Who is the manufacturer of SENTRYSUITE PRODUCT LINE?

Carefusion Germany 234 GmbH filed the 510(k) submission for SENTRYSUITE PRODUCT LINE (K113813).

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?

SentrySuite Product Line (K111053); MasterScreen PFT (K072061).

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

K113813 · Carefusion Germany 234 GmbH · BTY · May 10, 2012 · Anesthesiology

Device Facts

Record ID	K113813
Device Name	SENTRYSUITE PRODUCT LINE
Applicant	Carefusion Germany 234 GmbH
Product Code	BTY · Anesthesiology
Decision Date	May 10, 2012
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 Product Line is a software-based system for pulmonary function testing (PFT). It integrates with hardware modules (MasterScreen Pneumo, MasterScreen IOS, APS Pro, MasterScreen PFT) to collect respiratory data via mouthpiece, mask, or nasal adapter. The software processes inputs to perform measurements including spirometry, flow-volume, MVV, impulse oscillometry, bronchial challenge, and diffusion tests (FRC Helium, single-breath, intra-breath). Used in hospitals or physician offices under clinical direction; software displays real-time test results on a computer screen for physician review, report generation, and data storage. The system replaces legacy JLAB software, providing an updated graphical interface while maintaining equivalent measurement functionality. Benefits include standardized data collection and analysis to support clinical diagnosis of lung conditions.

Clinical Evidence

No clinical data. Bench testing only. Development followed CareFusion Design and Development SWI, IEC 62304 (software lifecycle), IEC 62366 (usability), and ISO 14971 (risk management/FMEA).

Technological Characteristics

Software-based PFT system; operates on workstations/servers. Hardware includes pneumotach handles, nebulizer heads, and compressors. Patient-contacting parts: single-use/silicone mouthpieces, polyacetal nose clips, EVA pads. Connectivity: online, Vlink, GDT, JINET server. Power: 100-240V/50-60Hz. Non-sterile. Software version 2.5.

Indications for Use

Indicated for patients 4 years and older capable of cooperating with testing procedures. Used for pulmonary function (PFT) parameter measurement, data collection, and analysis to aid in diagnosing related conditions. Bronchial challenge option 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

SentrySuite Product Line (K111053)
MasterScreen PFT (K072061)

Submission Summary (Full Text)

