(99 days)
K#981119
Not Found
Yes
The device name explicitly includes "AI" (CardioPAL AI with Diogenes SV).
No
The device is designed to record and transmit ECG signals for diagnostic purposes, not to treat a condition.
Yes
The device is designed to record ECG signals from patients experiencing cardiac arrhythmia symptoms, which is a diagnostic function.
No
The device description explicitly states it is a "pager-sized, hand-held or patient worn device" and "consists of the CardioPAL SV event monitor and patient cable," indicating it includes physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The CardioPAL SV is described as a device that records and transmits ambulatory ECG signals. This is a measurement of electrical activity of the heart, which is a physiological signal obtained directly from the patient's body, not from a sample taken from the body.
- Intended Use: The intended use is to capture and record ECG for patients experiencing symptoms potentially related to cardiac arrhythmia. This is a diagnostic tool used to monitor and assess the heart's electrical activity in real-time or over a period.
Therefore, the CardioPAL SV falls under the category of a medical device used for physiological monitoring and recording, not an in vitro diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section states "Not Found".
Intended Use / Indications for 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.
Product codes
MLO
Device Description
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.
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
Not Found
Intended User / Care Setting
Not Found
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)
Discussion of Non-Clinical Tests Performed for Determination of 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:
Not Applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#981119
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
CardioPAL (PM20) | Subject Device
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
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
2
(CardioPAL SV) Model PM410, is substantially equivalent to the predicate device, the CardioPAL Model PM20.
3
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.
4
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 (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 other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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
5
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