RSCRIBE ELECTROCARDIOGRAPH

K120865 · Mortara Instrument, Inc. · DPS · Jul 19, 2012 · Cardiovascular

Device Facts

• Record ID: K120865
• Device Name: RSCRIBE ELECTROCARDIOGRAPH
• Applicant: Mortara Instrument, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Jul 19, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The RScribe Electrocardiograph is a multi-channel electrocardiograph product used for acquiring, analyzing, displaying and printing resting ECG's. The RScribe is a 12-channel diagnostic electrocardiograph intended for recording and printing ECG's of adult and pediatric patients. The acquired ECG will be displayed for quality check purpose, analyzed using the Mortara VERITAS resting interpretation, optionally printed, stored and/or transmitted to a ECG Management System or Hospital Information System. The device is not intended to be used as a vital signs physiological monitor. It is a system comprised of a Mortara ECG amplifier (Wireless Acquisition Module [WAM] or AM12 Patient Cable) and an off-the-shelf personal computer with Mortara software application that allows clinicians to collect ECGs on patients during routine visits. The patient populations for which the device will be used may be healthy or diseased of any age. ECG's are taken with the patient in the supine position. The RScribe is intended to be used by a licensed health care practitioner in a hospital, medical clinic and offices of any size, including Clinical Research Organizations.

Device Story

RScribe is a 12-channel diagnostic electrocardiograph system; combines proprietary hardware with off-the-shelf PC. Inputs: ECG waveforms via Mortara Wireless Acquisition Module (WAM) or AM12 patient cable. Operation: system checks signal quality; applies VERITAS Resting Interpretation algorithm (adult/pediatric) to analyze waveforms; displays results on PC screen. Output: ECG tracings, automated analysis text, and measurements. Used in hospitals, clinics, and research organizations by clinicians. Workflow: user manages patient demographics, schedules exams, and reviews/edits interpretation text. Data stored locally or on networked servers; reports exported as PDF, DICOM, XML, or UNIPRO32. System integrates with Hospital Information Systems for demographic retrieval. Benefits: provides automated diagnostic support to assist physicians in clinical decision-making; facilitates efficient ECG management and reporting.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and the use of the previously cleared VERITAS Resting Interpretation algorithm (K082946).

Technological Characteristics

12-channel diagnostic electrocardiograph; PC-based architecture. Inputs: WAM or AM12 patient cables. Connectivity: Networked/Hospital Information System integration; supports DICOM, XML, UNIPRO32. Software: VERITAS Resting Interpretation algorithm (adult/pediatric). Output: Display, print, or digital export. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for acquisition, analysis, display, transmission, and printing of ECGs in adult and pediatric populations. Used in clinical settings by physicians or trained personnel under physician orders. Not for use as a vital signs monitor, in highly invasive environments (e.g., OR), or for out-of-hospital transport. Not a sole means of diagnosis; requires physician over-read.

Regulatory Classification

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.

Predicate Devices

• Mortara Instrument ELI PC Electrocardiograph (K093339)
• Mortara Instrument ELI 230 Electrocardiograph (K100127)

Reference Devices

• ELI 350 (K082946)

Submission Summary (Full Text)

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Summary
K120865

Special 510(k) Notification

JUL 19 2012

## 510(k): RScribe Electrocardiograph Device Summary

#### Submitter:

Date: July 18, 2012

Charles Morreale, Director of Regulatory Affairs and Quality Assurance Mortara Instrument, Inc. 7865 N. 86" Street Milwaukee, WI 53224 FAX: [phone] Phone: [phone] Contact: Charles Morreale (see above)

| Trade Name: | RScribe Electrocardiograph |
|----------------------|----------------------------|
| Common Name: | Electrocardiograph |
| Classification Name: | Electrocardiograph |
| | (Per 21 CFR 870.2340) |

#### Legally marketed devices to which S.E. is claimed:

The Mortara Instruments RScribe Electrocardiograph is substantially equivalent to the legally marketed devices presently in distribution:

- Mortara Instrument ELI PC Electrocardiograph (K0933339). .
- Mortara Instrument ELI 230 Electrocardiograph (K100127) ●

#### Description:

The proposed Mortara Instrument RScribe is an electrocardiograph that combines proprietary hardware and an off-the-shelf personal computer. The RScribe is intended to be used with the Mortara Wireless Acquisition Module (WAM) or Mortara Acquisition Module (AM12) patient cables. The RScribe acquires ECG waveforms from the WAM or the AM12 patient cable.

