(58 days)
Not Found
No
The summary describes the use of "algorithms" for ECG analysis and interpretation, but does not mention AI, ML, or related terms. The description of performance studies focuses on standards compliance and software testing, not AI/ML model validation.
No.
The device is used for diagnosis and monitoring by acquiring, recording, displaying, analyzing, and storing ECG signals, not for providing therapy.
Yes
The intended use states that the device is used to acquire, record, display, analyze, and store ECG signals, and specifically mentions, "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." This directly indicates a diagnostic purpose.
No
The device description explicitly states that the device consists of hardware components such as a digital patient acquisition module, LCD display, rechargeable battery, thermal printer, and optional barcode scanner or magnetic card strip reader, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- Device Function: The described device acquires and analyzes ECG signals directly from the patient's body surface using electrodes. This is an in vivo measurement, not an in vitro examination of a specimen.
- Intended Use: The intended use is to acquire, record, display, analyze, and store ECG signals for review by healthcare professionals to aid in evaluating the patient's cardiac status. While the analysis provides information for potential diagnosis and treatment decisions, it is based on direct physiological measurements from the patient, not on testing a sample outside the body.
Therefore, the device falls under the category of a medical device that performs physiological measurements in vivo, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
74DPS
Device Description
The PageWriter Trim 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
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in bold, sans-serif font at the top. Below the word is a circular emblem containing two wavy lines and four stars. The emblem is enclosed in a shield-like shape.
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
-
- 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)
-
- 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.
1
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.
2
Image /page/2/Picture/1 description: The image shows the Philips logo and brand name. The logo is on the left, and the brand name "PHILIPS" is in large, bold letters to the right of the logo. Below the brand name, there is a model number "K031422".
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.
3
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.
4
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
5
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY )
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Cardiovascular Devices | |
| Prescription Use | |
| (Per 21 CFR 801.109) | 510(k) Number K031427 |
| OR Over-The-Counter Use |
Indications for Use Statement