PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES
Device Facts
| Record ID | K020708 |
|---|---|
| Device Name | PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES |
| Applicant | Philips Medical Systems, Inc. |
| Product Code | DPS · Cardiovascular |
| Decision Date | Apr 25, 2002 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 870.2340 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for 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.
Device Story
M5000A Series Cardiograph acquires multi-channel ECG signals via body surface electrodes; processes signals using 12-LDx interpretive algorithm to provide measurements, graphical presentations, and interpretations. Used in healthcare facilities by trained professionals; device includes digital acquisition module, LCD display, rechargeable battery, thermal printer, and optional barcode/magnetic card readers. Output provided on standard page or display for clinician review; serves as advisory tool for clinical decision-making. Requires qualified physician to overread and validate computer-generated interpretations. Benefits include rapid data entry and clear ECG visualization to support diagnostic workflows.
Clinical Evidence
Bench testing only. Performance, functionality, and reliability verified through testing to AAMI EC11, IEC 60601-1, UL 2601.1, IEC 60601-2-25, and IEC 60601-1-2 standards.
Technological Characteristics
Electrocardiograph featuring digital patient acquisition module, thermal printer, LCD display, and rechargeable battery. Connectivity includes optional barcode scanner or magnetic card strip reader. Software includes 12-LDx interpretive algorithm for ECG analysis. Complies with AAMI EC11, IEC 60601-1, UL 2601.1, IEC 60601-2-25, and IEC 60601-1-2.
Indications for Use
Indicated for adult and pediatric patients when a clinician evaluates an electrocardiogram to assist in diagnosis, potential treatment, treatment effectiveness, or to rule-out causes for symptoms.
Regulatory Classification
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.
Predicate Devices
- M1700A Cardiograph (K895520)
Submission Summary (Full Text)
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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
- 3. CONTACT PERSON
Mr. Songhua Zhang Regulatory Affairs Engineer Telephone: (978) 659-7319 Facsimile: (978) 659-7360
- 4. 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)
- 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
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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<br>(Per 21 CFR 801.109) | <div style="text-align:left;"><img alt="checked" src="checkbox.png"/></div> |
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| OR Over-The-Counter Use | |
Division of Cardiovascular & Respiratory Devices
| Indications for Use Statement 510(k) Number | K200708 |
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APPENDIX H-1
