(330 days)
Not Found
No
The document describes a sensor-based device that collects and transmits vital sign data. There is no mention of AI or ML algorithms being used for data processing, analysis, or interpretation. The device appears to rely on direct measurement and derivation from physiological signals.
No
The device is described as a "physiological monitoring telemetry device" intended for "monitoring of adults" and "general patient monitor to provide physiological information." It collects and transmits vital sign data. There is no indication that it provides therapy or treatment for any condition.
No
This device is a physiological monitoring telemetry device intended for general patient monitoring, not for diagnostic purposes. Its primary function is to store and transmit vital sign data, not to diagnose conditions.
No
The device description explicitly states it consists of a chest strap with electrodes and an electronics module, which are hardware components. While it includes software for data transmission and display, it is not solely software.
Based on the provided information, the BioHarness is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the BioHarness is a "physiological monitoring telemetry device intended for monitoring of adults in the home, workplace and alternate care settings." It monitors vital signs like heart rate, respiration rate, temperature, posture, and activity.
- Device Description: The device description details how the BioHarness collects physiological data from the body (electrical activity for heart rate, thoracic movement for respiration).
- Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The BioHarness directly measures physiological parameters on the body.
The BioHarness is a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The BioHarness 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 heart rate, respiration rate, thoracic skin temperature, body orientation and activity.
The BioHarness collects and transmits measurements captured during both sedentary as well as rigorous activity for Heart Rate, Skin Temperature, Posture and Activity. Breathing rate values are accurately transmitted only during sedentary periods.
The BioHarness is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, and for general research and performance measurement purposes.
Product codes (comma separated list FDA assigned to the subject device)
MHX
Device Description
The BioHarness is a compact physiological monitor that consists of two components:
- A chest strap with conductive fabric skin electrodes and a thoracic expansion sensor.
- A battery-powered electronics module that attaches to the chest strap.
The device provides both storage and real-time transmission of the user's Heart Rate and Respiration Rate. The device uses heart electrical activity signals and respiratory breathing frequency inferred from thoracic movement to derive the Heart Rate and Respiration Rate.
The device also provides the following physiological measures:
. An indication of the user's activity level based on acceleration measured by an internal triaxial accelerometer.
. Body orientation
. Thoracic skin temperature.
. Alerts if physiological conditions exceed predefined thresholds.
An accessory cradle is provided to recharge the internal battery and transfer internally stored data to a computer.
The transmitted data provided by the device over Bluetooth may be integrated into third party monitoring applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest
Indicated Patient Age Range
adults
Intended User / Care Setting
Home, workplace and alternate care settings
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance measurement and review to the applicable sections of the following standards has been conducted and successfully demonstrated as recommended by available guidance from the agency:
ANSI/AAMI ES60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
ANSI/AAMI/IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility -Requirements and tests.
ANSI/AAMI/ISO 10993-1:2003, Biological evaluation of medical devices - Part 1: Evaluation and testing.
ANSI/AAMI EC13:2002/(R) 2007, Cardiac monitors, heart rate meters, and alarms. The device provides function as a heart rate meter, but is not indicated for use as an ECG monitor.
ASTM E1965 - 98(2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.
Reviews and tests have also been carried out for general functionality and performance of the BioHarness.
Software has been developed using a structured software development process which meets the requirements of IEC 60601-1-4:1996/(R)2005, Medical electrical equipment - Part 1: General requirements for safety. 4. Collateral Standard: Programmable electrical medical systems.
This pre-market notification has shown the substantial equivalence of the BioHarness to the identified predicates, by comparison to the descriptive material and performance testing of the device.
General functionality of the BioHarness has been reviewed and tested iteratively throughout the development cycle. Devices and accessories are also tested as part of the production process.
Development testing of BioHarness functionality has occurred at the bench level and under simulated field conditions (i.e. field trials).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Hidalgo Equivital EQ-10 Vital Signs Physiological Monitor (K061993), Respironics Actiheart K052489, VivoMetrics LifeShirt Real Time K043604, GMP Wireless Medicine LifeSync K030795
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
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.(b)
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.
