(141 days)
No
The summary describes a standard physiological monitoring system with data acquisition, processing for arrhythmia detection and parameter limit violations, and display. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The processing described appears to be based on predefined algorithms and thresholds, not learned patterns.
No
The device is designed to monitor physiological data and detect arrhythmia events, but it does not claim to treat or cure any medical condition. It provides data for clinicians, but does not provide therapy itself.
No
The device is primarily described as a monitoring and data acquisition system, not explicitly for diagnosis. While it detects arrhythmia events and limit violations, its stated purpose is to "provide clinicians with patient physiological data" and process it, rather than rendering a medical diagnosis itself.
No
The device description explicitly lists hardware components such as "patient worn data acquisition transmitters," "Receiver Infrastructures," and "Accessories to the patient-worn data acquisition transmitters," indicating it is not solely software.
Based on the provided information, the ApexPro Telemetry System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is designed to acquire and monitor physiological data from ambulating patients. This involves measuring parameters like ECG, blood pressure, temperature, and SpO2 directly from the patient's body.
- Device Description: The components listed are patient-worn transmitters, receivers, and computer platforms for processing and displaying this physiological data.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body. IVD devices are specifically designed for testing these types of samples.
The ApexPro Telemetry System is a patient monitoring system that collects data in vivo (from within the living body).
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, noninvasive temperature and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro Telemetry System 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 provides clinicians with patient data while allowing for patient mobility. The system consists of the following main components:
• The patient worn data acquisition transmitters
• Receiver Infrastructures
• Computer platforms hosting the ApexPro Software
• Computer platforms hosting the central station application
• Accessories to the patient-worn data acquisition transmitters Serviceability tools
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this 510(k) is a design modification for the ApexPro Telemetry System. The ApexPro Telemetry System complies with the voluntary standards as detailed in Section 9 (Declaration of Conformity and Summary Reports) of this submission. The following quality assurance measures were applied to the development of the ApexPro Telemetry System:
- Risk Analysis .
- Requirements Review .
- Design Reviews
- Testing on Unit Level (Module verification) .
- Intearation testina (System Verification) .
- Final Acceptance testing (Validation) .
- Performance testing .
- Safety and environmental testing .
Conclusion: The results of these measurements demonstrated that the ApexPro Telemetry System is as safe, as effective, and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
Image /page/0/Picture/0 description: The image shows handwritten text on a white background. The first line reads "K080251", which appears to be an identification or reference number. The second line reads "pg. 1/2", indicating it is page 1 of a 2-page document.
510(k) Summary of Safety and Effectiveness 5
| Date: | January 29, 2008 | JUN 20 2008 |
|---|---|---|
| Submitter: | GE Medical Systems Information Technologies | |
| 8200 West Tower Avenue | ||
| Milwaukee, WI 53223 USA | ||
| Contact Person: | Bernard Sandler | |
| Regulatory Affairs Specialist | ||
| GE Medical Systems Information Technologies | ||
| Phone: (414) 362-2090 | ||
| Fax: (414) 362-2585 | ||
| E-mail: Bernard.Sandler@med.ge.com | ||
| Secondary Contact | ||
| Person: | Lisa M. Baumhardt | |
| Regulatory Affairs Program Manager | ||
| GE Medical Systems Information Technologies | ||
| Phone: (414) 362-3242 | ||
| Fax: (414) 362-2585 | ||
| E-mail: Lisa.Baumhardt@med.ge.com | ||
| Device Trade Name: | ApexPro Telemetry System | |
| Common /Usual Name: | Telemetry Monitoring System | |
| Classification Names: | 21 CFR 870.1025 Physiological Patient Monitor (with arrhythmia | |
| detection or alarms | ||
| Predicate Devices: | K032369 ApexPro Telemetry System | |
| K033365 ApexPro FH Telemetry System | ||
| K980299 Apex OXIMETER | ||
| Device Description: | The ApexPro Telemetry System provides clinicians with patient | |
| data while allowing for patient mobility. The system consists of | ||
| the following main components: | ||
| • The patient worn data acquisition transmitters | ||
| • Receiver Infrastructures | ||
| • Computer platforms hosting the ApexPro Software | ||
| • Computer platforms hosting the central station | ||
| application | ||
| • Accessories to the patient-worn data acquisition | ||
| transmitters | ||
| Serviceability tools |
1
Image /page/1/Picture/0 description: The image shows handwritten text. The first line reads "K080251". The second line reads "pg. 2/2". The text is written in black ink on a white background.
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 tvpically 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, noninvasive blood pressure, non-invasive temperature and Sp02. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro Telemetry System is also intended to provide physiologic data over the Unity Network to clinical information systems for display.
Technology:
The ApexPro Telemetry Svstem emplovs the same functional technology as the predicate devices.
Test Summary:
The subject of this 510(k) is a design modification for the ApexPro Telemetry System. The ApexPro Telemetry System complies with the voluntary standards as detailed in Section 9 (Declaration of Conformity and Summary Reports) of this submission. The following quality assurance measures were applied to the development of the ApexPro Telemetry System:
- Risk Analysis .
- Requirements Review .
- Design Reviews �
- Testing on Unit Level (Module verification) .
- Intearation testina (System Verification) .
- Final Acceptance testing (Validation) .
- Performance testing .
- Safety and environmental testing .
Conclusion:
The results of these measurements demonstrated that the ApexPro Telemetry System is as safe, as effective, and performs as well as the predicate device.
2
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 eagle-like symbol with three curved lines representing wings or feathers. To the left of the symbol is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is in all caps and is arranged to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2008
GE Medical Systems Information Technologies c/o Mr. Bernard Sandler Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223
Re: K080251
Trade Name: ApexPro Telemetry Systems Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (with arrhythmia detector or alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: May 23, 2008 Received: May 27, 2008
Dear Mr. Sandler:
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.
3
Page 2 - Mr. Bernard Sandler
Please be advised that FDA's issuance of a substantial equivalence detcrmination 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 sct 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,
elmee
-Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement 4
K080251 510(k) Number:
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 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, noninvasive temperature and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro Telemetry System is also intended to provide physiologic data over the Unity Network to clinical information systems for display.
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
elamell
n of Cardiovascular Devices
K68025) 510/k) Number
Page 18