(358 days)
No
The summary describes standard physiological parameter measurement techniques (oscillometric for NIBP, infrared for temperature, pulse oximetry for SpO2) and data processing via a microcontroller and application software. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or prediction.
No.
The device is a vitals measuring and monitoring system for spot-checking and measuring physiological parameters (NIBP, SpO2, Body Temperature, Pulse Rate), not for therapeutic treatment.
Yes
Explanation: The device measures physiological parameters (blood pressure, oxygen saturation, body temperature) for spot-checking and monitoring. While it does not explicitly state it provides a diagnosis, the output is described as "results" or "values" that track physiological parameters, and users are "advised to contact their physician if any abnormal values are indicated." This strongly implies the device provides data that can be used by a healthcare professional (or the patient under guidance) to infer a medical condition, which falls within the broad definition of a diagnostic device.
No
The device description clearly states the system includes a "base unit VA01" and "accessory devices attachment (VA01-0, VA01-1 and VA01-2)" which are hardware components used for measuring physiological parameters. While the B.O.L.T application controls these devices and displays results, the system is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The B.O.L.T system measures physiological parameters directly from the patient's body (blood pressure from the arm, temperature from the ear canal, oxygen saturation and pulse rate from the fingertip). It does not analyze samples taken from the body.
The device is a patient vital signs monitoring system, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
B.O.L.T model (VA01) Base unit with it`s accessory devices attachment (VA01-0, VA01-1 and VA01-2) and the B.O.L.T application is a patient vitals measuring and monitoring system used for spot-checking and measuring the physiological parameters of adult patients / users of age or older). The physiological parameters measured and monitored are:
- Non-Invasive Blood Pressure (NIBP), Pulse Rate (PR)
- Oxygen saturation (SpO2), Pulse Rate (PR)
- Body Temperature (TEMP)
B.O.L.T application is downloaded and installed in a Bluetooth enabled smart devices/ computer. The operations of the base unit and the attached devices like start and stop are controlled by the B.O.L.T application and the results are displayed by the B.O.L.T application on the screen of the smart devices/ computer.
This device is applicable for use by an adult and it can be used in a clinical setting like a physician office and also in a home environment for patients to keep track of the physiological parameters mentioned above. Home users are advised to contact their physician if any abnormal values are indicated.
B.O.L.T. NIBP model Base unit (VA01) along with an inflatable cuff (VA01-0) that is wrapped around the upper arm, is a fully automatic, non-invasive, wireless blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual.
B.O.L.T, IRT model Base unit (VA01) along with a thermometer probe (VA01-1) using infrared sensor detects body temperature from the ear canal in the adult population.
B.O.L.T, Pulse Oximeter model Base unit (VA01) along with a pulse oximeter probe (VA01-2) is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) from the fingertip of adult users.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DXN, DQA, FLL
Device Description
The B.O.L.T patient monitor system base unit VA01 is elegantly designed with small form factor. The devices NIBP, IRT thermometer and Pulse Oximeter connects to the base unit. The device has two LED indicators that display power status and Bluetooth connectivity status. The device has an on/off slide switch on the side and USB power socket. The device has one accessories port with Lemo connector to connect IRT Thermometer and Pulse Oximeter, one at a time. There are two other ports to connect the twin tubes of the NIBP Cuff. The base unit has a rechargeable lithium polymer battery and device should be used only in battery mode and it should not be used while charging. The power adapter is given only for charging the device.
The B.O.L.T. NIBP device model VA01-0 connects to the VA01 Base unit's twin port and measures both systolic and diastolic blood pressure and pulse rate via a standard oscillometric method. The oscillometric method senses the vibrating signal via the closed air pipe system and utilizes a microcontroller in the base unit to automatically sense the characteristics of the pulse signal. Unlike with the traditional measuring method, based on the Korotkov sound, with the oscillometric method the use of a stethoscope is not required. Through simple calculations, this method provides accurate blood pressure readings: the systolic pressure is defined as the blood pressure when the cuff pressure oscillating amplitude begins to increase, while the diastolic blood pressure is defined as the pressure when the cuff pressure oscillating amplitude stops decreasing. The device includes a plastic enclosure and external wraparound cuff, and it requires an external device (e.g. a smartphone) to display results and perform user interaction.
The IRT Thermometer module of B.O.LT., model VA01-1, patient monitoring system is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the ear canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces. The unit measures the infrared energy emitting from the middle ear and the surrounding tissue. This energy is absorbed by lenses and converted into temperature values. The IRT electronic thermometer accessory (VA01-1) connects to the accessory connector of the B.O.L.T Base unit (VA01) patient monitoring system and readout value is displayed on the connected Bluetooth device like a Smart Phone, tablet or personal computer.
