RAISIN PERSONAL MONITOR

K093976 · Proteus Biomedical, Inc. · DXH · Mar 25, 2010 · Cardiovascular

Device Facts

• Record ID: K093976
• Device Name: RAISIN PERSONAL MONITOR
• Applicant: Proteus Biomedical, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Mar 25, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

The Raisin™ Personal Monitor is a miniaturized, wearable data-logger for ambulatory recording of heart rate, activity, body angle relatively to gravity, and time-stamped, patient-logged events. The Raisin™ Personal Monitor enables unattended data collection for clinical and research applications. The Raisin™ Personal Monitor may be used in any instance where quantifiable analysis of event-associated heart rate, activity, and body position is desirable.

Device Story

Raisin Personal Monitor (RPM) is a miniaturized, wearable, battery-operated data-logger worn on the torso. It captures heart rate via biopotential electrodes, physical activity and body angle via a 3-axis accelerometer, and patient-marked events via a manual button. Signals are processed on-device; heart rate is derived from R-wave frequency; body angle is calculated via double integration of accelerometer output. Data are stored locally (4 MB) and transferred via Bluetooth to a general computing device for display and export. Used in clinical and research settings for unattended data collection. Healthcare providers use the exported data to contextualize physiologic measures with patient-logged events, aiding clinical decision-making by providing objective, time-stamped records of patient activity and symptoms.

Clinical Evidence

Bench testing included accelerometer validation against known acceleration and R-wave detection validation using the MIT-BIH arrhythmia database (48 files) and ANSI/AAMI EC 13 guidelines. R-wave detection showed 99.7% positive detection accuracy. Clinical validation involved walking tests to confirm accelerometer capture of movement features and ECG capture across various body locations (anterior chest, xyphoid, stomach, lateral chest), with average R-wave detection accuracy ranging from 98.82% to 99.40%.

Technological Characteristics

Miniaturized, wearable, battery-operated (rechargeable Li-ion). Sensors: 3-axis accelerometer (motion/angle), biopotential amplifier (heart rate/impedance). Connectivity: Bluetooth telemetry. Form factors: one-piece (ovoid, 115x54x12mm, 50g) or two-piece (triangular, 95x84x10mm, 20g). Waterproof. Memory: 4 MB. Software: Modified Hamilton-Tompkins algorithm for R-wave detection.

Indications for Use

Indicated for ambulatory recording of heart rate, physical activity, body position relative to gravity, and patient-logged events in clinical and research settings where quantifiable analysis of these parameters is required.

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Predicate Devices

• HealthePod™ (K083174)
• Actiheart® (K052489)
• Actiwatch-Score® (K991033)

Submission Summary (Full Text)

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# 510(k) Summary

#### 1.4.1 -- 510(k) Owner

Proteus Biomedical 2600 Bridge Parkway, Suite 101 Redwood City, CA 94065 [phone] (tel) [phone] (fax)

MAR 2 5 2010

193976 777

### 1.4.2 -- Contact Person

Gregory Moon, MD

#### 1.4.3 -- Date Summary Prepared

February 10, 2010

### 1.4.4 -- Name of Device

| Trade name: | Raisin™ Personal Monitor |
|----------------------|------------------------------------------------------------|
| Common name: | Physiological Data and Event Logging Device |
| Classification name: | Cardiovascular Transmitter and Receiver (Product Code DXH) |

#### 1.4.5 -- Predicate Devices

HealthePod™ (K083174) Actiheart® (K052489) Actiwatch-Score® (K991033)

# 1.4.6 -- Device Description and Technologic Characteristics

.. .

The Raisin100 Personal Monitor (RPM) is a miniaturized, ambulatory, battery-operated datalogging device that is worn on the torso to record heart rate, activity, and patient-logged events.

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Patient-logged events can be extrinsic (e.g., dosing of a medication) or intrinsic (e.g., a symptom) and are time-stamped using a manual button on the device, in order to contextualize the physiologic measures. Subjective meaning of these events is assigned by the user. In addition to quantification of physical motion, signals from the device's accelerometer are used to determine body position relative to gravity. Electrode-to-electrode impedance is also measured to assess whether the device is attached properly to the user. RPM recorded data are transferred via Bluetooth telemetry to a general computing device for display and conversion for export to other programs. The RPM is available in two form factors to accommodate individual comfort preferences: one-piece and two-piece. The functionality, intended use, duration and location of wear, and fundamental scientific technologies are exactly the same between the two RPM form factors.

