(28 days)
Not Found
No
The description uses terms like "algorithms," "measures waveform components," "recognizes patterns," and "basic rhythm analysis," which are standard signal processing techniques and rule-based systems, not necessarily indicative of AI/ML. There is no mention of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML models.
No
The device aids in analysis and interpretation of ECG signals for diagnostic purposes, and its output is advisory, not directly therapeutic.
Yes
The device analyzes ECG signals and provides interpretations for review by a clinician as part of decisions regarding possible diagnosis, clearly indicating its role in the diagnostic process.
No
The device description explicitly states it analyzes ECG signals acquired from ten electrodes (12 leads), which are hardware components. The 510(k) summary also references a predicate device that is a cardiograph, a hardware device.
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 input: The input for this device is "ECG signals acquired from ten electrodes (12 leads)". This is a measurement of electrical activity from the body's surface, not a sample taken from the body.
- Intended Use: The intended use is to analyze ECG signals and provide interpretations for review by a clinician. This is a diagnostic aid based on physiological signals, not a test performed on a biological sample.
Therefore, this device falls under the category of a medical device that analyzes physiological signals, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To analyze multi-channel ECG signals from adult and pediatric patients with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user.
The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to overread and validate (or change) the computer generated ECG interpretation.
Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms.
Product codes
74 LOS, 74 DPS
Device Description
Based on ECG signals acquired from ten electrodes (12 leads), the 12-lead analysis algorithm monitors signal quality, measures waveform components and recognizes patterns, and performs basic rhythm analysis. Using the extended measurements and patient-specific information, the algorithm generates those interpretive statements from the criteria program that summarize the findings for the ECG and highlight key areas of concern for physician review.
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
adult and pediatric patients
Intended User / Care Setting
clinician
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)
Verification, validation, and testing activities establish the performance and functionality characteristics of the new device. Testing involved system level tests, integration tests and regression tests from hazard analysis. Pass/Fail criteria were based on the specifications and test results showed substantial equivalence. The results demonstrate that the functionality of the modified Philips 12-Lead Algorithm meets all performance claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the text 'K052049' on the top line. Below that, the text '11/2' is written. The text appears to be handwritten in black ink on a white background. The numbers and letters are clearly legible.
Image /page/0/Picture/2 description: The image shows the Philips logo. The logo consists of a shield-like emblem on the left and the word "PHILIPS" in bold, sans-serif font on the right. The emblem features a circular design with wavy lines and stars inside a shield shape, while the wordmark is in all caps and black.
9. 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. 8807.92.
- The submitter of this premarket notification is:
Philips Medical Systems 3000 Minuteman Road Andover, MA 01810
Contact Person: Mr. Songhua Zhang Regulatory Engineer Tel: 978-659-7319 Fax: 978-659-3712 Email: songhua.zhang@philips.com
This summary was prepared on July 18, 2005.
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- The name of this device is the Philips 12-Lead Algorithm. Classification names are as follows:
| Classification | ProCode | Description |
|---|---|---|
| Unclassified, Class II | 74 LOS | ECG Analysis System |
| 870.2340, II | 74 DPS | Electrocardiograph |
- Based on ECG signals acquired from ten electrodes (12 leads), the 12-lead analysis 3. algorithm monitors signal quality, measures waveform components and recognizes patterns, and performs basic rhythm analysis. Using the extended measurements and patient-specific information, the algorithm generates those interpretive statements from the criteria program that summarize the findings for the ECG and highlight key areas of concern for physician review.
1
Image /page/1/Picture/1 description: The image shows the Philips logo. The logo consists of a shield with the word "PHILIPS" at the top. Inside the shield, there is a wave-like design and two stars. To the right of the shield, the word "PHILIPS" is written in large, bold letters.
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- The new device is substantially equivalent to the previously cleared M5000A Series Cardiograph with Philips 12-Lead Algorithm cleared under K020708.
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- The new device has the same Indications for Use as the legally marketed predicate device.
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- The new device has the same technological characteristics as the legally marketed predicate device.
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- Verification, validation, and testing activities establish the performance and functionality characteristics of the new device. Testing involved system level tests, integration tests and regression tests from hazard analysis. Pass/Fail criteria were based on the specifications and test results showed substantial equivalence. The results demonstrate that the functionality of the modified Philips 12-Lead Algorithm meets all performance claims.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle with three heads, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle emblem. The seal is simple and monochromatic.
AUG 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical Systems c/o Ms. Songhua Zhang Regulatory Engineer 3000 Minuteman Road, Mail Stop 220 Andover, MA 01810-1099
Re: K052049
Trade Name: Philips 12-Lead Algorithm Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: July 26, 2005 Received: July 29, 2005
Dear Ms. Zhang:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed 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 encrease) to 10gains and date of the Medical Device Amendments, or to commerce prov to May 20, 1978, the ensordance with the provisions of the Federal Food, Drug, devices mat have been rocuse approval of a premarket approval approval application (PMA). alle Cosmetic Act (71ct) that to not requent to the general controls provisions of the Act. The 1 ou may, merelore, manel and act include requirements for annual registration, listing of general controls provision 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 If your device is classified (boo are ro) als. Existing major regulations affecting your device can may be subject to suen additional connotions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.
3
Page 2 - Ms. Songhua Zhang
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 (240) 276-0295. 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 may be obtained 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 yours.
B. Zimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement 8.
KO52046 510(k) Number (if known):
Device Name: Philips 12-Lead Algorithm
Indications for Use:
Intended Üse
To analyze multi-channel ECG signals from adult and pediatric patients with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user.
The interpreted ECG with measurements and interpretive statements is offered to the clinician on It is to be used in conjunction with the clinician's knowledge of the an advisory basis only. patient, the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to overread and validate (or change) the computer generated ECG interpretation.
Indications for Use
Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms.
Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/ OR
Over-The-Counter Use No (21 CFR 801 Subpart C)
Songhua Zhang Regulatory Specialist Philips Medical Systems
Date: July 25, 2005
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Blumalama
Division Sign Off
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