The Infrared Ear thermometer module of B.O.L.T, model VA01-1 patient monitoring system consists of the following parts:
- Thermopile Sensor
- Application-Specific Integrated Circuit
- Lens
- Probe cover (Single use and probe cover to be disposed after each measurement)
The B.O.L.T model VA01-2 fingertip pulse oximeter accessory device features a small form factor. low power consumption, a convenient operation, and portability. It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement. The fingertip pulse oximeter accessory device connects to the accessory connector of the B.O.L.T VA01 base unit. The readout value Spo2(%) and Pulse rate values are displayed on the connected Bluetooth device like a Smart Phone, tablet or personal computer.
The user manual which is provided with the device provides the detailed specifications.
The system is controlled and operated via the B.O.L.T application which is downloaded and installed in a Bluetooth enabled smartphone/tablet/computer. The B.O.L.T application is supported for the following versions of Android/IOS and Windows operating system.
- The Android OS version 4.0 or higher.
- The iOS version 7 or higher.
- The Windows OS version 8 or higher
The software communicates with the base unit (VA01) through Bluetooth communication to the connected smartphone/tablet/computer. The user has to pair the base unit with handheld mobile devices or computers through Bluetooth and use the Software application to operate and control the devices attached to the base unit. Functions like activating and stopping the device and display of the test value are all performed by the B.O.L.T application residing in the Bluetooth connected smartphone/tablet/computer. The device/s is connected to the accessory port of the base unit. The base unit takes signals from the connected device like NIBP Cuff, Pulse oximeter, IRT Thermometer. The software and firmware of the B.O.L.T patient monitoring system, process the data from the accessory devices, then display the parameters/measured data on the screen of a wirelessly connected Bluetooth device like a smartphone/ tablet/ personal computer. B.O.L.T application can hold any number of records and recognized by user ID. The number of records is limited by the data storage capacity of the secured cloud infrastructure. FCC grant is obtained under FCC ID: 2AFV6-AMI-BU-2.
The data collected from devices can be securely uploaded/stored in a secured cloud. The secured cloud is HIPAA compliant and hosted in a HIPAA compliant data Centre. All the protected health information and the physiological data of a user/patient is encrypted at rest. The communication over the internet to the cloud utilizes the HTTPS/TLS protocol. The B.O.L.T is also packaged with a SDK (Software Development Kit) to integrate the reading from the devices to an external system like a Care Portal/Electronic Medical Record software system
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper arm (for NIBP), Ear canal (for IRT), Fingertip (for Pulse Oximeter)
Indicated Patient Age Range
adult patients / users of age or older
Intended User / Care Setting
Home environment, clinical setting like a physician office
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)
B.O.L.T NIBP:
- Study Type: Clinical Study compliant to EN ISO 81060-2: 2014 Non-invasive sphygmomanometers – Part 2: Clinical investigation of automated measurement type Standard for Manual, electronic, or automated sphygmomanometers.
- Sample Size: 106 subjects (adult male and female between 18 and 65 years) for blood pressure, 318 readings for statistical analysis of blood pressure, 89 pulse rate readings for statistical analysis.
- Reference Device: Omron model HEM 907 (K032305).
- Key Results:
- Criterion I (Blood Pressure): Mean error is 2.1 for Systolic Blood Pressure and 1.2 for Diastolic Blood Pressure (within ISO criteria of less than 5). Standard deviation is 5.4 for Systolic Blood Pressure and 5.7 for Diastolic Blood Pressure (within ISO criteria of less than 8).
- Criterion 2 (Blood Pressure): Standard deviation for Systolic Blood Pressure is 4.39 and Diastolic Blood Pressure is 4.98 (Satisfied for both,
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
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September 6, 2019
AmZetta Technologies Private Limited Sridharan Mani Chief Executive Officer Kumaran Nagar, Semmanchery, Off Rajiv Gandhi Salai (OMR) Chennai, 600 119 In
Re: K182401
Trade/Device Name: B.O.L.T (Body Life Tracker) Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DXN, DQA, FLL Dated: August 29, 2018 Received: September 4, 2018
Dear Sridharan Mani:
This letter corrects our substantially equivalent letter of August 28, 2019.
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 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S5
Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182401
Device Name B.O.L.T (Body Life Tracker)
Indications for Use (Describe)
B.O.L.T model (VA01) Base unit with it's accessory devices attachment (VA01-0, VA01-1 and VA01-2) and the B.O.L.T application is a patient vitals measuring and monitoring system used for spot-checking and measuring the physiological parameters of adult patients / users of age or older). The physiological parameters measured and monitored are: · Non-Invasive Blood Pressure (NIBP), Pulse Rate (PR)
· Oxygen saturation (SpO2), Pulse Rate (PR)
· Body Temperature (TEMP)
B.O.L.T application is downloaded and installed in a Bluetooth enabled smart devices/ computer. The operations of the base unit and the attached devices like start and stop are controlled by the B.O.L.T application and the results are displayed by the B.O.L.T application on the screen of the smart devices/ computer.
This device is applicable for use by an adult and it can be used in a clinical setting like a physician office and also in a home environment for patients to keep track of the physiological parameters mentioned above. Home users are advised to contact their physician if any abnormal values are indicated.
