Who is the manufacturer of SENTRYSUITE PRODUCT LINE?

Carefusion Germany 234 GmbH filed the 510(k) submission for SENTRYSUITE PRODUCT LINE (K111053).

What is the FDA product code for SENTRYSUITE PRODUCT LINE?

BTY. It is classified under 21 CFR 868.1890 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for SENTRYSUITE PRODUCT LINE?

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

What are the predicate devices for SENTRYSUITE PRODUCT LINE?

MasterScreen Pneumo (K071753); MasterScreen IOS (K954140); APS Pro (K001502).

Who can help prepare an FDA 510(k) submission like SENTRYSUITE PRODUCT LINE?

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.

SENTRYSUITE PRODUCT LINE

K111053 · Carefusion Germany 234 GmbH · BTY · Aug 12, 2011 · Anesthesiology

Device Facts

Record ID	K111053
Device Name	SENTRYSUITE PRODUCT LINE
Applicant	Carefusion Germany 234 GmbH
Product Code	BTY · Anesthesiology
Decision Date	Aug 12, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1890
Device Class	Class 2
Attributes	Pediatric

Indications for Use

The SentrySuite Product line 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 on-line 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. Use of the Option Bronchial Challenge requires the supervision of a physician familiar with emergency medicine. 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.

Device Story

SentrySuite is a software-based pulmonary function testing (PFT) system operating on existing hardware (MasterScreen Pneumo, MasterScreen IOS, APS Pro). It replaces legacy JLAB software. Input data is collected via mouthpiece, mask, or nasal adapters during maneuvers like spirometry, flow-volume, MVV, R-occlusion, impulse oscillometry, and bronchial challenge. The software processes these inputs to calculate and display lung function parameters on a computer screen. Used in hospitals or clinics under physician direction. Output allows clinicians to view, print, and save test results for diagnostic support and trend observation. Benefits include standardized data collection and analysis for respiratory conditions in pediatric and adult populations.

Clinical Evidence

Bench testing only. No clinical data provided. The device modification involves a software update to an existing, cleared hardware platform. Equivalence is supported by design verification, software lifecycle process documentation (IEC 62304), usability testing (IEC 62366), and risk analysis (ISO 14971) demonstrating that the new software performs equivalently to the legacy JLAB software.

Technological Characteristics

Software-based PFT system. Hardware components: pneumotach handle, IOS head, nebulizer head, compressor, workstation/server, printer. Patient-contacting materials: Bormed RG835 MO (mouthpiece), silicone (mouthpiece), polyacetal (nose clip), ethylene vinyl acetate (nose clip pad). Connectivity: workstation/server, online/Vlink/GDT connections. Power: 100-240V/50-60Hz. Non-sterile. Software developed per IEC 62304.

Indications for Use

Indicated for patients 4 years and older capable of cooperation for pulmonary function testing (PFT), including spirometry, flow-volume, MVV, incentive spirometry, R-occlusion, impulse oscillometry, and bronchial challenge testing. Used for diagnosis of lung conditions. Bronchial challenge requires physician supervision.

Regulatory Classification

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Predicate Devices

MasterScreen Pneumo (K071753)
MasterScreen IOS (K954140)
APS Pro (K001502)

Reference Devices

SIDESTREAM nebulizer (K924123)

Submission Summary (Full Text)

