COR12+

K091505 · Viasys Healthcare GmbH · DSH · Jun 10, 2009 · Cardiovascular

Device Facts

• Record ID: K091505
• Device Name: COR12+
• Applicant: Viasys Healthcare GmbH
• Product Code: DSH · Cardiovascular
• Decision Date: Jun 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended 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.

Device Story

Cor12+ is a portable, battery-operated digital Holter ECG recorder; captures ECG signals via patient-connected leads; digitizes and stores data on an SD memory card. Device features a single-button interface for event recording and communication activation; dual-color LED provides visual feedback on electrode contact quality (green for good, red for insufficient). PC-based software connects via Bluetooth to program the device; measurement data is transferred to a computer via SD card for analysis. Used in clinical settings by medical professionals; performs no onboard cardiac analysis. Benefits include ambulatory monitoring for symptomatic patients to aid clinical diagnosis of cardiac conditions.

Clinical Evidence

Bench testing only. Testing included electrical safety per IEC 60601-1 and IEC 60601-2-47, and EMC testing per EN 60601-1-2 and EN 60601-2-47. Risk analysis performed via Failure Modes and Effects Analysis (FMEA). No clinical data provided.

Technological Characteristics

Portable ECG recorder; PC/ABS Cycoloy C1200 housing; 24-bit A/D conversion; 1000 Hz or 250 Hz sampling rate; 0.05-150 Hz frequency response. Powered by 2x AA Lithium batteries. Connectivity: Bluetooth (programming only), SD card (data storage). Electrode impedance measurement for contact quality assessment. Software-controlled via PC interface.

Indications for Use

Indicated for symptomatic patients aged 4 years and older, weighing at least 10 kg, requiring ambulatory (Holter) ECG monitoring for up to 24 hours in a clinical setting.

Regulatory Classification

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.

Predicate Devices

• H12+ Holter Recorder (K050896)
• Cardiette Microtel ECG (K082124)
• MasterScope ECG (K082539)

Reference Devices

• H-Scribe Holter analysis system (K004017)

Submission Summary (Full Text)

{0}------------------------------------------------

K091505
P1/6

# JUN 1 0 2009

# 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<br>Cardinal Health Germany 234 GmbH<br>Leibnizstrasse 7, 97204 Hoechberg<br>Germany |
|----------|-------------------------------------------------------------------------------------------------|
| Phone: | [phone] - 383 |
| FAX: | [phone] - 62383 |
| E-mail | [e-mail] |

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: [phone] Thomas. [e-mail] E-mail

{1}------------------------------------------------

- 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.
- 2. Et Medical devices SpA
- 3. 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:

{2}------------------------------------------------

K091505
p3/6

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<br>(K050896) | Cor12+<br>Holter Recorder |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The H12+ Holter recorder is<br>intended to acquire, record and<br>store ECG data of patients that<br>have been connected to the<br>Mortara H12+ recorder and are<br>undergoing Holter monitoring. The<br>H12+ acquires, digitizes and stores<br>data to be analyzed by the H-Scribe<br>Holter system. | The Cor12+ Holter Recorder is<br>intended to acquire, record and<br>store ECG data of patients that<br>have been connected to the<br>Cor12+ recorder and are<br>undergoing Holter monitoring. The<br>Cor12+ acquires, digitizes and<br>stores data to be analyzed on a<br>computer with special software. |
| | The H12+ is indicated for use:<br>- in a clinical setting, by qualified<br>medical professionals only, for<br>recording ECG data of<br>symptomatic patients requiring<br>ambulatory (Holter) monitoring<br>of up to 48 hours.<br>- the H12+ performs no cardiac<br>analysis by itself and is<br>intended to be used with the<br>H-Scribe Holter analysis<br>system (K004017). ECG data<br>prerecorded by the H12+ is<br>acquired and analyzed by the<br>H-Scribe. | The Cor12+ is indicated for use:<br>- in a clinical setting, by qualified<br>medical professionals only, for<br>recording ECG data of patients<br>requiring ambulatory (Holter)<br>monitoring of up to 24 hours.<br><br>The Cor12+ performs no cardiac<br>analysis by itself; it solely records<br>the ECG signals.<br><br>The patient population for this<br>device is from 4 years on and a<br>minimum weight of 10 kg. |
| Patient<br>population | The H12+ Holter Recorder can be<br>used for patients from 4 years on<br>and older. | The Cor12+ Holter Recorder can<br>be used for patients from 4 years<br>on and older. Minimum weight of 10<br>kg. |
| Dimensions<br>(housing) | Length x Width x Height:<br>$112*82*34$ mm | Length x Width x Height:<br>$100*70*26$ mm |
| | Weight:<br>145 g (batteries included) | Weight:<br>155 g (batteries included) |
| Display | LCD module<br>Size: 46,0 x 18,4 mm<br>100 x 32 dots | Dual color LED |
| Key-panel | Foil Key-panel (4 keys):<br>- ESC (on/off)<br>- UP-ARROW<br>- DOWN-ARROW<br>- OK | Single button:<br>- Activate communication |
| Housing | Material:<br>Rotec ABS 1001FR V0 | Material:<br>PC/ABS<br>Cycoloy C1200 |
| Input<br>dynamic<br>range | +/- 300mV @ DC | +/- 1300mV @ DC |
| Frequency<br>response /<br>Bandwith | 0,05 -150 Hz<br>According to EC11 and<br>IEC 60601-1 | identical |
| A/D<br>conversion | 20 bit | 24 bit |
| Sampling<br>rate for data<br>storage | 1000 Hz or 180 Hz | 1000 Hz or 250 Hz |
| Leads | 12 Standard - US color coding | identical |
| Interface | Compact Flash Memory Card<br>(data storage and programming) | SD Memory Card (data storage)<br>Bluetooth (programming) |
| Energy type | 1 x 1,5 V (AA size) | 2 x 1,5 V (AA size, Lithium) |
| Operating<br>Require-<br>ments | Programming Software | Identical |
| Mode of<br>operation | Manual, Manual delayed and<br>Automatic recording | Automatic recording |
| | Cardiette Microtel<br>(K082124) | Cor12+<br>Holter Recorder |
| Interface | Bluetooth & USB | Bluetooth & SD-Card |

- . . ^ . . ^

{3}------------------------------------------------

K091505
P4/6

…

...

ד

·

ﺴﻪ ﺍ

ﻪ ﻣ

ページ ウェ

Pane 4 of 6

{4}------------------------------------------------

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

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

| | MasterScope ECG<br>(K082539) | Cor12+<br>Holter Recorder |
|------------------------|----------------------------------------|---------------------------|
| Electrode<br>impedance | Impedance measurement for<br>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 [phone]. 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 [phone] or [phone] 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 |

Page 1 of