The Diagnostic Station DS20 is a 12-lead EGG device used for the recording, analysis and evaluation of ECG waveforms. Recordings made with the DS20 can be used as a diagnostic aid for heart function and heart conditions.

The DS20 also measures the following patient vital information to further assessment: pulmonary lung function (spirometry), blood pressure, functional oxygen saturation of arterial hemoglobin (SpO2), carboxyhemoglobin saturation (SpCO), respiration, temperature, and weight.

The DS20 is intended for data collection only. It is not intended for continuous momitoring use and does not provide an alarm function.

The DS20 is indicated for use in hospital and clinic settings, on adult and pediatric patients.

Device Description

The Diagnostic Station DS20 is a 12-lead EGG (Electrocardiograph) device used for the recording, analysis and evaluation of ECG waveforms. It also measures the following patient vital information to further aid in patient assessment: pulmonary lung function (spirometry), blood pressure, functional oxygen saturation of arterial hemoglobin (SpO>), carboxyhemoglobin saturation (SpCO), respiration, temperature and weight. It also supports a 5-lead ECG measurement of heart rate when 12-lead ECG analysis is not needed.

The DS20 does not provide a patient monitoring capability with alarm annunciation.

The DS20 has a color display. It accepts user input via a touch panel, barcode scanner or keyboard. It can generate a variety of reports that can be viewed on the display or printed on a strip chart recorder or laser printer.

The DS20 is mains- or battery-powered and uses sensors that come in contact with the patient.

The DS20 is intended to function in the patient vicinity alongside other medical devices. It can operate as a stand-alone device or can be connected to the SCHILLER SEMA3 Data Management System via Ethernet (land-line or WiFi) in order to store reports and retrieve work orders for a given patient.

AI/ML Overview

This document describes the Diagnostic Station DS20, a medical device for recording and analyzing ECG waveforms, along with other vital signs. The provided text outlines the device's indications for use and performance data, but it does not contain specific acceptance criteria, detailed study designs for clinical performance, or a comparative effectiveness study with human readers.

Based on the provided text, here's a breakdown of the information requested, with "N/A" indicating information not explicitly found:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on compliance with established regulatory standards for electrical safety, essential performance, and electromagnetic compatibility (EMC), as well as software verification and validation. It does not provide numerical acceptance criteria for specific diagnostic performance metrics (e.g., sensitivity, specificity for ECG interpretation) nor does it report those metrics.

Acceptance Criteria (from K-submission)	Reported Device Performance (from K-submission)
Compliance with IEC 60601-1:2005 + CORR 1 (2006) + CORR 2 (2007) (Medical Electrical Equipment, General requirements for basic safety and essential performance)	Successfully tested
Compliance with AAMI ES 60601-1:2005 (Medical Electrical Equipment, General requirements for basic safety and essential performance)	Successfully tested
Compliance with ANSI/AAMI SP10:2002, Am1:2003 (Manual, electronic and automated sphygmomanometers)	Successfully tested
Compliance with IEC 60601-1-2:2007 (Medical Electrical Equipment, EMC)	Successfully tested
Compliance with IEC 60601-1-4:2000 (Medical Electrical Equipment, Programmable electrical medical systems)	Successfully tested
Compliance with IEC 60601-1-6:2010 (Medical Electrical Equipment, Usability)	Successfully tested
Compliance with IEC 60601-2-25:2011 (Medical Electrical Equipment, Electrocardiographs)	Successfully tested
Compliance with IEC 60601-2-27:2011 (Medical Electrical Equipment, Electrocardiographic monitoring equipment)	Successfully tested
Compliance with IEC 80601-2-30:2009 (Medical Electrical Equipment, Automated noninvasive sphygmomanometers)	Successfully tested
Compliance with ISO 80601-2-49:2011 (Medical Electrical Equipment, Multifunction patient monitoring equipment)	Successfully tested
Compliance with ISO 80601-2-56:2009 (Medical Electrical Equipment, Clinical thermometers for body temperature measurement)	Successfully tested
Compliance with ISO 80601-2-61:2011 (Medical Electrical Equipment, Pulse oximeter equipment)	Successfully tested
Compliance with IEC 62366:2007 + A1:2014 (Medical Devices - Application of usability engineering to medical devices)	Successfully tested
Compliance with IEC 62304:2006 (Medical Device Software - Software life cycle processes)	Successfully tested
Software Verification and Validation as per FDA Guidance	Conducted for "moderate" level of concern software

