(28 days)
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 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.
The modification is a software-based change that adds QT/QTc interval monitoring features.
The provided text does not contain detailed acceptance criteria or a specific study proving the device meets those criteria. Instead, it is a 510(k) summary and an FDA clearance letter for the Philips ST/AR ST and Arrhythmia Software, Release H.0.
The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a detailed performance study with specific acceptance criteria and results.
However, based on the limited information available, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." It also says, "The results demonstrate that ST/AR Release H.0 meets all defined reliability requirements and performance claims."
Since the specific "specifications cleared for the predicate device" are not provided, a table of acceptance criteria and reported performance cannot be fully constructed. The performance is generally stated as "substantial equivalence" and meeting "all defined reliability requirements and performance claims," without quantifiable metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the given text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The focus is on the device's standalone performance in relation to predicate devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, based on the description, the testing appears to be a standalone evaluation of the device's performance. The text mentions "system level tests, performance tests, and safety testing from hazard analysis." This type of testing typically focuses on the algorithm's direct output and adherence to specifications without explicitly involving human-in-the-loop scenarios for comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the given text. The reference to "specifications cleared for the predicate device" suggests that performance was measured against established standards, but the basis of those standards (e.g., expert annotations on specific datasets) is not detailed.
8. The sample size for the training set
This information is not provided in the given text.
9. How the ground truth for the training set was established
This information is not provided in the given text.
Summary of the Study (as described in the document):
The study referenced is a set of "Verification, validation, and testing activities" aiming to establish the performance, functionality, and reliability characteristics of the new Philips ST/AR ST and Arrhythmia Software, Release H.0, with respect to its predicate devices.
- Test Types: System level tests, performance tests, and safety testing from hazard analysis.
- Acceptance Criteria Basis: Pass/Fail criteria were based on specifications cleared for the predicate device.
- Outcome: Test results reportedly showed substantial equivalence to the predicate device and demonstrated that ST/AR Release H.0 meets all defined reliability requirements and performance claims.
The document serves as a regulatory filing for substantial equivalence, which typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate, rather than providing a detailed scientific study with specific acceptance metrics and comprehensive dataset information. Therefore, many of the requested details about sample sizes, expert qualifications, and ground truth establishment are not present in this type of regulatory submission.
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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.
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- 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
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- 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.
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- 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.
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- 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.
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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
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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
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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
§ 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.