The Cor12+ Holter Recorder is intended to acquire, record and store ECG data of patients that have been connected to the Cor12+ recorder and are undergoing Holter monitoring. The Cor12+ acquires, digitizes and stores data to be analyzed on a computer with special software.

The Cor12+ is indicated for use:

in a clinical setting, by qualified medical professionals only, for recording ECG data of symptomatic patients requiring ambulatory (Holter) monitoring of up to 24 hours.

The Cor12+ performs no cardiac analysis by itself; it solely records the ECG signals. The patient population for this device is from 4 years on and a minimum weight of 10 kg.

Device Description

The digital Holter ECG recorder Cor12+ is a portable battery operated ECG amplifier with build in data storage on memory card (Mini SD size):

Single dual color (green/yellow) LED .
Button control (one Button) to activate communication interface, event . recording
Two standard size AA batteries .
Speaker for voice output for alarm messages .
PC program to set-up recorder via blue-tooth communication interface 0

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Cor12+ Holter Recorder based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly define specific numerical acceptance criteria for performance metrics. Instead, the device's performance is established through substantial equivalence to predicate devices, particularly the H12+ Holter Recorder. The "acceptance criteria" here are implied by meeting or exceeding the performance characteristics of the predicate device, or by demonstrating that differences do not raise new questions of safety or effectiveness.

Therefore, the table below highlights key performance characteristics compared to the primary predicate device, the H12+. Where performance is improved, it is noted.

Performance Characteristic	Predicate Device (H12+) Performance	Cor12+ Holter Recorder Performance	Acceptance/Equivalence
Indications for Use	Ambulatory monitoring up to 48 hours. No cardiac analysis itself.	Ambulatory monitoring up to 24 hours. No cardiac analysis itself. Patient population: 4 years on, min 10kg.	Substantially Equivalent (with reduced monitoring duration and explicit patient population)
Patient Population	4 years on and older	4 years on and older. Minimum weight of 10kg.	Substantially Equivalent
Input Dynamic Range	+/- 300mV @ DC	+/- 1300mV @ DC	Improved (Allows recording with increased baseline drift)
Frequency Response/Bandwidth	0.05 - 150 Hz (According to EC11 and IEC 60601-1)	Identical	Substantially Equivalent
A/D Conversion	20 bit	24 bit	Improved
Sampling Rate for Data Storage	1000 Hz or 180 Hz	1000 Hz or 250 Hz	Improved (Lower rate slightly higher, beneficial for accuracy)
Leads	12 Standard - US color coding	Identical	Substantially Equivalent
Interface (Data Storage)	Compact Flash Memory Card	SD Memory Card	Different technology, but serves same function. Considered equivalent.
Interface (Programming)	Compact Flash Memory Card (or keypad/display)	Bluetooth (for programming only)	Different technology, but serves same function. Considered equivalent.
Energy Type	1 x 1.5 V (AA size)	2 x 1.5 V (AA size, Lithium)	Different, but considered equivalent regarding function.
Mode of Operation	Manual, Manual delayed, Automatic recording	Automatic recording	Different (fewer modes), but still considered equivalent for intended use.
Electrode Impedance	Not explicitly stated as a feature of H12+.	Impedance measurement for electrode contact quality (similar to MasterScope ECG).	Equivalent to MasterScope ECG. This is an added feature for quality.

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

The provided document does not describe a clinical study with a "test set" in the traditional sense for evaluating device performance against pre-defined clinical endpoints or ground truth.

Instead, the submission relies on:

Bench testing: "Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards."
Compliance with standards: "The EMC testing was performed according EN 60601-1-2 and EN 60601-2-47. Electrical Safety testing was performed according IEC 60601-1 and IEC 60601-2-47."
Substantial equivalence arguments: Comparing technical specifications to predicate devices.

Therefore, there is no specific sample size for a clinical "test set" or information about data provenance (e.g., country of origin, retrospective/prospective) for a study directly proving the device meets performance claims through patient data. The evaluation methodology is primarily non-clinical.

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

Since there was no clinical "test set" with ground truth established on patient data, this information is not applicable and not provided in the document. The evaluation focuses on engineering, safety, and performance characteristic comparison.

4. Adjudication Method for the Test Set

As no clinical "test set" requiring ground truth and expert adjudication was conducted, this information is not applicable and not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically assesses the impact of an AI algorithm on human reader performance, which doesn't apply here as the Cor12+ is a data acquisition device, not an analytical AI system.

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

The Cor12+ is described as a "Holter Recorder" that "performs no cardiac analysis by itself; it solely records the ECG signals." Therefore, there is no standalone algorithm performance to evaluate. Its function is data acquisition, digitization, and storage, not diagnostic analysis.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on demonstrating compliance with recognized electrical safety and EMC standards and showing technical equivalence or improvement over predicate devices in terms of physical and performance specifications for ECG signal recording, rather than clinical outcomes or expert consensus on diagnostic accuracy.

