(28 days)
No
The summary describes standard ECG analysis algorithms and software modifications without mentioning AI or ML.
No
The device monitors cardiac arrhythmia, ST segment, heart rate, and QT/QTc interval, providing information for treatment, but it does not directly treat or alleviate a disease or condition.
No
The device is primarily described as a monitoring device that produces events/alarms based on various ECG analyses (heart rate, arrhythmias, ST segment, QT/QTc interval). While it provides information that can be used for risk assessment, the text explicitly states for QT/QTc analysis that it "is not intended to produce any interpretation or diagnosis of those measurements," indicating it does not provide a definitive diagnosis.
Yes
The device description explicitly states the modification is a "software-based change" and the intended use and device description focus solely on the analysis of ECG data through software algorithms. There is no mention of new or modified hardware components.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device monitors ECG signals directly from the patient's body. It analyzes electrical activity of the heart to provide information about heart rate, arrhythmias, and ST/QT segments. This is a form of in vivo monitoring, not in vitro testing of a sample.
- Intended Use: The intended use focuses on monitoring the patient's physiological state (cardiac activity) directly, not on analyzing a biological sample.
Therefore, while this device is a medical device used for diagnostic purposes (providing information to aid in diagnosis and treatment), it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
The intended use of the ST/AR cardiotach is to monitor a neonatal, pediatric, or adult patient's ECG for heart rate and produce events/alarms for one or two ECG leads. The cardiotach function is capable of monitoring both paced and non-paced patients.
The intended use of the ST/AR arthythmia analysis algorithm is to monitor a neonatal, pediatric, or adult patient ECG's for heart rate and ventricular arrhythmias and produce events/alarms for one or two ECG leads. The arrhythmia analysis algorithm is capable of monitoring both paced and non-paced patients.
The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient's ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST analysis algorithm is capable of monitoring paced and non-paced adult patients.
The ST algorithm does not analyze ventricularly paced or ventricular ectopic beats.
The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for neonatal, pediatric and adult patients with and without symptoms of arrhythmia. QT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements.
Product codes
74 MLD, 74 DSI, 74 MHX
Device Description
The modification is a software-based change that adds QT/QTc interval monitoring features.
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, pediatric, and neonatal patients.
Intended User / Care Setting
Qualified health professionals in hospital or clinical environments.
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)
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that ST/AR Release H.0 meets all defined reliability requirements and performance claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K964122, K991773, K001348, K003621, K014261, K021251
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image shows a handwritten text string. The string appears to be a combination of letters and numbers, specifically "K070260". There is also a superscripted fraction "P1/2" to the right of the number. The text is written in a dark ink on a white background.
FEB 2 3 2007
9.0 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR §807.92.
-
- The submitter of this premarket notification is:
Denise Haley Sr. Quality & Regulatory Engineer Ultrasound & Monitoring Systems Philips Medical Systems 3000 Minuteman Road, MS0240 Andover, MA 01810-1099
- The submitter of this premarket notification is:
Tel: 978 659 4358 Fax: 978 659 3819 Email: denise.haley@philips.com
This summary was prepared on 24 January 2007
-
- The name of this device is the Philips ST/AR ST and Arrhythmia Software, Release H.0. Classification names are as follows:
| Classification | ProCode | Description |
|---|---|---|
| 870.1025, II | 74 MLD | Monitor, ST Alarm |
| 870.1025, II | 74 DSI | Arrhythmia Detector and Alarm |
| None | 74 MHX | Physiological Monitor, Patient Monitor |
- The new device is substantially equivalent to the previously cleared ST/AR ST and 3. Arrhythmia Software device marketed pursuant to K964122, K991773, K001348, K003621, K014261 and K021251 and the Philips 2010 Plus Holter for Windows K010949.
-
- The modification is a software-based change that adds QT/QTc interval monitoring features.
- The new device has the same Indications for Use and Intended Use as the legally marketed న. predicate devices.
- The new device has the same technological characteristics as the legally marketed predicate 6. devices.
1
-
- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that ST/AR Release H.0 meets all defined reliability requirements and performance claims.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA". The text is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical Systems Ms. Denise Haley Sr. Quality and Regulatory Engineer 3000 Minuteman Road Andover, MA 01810
FEB 2 3 2007
Re: K070260
Trade Name: Philips Medical Systems ST/AR ST and Arrhythmia Software, Release H.0 Regulation Number: 21 CFR 870,1025 Regulation Name: Arrhythmia Detector and Alarm (including ST measurement and alarm) Regulatory Class: Class II Product Code: DSI Dated: January 24, 2007 Received: January 26, 2007
Dear Ms. Haley:
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.
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
3
Page 2 - Ms. Denise Haley
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), please contact the Office of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Prana D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
3.1 ODE Indications Statement
Indications for Use
510(k) Number (if known): Ko70260
Device Name: ____ ST/AR ST and Arrhythmia Software ___________________________________________________________________________________________________________________________
Indications for Use:
Where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
The intended use of the ST/AR cardiotach is to monitor a neonatal, pediatric, or adult patient's ECG for heart rate and produce events/alarms for one or two ECG leads. The cardiotach function is capable of monitoring both paced and non-paced patients.
The intended use of the ST/AR arthythmia analysis algorithm is to monitor a neonatal, pediatric, or adult patient ECG's for heart rate and ventricular arrhythmias and produce events/alarms for one or two ECG leads. The arrhythmia analysis algorithm is capable of monitoring both paced and non-paced patients.
The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient's ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST analysis algorithm is capable of monitoring paced and non-paced adult patients.
The ST algorithm does not analyze ventricularly paced or ventricular ectopic Note: beats.
The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for neonatal, pediatric and adult patients with and without symptoms of arrhythmia. QT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements.
| Prescription Use
(Part 21 CFR 801 Subpart D) | ✓ | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) |
| ------------------------------------------------- | --- | -------- | ------------------------------------------------ |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division/Sign-O.: | |
|---|---|
| Division of Cardiov: |
| 510(k) Number | Confidential K070260 |
|---|---|
| --------------- | ---------------------- |
Page 10