(16 days)
The ApexPro FH Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations.
The ApexPro FH Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.
The physiological parameters monitored include ECG, non-invasive blood pressure, non-invasive temperature and SpO2. The ApexPro FH Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro FH is also intended to provide physiologic data over the Unity network to clinical information systems for display.
The ApexPro FH Telemetry System is composed of six major components:
Accessories to the patient worn acquisition transceivers
The patient worn data acquisition transceivers
The transceiver access points with antenna
The network infrastructure
A computer platform running the ApexPro Telemetry Application
A computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application)
The provided text does not contain specific acceptance criteria or detailed study results that would traditionally be outlined for a medical device's performance evaluation against such criteria. The document is a 510(k) summary for the GE Medical Systems Information Technologies ApexPro FH Telemetry System, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with acceptance criteria.
However, based on the information provided, here's what can be extracted and inferred regarding the "study" that proves the device meets (implied or general) acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit numerical acceptance criteria and a table detailing individual device performance metrics are not present, the "acceptance criteria" are implied by the claim of substantial equivalence and compliance with voluntary standards. The device "performance" is generally stated as being as safe and effective as the predicate.
| Acceptance Criteria (Implied/General) | Reported Device Performance |
|---|---|
| Compliance with Voluntary Standards | The ApexPro FH complies with the voluntary standards as detailed in Section 9 of this submission (details of specific standards not provided in this extract). |
| Safety and Effectiveness Equivalent to Predicate Device | "The results of these measurements demonstrated that the ApexPro FH System is as safe, as effective, and performs as well as the predicate devices." (Predicate: K032369 ApexPro Telemetry System). |
| Functional Technology Equivalence to Predicate Device | "The ApexPro FH employs the same functional technology as the predicate devices." |
| Improved Performance and Integration via Advanced Technology | "The system architecture has taken advantage of improvements in signal processing technology as well as advances in RF component technologies to improve performance and level of integration." |
| Quality Assurance Measures Applied During Development | - Requirements specification review - Code inspections - Software and hardware testing - Safety testing - Environmental testing - Final validation |
| Performance of ECG Arrhythmia Event Detection and Parameter Limit Violation Detection | The system processes physiological data "to detect various ECG arrhythmia events and select physiological parameter limit violations." (No specific performance metrics are provided for these detections in the extract.) |
| Accurate Acquisition and Monitoring of Physiological Data | The system is "designed to acquire and monitor physiological data for ambulating patients within a defined coverage area." Physiological parameters monitored include ECG, non-invasive blood pressure, non-invasive temperature and SpO2. (No specific accuracy metrics are provided for these acquisitions in the extract.) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a test set for performance evaluation. The "Test Summary" lists various quality assurance measures (software testing, hardware testing, safety testing, environmental testing, final validation) but does not detail a specific clinical or performance test set with a defined sample size.
Data provenance is not mentioned. Given the nature of a 510(k) summary relying on substantial equivalence, the "study" appears to be an internal verification and validation process rather than a multi-site clinical trial. Therefore, information about country of origin or retrospective/prospective data collection is not available in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The text refers to "Requirements specification review," "Code inspections," and various types of testing, but it does not describe a process for establishing ground truth for a test set using external experts. The "study" described is largely focused on engineering and quality assurance processes, not clinical evaluation with ground truth established by medical experts for algorithm performance.
4. Adjudication Method for the Test Set
This information is not provided. As there's no mention of a clinical test set with established ground truth by experts, an adjudication method (like 2+1 or 3+1) would not be relevant in the context described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not provided. The ApexPro FH Telemetry System is described as a monitoring system that processes data to detect events, but there is no indication that it is an "AI" device in the sense of a diagnostic aid that would be evaluated for human reader improvement in an MRMC study. It's a continuous physiological monitoring system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document describes the device as processing "physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations." This implies standalone algorithmic detection. However, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy, F1-score for arrhythmia detection) are not provided in this summary. The "Test Summary" mentions "Software and hardware testing" and "Final validation," which would likely include standalone performance aspects, but the results are summarized broadly as being "as safe, as effective, and performs as well as the predicate devices."
