(51 days)
Not Found
No
The description mentions "algorithms that provide measurements, data presentations, graphical presentations and interpretations," but does not specifically mention AI or ML. The analysis is described as "computer generated ECG interpretation" which is a general term and doesn't necessarily imply AI/ML. The lack of mention of training or test sets for AI/ML models further supports this conclusion.
No
The device is described as a cardiograph used to acquire, record, display, analyze, and store ECG signals for review and to assist in diagnosis, not to perform treatment.
Yes
The device acquires, displays, analyzes, and stores ECG signals, providing measurements, data presentations, graphical representations, and interpretations "for review by the user." The interpretations, though advisory, are explicitly used "as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms," which are all functions of a diagnostic device.
No
The device description explicitly lists hardware components such as a digital patient acquisition module, LCD display, rechargeable battery, thermal printer, and optional barcode scanner or magnetic card strip reader. This indicates it is a hardware device with integrated software, not a software-only medical 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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The M5000A Series Cardiograph acquires and analyzes electrical signals from the body surface (ECG signals). It does not perform tests on biological samples taken from the body.
- Intended Use: The intended use is to acquire, record, display, analyze, and store ECG signals for review by healthcare professionals. While the analysis provides interpretations, these are advisory and require clinical validation. This is consistent with a diagnostic device that provides information about the body's electrical activity, not a test performed on a sample from the body.
Therefore, the device falls under the category of a diagnostic device that measures physiological signals, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
M5000 Series Cardiograph:
Intended Use
To acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record, display, analyze and store these ECG signals for review by the user. To be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished 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.
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.
12-LDx Interpretive Algorithm:
Intended 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.
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.
Product codes
74DPS, DPS
Device Description
The M5000A Series Cardiograph is Philips Medical Systems' cardiograph offering a full complement of features, for both adult and pediatric patients.
The Cardiograph offers increased speed and ease-of-use for patient data entry. The device also consists of a digital patient acquisition module, LCD display and rechargeable battery, thermal printer, optional barcode scanner or magnetic card strip reader.
The Cardiograph provides crisp, easy-to-read ECGs on a standard page. Records are clearly labeled with ECG data and patient information.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body surface
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
Healthcare facilities by trained healthcare professionals.
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)
Non-clinical testing to applicable standards: AAMI EC11, IEC 60601-1, UL 2601.1, IEC i 60601-2-25, IEC 60601-1-2. Performance, functionality, and reliability characteristics of the device and algorithm software testing followed established test procedures and quality system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
M1700A Cardiograph manufactured by Philips Medical Systems (formerly Healthcare Solutions Group of Hewlett-Packard Co.) - K895520
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).
0
Image /page/0/Picture/0 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in bold, uppercase letters above a shield-shaped emblem. Inside the shield, there are two wavy lines representing water, and four stars, two above the water and two below. The logo is black and white.
APR 2 5 2002
510(k) Summary of Safety and Effectiveness
for
Philips Medical Systems M5000A Series Cardiograph
| 1. DATE SUMMARY PREPARED | January 23rd, 2002 | |
|---|---|---|
| -- | -------------------------- | -------------------- |
2. SUBMITTER'S NAME AND ADDRESS
Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099
-
- CONTACT PERSON
Mr. Songhua Zhang Regulatory Affairs Engineer Telephone: (978) 659-7319 Facsimile: (978) 659-7360
- CONTACT PERSON
-
- DEVICE NAME
Proprietary (trade) Name: M5000A Series Cardiograph Common Name: Electrocardiograph Electrocardiograph, CFR 870.2340 Classification Name: 74DPS Product Code: Class: II Panel: Cardiovascular / Circulatory System Devices Panel (74)
- DEVICE NAME
-
The legally marketed devices to which equivalence is being 5. PREDICATE DEVICE claimed is the M1700A Cardiograph manufactured by Philips Medical Systems (formerly Healthcare Solutions Group of Hewlett-Packard Co.) - K895520
6. DEVICE DESCRIPTION
The M5000A Series Cardiograph is Philips Medical Systems' cardiograph offering a full complement of features, for both adult and pediatric patients.
The Cardiograph offers increased speed and ease-of-use for patient data entry. The device also consists of a digital patient acquisition module, LCD display and rechargeable battery, thermal printer, optional barcode scanner or magnetic card strip reader.
The Cardiograph provides crisp, easy-to-read ECGs on a standard page. Records are clearly labeled with ECG data and patient information.
1
Image /page/1/Picture/0 description: The image shows the Philips logo, which is a shield shape with the word "PHILIPS" at the top. Inside the shield, there is a circle containing two wavy lines representing water and two four-pointed stars. The logo is black and white.
7. INTENDED USE
M5000 Series Cardiograph:
Intended Use
To acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record, display, analyze and store these ECG signals for review by the user. To be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished 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.
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.
12-LDx Interpretive Algorithm:
Intended 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.
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.
8. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The M5000A Series Cardiograph has the similar cardiograph characteristics as the
2
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predicate M1700A PageWriter Xli Cardiograph. For example, they both contain the same ECG measurements, adult and pediatric analysis programs, software filtering algorithm, ECG basic controls and both have the similar standardization, DC offset sensitivity, time base and accuracy stability, bandwidth, input dynamic range, storage of recorded signals. The M5000A Series Cardiograph has similar hardware design as the predicate M1700A Cardiograph, they both have thermal ECG printer, digital patient acquisition module, rechargeable battery, and LCD display.
The technological differences do not affect the safety or effectiveness of the device. Any safety issues that may be raised by the new device are addressed in the device's risk analysis and the device verification and validation activities.
9. NON-CLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The substantial equivalence of the M5000A Series Cardiograph is demonstrated by the following non-clinical testing:
- Testing to applicable standards: AAMI EC11, IEC 60601-1, UL 2601.1, IEC i 60601-2-25, IEC 60601-1-2
- The performance, functionality, and reliability characteristics of the device and ■ algorithm software testing follow established test procedures and quality system.
10. CONCLUSIONS FROM NON-CLINICAL TESTING
Prior to marketing in the US, M5000A will have completed the testing listed above with acceptable results, demonstrating substantial equivalence.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 5 2002
Philips Medical Systems, Inc. c/o Mr. Ned E. Devine Program Manager III Entela, Inc. 3033 Madison Avenue SE Grand Rapids, MI 49548
Re: K020708
Trade Name: M5000A Series Cardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: April 8, 2002 Received: April 10, 2002
Dear Mr. Devine:
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, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Ned E. Devine
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
V
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name: M5000A Series Cardiograph
M5000A Series Cardiograph
Intended Use
To acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record, display, analyze and store these ECG signals for review by the user. To be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished 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.
12-LDx Interpretive Algorithm
Intended 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.
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| OR Over-The-Counter Use |
Division of Cardiovascular & Respiratory Devices
| Indications for Use Statement 510(k) Number | K200708 |
|---|---|
| --------------------------------------------- | --------- |
APPENDIX H-1