B.O.L.T. NIBP model Base unit (VA01) along with an inflatable cuff (VA01-0) that is wrapped around the upper arm, is a fully automatic, non-invasive, wireless blood pressurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual.
B.O.L.T, IRT model Base unit (VA01) along with a thermometer probe (VA01-1) using infrared sensor detects body temperature from the ear canal in the adult population.
B.O.L.T, Pulse Oximeter model Base unit (VA01) along with a pulse oximeter probe (VA01-2) is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) from the fingertip of adult users.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image shows the logo for AmZetta. The logo features the name "AmZetta" in a stylized font, with "Am" in blue and "Zetta" in green. A light blue cloud shape is above and behind the "Am" portion of the name. The letters are bold and slightly slanted to the right, giving the logo a dynamic and modern appearance.
510k Summary
Sponsor Details
AmZetta Technologies Private Limited., (Formerly Known As American Megatrends India Private Limited) Kumaran Nagar, Semmanchery, Off. Old Mahabalipuram Road Chennai-600119, Tamilnadu India Phone : +914461240022 Fax : +914461240025 Contact : Sridharan Mani Title : Chief Executive Officer Email : sridharanm@amzetta.co.in Alternate Contact
| Alternate Contact | : G. Ketharaman |
|---|---|
| Title | : Unit Head- Healthcare Group |
| : amzusfda@amzetta.co.in |
Summary Preparation Date: 22nd July, 2019
Device/s Submitted for FDA 510K Premarket Notification
| Trade Name | B.O.L.T. (Body Life Tracker) |
|---|---|
| Product Codes | B.O.L.T BT1, BT2, BT3, BT4 |
| Device Model Numbers | VA01 - B.O.L.T Base Unit |
| VA01-0 - B.O.L.T Non-Invasive Blood Pressure(NIBP) Cuff | |
| VA01-1 - B.OL.T Infrared Radiation Energy | |
| Technology (IRT) Thermometer probe | |
| VA01-2 - B.O.L.T Pulse Oximeter (SPO2) probe | |
| Common Name | Patient Physiological Monitor |
| Classification Name | Monitor, Physiological, Patient (without arrhythmia |
| detection or alarms) | |
| Classification | Class II |
| Product code | MWI |
| Other Product codes | DQA- Pulse Oximeter |
| DXN - Blood Pressure, non-invasive | |
| FLL -Thermometer, electronic, clinical | |
| Regulation Number | 21 CFR 870.2300 |
| Review Panel | Cardiovascular, General Hospital |
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Image /page/5/Picture/0 description: The image shows the AmZetta logo. The logo features the word "AmZetta" in a combination of blue and green colors. The "Am" portion of the word is in blue, while the "Zetta" portion is in green. There is a light blue cloud graphic above and behind the "Am" portion of the logo.
Devices submitted for 510K:
The B.O.L.T Patient Physiological Monitor which is called the B.O.L.T Life tracker is a patient vitals measuring and monitoring device which can be used by home users as well as a clinical setting like physician office for spot-checking and measuring of the following patient's physiological parameters:
- Measurement of the Systolic Blood Pressure, Diastolic Blood Pressure and Pulse Rate ● (PR), non- invasively;
- . Spot measurement of functional blood Oxyqen saturation (SpO2) and Pulse Rate (PR), non-invasively; and
- . Measurement of the Body Temperature through ear canal, non invasively
The B.O.L.T system is modularly designed and consists of:
- Base unit (model VA01); ●
- NIBP (Non-Invasive Blood Pressure) Cuff (model VA01-0); ●
- Infrared Radiation Energy Technology-IRT Thermometer (model VA01-1); and
- . Pulse Oximeter (VA01-2).
The system is packaged as a complete system with all the devices included or alternatively packaged separately with the base unit and individual device/s. When individually packaged, the system is supplied with a base unit and the required device/s. The different product bundle along with the product code/name is given below,
| B.O.L.T.
Product
| Name/code | Package Bundle | Devices model numbers |
|---|---|---|
| BT1 | Base Unit and NIBP | VA01 and VA01-0 |
| BT2 | Base Unit, NIBP and Body | |
| Temperature | VA01, VA01-0 and VA01-1 | |
| BT3 | Base Unit, NIBP and SpO2 | VA01, VA01-0 and VA01-2 |
| BT4 | NIBP, Body Temperature and SpO2 | VA01, VA01-0, VA01-1 and |
| VA01-2 |
Device Description:
The B.O.L.T patient monitor system base unit VA01 is elegantly designed with small form factor. The devices NIBP, IRT thermometer and Pulse Oximeter connects to the base unit. The device has two LED indicators that display power status and Bluetooth connectivity status. The device has an on/off slide switch on the side and USB power socket. The device has one accessories port with Lemo connector to connect IRT Thermometer and Pulse Oximeter, one at a time. There are two other ports to connect the twin tubes of the NIBP Cuff. The base unit has a rechargeable lithium polymer battery and device should be used only in battery mode and it should not be used while charging. The power adapter is given only for charging the device.
