(84 days)
The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes heart rate, electrocardiography (ECG), heart rate variability (R-R interval), 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 Vital Connect Platform can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients.
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) Adhesive 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 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. During normal operation, continuous wireless transmission occurs with a delay or latency of seconds between continuous data collection and transmission. However, for continuous transmission of data to a healthcare professional, a continuous connection is needed between the module, the relay, and the server. Data can be stored on the VitalConnect Sensor for several hours and then transferred once connectivity is reestablished.
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 (R-R interval), respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall).
The provided text describes the VitalConnect Platform, a wireless remote monitoring system. While it mentions non-clinical bench testing for various physiological parameters and a "Long-term Field Study for Home Use," it does not provide specific acceptance criteria or reported device performance values in a table. It also does not present a formal clinical study designed to prove the device meets pre-defined acceptance criteria with detailed statistical analysis.
Therefore, many of the requested details cannot be extracted directly from the provided text.
Here's an attempt to answer based on the available information, with clear indications of what is not present:
Acceptance Criteria and Study Details for VitalConnect Platform (K141161 JIII 2 9 2014)
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria or reported device performance values are provided in the document. The non-clinical testing section lists various parameters that were tested (e.g., ECG, Heart rate, Respiration rate, etc.), but does not give quantitative thresholds or specific results.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Study):
- Sample Size: 76 participants
- Data Provenance: The study was conducted by Vital Connect, likely in the USA. It was a "Long-term Field Study for Home Use." The context implies it was a prospective study focused on usability and wearability in a home setting.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The clinical study described is focused on "usability" and "long-term wearability," rather than diagnostic accuracy against an expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided as the study described does not appear to involve expert adjudication for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The study described focuses on the device's performance (usability, wearability) in a home setting rather than comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
While "Non-clinical bench testing" was performed for various physiological parameters, the document does not report standalone algorithm performance metrics (e.g., sensitivity, specificity, accuracy) that would demonstrate the algorithm's performance in isolation without human intervention. The mention of "Measurement accuracy" in non-clinical testing suggests this was assessed, but no results are given.
7. Type of Ground Truth Used
For the "Long-term Field Study for Home Use," the "ground truth" implicitly relates to the successful use and wearability in a real-world setting, as assessed by participants and potentially monitored by the study conductors. It does not mention a gold standard for physiological measurement accuracy, pathology, or specific clinical outcomes data as the primary ground truth for the clinical study described. The non-clinical testing likely used calibrated reference instruments for accuracy assessments, but this is not explicitly stated for a "ground truth" as typically understood in clinical validation studies.
8. Sample Size for the Training Set
The document does not mention any details about a training set for an AI algorithm. It refers to a "VitalConnect Platform," which suggests an integrated system rather than a separately described AI component with a distinct training phase.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned for an AI algorithm, this information is not provided.
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K141161 JIII 2 9 2014
510(k) Summary
The summary 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) 963-2828Vital Connect Inc.900 East Hamilton AvenueSuite 500Campbell, CA 95008 |
| Date Prepared: | June 03, 2014 |
| Trade name: | VitalConnect Platform (consisting of VitalConnect Sensor,Relay Software Library and Secure Server Software Library) |
| Classification: | Class II |
| Classification: | Classifications presented as part of the VitalConnectPlatform cleared 510(k) submission (K132447):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)New classification for home use indication:21 CFR 870.1025, Product Code: MHX• Monitor, physiological, patient (with arrhythmia detectionor alarm) |
| Predicate Device: | Predicate devices presented as part of the VitalConnectPlatform cleared 510(k) submission (K132447):• CareFusion, Wireless Monitoring System, 510(k) #:K110809• Preventice, BodyGuardian System, 510(k) #: K121197• Corventis, Mobile Patient Management System, 510(k) #:K083287 |
| New predicate device for home use indication: | |
| • Hidalgo Ltd, Equivalent™ Vital Signs Physiological Monitor EQo2, K113054 | |
| Classification Panel: | Cardiology |
| Device Description: | 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 LibraryVitalConnect Platform sub-system includes:• VitalConnect Sensora) Adhesive PatchThe Patch is designed as a disposable self-adhesive interface to the body.b) Sensor ModuleResiding 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 LibraryThe 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 LibraryThe Server Software Library is installed on a central server, manages the upload, processing and storage of sensor data, as well as 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. During normal operation, continuous wireless transmission occurs with a delay or latency of seconds between continuous data collection and transmission. However, for continuous transmission of data to a healthcare professional, a continuous connection is needed between the module, the relay, and the server. Data can be stored on the VitalConnect Sensor for several hours and then transferred once connectivity is reestablished. |