0
K1000 40
Traditional 510(k)
Premarketing Notification
Traditional 510(k) Submission
DEC - 3 2010
| Submission date: | December 31, 2009 |
|---|---|
| Submitter | Zephyr Technology Corporation |
| 1 Annapolis Street | |
| Suite 200 | |
| Annapolis, Maryland 21401 | |
| Contact Person: | Code Cubitt |
| Chief Operating Officer | |
| Telephone: | +1 (443) 569 3603 |
| Fax: | +1 (443) 926 9402 |
| Common Name: | Ambulatory Patient Monitor |
| Trade Name: | BioHarness |
| Classification Name: | 21CFR 870 1025 |
| Establishment Registration Number: | |
| Product code: | MHX |
| Device Class: | Class II |
1
GENERAL INFORMATION 1
This document contains the Premarket Notification for Zephyr Technology Corporation's BioHarness product. The BioHarness is an ambulatory patient monitor and provides remote vital signs monitoring for subjects in healthcare, occupational and home settings.
Zephyr's recommended classification for the BioHarness is as a class II medical device under regulation 21 CFR 870.1025 with product code MHX. The BioHarness product is a new medical device based on a legacy non-medical product already marketed by Zephyr. The intended use and technological characteristics of the BioHarness are the same as that of an existing legally marketed medical device manufactured by Hidalgo Ltd, the Equivital EQ-10 Vital Signs Physiological Monitor (K061993).
Zephyr Technology Corporation is a developer and manufacturer of real-time monitoring solutions for defense, emergency responder, training and research markets. Based in Annapolis, Maryland, Zephyr leverages a world class team of engineers, scientists, physiologists and business experts. Local universities and government labs augment Zephyr's internal development in specialized areas such as materials science, garment and textile design, sports science, physiological monitoring and software / web applications. Zephyr Technology Ltd, a wholly-owned R&D subsidiary of Zephyr Technology Corporation, is located in Auckland, New Zealand.
2
Zephyr Technology
2 PROPOSED LABELLING
2.1 User Documentation
The user manual is available. "Zephyr Technology BioHarness Bluetooth User Manual"
Images of labels on the device are shown below.
Image /page/2/Picture/6 description: The image shows two different views of a small, dark-colored electronic device. The left side of the image shows the top of the device, which has a power button symbol in the center. The right side of the image shows the bottom of the device, which has a label with some text and symbols on it, as well as some screws and other components. The device has a rounded, triangular shape.
Image /page/2/Picture/7 description: The image shows a product label with regulatory information. The label includes the serial number "ZBH001366", and states that the product contains a transmitter module. It also lists the FCC ID as "QOQWT12" and the IC ID as "5123A-BGTWT12A". The label also features the CE marking and a crossed-out wheeled bin symbol, along with the text "ZEPHYR BIOHARNESS BT".
Front and rear view of BioHarness device
Rear label
2.2 Carton Label
The BioHarness ships in a package 25.5cm x 16.5cm. The figures below show the package labelling.
Image /page/2/Picture/12 description: The image shows the Zephyr BioHarness product. The product name "Zephyr BioHarness" is displayed in a stylized font on the left side of the image. To the right of the text, there is a picture of the BioHarness device, which appears to be a wearable sensor. The image is labeled as "Figure 3.2.1 - BioHarness Carton Top".
Figure 3.2.1 – BioHarness Carton Top
Image /page/2/Picture/14 description: The image shows two panels side by side. The left panel shows a Zephyr BioHarness product with a person running in the background. The right panel shows a Zephyr BioHarness Quick Start Guide. The text in the image is difficult to read due to the image quality.
Figure 3.2.2 – BioHarness Carton Front
Figure 3.2.3 - BioHarness Carton Rear
Zephyr BioHarness
FCC CE & 2
Figure 3.2.4 – BioHarness Carton Bottom
3
4/12
3 SUBSTANTIAL EQUIVALENCE
The BioHarness and the Hidalgo Equivital EQ-10 Vital Signs Physiological Monitor are each ambulatory physiological monitoring devices capable of storing and transmitting multiple physiological parameters. Each of these devices is composed of two main components, a chest strap and a battery-powered electronics module. Both chest straps are used to sense heart electrical activity, thoracic movement and skin temp.