The B.O.L.T. NIBP device model VA01-0 connects to the VA01 Base unit's twin port and measures both systolic and diastolic blood pressure and pulse rate via a standard oscillometric method. The oscillometric method senses the vibrating signal via the closed air pipe system and utilizes a microcontroller in the base unit to automatically sense the characteristics of the pulse
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Image /page/6/Picture/0 description: The image shows the logo for AmZetta. The logo features a light blue cloud outline above the company name. The "Am" portion of the name is in blue, while the "Zetta" portion is in green, with a trademark symbol next to it.
signal. Unlike with the traditional measuring method, based o6i the Korotkov sound, with the oscillometric method the use of a stethoscope is not required. Through simple calculations, this method provides accurate blood pressure readings: the systolic pressure is defined as the blood pressure when the cuff pressure oscillating amplitude begins to increase, while the diastolic blood pressure is defined as the pressure when the cuff pressure oscillating amplitude stops decreasing. The device includes a plastic enclosure and external wraparound cuff, and it requires an external device (e.g. a smartphone) to display results and perform user interaction.
The IRT Thermometer module of B.O.LT., model VA01-1, patient monitoring system is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the ear canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces. The unit measures the infrared energy emitting from the middle ear and the surrounding tissue. This energy is absorbed by lenses and converted into temperature values. The IRT electronic thermometer accessory (VA01-1) connects to the accessory connector of the B.O.L.T Base unit (VA01) patient monitoring system and readout value is displayed on the connected Bluetooth device like a Smart Phone, tablet or personal computer.
The Infrared Ear thermometer module of B.O.L.T, model VA01-1 patient monitoring system consists of the following parts:
- Thermopile Sensor .
- Application-Specific Integrated Circuit .
- . Lens
- Probe cover (Single use and probe cover to be disposed after each measurement) ●
The B.O.L.T model VA01-2 fingertip pulse oximeter accessory device features a small form factor. low power consumption, a convenient operation, and portability. It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement. The fingertip pulse oximeter accessory device connects to the accessory connector of the B.O.L.T VA01 base unit. The readout value Spo2(%) and Pulse rate values are displayed on the connected Bluetooth device like a Smart Phone, tablet or personal computer.
The user manual which is provided with the device provides the detailed specifications.
The system is controlled and operated via the B.O.L.T application which is downloaded and installed in a Bluetooth enabled smartphone/tablet/computer. The B.O.L.T application is supported for the following versions of Android/IOS and Windows operating system.
- . The Android OS version 4.0 or higher.
- . The iOS version 7 or higher.
- . The Windows OS version 8 or higher
The software communicates with the base unit (VA01) through Bluetooth communication to the connected smartphone/tablet/computer. The user has to pair the base unit with handheld mobile devices or computers through Bluetooth and use the Software application to operate and control the devices attached to the base unit. Functions like activating and stopping the device and display of the test value are all performed by the B.O.L.T application residing in the Bluetooth connected smartphone/tablet/computer. The device/s is connected to the accessory port of the base unit. The base unit takes signals from the connected device like NIBP Cuff, Pulse oximeter, IRT Thermometer. The software and firmware of the B.O.L.T patient monitoring system, process the data from the accessory devices, then display the parameters/measured data on the screen
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Image /page/7/Picture/0 description: The image shows the logo for AmZetta. The logo features the name "AmZetta" in a stylized font, with "Am" in blue and "Zetta" in green. Above the name is a light blue cloud shape, and a small "TM" symbol is next to the "a" in "Zetta."
of a wirelessly connected Bluetooth device like a smartphone/ tablet/ personal computer. B.O.L.T application can hold any number of records and recognized by user ID. The number of records is limited by the data storage capacity of the secured cloud infrastructure. FCC grant is obtained under FCC ID: 2AFV6-AMI-BU-2.
The data collected from devices can be securely uploaded/stored in a secured cloud. The secured cloud is HIPAA compliant and hosted in a HIPAA compliant data Centre. All the protected health information and the physiological data of a user/patient is encrypted at rest. The communication over the internet to the cloud utilizes the HTTPS/TLS protocol. The B.O.L.T is also packaged with a SDK (Software Development Kit) to integrate the reading from the devices to an external system like a Care Portal/Electronic Medical Record software system
Indications for use:
B.O.L.T model (VA01) Base unit with it`s accessory devices attachment (VA01-0, VA01-1 and VA01-2) and the B.O.L.T application is a patient vitals measuring and monitoring system used for spot-checking and measuring the physiological parameters of adult patients / users of age or older). The physiological parameters measured and monitored are:
- Non-Invasive Blood Pressure (NIBP), Pulse Rate (PR)
- · Oxygen saturation (SpO2), Pulse Rate (PR)
- Body Temperature (TEMP)
B.O.L.T application is downloaded and installed in a Bluetooth enabled smart devices/ computer. The operations of the base unit and the attached devices like start and stop are controlled by the B.O.L.T application and the results are displayed by the B.O.L.T application on the screen of the smart devices/ computer.
