BIOHARNESS
Device Facts
| Record ID | K113045 |
|---|---|
| Device Name | BIOHARNESS |
| Applicant | Zephyr Technology Corporation |
| Product Code | MHX · Cardiovascular |
| Decision Date | Aug 14, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
Indications for Use
The intended use of the BioHamess 3.0 is to provide a facility in the home, workplace and alternate care settings for detecting, storing and transmitting Adult - single lead ECG data to third party ECG instruments for interpretation by qualified persons. The BioHarness 3.0 stores over 140 hours of ECG signals for transmission via USB or real time Bluetooth. The scientific concept on which this device is based is the principle that low level electrical pulses from the heart are measurable of the surface of the skin. This device functions by capturing these electrical pulses via electrodes and delivering these signals to sophisticated electronics for signal processing. The calibration is established by the factory and vields accurate and calibrated signals that can maintain calibration over its useful life.
Device Story
BioHarness 3.0 is a physiological/cardiographic electrode transmitter; consists of reusable chest harness with embedded electrodes, elastic belt, and electronics module (puck). Device captures single-lead ECG signals from skin without gels or adhesives; processes signals via internal micro-processors and firmware; stores up to 140 hours of data. Transmits data via Bluetooth or USB to compatible third-party ECG instruments for interpretation by qualified persons. Used in home, workplace, or alternate care settings; operated by patients or healthcare professionals. Provides real-time monitoring of heart rate, respiration, posture, and activity. Benefits include ambulatory monitoring of vital signs during sedentary or rigorous activity, facilitating clinical decision-making through remote data transmission.
Clinical Evidence
Bench testing only. No clinical data provided. Factory tests conducted to verify signal accuracy and maintenance of calibrated energy patterns over the device's useful life.
Technological Characteristics
Reusable chest harness with embedded electrodes; elastic belt; electronics module (puck) with rechargeable battery. Sensing principle: surface ECG electrical pulse detection. Connectivity: Bluetooth (Class I, ~100m range) and USB. Signal processing: internal micro-processors and firmware. Form factor: wearable chest strap. Sterilization: not specified.
Indications for Use
Indicated for monitoring adults in home, workplace, and alternate care settings. Used as a general patient monitor for physiological information in occupational welfare systems, general research, performance measurement, or where prescribed by a healthcare professional. Monitors ECG, heart rate, respiration rate, body orientation, and activity. Contraindication: Breathing rate values are only accurate during sedentary periods.
Regulatory Classification
Identification
The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
Predicate Devices
Submission Summary (Full Text)
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K113045
# 510(k) Summary
(per 21 CFR 807.92)
AUG 1 4 2012
### 31 July 2012
Sponsor Mr. Sailor Mohler Quality Manager Zephyr Technology Corporation 1 Annapolis Street, Suite 200 Annapolis MD 21401 USA Office: 443-569-3603 sailor.mohler@zephyranywhere.com
# Consultant
Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, CT 06907-1659 203 329 2700 F 203 329 2345 rkeen@fda-complianceconsultants.com
| Proprietary Name: | BioHarness 3.0 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | BioHarness 3.0 |
| Device Classification Name | (1) Electrocardiograph Electrode<br>(2) Arrhythmia Detector and Alarm |
| Classification Number: | (1) 21CFR870.2360<br>(2) 21CFR870.1025 |
| Product Code | (1) DRX<br>(2) MHX |
| Reviewing Group | Cardiovascular |
| Device Classification | Class II |
| Establishment registration No. | # 233836 |
| Predicate Device | (1) Monebo, CardioBelttm, K063044, is a reusable electrode system consisting of an electrode assembly, an elastic chest, and an electronic package to transmit ECG information to a compatible Bluetooth enabled device.<br>(2) Zephyr Technology, BioHarness 2.0, K100040, is an ambulatory patient monitor consisting of a chest strap and an electronics module that attaches to the strap to acquire, store and transmit physiologic data. |
Trademark Notice: All Trademarks used other than those of Zephyr Technology Corporation are registered to their respective owners.
Confidentiality Notice: All data contained in this application and all documents provided with this document may contain trade secrets or proprietary data which the sponsor requests are treated in accordance with law.
### Device Description
The BioHarness 3.0, a cardiographic electrode transmitter is composed of:
- proprietary hardware and firmware, enclosed in ●
- a user case (puck) with a re-chargeable battery, ◆
- various sensors embedded in a reusable chest harness, and ●
- ECG detection and transmission and .
- A cradle (to recharge battery and transfer internally stored date to an ancillary computer). .
