(168 days)
Not Found
No
The document describes a cardiac monitoring system that transmits physiological data but does not mention any AI or ML capabilities for analysis or interpretation.
No.
The device is a cardiac monitoring system that acquires and transmits patient data; it does not provide treatment or therapy.
Yes
The device is described as a "cardiac monitoring system" that acquires and transmits various physiological data such as ECG, SpO2, NIBP, and GCS. The purpose of monitoring this data is to provide information for "emergency care," which implies using the data to assess the patient's condition and guide treatmentdecisions. This aligns with the definition of a diagnostic device, as it provides information used to identify or analyze a patient's medical condition.
No
The device description clearly outlines both portable and stationary hardware units (Pegasus and Polaris) that acquire and transmit physiological data. The performance studies also include testing of electrical safety, ECG performance, SpO2 performance, power source, environmental factors, and EMC, all of which are related to hardware components.
Based on the provided information, the Ortivus AB Mobimed™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This is typically done in vitro (outside the body).
- Mobimed™ Function: The Mobimed™ system is a cardiac monitoring system that acquires physiological data directly from the patient's body (ECG, SpO2, NIBP, GCS). It does not analyze specimens taken from the body.
- Intended Use: The intended use is for monitoring patients in emergency and pre-hospital care settings, focusing on real-time physiological data acquisition and transmission.
Therefore, the Mobimed™ falls under the category of a physiological monitoring system, not an IVD.
N/A
Intended Use / Indications for Use
The Ortivus AB Mobimed(TM) is a cardiac monitoring system consisting of a portable and stationary unit which communicate with each other using the Mobitex radio-based cellular telecommunications network. The cardiac data includes ECG, SpO2, NIBP, GCS, and patient information. The system is intended for use by trained personnel in emergency care, specifically emergency ambulance and pre-hospital care.
Product codes (comma separated list FDA assigned to the subject device)
74DRT, 74DRG, 74DQA, 74 MSX
Device Description
The Mobimed(TM) System consists of one or several stationary units called Polaris (typically hospital located) receiving patient cardiac information from mobile units called Pegasus. A mobile unit can be permanently mounted in an ambulance or operate as a portable unit. The Mobimed(TM) equipment can telemonitor (using radiobased cellular telecommunications network) a patient where he or she is at the moment. This makes it possible to monitor the patient and acquire data during transportation to the hospital. The system can acquire and transmit the following information:
- VCG or 12-Lead ECG (automatically and manually acquired reports).
- One channel ECG or VCG reports .
- Monitoring ECG (not transmitted)
- . Trends (automatically and manually acquired).
- Patient records/forms
- Alarms (presented on the Pegasus and not transmitted to Polaris) .
- Messages .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained personnel in emergency care, specifically emergency ambulance and pre-hospital care.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An extensive collection of tests has been conducted and successfully completed, including electrical safety (to IEC-601-1), ECG performance (using appropriate sections of IEC 601-2.27), SpO2 performance (Using ISO 9919), power source (battery and charger), environmental (shock, humidity, vibration, temperature), EMC (using CISPR 11 and IEC 61000-4-2,3,4, and 5) and communications to and from the hospital based unit.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
SECTION 2. SUMMARY AND CERTIFICATION
510(K) SUMMARY A.
FEB 1 9 1998
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the Ortivus AB summary for the Mobimed™ System.
| SUBMITTER'S NAME: | Ortivus AB |
|---|---|
| ADDRESS: | Enhagsslingan 5 |
| S-183 25 Täby, Sweden | |
| CONTACT PERSON: | Jörgen Eklund, Quality Manager |
| TELEPHONE NUMBER: | 011-46-8-446 45 10 |
| FAX NUMBER: | 011-46-8-446 45 19 |
| DATE OF SUBMISSION: | 2 September 1997 |
- Identification of device
Proprietary Name: Mobimed™ System, (Pegasus and Polaris) Common Name: Monitor, Cardiac; Radio-frequency physiological signal transmitter and receiver; Oximeter. Classification Status: Class II per regulations 870.2300 and 870.2910 and 870.2700 Product Codes: 74DRT, 74DRG, and 74DQA
-
- Description of the Device
The Mobimed™ System consists of one or several stationary units called Polaris (typically hospital located) receiving patient cardiac information from mobile units called Pegasus. A mobile unit can be permanently mounted in an ambulance or operate as a portable unit. The Mobimed™ equipment can telemonitor (using radiobased cellular telecommunications network) a patient where he or she is at the moment. This makes it possible to monitor the patient and acquire data during transportation to the hospital. The system can acquire and transmit the following information:
- Description of the Device
-
VCG or 12-Lead ECG (automatically and manually acquired reports). ●
-
One channel ECG or VCG reports .
