(71 days)
No
The description focuses on automatic detection of arrhythmias based on pre-programmed criteria, not on learning or adaptive algorithms. There is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML models.
No.
The device is described as a monitoring system that records ECG and detects arrhythmias; it does not provide therapy.
Yes
The device records subcutaneous ECG and is used to monitor patients for cardiac arrhythmias, which involves diagnosing the presence of such conditions. Its stated use includes verifying whether the implanted device has detected a suspected arrhythmia and recording cardiac event data.
No
The device description clearly states that the Reveal XT/DX Insertable Cardiac Monitors are "small, leadless devices that are typically implanted under the skin, in the chest" and have "Two electrodes on the body of the device." This indicates a significant hardware component. The Patient Assistant is also described as a "hand-held, battery-operated telemetry device." While software is involved in the functionality, the core device is hardware.
Based on the provided text, this device 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 Reveal XT/DX Insertable Cardiac Monitor and Patient Assistant system works by monitoring and recording subcutaneous ECG (electrical activity of the heart) directly from within the patient's body. This is an in vivo (within the living organism) measurement, not an in vitro (in glass/outside the body) test on a sample.
- Lack of Sample Analysis: The description focuses on recording and analyzing electrical signals from the heart, not on analyzing biological samples.
Therefore, the device falls under the category of implantable medical devices for physiological monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Reveal XT and DX Insertable Cardiac Monitors are implantable patientactivated and automatically-activated monitoring systems that record subcutaneous ECG and are indicated in the following cases:
- . patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
- · patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain, that may suggest a cardiac arrhythmia.
The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the data management features in the Reveal Insertable Cardiac Monitor:
- To verify whether the implanted device has detected a suspected arrhythmia or device related event.
- To initiate recording of cardiac event data in the implanted device memory. .
Product codes
DSI
Device Description
The Reveal XT Model 9529 and Reveal DX Model 9528 Insertable Cardiac Monitors (ICM) are designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial tachyarrhythmia/atrial fibrillation (AT/AF), bradyarrhythmia, asystole, or (fast) ventricular tachyarrhythmia. The Reveal XT ICM provides storage of ECG and Marker Channel during patient-activated and automatically-detected (auto-activated) events. Auto activation may help to detect abnormal heart rhythms in patients who may not activate/trigger the ICM.
The Reveal XT ICM Model 9529 and Reveal DX Model 9528 are small, leadless devices that are typically implanted under the skin, in the chest. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG.
The Reveal XT Patient Assistant Model 9539 and the Reveal DX Patient Assistant Model 9538 are hand-held, battery-operated telemetry devices that enable the patient to start recording cardiac information in the Reveal XT and DX ICMs, respectively after experiencing symptoms of a possible cardiac event. The Reveal XT Patient Assistant query function enables the patient to check the status of physician-programmed parameters. A query function enables the patient to check his or her device and receive notification when an arrhythmia has occurred or when the device status has changed.
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
"The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic."
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)
Software and system verification testing, system validation testing, functional testing and performance validation testing (bench) was performed to demonstrate the Reveal XT Model 9529 Insertable Cardiac Monitor meets established performance criteria and to support equivalency to the reference predicate devices.
The results of the testing indicate that the Reveal XT Insertable Cardiac Monitor Model 9529 performs as intended and is safe for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic Reveal XT Model 9529 Insertable Cardiac Monitor (ICM) cleared via 510k . reference K071641 and the Reveal DX Model 9528 Insertable Cardiac Monitor clearcd via 510k reference K071655 on August 9, 2007., Instromedix King of Hearts Express AF Recorder K020825
Reference Device(s)
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)
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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K082475
+1/3
510(K) SUMMARY
NOV - 7 2008
| Date Prepared: | November 3, 2008 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Cardiac Rhythm Disease Management | |
| 8200 Coral Sea Street NE | |
| Mounds View, MN 55112 | |
| Contact: | Debbie Kidder |
| Senior Regulatory Affairs Specialist | |
| Telephone: | (763)526-3561 |
| Fax: | (651)367-0603 |
| E-mail: | deborah.a.kidder@medtronic.com |
| Proprietary Name: | Reveal XT Insertable Cardiac Monitor, |
| Model 9529 | |
| Reveal XT Patient Assistant 9539 | |
| Reveal DX Insertable Cardiac Monitor, | |
| Model 9528 | |
| Reveal DX Patient Assistant 9538 | |
| Common Name: | Insertable Cardiac Monitor |
| Device Classification | Class II, 21 CFR 870.1025, Arrhythmia |
| detector and alarm | |
| Product Code: | DSI |
Summary of Substantial Equivalence
The intended use, design, materials and performance of the Reveal XT Model 9529 and Reveal DX Model 9528 Insertable Cardiac Monitors are substantially equivalent to the following predicate devices:
- Medtronic Reveal XT Model 9529 Insertable Cardiac Monitor (ICM) cleared via 510k . reference K071641 and the Reveal DX Model 9528 Insertable Cardiac Monitor clearcd via 510k reference K071655 on August 9, 2007.
- Instromedix King of Hearts Express AF Recorder K020825, Cleared 05 April 2002 .
