(249 days)
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No
The provided text describes a remote monitoring system that collects physiological data for storage and analysis, but it does not mention the use of AI or ML for this analysis. The sections specifically looking for mentions of AI, DNN, or ML are marked as "Not Found".
No
The device is described as a remote monitoring system that aids in diagnosis and treatment by providing physiological data, not by treating a condition directly.
Yes
The text explicitly states, "The data from the CPM System is intended for use by healthcare professionals as an aid to diagnosis and treatment." This indicates that the device generates data used in the diagnostic process.
No
The description explicitly mentions a "Sensinel™ CPM Wearable and Base Station," which are hardware components used to acquire physiological data. The software is part of a larger system that includes hardware.
Based on the provided information, the Sensinel™ CPM System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Sensinel™ CPM System Function: The Sensinel™ CPM System directly measures physiological data from the patient's body (ECG, temperature, impedance, etc.) through a wearable device placed on the chest. This is a form of in vivo (within the living body) measurement.
The Sensinel™ CPM System is a remote physiological monitoring system, not a device that analyzes samples taken from the body.
N/A
Intended Use / Indications for Use
The Sensinel™ CPM System is a wireless remote monitoring system intended for use by healthcare professionals for spot-checking of physiological data in home and healthcare settings. This can include:
- ECG
- Heart Auscultation Sounds
- Skin Temperature (Obtained from left chest area)
- Thoracic Impedance (including changes in Thoracic Impedance)
- Respiration Rate and relative changes in Tidal Volume
- Heart Rate
- Diastolic Heart Sounds Strength
- Body Posture (including Tilt Angle)
Data are transmitted wirelessly from the Sensinel™ CPM Wearable and Base Station for storage and analysis. The CPM Wearable is intended for use on general care adult patients 18 years of age or older to provide physiological information. The data from the CPM System is intended for use by healthcare professionals as an aid to diagnosis and treatment.
The CPM System is intended to be used by patients at rest and not performing any activities or movements. This system is for spot-checking and does not have continuous monitoring capability. The CPM Wearable does not produce alarms and is not intended for active patient monitoring (in real-time).
The Sensinel™ CPM System is contraindicated for those patients with life threatening arrhythmias requiring immediate medical intervention.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DPS, DXH, DSB, DQD, BZQ, FLL
Device Description
The Sensinel™ CPM System is a wireless remote monitoring system. It consists of a Sensinel™ CPM Wearable and Base Station. Data are transmitted wirelessly from the Wearable and Base Station for storage and analysis. The system is designed for spot-checking physiological data.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
left chest area (for Skin Temperature), Body (for Body Posture), Thoracic (for Thoracic Impedance)
Indicated Patient Age Range
adult patients 18 years of age or older
Intended User / Care Setting
healthcare professionals for use in home and healthcare settings.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of "ADMINISTRATION".
December 22, 2023
Analog Devices, Inc. Sam Rajkumar Senior Manager, Regulatory Affairs, Ouality & Compliance One Analog Way Wilmington, Massachusetts 01887
Re: K231086
Trade/Device Name: CPM System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DPS, DXH, DSB, DQD, BZQ, FLL Dated: November 29, 2023 Received: November 29, 2023
Dear Sam Rajkumar:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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,
Jennifer W. Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231086
Device Name Sensinel™ CPM System
Indications for Use (Describe)
The Sensinel™ CPM System is a wireless remote monitoring system intended for use by healthcare professionals for spot-checking of physiological data in home and healthcare settings. This can include:
- ECG
- · Heart Auscultation Sounds
- · Skin Temperature (Obtained from left chest area)
- · Thoracic Impedance (including changes in Thoracic Impedance)
- · Respiration Rate and relative changes in Tidal Volume
- Heart Rate
- Diastolic Heart Sounds Strength
- · Body Posture (including Tilt Angle)
Data are transmitted wirelessly from the Sensinel™ CPM Wearable and Base Station for storage and analysis. The CPM Wearable is intended for use on general care adult patients 18 years of age or older to provide physiological information. The data from the CPM System is intended for use by healthcare professionals as an aid to diagnosis and treatment.
The CPM System is intended to be used by patients at rest and not performing any activities or movements. This system is for spot-checking and does not have continuous monitoring capability. The CPM Wearable does not produce alarms and is not intended for active patient monitoring (in real-time).
The Sensinel™ CPM System is contraindicated for those patients with life threatening arrhythmias requiring immediate medical intervention.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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