This device is applicable for use by an adult and it can be used in a clinical setting like a physician office and also in a home environment for patients to keep track of the physiological parameters mentioned above. Home users are advised to contact their physician if any abnormal values are indicated.
B.O.L.T, NIBP model Base unit (VA01) along with an inflatable cuff (VA01-0) that is wrapped around the upper arm, is a fully automatic, non-invasive, wireless blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual.
B.O.L.T, IRT model Base unit (VA01) along with a thermometer probe (VA01-1) using infrared sensor detects body temperature from the ear canal in the adult population.
B.O.L.T, Pulse Oximeter model Base unit (VA01) along with a pulse oximeter probe (VA01-2) is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) from the fingertip of adult users.
Contraindications:
The following contraindications are mentioned in the labelling information: The B.O.L.T device is not recommended for people with serious arrhythmia. Consult your doctor during pregnancy, arrhythmia, and arteriosclerosis. The analyzed results from the devices are not
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Image /page/8/Picture/0 description: The image shows the logo for AmZetta. The logo features the word "AmZetta" in a stylized font, with the "Am" in blue and the "Zetta" in green. There is a cloud graphic above the word "Am", also in blue. The letters are bold and slightly slanted to the right, giving the logo a dynamic and modern feel.
sufficient to make a correct diagnosis of the patient`s clinical condition. A detailed clinical history of the patient together with the results of any other tests suggested by a doctor is also required. This device is contraindicated for any person who is connected to a wearable or implantable electronic device or instrument, such as a pacemaker or defibrillator.
Substantial Equivalence comparison of the B.O.L.T NIBP with predicate Devices:
The B.O.L.T NIBP model VA01- 0 is compared against the following predicate devices:
K133125 Withings Blood Pressure Monitor, Upper Arm Type: BP-801 model BP01 from Withings
K120672 Blood Health BPS Fully Automatic Arm Cuff Wireless Blood Pressure dock model KD 936 from Andon Health
| Comparison Item | Submitted proposed device | Predicate device 1 | Predicate device 2 |
|---|---|---|---|
| Applicant | AmZetta Technologies | ||
| Private Limited. | Withings | Andon Health Co., | |
| Ltd | |||
| Trade Name | B.O.L.T | Withings Blood | |
| Pressure Monitor, | |||
| Upper Arm | |||
| Type: BP-801 | Blood Health BPS | ||
| Fully Automatic Arm | |||
| Cuff Wireless Blood | |||
| Pressure dock | |||
| Model Name | B.O.L.T VA01-0 | BP-801 | KD-936 |
| 510K Number | New Listing | K133125 | K120672 |
| Technological | |||
| characteristics | Oscillometric method | Oscillometric method | Oscillometric method |
| Measuring method | Oscillometric method, automatic inflation and measurement | Oscillometric method, automatic inflation and measurement | Oscillometric method, automatic inflation and measurement |
| Sensor | Semiconductor gauge sensor | Semiconductor gauge sensor | Semiconductor gauge sensor |
| Rapid Air release | Through an active electronic control valve | Through an active electronic control valve | Through an active electronic control valve |
| Cuff tissues | Lycra, Velcro loop, Velcro hook, PU leather, bias | Lycra, Velcro loop, Velcro hook, PU leather, bias | Lycra, Velcro loop, Velcro hook, PU leather, bias |
| Pressure Accuracy | Pressure: $\pm$ 3mmHg | Pressure: $\pm$ 3mmHg or | |
| $\pm$ 2% of Pressure | |||
| readout value | Pressure: $\pm$ 3mmHg | ||
| Pulse accuracy | $\pm$ 5% of Pressure | ||
| reading value | $\pm$ 5% of Pressure | ||
| reading value | $\pm$ 5% of Pressure | ||
| reading value | |||
| System | |||
| Architecture | Requires an external device to constitute a complete blood pressure measurement system | ||
| e.g. blood pressure cuff | Independent operation | Requires an external device to constitute a complete blood pressure measurement system |
AmZetta Technologies Private Ltd.,
9
Image /page/9/Picture/0 description: The image shows the logo for AmZetta. The word "AmZetta" is written in a stylized font, with "Am" in blue and "Zetta" in green. There is a light blue cloud shape behind the "Am" portion of the logo. The trademark symbol is located to the right of the word "Zetta".
| Display an User
Interaction | Requires an external
device to display
results and perform
user interaction.