Image /page/0/Picture/10 description: The image shows the Medtronic logo with the word "Confidential" to the right of it. The Medtronic logo consists of a stylized image on the left and the word "Medtronic" in bold, sans-serif font. The word "Confidential" is in a smaller, regular font. The logo is likely used on documents or materials that are intended to be kept private.
1
Device Description
The Reveal XT Model 9529 and Reveal DX Model 9528 Insertable Cardiac Monitors (ICM) are designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial tachyarrhythmia/atrial fibrillation (AT/AF), bradyarrhythmia, asystole, or (fast) ventricular tachyarrhythmia. The Reveal XT ICM provides storage of ECG and Marker Channel during patient-activated and automatically-detected (auto-activated) events. Auto activation may help to detect abnormal heart rhythms in patients who may not activate/trigger the ICM.
The Reveal XT ICM Model 9529 and Reveal DX Model 9528 are small, leadless devices that are typically implanted under the skin, in the chest. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG.
The Reveal XT Patient Assistant Model 9539 and the Reveal DX Patient Assistant Model 9538 are hand-held, battery-operated telemetry devices that enable the patient to start recording cardiac information in the Reveal XT and DX ICMs, respectively after experiencing symptoms of a possible cardiac event. The Reveal XT Patient Assistant query function enables the patient to check the status of physician-programmed parameters. A query function enables the patient to check his or her device and receive notification when an arrhythmia has occurred or when the device status has changed.
Indications for Use
The Reveal XT and DX Insertable Cardiac Monitors are implantable patientactivated and automatically-activated monitoring systems that record subcutaneous ECG and are indicated in the following cases:
- . patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
- · patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain, that may suggest a cardiac arrhythmia.
The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the data management features in the Reveal Insertable Cardiac Monitor:
- To verify whether the implanted device has detected a suspected arrhythmia or device related event.
- To initiate recording of cardiac event data in the implanted device memory. .
Technological Characteristics
Image /page/1/Picture/15 description: The image shows the Medtronic logo with the word "Confidential" next to it. The Medtronic logo consists of a stylized image to the left of the word "Medtronic". The word "Confidential" is in a smaller font size than the word "Medtronic". The image is in black and white.
2
Intended use, design, materials, performance and technological characteristics are substantially equivalent to the predicate devices referenced.
Summary of Testing
There are no changes to the hardware, materials, processes, packaging, shelf life and sterilization of the Reveal XT and Reveal DX Systems included in this submission. Therefore, electromagnetic compatibility (EMC), electrical safety, mechanical performance, component, usability, biocompatibility, sterilization and packaging testing was not repeated since 510k clearance via K071641 and K071655.
Software and system verification testing, system validation testing, functional testing and performance validation testing (bench) was performed to demonstrate the Reveal XT Model 9529 Insertable Cardiac Monitor meets established performance criteria and to support equivalency to the reference predicate devices.
The results of the testing indicate that the Reveal XT Insertable Cardiac Monitor Model 9529 performs as intended and is safe for its intended use.
Conclusion
Medtronic considers the Reveal XT and Reveal DX Insertable Cardiac Monitor systems to be substantially equivalent to legally marketed predicate devices through the data and information presented. No safety or effectiveness issues were identified.
Image /page/2/Picture/10 description: The image shows the Medtronic logo with the word "Confidential" next to it. The Medtronic logo consists of a stylized image of a person with outstretched arms inside of a circle. The word "Medtronic" is written in a bold, sans-serif font.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings, rendered in a simple, graphic style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2008
Medtronic, Inc. Ms. Debbie Kidder Senior Regulatory Affairs Specialist Cardiac Rhythm Disease Management 8200 Coral Sea Street, N.E. Mounds View, MN 55112
Re: K082475
Trade/Device Name: Reveal XT Insertable Cardiac Monitor and Reveal XT Patient Assistant; Revcal DX Insertable Cardiac Monitor and Reveal DX Patient Assistant Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST)-segment measurement and alarm) Regulatory Class: Class II (two) Product Code: DSI Dated: October 7, 2008 Received: October 8, 2008
Dear Ms. Kidder:
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
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Page 2 - Ms. Debbie Kidder
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 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-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Arlene B. Boa
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use
510(k) Number (if known):
Device Name: Reveal XT Insertable Cardiac Monitor and Reveal XT Patient Assistant Reveal DX Insertable Cardiac Monitor and Reveal DX Patient Assistant
Indications for Use:
The Reveal XT/DX Insertable Cardiac Monitor is an implantable patientactivated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:
- Patients with clinical syndromes or situations at increased risk of . cardiac arrhythmias.
- . Patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain, that may suggest a cardiac arrhythmia.
The Reveal XT/DX Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the data management features in the Reveal Insertable Cardiac Monitor:
- . To verify whether the implanted device has detected a suspected arrhythmia or device related event. *
- To initiate recording of cardiac event data in the implanted device . memory.
*only applicable to the Reveal XT Patient Assistant Model 9539
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arlene Braun for BDZ
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K082475
Reveal 9529 XT & Reveal 9528 DX Medtronic Confidential
K082475 1 - 62