The physiological monitoring device presented in this 510(k) submission (BioHarness) is substantially equivalent to the physiological monitor marketed as the Hidalgo Equivital EQ-10 Vital Signs Physiological Monitor (K061993). Additional predicate devices include:
| Respironics | Actiheart | K052489 |
|---|---|---|
| VivoMetrics | LifeShirt Real Time | K043604 |
| GMP Wireless Medicine | LifeSync | K030795 |
A summary of similarities and differences between BioHarness and predicate devices are presented in the table below.
| Function | BioHarness | Predicate 1 | Predicate 2 |
|---|---|---|---|
| Heart Rate | A single-ended amplifier | ||
| senses heart electrical activity | |||
| through a chest strap with | |||
| conductive fabric electrodes. | |||
| The device filters and converts | |||
| signal to digital form. The | |||
| output is a digital value that | |||
| corresponds to heart beats per | |||
| minute. | Hidalgo Equivital EQ-10 | ||
| K061993 | |||
| Heart rate is derived | |||
| from ECG sensed | |||
| through a chest belt. A | |||
| secondary | |||
| measurement of R | |||
| wave is also available. | Respironics Actiheart | ||
| K052489 | |||
| A differential amplifier | |||
| senses and amplifies ECG | |||
| through electrodes. The | |||
| output is a digital value | |||
| that corresponds to heart | |||
| beats per minute. | |||
| Respiration Rate | Respiration rate is inferred | ||
| from thoracic movement | |||
| sensed by a chest strap | |||
| containing a proprietary | |||
| capacitive sensor. The | |||
| thoracic movement waveform | |||
| is amplified, digitized and | |||
| analyzed to determine | |||
| respiration rate. | Hidalgo Equivital EQ-10 | ||
| K061993 | |||
| Respiratory breathing | |||
| frequency is inferred | |||
| from thoracic cavity | |||
| movement sensed by a | |||
| chest belt containing an | |||
| expansion sensor. | VivoMetrics LifeShirt Real | ||
| Time K043604 | |||
| Respiratory rate is derived | |||
| from signals sensed via | |||
| torso vest with embedded | |||
| respiratory inductive | |||
| plethysmography bands. | |||
| Skin Temperature | Measurement of skin | ||
| temperature on the chest is | |||
| performed with an integrated | |||
| infrared thermometer. | Hidalgo Equivital EQ-10 | ||
| K061993 | |||
| Skin surface | |||
| temperature. | |||
| Activity/Body | |||
| Orientation | The signal from an internal tri- | ||
| axis accelerometer is digitized | |||
| and analyzed using proprietary | |||
| algorithms to determine | |||
| activity and body orientation. | Hidalgo Equivital EQ-10 | ||
| K061993 | |||
| Activity and motion | |||
| detection using a tri- | |||
| axis accelerometer. | Respironics Actiheart | ||
| K052489 | |||
| The signal from an internal | |||
| tri-axis accelerometer is | |||
| used to detect motion. | |||
| Bluetooth | |||
| Telemetry | An internal Bluetooth | ||
| communications module is | |||
| used to transmit digital | |||
| physiological data | Hidalgo Equivital EQ-10 | ||
| K061993 | |||
| Transmission of ECG | |||
| data over Bluetooth | GMP Wireless Medicine | ||
| LifeSync K030795 | |||
| Transmission of ECG data | |||
| over Bluetooth link |
Table 5.1: Comparison To Predicate
4
,
510(K) EXECUTIVE SUMMARY 4
| 1. | Submitter: | Zephyr Technology Corporation
1 Annapolis Street
Suite 200
Annapolis, Maryland 21401 |
|----|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact Person: | Code Cubitt
Chief Operating Officer
Telephone: +1 (443) 569 3603
Fax: +1 (443) 926 9402 |
| 3. | Date submitted: | December 31, 2009 |
| 4. | Trade Name: | BioHarness |
| 5. | Common Name: | Ambulatory Patient Monitor |
| 6. | Classification Name: | 21CFR 870 1025
Product code: MHX |
| 7. | Predicate Device | Hidalgo Equivital EQ-10 (K061993)
VivoMetrics LifeShirt Real Time (K043604)
Respironics Actiheart (K052489)
GMP Wireless Medicine LifeSync K030795 |
| 8. | Substantial
Equivalence
Statement | The Zephyr Technology BioHarness is substantially equivalent in
intended use to the Hidalgo Equivital EQ-10. The intended use and
application of the proposed device are substantially equivalent to
the legally marketed predicate device currently on the market. |
| 9. | Device description | The BioHarness is a compact physiological monitor that consists of
two components:
- A chest strap with conductive fabric skin electrodes and a thoracic
expansion sensor. - A battery-powered electronics module that attaches to the chest
strap. |
ﺎ
5
The device provides both storage and real-time transmission of the user's Heart Rate and Respiration Rate. The device uses heart electrical activity signals and respiratory breathing frequency inferred from thoracic movement to derive the Heart Rate and Respiration Rate.
The device also provides the following physiological measures:
- . An indication of the user's activity level based on acceleration measured by an internal triaxial accelerometer.