Devices supported
any Bluetooth enabled
smart phone, tablet or
personal computer. | LCD monitor and
personal computer | Requires an external
device to display
results and perform
user interaction |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Communication | Wireless, based on
Bluetooth V4.0 + EDR
(Bluetooth Low
energy) | Wireless, based on
Bluetooth V4.0
Dual mode(V2.1 +
EDR) | Wireless, based on
Bluetooth V3.0 +
EDR |
| Power Source | Rechargeable
batteries (Li-Polymer)
3.7 volt,850mAh
and DC power 5V, 2A. | Disposable 4xAAA
alkaline batteries | Rechargeable
batteries (Li-lon 400
mAh) |
| Cuff Type and Size | Upper arm type, size:
22 to 42 cm | Upper arm type, size:
22 to 42 cm | Upper arm type, size:
23 to 48 cm |
| Operating
Temperature and
Humidity | 10 to 40° C
Atmospheric: 15 to
85% RH non-
condensing | 10 to 40° C 15 to
90% RH.
Atmospheric:86Kpa
to 106Kpa
Altitude: 2000m | 5 to 40° C
Atmospheric: 42° C |
| Position indicator | Yes(Application shows the
usage) | Yes |
| Elevated
Temperature Alarm | No | Yes (10 short beeps when
measured temperature is greater
than 37.5 °C) |
| Display an User
Interaction | Requires an external device to
display results and perform user
interaction. Devices supported
any Bluetooth enabled smart
phone, tablet or personal
computer RUNNING on Android
OS version 4.0 and higher Or
IOS OS version 7.0 or higher or
Windows OS version 8.0 or
higher | LCD display built in to the device |
| Communication | Wireless, based on Bluetooth
V4.0 + EDR (Bluetooth Low
energy) | Independent |
| Power Source | Rechargeable batteries (Li-
Polymer3.7V, 850 mAh) and DC
power 5V, 2A | 2*AAA 1.5v alkaline battery |
| Operating
Temperature and
Humidity | 10 to 40°C ((50.0°F104.0°F)104.0°F)
Atmospheric: 15 to 85% RH non-
condensing | 10.0°C - 40°C (50.0°F
with relative humidity 95% |
| Storage
temperature and
Humidity | -10 to 55° C
Atmospheric: 15 to 85% RH non-
condensing | -25°C to 55 °C/-13°F ~131°F with
relative humidity 95% |
| Probe head: Tip
Width | 7.5mm | 7.3mm |
| Probe head:
Thickness at 5mm
height | 8.0mm | 8.56mm |
| Probe head:
Thickness at 10mm
height | 9.2mm | 10.32mm |
| Comparison Item | Applicant | Predicate Device 1 |
| IRT Probe cover | Polypropylene material | Polypropylene material |
| IRT Probe | ABS Plastic | ABS Plastic |
| Plastic material | ABS+PC Plastic | ABS Plastic |
11
Image /page/11/Picture/0 description: The image shows the logo for AmZetta. The logo features the word "AmZetta" in a stylized font, with "Am" in blue and "Zetta" in green. There is a cloud graphic above and behind the "Am" portion of the logo. The trademark symbol is located to the right of the word "Zetta".
12
Material Make-up of the Device:
Summary with predicate device:
The principles of operations, core technology, the technological characteristics of patient contact materials, performance, biocompatibility function, mechanical safety, standards met, electrical safety, and EMC in the IRT temperature module of the B.O.L.T model VA01-1 are similar to the predicate device except the assembly and the implementation of the core design. A detailed document on the principles of operations, design, assembly and technology characteristics were submitted.
The device is similar to the predicate device in intended patient population, intended application site, working principle, contact material, resolution. Only their internal power supply. display range, communication and appearance differ and readout of the data/results where the B.O.L.T uses a wireless Bluetooth device to display the results and the predicate device has a built-in LCD display.
The material make up of the B.O.L.T IRT thermometer, model VA01-1 and the two predicate devices compared are similar and the exception is only in the color of the material.
AmZetta Technologies Private Limited believe that the B.O.L.T model VA01-1 patient monitor's IRT thermometer is substantially equivalent to the predicate devices.
Substantial Equivalence Comparison B.O.L.T Pulse Oximeter with Predicate Devices:
The B.O.L.T Pulse Oximeter model VA01-2 is compared with the following 510K approved devices:
K163135 - Fingertip Pulse Oximeter model A330, A310 from Shenzhen Fitfaith Technology Co..Ltd
K140582 – Fingertip Pulse Oximeter JPD-500A from Shenzhen Jumper Medical Equipment Co.,Ltd
| Comparison Item | Submitted proposed
device | Predicate device 1 | Predicate device 2 |
|-----------------|---------------------------------------------|-----------------------------------------|-------------------------------------------------|
| Applicant | AmZetta
Technologies Private
Limited. | Shenzhen Fitfaith
Technology Co.,Ltd | Shenzhen Jumper
Medical Equipment
Co.,Ltd |
| Trade Name | B.O.L.T Pulse
Oximeter | Fingertip Pulse
Oximeter | Fingertip Pulse
Oximeter |
| Model Name | B.O.L.T VA01-2 | A330, A310 | JPD-500A |
| 510K Number | New Listing | K163135 | K140582 |
13
Image /page/13/Picture/0 description: The image shows the logo for AmZetta. The logo features the word "AmZetta" in a stylized font, with the "Am" in blue and the "Zetta" in green. Above the word is a light blue cloud shape. The letters are bold and slightly slanted to the right, giving the logo a dynamic and modern feel.
