(214 days)
Instromedix King of Hearts Express® 3X™ Model 5328-00, Medtronic Minix Model 8341M
Instromedix King of Hearts Express® 3X™ Model 5328-00, Medtronic Minix Model 8341M
No
The document describes a standard insertable loop recorder system for ECG monitoring and does not mention any AI or ML capabilities in its description, intended use, or performance studies.
No.
The device is a diagnostic tool, designed to record ECG for the diagnostic evaluation of transient symptoms, not to provide therapy.
Yes
The device is designed for "diagnostic evaluation of patients who experience transient symptoms that may suggest a cardiac arrhythmia." It monitors and records ECG data, which is then used by a clinician for diagnosis.
No
The device description explicitly states the system consists of an "implanted recorder" and an "Activator," which are hardware components. It also mentions a "programmer" and "telemetry head" as required hardware for operation.
Based on the provided information, the Medtronic Model 9525 Reveal Insertable Loop Recorder 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.
- Device Function: The description clearly states that the device is an "implantable, patient-activated monitoring system that records subcutaneous ECG." It records electrical activity of the heart from within the body, not from a sample taken from the body.
- Intended Use: The intended use is for "diagnostic evaluation of patients who experience transient symptoms that may suggest a cardiac arrhythmia," which is a diagnostic process based on physiological signals recorded in vivo.
Therefore, the device operates in vivo (within the living body) rather than in vitro (in a test tube or other artificial environment).
N/A
Intended Use / Indications for Use
The Medtronic Model 9525 Reveal Insertable Loop Recorder is an implantable, patient-activated monitoring system that records subcutaneous ECG and is designed for diagnostic evaluation of patients who experience transient symptoms that may suggest a cardiac arrhythmia.
Product codes
74 MXC
Device Description
The Reveal ILR system is designed to record and store subcutaneous electrocardiogram (ECG) during symptomatic events. The system consists of the Model 9525 implanted recorder and the Model 6190 Activator. A Medtronic Model 9790 programmer equipped with a Medtronic Model 9766A radio frequency telemetry head and Model 9802E software is required for programming and retrieving data from the recorder.
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
Not Found
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
The following studies were performed to ensure that the Reveal ILR system meets all of its design and performance requirements.
In Vitro/Bench Testing
To evaluate the Reveal ILR system, the following in vitro testing was completed:
- Model 9525 implanted recorder testing (hybrid qualification testing, electromagnetic . compatibility testing, mechanical testing, and battery testing)
- Model 6190 Activator testing .
- . Package testing
The Reveal ILR system passed all of the in vitro requirements.
In Vivo Canine Testing
Two comparative studies of the Reveal ILR system were performed with canines. One study compared the Reveal ILR system to a surface ECG monitor. The other study compared the Reveal ILR system to a surface monitor and two competitive devices currently available: the Instromedix King of Hearts Express® 3X™ and the Instromedix HeartCard 3X™ (cardiac event recorders). The data generated by these studies demonstrate that the Reveal ILR system is safe and provides ECG information which is substantially equivalent to that provided by the surface monitor and cardiac event recorders.
Biocompatibility Information
Biocompatibility testing was not required because blood-contacting materials of the Reveal ILR implanted device are the same as the Medtronic Minix implantable pulse generator.
Sterilization Validation
The Model 9525 implanted recorder is sterilized using a 100% Ethylene Oxide (EtO) sterilization process. A process appropriate for sterilizing the Model 9525 implanted recorder was validated.
Key Metrics
Not Found
Predicate Device(s)
Instromedix King of Hearts Express® 3X™ Model 5328-00, Medtronic Minix Model 8341M
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
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510(k) SUMMARY
Submitter
JAN | 6 |998
Medtronic, Inc. 7000 Central Avenue N.E. Minneapolis, MN 55432
Contact: Nora K. Hadding, Product Regulation Manager Telephone: (612) 514-4189 Fax: (612) 514-6424 E-Mail: nora.hadding@medtronic.com
Date Prepared: June 13, 1997
Name of Device
Trade Name: "Reveal™ Insertable Loop Recorder" (ILR) System. The system is composed of the Model 9525 implanted recorder and the Model 6190 Activator. The Model 9802E Reveal software, Model 9790 programmer and Model 9766A telemetry head are also part of the system.