8. The Sample Size for the Training Set

Since the device does not employ machine learning or AI algorithms requiring a training set for analysis, this information is not applicable and not provided.

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

As there is no training set for an AI/ML algorithm, this information is not applicable and not provided.

Summary

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510(k) Summary

GENERAL INFORMATION

Type of Submission 5.1

Traditional 510(k) Submission

Submission date: 04/21/2009

Submitter 5.2

Cardinal Health Germany 234 GmbH

Address:

Name:

Leibnizstrasse 7 D-97204 Hoechberg Germany

Contact person in Germany:

Address:	Thomas RustCardinal Health Germany 234 GmbHLeibnizstrasse 7, 97204 HoechbergGermany
Phone:	+49 931 49 72 - 383
FAX:	+49 931 49 72 - 62383
E-mail	Thomas.Rust@cardinalhealth.com

Contact person in the U.S .: Thomas Gutierrez (Official Correspondent) Cardinal Health 207 INC Address 22745 Savi Ranch Parkway Yorba Linda, CA 92887 Phone/Fax: 714-283-8472 Thomas. Gutierrez@cardinalhealth.com E-mail

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5.3 Establishment Registration Number 9615102
5.4 Common Name or Classification Name Recorder, Magnetic Tape, Medical (CFR 870.2800, Product Code DSH)
5.5 Trade Name Cor12+
5.6 Device Classification This is a Class II device

5.7 Classification Panel

74 Cardiovascular Part 870 Code DSH

5.8 Reason for Premarket Notification New Device

Legally predicate marketed device 5.9

1. H12+ Holter Recorder	K050896	Code DSH
2. Cardiette Microtel ECG	K082124	Code DPS
3. MasterScope ECG	K082539	Code BTY / DPS

5.10 Predicate Device Company

1. Mortara Instrument. INC.
1. Et Medical devices SpA
1. Cardinal Health Germany 234 GmbH

5.11 Device Description

The digital Holter ECG recorder Cor12+ is a portable battery operated ECG amplifier with build in data storage on memory card (Mini SD size):

Single dual color (green/yellow) LED .
Button control (one Button) to activate communication interface, event . recording
Two standard size AA batteries .
Speaker for voice output for alarm messages .
PC program to set-up recorder via blue-tooth communication interface 0

5.12 Intended Use Statement

The Cor12+ is indicated for use:

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in a clinical setting, by qualified medical professionals only, for recording ECG data of symptomatic patients requiring ambulatory (Holter) monitoring of up to 24 hours.

The Cor12+ performs no cardiac analysis by itself; it solely records the ECG signals. The patient population for this device is from 4 years on and a minimum weight of 10 kg.

5,13 Required Components

Cor12+ recorder Accessories User Manual

5.14 Summary Table of Comparison

a) Comparison of Cor12+ with H12+ (complete device functions)

	H12+ Holter Recorder(K050896)	Cor12+Holter Recorder
Indicationsfor Use	The H12+ Holter recorder isintended to acquire, record andstore ECG data of patients thathave been connected to theMortara H12+ recorder and areundergoing Holter monitoring. TheH12+ acquires, digitizes and storesdata to be analyzed by the H-ScribeHolter system.	The Cor12+ Holter Recorder isintended to acquire, record andstore ECG data of patients thathave been connected to theCor12+ recorder and areundergoing Holter monitoring. TheCor12+ acquires, digitizes andstores data to be analyzed on acomputer with special software.
	The H12+ is indicated for use:- in a clinical setting, by qualifiedmedical professionals only, forrecording ECG data ofsymptomatic patients requiringambulatory (Holter) monitoringof up to 48 hours.- the H12+ performs no cardiacanalysis by itself and isintended to be used with theH-Scribe Holter analysissystem (K004017). ECG dataprerecorded by the H12+ isacquired and analyzed by theH-Scribe.	The Cor12+ is indicated for use:- in a clinical setting, by qualifiedmedical professionals only, forrecording ECG data of patientsrequiring ambulatory (Holter)monitoring of up to 24 hours.The Cor12+ performs no cardiacanalysis by itself; it solely recordsthe ECG signals.The patient population for thisdevice is from 4 years on and aminimum weight of 10 kg.
Patientpopulation	The H12+ Holter Recorder can beused for patients from 4 years onand older.	The Cor12+ Holter Recorder canbe used for patients from 4 yearson and older. Minimum weight of 10kg.
Dimensions(housing)	Length x Width x Height:$1128234$ mm	Length x Width x Height:$1007026$ mm
	Weight:145 g (batteries included)	Weight:155 g (batteries included)
Display	LCD moduleSize: 46,0 x 18,4 mm100 x 32 dots	Dual color LED
Key-panel	Foil Key-panel (4 keys):- ESC (on/off)- UP-ARROW- DOWN-ARROW- OK	Single button:- Activate communication
Housing	Material:Rotec ABS 1001FR V0	Material:PC/ABSCycoloy C1200
Inputdynamicrange	+/- 300mV @ DC	+/- 1300mV @ DC
Frequencyresponse /Bandwith	0,05 -150 HzAccording to EC11 andIEC 60601-1	identical
A/Dconversion	20 bit	24 bit
Samplingrate for datastorage	1000 Hz or 180 Hz	1000 Hz or 250 Hz
Leads	12 Standard - US color coding	identical
Interface	Compact Flash Memory Card(data storage and programming)	SD Memory Card (data storage)Bluetooth (programming)
Energy type	1 x 1,5 V (AA size)	2 x 1,5 V (AA size, Lithium)
OperatingRequire-ments	Programming Software	Identical
Mode ofoperation	Manual, Manual delayed andAutomatic recording	Automatic recording
	Cardiette Microtel(K082124)	Cor12+Holter Recorder
Interface	Bluetooth & USB	Bluetooth & SD-Card

