EASI ECG ALGORITHM

K033513 · Philips Medical Systems · DRW · Jan 15, 2004 · Cardiovascular

Device Facts

• Record ID: K033513
• Device Name: EASI ECG ALGORITHM
• Applicant: Philips Medical Systems
• Product Code: DRW · Cardiovascular
• Decision Date: Jan 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2350
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

EASI ECG is a lead switching adapter for electrocardiographs; it processes ECG signals to derive multiple leads from specific electrode placements. Operated by healthcare professionals in clinical settings, the device provides continuous ECG monitoring. It transforms raw electrode inputs into derived ECG leads, enabling arrhythmia detection and ST segment analysis (adults only). The output is displayed on a patient monitor, allowing clinicians to assess cardiac rhythm, evaluate therapy efficacy, monitor pacemaker function, and screen for ischemic heart disease. This facilitates clinical decision-making regarding patient treatment and symptom management.

Clinical Evidence

Bench testing only. Performance was verified using a 1185-patient database. Results were compared against the predicate device and direct ECG measurements. The device met all pre-defined pass/fail criteria based on predicate specifications, demonstrating substantial equivalence.

Technological Characteristics

Lead switching adapter for electrocardiographs (Class II, 21 CFR 870.2350). Uses specific electrode placements to derive multiple ECG leads. Software-based algorithm for signal processing and lead derivation. Designed for integration with Philips patient monitoring systems.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring ECG monitoring, including arrhythmia monitoring or ST segment changes (adults only). Used to gain treatment information, monitor treatment adequacy, or exclude symptom causes. Specific indications include: assessment of symptoms related to heart rhythm disturbances; patients with palpitations; evaluation of arrhythmias across all age groups; assessment of anti-arrhythmic therapy efficacy; assessment of pacemaker function; and evaluation of symptomatic or asymptomatic patients for ischemic heart disease and arrhythmia analysis during exercise testing.

Regulatory Classification

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.

Predicate Devices

• EASI Algorithm (K020456)
• Philips patient monitors (K990476)
• Philips patient monitors (K032858)

Submission Summary (Full Text)

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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.

1. The submitter of this premarket notification is:

Philips Medical Systems

This summary was prepared on November 5, 2003.

- 2. 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,<br>electrocardiograph |

- 3. The new device is substantially equivalent to the previously cleared EASI Algorithm cleared under K020456 and Philips patient monitors cleared under K990476 & K032858.
- 4. The modification is a change that provides additional derived leads, alternative electrode placements, and an expanded patient population.
- 5. 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.
- 6. The new device has the same technological characteristics as the legally marketed predicate device.
- 7. 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 [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 Manufacturers, 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 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)