever is greater)• Flow Range: 0 - 18 L/Sbidirectional• Flow Resolution: 1mL/s• Volume Accuracy(exhalation): 0 to 14L: 1.5%or 0.05L (whichever isgreater)• Volume Accuracy(inhalation): 0 to 14L: 2.5%or 0.05L (whichever isgreater)• Volume Range: +/- 30 L(software limited) | Identical toK181524 | |
| Vyntus BODY(Subject Device) | SentrySuite Product Line(K122699) | Vyntus ONE(K181524) | Comparison | ||
| Volume Resolution: 1 mL | Volume Resolution: 1 mL | ||||
| Gases used for VyntusBODY | Single Breath RT & Intrabreath0.3 + 0.021% Methane (CH4)0.3 + 0.021% Carbon Monoxide(CO)21 + 1.47% Oxygen (O2)Rest: Nitrogen | Single Breath RT & Intrabreath0.3 + 0.021% Methane (CH4)0.3 + 0.021% Carbon Monoxide(CO)21 + 1.47% Oxygen (O2)Rest: Nitrogen | Single Breath RT & Intrabreath0.3 + 0.021% Methane (CH4)0.3 + 0.021% Carbon Monoxide(CO)21 + 1.47% Oxygen (O2)Rest: Nitrogen | Identical | |
| Patient Direct ContactingParts | • Single Use mouthpiece• Silicone mouthpiece• Nose clip• Nose clip pad• MicroGard II Filter | • Single Use mouthpiece• Silicone mouthpiece• Nose clip• Nose clip pad• MicroGard II Filter | • Single Use mouthpiece• Silicone mouthpiece• Nose clip• Nose clip pad• MicroGard II Filter | Identical | |
| Sterilization | The device and accessories areprovided non-sterile and are notintended for sterilization prior touse. | The device and accessories areprovided non-sterile and are notintended for sterilization prior touse. | The device and accessories areprovided non-sterile and are notintended for sterilization prior touse. | Identical | |
| Energy | 100 - 240 V/ 50 - 60 Hz | 100 – 240 V/ 50 – 60 Hz | 100 - 240 V/ 50 - 60 Hz | Identical | |
| Electrical Safety | Class I protection | Class I protection | Class I protection | Identical | |
| Environmental OperatingParameters | Temperature: +10° to 34°CRelative humidity: 20 to 80%,non-condensingBarometric pressure: 700 -1060hPa | Temperature: +10° to 34°CRelative humidity: 15 to 95%,non-condensingBarometric pressure: 700 - 1060hPa | Temperature: +10° to 34°CRelative humidity: 20 to 80%,non-condensingBarometric pressure: 700 -1060hPa | Different |
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| Vyntus BODY(Subject Device) | SentrySuite Product Line(K122699) | Vyntus ONE(K181524) | Comparison | ||
|---|---|---|---|---|---|
| Accessories | General | • Silicone mouthpiece for children• Silicone mouthpiece• Plastic mouthpiece• Manual calibration syringe, 1L• Manual calibration syringe, 3L• Silicone sleeve, 60 mm for manualcalibration syringe, 3 L• Silicone adapter "Oval" forMicroGard IIB• Adapter ID 3• Nose-clip "plastic"• Nose-clip pad "foam material"• MicroGard IIC• MicroGard IIB with integratedmouthpiece• Filter kit MicroGard type IIB• Filter kit MicroGard type IIC• Nebulizer end cap Medic-Aid• Drying Tube ME series 48 inch• Silicone mouthpieceFreeFlow™• Mouthpiece (disposablemouthpiece blue)• Nose-clip disposable | • Silicone mouthpiece forchildren• Siliconemouthpiece• Plastic mouthpiece• Manual calibration syringe, 1L• Manual calibration syringe, 3 L• Silicone sleeve, 60 mm formanual calibration syringe, 3L• Silicone adapter "Oval" forMicroGard IIB• Adapter ID 3• Nose-clip "plastic"• Nose-clip pad "foam material"• MicroGard IIC• MicroGard IIB with integratedmouthpiece• Filter kit MicroGard type IIB• Filter kit MicroGard type IIC• Nebulizer end cap Medic-Aid• Drying Tube ME series 48 inch | • Silicone mouthpiece for children• Silicone mouthpiece• Plastic mouthpiece• Manual calibration syringe, 1L• Manual calibration syringe, 3 L• Silicone sleeve, 60 mm formanual calibration syringe, 3 L• Silicone adapter "Oval" forMicroGard IIB• Nose-clip "plastic"• Nose-clip pad "foam material"• MicroGuard IIC• MicroGard IIB with integratedmouthpiece• Filter kit MicroGard type IIB• Filter kit MicroGard type IIC• Nebulizer end cap Medic-Aid• Drying Tube ME series 48 inch• Silicone mouthpieceFreeFlow™• Mouthpiece (disposablemouthpiece blue)• Nose-clip disposable | Identical toK181524 |
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| Vyntus BODY(Subject Device) | SentrySuite Product Line(K122699) | Vyntus ONE(K181524) | Comparison | |
|---|---|---|---|---|
| Patient User Interface Accessories | • USS Module with adapter andprot. cover• USS MicroGard Adapter• Cable port protective cover• FPV block• FPV shutter mechanism• FPV silicone valves• FPV X-Ring Kit consists of 3 xX-ring and 1 x small rod• USS Module holder• FPV block holder• Disinfection tray insert• USS MicroGard Adapter forgas sampling | N/A | • USS Module with adapter andprot. cover• USS MicroGard Adapter• Cable port protective cover• FPV block• FPV shutter mechanism• FPV silicone valves• FPV X-Ring Kit consists of 3 xX-ring and 1 x small rod• USS Module holder• FPV block holder• Disinfection tray insert• USS MicroGard Adapter forgas sampling | Identical toK181524 |
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Discussion:
As seen above, differences between the subject and predicate devices include minor differences in hardware components and use of a different software version.
These technological differences do not create new questions of safety and effectiveness and are addressed by the testing described below. In addition, the general accessories were previously cleared under K181884 and K122699.
Performance Data VII.
The following performance data were provided in support of the substantial equivalence determination:
- Electrical safety and EMC per IEC 60601-1:2005 and IEC 60601-2:2014; ●
- Usability per IEC 62366:2007;
- Software validation per IEC 62304:2006;
- Accuracy testing;
- Climatic testing; and
- ATS/ERS Task Force: Standardization of Lung Function Testing ●
VIII. Conclusion
The information provided above supports that the Vyntus BODY is substantially equivalent to the predicate devices. Although minor differences in design and technology exist between the subject and predicate devices, the testing supports that these differences do not raise any new questions of safety and effectiveness. Therefore, it is concluded that the Vyntus BODY is substantially equivalent to the predicate devices.
§ 868.1880 Pulmonary-function data calculator.
(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).