| The VitalConnect Sensor is a battery-operated adhesive patchwith integrated sensors and wireless transceiver module, wornon the torso to record heart rate, electrocardiography (ECG),heart rate variability (R-R interval), respiratory rate, skintemperature, activity (including step count), and posture (bodyposition relative to gravity including fall). | |
| PhysicalDescription: | VitalConnect Sensor consisting of Patch and the SensorModule 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 |
| Indication ForUse: | The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes heart rate, electrocardiography (ECG), heart rate variability (R-R interval), 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 Vital Connect Platform can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients. |
| Comparison ofTechnologicalCharacteristics: | Technological review and comparison to the predicate device,Hidalgo Ltd, EquivalentTM Vital Signs Physiological MonitorEQo2, K113054, has been performed through product testingpresented as part of the cleared 510(k) submission K132447.The VitalConnect Platform and the predicate device (HidalgoLtd, EquivalentTM Vital Signs Physiological Monitor EQo2,K113054) contain small ambulatory monitoring sensors thatmeasure ECG, heart rate, respiration rate, activity, bodyorientation, body/skin temperature. Both transmit their data to aremote computer server that allows healthcare professionals toaccess and review the data. There are no fundamentaldifferences between their technological characteristics forhome setting environment. Therefore, we claim thatVitalConnect Platform is substantially equivalent to Hidalgo Ltd,EquivalentTM Vital Signs Physiological Monitor EQo2(K113054) in this regard. |
| Non-ClinicalTesting: | Non-clinical bench testing was presented as part of theVitalConnect Platform cleared 510(k) submission (K132447).This testing is applicable to the indication submitted here in,including testing of:Electrocardiograph (ECG) Heart rate Heart rate variability (R-R interval) 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: | An IRB-approved "Long-term Field Study for Home Use" wasconducted by Vital Connect with the VitalConnect Platform fromSeptember 2013 to March 2014, to assess the long-term use ofthe VitalConnect Platform in a home setting. The assessmentincludes the usability of the VitalConnect Platform in a homesetting, including interaction with the module, patch, and relay. |
| In addition, the assessment includes the long-term wearabilityof a series of patches on the same participants. Resultsindicate successful use of the VitalConnect Platform over a 50-day home use study on 76 participants. | |
| Biocompatibility: | The initial 510k submission, K132447, included biocompatibilitydata for the hydrocolloid adhesive. In this submission, amedical grade silicone adhesive has been added as a separateoption for the patch. The silicone adhesive has been subjectedto the following safety evaluation:• In Vitro Cytotoxicity• MEM Elution• Primary Skin Irritation• Guinea Pig Sensitization |
| Conclusion: | The performance results for the VitalConnect Platform includednon-clinical and clinical testing already submitted as part ofK132447, and the biocompatibility testing data of siliconeadhesive and clinical study in a home setting are provided inthis 510(k) demonstrate that VitalConnect Platform is safe andeffective for its intended use, including use in the homeenvironment. |
| Based on the intended use and product performance results,VitalConnect Platform has been shown to be substantiallyequivalent for home use to the currently marketed predicatedevice, Hidalgo Ltd, EquivalentTM Vital Signs PhysiologicalMonitor EQo2, K113054. |
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July 29, 2014
Vital Connect Inc. Sam Mostafavi VP Quality Assurance & Regulatory Affairs 900 E. Hamilton Ave., Suite 500 Campbell. California 95008
Re: K141167
Trade/Device Name: Vitalconnect platform (consisting of vitalconnect sensor, relay software library and secure server software library) Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II Product Code: DRG, DSI, MHX Dated: June 3, 2014 Received: June 4. 2014
Dear Sam Mostafavi,
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
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Page 2 - Sam Mostafavi
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 devicerelated 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), 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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,
Image /page/6/Picture/8 description: The image shows a logo with the text "Ken Skodacek for" below it. The logo consists of the letters K, S, and A, with the A being in the shape of a triangle. The text is in a bold, sans-serif font. The logo and text are black and white.
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 Statement
510(k) Number (if known): K141167
Device Name: VitalConnect Platform
Indication for use:
- . The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes heart rate, electrocardiography (ECG), heart rate variability (R-R interval), 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 Vital Connect Platform can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters.
- The device is intended for use on general care patients who are 18 years of age . or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients.
Prescription Use × (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)
Image /page/7/Picture/12 description: The image shows a logo with the letters "KDA" in a stylized, bold font. Below the letters, the name "Ken Skodacek" is written in a smaller, less bold font. The overall design appears to be a logo or emblem, possibly for a person or organization with the initials KDA.
Bram Zuckerman
§ 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).