{0}------------------------------------------------ # K111053 . # 510(k) Summary ## GENERAL INFORMATION #### Type of Submission 5.1 Traditional 510(k) Submission 28/03/2011 Submission date: #### 5.2 Submitter Name: CareFusion Germany 234 GmbH Address: Leibnizstrasse 7 D-97204 Hoechberg Germany | Contact person in Germany: | |---------------------------------| | (Regulatory Affairs Specialist) | | Address: | Elmar Niedermeyer CareFusion Germany 234 GmbH Leibnizstrasse 7, 97204 Hoechberg Germany +49 931 49 72 - 361 +49 931 49 72 - 62361 elmar.niedermeyer@carefusion.com Phone: FAX: E-mail Phone: E-mail: Fax: / Contact person in the U.S .: (Official Correspondent) Address ## Carol Emerson CareFusion 22745 Savi Ranch Parkway Yorba Linda, CA 92887 714-919-3342 714-283-8420 carol.emerson@carefusion.com {1}------------------------------------------------ | 5.3 | Establishment Registration Number 9615102 | |------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 5.4 | Common Name or Classification Name Calculator, Predicted Values, Pulmonary Function (CFR 868.1890, Product Code BTY) Diagnostic Spirometer (CFR 868.1840, Product Code BZG) Pulmonary function data calculator (CFR 868.1880, Product Code BZC) | | 5.5 | Trade Name SentrySuite Product line | | 5.6 | Device Classification This is a Class II device | | 5.7 | Classification Panel 73 Anesthesiology Part 868 Code BTY, BZG, BZC | | 5.8 | Reason for Premarket Notification --- Modification of legally marketed devices --- Change from previously JLAB software to SentrySuite software for the devices MasterScreen Pneumo, MasterScreen IOS, APS Pro | | 5.9 | Legally predicate marketed device MasterSreen Pneumo K071753 Code BTY MasterScreen IOS K954140 Code BZG APS Pro K001502 Code BZC | | 5.10 | Predicate Device Company CareFusion Germany 234 GmbH | | 5.11 | Device Description The SentrySuite Product line when operating on the existing hardware for MasterScreen Pneumo, MasterScreen IOS and APS Pro will be as functional as the existing version of JLAB software for all the available measuring | - programs and options for these devices. - The SentrySuite software replaces the JLAB software and got a brand-new . graphical surface. - Measurement can be accomplished under SentrySuite software equivalent . as it was possible under the previously powerful JLAB software {2}------------------------------------------------ - · The results of the tests can be viewed on-line on the computer screen during the test and can be saved on the computer hard disk for further referral or report generation purposes. - SentrySuite provides the functionality currently available on the MasterScreen devices using the JLAB software. - SentrySuite can be operated on workstations and on servers. . Measurements: - Spiormetry . - Flow Volume . - Maximal Voluntary Ventilation (MVV) . - Incentive Spirometry . - . R-Occlusion - Impulse oscillometry . - Bronchial test . #### 5.12 Intended Use Statement The SentrySuite Product line 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 on-line 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. Use of the Option Bronchial Challenge requires the supervision of a physician familiar with emergency medicine. 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. #### Required Components 5.13 - Measuring device MS-Pneumo or MS-IOS or APS Pro . - . Or Workstation / Server - Trolley / Stand . - High performance computer . - Printer . - Accessories ● - SentrySuite software . - Instruction for Use � .**** {3}------------------------------------------------ #### Summary Table of Comparison 5.14 Comparison with the predicate devices | | MasterScreen IOS (K954140) | MasterScreen Pneumo (K071753) | APS Pro (K001502) | SentrySuite Product line | |--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The MasterScreen IOS is intended to be used for measurement and data collection of lung function parameters in humans. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow- Volume/Resistance measurements and the IOS (multifrequent oscillometry determination) measurement. Tests can be easily and quickly conducted on the basis of Impulse Oscillometry. The device is useful in the field of early diagnosis in every- day-routine, for clinical trend observations as well as for epidemiologic studies. As only a minimum of patient cooperation is required, Impulse Oscillometry is also suitable for pediatric and geriatric studies. Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital. The MasterScreen IOS is powered from 100-240 V / 50-60 Hz wall outlets. No energy is transferred to the patient. | The Masterscreen Pneumo 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, doctor's office or hospital. It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance. The Masterscreen Pneumo is powered from 100-240V / 50-60Hz wall outlets. No energy is transferred to the patient. | General The Aerosol Provocation System (APSpro) is intended for specific and non-specific bronchial hyperreactivity tests (provocation tests), as well as for reversibility tests using bronchodilatators. The system is to be used together with a PC-based lung-function equipment of Jaeger together with a Jaeger compressor to measure and to display simultaneously the results during a patient reaction. For the D.S. market only legally marketed nebulizers which are also approved by Jaeger are allowed to be used with the APS-pro. Currently only the SIDESTREAM nebulizer manufactured by Medic-Aid Ltd. is approved (K924123). Place of use The system is only to be used in-door. The required ambient conditions are • Temperature: +10 to +40°C • Relative humidity: 30% to 75% • Barometric pressure: 700 to 1060 mBar Patient groups The system is to be used for testing patients from 4 years upwards. Tests with the APSpro are to be performed by the order of a physician only. During the tests trained personal must be available. | The SentrySuite Product line 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 on-line 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. Use of the Option Bronchial Challenge requires the supervision of a physician familiar with emergency medicine. 