(156 days)
Not Found
No
The document describes automatic detection of arrhythmias based on pre-defined classifications (bradyarrhythmia, asystole, ventricular tachyarrhythmia) and does not mention any AI/ML techniques for this detection or any other function.
No
The device is described as a monitoring system that records ECG and detects cardiac arrhythmias. It does not actively treat or provide therapy to the patient.
Yes
The device is described as a "monitoring system that records subcutaneous ECG" and is used to detect and record "cardiac arrhythmias," which are abnormalities in heart rhythm. This collection and analysis of physiological data to identify a medical condition is the definition of a diagnostic device.
No
The device description clearly outlines both an implantable hardware component (Reveal DX Insertable Cardiac Monitor) and a hand-held hardware component (Reveal Patient Assistant). The performance studies also include testing for hardware aspects like electrical safety, EMC, and mechanical performance.
Based on the provided information, 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 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. It does not analyze samples taken from the body.
- Intended Use: The intended use is to monitor for cardiac arrhythmias based on the electrical signals of the heart, not to diagnose conditions based on analysis of biological samples.
Therefore, this device falls under the category of an implantable medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Reveal DX Insertable Cardiac Monitor is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous FCG and is indicated in the following cases:
- · patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
- · patients who experience transient symptoms 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 DX Model 9528 Insertable Cardiac Monitor (ICM) is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as bradyarrhythmia, asystole, or (fast) ventricular tachyarrhythmia. The Reveal DX ICM provides storage of ECG and marker channels during patientactivated 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 DX ICM Model 9528 is a small, leadless device that is 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 Patient Assistant Model 9538 is a hand-held, battery-operated telemetry device that enables the patient to start recording cardiac information in the Reveal DX ICM after experiencing symptoms of a possible cardiac event.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest (subcutaneous)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Device verification testing was performed to demonstrate the Reveal DX Model 9528 Insertable Cardiac Monitor and Reveal Patient Assistant Model 9538 meet established performance criteria and to support equivalency to the reference predicate devices. Electromagnetic compatibility (EMC), clectrical safety, component, environmental handling, sterilization, firmware, MRI compatibility and sensing and detection performance validation testing were completed for the Reveal DX Model 9528 Insertable Cardiac Monitor. Functional and mechanical performance testing, firmware testing and usability testing was completed for the Reveal Patient Assistant Model 9538. System verification and validation and packaging testing were also completed. The results of the testing indicate that the Reveal DX Insertable Cardiac Monitor Model 9528 and Reveal Patient Assistant Model 9538 perform as intended and are safe for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 994331, K042108, K992410, K053462, K003667
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
510(K) SUMMARY
NOV 2 1 2007
| Date Prepared: | June 15, 2007 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Cardiac Rhythm Disease Management | |
| 710 Medtronic Parkway | |
| Minneapolis, MN 55432-5604 | |
| Contact: | Sara Christiansen |
| Senior Regulatory Affairs Specialist | |
| Telephone: | (763)505-7864 |
| Fax: | (763)505-7877 |
| E-mail: | sara.christiansen@medtronic.com |
| Proprietary Name: | Reveal DX Insertable Cardiac Monitor |
| Reveal Patient Assistant | |
| Common Name: | Insertable Cardiac Monitor |
| Device Classification | Class 11, 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 DX Insertable Cardiac Monitor (Model 9528) are substantially equivalent to the following predicate devices:
- · Medtronic Reveal Plus (Model 9526) ILR K 994331, Cleared 21 January 2000/K003667, Cleared 14 February 2001
- · Novacor Vista Plus Holter Recorder K042108, Cleared 19 January 2005
- · IM Systems Actitrac Activity Monitor K992410, Cleared 15 October 1999
- · Invivo Corporation Model 3160 MRI Patient Monitor (MRI compatible multiparameter patient monitor) - K053462, Cleared 18 January 2005
The intended use, design, materials and performance of the Reveal Patient Assistant (Model 9538) are substantially equivalent to the following predicate device.
