Who is the manufacturer of Vyntus BODY?

Vyaire Medical, Inc. filed the 510(k) submission for Vyntus BODY (K190853).

What is the FDA product code for Vyntus BODY?

BZC. It is classified under 21 CFR 868.1880 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Vyntus BODY?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Vyntus BODY?

SentrySuite Product Line (K122699); Vyntus ONE (K181524).

Who can help prepare an FDA 510(k) submission like Vyntus BODY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Vyntus BODY

K190853 · Vyaire Medical, Inc. · BZC · Aug 16, 2019 · Anesthesiology

Device Facts

Record ID	K190853
Device Name	Vyntus BODY
Applicant	Vyaire Medical, Inc.
Product Code	BZC · Anesthesiology
Decision Date	Aug 16, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1880
Device Class	Class 2
Attributes	Pediatric

Intended 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 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.

Device Story

Vyntus BODY is a stationary whole-body plethysmograph for pulmonary function testing (PFT). System inputs include respiratory flow/volume data via ultrasonic flow sensor (USS) and gas concentrations (CH4, CO) for lung diffusion (DLCO) analysis. Device transforms these inputs into PFT parameters (e.g., FRCpleth, TLC, RV, sRaw, DLCO, spirometry metrics). Used in professional healthcare facilities (hospitals, clinics) under physician direction. Data is transmitted via cable to a host computer running SentrySuite software for processing, storage, and reporting. Healthcare providers review results on-screen or via printouts to aid clinical diagnosis. Benefits include standardized, objective assessment of lung function to support respiratory condition management.

Clinical Evidence

Bench testing only. Evidence includes electrical safety and EMC (IEC 60601-1, IEC 60601-2), usability (IEC 62366), software validation (IEC 62304), accuracy testing, climatic testing, and adherence to ATS/ERS Task Force standards for lung function testing.

Technological Characteristics

Stationary whole-body plethysmograph. Components: cabin, ultrasonic flow sensor, shutter, gas analyzers (CH4, CO). Materials: aluminum frame, glass windows. Energy: 100-240V, 50-60Hz. Connectivity: cable to host PC, networked via LAN/WLAN/Internet. Software: SentrySuite (Windows-based). Non-sterile, not intended for sterilization.

Indications for Use

Indicated for patients aged 4 years and older capable of cooperating with pulmonary function testing (PFT) to aid in the diagnosis of lung conditions. No contraindications based on sex or height.

Regulatory Classification

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.

Predicate Devices

SentrySuite Product Line (K122699)
Vyntus ONE (K181524)

