(49 days)
K#900207
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not contain other language typically associated with AI/ML (e.g., training sets, test sets, performance metrics like AUC, sensitivity/specificity derived from algorithmic performance). The analysis is described as being based on "EPICARDIA classifications," suggesting a rule-based or deterministic approach rather than a learned model.
No
The device is described as a "screening tool" and provides "summary reports" for review and confirmation by a clinician, indicating it aids in diagnosis rather than providing direct treatment.
Yes
Explanation: The device is described as a "screening tool" that "records and analyzes the patient's ECG, and provides various summary reports that detail any clinically-significant events the patient may have had." These reports are then "reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician." This process of collecting and analyzing data to identify and report potential health issues is characteristic of a diagnostic device, even if it's primarily for screening and requires human confirmation.
Unknown
The summary describes a system that records and analyzes ECG data, but it does not explicitly state whether the system includes hardware for recording the ECG or if it relies solely on software processing of data acquired by a separate device. The description of "software validation testing" is not conclusive enough to confirm it is software-only.
Based on the provided text, the Epicardia 50000 system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The Epicardia 50000 system records and analyzes the patient's ECG, which is an electrical signal measured on the body's surface, not a sample taken from the body.
- The intended use and device description clearly state it's for ECG monitoring. This is a physiological measurement, not an in vitro test.
Therefore, the Epicardia 50000 system falls under the category of a medical device that performs physiological monitoring and analysis, not an IVD.
N/A
Intended Use / Indications for Use
The EPICARDIA System is designed to acquire, store and analyze ECG signals from ECG electrodes on ambulatory patients. Epicardia is a software application that receives the data from patient monitors, provides user operations for editing the results of the analysis and then formats the data for printing.
The system is to be used by a trained operator; the summary reports should be confirmed by a qualified clinician.
The Epicardia 5000 system is indicated as a screening tool for patients who require ambulatory EDG montaring for extended time periods. The system rocarde and analyzes the cation's ECG, and provides various summary reports that detail any clinically-significant events the patient may have had, based on the EPICARDIA classifications. These reports are then reviewed, revised If nocessary by a trained operator and then confirmed by a qualified oliniolan.
Product codes (comma separated list FDA assigned to the subject device)
DSI
Device Description
The EPICARDIA System is a screening tool for patients who require ambulatory ECG monitoring for extended time periods. The system records and analyzes the patient's ECG, and provides various summary reports that detail any clinically-significant events the patient may have had, based on the EPICARDIA classifications. These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician.
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
"The system is to be used by a trained operator; the summary reports should be confirmed by a qualified clinician."
"These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified oliniolan."
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)
All testing performed on the Epicardia 5000 was derived from the risk assessment which evaluated the effects of the feature changes. Testing included software validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K#900207
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
MAY 15 2009
p //2
EXHIBIT #1
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is:_
1. Submitter's Identification:
Medicomp, Inc. 7845 Ellis Road Melbourne, Florida 32904
Date Summary Prepared: March 12, 2009
Contact: Mr. Michael Thomas
2. Name of the Device:
Epicardia 5000
Predicate Device Information: 3.
K#900207, Epicardia 4000, Medicomp, Inc.
4. Device Description:
The EPICARDIA System is a screening tool for patients who require ambulatory ECG monitoring for extended time periods. The system records and analyzes the patient's ECG, and provides various summary reports that detail any clinically-significant events the patient may have had, based on the EPICARDIA classifications. These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician.
5. Intended Use:
The EPICARDIA System is designed to acquire, store and analyze ECG signals from ECG electrodes on ambulatory patients. Epicardia is a software application that receives the data from patient monitors, provides user operations for editing the results of the analysis and then formats the data for printing.
The system is to be used by a trained operator; the summary reports should be confirmed by a qualified clinician.
1
K090834
P2/2
Comparison to Predicate Device: 6.
The following comparison chart outlines similarities and differences between the subject device and the predicate device:
| Features | Predicate Device
Epicardia 4000 | Subject Device
Epicardia 5000 |
|------------------|------------------------------------|-----------------------------------------------------------------|
| ECG Analysis | Yes (Diogenes) | Yes (Diogenes SV) |
| User Interface | Personal Computer (DOS) | Personal Computer (Windows) |
| PC Interface | Direct
USB
File | TCP/IP
Trans-telephonic
Cellular
Direct
USB
File |
| Operating System | MSDOS, Microsoft Windows | Microsoft Windows |
| EC38 Type | Type 3 | Type 3 |
Discussion of Non-Clinical Tests Performed for Determination of 6. Substantial Equivalence:
All testing performed on the Epicardia 5000 was derived from the risk assessment which evaluated the effects of the feature changes. Testing included software validation testing.
Discussion of Clinical Tests Performed: 8.
Not Applicable
9. Conclusions:
The subject device, Epicardia 5000, has identical indications for use as the predicate device, Epicardia 4000. 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 Epicardia 5000, is substantially equivalent to the predicate device, the Epicardia 4000.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the eagle in a circular pattern. The text is in all capital letters and is evenly spaced around the circle.
UUN 2 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medicomp, Inc. c/o Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, NY 11021
Re: K090834
Trade/Device Name: Epicardia 5000 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II (two) Product Codes: DSI Dated: April 23, 2009 Received: April 24, 2009
Dear Ms. Goldstein-Falk:
This letter corrects our substantially equivalent letter of May 15, 2009.
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 (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 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 mav publish further announcements concerning your device in the Federal Register. 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
3
Page 2 - Ms. Susan D. Goldstein-Falk
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 (OS) 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 continue 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/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
80.58132 8334
Exhibit B
2:2033
510(k) Number (if known): _ Ko¶0834
Devica Name: Enloardia 5000
indloations For Use:
The Epicardia 50000 system is indicated as a screening tool for patients who require ambulatory EDG montaring for extended time periods. The system rocarde and analyzes the cation's ECG, and provides various summary reports that detail any clinically-significant events the patient may have had, based on the EPICARDIA classifications. These reports are then reviewed, revised If nocessary by a trained operator and then confirmed by a qualified oliniolan.
Prescription Use X (Per 21 OPR 801 Bubpart D)
భాష
Over-The Countor Use (21 OFT 807 Subpert Of
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER Page if Needed)
Concurrance of ODRH, Office of Device Evaluation (ODE)
EVALUATION OF
A. leucantha
Kir - Cantone - 350 for Devlean
810(k) Number_ Ko40824