- . Body orientation
- . Thoracic skin temperature.
- . Alerts if physiological conditions exceed predefined thresholds.
An accessory cradle is provided to recharge the internal battery and transfer internally stored data to a computer.
The transmitted data provided by the device over Bluetooth may be integrated into third party monitoring applications.
-
- Intended use The BioHarness 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 heart rate, respiration rate, thoracic skin temperature, body orientation and activity.
The BioHarness collects and transmits measurements captured during both sedentary as well as rigorous activity for Heart Rate, Skin Temperature, Posture and Activity. Breathing rate values are accurately transmitted only during sedentary periods.
- Intended use The BioHarness 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 heart rate, respiration rate, thoracic skin temperature, body orientation and activity.
The BioHarness is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, and for general research and performance measurement purposes.
ਹੈ ਹੈ. Technological characteristics
Substantial equivalence has been measured by review and comparison of performance data for the following. The technological characteristics compare to the following predicates:
| Function | Predicate 1 | Predicate 2 |
|---|---|---|
| Heart Rate | Hidalgo Equivital EQ-10 | |
| K061993 | Respironics | |
| Actiheart | ||
| K052489 | ||
| Respiration Rate | Hidalgo Equivital EQ-10 | |
| K061993 | VivoMetrics | |
| LifeShirt Real | ||
| Time K043604 |
6/12
6
| Skin Temperature | Hidalgo Equivital EQ-10
K061993 | |
|------------------------------|------------------------------------|-------------------------------------------------|
| Activity/Body
Orientation | Hidalgo Equivital EQ-10
K061993 | Respironics
Actiheart
K052489 |
| Bluetooth
Telemetry | Hidalgo Equivital EQ-10
K061993 | GMP Wireless
Medicine
LifeSync
K030795 |
- Performance data Performance measurement and review to the applicable sections of the following standards has been conducted and successfully demonstrated as recommended by available guidance from the agency:
ANSI/AAMI ES60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
ANSI/AAMI/IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility -Requirements and tests.
ANSI/AAMI/ISO 10993-1:2003, Biological evaluation of medical devices - Part 1: Evaluation and testing.
ANSI/AAMI EC13:2002/(R) 2007, Cardiac monitors, heart rate meters, and alarms. The device provides function as a heart rate meter, but is not indicated for use as an ECG monitor.
ASTM E1965 - 98(2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.
Reviews and tests have also been carried out for general functionality and performance of the BioHarness.
Software has been developed using a structured software development process which meets the requirements of IEC 60601-1-4:1996/(R)2005, Medical electrical equipment - Part 1: General requirements for safety. 4. Collateral Standard: Programmable electrical medical systems.
14. Conclusion
This pre-market notification has shown the substantial equivalence of the BioHarness to the identified predicates, by comparison to the descriptive material and performance testing of the device.
7
5 DESCRIPTION OF DEVICE
The BioHarness is a compact physiological monitor that consists of two components:
-
- A chest strap with conductive fabric skin electrodes and a thoracic expansion sensor.
-
- A battery-powered electronics module that attaches to the chest strap.
The device provides both storage and real-time transmission of the user's Heart Rate, Resoiration Rate, Temperature, Posture and Activity Level. The device uses heart electrical activity signals and respiratory breathing frequency inferred from thoracic movement to derive the Heart Rate and Respiration Rate respectively.
An accessory cradle is provided to recharge the internal battery and transfer internally stored data to a computer.
The transmitted data provided by the device over Bluetooth may be integrated into third party monitoring applications. A simple software utility that displays vital sign data is provided. Users may transmit vital sign data from the BioHarness to the application on a PC via Bluetooth using the Bluetooth adapter.
The figures below show the BioHarness and accessories.
Image /page/7/Picture/10 description: The image shows two views of a Zephyr Bioharness device. The left side shows the front of the device, which has a power button and an LED window. The right side shows the back of the device, which has an IR sensor, strap attachment studs, and a cradle interface. The OCR text also shows the CE marking and the name of the manufacturer, Zephyr Bioharness.
Figure 7.1 - BioHarness, external front and rear views
Image /page/7/Picture/12 description: The image shows two views of a Zephyr BioHarness. The left side of the image shows the BioHarness with the Zephyr BioHarness logo and velcro. The right side of the image shows the BioHarness with conductive fabric sensors.
Figure 7.2 - BioHarness strap, front and rear views
8
б TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the BioHarness are described in the following sections.
