B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter

K182401 · Amzetta Technologies Private Limited · MWI · Aug 28, 2019 · Cardiovascular

Device Facts

• Record ID: K182401
• Device Name: B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter
• Applicant: Amzetta Technologies Private Limited
• Product Code: MWI · Cardiovascular
• Decision Date: Aug 28, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended 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 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.

Device Story

Modular patient monitoring system (B.O.L.T) comprising base unit (VA01) and interchangeable accessories: NIBP cuff (VA01-0), IRT thermometer (VA01-1), and pulse oximeter (VA01-2). Device inputs: oscillometric pressure signals (NIBP), infrared thermal radiation (IRT), and photoelectric absorption signals (SpO2). Base unit processes signals via microcontroller and transmits data via Bluetooth to smartphone/tablet/PC application. Application controls device operation (start/stop) and displays results. Used in clinical settings or home environments by patients or clinicians. Data can be stored in HIPAA-compliant cloud. Benefits include convenient, non-invasive tracking of vitals for adult users.

Clinical Evidence

Clinical studies conducted for all modules. NIBP: 106 subjects, 318 readings, met ISO 81060-2:2014 accuracy criteria. IRT Thermometer: 105-120 subjects, met ISO 80601-2-56:2012 and ASTM E1965-98 accuracy requirements. Pulse Oximeter: 10 subjects, 250 readings, met ISO 80601-2-61:2011 accuracy (Arms 2.57% for SpO2). All studies demonstrated performance within predetermined acceptance criteria.

Technological Characteristics

Modular system with base unit (VA01) and accessories. NIBP: oscillometric method, semiconductor gauge sensor. IRT: thermopile sensor (MLX90615). SpO2: photoelectric inspection (660nm/905nm). Materials: ABS+PC plastic, silicone rubber. Connectivity: Bluetooth V4.0+EDR. Power: 3.7V Li-Polymer battery. Software: Class B (Moderate) level of concern.

Indications for Use

Indicated for adult patients for spot-checking and monitoring of non-invasive blood pressure, pulse rate, oxygen saturation (SpO2), and body temperature (via ear canal). Contraindicated for individuals with serious arrhythmia, pregnancy, or arteriosclerosis (consult physician), and those with wearable/implantable electronic devices like pacemakers or defibrillators.

Regulatory Classification

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.

Predicate Devices

• Withings Blood Pressure Monitor, Upper Arm Type: BP-801 (K133125)
• Blood Health BPS Fully Automatic Arm Cuff Wireless Blood Pressure dock model KD 936 (K120672)
• Microlife Digital Infrared Ear Thermometer model IR1DR1-1 (K170219)
• Fingertip Pulse Oximeter model A330, A310 (K163135)
• Fingertip Pulse Oximeter JPD-500A (K140582)

Reference Devices

• Omron Intellisense Digital Blood Pressure Monitor, Model HEM-907 (K032305)
• Braun ear thermometer, Model Pro 4000 (K031928)
• DT-K11E contact reference thermometer (K172861)
• Contec Medical Systems model CMS-50D (K082641)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 : [phone] Fax : [phone] Contact : Sridharan Mani Title : Chief Executive Officer Email : [e-mail] Alternate Contact

| Alternate Contact | : G. Ketharaman |
|-------------------|-------------------------------|
| Title | : Unit Head- Healthcare Group |
| Email | : [e-mail] |

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<br>VA01-0 - B.O.L.T Non-Invasive Blood Pressure(NIBP) Cuff<br>VA01-1 - B.OL.T Infrared Radiation Energy<br>Technology (IRT) Thermometer probe<br>VA01-2 - B.O.L.T Pulse Oximeter (SPO2) probe |
| Common Name | Patient Physiological Monitor |
| Classification Name | Monitor, Physiological, Patient (without arrhythmia<br>detection or alarms) |
| Classification | Class II |
| Product code | MWI |
| Other Product codes | DQA- Pulse Oximeter<br>DXN - Blood Pressure, non-invasive<br>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.<br>Product<br>Name/code | Package Bundle | Devices model numbers |
|----------------------------------|-----------------------------------------|------------------------------------|
| BT1 | Base Unit and NIBP | VA01 and VA01-0 |
| BT2 | Base Unit, NIBP and Body<br>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<br>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<br>Private Limited. | Withings | Andon Health Co.,<br>Ltd |
| Trade Name | B.O.L.T | Withings Blood<br>Pressure Monitor,<br>Upper Arm<br>Type: BP-801 | Blood Health BPS<br>Fully Automatic Arm<br>Cuff Wireless Blood<br>Pressure dock |
| Model Name | B.O.L.T VA01-0 | BP-801 | KD-936 |
| 510K Number | New Listing | K133125 | K120672 |
| Technological<br>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<br>$\pm$ 2% of Pressure<br>readout value | Pressure: $\pm$ 3mmHg |
| Pulse accuracy | $\pm$ 5% of Pressure<br>reading value | $\pm$ 5% of Pressure<br>reading value | $\pm$ 5% of Pressure<br>reading value |
| System<br>Architecture | Requires an external device to constitute a complete blood pressure measurement system<br>e.g. blood pressure cuff | Independent operation | Requires an external device to constitute a complete blood pressure measurement system |

