(168 days)
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.
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: 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.
This submission (K973318) for the Mobimed™ System is a 510(k) summary and does not contain detailed information about specific acceptance criteria or a dedicated study demonstrating the device's performance against predefined criteria. Instead, it relies on a comparison to a predicate device and general performance testing to argue for substantial equivalence.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of acceptance criteria and the reported device performance
The submission does not explicitly define acceptance criteria in a quantitative table format. Instead, it describes general categories of testing performed and states that these were "successfully completed."
| Category of Testing | Reported Device Performance |
|---|---|
| Electrical Safety | Successfully completed (to IEC-601-1) |
| ECG Performance | Successfully completed (using appropriate sections of IEC 601-2.27) |
| SpO2 Performance | Successfully completed (Using ISO 9919) |
| Power Source | Successfully completed (battery and charger) |
| Environmental | Successfully completed (shock, humidity, vibration, temperature) |
| EMC | Successfully completed (using CISPR 11 and IEC 61000-4-2,3,4, and 5) |
| Communications | Successfully completed (to and from the hospital based unit) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide any information regarding the sample sizes used for performance testing, data provenance, or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. Given the nature of the device (cardiac monitoring system used for data acquisition and transmission), ground truth for performance testing would likely involve standardized test signals, calibrated equipment, and potentially human review of acquired waveforms. However, the specifics are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed based on this document. The device is a "cardiac monitoring system" that acquires and transmits physiological data, including ECG and SpO2. It is not an AI-based diagnostic tool that would typically involve human readers interpreting output to improve diagnostic accuracy. The interpretive ECG feature is present in the predicate device, but explicitly not present in the Mobimed™ System.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept doesn't directly apply as the Mobimed™ System is a hardware-based monitoring and transmission system, not an algorithm performing interpretation. The performance testing described (electrical safety, ECG performance, SpO2 performance, etc.) assesses the standalone function of the device in acquiring and handling physiological signals.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used for each test. However, based on the types of tests mentioned:
- Electrical Safety, Environmental, EMC, Power Source: Ground truth would be defined by the standards themselves (e.g., specific thresholds for leakage current, acceptable levels of shock resistance, battery life specifications).
- ECG Performance: Ground truth would likely be established using standardized ECG simulators or calibrated signal generators whose output is known and compared against the device's acquired waveforms. The phrase "appropriate sections of IEC 601-2.27" suggests reliance on established technical standards for ECG measurement accuracy.
- SpO2 Performance: Similarly, "Using ISO 9919" indicates reliance on an international standard for oximeter performance, which would define the ground truth for SpO2 measurements.
8. The sample size for the training set
The concept of a "training set" is not applicable here as the Mobimed™ System is a hardware device for monitoring and transmitting physiological data, not a machine learning or AI-based system that requires training data.
9. How the ground truth for the training set was established
Not applicable (as explained in point 8).
Summary of the Study (Based on Submitted Document):
The Mobimed™ System's "study" consists of a collection of performance tests against various international and industry standards, electrical safety regulations, and environmental specifications. The core argument for its market clearance is its substantial equivalence to existing predicate devices (LifePak® Cardiac Monitor/LifeNet RS100 and Nellcor MP204P for SpO2). The submission highlights that the Mobimed™ System successfully completed these standard-based tests and offers an enhanced communication capability through cellular digital technology. There is no mention of a clinical trial or a study involving human subjects for performance evaluation in a comparative sense. The document focuses on technical compliance and functional equivalence.
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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 5S-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
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- 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). ●
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One channel ECG or VCG reports .
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Monitoring ECG (not transmitted)
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. Trends (automatically and manually acquired).
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Patient records/forms
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- Alarms (presented on the Pegasus and not transmitted to Polaris) .
- Messages .
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- 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.
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- 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 batteryor AC line (charging source) | Internal rechargeable batteryor 12 volt automotivesystem (charging source)orAC line |
| Labeling | Labels on devices, anoperating manual and aphysicians guide | Labels on devices, aPegasus User's Manual, anda Polaris User's Manual |
Comnarison table
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- 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.
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- 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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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.
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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.
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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)
§ 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).