| Technological
characteristics | Photoelectric
Oxyhemoglobin
Inspection
Technology | Photoelectric
Oxyhemoglobin
Inspection
Technology | Photoelectric
Oxyhemoglobin
Inspection
Technology |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measuring method | A mathematical
formula is established
making use of
Lambert Beer Law
according to
Spectrum Absorption
Characteristics of
Reductive
hemoglobin (RHb)
and
Oxyhemoglobin
(HbO2) in red and
near-infrared
zones. Operation
principle of the
instrument:
Photoelectric
Oxyhemoglobin
Inspection
Technology is
adopted in
accordance with
Capacity Pulse
Scanning and
Recording
Technology, so that
two beams of
different wavelength
of lights can be
focused onto a
human nail tip
through a clamping
finger-type sensor. A
measured signal
obtained by a
photosensitive
element, is shown on
the connected
Bluetooth device like
a smartphone, tablet
or personal computer
display through
process in electronic
circuits and
microcontroller of the | A mathematical
formula is
established making
use of
Lambert Beer Law
according to
Spectrum Absorption
Characteristics of
Reductive
hemoglobin (RHb)
and
Oxyhemoglobin
(HbO2) in red and
near-infrared
zones. Operation
principle of the
instrument:
Photoelectric
Oxyhemoglobin
Inspection
Technology is
adopted in
accordance with
Capacity Pulse
Scanning and
Recording
Technology, so that
two beams of
different wavelength
of lights can be
focused
onto a human nail tip
through a clamping
finger-type sensor. A
measured signal
obtained by a
photosensitive
element, is shown on
the Oximeter's
display through
process in electronic
circuits and
microprocessor. | A mathematical
formula is
established making
use of
Lambert Beer Law
according to
Spectrum Absorption
Characteristics of
Reductive
hemoglobin (RHb)
and
Oxyhemoglobin
(HbO2) in red and
near-infrared
zones. Operation
principle of the
instrument:
Photoelectric
Oxyhemoglobin
Inspection
Technology is
adopted in
accordance with
Capacity Pulse
Scanning and
Recording
Technology, so that
two beams of
different wavelength
of lights can be
focused
onto a human nail tip
through a clamping
finger-type sensor. A
measured signal
obtained by a
photosensitive
element, is shown on
the Oximeter's
display through
process in electronic
circuits and
microprocessor. |
14
Image /page/14/Picture/0 description: The image shows the logo for AmZetta. The logo features a light blue cloud in the background, with the word "AmZetta" in front of it. The "Am" portion of the word is in blue, while the "Zetta" portion is in green. There is a trademark symbol to the right of the word.
| Semiconductor gauge sensor | Semiconductor gauge sensor | Semiconductor gauge sensor | |
|---|---|---|---|
| Sensor | Semiconductor gauge sensor | Semiconductor gauge sensor | Semiconductor gauge sensor |
| Light Specification | |||
| Wavelength | 660nm±3nm for red light,905nm±5nm for infrared light (IR) | 660nm±3nm for red light, 905nm±5nm for infrared light (IR) | 660nm±3nm for red light, 905nm±5nm for infrared light (IR) |
| Maximum optical power | 1.5 mW for red light (660nm) | ||
| 1.2 mW for IR (905nm) | 1.5 mW for red light (660nm) | ||
| 1.2 mW for IR (905nm) | 1.5 mW for red light (660nm) | ||
| 1.2 mW for IR (905nm) | |||
| Contact material | ABS+PC for enclosure, Silicone Rubber clip | ABS for enclosure, silica gel for clip | ABS for enclosure, silica gel for clip |
| Resolution | |||
| SpO2 | 1% | 1% | 1% |
| Pulse rate | 1 bpm | 1 bpm | 1 bpm |
| Measurement Range | |||
| SpO2 | 0%~100% | 0%~100% | 0%~100% |
| Pulse rate | 30~250 bpm | 25~250 bpm | 25~250 bpm |
| Measurement Accuracy | |||
| SpO2 | Arms ≤2.6%: | ||
| (70%~100%) | |||
| Unspecified: | |||
| (0%~69%) | ±2%: (70%~100%) | ||
| Unspecified: | |||
| (0%~69%) | ±2%: (70%~100%) | ||
| No definition: | |||
| (0%~69%) | |||
| Pulse rate | ±2 bpm | ±2 bpm | ±2 bpm |
| System Architecture | Requires the base unit B.O.L.T to connect to constitute a complete measurement system | Independent operation | Independent operation |
| Display an User Interaction | Requires an external device to display results and perform user interaction. | ||
| Devices supported any Bluetooth enabled smart phone, tablet or personal computer running Android OS version 4.0 and higher Or iOS OS version 7.0 or higher or Windows OS version 8.0 or higher | LED display built in to the device | LED display built in to the device | |
| Communication | Wireless, based on Bluetooth V4.0 + EDR (Bluetooth Low energy) | Independent | Independent |
| Power Source | Rechargeable | ||
| batteries (Li-Polymer | |||
| 3.7V, 850 mAh) and | |||
| DC power 5V, 2A | 2*AAA 1.5V alkaline | ||
| battery | 2*AAA 1.5V alkaline | ||
| battery | |||
| Operating | |||
| Temperature and | |||
| Humidity | 10 to 40°C | ||
| Atmospheric: 15 to | |||
| 85% RH non- | |||
| condensing | 5°C~40°C | ||
| Atmospheric: | |||
| 15%~85% | |||
| noncondensing | 5°C~40°C | ||
| Atmospheric: | |||
| 15%~85% | |||
| noncondensing | |||
| Storage | |||
| Temperature and | |||
| Humidity | -10 to 55°C | ||
| Atmospheric: 15 to | |||
| 85% RH non- | |||
| condensing | -20°C~+55°C | ||
| Atmospheric: | |||
| 10%~95% | -10°C~+50°C | ||
| Atmospheric: | |||
| 15%~93% |
15
Image /page/15/Picture/0 description: The image shows the logo for AmZetta. The logo features a light blue cloud in the background, with the word "AmZetta" in front of it. The "Am" portion of the word is in blue, while the "Zetta" portion is in green. There is a trademark symbol to the right of the word.