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: N/A (The document primarily details compliance with regulatory standards through successful testing, not a specific clinical test set for diagnostic performance.)
Data Provenance (e.g., country of origin, retrospective/prospective): N/A (Clinical study data for performance evaluation is not detailed in this submission summary.)

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

N/A (The document does not describe a test set with expert-established ground truth for diagnostic performance.)

4. Adjudication Method for the Test Set

N/A (No specific test set or adjudication method is described.)

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done? No. The document does not mention any MRMC comparative effectiveness study or any studies involving human readers, with or without AI assistance.
Effect size of human reader improvement: N/A (Not applicable as no such study was performed/reported.)

6. Standalone (Algorithm Only) Performance Study

The Diagnostic Station DS20 is described as a device that records, analyzes, and evaluates ECG waveforms and measures vital information. It supports a 5-lead ECG measurement of heart rate. The document mentions "analysis and evaluation of ECG waveforms" which implies an algorithmic component. However, it does not describe a standalone performance study comparing its algorithmic output against ground truth for specific diagnostic accuracy metrics (e.g., automated ECG interpretation accuracy). The performance data section focuses on general safety, performance, and software standards compliance rather than diagnostic performance of its analytical features.

7. Type of Ground Truth Used

N/A (For the aspects related to diagnostic performance of ECG interpretation or vital signs analysis, specific ground truth methods are not detailed. The "successful testing" refers to compliance with performance standards rather than clinical accuracy against a gold standard.)

8. Sample Size for the Training Set

N/A (The document does not provide information about a training set for any algorithmic components within the device.)

9. How the Ground Truth for the Training Set Was Established

N/A (No training set is mentioned in the provided text.)

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 6, 2016

Schiller Ag % Jim Chickering Regulatory Affairs Manager Zoe Medical, Inc. 460 Boston Street Topsfield, Massachusetts 01983

Re: K152043 Trade/Device Name: Diagnostic Station Ds20 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DXN, BZG, DQA, MWI, BZQ, FLL, JKS Dated: March 21, 2016 Received: March 29, 2016

Dear Jim Chickering:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Shawn W. Forrest -S 2016.05.06 09:06:22 -04'00'

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152043

Device Name Diagnostic Station DS20

Indications for Use (Describe)

The DS20 is intended for data collection only. It is not intended for continuous momitoring use and does not provide an alarm function.

The DS20 is indicated for use in hospital and clinic settings, on adult and pediatric patients.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CER 801 Subpart D)	Over The Counter Use (21 CER 801 Subpart C)
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510(k) Summarv

I. SUBMITTER

SCHILLER AG Altgasse 68 CH-6341 Baar Switzerland

Phone: +41 41 766 42 52 FAX: +41 41 761 08 80

Contact Person: Zhenrong Yu MD, PhD Date Prepared: June 30, 2015

II. DEVICE

Name of Device: Diagnostic Station DS20

Common Name: Electrocardiograph, Diagnostic Spirometer, Vital Signs Device

Classification Product Code:

DPS - Electrocardiograph (21 CFR 870.2340)

Secondary Product Codes:

DXN - NIBP Measurement System (21 CFR 870.1130) BZG - Diagnostic Spirometer (21 CFR 870.1840) DQA - Oximeter (21 CFR 870.2700) MWI - Physiological Patient Monitor (21 CFR 870.2300) BZQ - Breathing Frequency Monitor (21 CFR 868.2375) FLL - Clinical Electronic Thermometer (21 CFR 880.2910) JKS - Carbon Monoxide Test System (21 CFR 862.3220)

Regulatory Class: II

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III. PREDICATE DEVICE

The primary predicate device is the SCHILLER Cardiovit AT-10 Plus.

