(14 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description of the device and its function focuses on standard physiological monitoring and processing.
No
The device is a monitoring and data acquisition system, not a device that provides therapy.
No
The device is primarily for monitoring physiological data and detecting events like ECG arrhythmia and parameter limit violations. While it processes data to identify these events, its core function is data acquisition and surveillance rather than providing a definitive diagnosis of a disease or condition. It aids clinicians by providing data, but it does not independently diagnose.
No
The device description explicitly lists multiple hardware components, including transmitters, receivers, and antenna systems, in addition to the software application running on a computer platform.
Based on the provided information, the ApexPro Telemetry System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ApexPro Function: The ApexPro Telemetry System acquires and monitors physiological data directly from the patient (ECG, non-invasive blood pressure, SpO2). It processes this data to detect events and violations.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The system works by monitoring real-time physiological signals.
Therefore, the ApexPro Telemetry System falls under the category of a patient monitoring system, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes
MHX
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)
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
Not Found
Intended User / Care Setting
licensed healthcare practitioner.
hospital or clinical environment
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
Test Summary: The ApexPro 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
Conclusion: The results of these measurements demonstrated that the ApexPro System is as safe, as effective, and performs as well as the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K021325 ApexPro Telemetry System
Reference Device(s)
Not Found
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.
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K032369
page 1 of 2
AUG 1 5 2003
Section 2 Summary 510(k) Summary of Safety and Effectiveness July 30, 2003 Date: Submitter: GE Medical Systems Information Technologies 8200 West Tower Avenue Milwaukee, WI 53223 USA Diana M. Thorson Contact Person: Regulatory Affairs Specialist GE Medical Systems Information Technologies Phone: 714-247-4135 Fax: 714-247-4155 Device: Trade Name: ApexPro Telemetry System Common/Usual Name: Telemetry Monitoring System Classification Names: 21 CFR 870.1025 Detector and Alarm, Arrhythmia 21 CFR 870.2910 Transmitters & Receivers, Physiological Signal, Radio Frequency Predicate Device: K021325 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
GE Medical Systems Information Technologies Confidential
1
K032369
page 2 of 2
improvements in signal processing technology as well as advances in RF component technologies to improve performance and level of integration.
Test Summary: The ApexPro 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 Conclusion: System is as safe, as effective, and performs as well as the predicate devices.
2
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles three human profiles facing right, with flowing lines beneath them.
AUG 1 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Medical Systems Information Technologies c/o Ms. Diana M. Thorson Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223
Re: K032369
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: July 30, 2003 Received: August 1, 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.
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
3
Page 2 -- Ms. Diana M. Thorson
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 yours.
J. R. Zukerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known):
510(k) filed on July 29, 2003
ApexPro Telemetry System Device Name:
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 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
NOC
(Division Sign-Off)
(Division Sign-On)
Division of Cardiovascular Devices
510(k) Number K030369