(202 days)
Not Found
No
The summary describes a simple hand-held device used to manually mark events in an implantable device's memory. There is no mention of any analytical or interpretive functions that would typically involve AI/ML. The performance studies focus on basic device functionality and safety, not algorithmic performance.
No
The device is described as initiating recording of cardiac event data and marking symptoms, not directly treating a condition.
No
The device is described as initiating and marking the recording of cardiac event data, but it does not analyze or interpret this data to provide a diagnosis. Its function is to assist in data collection, not diagnosis. This is supported by the fact that it mentions "marking symptoms" and "initiates the recording of cardiac event data," suggesting a data input/triggering function rather than an analytical one.
No
The device description explicitly states it is a "hand-held, battery operated, Bluetooth Low Energy (BLE) device," indicating it is a hardware device, not software-only. The performance studies also include hardware-related testing like EMC, Environmental, and Mechanical Design Verification.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device's intended use is to "initiate the recording of cardiac event data in the device memory of a Medtronic insertable cardiac monitor." This is a function related to monitoring physiological events within the body, not analyzing samples taken from the body (which is the core of IVD).
- Device Description: The description reinforces its function as a hand-held device used by patients to "mark symptoms in the memory of their implantable device." Again, this is about interacting with an implanted device and recording in-vivo events, not performing tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Reagents or test kits
- Laboratory or clinical testing procedures
The device is a patient-operated tool for interacting with an implanted medical device to record symptomatic events. This falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Patient Assistant model PA97000 initiates the recording of cardiac event data in the device memory of a Medtronic insertable cardiac monitor. The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic.
Product codes
DSI
Device Description
The PA97000 Patient Assistant (hereinafter referred to as PA97000) is a hand-held, battery operated, Bluetooth Low Energy (BLE) device used by patients to mark symptoms in the memory of their implantable device, as illustrated in Figure 1: Image of PA97000. It is intended for unsupervised use away from a hospital or clinic.
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
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
The proposed changes to the PA97000 were fully verified and validated in accordance with design control requirements. Device verification testing was performed to demonstrate the PA97000 meets established performance criteria and supports substantial equivalency to the Patient Assistant Model PA96000.
The following performance data were provided in support of the substantial equivalence determination.
- Safety Design Verification
- EMC Design Verification
- Environmental Design Verification
- Mechanical Design Verification
- Firmware Design Verification
- Packaging Design Verification
- Security Design Validation
- System Design Validation
- Human Factors Testing
- Biocompatibility
Key Metrics
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medtronic, Inc Cheryl Swanson Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112
Re: K190574
Trade/Device Name: Patient Assistant Model PA97000 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: DSI Dated: August 21, 2019 Received: August 22, 2019
Dear Cheryl Swanson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole Goodsell Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190574
Device Name Patient Assistant Model 97000
Indications for Use (Describe)
The Patient Assistant model PA97000 initiates the recording of cardiac event data in the device memory of a Medtronic insertable cardiac monitor. The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) |
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510(k) SUMMARY
The following table provides background information regarding this Traditional 510(k) submission:
| Date Prepared: | March 1, 2019 |
|---|---|
| 510(k) Owner / Address: | Medtronic, Inc. |
| Cardiac Rhythm and Heart Failure | |
| 8200 Coral Sea Street NE | |
| Mounds View, MN 55112 | |
| Contact Person: | Cheryl Swanson |
| Senior Principal Regulatory Affairs Specialist | |
| cheryl.swanson@medtronic.com | |
| Office: (763) 514-0088 | |
| Cell: (651) 242-3506 |
Secondary Contact:
Ryan Calabrese
Senior Regulatory Affairs Director
ryan.s.calabrese@medtronic.com
Office: (763) 526-3515 |
| Submission Type: | Traditional 510(k) |
| Device Trade Name: | Patient Assistant, Model 97000 |
| Device Common Name: | Patient Assistant |
| Product Code and Classification
Regulation Name: | DSI: Arrhythmia Detector and Alarm
21 CFR 870.1025
Class II |
| Predicate Devices: | K150177 |
Device Description
The PA97000 Patient Assistant (hereinafter referred to as PA97000) is a hand-held, battery operated, Bluetooth Low Energy (BLE) device used by patients to mark symptoms in the memory of their implantable device, as illustrated in Figure 1: Image of PA97000. It is intended for unsupervised use away from a hospital or clinic.
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Image /page/4/Picture/0 description: The image shows a gray Medtronic device with a white button. There are two small lights on the top of the device, one green and one blue. The word "Medtronic" is printed on the bottom right of the device. The device has a hole at the bottom.
Figure 1: Image of PA97000
Device Purpose
The PA97000 Patient Assistant provides three key functions for the user:
-
- Activates the data management feature in an insertable cardiac device to initiate recording of cardiac event data in the implanted device memory. The stored episodes are used by the clinician to correlate the patient's cardiac rhythm with their symptoms.
-
- Provides feedback to the user that the PA97000 is searching for the implanted device.
-
- Provides feedback to the user that the PA97000 has marked a symptom in the implanted device memory.
Indications for Use
The Patient Assistant model PA97000 initiates the recording of cardiac event data in the device memory of an Insertable Cardiac Monitor. The Patient is intended for unsupervised patient use away from a hospital or clinic.
Summary of Changes
The primary changes from the Patient Assistant Model PA96000 to the PA97000 are as follows:
-
- Update the communication protocol from Telemetry B to Bluetooth Low Energy (BTLE)
-
- Update the Indications for Use to state the PA97000 can be used with the an Insertable Cardiac Monitor that the subject device is tested with.
Technological Characteristics
The PA97000 operates identically to the PA96000. The only difference is the communication protocol used by PA97000 is Bluetooth LE rather than Telemetry B that is used by the predicate device. Analysis of the change confirms it does not raise new questions of safety or effectiveness. This conclusion is supported by a thorough hazard analysis and extensive testing.
Summary of Testing and Performance Data
The proposed changes to the PA97000 were fully verified and validated in accordance with design control requirements. Device verification testing was performed to demonstrate the
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PA97000 meets established performance criteria and supports substantial equivalency to the Patient Assistant Model PA96000.
The following performance data were provided in support of the substantial equivalence determination.
- Safety Design Verification
- EMC Design Verification
- Environmental Design Verification ●
- Mechanical Design Verification ●
- Firmware Design Verification
- Packaging Design Verification
- Security Design Validation ●
- . System Design Validation
- Human Factors Testing
- Biocompatibility
Conclusion
The intended use, design, materials and performance of the PA97000 are substantially equivalent to the predicate Patient Assistant Model PA96000. This is supported by a thorough hazard analysis and extensive testing.