(18 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 arrhythmia 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 modification is a software-based change that provides Cardiotach functionality without arrhythmia analysis and ST Segment Analysis without arrhythmia analysis.
The provided text describes a 510(k) summary for the Philips ST/AR ST and Arrhythmia Software, Release E.1. However, it does not contain detailed information regarding acceptance criteria, specific device performance metrics, sample sizes for test or training sets, ground truth establishment methods, or whether MRMC or standalone studies were conducted.
The document mainly focuses on establishing substantial equivalence to previously cleared predicate devices through software-based changes. It states that "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." and "The results demonstrate that ST/AR Release E.1 meets all reliability requirements and performance claims." but does not elaborate on what these specifications or claims are.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's an attempt to answer the questions based only on the provided information, noting where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Based on specifications cleared for predicate device | Test results showed substantial equivalence to the predicate device. |
| Meet all reliability requirements | Addressed; results demonstrate meeting requirements. |
| Meet all performance claims | Addressed; results demonstrate meeting claims. |
(Note: Specific numerical criteria for performance (e.g., sensitivity, specificity, accuracy for arrhythmia or ST detection) are not provided in the text.)
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "test results" and "system level tests, performance tests, and safety testing from hazard analysis" but does not provide details on the number of cases or patients used.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: Not specified. The document describes the device as "ST/AR ST and Arrhythmia Software" which is a standalone software, not explicitly an AI-assisted interpretation tool for human readers in the context of comparative effectiveness.
- Effect Size: Not applicable/not provided.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Evaluation: Yes, implied. The testing activities mentioned ("system level tests, performance tests") evaluated the device's inherent capabilities against predicate device specifications, suggesting a standalone evaluation of the algorithm. The device itself is described as "Software" that provides "Cardiotach functionality" and "ST Segment Analysis," indicating it operates independently to perform these functions. However, specific standalone metrics (e.g., sensitivity, specificity) are not provided.
7. The type of ground truth used
- Type of Ground Truth: Not specified. Given the context of arrhythmia and ST segment analysis, it would typically involve expert consensus on ECGs, potentially correlated with clinical outcomes or other diagnostic tests, but this is not explicitly stated in the document.
8. The sample size for the training set
- Sample Size for Training Set: Not specified.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not specified.
In summary, the provided submission primarily focuses on the regulatory aspect of substantial equivalence based on a software modification, rather than a detailed technical performance study with quantitative results and specific methodologies for clinical validation. This type of information is often found in more detailed technical reports or other sections of a 510(k) submission not included in this summary.
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MAY 0 7 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 Regulatory Affairs Engineer Cardiac & Monitoring Systems Group Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1085
978 659 3178 Tel: 978 685 5624 Fax: Email: dosborn@hsgmed.com
This summary was prepared on 17 April, 2002
-
- The name of this device is the Philips ST/AR ST and Arrhythmia Software, Release E.1. 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, K003621 and K014261.
- The modification is a software-based change that provides 4 . Cardiotach functionality without arrhythmia analysis and ST Segment Analysis without arrhythmia analysis.
- 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 the new device with respect to the predicate. Testing involved
44
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K021251
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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.1 meets all 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 & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 7 2002
Mr. Dave Osborn Quality Program Manager Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099
Re: K021251
Trade Name: Philips Medical Systems ST/AR and Arrhythmia Software, Release E.1. Regulation Name: Arrhythmia Detector and Alarm Regulation Number: 21 CFR 870.1025 Regulatory Class: Class III (three) Product Code: DSI Dated: April 18, 2002 Received: April 19, 2002
Dear Mr. Osborn:
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. Iisting 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.
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Page 2 -- Mr. Dave Osborn
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 car) x 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 Erth 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 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,
Darla Tule
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page / of /
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Philips Medical Systems ST/AR Software, Release E.1.
Where the clinician decides to monitor cardiac Indications for Use: 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 arrhythmia 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 Note: or ventricular ectopic beats.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use ✓ | OR | Over-The-Counter |
|---|---|---|
| --------------------------------------------------------------------------- | ---- | ------------------ |
Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)
Jada tu
Division of Cardiovascular & Respiratory Devices
510(k) Number K061251
§ 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.