(57 days)
No
The document does not mention AI, ML, or related terms, and the description of the technology and performance studies aligns with traditional signal processing and algorithm-based analysis.
No
Explanation: The device is described as a monitor that provides information for treatment, but it does not directly administer therapy or physically interact with the patient to treat a condition. It is a diagnostic/monitoring device.
Yes
The device's intended use explicitly mentions gaining information for treatment, monitoring adequacy of treatment, or excluding causes of symptoms, as well as providing "information to aid in the diagnosis of cardiac arrhythmias." This aligns with the definition of a diagnostic device.
No
The device description explicitly states the modification is a "software-based change" that adds features to an existing system. The intended use and performance studies refer to monitoring ECGs, which requires hardware (ECG electrodes, cables, and a device to acquire the signal). The software processes the data from this hardware. Therefore, it is not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device analyzes ECG signals, which are electrical signals measured directly from the patient's body surface. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly describes monitoring cardiac activity and providing information for treatment decisions based on those measurements. This is a direct physiological measurement and analysis, not an in vitro test.
Therefore, this device falls under the category of a medical device that performs physiological monitoring and analysis, but it is not an IVD.
N/A
Intended Use / Indications for Use
Where the clinician decides to monitor cardiac arthythmia 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, pediatic, 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 arrhythmia analysis algorithm is to monitor a neonatal, pediation of adult patient ECG's for heart rate and ventricular arthythmias, 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.
Note: 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, pediatic and adult patients with and without symptoms of arrhythmia. OT 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.
EASI ECG is intended for monitoring multiple leads of ECG of adults, pediatrics and neonates. EASI ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult, pediatric, or neonatal patients including arrhythmia monitoring or ST segment changes of adult patients, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
RLS ECG is intended for monitoring multiple leads of ECG of adults.
RLS ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult patients including arrhythmia, ST segment changes, and QT/QTc, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
Product codes
MHX, MLD, DSI
Device Description
The modification is a software-based change that adds the following features:
- Support derived 12-lead ECG (RLS ECG) from a 6-electrode lead set.
- Provide enhanced AF and Irregular HR alarms detection
- Provide enhanced QT and ST analysis and alarms.
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. Health care 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
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 K.O meets all defined reliability requirements and performance claims.
Key Metrics
Not Found
Predicate Device(s)
K080461, K964122, K991773, K001348, K003621, K014261, K021251, K033513, K040357, K070260
Reference Device(s)
K073376, K033515, K060307, K030738
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
Kiołszl
Philips Medical Systems
1 - 1 -
PHILIPS
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 8807.92.
- 】. The submitter of this premarket notification is: Lois Giegerich RN Quality Specialist/Clinician Philips Medical Systems 3000 Minuteman Road. Andover, Massachusetts 01810-1099 Tel: 978-659-7809 Fax: 978-659-4481 e-mail: lois.giegerich@philips.com
JUL 2 9 2010
This summary was prepared on May 28, 2010.
-
- The name of this device is the Philips ST/AR ST and Archythmia Software, Release K.O. 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 Arrhythmia Software device marketed pursuant to K080461, K964122, K991773, K001348, K003621, K014261, K021251, K033513, K040357, K070260 and the Philips ECG Algorithm K073376, the Philips EASI ECG K033515, the GE 12RL Algorithm K060307, and the Siemens Infinity MultiView Workstation K030738.
-
- The modification is a software-based change that adds the following features:
- · Support derived 12-lead ECG (RLS ECG) from a 6-electrode lead set.
- · Provide enhanced AF and Irregular HR alarms detection
- · Provide enhanced QT and ST analysis and alarms.
- ನ್ನ The new device has the same Indications for Use and Intended Use as the legally marketed predicate devices.
-
- The new device has the same technological characteristics as the legally marketed predicate devices.
-
- 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
1
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test.results showed substantial equivalence. The results demonstrate that ST/AR Release K.O meets all defined reliability requirements and performance claims.
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 9 2010
Philips Medical Systems c/o Ms. Lois Giegerich Quality Specialist/Clinician 3000 Minuteman Road Andover, MA 01810-1099
Re: K101521
Device Name: Philips ST/AR ST and Arrhythmia Software, Release K.0 Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (With Arrhythmia Detection or Alarms) Regulatory Class: Class II (Two) Product Codes: MHX, MLD, DSI Dated: June 30, 2010 Received: July 8. 2010
Dear Ms. Giegerich:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Lois Giegerich
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1.1.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Prem 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
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1.1 ODE Indications Statement
Indications for Use
510(k) Number (if known): K101521
Device Name: ST/AR ST and Arrhythmia Software
Indications for Use:
Where the clinician decides to monitor cardiac arthythmia 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, pediatic, 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 arrhythmia analysis algorithm is to monitor a neonatal, pediation of adult patient ECG's for heart rate and ventricular arthythmias, 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.
Note: 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, pediatic and adult patients with and without symptoms of arrhythmia. OT 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.
EASI ECG is intended for monitoring multiple leads of ECG of adults, pediatrics and neonates. EASI ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult, pediatric, or neonatal patients including arrhythmia monitoring or ST segment changes of adult patients, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
RLS ECG is intended for monitoring multiple leads of ECG of adults.
RLS ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult patients including arrhythmia, ST segment changes, and QT/QTc, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
| Prescription Use (Part 21 CFR 801 Subpart D) | YES | AND/OR | Over-The-Counter Use NO (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-Off)
Division of Cardiovascular Devices
| 510(k) Number | K101521 |
|---|---|
| --------------- | --------- |
JUL 2 5 2010