### 1.4.6.1 -- Basic technologies

| Parameter | Sensor Technology | Method |
|---------------------------|---------------------------------------|--------------------------------------------------|
| Heart rate | Biopotential low-frequency amplifier | Digitized R wave |
| Activity | Accelerometer | Digitized accelerometer output |
| Body angle | Accelerometer | Double integration of accelerometer output |
| Patient event logging | Patient activated button | Digital pulse |
| Inter-electrode impedance | Biopotential high-frequency amplifier | Digitized impedance from small auxiliary current |

Proteus Biomedical, Inc.

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### 1.4.6.2 -- Physical Characteristics

| Parameter | Value |
|-------------------------|-----------------------------|
| Shape | One-piece: ovoid |
| | Two-piece: triangular |
| Size | One-piece: 115 x 54 x 12 mm |
| | Two-piece: 95 x 84 x 10 mm |
| Weight | 50 g |
| | 20 g |
| Battery type | Rechargeable lithium ion |
| Moisture susceptibility | Waterproof |
| Memory | 4 MB |
| Storage temperature | -25 °C to +75 °C |
| Relative humidity | 10% to 90%, not condensing |

# 1.4.6.3 – Theory of Operation

The Raisin™ Personal Monitor acquires, time-stamps and logs digital data corresponding to physiologic signals and patient-marked events. Heart rate, quantified using R-wave frequency, is sensed via three adhesive skin electrodes on the base of the data recorder. Activity data are provided by a 3-axis accelerometer integrated into the RPM. Subjects can mark subjectively defined, personally relevant events by depressing a button on the data recorder. Raisin™ Personal Monitor data are periodically uploaded to a general computing device via Bluetooth telemetry for display and export.

# 1.4.7 -- Intended Use

The Raisin" Personal Monitor is a miniaturized, wearable data-logger for ambulatory recording of heart rate, activity, body angle relatively to gravity, and time-stamped, patient-logged events. The Raisin™ Personal Monitor enables unattended data collection for clinical and research

Proteus Biomedical, Inc.

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applications. The Raisin™ Personal Monitor may be used in any instance where quantifiable analysis of event-associated heart rate, activity, and body position is desirable.

### 1.4.8 -- Summary of Non-Clinical Performance Data

The three-axis accelerometer provides motion and position data and is validated against a known acceleration applied against each of its three axes.

The figure below shows bench validation of the accelerometer in all three of its axes.

Image /page/3/Figure/5 description: The image contains three scatter plots, each titled "Measured Acceleration vs. Applied Acceleration." The plots show the relationship between measured acceleration and applied acceleration for the X, Y, and Z axes. In each plot, the data points form a linear pattern, indicating a strong correlation between measured and applied acceleration. The axes are labeled with values ranging from -1 to 1.

Proteus Biomedical, Inc.

Raisin System 510k

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The biopotential low-frequency amplifier is used to quantify heart rate by measuring R-wave frequency. The table below shows R-wave detection validation results, based upon a modified Hamilton-Tompkins algorithm, tested using guidelines set forth in the ANSV/AAMI EC 13 standard.

| Test Description | Expected Results (bpm) | Algorithm Results (bpm) |
|----------------------------------------------------------------------------|------------------------|-------------------------|
| Default ECG waveform | 80 | 80.0 |
| T-wave rejection<br>R-wave amplitude of 1 mV<br>T-wave amplitude of 0.4 mV | 80 | 80.0 |
| Ventricular bigeminy | 80 | 79.9 |
| Slow alternating ventricular<br>bigeminy | 60 | 60.5 |
| Rapid alternating ventricular<br>bigeminy | 120 | 119.8 |
| Bidirectional systoles | 90 | 90.1 |
| Default ECG waveform<br>Pacing pulse with 2 mV<br>amplitude, 2 ms width | 80 | 80.0 |

The table below shows validation testing results of R-wave detection during arrhythmia. Raisin™ Personal Monitor-reported R-wave locations were compared with annotated R-wave locations in all 48 test files from the MIT-BIH arrhythmia database.

| Metric | Median | Standard Deviation |
|-----------------------------|--------|--------------------|
| Positive Detection Accuracy | 99.7% | 5.9% |
| False Positive Rate | 0% | 1.7% |

Proteus Biomedical, Inc.