Image /page/0/Picture/12 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 inside of a circle. The word "Medtronic" is written in a bold, sans-serif font.
1
Traditional 510(k) 510(k) Summary
1.213
- · Medtronic Model 6191 Patient Activator K994331, Clearcd 21 January 2000/ K003667, Cleared 14 February 2001
Device Description
The Reveal DX Model 9528 Insertable Cardiac Monitor (ICM) is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as bradyarrhythmia, asystole, or (fast) ventricular tachyarrhythmia. The Reveal DX ICM provides storage of ECG and marker channels during patientactivated 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 DX ICM Model 9528 is a small, leadless device that is 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 Patient Assistant Model 9538 is a hand-held, battery-operated telemetry device that enables the patient to start recording cardiac information in the Reveal DX ICM after experiencing symptoms of a possible cardiac event.
Indications for Use
The Reveal DX Insertable Cardiac Monitor is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous FCG and is indicated in the following cases:
- · patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
- · patients who experience transient symptoms 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
Intended use, design, materials, performance and technological characteristics are substantially equivalent to the predicate devices referenced.
Image /page/1/Picture/17 description: The image shows the Medtronic logo with the word "Confidential" next to it. The Medtronic logo consists of a circular emblem on the left and the company name in bold, black letters. The word "Confidential" is in a smaller, lighter font, indicating the sensitive nature of the document or information associated with the logo. The emblem appears to depict a stylized representation of the human body.
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Summary of Testing
Device verification testing was performed to demonstrate the Reveal DX Model 9528 Insertable Cardiac Monitor and Reveal Patient Assistant Model 9538 meet established performance criteria and to support equivalency to the reference predicate devices. Electromagnetic compatibility (EMC), clectrical safety, component, environmental handling, sterilization, firmware, MRI compatibility and sensing and detection performance validation testing were completed for the Reveal DX Model 9528 Insertable Cardiac Monitor. Functional and mechanical performance testing, firmware testing and usability testing was completed for the Reveal Patient Assistant Model 9538. System verification and validation and packaging testing were also completed. The results of the testing indicate that the Reveal DX Insertable Cardiac Monitor Model 9528 and Reveal Patient Assistant Model 9538 perform as intended and are safe for their intended use.
Biocompatibility testing was not required because blood-contacting materials of the Reveal DX Model 9528 Insertable Cardiac Monitor implanted device are similar to the predicate device, the Medtronic Reveal Plus ILR.
The Reveal DX Model 9528 Insertable Cardiac Monitor will be sterilized using a validated EtO sterilization process.
Conclusion
Medtronic considers the Reveal DX Insertable Cardiac Monitor system 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/9 description: The image shows the Medtronic logo with the word "Confidential" to the right of it. The Medtronic logo consists of a stylized human figure inside of a circle with arrows indicating movement. The word "Medtronic" is written in a bold, sans-serif font.
3
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2007
Medtronic, Inc. c/o Ms. Michelle Nivala Regulatory Affairs Specialist Cardiac Rhythm Disease Management 8200 Coral Sea Street NW Mounds View, MN 55112
Re: K071655
Trade/Device Name: Reveal DX (Model 9528) and Reveal Patient Assistant (Model 9538) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class II (two) Product Code: DSI Dated: November 1, 2007 Received: November 2, 2007
Dear Ms. Nivala:
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.
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Page 2 - Ms. Michelle Nivala
Please be 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 set 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Duna R. Lachner
Bram D. Zuckerman, M.D. - Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Traditional 510(k) Indications for Use Reveal DX Insertable Cardiac Monitor System
K
INDICATIONS FOR USE
510(k) Number (if known): __KD71655
Device Name: Reveal DX Insertable Cardiac Monitor and Reveal Patient Assistant
Indications for Use:
The Reveal DX Insertable Cardiac Monitor is an implantable patient-activated 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 that may . suqqest a cardiac arrhythmia
The Reveal 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
(Part 21 CFR 801 Subpart D)
AND/OR
Confidential
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Holmes
Division of Cardiovascular Devices
510(k) Number K071653
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