Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)

K243216 · Analog Devices · MWI · Dec 10, 2024 · Cardiovascular

Device Facts

• Record ID: K243216
• Device Name: Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)
• Applicant: Analog Devices
• Product Code: MWI · Cardiovascular
• Decision Date: Dec 10, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The ADI Sensinel CPM (Cardiopulmonary Management) 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 • 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 ADI CPM (Cardiopulmonary Management) Wearable and Base Station for storage and analysis. The device is intended for use on general care adult patients who are 18 years of age or older to provide physiological information. The data from the ADI CPM (Cardiopulmonary Management) System Platform are intended for use by healthcare professional as an aid to diagnosis and treatment. The ADI 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 device does not produce alarms and is not intended for active patient monitoring (real-time). The ADI CPM System in contraindicated for those patients with life threatening arrhythmias requiring immediate medical intervention.

Device Story

Sensinel CPM System (ADCP1100) is a wireless remote monitoring platform for spot-checking physiological parameters. Input data includes ECG, heart auscultation sounds, skin temperature, thoracic impedance, respiration rate, tidal volume, heart rate, and body posture. System consists of a wearable device and base station; data transmitted wirelessly for storage and analysis. Used in home or healthcare settings by patients at rest; operated by healthcare professionals to aid diagnosis and treatment. Device does not provide continuous monitoring or real-time alarms. Output provides physiological information to clinicians for decision-making; benefits include remote access to patient data for non-acute management.

Technological Characteristics

Wireless remote monitoring system; includes wearable sensor and base station. Measures ECG, heart sounds, temperature, thoracic impedance, respiration, and posture. Connectivity via wireless transmission to base station for storage/analysis. Intended for spot-checking only; no continuous monitoring or alarm functionality.

Indications for Use

Indicated for general care adult patients (18+ years) for spot-checking physiological data (ECG, heart sounds, temperature, thoracic impedance, respiration, heart rate, posture) in home or clinical settings. Contraindicated for patients with life-threatening arrhythmias requiring immediate intervention.

Regulatory Classification

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.

Submission Summary (Full Text)

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December 10, 2024

Analog Devices, Inc. Phani Puppala Senior Strategist. Ouality & Regulatory 1 Analog Wav Wilmington, Massachusetts 01887

Re: K243216

Trade/Device Name: Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) 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: October 2, 2024 Received: October 3, 2024

Dear Phani Puppala:

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"

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(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).

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Jennifer W. Shih -S

Jennifer 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

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## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K243216

Device Name

Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)

#### Indications for Use (Describe)

The ADI Sensinel CPM (Cardiopulmonary Management) 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
- · 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 ADI CPM (Cardiopulmonary Management) Wearable and Base Station for storage and analysis. The device is intended for use on general care adult patients who are 18 years of age or older to provide physiological information. The data from the ADI CPM (Cardiopulmonary Management) System Platform are intended for use by healthcare professional as an aid to diagnosis and treatment.

The ADI 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 device does not produce alarms and is not intended for active patient monitoring (real-time).

The ADI CPM System in 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)

he-Counter Use (21 CFR 801 Subpart C)

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