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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the COR12 ECG device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The device is claiming substantial equivalence to its predicate (Vyntus ECG – K150810) by stating that they are identical in all aspects. Therefore, the "acceptance criteria" and "reported device performance" are assumed to be the same as the predicate device, as per the submission's claim of identicality.

Feature / Acceptance Criteria	Reported Device Performance (COR12 ECG & Predicate)	Comment
Indications for Use
Measures Surface ECG	Yes	Identical
Records & Displays/Prints ECG	Yes	Identical
Patient Age	4 years and older	Identical
Patient Weight	20 kg or higher	Identical
Use Conditions	Routine ECG, resting and stress conditions	Identical
User	Trained healthcare professionals	Identical
Environment of Use	Healthcare facilities (doctor's office/hospital)	Identical
Technical Specifications
Records ECG only	Yes	Identical
Data output	Recorded and displayed on screen or printed	Identical
Records under	Resting and stress conditions	Identical
Dimensions (W x H x D)	8.0 x 9.3 x 2.1 cm (3.3 x 3.7 x 0.8 in)	Identical
Weight (without battery)	200 g (0.4 lbs)	Identical
12-channel Surface ECG	Yes	Identical
Electrodes	Standard ECG electrodes	Identical
Electrode Connection	4 mm snap, gilded	Identical
ECG signal Technology	Impedance measurement	Identical
Accuracy of ECG signal	1.94 μV/bit resolution (at 500 Hz sampling)	Identical
Filter	Bandpass 0.05 Hz – 150 Hz, No line filter	Identical
Pacemaker detection	4000 Hz	Identical
Operating Temperature	10 – 37 °C	Identical
Ambient Pressure	700 to 1060 hPa	Identical
Humidity	5 – 95% RH (not condensing)	Identical
Power Supply	1x AA Alkaline or rechargeable NiMH battery	Identical
Runtime (with AA battery)	> 5h	Identical
Runtime (with NiMH battery)	> 8h (2850 mAh)	Identical
Current Consumption	230 mA (Operation) / 185 mA (Idle)	Identical
Protection Classification	Device with internal power supply, Type CF	Identical
Recovery Time (defibrillation)	< 8 seconds	Identical
EMC Emission	CISPR 11 Class B	Identical
EMC Immunity	IEC 61000-4 parts 2, 3, 6, 8	Identical
Data Transmission	Bluetooth 2.1+EDR Protocol: SPP	Identical

2. Sample size used for the test set and the data provenance

The submission explicitly states, "The subject and predicate devices are identical as the supplier of the predicate and thus the technical specifications are identical." This indicates that no separate test set was used for the COR12 ECG device in this submission. The device's performance is established by its claimed identicality to the predicate device. Therefore, no specific sample size or data provenance is reported for a unique test set for the COR12 ECG.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no independent test set was used for the COR12 ECG to demonstrate performance, there were no experts establishing ground truth for such a set. The claims are based on identicality to the predicate.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No independent test set with adjudication was performed for the COR12 ECG in this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an electrocardiograph for recording and displaying ECG data and does not involve AI assistance for interpretation or comparative effectiveness studies with human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a hardware electrocardiograph for data acquisition, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the COR12 ECG, the "ground truth" for its performance is implicitly derived from the established performance and safety of its identical predicate device, the Vyntus ECG (K150810). No new ground truth was established for the COR12 ECG in this submission. The submission relies on the predicate's prior clearance which would have involved demonstrating accuracy against established standards for ECG measurement.

8. The sample size for the training set

Not applicable. This device is a measurement device (electrocardiograph) and does not involve machine learning or AI models that require a training set.

9. How the ground truth for the training set was established

Not applicable. As there is no training set.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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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 - Karlheinz.Trost@corscience.de
	Tel +49-9131-977986-518
Submission Correspondent:	Paul Dryden
	ProMedic, LLC
	131 Bay Point Dr NE
	St. Petersburg, FL 33704
	E-mail - paul.dryden@promedic.cc
	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

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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 LineVyntus ECG
Product Code	DPS	DPS and BZC	DPS is a secondaryproduct code and
CFR	870.2340	868.1880	CFR in thepredicate
Classification Name	Electrocardiograph	Pulmonary Function DataCalculator
Indications for Use	The COR12 ECG is intended formeasuring the surfaceelectrocardiogram (ECG) of apatient. The acquired ECG can berecorded and displayed on a screenor printed on paper.	The Vyntus ECG is intended formeasuring the surfaceelectrocardiogram (ECG) of apatient. The acquired ECG can berecorded and displayed on thescreen or printed on paper.	Identical
Data collection only	Yes	Yes
Test conditions	The COR12 ECG is intended to beused for routine ECG collection,recording both under resting andstress conditions.	The Vyntus ECG is intended to beused for routine ECG collection,recording both under resting andstress conditions.	Identical
Population	The patient population for thisdevice is age 4 years and older and aweight of 20 kg or higher.	The patient population for thisdevice is age 4 years and older anda weight of 20 kg or higher.	Identical
Environments of Use	The measurement is performed bytrained healthcare professionalsunder the direction of a physician inhealthcare facilities (e.g. thedoctor's office or hospital).	The measurement is performed bytrained healthcare professionalsunder the direction of a physicianin healthcare facilities (e.g. thedoctor'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 Noline filter (50 Hz / 60 Hz)	Bandpass 0.05 Hz – 150 Hz Noline 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)battery or rechargeable NiMH battery	1x AA Alkaline (professional or rechargeable)battery or rechargeable NiMH battery
Runtime	> 5h with AA battery> 8h with rechargeable NiMH battery (2850 mAh)	> 5h with AA battery> 8h with rechargeable NiMH battery (2850 mAh)
Current consumption at 1.5 V- Operation / Idle	230 mA / 185 mA	230 mA / 185 mA
Classification according to 60601-1- Protection type against electric shock- Protection level against electric shock	Device with internal power supplyType CF	Device with internal power supply Type CF

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K183369

Corscience

510(k) SummaryPage 4 of 526-Nov-18
Recovery Time after defibrillation	< 8 seconds	< 8 seconds
Electromagnetic compatibility (EMC)according to 60601-1-2 and 60601-2-25- Emission- Immunity	CISPR 11 Class BIEC 61000-4 parts 2, 3, 6, 8	CISPR 11 Class BIEC 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.

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).