The system is based on the following components:

- The RScribe is compatible with proprietary detachable patient applied lead sets. The RScribe acquires ● ECG waveforms from the Mortara Wireless Acquisition Module (WAM) or Mortara Acquisition Module (AM12) patient cables. The received ECG data will be first analyzed to determine the quality of the ECG then the record will be analyzed using the latest VERITAS™ Resting Interpretation criteria (adults / pediatric, K082946) used in other Mortara Electrocardiographs. The analyzed ECG will be displayed on the PC screen and will include measurements performed by the interpretation algorithm and the text of the automatic analysis. The user will have the possibility to edit the patient demographic data and, also the interpretation text.
- . RScribe allows the user to schedule new exams and viewing of the existing schedule. The system controls user access and authentication, submits demographic and visit information to the repository. It also allows the user to view scheduled modality procedures, select the appropriate exams and enter patient demographics and download modality worklist when necessary.

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Image /page/1/Picture/0 description: The image shows a logo above the text "Special 510(k) Notification". The logo is a white heart shape inside of a black square. The heart shape is formed by two curves that meet at a point at the bottom and curve outwards at the top. The text is in a simple, sans-serif font.

- . After the exams are saved, the reports will be generated (Report Generator) upon request of the modality application. The request includes the template file and data necessary to generate the report. User is also able to print the report and/or export it to a pdf file. The Report Viewer will provide the possibility to open saved reports and read the data directly from the report file. It allows the user to print to a selected windows printer, Mortara Z200+ printer, the ability to zoom the previewed final report, enable/disable the display and print of grid and navigation of the report pages.
The received ECG data will be first analyzed to determined the quality of the ECG then the record will be analyzed using the Mortara Resting Interpretation (adults and pediatric). The analyzed ECG will be displayed on the PC screen and it will include measurements performed by the interpretation algorithm and the text of the automatic analysis. The user will have the possibility to edit the patient demographic data and, in some versions of the product, also the interpretation text.

The user will be able to store the record on the local hard disk or on a networked server. In addition, printouts will be possible as well as file export in several formats (DICOM, UNIPRO32, XML, FDA-XML, etc).

Additional to the above mentioned features, the RScribe will be capable of being interfaced with Hospital Information System (or similar) in order to receive patient demographics.

The user interface of the RScribe will also be customizable in order to better fit the customer workflow. RScribe implements the latest VERITAS™ Resting Interpretation criteria (adult/pediatric) (ELI 350 K082946).

#### Intended Use:

The RScribe Electrocardiograph is a multi-channel electrocardiograph product used for acquiring, analyzing, displaying and printing resting ECG's. The RScribe is a 12-channel diagnostic electrocardiograph intended for recording and printing ECG's of adult and pediatric patients. The acquired ECG will be displayed for quality check purpose, analyzed using the Mortara VERITAS resting interpretation, optionally printed, stored and/or transmitted to a ECG Management System or Hospital Information System. The device is not intended to be used as a vital signs physiological monitor.

It is a system comprised of a Mortara ECG amplifier (Wireless Acquisition Module [WAM] or AM12 Patient Cable) and an off-the-shelf personal computer with Mortara software application that allows clinicians to collect ECGs on patients during routine visits. The patient populations for which the device will be used may be healthy or diseased of any age. ECG's are taken with the patient in the supine position. The RScribe is intended to be used by a licensed health care practitioner in a hospital, medical clinic and offices of any size, including Clinical Research Organizations.

### Indications for Use:

The proposed Mortara RScribe Electrocardiograph is a non-invasive prescription device.

- The device is indicated for use to acquire, analyze, display, transmit and print electrocardiograms. .
- The device is indicated for use to provide interpretation of the data for consideration by a physician. .
- The device is indicated for use in a clinical setting, by a physician or by trained personnel who are � acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
- . The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
- . The device is indicated for use on adult and pediatric populations.
- The device is not intended to be used as a vital signs physiological monitor. .
- The device is not designed for out of hospital transport. .
- The device is not designed for use in highly invasive environments, such as an operating theatre. ●

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUL 1 9 2012 .

Mortara, Inc. c/o Mr. Charles Morreale Director of Regulatory Affairs and Quality Assurance 7865 North 86th Street Milwaukee, WI 53224

Re: K120865

Trade/Device Name: RScribe Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: June 22, 2012 Received: June 25, 2012

Dear Mr. Morreale:

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.

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Page 2 - Mr. Charles Morreale

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

Sincerely yours,

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): _ | | 20865

Mortara RScribe Electrocardiograph Device Name:

Indications for Use:

The proposed Mortara RScribe Electrocardiograph is a non-invasive prescription device.

- The device is indicated for use to acquire, analyze, display, transmit and print . electrocardiograms.
- The device is indicated for use to provide interpretation of the data for . consideration by a physician.
- The device is indicated for use in a clinical setting, by a physician or by trained ● personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
- The interpretations of ECG offered by the device are only significant when used ● in conjunction with a physician over-read as well as consideration of all other relevant patient data.
- The device is indicated for use on adult and pediatric populations. ●
- The device is not intended to be used as a vital signs physiological monitor. .
- The device is not designed for out of hospital transport. .
- The device is not designed for use in highly invasive environments, such as an operating theatre.

Prescription Use × (21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K120865

Concurrence of CDRH, Office of Device Evaluation (ODE)

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