(51 days)
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.
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.
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.
This document (K020708) is a 510(k) Summary of Safety and Effectiveness for the Philips Medical Systems M5000A Series Cardiograph. It does not contain the detailed information necessary to answer all the questions regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the document states:
- "Prior to marketing in the US, M5000A will have completed the testing listed above with acceptable results, demonstrating substantial equivalence." (Section 10)
- "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 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." (Section 9)
This indicates that while testing was planned and results were expected to be acceptable, the document itself does not report the specific acceptance criteria or the detailed results of a study that proves the device meets them. It also does not discuss AI assistance, ground truth establishment for a training set, or other detailed performance metrics beyond general compliance with standards.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I provide information related to sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth used, training set sample size, or how ground truth for the training set was established. This information would typically be found in detailed validation reports, which are not included in this 510(k) summary.
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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.
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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
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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.
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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.
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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
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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
§ 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).