6.1 General Functionality
The BioHarness stores and transmits physiological data including heart rate, respiration rate, thoracic skin temperature, body orientation and activity level. The digital data are derived from physiological signals acquired from the user through the chest strap for heart rate and respiration rate. An infrared sensor is used to measure skin temperature on the user's chest. The user's activity and body orientation are derived from accelerometry signals from an internal triaxial accelerometer. Data may be transmitted over Bluetooth to a computer. The BioHarness has an internal rechargeable lithium polymer battery.
A. Heart Rate
The BioHarness monitors electrical signals produced by the heart through a chest strap with conductive fabric skin electrodes and derives heart rate based on proprietary analysis of the QRS complex. The BioHarness is not an ECG monitor and provides no analysis capability in cases of abnormal QRS complex. The chest strap uses conductive lycra fabric to form a sensor, measuring electrical activity in the V4 lead position (fifth intercostals space in the midclavicular). A single-ended ECG circuit is used to detect QRS complexes. The circuit incorporates ESD protection, both passive and active filtering and an ADC to convert the signal to a digital representation. Proprietary digital filtering and signal analysis is performed on the signal with a microcontroller circuit to derive heart rate.
B. Respiration Rate
The BioHarness monitors thoracic movement (chest expansion and contraction) through a chest strap containing a proprietary capacitive sensor is composed of layers of conductive fabric, · foam and flexible mylar (dielectric). The sensor capacitance is driven with a low-level 500kHz PWM signal. Thoracic expansion and contraction cause changes in capacitance which in turn result in changes in impedance causing the amplitude of the drive signal to vary. The BioHarness respiration circuit detects, filters and amplifies this change in amplitude to produce a varying voltage signal that represents thoracic movement. The signal is passed to an ADC and proprietary digital filtering and signal analysis is performed with a microcontroller circuit to derive respiration rate is inferred by thoracic movement measured via the capacitive sensor and circuit.
C. Skin Temperature
The BioHarness uses an infrared thermometer to perform non-contact temperature measurements on user's chests. The infrared thermometer is mounted internal to the device, but has a viewing window that faces the user's chest. The Hidalgo uses a thermistor in the sensor module near an ECG electrode to measure skin temperature. Both sensors provide similar accuracy in temperature measurement.
D. Body Orientation
The BioHarness measures body orientation by proprietary analysis of acceleration values output by an internal precision triaxial accelerometer and provides a measure of user posture (upright, supine) in degrees from vertical. The Hidalgo device calculates body orientation using three orthogonal accelerometer channels.
E. Activity
The BioHarness measures activity level by proprietary analysis of acceleration values output by an internal precision triaxial accelerometer (Analog Devices ADXL330 3-axis +/-3 g iMEMS) and provides activity level in Vector Magnitude Units (VMU). The Hidalgo device calculates activity using three orthogonal accelerometer channels.
9
6.2 Basic Safety and Essential Performance
The BioHarness meets the relevant requirements of ANSI/AAMI ES60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
1. Electrical Safety
A review of ANSI/AAMI ES60601-1:2005 has been conducted with respect to electrical hazards, with specific attention given to the relevant subclauses in clauses 8, 13 and 4. The risks associated with electrical hazards were assessed in accordance with Zephyr's risk management procedure. The subclauses relevant for Zephyr's device are discussed below.
2. Mechanical Safety
A review of ANSI/AAMI ES60601-1:2005 has been conducted with respect to mechanical hazards, with specific attention given to the relevant subclauses in clauses 9, 13 and 4. The risks associated with mechanical hazards were assessed in accordance with Zephyr's risk management procedure. The subclauses relevant for Zephyr's device are discussed below.
3. Radiation Hazards
A review of ANSI/AAMI ES60601-1:2005 has been conducted with respect to radiation hazards, with specific attention given to the relevant subclauses in clauses 10, 13 and 4. The risks associated with these hazards were assessed in accordance with Zephyr's risk management procedure. The subclauses relevant for Zephyr's device are discussed below.
4. Temperature and Other Safety Concerns
A review of ANSI/AAMI ES60601-1:2005 has been conducted with respect to excessive temperatures and other hazards, with specific attention given to the relevant subclauses in clauses 11, 13 and 4. The risks associated with these hazards were assessed in accordance with Zephyr's risk management procedure.
