(240 days)
The VitalConnect Platform is a wireless monitoring system intended for use by healthcare professionals for unattended surveillance of physiological data within healthcare settings. This includes heart rate, electrocardiography (ECG), heart rate variability, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data is transmitted wirelessly to a central location where it is stored for analysis. The VitalConnect Platform can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters.
The device is not intended to be used on critical care patients and is intended to supplement vital signs monitoring by healthcare professionals, not to replace current standards of care. The device is intended for use on general care patients and on patients who are 18 years of age or older. It is not intended for home use.
The VitalConnect Platform is a wireless data collection system that monitors physiological data and consists of the following sub systems:
• VitalConnect Sensor (includes adhesive Patch and Sensor Module)
• Relay Software Library
• Server Software Library
VitalConnect Platform sub-system includes: VitalConnect Sensor . a) Patch The Patch is designed as a disposable self-adhesive interface to the body. b) Sensor Module Residing within the patch, the sensor module performs processing functions related to capture of physiological data and also performs bi-directional communication with the relay device. VitalConnect Relay Software Library ● The Relay Software Library manages bi-directional communication between the Sensor Module and the Server Software Library and is installed on a relay device. VitalConnect Secure Server Software Library . The Server Software Library is installed on a central server, manages the upload, processing and storage of sensor data, as well as real-time configuration of and notifications from the VitalConnect Platform. The VitalConnect Sensor continuously gathers physiological data from the person being monitored and then transmits encrypted data via a bi-directional relay to the central server. The VitalConnect Sensor is a battery-operated adhesive patch with integrated sensors and wireless transceiver module, worn on the torso to record heart rate, electrocardiography (ECG), heart rate variability, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall) for in-patient use.
The VitalConnect Platform (K132447) is a wireless monitoring system intended for use by healthcare professionals for unattended surveillance of physiological data within healthcare settings. This includes heart rate, electrocardiography (ECG), heart rate variability, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria for each physiological parameter. Instead, it states that "The results of the non-clinical and clinical studies demonstrate that the VitalConnect Platform is safe and effective for its intended use" and that the device is "substantially equivalent to the currently marketed predicate devices" based on intended use and product performance.
However, the non-clinical testing section lists the parameters for which testing was conducted, implying that the device's performance for these parameters was evaluated for accuracy and safety. For the purpose of this analysis, we will infer the "reported device performance" as the successful completion of these tests, leading to the substantial equivalence determination.
| Physiological Parameter / Test | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Non-Clinical Testing: | ||
| Electrocardiograph (ECG) | Met industry standards for ECG monitoring and safety. | Bench testing conducted; deemed safe and effective and substantially equivalent to predicate devices. |
| Heart rate | Met industry standards for heart rate measurement accuracy. | Bench testing conducted; deemed safe and effective and substantially equivalent to predicate devices. |
| Heart rate variability | Met industry standards for heart rate variability measurement. | Bench testing conducted; deemed safe and effective and substantially equivalent to predicate devices. |
| Respiration rate | Met industry standards for respiration rate measurement accuracy. | Bench testing conducted; deemed safe and effective and substantially equivalent to predicate devices. |
| Body impedance | Met industry standards, if applicable, for measurement. | Bench testing conducted; deemed safe and effective and substantially equivalent to predicate devices. |
| Activity (step count) | Met industry standards for activity tracking accuracy. | Bench testing conducted; deemed safe and effective and substantially equivalent to predicate devices. (The predicate device K083287, Corventis, Mobile Patient Management System, is specifically mentioned for Activity and Posture comparison, implying similar performance expectations.) |
| Posture (body position, fall) | Met industry standards for posture detection and fall alerts. | Bench testing conducted; deemed safe and effective and substantially equivalent to predicate devices. (The predicate device K083287, Corventis, Mobile Patient Management System, is specifically mentioned for Activity and Posture comparison, implying similar performance expectations.) |
| Bluetooth verification | Successful communication and data transfer. | Bench testing conducted. |
| Notification | Timely and accurate alerts when parameters are outside limits. | Bench testing conducted. |
| Measurement accuracy | As defined by relevant standards for each parameter. | Bench testing conducted. (This is a general category covering the accuracy of the physiological measurements listed above). |
| Communication, data transmission and storage | Reliable and secure data flow and storage. | Bench testing conducted. |
| Reliability | Consistent and dependable operation. | Bench testing conducted. |
| Electromagnetic compatibility | Compliance with EMC standards. | Bench testing conducted. |
| Electrical safety testing | Compliance with IEC 60601-1 and related standards. | Bench testing conducted. |
| Co-existence testing | No adverse interference with other medical devices. | Bench testing conducted. |
| Software verification and validation | Software functions as intended, safely and effectively. | Bench testing conducted. |
| Biocompatibility verification and testing | No adverse biological reactions from device contact. | Bench testing conducted. |
| Clinical Testing: | Safe and effective for intended use in human subjects. | Clinical study performed on human subjects; results demonstrate safety and effectiveness, supporting substantial equivalence. The summary doesn't detail specific metrics (e.g., sensitivity, specificity, accuracy) from the clinical study, but concludes it demonstrated the device is safe and effective for its intended use. |
2. Sample Size Used for the Test Set and the Data Provenance
The 510(k) summary states that "Clinical study was performed on human subjects" but does not provide any details regarding the sample size used for the test set.