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# 510(k) Summary
(per 21 CFR 807.92)
The BioHarness 3.0 is a physiological / cardiographic electrode transmitter manufactured by Zephyr Technology Corporation with reusable electrodes in a chest harness consisting of an electrode assembly, an elastic chest belt, and an electronics package containing a Bluetooth transmitter. The BioHarness 3.0 electrodes are positioned against the patient's skin with light pressure, using the elastic chest belt. The BioHarness 3.0 is designed to be used without electrolytic gels and without adhesives on unorepared skin: that is without the requirements for shaving, abrading, or other skin preparation. This device transmits ECG information to a compatible Bluetooth - enabled device. This transmitter is a class I Bluetooth radio with a range of approximately 100 meters (spherical range).
### Indications for Use
The BioHarness 3.0 is a physiological monitoring telemetry device intended for monitoring of adults in the home, workplace and alternate care settings. The device consists of a chest strap and an electronics module that attaches to the strap. The device stores and transmits vital sign data including ECC, heart rate, respiration rate, body orientation and activity. The BioHamess 3.0 provides a facility to detect and transmit single lead ECG signals to be received by Bluetooth / USB qualified ECG instruments.
The BioHarness 3.0 collects and transmits measurements captured during both sedentary as well as rigorous activity for Heart Rate, Posture and Activity. Breathing rate values are accurately transmitted only during sedentary periods.
The BioHarness 3.0 is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, for general research and performance measurement purposes, or where prescribed by a healthcare professional.
### Intended Use
The intended use of the BioHamess 3.0 is to provide a facility in the home, workplace and alternate care settings for detecting, storing and transmitting Adult - single lead ECG data to third party ECG instruments for interpretation by qualified persons. The BioHarness 3.0 stores over 140 hours of ECG signals for transmission via USB or real time Bluetooth. The scientific concept on which this device is based is the principle that low level electrical pulses from the heart are measurable of the surface of the skin. This device functions by capturing these electrical pulses via electrodes and delivering these signals to sophisticated electronics for signal processing. The calibration is established by the factory and vields accurate and calibrated signals that can maintain calibration over its useful life.
### Substantial Equivalence
Zephyr Technology Corporation has determined that the BioHamess 3.0 is substantially equivalent to the performance of a predicate Device. The differences between these systems are incidental and not significant. Both devices use a similar technological characteristics and principles.
- Both devices use electrodes to capture signals from the skin, ●
- both devices convert analog cardiological signals to digital signals, .
- both devices use micro-processors, firmware and signal processing, �
- both devices transmit the signals to receivers that detect and present the information as ECG . waveforms.
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# 510(k) Summary
(per 21 CFR 807.92)
### Safety and Effectiveness
There are no substantial differences between the BioHarness 3.0 defined in this 510(k) submission and the stated predicate device. They are similar to the technologies that are currently used in other similar medical devices.
This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy. A series of factory tests are conducted to verify the intended signals are accurate and can maintain a calibrated energy pattern over its useful life. The BioHarness 3.0 has benefited from design, development, testing and production procedures that conform to Quality Systems.
Zephyr Technology Corporation continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting device to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple, using black and white, and is designed to be easily recognizable.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
AUG 1 4 2012
Zephyr Technology Corporation c/o Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, CT 06907
Re: K113045
Trade/Device Name: BioHarness 3.0 Regulation Number: 21 CFR 870.1025 Regulation Name: Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms) Regulatory Class: Class II (two) Product Code: MHX, DRX Dated: July 31, 2012 Received: August 9, 2012
Dear Mr. Keen:
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.
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## Page 2 - Mr. Richard Keen
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
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# 510(K) Number Assigned k113045 Name: BioHarness 3.0
### INDICATIONS FOR USE
The BioHarness 3.0 is a physiological monitoring telemetry device intended for monitoring of adults in the home, workplace and alternate care settings. The device consists of a chest strap and an electronics module that attaches to the strap. The device stores and transmits vital sign data including ECG, heart rate, respiration rate, body orientation and activity. The BioHarness 3.0 provides a facility to detect and transmit single lead ECG signals to be received by Bluetooth / USB qualified ECG instruments.
The BioHarness 3.0 collects and transmits measurements captured during both sedentary as well as rigorous activity for Heart Rate, Posture and Activity. Breathing rate values are accurately transmitted only during sedentary periods.
The BioHarness 3.0 is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, for general research and performance measurement purposes, or where prescribed by a healthcare professional.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | XXX |
|--------------------------|--------------------------|
| | or |
| Over - The - Counter Use | (Per 21 CFR 801.109) |
| | (Optional Format 1-2-96) |
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K113045 |
