CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410

K043454 · Medicomp, Inc. · MLO · Mar 24, 2005 · Cardiovascular

Device Facts

• Record ID: K043454
• Device Name: CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410
• Applicant: Medicomp, Inc.
• Product Code: MLO · Cardiovascular
• Decision Date: Mar 24, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The CardioPAL AI with Diogenes SV (CardioPAL SV) Model PM410, is a pager-sized, hand-held or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.

Device Story

CardioPAL SV (Model PM410) is a pager-sized, hand-held or wearable event/loop recorder for ambulatory ECG monitoring. Device captures ECG signals via 1-channel (2 or 3 wires) or 2-channel (3 or 5 wires) configurations. Features on-board analysis (Diogenes SV) to automatically trigger recordings based on detected events. Operated by patients in home or clinic settings; prescribed by physicians. Data transmitted via trans-telephonic interface or USB to PC. Provides clinicians with recorded ECG data to assist in diagnosing cardiac arrhythmias. Benefits include long-term monitoring capability for transient symptoms.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and software validation.

Technological Characteristics

Plastic enclosure; 1 AA battery; 2-line x 16-character LCD; 3-button interface. ECG input: 1-channel (2/3 wires) or 2-channel (3/5 wires). Connectivity: USB and trans-telephonic. Software includes on-board analysis (Diogenes SV).

Indications for Use

Indicated for patients experiencing transient and infrequent symptoms potentially attributable to cardiac arrhythmia, such as palpitations or shortness of breath, requiring ambulatory ECG monitoring over a period of days or weeks.

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

• CardioPAL (Model PM20) Event/Loop Recorder (K981119)

Submission Summary (Full Text)

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રિપન્ડનેક્રમ

### EXHIBIT #1

## 510(K) SUMMARY

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________

#### Submitter's Identification: 1.

MAR 2 1 2005

Medicomp, Inc. 7845 Ellis Road Melbourne, Florida 32904

Date Summary Prepared: September 16, 2004

Contact: Mr. Michael Thomas

#### Name of the Device: 2.

CardioPAL AI with Diogenes SV (CardioPAL SV) Model PM410

#### Predicate Device Information: 3.

K#981119, CardioPAL (Model PM20) Event/Loop Recorder, Medicomp, Inc.

#### Device Description: 4.

The CardioPAL AI with Diogenes SV (CardioPAL SV) Model PM410, is a small, auto triggered, hand-held device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. Shortness of breath and palpitations are examples of these symptoms. This device may be worn for a period of days or weeks – whatever time is necessary to capture and record the ECG.

The device consists of the CardioPAL SV event monitor and patient cable. The device can be used with accessories, including a belt clip, lanyard, and PC interface cable.

#### 5. Intended Use:

The CardioPAL AI with Diogenes SV (CardioPAL SV) Model PM410, is a pagersized, hand-held or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as

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it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.

#### Comparison to Predicate Device: 6.

The following comparison chart outlines similarities and differences between the subject device and the predicate device:

| Features | Predicate Device<br>CardioPAL (PM20) | Subject Device<br>CardioPAL SV (PM410) |
|-------------------|--------------------------------------|----------------------------------------|
| ECG Storage | 20 Minutes | 20 Minutes |
| On Board Analysis | No | Yes |
| ECG Input | Finger Electrodes | 1 Channel 2 Wires |
| | 1 Channel 2 Wires | 1 Channel 3 Wires |
| | | 2 Channel 3 Wires<br>2 Channel 5 Wires |
| User Interface | Audio Beeper | Audio Beeper |
| | 2 LEDs | 2 Line x 16 Character LCD |
| | 2 Buttons | 3 Buttons |
| PC Interface | Trans-telephonic | Trans-telephonic |
| | RS232 | USB |
| Case | Plastic | Plastic |
| EC38 Type | Type 3 | Type 3 |
| Battery | 2 N Cell | 1 AA |

### Discussion of Non-Clinical Tests Performed for Determination of 6. Substantial Equivalence:

All testing performed on the CardioPAL Al with Diogenes SV (CardioPAL SV) Model PM410 was derived from the risk assessment which evaluated the effects of the feature changes. Testing included IEC 60601-1, IEC 60601-1-2, and environmental and software validation testing.

#### Discussion of Clinical Tests Performed: 8.

Not Applicable

#### 9. Conclusions:

The subject device, CardioPAL Al with Diogenes SV (CardioPAL SV) Model PM410, has indications for use as the predicate device, CardioPAL Model PM20. The bench testing contained in our submission demonstrates that there are no differences in their technological characteristics, thereby not raising any new issues of safety or effectiveness. Thus, the CardioPAL AI with Diogenes SV

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(CardioPAL SV) Model PM410, is substantially equivalent to the predicate device, the CardioPAL Model PM20.

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Public Health Service

Image /page/3/Picture/2 description: The image is a logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 2005

Medicomp, Inc. c/o Ms. Susan Goldstein-Falk MDI Consultants 55 Northern Blvd., Suite 200 Great Neck NY 11021

Re: K043454

. K043434
Trade/Device Name: Cardiopal AI with Diogenes SV (Cardiopal SV), Model PM410 Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II Product Code: MLO Dated: March 10, 2005 Received: March 11, 2005

Dear Ms. Golstein-Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bected by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regarly management date of the Medical Device Amendments, or to commerce prices that have been reclassified in accordance with the provisions of the Federal Food, DINAA devices that have been recassined in quire approval of a premarket approval application (PMA). allu Cosmetic Act (110.) that do not requently of the general controls provisions of the Act. The r ou may, dierelove, mains of the Act include requirements for annual registration, listing of general controll pro rectice, 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 may be sabject to back as back as a 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 - Ms. Susan Goldstein-Falk

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advisou that I Dristian that your device complies with other requirements of the Act that I Dr Haral statutes and regulations administered by other Federal agencies. You must or any I edelul statutes and registements, 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. production of the resires to begin marketing your device as described in your Section 510(k) I mis letter with are n your he FDA finding of substantial equivalence of your device to a legally promated notification " mesults 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 it you attitle 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 other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Rhimtimmoofor

ran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Attachment #1

Page _ 1

K043454 510(k) Number (if known): __

# Device Name: CardioPAL Al with Diogenes SV (CardioPAL SV) Model PM410

## Indications For Use:

The CardioPAL A1 with Diogenes SV (CardioPal SV) Model PM410, is a pager-The Ourdlor AEA .. watient worn device designed specifically to record and sized, handheid of patient worn as not as a seagle can be worn for days or weeks, as than mit ambalatery and by patients who are experiencing symptoms that are transient and infrequent in nature.

Prescription Use __ X (Per 21 CFR 801 Subpart D)

OR

Over-The Counter Use_ (21 CFT 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

immenter (Division Sign-Off) Division of Cardlovascular Devices 510/k) Number