(70 days)
EASI ECG is intended for monitoring multiple leads of ECG of adults, pediatrics and neonates. ST. Segment monitoring is restricted to adult patients only.
EASI ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult, pediatric, or neonatal patients including arrhythmia monitoring or ST segment changes of adult patients, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms, including:
- Assessment of symptoms that may be related to rhythm disturbances of the heart
- -Patients with palpitations
- The evaluation of arrhythmias in patients from neonatal to pediatric to adult age
- arrhythmia
- -- Assessment of efficacy of anti-arrhythmic therapy
- -- Assessment of pacemaker function
- Assessment of symptomatic or asymptomatic patients, to evaluate for, ischemic heart disease and arrhythmia analysis during exercise testing
Not Found
The provided text describes the 510(k) summary for the EASI ECG device (K033513). However, it is very brief regarding detailed acceptance criteria and study particulars. Based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Standard (Implied) | Device Performance (Reported) |
|---|---|---|
| Substantial Equivalence | To predicate device (K020456 and K990476 & K032858) | "Testing involved performance verification... and comparison of results to the predicate and direct ECG. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that EASI ECG meets all requirements and performance claims." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 1185 patients.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The data is referred to as a "database."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Not specified. The text only mentions "comparison of results to the predicate and direct ECG."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study is not mentioned. The comparison was primarily against a predicate device and "direct ECG."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the performance verification involved the device (EASI ECG) being compared to "direct ECG" and a "predicate" algorithm/device. This implies a standalone evaluation of the EASI ECG algorithm's output.
7. The Type of Ground Truth Used
- The "ground truth" for the test set appears to be derived from a "direct ECG." This suggests a reference standard obtained by conventional, established ECG recording methods.
8. The Sample Size for the Training Set
- Not specified. The document only mentions the test set of 1185 patients.
9. How the Ground Truth for the Training Set Was Established
- Not specified, as the training set details are not provided.
Summary of Limitations in the Provided Information:
The 510(k) summary provided is very high-level and lacks specific details regarding:
- The exact "Pass/Fail criteria" for substantial equivalence.
- The specific metrics used for comparison (e.g., accuracy, sensitivity, specificity for arrhythmia detection or ST segment analysis).
- Details on the "direct ECG" used as a reference.
- The nature of the "database" of 1185 patients (e.g., demographics, disease prevalence, data collection method).
- Any details about the training data or how its ground truth was established.
- The role of human experts in establishing ground truth for either the training or test sets.
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K033513
page 1 of 1
510 (k) Summary 9.0
summary of 510(k) safety and effectiveness information is This submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.
- The submitter of this premarket notification is:
Philips Medical Systems
This summary was prepared on November 5, 2003.
-
- The name of this device is the EASI ECG. Classification names are as follows:
| Classification | ProCode | Description |
|---|---|---|
| 870.2350, II | 74 DRW | Adapter, Lead Switching,electrocardiograph |
-
- The modification is a change that provides additional derived leads, alternative electrode placements, and an expanded patient population.
-
- EASI ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult, pediatric, or neonatal patients including arrhythmia monitoring or ST seqment changes of adult patients, to qain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
-
- The new device has the same technological characteristics as the legally marketed predicate device.
-
- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved performance verification to a 1185 patient database and comparison of results to the predicate and direct ECG. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that EASI ECG meets all requirements and performance claims.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2004
Philips Medical Systems c/o Mr. David Osborne Quality Program Manager Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099
Re: K033513
Trade Namc: EASI ECG Regulation Number: 21 CFR 870.2350 Regulation Name: Electrocardiograph Lead Switching Adaptor Regulatory Class: Class II (two) Product Code: DRW Dated: November 5, 2003 Received: November 6, 2003
Dear Mr. Osborn:
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, I'DA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Mr. David Osborne
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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
C. Mepastmap
$\omega$
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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Page
510(k) Number (if known): K0 33513
EASI ECG Device Name:
Intended Use: EASI ECG is intended for monitoring multiple leads of ECG of adults, pediatrics and neonates.
ST. Segment monitoring is restricted to adult patients only.
Indications for Use: EASI ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult, pediatric, or neonatal patients including arrhythmia monitoring or ST segment changes of adult patients, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms, including:
- Assessment of symptoms that may be related to rhythm disturbances of the heart
- -Patients with palpitations
- The evaluation of arrhythmias in patients from neonatal to pediatric to adult age
- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------arrhythmia
- -- Assessment of efficacy of anti-arrhythmic therapy
- -- Assessment of pacemaker function
- Assessment of symptomatic or asymptomatic patients, to evaluate for, ischemic heart disease and arrhythmia analysis during exercise testing
Ceres
(Division Sign-Off)
Division of Cardiovascular Devices
(PLEASE DO NOT WRITE BELOW THIS LINE Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use X | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)
§ 870.2350 Electrocardiograph lead switching adaptor.
(a)
Identification. An electrocardiograph lead switching adaptor is a passive switching device to which electrocardiograph limb and chest leads may be attached. This device is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations such as leads I, II, and III.(b)
Classification. Class II (performance standards).