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not specify the type of ground truth used for any performance evaluation. For a device detecting ECG arrhythmias, ground truth would typically be established by expert cardiologists reviewing ECG waveforms; however, this is not detailed in the provided text.
8. The Sample Size for the Training Set
This information is not provided. If the device indeed uses machine learning or adaptive algorithms, the training set size would be relevant. However, the description states the system "employs the same functional technology as the predicate devices" and "has taken advantage of improvements in signal processing technology." This suggests traditional signal processing and rule-based algorithms more than a data-driven machine learning approach that would necessitate a "training set" in the modern AI sense.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, as there is no mention of a training set or how ground truth for such a set would have been established.
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| Section 2 Summary | |
|---|---|
| 510(k) Summary of Safety and Effectiveness | |
| Date: | October 20, 2003 |
| Submitter: | GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA |
| Contact Person: | Diana M. ThorsonRegulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: 714-247-4135Fax: 714-247-4155 |
| Device:Trade Name: | ApexPro FH Telemetry System |
| Common/Usual Name: | Telemetry Monitoring System |
| Classification Names: | 21 CFR 870.1025 Detector and Alarm, Arrhythmia21 CFR 870.2910 Transmitters & Receivers, Physiological Signal, Radio Frequency |
| Predicate Device: | K032369 ApexPro Telemetry System |
| Device Description: | The ApexPro FH Telemetry System is composed of six majorcomponents:Accessories to the patient worn acquisition transceivers The patient worn data acquisition transceivers The transceiver access points with antenna The network infrastructure A computer platform running the ApexPro Telemetry Application A computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application) |
| Intended Use: | The ApexPro FH Telemetry System is intended for use under the directsupervision of a licensed healthcare practitioner. The system isdesigned to acquire and monitor physiological data for ambulatingpatients within a defined coverage area. The system processes thisphysiological data to detect various ECG arrhythmia events and selectphysiological parameter limit violations.The ApexPro FH Telemetry System is intended to be installed in thehospital or clinical environment in order to provide clinicians with patientphysiological data, while allowing for patient mobility. These systemsare typically deployed in sub acute care areas in hospitals or clinicalsites where patient mobility can enhance the effectiveness of themedical procedures administered.The physiological parameters monitored include ECG, non-invasiveblood pressure, non-invasive temperature and SpO2. The ApexPro FHTelemetry System is intended to provide ECG data via Ethernet to thecomputer platform for processing. The ApexPro FH is also intended toprovide physiologic data over the Unity network to clinical informationsystems for display. |
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- The ApexPro FH employs the same functional technology as the Technology: predicate devices. The system architecture has taken advantage of improvements in signal processing technology as well as advances in RF component technologies to improve performance and level of integration.
- Test Summary: The ApexPro FH complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the system:
- Requirements specification review .
- Code inspections .
- Software and hardware testing .
- Safety testing .
- Environmental testing .
- . Final validation
- The results of these measurements demonstrated that the ApexPro FH Conclusion: System is as safe, as effective, and performs as well as the predicate devices.
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Image /page/2/Picture/11 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 6 2003
GE Medical Systems Information Technologies c/o Ms. Diane M. Thorson Corporate Regulatory Affairs 8200 West Tower Avenue Milwaukee, WI 53223
Re: K033365
Trade Name: ApexPro FH Telemetry System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II (three) Product Code: MHX Dated: October 20, 2003 Received: October 21, 2003
Dear Ms. Thorson:
'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.
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Page 2 - Ms. Diane M. Thorson
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); 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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Afgar May
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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510(k) Number (if known):
510(k) filed on October 10, 2003
ApexPro FH Telemetry System Device Name:
Indications For Use:
The ApexPro FH Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations.
The ApexPro FH Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.
The physiological parameters monitored include ECG, non-invasive blood pressure, non-invasive temperature and SpO2. The ApexPro FH Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro FH is also intended to provide physiologic data over the Unity network to clinical information systems for display.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Cardiovascular Devices | ||
| 510(k) Number | K033365 | |
Prescription Use_X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.