5. Accuracy of Controls and Protection Against Hazardous Outputs
A review of ANSI/AAMI ES60601-1:2005 has been conducted with respect to accuracy of controls and instruments and protection against hazardous outputs, with specific attention given to the relevant subclauses in clauses 12, 13 and 4. The risks associated with these hazards were assessed in accordance with Zephyr's risk management procedure
6. Hazardous Situations and Fault Conditions
A review of ANSI/AAMI ES60601-1:2005 has been conducted with respect to hazardous situations and fault conditions, with specific attention given to the relevant subclauses in clauses 13 and 4. The risks associated with these hazards were assessed in accordance with Zephyr's risk management procedure.
10
7. Construction of ME Equipment
A review of ANSI/AAMI ES60601-1:2005 has been conducted with respect to construction of ME Equipment, with specific attention given to the relevant subclauses in clauses 15, 13 and 4. The risks associated with these hazards were assessed in accordance with Zephyr's risk management procedure.
8. Electromagnetic Compatibility
The BioHarness has been tested and shown to be compliant with electromagnetic compatibility requirements in the US (FCC) and the EU (R&TTE Directive).
The BioHarness complies with FCC Part 15 Subparts A and B as a Class B Unintentional Radiator (using methods described in ANSI C63.4 – 2003). The BioHarness also complies with the essential requirements of the R&TTE Directive. The BioHarness complies with EN 301 489-17 V1.2.1 (2002-08) when tested in accordance with EN 301-489-1 V1.6.1 (2005-09).
The AC Adapter complies with the requirements of the electrical safety standard AS/NZS 60950.1:2003 + A1 + A2 + A3.
9. Biocompatibility
The BioHarness meets the relevant requirements of ANSI/AAMI/ISO 10993-1:2003, Biological evaluation of medical devices - Part 1: Evaluation and testing.
10. Cardiac monitoring
The BioHarness meets the relevant requirement for heart rate metering in ANSI/AAMI EC13:2002/(R) 2007, Cardiac monitors, heart rate meters, and alarms.
11. Infrared Thermometry
The BioHarness meets the relevant requirements of ASTM E1965 - 98(2009), Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.
12. Software
The BioHarness software has been developed using a structured software lifecycle which meets the requirements of IEC 60601-1-4:1996/(R)2005, Medical electrical equipment - Part 1: General requirements for safety. 4. Collateral Standard: Programmable electrical medical systems.
11
PERFORMANCE DATA 7
Reviews and tests have been carried out for general functionality and performance of the BioHarness.
Additional performance measurement and review to the applicable sections of the following standards has been undertaken and successfully demonstrated as recommended by available guidance from the agency:
ANSI/AAMI ES60601-1.2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ANSI/AAMI/IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility - Requirements and tests
ANSI/AAMI/ISO 10993-1:2003, Biological evaluation of medical devices - Part 1: Evaluation and testing
ANSI/AAMI EC13:2002/(R) 2007, Cardiac monitors, heart rate meters, and alarms
ASTM E1965 - 98(2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
The BioHarness software has been developed using a structured software lifecycle which meets the requirements of IEC 60601-1-4:1996/(R)2005, Medical electrical equipment - Part 1: General requirements for safety. 4. Collateral Standard: Programmable electrical medical systems
7.1 General Functionality
General functionality of the BioHarness has been reviewed and tested iteratively throughout the development cycle. Devices and accessories are also tested as part of the production process.
Development testing of BioHarness functionality has occurred at the bench level and under simulated field conditions (i.e. field trials).
12
Image /page/12/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zephyr Technology Corporation c/o Mr. Code Cubitt Chief Operating Officer 1 Annapolis Street, Suite 200 Annapolis, MD 21401
DEC - 3 2010
Re: K100040
Trade/Device Name: BioHarness Regulation Numbe r: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: Undated Received: December 1, 2010
Dear Mr. Cubitt:
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.
:
.
13
Page 2 - Mr. Code Cubitt
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 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/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
14
ZEPHYR TECHNOLOGY BIOHARNESS
INDICATIONS FOR USE STATEMENT
510(k)Number (If Known):
K10047
Device Name:
BioHarness
Indications for Use:
The BioHarness 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 heart rate, respiration rate, thoracic skin temperature, body orientation and activity.
The BioHarness collects and transmits measurements captured during both sedentary as well as rigorous activity for Heart Rate, Skin Temperature, Posture and Activity. Breathing rate values are accurately transmitted only during sedentary periods.
The BioHarness is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, and for general research and performance measurement purposes.
Prescription Use (Part 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 by CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K100040 |
|---|---|
| --------------- | --------- |