-
Monitoring ECG (not transmitted)
-
. Trends (automatically and manually acquired).
-
Patient records/forms
1
- Alarms (presented on the Pegasus and not transmitted to Polaris) .
- Messages .
-
- Intended use
The Ortivus AB Mobimed™ is a cardiac monitoring system consisting of a portable and stationary unit which communicate with each other using the Mobitex radio-based cellular telecommunications network. The cardiac data includes ECG, SpO2, NIBP, GCS, and patient information. The system is intended for use by trained personnel in emergency care, specifically emergency ambulance and pre-hospital care.
-
- Technological characteristics, comparison to predicate device.
Like the predicate devices, the Mobimed™ System is intended to be used in an emergency care situation to communicate cardiac information from a remote site such as an ambulance to a hospital. Standard ECGs can be transmitted, but in addition, SpO2, NIBP and GCS information can also be transmitted. The NIBP (Non-invasive blood pressure) values are entered manually into the Pegasus. This means that the values must be obtained by some other equipment, for example a standard blood pressure cuff. There is no automatic NIBP measurement equipment. The GCS (Glasgow Coma Scale) is a scoring system for the patient's status. GCS is an internationally well spread scoring system for estimating the degree of consciousness of the patient. The GCS value is based upon the observation of three fundamental physiological parameters; eye movements, motor response, and verbal response. Each parameter gets a numerical value based on standardized questions, and the sum of the three individual values is the GCS.
- Technological characteristics, comparison to predicate device.
| Characteristic | Predicate device,
Lifepak 11 | Mobimed™ System |
|----------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Single lead ECG | Yes | No |
| 12 lead ECG | Yes | Yes |
| Frank lead (VCG)ECG | No | Yes |
| SpO₂ | No | Yes |
| Interpretive ECG | Yes | No |
| Digital telecommunications | Yes | Yes |
| Local ECG display | Paper and Monitor | Monitor only |
| Receiving station display | Paper only | Monitor and paper |
| Power sources | Internal rechargeable battery
or AC line (charging source) | Internal rechargeable battery
or 12 volt automotive
system (charging source)or
AC line |
| Labeling | Labels on devices, an
operating manual and a
physicians guide | Labels on devices, a
Pegasus User's Manual, and
a Polaris User's Manual |
Comnarison table
2
-
- Discussion of performance testing.
An extensive collection of tests has been conducted and successfully completed, including electrical safety (to IEC-601-1), ECG performance (using appropriate sections of IEC 601-2.27), SpO2 performance (Using ISO 9919), power source (battery and charger), environmental (shock, humidity, vibration, temperature), EMC (using CISPR 11 and IEC 61000-4-2,3,4, and 5) and communications to and from the hospital based unit.
- Discussion of performance testing.
-
- Conclusion
Based on extensive performance testing and a comparison to the predicate device, it is the conclusion of Ortivus AB that the Mobimed™ System is substantially equivalent to devices already on the marked (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness. In fact, the use of cellular digital technology enhances communication capability over previous direct radio frequency communications systems.
- Conclusion
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
FEB 1 9 1998
Ms. Constance G. Bundy Ortivus, AB Enhagsslingan 5 SE-183 25 Täby, Sweden
Re: K973318 Trade Name: Ortivus AB Mobimed™ System Requlatory Class: II (two) Product Code: 74 MSX January 21, 1998 -Dated: February 3, 1998 Received:
Dear Ms. Bundy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions . Failure to comply with the GMP regulation may result in" In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Ms. Constance G. Bundy
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE B.
510(k) Number_ K 97 3318
Device Name: Mobimed™ System
Indications for Use: The Ortivus AB Mobimed™ is a cardiac monitoring system consisting of a portable and stationary unit which communicate with each other using the Mobitex radio-based cellular telecommunications network. The cardiac data includes ECG, SpO2, NIBP, GCS, and patient information. The system is intended for use by ........ trained personnel in emergency care, specifically emergency ambulance and pre-hospital care.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE) M. f (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_ Prescription Use OR Over the Counter Use (Per 21 CFR 801.109)