Related Devices

K240706 — PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) · Ganshorn Medizin Electronic GmbH · Dec 9, 2024
K181524 — Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART · Vyaire Medical, Inc. · Nov 30, 2018
K052328 — ZAN LUNG-FUNCTION LAB · Zan Messgerate GmbH · Dec 22, 2005
K221030 — Model 9100 PFT/DICO · Vitalograph Ireland, Ltd. · Jul 15, 2022
K223818 — Model 9160 VitaloQUB · Vitalograph Ireland, Ltd. · May 25, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. 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 {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, James Lee, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 {4}------------------------------------------------ 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. {5}------------------------------------------------ #### 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. {6}------------------------------------------------ | | | 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 | | Hardware Components | Cabin | Frame: aluminum Windows: glass Volume: 1110 L Locking Mechanism: electromagnetic Electronics: built into the cabin ceiling | Frame: aluminum Windows: acrylic glass Volume: 830 L Locking Mechanism: mechanical Electronics: built into the cabin floor | N/A | Different | | | Patient User Interface | Ultrasonic flow sensor (ultrasonic signal) Flow Path Valve | Pneumotach (pressure difference to detect flow) Cross adapter Shutter | Ultrasonic flow sensor (ultrasonic signal) Flow Path Valve | Identical to K181524 | | | Trolley | Vyntus CART 3b | Trolley E | Vyntus CART 3.0N Vyntus CART 3.1N | Different | | | Diffusion Option | 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 ONE unit) | Different | | | | Demand Valve (to supply gas) | Demand Valve (to supply gas) | Electronic demand valve (to supply gas) | Identical to K122699 | | 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 (Measuring programs) | | 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 to K122699 | | | 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-SB DLCLO) • 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-SB DLCLO) • 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-SB DLCLO) • 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 Interface Specifications | • 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 0.05 L/S (whichever is greater) • Flow Range: 0 - 18 L/S bidirectional • Flow Resolution: 1mL/s • Volume Accuracy (exhalation): 0 to 14L: 1.5% or 0.05L (whichever is greater) • Volume Accuracy (inhalation): 0 to 14L: 2.5% or 0.05L (whichever is greater) • Volume Range: +/- 30 L (software limited) | • Flow Accuracy (exhalation): 0.2 - 12 L/S: +/- 2% or +/- 0.2 L/S (whichever is greater) • Flow Accuracy (inhalation): 0.1 - 14 L/S: +/- 5% or +/- 0.2 L/S (whichever is greater) • 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 0.05 L/S (whichever is greater) • Flow Range: 0 - 18 L/S bidirectional • Flow Resolution: 1mL/s • Volume Accuracy (exhalation): 0 to 14L: 1.5% or 0.05L (whichever is greater) • Volume Accuracy (inhalation): 0 to 14L: 2.5% or 0.05L (whichever is greater) • Volume Range: +/- 30 L (software limited) | Identical to K181524 | | | | Vyntus BODY (Subject Device) | SentrySuite Product Line (K122699) | Vyntus ONE (K181524) | Comparison | | | | Volume Resolution: 1 mL | | Volume Resolution: 1 mL | | | | Gases used for Vyntus BODY | Single Breath RT & Intrabreath 0.3 + 0.021% Methane (CH4) 0.3 + 0.021% Carbon Monoxide (CO) 21 + 1.47% Oxygen (O2) Rest: Nitrogen | Single Breath RT & Intrabreath 0.3 + 0.021% Methane (CH4) 0.3 + 0.021% Carbon Monoxide (CO) 21 + 1.47% Oxygen (O2) Rest: Nitrogen | Single Breath RT & Intrabreath 0.3 + 0.021% Methane (CH4) 0.3 + 0.021% Carbon Monoxide (CO) 21 + 1.47% Oxygen (O2) Rest: Nitrogen | Identical | | | Patient Direct Contacting Parts | • 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 are provided non-sterile and are not intended for sterilization prior to use. | The device and accessories are provided non-sterile and are not intended for sterilization prior to use. | The device and accessories are provided non-sterile and are not intended for sterilization prior to use. | 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 Operating Parameters | Temperature: +10° to 34°C Relative humidity: 20 to 80%, non-condensing Barometric pressure: 700 -1060 hPa | Temperature: +10° to 34°C Relative humidity: 15 to 95%, non-condensing Barometric pressure: 700 - 1060 hPa | Temperature: +10° to 34°C Relative humidity: 20 to 80%, non-condensing Barometric pressure: 700 -1060 hPa | Different | | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ | | | 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 manual calibration syringe, 3 L • Silicone adapter "Oval" for MicroGard IIB • Adapter ID 3 • Nose-clip "plastic" • Nose-clip pad "foam material" • MicroGard IIC • MicroGard IIB with integrated mouthpiece • Filter kit MicroGard type IIB • Filter kit MicroGard type IIC • Nebulizer end cap Medic-Aid • Drying Tube ME series 48 inch • Silicone mouthpieceFreeFlow™ • Mouthpiece (disposable mouthpiece blue) • Nose-clip disposable | • Silicone mouthpiece for children • Siliconemouthpiece • Plastic mouthpiece • Manual calibration syringe, 1L • Manual calibration syringe, 3 L • Silicone sleeve, 60 mm for manual calibration syringe, 3L • Silicone adapter "Oval" for MicroGard IIB • Adapter ID 3 • Nose-clip "plastic" • Nose-clip pad "foam material" • MicroGard IIC • MicroGard IIB with integrated mouthpiece • 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 for manual calibration syringe, 3 L • Silicone adapter "Oval" for MicroGard IIB • Nose-clip "plastic" • Nose-clip pad "foam material" • MicroGuard IIC • MicroGard IIB with integrated mouthpiece • Filter kit MicroGard type IIB • Filter kit MicroGard type IIC • Nebulizer end cap Medic-Aid • Drying Tube ME series 48 inch • Silicone mouthpiece FreeFlow™ • Mouthpiece (disposable mouthpiece blue) • Nose-clip disposable | Identical to K181524 | {10}------------------------------------------------ | | Vyntus BODY (Subject Device) | SentrySuite Product Line (K122699) | Vyntus ONE (K181524) | Comparison | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | Patient User Interface Accessories | • USS Module with adapter and prot. cover • USS MicroGard Adapter • Cable port protective cover • FPV block • FPV shutter mechanism • FPV silicone valves • FPV X-Ring Kit consists of 3 x X-ring and 1 x small rod • USS Module holder • FPV block holder • Disinfection tray insert • USS MicroGard Adapter for gas sampling | N/A | • USS Module with adapter and prot. cover • USS MicroGard Adapter • Cable port protective cover • FPV block • FPV shutter mechanism • FPV silicone valves • FPV X-Ring Kit consists of 3 x X-ring and 1 x small rod • USS Module holder • FPV block holder • Disinfection tray insert • USS MicroGard Adapter for gas sampling | Identical to K181524 | {11}------------------------------------------------ ## 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.