COR12 ECG

K183369 · Corscience GmbH & Co. · DPS · Dec 28, 2018 · Cardiovascular

Device Facts

• Record ID: K183369
• Device Name: COR12 ECG
• Applicant: Corscience GmbH & Co.
• Product Code: DPS · Cardiovascular
• Decision Date: Dec 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The COR12 ECG is intended for measuring the surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. The COR12 ECG can be used for applications in patients age 4 years and older and a weight of 20 kg or higher. The COR12 ECG is intended to be used for routine ECG collection, recording both under resting and stress conditions. The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.g. the doctor's office or hospital).

Device Story

COR12 ECG is a 12-lead surface electrocardiograph; collects ECG signals via standard electrodes using impedance measurement; transmits data via Bluetooth 2.1+EDR (SPP protocol) to external customer-defined host software for display or printing. Device lacks onboard display; features single power-on button; auto-shuts off after 10 minutes inactivity. Operated by trained healthcare professionals (nurses, doctors) in clinical settings (doctor's office, hospital). Not for home, EMS, or intracranial use. Provides ECG data to clinicians to support diagnostic decision-making; benefits patients through routine cardiac monitoring.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified through compliance with ISO 62304 (software life cycle), IEC 60601-1 (general safety), IEC 60601-2-25 (ECG safety), and IEC 60601-1-2 (EMC).

Technological Characteristics

12-lead surface ECG; impedance measurement principle; 1.94μV/bit resolution at 500 Hz sampling; 0.05–150 Hz bandpass filter; 4000 Hz pacemaker detection. Connectivity: Bluetooth 2.1+EDR. Power: 1x AA alkaline or NiMH battery. Dimensions: 8.0 x 9.3 x 2.1 cm; Weight: 200g. Electrodes: 4mm gilded snap. Type CF protection against electric shock.

Indications for Use

Indicated for measuring surface ECG in patients age 4 years and older weighing 20 kg or higher. Used for routine ECG collection under resting and stress conditions by trained healthcare professionals in clinical facilities.

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

• Vyntus ECG (K150810)

Submission Summary (Full Text)

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December 28, 2018

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Corscience GmbH & Co. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K183369

Trade/Device Name: COR12 ECG Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 2, 2018 Received: December 4, 2018

Dear Mark Job:

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 Mav 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Arielle Drummond -S

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)

#### K183369

Device Name

## COR12 ECG

Indications for Use (Describe)

The COR12 ECG is intended for measuring the surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. The COR12 ECG can be used for applications in patients age 4 years and older and a weight of 20 kg or higher. The COR12 ECG is intended to be used for routine ECG collection, recording both under resting and stress conditions. The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.g. the doctor's office or hospital).

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)

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FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services [phone]

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K183369

Corscience

| 510(k) Summary | | |
|----------------------------|---------------------------------------------------|--|
| Page 1 of 5 | | |
| 26-Nov-18 | | |
| Submitter: | Karlheinz Trost | |
| | Head of Quality Management and Regulatory Affairs | |
| | Corscience GmbH & Co. KG | |
| | Hartmannstraße 65 | |
| | D-91052 Erlangen, Germany | |
| | E-mail - [e-mail] | |
| | Tel [phone] | |
| Submission Correspondent: | Paul Dryden | |
| | ProMedic, LLC | |
| | 131 Bay Point Dr NE | |
| | St. Petersburg, FL 33704 | |
| | E-mail - [e-mail] | |
| | Tel - 239-307-6061 | |
| Proprietary or Trade Name: | COR12 ECG | |
| Common/Usual Name: | Electrocardiograph | |
| Classification Name: | 21 CFR 870.2340 | |
| | DPS – Electrocardiograph | |
| | Class II | |
| Predicate Devices: | K150810 – CareFusion - Vyntus ECG | |

#### Device Description

The COR12 ECG is intended for the recording of 12-lead ECG data of a patient by trained staff, e.g., nurse, doctor's assistant or the doctor. This can be performed as a resting or a stress ECG.