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K093976
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### 1.4.9 -- Summary of Clinical Performance Data

The three-axis accelerometer was also validated clinically by assessing subject movement, in this case walking, to assess capture of expected features. The figure below demonstrates data from a representative walking test.

Image /page/5/Figure/3 description: The image shows three line graphs representing a walking test across the X, Y, and Z axes. Each graph plots 'time(sec)' on the x-axis, ranging from 0 to 3.5, against 'Acceleration (G)' on the y-axis. The X-axis graph shows acceleration fluctuating between approximately 0.5 and 1.5 G, the Y-axis graph shows acceleration fluctuating between approximately -1 and 0 G, and the Z-axis graph shows acceleration fluctuating between approximately -0.6 and 0.2 G.

The figure below shows a representative subject ECG captured by the RPM, with the automatically identified R-waves highlighted.

Image /page/5/Figure/5 description: The image shows an example captured and processed ECG waveform for subject 1, chest location, sitting. The x-axis represents time in seconds, ranging from 40 to 55. The y-axis represents ECG raw amplitude, ranging from -100 to 100. The plot shows the ECG waveform and R-waves, with the R-waves marked by diamond symbols.

Proteus Biomedical, Inc.

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The table below shows robust R-wave detection accuracy when heart rate data were collected from different body locations.

| Anterior<br>Chest | Xyphoid | Stomach | Lateral<br>Chest | |
|------------------------------------------|---------|---------|------------------|-------|
| Subject 1 | 100 | 99.72 | - | - |
| Subject 2 | 99.30 | 99.00 | 99.24 | 99.61 |
| Subject 4 | 99.14 | 98.58 | 99.31 | 98.05 |
| Subject 5 | 99.14 | 99.37 | 98.66 | 98.81 |
| Average R-<br>wave detection<br>accuracy | 99.40 | 99.17 | 99.07 | 98.82 |

### 1.4.10 -- Conclusions

The Raisin" Personal Monitor (RPM) is a small, ambulatory, battery-operated data-logging device that is worn on the chest surface to record heart rate, activity, body angle relative to gravity, and patient-logged events. Patient-logged events are used to contextualize the physiologic measures. The RPM's functionality has been validated in non-clinical and clinical testing as summarized above.

Proteus Biomedical, Inc.

.

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Image /page/7/Picture/1 description: The image shows the logo of the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure with outstretched arms, suggesting care and protection. The overall design is simple and conveys a sense of governmental authority and public service.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAR 2 5 2010

Proteus Biomedical, Inc. c/o Gregory Moon, M.D. Director of Clinical Affairs 2600 Bridge Parkway, Suite 101 Redwood City, CA 94065

Re: K093976

> Trade/Device Name: Raisin™ Personal Monitor Regulatory Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitters and Receivers Regulatory Class: II (two) Product Code: 74 DXH Dated: February 26, 2010 Received: March 2, 2010

Dear Dr. Moon:

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 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 - Gregory Moon, M.D.

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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# Indications for Use

510(k) Number (if known): K093976

Device Name: Raisin™ Personal Monitor

#### Indications for use:

The Raisin™ Personal Monitor is a miniaturized, wearable data-logger for ambulatory recording of heart rate, activity, body angle relatively to gravity, and time-stamped, patient-logged events. The Raisin™ Personal Monitor enables unattended data collection for clinical and research applications. The Raisin™ Personal Monitor may be used in any instance where quantifiable analysis of eventassociated heart rate, activity, and body position is desirable.

Prescription Use _ J (21 CFR 801 Subpart D) AND/OR

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) |
|---------------------|--------------------------------------------------------|
| | |
| (Division Sign-Off) | Division of Cardiovascular Devices |
| 510(k) Number | K093976 |