Secondary predicate devices are cited for their use of the same physiological parameter OEM module as the subject device.

No reference devices were used in this submission.

Predicate Scope	Predicate Device	510(k)	Classification
Primary Predicate(12-lead ECG Electrocardiographwith Spirometry option)	SCHILLER Cardiovit AT-10 Plus	K050686	DPS
OEM ModuleNon-invasive Blood Pressure (NIBP)	SCHILLER BP-200 Plus	K063814	DXN
OEM ModulePulse Oximetry (SpO2)	Covidien Respiratory PatientMonitor	K130320	DQA
OEM ModulePulse Oximetry (SpO2, SpCO)	Masimo Radical 7	K110028	DQA, JKS
OEM Module5-lead ECG and Respiration	Zoe Medical NightingaleMonitoring System	K130740	MWI
OEM ModuleTemperature	ExergenTemporal Scanner Thermometer	K011291	FLL

IV. DEVICE DESCRIPTION

The DS20 does not provide a patient monitoring capability with alarm annunciation.

The DS20 is mains- or battery-powered and uses sensors that come in contact with the patient.

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V. INDICATIONS FOR USE

The DS20 also measures the following patient vital information to further aid in patient assessment: pulmonary lung function (spirometry), blood pressure, functional oxygen saturation of arterial hemoglobin (SpO-), carboxyhemoglobin saturation (SpCO), respiration, temperature, and weight.

The DS20 is intended for data collection only. It is not intended for continuous monitoring use and does not provide an alarm function.

The DS20 is indicated for use in hospital and clinic settings, on adult and pediatric patients.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE

The subject device has the same technological characteristics and intended use as the primary predicate.

Differences between the subject device and primary predicate include the use of:

. a larger display
a touch panel instead of fixed keys for user input ●
an external laser printer instead of an integrated thermal printer for reports ●
. newer battery technology
. more readily available electrical components (e.g., microcontrollers, memory chips)

Additional physiological parameters have been added to the subject device, which are provided by OEM modules. These OEM modules are used in the cited secondary predicates.

These differences do not raise different questions of safety and effectiveness.

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VII. PERFORMANCE DATA

Electrical safety, essential performance and electromagnetic compatibility (EMC) testing

The Diagnostic Station DS20 was successfully tested to the following regulatory standards:

Standard	Standard Title
IEC 60601-1:2005 +CORR 1 (2006) +CORR 2 (2007)	3rd Edition, Medical Electrical Equipment, Part 1: General requirements for basic safety and essential performance
AAMI ES 60601-1:2005	3rd Edition, Medical Electrical Equipment, Part 1: General requirements for basic safety and essential performance
ANSI/AAMI SP10:2002,Am1:2003	Manual, electronic and automated sphygmomanometers
IEC 60601-1-2:2007	Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility
IEC 60601-1-4:2000	Medical Electrical Equipment, Part 1-4: General Requirements for basic safety and essential performance - Collateral Standard: Programmable electrical medical systems
IEC 60601-1-6:2010	Medical Electrical Equipment, Part 1-6: General Requirements for basic safety and essential performance - Collateral Standard: Usability
IEC 60601-2-25:2011	Medical Electrical Equipment, Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
IEC 60601-2-27:2011	Medical Electrical Equipment, Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
IEC 80601-2-30:2009	Medical Electrical Equipment, Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers
ISO 80601-2-49:2011	Medical Electrical Equipment, Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
ISO 80601-2-56:2009	Medical Electrical Equipment, Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
ISO 80601-2-61:2011	Medical Electrical Equipment, Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
IEC 62366:2007 +A1:2014	Medical Devices - Application of usability engineering to medical devices
IEC 62304:2006	Medical Device Software - Software life cycle processes

Software Verification and Validation Testing

Software verification and validation testing was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered as a "moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury to the patient through incorrect or delayed information or through the action of a care provider.

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VIII. CONCLUSIONS

Based upon a comparison of devices and performance testing results, the SCHILLER Diagnostic Station DS20 is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).