AmZetta Technologies Private Ltd.,

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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<br>Interaction | Requires an external<br>device to display<br>results and perform<br>user interaction.<br>Devices supported<br>any Bluetooth enabled<br>smart phone, tablet or<br>personal computer. | LCD monitor and<br>personal computer | Requires an external<br>device to display<br>results and perform<br>user interaction |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Communication | Wireless, based on<br>Bluetooth V4.0 + EDR<br>(Bluetooth Low<br>energy) | Wireless, based on<br>Bluetooth V4.0<br>Dual mode(V2.1 +<br>EDR) | Wireless, based on<br>Bluetooth V3.0 +<br>EDR |
| Power Source | Rechargeable<br>batteries (Li-Polymer)<br>3.7 volt,850mAh<br>and DC power 5V, 2A. | Disposable 4xAAA<br>alkaline batteries | Rechargeable<br>batteries (Li-lon 400<br>mAh) |
| Cuff Type and Size | Upper arm type, size:<br>22 to 42 cm | Upper arm type, size:<br>22 to 42 cm | Upper arm type, size:<br>23 to 48 cm |
| Operating<br>Temperature and<br>Humidity | 10 to 40° C<br>Atmospheric: 15 to<br>85% RH non-<br>condensing | 10 to 40° C 15 to<br>90% RH.<br>Atmospheric:86Kpa<br>to 106Kpa<br>Altitude: 2000m | 5 to 40° C<br>Atmospheric: <90%<br>RH |
| Storage<br>Temperature and<br>Humidity | -10 to 55° C<br>Atmospheric: 15 to<br>85% RH non-<br>condensing | -5 to 70° C 10 to<br>95% RH.<br>Atmospheric:86Kpa<br>to 106Kpa<br>Altitude: 2000m | -22 to 55° C<br>Atmospheric: <90%<br>RH |

#### Material Make-up of the device:

| Comparison Item | Applicant | Predicate Device 1 | Predicate Device 2 |
|---------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|
| BP Cuff | Lycra fabric on the<br>rear side, Velcro<br>loop, Velcro hook,<br>PU leather, bias | Lycra, Velcro loop,<br>Velcro hook, PU<br>leather, bias | Lycra, Velcro loop,<br>Velcro hook, PU<br>leather, bias |
| Rubber tube of BP<br>Cuff | Neoprene (tubing<br>wall) | Neoprene (tubing<br>wall) | Neoprene (tubing<br>wall) |

#### Summary with predicate device:

The principles of operations, core technology and design specifications used in the NIBP module of the B.O.L.T model VA01-0 are similar to the predicate devices 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 intended use and the indications for use of the B.O.L.T blood pressure monitor, model VA01-0 as described in its labeling are similar as the two predicate devices and all three devices are intended to be used in similar manner and environments, except B.O.L.T blood pressure system model VA01-0 can be used by the medical professional in a clinical as well as home users.

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Image /page/10/Picture/0 description: The image shows the logo for AmZetta. The logo features the word "AmZetta" in a stylized font, with the "Am" portion in blue and the "Zetta" portion in green. Above the word "AmZetta" is a light blue cloud shape. To the right of the word "Zetta" is the trademark symbol.

Patient contact materials, performance, biocompatibility function, mechanical safety, standards met, electrical safety, and EMC are similar. The material make up of the B.O.L.T blood pressure monitor, model VA01-0 and the two predicate devices compared are similar and the exception is only in the color of the material.

B.O.L.T blood pressure monitor, model VA01-0 and the predicate devices use Bluetooth to communicate wirelessly with a smartphone, tablet or PC. While B.O.L.T blood pressure monitor uses Bluetooth V4.0 + EDR, predicate device KD-936 uses Bluetooth V3.0+EDR and the Withings Blood Pressure Monitor, Upper Arm Type: BP-801 uses Bluetooth V4.0. The user interface, visual appearance and cuff size for the new device and the predicate devices differ.

AmZetta Technologies Private Limited believe that the B.O.L.T blood pressure monitor model VA01-0 is substantially equivalent to the predicate devices and other products currently in distribution.