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b) Comparison of Cor12+ with Cardiette Microtel ECG Recorder (communication interfaces)

c) Comparison of Cor12+ with MasterScope ECG (electrode impedance)

	MasterScope ECG(K082539)	Cor12+Holter Recorder
Electrodeimpedance	Impedance measurement forelectrode	Identical

Discussion to the device differences of the table a), b) and c) above.

The significant differences to the H12+ ECG Recorder are found as:

No display The main purpose of the display on the H12+ recorder is the . programming of the device (set of time, subject ID, etc.). In the Cor12+ this programming of the device is performed by a PC program and direct bluetooth communication. Therefore no display is needed on the Cor12+ to allow its intended use
Input Dynamic Range The Cor12+ has a better input range compared with . the predicate device. This allows the recording of the ECG even with increased baseline drift.
Sampling Rate The lower sampling rate (250 Hz) for data storage is slightly . higher compared with the predicate device H12+ (160 Hz). This slightly higher frequency is beneficial for the accuracy and resolution of further data processing.
Bluetooth is used for programming the Cor12+ instead programming by . keypad/display and memory-card as it is with the H12+ device. The Bluetooth is not for data transfer of measurement data, it is only for the purpose to program the Cor12+ for the patient. The measurement data are transferred to the computer by memory-card as it is provided also by the predicate device H12+.

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The community to the Cardiette Microtel ECG Recorder is found as:

Interface Bluetooth Common is that both devices work with a Bluetooth . interface, whereas the Corr2+ uses the Bluetooth interface only to program the patient device and not to transfer the measurement data.
The community to the MasterScope ECG is found as:
Electrode impedance Common is that both devices work with electrod . impedance measurement. Electrode contact quality is determined by measuring the impediate at each electrode. If impedance is below a certain value, electrode contact is good and the green LED lights up. For impedance values above this value, the electrode contact is not sufficient to guarantee good ECG quality. The red LED on the corresponding electrode clip lights up. This feature enables easy and straightforward check of electrode contact quality.

5.15 Summary of Device Testing

The following practices were followed and monitored for development of the Holter ECG recorder Cor12+:

The Cor12+ was developed in accordance with the Cardinal Health . development standard operating procedures (000490 06 – Design Control).
The risk analysis method used to assess the impact of Cor12+ was a � Failure Modes and Effects Analysis (FMEA).
Safety test procedures demonstrate satisfaction of all safety . requirements and mitigation of all identified hazards.
The EMC testing was performed nazards.
The EMC testing was performed according EN 60601-1-2 and . EN 60601-2-47.
Electrical Safety.testing was performed according IEC 60601-1 and IEC
60601-2-47 . 60601-2-47.

· 5.16 Conclusions

Based on the above, Cardinal Health Germany 234 GmbH concludes that the Cor12+ is substantially equivalent to legally marketed predicate that the
Cor12+ is substantially equivalent to legally marketed predicate device "H12+" and the two options Bluetooth and Electrode impedance are equivalent to the fi
and the two options Bluetooth and Electrode impedance are equivalent to the devices "Cardiette Microtel" and "MasterScope ECG". The Cor12+ is safe and effective for its microlor and "MasterScope ECJ . The Cor12+ is safe a
ffective for its intended use, and performs at least as well as the predicate devices.

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Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird-like symbol with outstretched wings, representing the department's mission related to health and human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2009

Cardinal Health 207, Inc. c/o Mr. Thomas Gutierrez 22745 Savi Ranch Parkway Yorba Linda, CA 92887

K091505 Re:

Cor12+ Regulation Number: 21 CFR 870. 2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: DSH Dated: May 15, 2009 Received: May 21, 2009

Dear Mr. Gutierez:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Thomas Gutierrez

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally. marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

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): K

Device Name: Cor12+

Indications for Use:

The Cor12+ is indicated for use:

in a clinical setting, by qualified medical professionals only, for recording ECG data of symptomatic patients requiring ambulatory (Holter) monitoring of up to 24 hours.

The Cor12+ performs no cardiac analysis by itself; it solely records the ECG signals. The patient population for this device is from 4 years on and a minimum weight of 10 kg.

Prescription Use X (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)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K091505

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Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).