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. | | Patient population | MasterScreen IOS can be used for pediatric and geriatric studies. | It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance. | The system is to be used for testing patients from 4 years upwards. | 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. | | Hardware | • IOS head • Trolley or Stand with power supply • Pneumotach handle • Desktop / Notebook • Accessories | • Trolley or Stand with power supply • Pneumotach handle • Desktop / Notebook • Accessories | • Nubulizer head • Compressor • Trolley or Stand with power supply • Desktop / Notebook • Accessories | identical | | Software | JLAB Software | JLAB Software | JLAB Software | SentrySuite Software | | Perfor- mance specifica- tion (measure- ment programs) | • Impulse oscillometry • Spirometry • Flow / Volume • Maximal Voluntary Ventilation (MVV) • Incentive Spirometry | • R-Occlusion • Spirometry • Flow / Volume • Maximal Voluntary Ventilation (MVV) • Incentive Spirometry | • Bronchial test o Bronchospas- molysis o Bronchoprovo- cation o Pulsed Nebulization o Continuous Nebulization | identical | | Energy type | 100 - 240V / 50 - 60Hz | 100 - 240V / 50 - 60Hz | 100 - 240V / 50 - 60Hz | identical | | Patient contacting parts ( | • Single Use mouthpiece (material: Bormed RG835 MO) • Silicone mouthpiece • Nose clip (material: Polyacetal) • Nose clip pad (material: Ethylene Vinyl Acetate) | • Single Use mouthpiece (material: Bormed RG835 MO) • Silicone mouthpiece • Nose clip (material: Polyacetal) • Nose clip pad (material: Ethylene Vinyl Acetate) | • Single Use mouthpiece (material: Bormed RG835 MO) • Silicone mouthpiece • Nose clip (material: Polyacetal) • Nose clip pad (material: Ethylene Vinyl Acetate) | identical | | Sterili- zation | The MasterScreen IOS along with its accessories is neither supplied sterile nor intended to be sterilized | The MasterScreen Pneumo along with its accessories is neither supplied sterile nor intended to be sterilized | The APS Pro along with its accessories is neither supplied sterile nor intended to be sterilized | identical | | Software Network options | • Use as Workstation • Use as Server • Online connection • Vlink connection • GDT connection • Data integration • Database handling | • Use as Workstation • Use as Server • Online connection • Vlink connection • GDT connection • Data integration • Database handling | • Use as Workstation • Use as Server • Online connection • Vlink connection • GDT connection • Data integration • Database handling | Identical | . . --•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• . {4}------------------------------------------------ # 5 510(k) Summary ్లో ప్రా .. · . . : {5}------------------------------------------------ ### Discussion to the table above: The insignificant difference from the SentrySuite Product line to the devices MasterScreen lOS K954140, MasterScreen Pneumo K071753 and-APS-Pro K001502 is: - The JLAB software will be superseded by the new SentrySuite � software. The measurement programs for the medical applications for each device remain the same. #### 5.15 Summary of Device Testing The following practices were followed and monitored for development of the SentrySuite Product line: - The modification for the above device was developed in accordance . with the CareFusion Design and Development SWI (0301-5001-000-SWI). - The software was developed according to IEC 62304 (Software life-. cycle processes) and IEC 62366 (Usability) standard. - The risk analysis method used to assess the impact of the new software . SentrySuite was a Failure Modes and Effects Analysis (FMEA) according standard ISO 14971. #### Conclusions 5.16 Based on the above. CareFusion Germany 234 GmbH concludes that the SentrySuite Product line with the SentrySuite software is substantially equivalent to the legally marketed predicate devices and is safe and effective for its intended use, and performs at least as well as the predicate devices. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains a logo for the Department of Health & Human Services USA. The logo features the department's seal, which includes an abstract symbol consisting of three stylized human figures or shapes connected by curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the seal. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Carefusion Germany 234 GmbH Mr. Elmar Niedermeyer Regulatory Affairs Specialist Leibnizstrasse 7 Hoechberg, Bavaria Germany 97204 AUG 1 2 2011 Re: K111053 Trade/Device Name: SentrySuite Product Line Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: BTY, BZC, BZG Dated: July 28, 2011 Received: August 1, 2011 Dear Mr. Niedermeyer: · 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. 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 fiability warranties. We remind you, however, that device labeling must be truthful and not misleading. ff 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. {7}------------------------------------------------ Page 2 – Mr. Niedermeyer Please be advised that FDA's issuance of a substantial equivalence determination does notmean 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Nh for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health ### Enclosure {8}------------------------------------------------ # Indications for Use 510(k) Number (if known): K111053 Device Name: SentrySuite Product Line Indications for Use: The SentrySuite Product line 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. Use of the Option Bronchial Challenge requires the supervision of a physician familiar with emergency medicine. 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. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) oncurrence of CDRH, Office of Device Evaluation (ODE) Nungesser for L. Schultheiss (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices KII1052 510(k) Number: Page 1 of

SENTRYSUITE PRODUCT LINE

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Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

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Regulatory Classification

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

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SENTRYSUITE PRODUCT LINE

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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