(47 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the descriptions of the device and testing do not mention any AI/ML techniques.
Yes
The device monitors cardiac arrhythmia, ST segments, and heart rate to provide information for treatment, monitor treatment adequacy, or exclude causes of symptoms, which are therapeutic purposes.
Yes
The device monitors cardiac arrhythmia and ST segments to gain information for treatment, monitor adequacy of treatment, or exclude causes of symptoms, which are all diagnostic activities.
Yes
The device description explicitly states the modification is "software-based" and the predicate devices are also described as "ST/AR ST and Arrhythmia Software," strongly indicating a software-only nature. While it processes ECG data, the description focuses solely on the software algorithms and their analysis capabilities, without mentioning any associated hardware components included in the submission.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The intended use and device description clearly indicate that this device monitors physiological signals from the patient (ECG leads) to assess cardiac activity. It does not analyze samples taken from the patient.
- The device description focuses on software changes for analyzing ECG signals. This is a form of physiological monitoring, not in vitro analysis.
- The intended use describes monitoring cardiac arrhythmias and ST segments. These are direct measurements of the heart's electrical activity, not analyses of bodily fluids or tissues.
Therefore, this device falls under the category of a physiological monitoring device, not 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 STAR cardiotach is to monitor a neonatal, pediatric, or adult patient's heart rate and produce events/alarms for one of two ECG leads. The cardiotach function is for use on both paced and non-paced patients.
The intended use of the STAR arrhythmia analysis algorithm is to monitor a neonatal, pediatric, or adult patient for ventricular and other serious ventricular and atrial arrhythmias. The arrhythmia analysis algorithm is for use on both paced and non-paced patients.
The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient for ST segment elevation or depression in all possible ECG leads. The ST analysis produce events/alarms for both paced and non-paced patients.
Note: The ST algorithm does not analyze ventricularly paced or ventricular ectopic beats.
Product codes (comma separated list FDA assigned to the subject device)
74 MLD, 74 DSI, 74 MHX
Device Description
The modification is a software-based change that provides ST analysis for conventional 12-lead, MCL/V ST derivation, and single-lead QRS detection with adjustable QRS detection threshold capabilities.
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
clinician
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 E meets all reliability requirements and performance claims.
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.
K964122, K991773, K001348, and K003621
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
§ 870.1025 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
FEB 1 2 2002
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: Dave Osborn Requlatory Affairs Engineer Cardiac & Monitoring Systems Group Philips Medical Systems
3000 Minuteman Road Andover, MA 01810-1085 978 659 3178
- The submitter of this premarket notification is: Dave Osborn Requlatory Affairs Engineer Cardiac & Monitoring Systems Group Philips Medical Systems
Tel: 978 685 5624 Fax: Email: dosborn@hsgmed.com
This summary was prepared on 21 December, 2001
-
- The name of this device is the Philips ST/AR ST and Arrhythmia Software, Release E.0. Classification names are as follows:
| Classification | ProCode | Description |
|---|---|---|
| 870.1025, III | 74 MLD | Monitor, ST Alarm |
| 870.1025, III | 74 DSI | Arrhythmia Detector and Alarm |
| None | 74 MHX | Physiological Monitor, Patient Monitor |
- The new device is substantially equivalent to the previously 3. cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, K001348, and K003621.
- The modification is a software-based change that provides ST 4 . analysis for conventional 12-lead, MCL/V ST derivation, and single-lead QRS detection with adjustable QRS detection threshold capabilities.
- The new device has the same Indications for Use as the legally 5. marketed predicate device. 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 new device has the same technological characteristics as the 6. legally marketed predicate device.
-
- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of
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K014261
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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 E meets all reliability requirements and performance claims.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2002
Mr. Dave Osborne Quality Program Manager Philips Medical Systems Cardiac & Monitoring Systems Group 3000 Minuteman Road Andover, MA 01810-1099
Re: K014261
Trade Name: ST/AR and Arrhythmia Software, Model Release E.O. Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: January 31, 2002 Received: February 1, 2002
Dear Mr. Osborne:
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.
3
Page 2 - Mr. Dave Osborne
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 or any is 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 orth 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 promoted 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,
Bram D. Zuckerman, M.D.
Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page _ of _
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Philips Medical Systems ST/AR Software, Release E.O.
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Use (Per 21 CFR 801.109) (Optional Format 1-2-96) OR
Over-The-Counter
Division of Cardiovascular & Respiratory Devices
510(k) Number 201426
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