(11 days)
The ApexPro 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 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 and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro is also intended to provide physiologic data over the Unity network to clinical information systems for display.
The ApexPro Telemetry System is composed of six major components:
• The patient worn data acquisition transmitters
• The receiver antenna system infrastructure
• The receivers
• The receiver subsystem
• 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 is a 510(k) summary for the ApexPro Telemetry System. While it states that the device complies with voluntary standards and mentions quality assurance measures, it does not include detailed acceptance criteria or a study proving that the device meets specific performance metrics.
Here's what can be extracted based on the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified in the document) | "The results of these measurements demonstrated that the ApexPro is safe and effective, and performs as well as the predicate devices." |
Missing Information: The document states that the ApexPro "complies with the voluntary standards as detailed in The following quality assurance Section 9 of this submission." However, Section 9 is not provided in this document, so the specific voluntary standards and their associated acceptance criteria are unknown. No quantitative performance metrics for the device (e.g., accuracy of arrhythmia detection, sensitivity, specificity) are given in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
Missing Information: The document does not specify any sample size used for a test set, nor does it mention the data provenance (country of origin, retrospective/prospective). The study described is a general "test summary" of quality assurance measures, not a clinical trial with a defined test set of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Missing Information: Since no specific clinical test set is described, there is no information about experts used to establish ground truth.
4. Adjudication Method for the Test Set:
Missing Information: No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
Missing Information: No MRMC study is mentioned. The document primarily focuses on demonstrating substantial equivalence to a predicate device through technological similarity and quality assurance, rather than a comparative effectiveness study with human readers.
6. If a Standalone (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 an algorithmic component. However, no standalone performance study details (e.g., sensitivity, specificity of the algorithm itself) are provided in this summary. The "Test Summary" section refers to "Software and hardware testing," which might include standalone performance, but no results are detailed.
7. The Type of Ground Truth Used:
Ground truth for "software and hardware testing" and "safety testing" would likely refer to internal verification and validation against known standards and simulated or real-world scenarios. However, the exact type of ground truth (e.g., expert consensus, pathology, outcomes data) for specific physiological data detection claims is not stated.
8. The Sample Size for the Training Set:
Missing Information: No training set or its sample size is mentioned, as this document is not describing a machine learning model training process in detail.
9. How the Ground Truth for the Training Set was Established:
Missing Information: Since no training set is described, there is no information on how its ground truth was established.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through system description, intended use, and a high-level overview of quality assurance measures, rather than a detailed performance study with specific acceptance criteria and outcome metrics.
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MAY 0 7 2002
K021325
page 1 of 2
510(k) Summary of Safety and Effectiveness
ﺑ
,
:
| Date: | April 19, 2002 |
|---|---|
| Submitter: | GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA |
| Contact Person: | Joelle NeiderRegulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: 203-949-8232Fax: 414-918-8113 |
| Device: | |
| Trade Name: | ApexPro 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: | K000779 ApexPro Telemetry System |
| Device Description: | The ApexPro Telemetry System is composed of six major components:• The patient worn data acquisition transmitters• The receiver antenna system infrastructure• The receivers• The receiver subsystem• 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 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 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 and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro is also intended to provide physiologic data over the Unity network to clinical information systems for display. |
| Technology: | The ApexPro employs the same functional technology as the 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. |
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K021325
page 2 of 2
Test Summary: The ApexPro complies with the voluntary standards as detailed in The following quality assurance Section 9 of this submission. 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 Conclusion: THE Toodite of thous effective, and performs as well as the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 7 2002
Ms. Joelle Neider Regulatory Affairs Specialist GE Medical Systems Information Technologies 8200 West Tower Avenue Milwaukee, WI 53223
Re: K021325
Trade Name: ApexPro Telemetry System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: April 22, 2002 Received: April 26, 2002
Dear Ms. Neider:
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. Joelle Neider
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 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,
Dak Tiller Ph.D.
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 1 of 1
510(k) Number (if known):
510(k) filed on April 19, 2002
Device Name:
ApexPro Telemetry System
Indications For Use:
The ApexPro 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 noulating 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 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 and SpO2 The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro 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)
Prescription Use 7 (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K021325
§ 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.