(91 days)
No
The description focuses on data logging and basic signal processing (R-wave detection using a modified Hamilton-Tompkins algorithm), with no mention of AI or ML techniques for data analysis or interpretation. The validation against the MIT-BIH database is a standard method for evaluating ECG algorithms, not necessarily indicative of ML.
No.
The device is described as a "data-logger" and "Personal Monitor" for "unattended data collection for clinical and research applications" to quantify physiological measures, but it does not claim to treat, mitigate, or prevent any condition.
No.
The Intended Use and Device Description sections describe the device as a "data-logger" and "Personal Monitor" for "unattended data collection." It quantifies heart rate, activity, and body position, and contextualizes patient-logged events. There is no mention of the device providing a diagnosis or diagnostic information based on the collected data. The data is for "quantifiable analysis" in clinical and research applications, suggesting it provides raw or processed physiological parameters rather than a diagnostic output.
No
The device description explicitly states it is a "miniaturized, ambulatory, battery-operated datalogging device that is worn on the torso" and mentions hardware components like an accelerometer, biopotential low-frequency amplifier, and a manual button. It also describes electrode-to-electrode impedance measurement, indicating physical contact and hardware.
Based on the provided information, the Raisin™ Personal Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Raisin™ Personal Monitor Function: The Raisin™ Personal Monitor is a wearable device that collects physiological data directly from the body (in vivo). It measures heart rate, activity, and body angle through sensors attached to the torso. It does not analyze biological specimens.
The device's function aligns with being a physiological monitoring device, not an IVD.
N/A
Intended Use / 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 event-associated heart rate, activity, and body position is desirable.
Product codes
DXH
Device Description
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.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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
torso, chest surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
R-wave detection validation results, based upon a modified Hamilton-Tompkins algorithm, tested using guidelines set forth in the ANSVI/AAMI EC 13 standard.
R-wave detection during arrhythmia validation testing results: 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.
Summary of Performance Studies
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 biopotential low-frequency amplifier is used to quantify heart rate by measuring R-wave frequency. The table 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.
The table 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.
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 table shows robust R-wave detection accuracy when heart rate data were collected from different body locations.
Key Metrics
R-wave detection during arrhythmia:
Positive Detection Accuracy: 99.7% Median, 5.9% Standard Deviation
False Positive Rate: 0% Median, 1.7% Standard Deviation
Average R-wave detection accuracy by body location:
Anterior Chest: 99.40%
Xyphoid: 99.17%
Stomach: 99.07%
Lateral Chest: 98.82%
Predicate Device(s)
HealthePod™ (K083174), Actiheart® (K052489), Actiwatch-Score® (K991033)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
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.(b)
Classification. Class II (performance standards).
0
510(k) Summary
1.4.1 -- 510(k) Owner
Proteus Biomedical 2600 Bridge Parkway, Suite 101 Redwood City, CA 94065 (650) 632-4031 (tel) (650) 632-4071 (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.
1
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.
2
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.
3
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
1-21
4
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 | ||
| R-wave amplitude of 1 mV | ||
| T-wave amplitude of 0.4 mV | 80 | 80.0 |
| Ventricular bigeminy | 80 | 79.9 |
| Slow alternating ventricular | ||
| bigeminy | 60 | 60.5 |
| Rapid alternating ventricular | ||
| bigeminy | 120 | 119.8 |
| Bidirectional systoles | 90 | 90.1 |
| Default ECG waveform | ||
| Pacing pulse with 2 mV | ||
| 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
P6/7
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.
6
The table below shows robust R-wave detection accuracy when heart rate data were collected from different body locations.
| Anterior
Chest | Xyphoid | Stomach | Lateral
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-
wave detection
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.
8
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 (800) 638-2041 or (301) 796-7100 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
9
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 |