Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states that the device "performs no cardiac analysis by itself; it solely records the ECG signals." There are no mentions of AI, ML, or related concepts in the description or performance studies.

Therapeutic

No
The device is a Holter recorder used to acquire, record, and store ECG data for diagnostic purposes, not to treat a medical condition.

Diagnostic

No

The device is solely a recorder of ECG data; it performs no cardiac analysis itself, which is typically a function of a diagnostic device. The analysis is done by special software on a computer, separate from this device.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "portable battery operated ECG amplifier with build in data storage on memory card" and lists hardware components like an LED, button, batteries, and speaker.

IVD (In Vitro Diagnostic)

Based on the provided information, the Cor12+ Holter Recorder is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The Cor12+ directly records electrical signals from the patient's body (ECG data) via electrodes attached to the skin. It does not analyze blood, urine, tissue, or other bodily fluids or substances.
The intended use clearly states it records and stores ECG data. It explicitly mentions it "performs no cardiac analysis by itself; it solely records the ECG signals." This reinforces that it's a data acquisition device, not a diagnostic test performed on a sample.
The device description aligns with a physiological monitoring device. It describes a portable recorder with electrodes, batteries, and storage, consistent with a device that captures physiological signals.

Therefore, the Cor12+ Holter Recorder falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DSH

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

from 4 years on

Intended User / Care Setting

in a clinical setting, by qualified medical professionals only

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 according EN 60601-1-2 and . EN 60601-2-47.
Electrical Safety.testing was performed according IEC 60601-1 and IEC 60601-2-47.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K050896, K082124, K082539

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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 Rust
Cardinal Health Germany 234 GmbH
Leibnizstrasse 7, 97204 Hoechberg
Germany |
|----------|-------------------------------------------------------------------------------------------------|
| 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+ 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:

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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 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The H12+ Holter recorder is
intended to acquire, record and
store ECG data of patients that
have been connected to the
Mortara H12+ recorder and are
undergoing Holter monitoring. The
H12+ acquires, digitizes and stores
data to be analyzed by the H-Scribe
Holter system. | 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 H12+ 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 48 hours.
the H12+ performs no cardiac
analysis by itself and is
intended to be used with the
H-Scribe Holter analysis
system (K004017). ECG data
prerecorded by the H12+ is
acquired and analyzed by the
H-Scribe. | The Cor12+ is indicated for use:
in a clinical setting, by qualified
medical professionals only, for
recording ECG data of patients
requiring ambulatory (Holter)
monitoring of up to 24 hours.

The Cor12+ performs no cardiac
analysis by itself; it solely records
the ECG signals.

ESC (on/off)
UP-ARROW
DOWN-ARROW
OK | Single button:
Activate communication |
| Housing | Material:
Rotec ABS 1001FR V0 | Material:
PC/ABS
Cycoloy C1200 |
| Input
dynamic
range | +/- 300mV @ DC | +/- 1300mV @ DC |
| Frequency
response /
Bandwith | 0,05 -150 Hz
According to EC11 and
IEC 60601-1 | identical |
| A/D
conversion | 20 bit | 24 bit |
| Sampling
rate for data
storage | 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) |
| Operating
Require-
ments | Programming Software | Identical |
| Mode of
operation | Manual, Manual delayed and
Automatic 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 |
|------------------------|----------------------------------------|---------------------------|
| Electrode
impedance | Impedance measurement for
electrode | 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+.

5

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.

6

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.

7

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

8

Indications for Use

510(k) Number (if known): K

Device Name: Cor12+

Indications for Use:

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.

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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