(49 days)
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.
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.
Here's an analysis of the provided text regarding the Epicardia 5000 device, focusing on the acceptance criteria and study details:
This submission (K090834) is a 510(k) Pre-Market Notification, which primarily demonstrates substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, no specific quantitative acceptance criteria or detailed performance metrics are explicitly stated for the Epicardia 5000. This is typical for a 510(k) submission where the goal is to show equivalence to an already marketed device, not necessarily to prove specific performance against novel criteria.
The submission focuses on the discussion of non-clinical tests performed, stating: "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." This implies that the 'acceptance criteria' were likely tied to the successful completion of software validation and risk assessment mitigation, ensuring the new features did not negatively impact the device's fundamental function or safety/effectiveness compared to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Discussion of Clinical Tests Performed: Not Applicable". This indicates that no new clinical test set, in the traditional sense, was used to evaluate the Epicardia 5000's performance in humans. The evaluation was primarily based on software validation and comparison to the predicate device's existing performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical tests were performed, there was no test set for which ground truth was established by experts.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document states "Discussion of Clinical Tests Performed: Not Applicable."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device's "ECG Analysis" component is mentioned as "Diogenes SV" (an updated version of the predicate's "Diogenes"), no specific standalone performance study of this algorithm is detailed. The description states: "The system records and analyzes the patient's ECG, and provides various summary reports... These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician." This indicates a human-in-the-loop system, and no data is presented for the algorithm operating in a purely standalone mode without human review and confirmation. The testing focused on software validation, which would assess the algorithm's functional correctness but not necessarily its clinical performance in isolation.
7. The Type of Ground Truth Used
Given that clinical tests were "Not Applicable," there's no mention of specific clinical ground truth (e.g., pathology, outcomes data). The 'ground truth' for the software testing would have been the expected output or behavior according to the software design specifications and risk assessment.
8. The Sample Size for the Training Set
The document does not mention any training set for the Epicardia 5000. As it's a 510(k) submission for a device that uses an analysis system (Diogenes SV), it's possible the "Diogenes SV" algorithm itself was developed with training data, but no details regarding this are provided in this specific submission. The focus is on the substantial equivalence of the system rather than the development of the underlying algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set details are provided in this document.
Summary Takeaway:
The K090834 submission for the Epicardia 5000 is a 510(k) pre-market notification that explicitly states "Discussion of Clinical Tests Performed: Not Applicable." Therefore, it does not provide detailed information on acceptance criteria, test set sample sizes, expert ground truth establishment, or multi-reader studies as would be expected for a device proving novel safety or effectiveness claims. The basis for its clearance is a comparison to a predicate device (Epicardia 4000) and evidence of non-clinical software validation demonstrating that the technological changes do not raise new safety or effectiveness concerns.
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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.
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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 DeviceEpicardia 4000 | Subject DeviceEpicardia 5000 |
|---|---|---|
| ECG Analysis | Yes (Diogenes) | Yes (Diogenes SV) |
| User Interface | Personal Computer (DOS) | Personal Computer (Windows) |
| PC Interface | DirectUSBFile | TCP/IPTrans-telephonicCellularDirectUSBFile |
| 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.
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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
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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
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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
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Kir - Cantone - 350 for Devlean
810(k) Number_ Ko40824
§ 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.