Common Name: insertable loop recorder
Classification Name: The Reveal Insertable Loop Recorder (ILR) system is a combination of existing devices. The classification names and numbers of these devices are:
- "Telephone electrocardiograph transmitter and receiver" (870.2920) (Class II) .
- "Implantable pacemaker pulse generator" (870.3610) (Class III) .
Predicate Devices
Table 1. Reveal ILR System - Predicate Devices
| Product | Features Similar to the Reveal ILR System |
|---|---|
| Instromedix King of Hearts Express® 3X™ Model | |
| 5328-00 (cardiac event recorder-looping memory) | • Ambulatory event recorder |
| • Continuous ECG recording | |
| • Looping memory | |
| • Pre- and post-event storage | |
| • Patient-activated | |
| Medtronic Minix Model 8341M (single-chamber | |
| implantable pulse generator) | • Implantable |
| • Dimensions | |
| • Subcutaneous electrode (in unipolar mode) | |
| • Programmable via a programmer unit | |
| • Transmit real time ECG waveform | |
| • Data retrieval (radio-frequency telemetry) |
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Device Description
System Description
The Reveal ILR system is designed to record and store subcutaneous electrocardiogram (ECG) during symptomatic events. The system consists of the Model 9525 implanted recorder and the Model 6190 Activator. A Medtronic Model 9790 programmer equipped with a Medtronic Model 9766A radio frequency telemetry head and Model 9802E software is required for programming and retrieving data from the recorder.
Model 9525 Implanted Recorder
The implanted recorder is a single-use, programmable device which is constructed of the same tissue-contacting materials used in Medtronic pacemakers. The implanted recorder is designed for long-term subcutaneous implantation. The implanted recorder is programmed using a Medtronic Model 9790 programmer. It continually records subcutaneous ECG into its looping memory and stores recorded ECG when signaled by the Activator.
Model 6190 Activator
The Activator is a hand-held, battery-operated telemetry device that communicates with the implanted recorder through the skin. It is used to signal the implanted recorder to store ECG recorded during a symptomatic event, for later retrieval and evaluation. The Activator is designed to be used during symptoms or immediately after symptoms. When the Activator is placed over the implanted recorder and the Activator button is pushed, the implanted recorder stores the ECG recorded during a pre-determined period of time before and after the Activator is used.
Stored ECG is retrieved via telemetry using a Medtronic programmer. The retrieved ECG can be viewed on the programmer screen, printed, or saved to disk. Stored ECG is erased and the recorder is restarted for continued use with a Medtronic programmer.
Programmer
Reveal Model 9802E software is loaded onto the Medtronic Model 9790 programmer. The programmer, with the Model 9766A radio frequency (RF) telemetry programming head, is used to communicate with the implanted recorder. The programmer uses radio frequency (RF) telemetry to transmit to and receive data from the implanted recorder and is used to program parameters of the implanted recorder, and to retrieve and display stored events for analysis.
Software
Reveal Model 9802E software is run from the Model 9790 programmer. It allows the clinician to program parameters of the recorder and to retrieve stored events for analysis. The clinician may select one of four modes for data storage. When the device memory is full, the software is used to erase stored events and restart recording for continued use.
When event(s) are stored in the implanted recorder's memory, the clinician may retrieve these event(s). The clinician can view the stored event on the programmer screen or print all or portions of the waveform to the programmer printer or to a full size external printer.
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The events can also be saved on a diskette for later use. This allows the clinician to read the events from diskette at a later time when the patient and device are not present. At that time, events can be analyzed on the programmer screen or printed.
Packaging
Two package configurations are available. The ILR system package contains the implanted recorder, the Activator, and the product information manual. A replacement Activator is available in the other package configuration. Both package configurations were fully validated.
Intended Use
The Medtronic Model 9525 Reveal Insertable Loop Recorder is an implantable, patientactivated monitoring system that records subcutaneous ECG and is designed for diagnostic evaluation of patients who experience transient symptoms that may suggest a cardiac arrhythmia.