{0}------------------------------------------------ MAY 1 0 2012 . r : : : ' r ﻟﻤﻌ ್ಕೆ KIJ3813 # 510(k) Summary ## GENERAL INFORMATION #### 5.1 Type of Submission Traditional 510(k) Submission Submission date: 12/12/2011 #### 5.2 Submitter Name: CareFusion Germany 234 GmbH Address: Leibnizstrasse 7 D-97204 Hoechberg Germany # Contact person in Germany: (Regulatory Affairs Specialist) Elmar Niedermeyer Address: CareFusion Germany 234 GmbH Leibnizstrasse 7, 97204 Hoechberg Germany Phone: +49 931 49 72 - 361 +49 931 49 72 - 62361 FAX: E-mail elmar.niedermeyer@carefusion.com Contact person in the U.S .: # (Official Correspondent) Carol Emerson Address CareFusion 22745 Savi Ranch Parkway Yorba Linda, CA 92887 Phone: Fax: E-mail: 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) Pulmonary function data calculator (CFR 868.1880, Product Code BZC) Diagnostic Spirometer (CFR 868.1840, Product Code BZG) #### 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 device MasterScreen PFT K072061 by adding it to the SentrySuite Product Line. #### 5.9 Legally predicate marketed device SentrySuite Product Line K111053 Code BTY, BZC, BZG MasterScreen PFT K072061 Code JEH #### 5.10 Predicate Device Company CareFusion Germany 234 GmbH #### Device Description 5.11 The SentrySuite Product line when operating on the existing hardware for MasterScreen Pneumo, MasterScreen IOS, APS Pro and MasterScreen PFT 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 - 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. {2}------------------------------------------------ ### 5 510(k) Summary - 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 ● - . FRC Helium Rebreathing - Real Time Single Breath Diffusion . - Intra Breath Diffusion . #### Intended Use Statement 5.12 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 MS-PFT . - Or Workstation / Server . - Trolley / Stand . - High performance computer . - Printer . - Accessories . - SentrySuite software 2.5 . - Instruction for Use . {3}------------------------------------------------ ## 5.14 Summary Table of Comparison A) Comparison to predicate device SentrySuite Product Line 510(k) # K111053 | | SentrySuite Product Line (K111053) | 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 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. | identical | | Patient population | 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. | identical | | Hardware | APS Pro · Nebulizer head · Compressor · Trolley or Stand with power supply · Desktop / Notebook · Accessories MasterScreen Pneumo · Trolley or Stand with power supply · Pneumotach handle • Desktop / Notebook · Accessories MasterScreen IOS · Trolley or Stand with power supply · Pneumotach handle · Desktop / Notebook · Accessories | identical | | Software | SentrySuite Software (version 2.3) | SentrySuite Software (version 2.5) | | Perfor- mance specifica- tion (measure- ment programs) | APS Pro • Bronchial test • Bronchospasmolysis • Bronchoprovocation • Pulsed Nebulization • Continuous Nebulization MasterScreen Pneumo • Spirometry • Incentive Spirometry • Flow / Volume • MVV • R-Occlusion (Airway Resistance) MasterScreen IOS • Spirometry • Incentive Spirometry • Flow / Volume • MVV • Impulse oscillometry | identical | | Energy type | 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) | identical | | Sterili- zation | The devices from the SentrySuite Product Line (APS Pro, MS Pneumo, MS IOS) along with its accessories are 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 • JINET server | Identical | - 7 {4}------------------------------------------------ . . . 4. ・ . : . . : . {5}------------------------------------------------ - B} Comparison to predicate device MasterScreen PFT 510(k) # K072061 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . | | New feature comparison | | |--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------| | | MasterScreen PFT (K072061) | SentrySuite Product Line | | Perfor- mance specifica- tion (measure- ment programs) | MasterScreen PFT • Spirometry • Incentive Spirometry • Flow / Volume • MVV • R-Occlusion (Airway Resistance) • FRC Helium Rebreathing • Real Time Single Breath Diffusion • Intra Breath Diffusion | Identical | | Hardware | • Trolley with power supply • Analyzer box (gas) • Pneumotach handle • Desktop / Notebook • Accessories | Identical | | Software | JLAB Software 5.x | SentrySuite Software (version 2.5) | ## Discussion to the two tables above: The insignificant difference from the SentrySuite Product Line with 510(k) K111053 to the extended SentrySuite Product Line is: - The SentrySuite software with version 2.3 will be superseded by the . SentrySuite software with version 2.5. The measurement programs for the medical applications for APS Pro, MasterScreen Pneumo and MasterScreen IOS remain thereby untouched. - The device MasterScreen PFT K072061 with the measurement programs . from the table "B" above will be added to the SentrySuite Product Line under the SentrySuite software version 2.5. In Summary: The SentrySuite Product Line K111053 with software SentrySuite 2.3 will be expanded with the measurements "FRC Helium Rebreathing, Real Time Single Breath Diffusion and Intrabreath Diffusion" and the software version is the SentrySuite 2.5. {6}------------------------------------------------ #### 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 SentrySuite . software was a Failure Modes and Effects Analysis (FMEA) according standard ISO 14971. #### 5.16 Conclusions 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. : {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle in flight, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Elmar Niedermeyer Regulatory Affairs Specialist CareFusion Germany 234 GmbH Leibnizstrasse 7 Hoechberg GERMANY 97204 MAY 1 0 2012 Re: K113813 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: April 23, 2012 Received: April 26, 2012 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 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. {8}------------------------------------------------ ### Page 2 – Mr. Niedermeyer 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.htm 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 vours. 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 {9}------------------------------------------------ # Indications for Use 510(k) Number (if known): K 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 × (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) Concurrence of CDRH, Office of Device Evaluation (ODE) L. Selmer (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: Page 1 of 14

SENTRYSUITE PRODUCT LINE

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate 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

Submission Summary (Full Text)

Panel 1

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