The data provenance (e.g., country of origin, retrospective or prospective) is also not specified in the provided document. It only indicates that the study was "performed on human subjects."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The 510(k) summary does not provide information on the number of experts used, their qualifications, or how ground truth was established for the clinical study. Given the nature of physiological monitoring, ground truth would likely be established by simultaneously using validated, reference-standard monitoring equipment.
4. Adjudication Method for the Test Set
The 510(k) summary does not describe any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not mentioned or implied. The device is a physiological monitoring system, not an imaging diagnostic device that typically involves human readers interpreting cases. Therefore, the concept of human readers improving with AI assistance is not directly applicable in the context of this device as described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a physiological monitoring system that captures and processes data. The non-clinical "bench testing" of parameters like heart rate, ECG, respiratory rate, etc., represents a standalone performance evaluation of the device's algorithms and sensors without direct human intervention in the continuous data capture and processing (though humans would be setting up the test and evaluating the output). The clinical study, while involving human subjects, evaluates the device's performance in a real-world setting, also largely as a "standalone" system in terms of its ability to collect and transmit physiological data. The system is designed to provide unattended surveillance and notify healthcare professionals, implying its algorithms operate independently to detect deviations.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not explicitly state the type of ground truth used. However, for physiological monitoring devices, ground truth for parameters like heart rate, ECG, respiration rate, and temperature would typically be established using:
- Reference standard medical devices: e.g., a calibrated ECG machine for heart rate and ECG, a capnograph or spirometer for respiration, a precision thermometer for skin temperature.
- Direct observation/manual counting: for respiration rate.
- Known physical movements/positions: for activity and posture.
While not stated, it is highly probable that validated, higher-accuracy reference devices were used in parallel during the clinical study to establish ground truth for comparison.
8. The Sample Size for the Training Set
The 510(k) summary does not mention a separate training set or its sample size. This device is primarily a physiological sensor and data transmission platform, not a machine learning-based diagnostic algorithm that typically requires a distinct training phase on a large dataset. While its internal algorithms (e.g., for heart rate variability, or detecting fall) would have been developed and tested, the document focuses on the validation studies rather than the development phase data.
9. How the Ground Truth for the Training Set Was Established
As no specific training set is mentioned (see point 8), the method for establishing its ground truth is not provided. If internal algorithm development involved data, it would logically follow similar ground truth establishment methods as for the clinical validation, likely using reference standard devices.
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510(K) SUMMARY
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter: | Vital Connect Inc.900 East Hamilton AvenueSuite 500Campbell, CA 95008 |
|---|---|
| Contact Person: | Sam MostafaviVice President of Quality Assurance and Regulatory AffairsE-mail: smostafavi@vitalconnect.comPhone: (408) 963-4620Fax: (408) 963-2828 |
| Date Prepared: | Vital Connect Inc.900 East Hamilton AvenueSuite 500Campbell, CA 95008March 27, 2014 |
| Trade name: | VitalConnect Platform (consisting of VitalConnect Sensor,Relay Software Library and Secure Server Software Library) |
| Classification: | Class II |
| Classification: | 21 CFR 870.2910, Product Code: DRG• Transmitters and Receivers, Physiological Signal,Radiofrequency21 CFR 870.1025, Product Code: DSI• Arrhythmia detection and alarm (including ST-segmentmeasurement and alarm) |
| Predicate Device: | • CareFusion, Wireless Monitoring System, 510(k) #:K110809• Preventice, BodyGuardian System, 510(k) #: K121197• Corventis, Mobile Patient Management System, 510(k) #:K083287 |
| ClassificationPanel: | Cardiology |
| DeviceDescription: | The VitalConnect Platform is a wireless data collection systemthat monitors physiological data and consists of the followingsub systems:• VitalConnect Sensor (includes adhesive Patch and SensorModule)• Relay Software Library• Server Software Library |