Technological Characteristics
The technology used with the Reveal ILR system is similar to several devices currently available on the market. The table on the following page outlines the functional similarities between the Reveal ILR system and the identified predicate devices.
| Device Feature | Reveal™ ILR | Instromedix
King of Hearts | Medtronic
Minix™ IPG |
|--------------------------------------|------------------------------|--------------------------------------|---------------------------|
| ECG Recorder | Yes | Yes | No |
| Real-time
Waveforms | Yes | No | Yes |
| Looping Memory | Yes | Yes | No |
| Implantable | Yes | No | Yes |
| Pre and Post Event
Storage | Yes | Yes | No |
| Subcutaneous
Electrode | Yes | No | Yes
(in unipolar mode) |
| Patient-Activated | Yes | Yes | No |
| Implantable Battery | Yes | No | Yes |
| Total Storage Time | 42 min.* | 5 min. | No |
| Maximum Single
Event Storage Time | 42 min. | 5 min. | N/A |
| Storage Modes | 4 modes | Programmable | N/A |
| Number of Events | 1 or 3 | Up to 60 | N/A |
| Data Retrieval | Radio-frequency
telemetry | Transtelephonic
or audio-coupling | Radio-frequency telemetry |
| Bandwidth | 0.85-32 Hz | 0.05-30 Hz | N/A |
| Sampling Rate | 100 Hz | 218 Hz | N/A |
| Volume | 8 cc | N/A | 10.4 cc |
| Mass | 17 g | N/A | 24.8 g |
| Dimensions | 61 x 19 x 8 mm | N/A | 50x14x6 mm |
*ECG waveforms stored in modes with a total storage time to increase storage time. Data sampled at 100Hz is stored to memory at 50Hz.
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Summary of Studies
The following studies were performed to ensure that the Reveal ILR system meets all of its design and performance requirements.
In Vitro/Bench Testing
To evaluate the Reveal ILR system, the following in vitro testing was completed:
- Model 9525 implanted recorder testing (hybrid qualification testing, electromagnetic . compatibility testing, mechanical testing, and battery testing)
- Model 6190 Activator testing .
- . Package testing
The Reveal ILR system passed all of the in vitro requirements.
In Vivo Canine Testing
Two comparative studies of the Reveal ILR system were performed with canines. One study compared the Reveal ILR system to a surface ECG monitor. The other study compared the Reveal ILR system to a surface monitor and two competitive devices currently available: the Instromedix King of Hearts Express® 3X™ and the Instromedix HeartCard 3X™ (cardiac event recorders). The data generated by these studies demonstrate that the Reveal ILR system is safe and provides ECG information which is substantially equivalent to that provided by the surface monitor and cardiac event recorders.
Biocompatibility Information
Biocompatibility testing was not required because blood-contacting materials of the Reveal ILR implanted device are the same as the Medtronic Minix implantable pulse generator.
Sterilization Validation
The Model 9525 implanted recorder is sterilized using a 100% Ethylene Oxide (EtO) sterilization process. A process appropriate for sterilizing the Model 9525 implanted recorder was validated.
Conclusion
The testing described above provides reasonable assurance that the Reveal ILR system will perform as intended when used in accordance with its labeling. Additionally, based on similarities in design, materials, in vitro test data and canine in vivo electrical performance, Medtronic considers the Reveal ILR system to be substantially equivalent to these pre-regulation devices: the Instromedix King of Hearts Express 3X, and the Medtronic Minix implantable pulse generator.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 23 1999
Ms. Nora K. Hadding Cardiac Pacing Business Medtronic, Inc. 7000 Central Avenue, N.E. Minneapolis, MN 55432-3576
Re: K972242 The Reveal™ Insertable Loop Recorder System including the Model 9525 Implantable Recorder and the Model 6190 Patient Activator Requlatory Class: II (two) Product Code: 74 MXC Dated: October 17, 1997 Received: October 20, 1997
Dear Ms. Hadding:
This letter corrects our substantially equivalent letter of January 16, 1998, regarding the Reveal™ Insertable Loop Recorder We believe that the product code and regulatory classification System. of the device should have been 74 MXC/II(two).
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 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). 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 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS
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Page 2 - Ms. Nora K. Hadding
inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements 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.
This letter will allow you to continue 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) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
DA Speyh
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
: ・ ・
| 510(k) Number (if known): | N/A | K972242 |
|---|---|---|
| Device Name: | Reveal TM Insertable Loop Recorder System | |
| Indications For Use: | The Medtronic Model 9525 Reveal TM Insertable Loop Recorder is an implantable, patient-activated monitoring system that records subcutaneous ECG and is indicated for patients who experience transient symptoms that may suggest a cardiac arrhythmia. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Cardiovascular | ||
| and Neurological Devices | ||
| 510(k) Number | ||
| Prescription Use ✓ | ||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
| Thomas J. Callahan |
(Optional Format 1-2-96)