It transmits the ECG data in a specified format by Bluetooth® transmission to a customer-defined host software running with its own display, which is not part of the COR12. There is no display of ECG waveforms on the COR12.

Limitation:

- It is not suitable to be used with High Frequency surgery devices. •
- . Not intended for intracranial use.
- . Not intended for use in an EMS environment (Emergency Medical Services Environment).
- . Not intended for use in home healthcare environments.

It has a single power-ON button to start data collecting and automatically turns off after 10 minutes of inactivity.

#### Indications for Use

The COR12 ECG is intended for measuring the surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. The COR12 ECG can be used for applications in patients age 4 years and older and a weight of 20 kg or higher. The COR12 ECG is intended to be used for routine ECG collection, recording both under resting and stress conditions. The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.g. the doctor's office or hospital).

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#### 510(k) Summary Page 2 of 5 26-Nov-18

### Comparison to Predicate

We present in Tables 5.1 – 5.2 a comparison of the subject device compared to the predicate.

#### Table 5.1 - Indications and Classification Comparison of Subject and Predicates

| | Subject Device | K150810 | Comment |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Product Name | COR12 ECG | Vyntus/Sentry Suite Product Line<br>Vyntus ECG | |
| Product Code | DPS | DPS and BZC | DPS is a secondary<br>product code and |
| CFR | 870.2340 | 868.1880 | CFR in the<br>predicate |
| Classification Name | Electrocardiograph | Pulmonary Function Data<br>Calculator | |
| Indications for Use | The COR12 ECG is intended for<br>measuring the surface<br>electrocardiogram (ECG) of a<br>patient. The acquired ECG can be<br>recorded and displayed on a screen<br>or printed on paper. | The Vyntus ECG is intended for<br>measuring the surface<br>electrocardiogram (ECG) of a<br>patient. The acquired ECG can be<br>recorded and displayed on the<br>screen or printed on paper. | Identical |
| Data collection only | Yes | Yes | |
| Test conditions | The COR12 ECG is intended to be<br>used for routine ECG collection,<br>recording both under resting and<br>stress conditions. | The Vyntus ECG is intended to be<br>used for routine ECG collection,<br>recording both under resting and<br>stress conditions. | Identical |
| Population | The patient population for this<br>device is age 4 years and older and a<br>weight of 20 kg or higher. | The patient population for this<br>device is age 4 years and older and<br>a weight of 20 kg or higher. | Identical |
| Environments of Use | The measurement is performed by<br>trained healthcare professionals<br>under the direction of a physician in<br>healthcare facilities (e.g. the<br>doctor's office or hospital). | The measurement is performed by<br>trained healthcare professionals<br>under the direction of a physician<br>in healthcare facilities (e.g. the<br>doctor's office or hospital). | Identical |

