(156 days)
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 suggest 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.
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.
The provided 510(k) summary for the Medtronic Reveal DX Insertable Cardiac Monitor (Model 9528) and Reveal Patient Assistant (Model 9538) does not contain specific acceptance criteria or a detailed study proving the device meets particular quantitative performance metrics for arrhythmia detection (e.g., sensitivity, specificity for bradyarrhythmia, asystole, or fast ventricular tachyarrhythmia).
Instead, the summary focuses on demonstrating substantial equivalence to predicate devices. The "Summary of Testing" section broadly states that "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." It lists various types of testing completed (EMC, electrical safety, firmware, MRI compatibility, sensing and detection performance validation testing, etc.) but does not provide results for these tests or specific acceptance criteria met.
Therefore, many of the requested details about a study proving specific acceptance criteria cannot be extracted from this document, as it primarily serves to establish substantial equivalence through general verification and validation, rather than a detailed performance study with quantitative acceptance criteria.
However, based on the information provided, here's what can be answered:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices rather than reporting specific quantitative acceptance criteria or performance metrics for arrhythmia detection (e.g., sensitivity, specificity, accuracy). It generally states that "sensing and detection performance validation testing" was completed and that the device performs "as intended."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the summary. No details about a specific test set, its size, or the origin of the data are mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The summary does not detail any expert review process for a test set.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study is not mentioned in the summary. The device's primary function is automatic arrhythmia detection, not as an AI assistant for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The summary indicates that standalone performance testing was done for the automated detection capabilities. It states: "The Reveal DX Model 9528 Insertable Cardiac Monitor (ICM) is designed to automatically record the occurrence of arrhythmias in a patient. ... Auto activation may help to detect abnormal heart rhythms in patients who may not activate/trigger the ICM." The "sensing and detection performance validation testing" mentioned under "Summary of Testing" would pertain to this standalone performance. No specific quantitative results are provided, but the statement "the results of the testing indicate that the Reveal DX Insertable Cardiac Monitor Model 9528 ... perform as intended" suggests the standalone algorithm's performance was evaluated.
7. The Type of Ground Truth Used
The type of ground truth used for "sensing and detection performance validation testing" is not explicitly stated. However, for arrhythmia detection devices, the ground truth is typically established by expert review of ECG signals, sometimes correlated with clinical outcomes or invasive EP studies, but the document does not specify.
8. The Sample Size for the Training Set
This information is not provided. The summary does not mention a training set, which is typical for devices cleared under substantial equivalence based on established predicate technology rather than novel AI/ML development requiring explicit training data.
9. How the Ground Truth for the Training Set was Established
This information is not provided, as no training set is mentioned.
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510(K) SUMMARY
NOV 2 1 2007
| Date Prepared: | June 15, 2007 |
|---|---|
| Submitter: | Medtronic, Inc.Cardiac Rhythm Disease Management710 Medtronic ParkwayMinneapolis, MN 55432-5604 |
| Contact: | Sara ChristiansenSenior Regulatory Affairs Specialist |
| Telephone: | (763)505-7864 |
| Fax: | (763)505-7877 |
| E-mail: | sara.christiansen@medtronic.com |
| Proprietary Name: | Reveal DX Insertable Cardiac MonitorReveal Patient Assistant |
| Common Name: | Insertable Cardiac Monitor |
| Device Classification | Class 11, 21 CFR 870.1025, Arrhythmiadetector 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.
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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.
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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
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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
1-26
§ 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.