PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291
Device Facts
| Record ID | K031422 |
|---|---|
| Device Name | PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291 |
| Applicant | Philips Medical Systems |
| Product Code | DPS · Cardiovascular |
| Decision Date | Jul 3, 2003 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 870.2340 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
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.
Device Story
PageWriter Trim Series Cardiograph is a multi-channel electrocardiograph for use in healthcare facilities by trained professionals. It acquires ECG signals via body surface electrodes; processes signals using internal algorithms to provide measurements, graphical presentations, and interpretive statements; and displays/prints results. The device includes a digital patient acquisition module, LCD display, rechargeable battery, thermal printer, and optional barcode/magnetic card readers. The system provides advisory interpretations intended to support, not replace, clinical judgment; a qualified physician must overread and validate all computer-generated interpretations. The device aids clinicians in diagnosing, treating, or monitoring cardiac conditions.
Clinical Evidence
Bench testing only. The device underwent performance, functionality, and reliability testing in accordance with established quality systems and standards, including AAMI EC11, IEC 60601-1, UL 2601.1, IEC 60601-2-25, and IEC 60601-1-2.
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 adult and pediatric analysis programs and filtering algorithms. Complies with AAMI EC11, IEC 60601-1, UL 2601.1, IEC 60601-2-25, and IEC 60601-1-2 standards.
Indications for Use
Indicated for adult and pediatric patients where the clinician decides to evaluate the electrocardiogram as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment, 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
- PageWriter Touch Cardiograph (K020708)
Related Devices
- K020708 — PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES · Philips Medical Systems, Inc. · Apr 25, 2002
- K080999 — PAGEWRITER CARDIOGRAPH · Philips Medical Systems · May 9, 2008
- K971440 — FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH · Fukuda Denshi USA, Inc. · Dec 2, 1997
- K101115 — ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 · Mortara Instrument, Inc. · Jun 18, 2010
- K171360 — CONTEC Electrocardiograph · Contec Medical Systems Co.,Ltd · Jan 22, 2018
Submission Summary (Full Text)
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# Philips Medical Systems
# 510(k) Summary of Safety and Effectiveness for Philips Medical Systems PageWriter Trim Series Cardiograph
- March 27th, 2003 1. DATE SUMMARY PREPARED
### 2. SUBMITTER'S NAME AND ADDRESS
Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099
- Mr. Songhua Zhang 3. CONTACT PERSON Regulatory Affairs Engineer Email: songhua.zhang@philips.com Telephone: (978) 659-7319 Facsimile: (978) 659-3610
- 4. DEVICE NAME Proprietary (trade) Name: Page Writer Trim Series Cardiograph Common Name: Electrocardiograph Classification Name: Electrocardiograph, CFR 870.2340 Product Code: 74DPS Class: II Panel: Cardiovascular / Circulatory System Devices Panel (74)
- 5. PREDICATE DEVICE The legally marketed devices to which equivalence is being claimed is the PageWriter Touch Cardiograph manufactured by Philips Medical Systems - K020708
### 6. DEVICE DESCRIPTION
The PageWriter Trim Series Cardiograph is Philips Medical Systems' cardiograph offering a full complement of features, for both adult and pediatric patients.
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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.
### 7. 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.
### 8. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The PageWriter Trim Series Cardiograph has the similar cardiograph characteristics as the predicate PageWriter Touch 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. The Page Writer Trim Series Cardiograph has similar hardware design as the predicate PageWriter Touch 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.
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# 9. NON-CLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The substantial equivalence of the PageWriter Trim 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
- s 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, PageWriter Trim Series Cardiograph will have completed the testing listed above with acceptable results, demonstrating substantial equivalence.
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Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
3 2003 JUL
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical Systems c/o Mr. Ned E. Devine Entela, Inc. Regulatory Affairs Engineer 3000 Minuteman Road Andover. MA 01810-1099
Re: K031422
Trade Name: Page Writer Trim Series Cardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: June 18, 2003 Received: June 20, 2003
Dear Mr. Zhang:
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. Divine
Please be advised that FDA`s issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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 (OS) 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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
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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## Indications for Use Statement
510(k) Number (if known): Device Name: PageWriter Trim Series Cardiograph
### PageWriter Trim 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-Lead 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.
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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|------------------------------------------|-------------------------------------------------------------------|
| | (Division Sign-Off) <div>Division of Cardiovascular Devices</div> |
| Prescription Use<br>(Per 21 CFR 801.109) | 510(k) Number K031427<br>OR Over-The-Counter Use |
Indications for Use Statement