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K183369

Corscience

# 510(k) Summary

#### Table 5.2 – Comparison of Technical Specifications

| | Subject Device – COR12 ECG | Primary Predicate - Vyntus ECG – K150810 |
|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Feature | Value | |
| Records ECG only | Yes | Yes |
| Data output | Recorded and displayed on screen or printed | Recorded and displayed on screen or printed |
| Records | Under resting and stress conditions | Under resting and stress conditions |
| Dimensions W x H x D | 8.0 x 9.3 x 2.1 cm (3.3 x 3.7 x 0.8 in) | 8.0 x 9.3 x 2.1 cm (3.3 x 3.7 x 0.8 in) |
| Weight (without battery) | 200 g (0.4 lbs) | 200 g (0.4 lbs) |
| 12-channel Surface ECG Recording | Yes | Yes |
| Electrodes | Standard ECG electrodes | Standard ECG electrodes |
| Connection of the electrodes | 4 mm snap, gilded | 4 mm snap, gilded |
| Technology of ECG signal | Impedance measurement | Impedance measurement |
| Accuracy of the ECG signal | 1,94μV/bit resolution (at sampling rate of 500 Hz) | 1,94μV/bit resolution (at sampling rate of 500 Hz) |
| Filter | Bandpass 0.05 Hz – 150 Hz No<br>line filter (50 Hz / 60 Hz) | Bandpass 0.05 Hz – 150 Hz No<br>line filter (50 Hz / 60 Hz) |
| Pacemaker detection | 4000 Hz | 4000 Hz |
| Temperature range operation | T = 10 – 37 °C | T = 10 – 37 °C |
| Ambient pressure range operation | 700 to 1060 hPa (525 to 795 mmHg) | 700 to 1060 hPa (525 to 795 mmHg) |
| Humidity (operation, storage, transport) | 5 – 95% RH (not condensing) | 5 – 95% RH (not condensing) |
| Power supply | 1x AA Alkaline (professional or rechargeable)<br>battery or rechargeable NiMH battery | 1x AA Alkaline (professional or rechargeable)<br>battery or rechargeable NiMH battery |
| Runtime | > 5h with AA battery<br>> 8h with rechargeable NiMH battery (2850 mAh) | > 5h with AA battery<br>> 8h with rechargeable NiMH battery (2850 mAh) |
| Current consumption at 1.5 V<br>- Operation / Idle | 230 mA / 185 mA | 230 mA / 185 mA |
| Classification according to 60601-1<br>- Protection type against electric shock<br>- Protection level against electric shock | Device with internal power supply<br>Type CF | Device with internal power supply Type CF |

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# K183369

Corscience

| 510(k) Summary<br>Page 4 of 5<br>26-Nov-18 | | |
|----------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------|
| Recovery Time after defibrillation | < 8 seconds | < 8 seconds |
| Electromagnetic compatibility (EMC)<br>according to 60601-1-2 and 60601-2-25<br>- Emission<br>- Immunity | CISPR 11 Class B<br>IEC 61000-4 parts 2, 3, 6, 8 | CISPR 11 Class B<br>IEC 61000-4 parts 2, 3, 6, 8 |
| Data transmission | Bluetooth 2.1+EDR Protocol: SPP. | Bluetooth 2.1+EDR Protocol: SPP. |

#### Discussion of the Comparison and Differences

As presented in Tables 5.1 to 5.2, we have compared the subject device, Vyntus ECG cleared under K150810 for equivalence of:

#### Indications, Patient Population and Environment of Use -

Both devices are the same indications for use which the surface electrocardiogram (ECG) of a patient. The aquired ECG can be recorded and displayed on a screen or printed on paper recording ECG signals.

The patient population and environment of use are identical.

- The patient population from 4 years on and a minimum weight of 20 kg. ●
- · The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.g. the doctor's office or hospital)..

Discussion - The subject and predicate device are identical.

Prescription-Use Only – Both devices are prescription-use only.

Discussion – There is no difference in the type of device as a prescription device; thus, they are substantially equivalent.

Design, Technology and Principle of Operation – The fundongy, and principle of operation is measuring ECG signals via impedance from a surface electrode is identical.

Discussion - The subject and predicate devices have the identical technological characteristics for measuring ECG signals.

#### Performance - Non-Clinical Testing Summary -

Biocompatibility - The only component which in in patient is the off-the-shelf electrodes. These are 510(k) cleared and we have provided an example of one in the submission.

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#### 510(k) Summary Page 5 of 5 26-Nov-18

Bench Testing - The subject and predicate devices are identical as the supplier of the predicate and thus the technical specifications are identical.

- Software life cycle ISO 62304 ●
- IEC 60601-1
- IEC 60601-2-25
- EMC Compatibility IEC 60601-2

#### Substantial Equivalence Conclusion

The COR12 ECG is substantially equivalent to the predicate in all aspects of substantial equivalence comparison, as it is identical to the predicate, K150810. There are no differences.