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VitalConnect Platform sub-system includes: VitalConnect Sensor . a) Patch The Patch is designed as a disposable self-adhesive interface to the body. b) Sensor Module Residing within the patch, the sensor module performs processing functions related to capture of physiological data and also performs bi-directional communication with the relay device. VitalConnect Relay Software Library ● The Relay Software Library manages bi-directional communication between the Sensor Module and the Server Software Library and is installed on a relay device. VitalConnect Secure Server Software Library . The Server Software Library is installed on a central server, manages the upload, processing and storage of sensor data, as well as real-time configuration of and notifications from the VitalConnect Platform. The VitalConnect Sensor continuously gathers physiological data from the person being monitored and then transmits encrypted data via a bi-directional relay to the central server. The VitalConnect Sensor is a battery-operated adhesive patch with integrated sensors and wireless transceiver module, worn on the torso to record heart rate, electrocardiography (ECG), heart rate variability, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall) for in-patient use. VitalConnect Sensor consisting of Patch and the Sensor Physical Description: Module dimensions are: Patch: approximately 111 mm long x 47mm wide x 6 mm . high (without the release liner) Sensor Module: approximately 21 mm long x 12 mm wide x . 4 mm high The VitalConnect Platform is a wireless monitoring system Intended Use: ● intended for use by healthcare professionals for unattended surveillance of physiological data within healthcare settings. This includes heart rate, electrocardiography (ECG), heart rate variability, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data is transmitted wirelessly to a central location where it is stored for analysis. The VitalConnect Platform can be configured by Authorized Persons to notify healthcare professionals when
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| • physiological data falls outside selected parameters.The device is not intended to be used on critical carepatients and is intended to supplement vital signsmonitoring by healthcare professionals, not to replacecurrent standards of care. The device is intended for use ongeneral care patients and on patients who are 18 years ofage or older. It is not intended for home use. | |
|---|---|
| Comparison ofTechnologicalCharacteristics: | VitalConnect Platform and the primary predicate device(CareFusion, Wireless Monitoring System, 510(k) #: K110809)contain small ambulatory monitoring sensors that measureECG, heart rate variability, respiratory rate, skin temperature,activity (including step count), and posture (body positionrelative to gravity including fall). All transmit their data to anexternal device, which in turn, transmits the data to a remotecomputer server that allows healthcare professionals to accessand review the data. There are no fundamental differencesbetween their technological characteristics.Additionally, we claim Preventice BodyGuardian System,K121197, and Corventis, Mobile Patient Management System,K083287 as secondary predicates. Preventice BodyGuardianSystem for ECG data, and Corventis, Mobile PatientManagement System for Activity and Posture. |
| Non-ClinicalTesting: | The following bench testing was conducted on theVitalConnect Platform system:• Electrocardiograph (ECG)• Heart rate• Heart rate variability.• Respiration rate• Body impedance• activity (including step count),• Posture (body position relative to gravity including fall)• Bluetooth verification• Notification• Measurement accuracy• Communication, data transmission and storage• Reliability• Electromagnetic compatibility• Electrical safety testing• Co-existence testing• Software verification and validation testing• Biocompatibility verification and testing |
| Clinical Testing: | Clinical study was performed on human subjects. |
| Conclusion: | The results of the non-clinical and clinical studies demonstratethat the VitalConnect Platform is safe and effective for itsintended use. |
| Based on the intended use and product performance results.the subject device has been shown to be substantially | |
| equivalent to the currently marketed predicate devices. |
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 2, 2014
VITAL CONNECT, Inc. Sam Mostafavi VP of QA & RA 900 E. Hamilton Ave. Ste # 500 Campbell, CA 95008 US
Re: K132447
Trade/Device Name: Vitalconnect platform by VITAL CONNECT Inc. Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (includes ST-segment measurement,alarm) Regulatory Class: Class II Product Code: DSI, DRG Dated: February 12, 2014 Received: February 20, 2014
Dear Sam Mostafavi:
This letter corrects our substantially equivalent letter of April 3, 2014.
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. 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
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Page 2 - Mr. Sam Mostafavi
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); 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address:
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
FDA
forBram 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 STATEMENT
510(k) Number (if known): K132447
Device Name: VitalConnect Platform
Indication for use:
- The VitalConnect Platform is a wireless monitoring system intended for use by . healthcare professionals for unattended surveillance of physiological data within healthcare settings. This includes heart rate, electrocardiography (ECG), heart rate variability, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data is transmitted wirelessly to a central location where it is stored for analysis. The VitalConnect Platform can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters.
- The device is not intended to be used on critical care patients and is intended to . supplement vital signs monitoring by healthcare professionals, not to replace current standards of care. The device is intended for use on general care patients and on patients who are 18 years of age or older. It is not intended for home use.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kenneth J. Cavanaugh -S
Page 1 of 1
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).