Material make-up of the device:
| Comparison Item | Applicant | Predicate Device 1 | Predicate Device 2 |
|---|---|---|---|
| SPO2 Finger clip | |||
| Material | Silicon rubber | Silicon Gel | Silicon Gel |
| Plastic Material for | |||
| enclosure | ABS+PC Plastic | ABS Plastic | ABS Plastic |
Summary with predicate device:
The principles of operations, core technology and the design used in the B.O.L.T Pulse oximeter, model VA01-2 Pulse oximeter are similar to the predicate device except the implementation design and the system architecture. A detailed design document on the principles of operations. design, assembly and technology characteristics were submitted.
The B.O.L.T pulse oximeter, model VA01-2 is similar to the predicate device in intended use. intended patient population, intended application site, working principle display range, resolution. Only their contact material, internal power supply, appearance differ and readout of the data/results where B.O.L.T uses a wireless Bluetooth connected devices to display the results and the predicate devices has a built-in display.
The B.O.L.T pulse oximeter, model VA01, VA01-2 and the predicate devices are substantially equivalent in the technological characteristics of patient contact materials, performance, biocompatibility function, mechanical safety, standards met, electrical safety, and EMC. The material make up of the B.O.L.T pulse oximeter, model VA01, VA01-2 and the two predicate devices compared are similar and the exception is only in the color of the material and B.O.L.T pulse oximeter uses Silicon rubber and the predicate devices use silicon gel.
AmZetta Technologies Private Limited believe that the B.O.L.T pulse oximeter model VA01, VA01-2 is substantially equivalent to the predicate devices.
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Image /page/16/Picture/0 description: The image shows the logo for AmZetta. The logo features the company name in a stylized font, with the "Am" portion in blue and the "Zetta" portion in green. A light blue cloud-like shape is above the "Am" portion of the name. The letters are bold and slightly slanted to the right.
Discussion of Clinical Tests performed:
B.O.L.T NIBP:
The B.O.L.T blood pressure monitor, model VA01-0 is compliant to the EN ISO 81060-2: 2014 Non-invasive sphygmommsnometers – Part 2: Clinical investigation of automated measurement type Standard for Manual, electronic, or automated sphygmomanometers. All the relevant activities were performed and the results demonstrated that the predetermined acceptance criteria were fully met.
106 subjects were recruited for the clinical study which included adult both male and female between 18 years and 65 years for Blood pressure and a total of 318 reading were taken for statistical analysis. For pulse rate statistical analysis 89 pulse rate reading was obtained. Omron model HEM 907 was used as the reference device. Omron IntellisenseTM Digital Blood Pressure Monitor, Model HEM-907 is approved under K032305.
subject distribution was as per the EN ISO 81060-2:2014 Non-invasive The sphygmommsnometers – Part 2: Clinical investigation of automated measurement type Standard for Manual, electronic, or automated sphygmomanometers standards.
The clinical study met the accuracy criteria as specified by EN ISO 81060-2:2014 standards. As per the Criterion I, mean error is 2.1 and 1.2 for Systolic Blood Pressure and Diastolic Blood Pressure respectively (falling within specified ISO criteria of less than 5). The standard deviation is 5.4 and 5.7 for Systolic Blood Pressure and Diastolic Blood Pressure respectively (falling within specified ISO criteria of less than 8). As per the Criterion 2, standard deviation for Systolic Blood Pressure is 4.39; and Diastolic Blood Pressure is 4.98 (Satisfied for both Systolic Blood Pressure (4.39