#### Substantial Equivalence comparison of the B.O.L.T IRT Thermometer with predicate Devices:

B.O.L.T IRT Thermometer model VA01-1 is compared against K170219 Microlife Digital Infrared Ear Thermometer model IR1DR1-1 from Microlife Intellectual Property GmbH, Switzerland

| Comparison Item | Submitted proposed device | Predicate Device |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | AmZetta Technologies Private Limited. | Microlife Intellectual Property GmbH, Switzerland |
| Trade Name | B.O.L.T IRT Thermometer | Microlife Digital Infrared Ear Thermometer |
| Model Name | B.O.L.T VA01-1 | IR1DR1-1 |
| 510K Number | New Listing | K170219 |
| Device Measurement Technology | Infrared | Infrared |
| Measuring method | Uses 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.<br>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 | Uses 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.<br>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 |
| Measurement location | Ear Canal | Ear canal |
| Probe cover<br>needed? | Yes | No |
| Sensor type | MLX90615 | TPS23B sensor |
| Lens Type | Transparent | Transparent |
| Measurement range | 35.0- 42.0°C (95 -107.6 °F) | 32.0- 42.2°C (89.6 -108.0 °F) |
| Display resolution | 0.1°C or 0.1°F | 0.1°C or 0.1°F |
| Temperature | ±0.2° C (35.0° C to 42°C), | ±0.3° C < 35.5° C, |
| measurement | outside this range: | ±0.2° C (35.5° C - 42° C); |
| accuracy | High / Low | ±0.3° C > 42° C |
| Position indicator | Yes(Application shows the<br>usage) | Yes |
| Elevated<br>Temperature Alarm | No | Yes (10 short beeps when<br>measured temperature is greater<br>than 37.5 °C) |
| Display an User<br>Interaction | Requires an external device to<br>display results and perform user<br>interaction. Devices supported<br>any Bluetooth enabled smart<br>phone, tablet or personal<br>computer RUNNING on Android<br>OS version 4.0 and higher Or<br>IOS OS version 7.0 or higher or<br>Windows OS version 8.0 or<br>higher | LCD display built in to the device |
| Communication | Wireless, based on Bluetooth<br>V4.0 + EDR (Bluetooth Low<br>energy) | Independent |
| Power Source | Rechargeable batteries (Li-<br>Polymer3.7V, 850 mAh) and DC<br>power 5V, 2A | 2*AAA 1.5v alkaline battery |
| Operating<br>Temperature and<br>Humidity | 10 to 40°C ((50.0°F~104.0°F)<br>Atmospheric: 15 to 85% RH non-<br>condensing | 10.0°C - 40°C (50.0°F~104.0°F)<br>with relative humidity 95% |
| Storage<br>temperature and<br>Humidity | -10 to 55° C<br>Atmospheric: 15 to 85% RH non-<br>condensing | -25°C to 55 °C/-13°F ~131°F with<br>relative humidity 95% |
| Probe head: Tip<br>Width | 7.5mm | 7.3mm |
| Probe head:<br>Thickness at 5mm<br>height | 8.0mm | 8.56mm |
| Probe head:<br>Thickness at 10mm<br>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 |

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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".

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#### 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<br>device | Predicate device 1 | Predicate device 2 |
|-----------------|---------------------------------------------|-----------------------------------------|-------------------------------------------------|
| Applicant | AmZetta<br>Technologies Private<br>Limited. | Shenzhen Fitfaith<br>Technology Co.,Ltd | Shenzhen Jumper<br>Medical Equipment<br>Co.,Ltd |
| Trade Name | B.O.L.T Pulse<br>Oximeter | Fingertip Pulse<br>Oximeter | Fingertip Pulse<br>Oximeter |
| Model Name | B.O.L.T VA01-2 | A330, A310 | JPD-500A |
| 510K Number | New Listing | K163135 | K140582 |

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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<br>characteristics | Photoelectric<br>Oxyhemoglobin<br>Inspection<br>Technology | Photoelectric<br>Oxyhemoglobin<br>Inspection<br>Technology | Photoelectric<br>Oxyhemoglobin<br>Inspection<br>Technology |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measuring method | A mathematical<br>formula is established<br>making use of<br>Lambert Beer Law<br>according to<br>Spectrum Absorption<br>Characteristics of<br>Reductive<br>hemoglobin (RHb)<br>and<br>Oxyhemoglobin<br>(HbO2) in red and<br>near-infrared<br>zones. Operation<br>principle of the<br>instrument:<br>Photoelectric<br>Oxyhemoglobin<br>Inspection<br>Technology is<br>adopted in<br>accordance with<br>Capacity Pulse<br>Scanning and<br>Recording<br>Technology, so that<br>two beams of<br>different wavelength<br>of lights can be<br>focused onto a<br>human nail tip<br>through a clamping<br>finger-type sensor. A<br>measured signal<br>obtained by a<br>photosensitive<br>element, is shown on<br>the connected<br>Bluetooth device like<br>a smartphone, tablet<br>or personal computer<br>display through<br>process in electronic<br>circuits and<br>microcontroller of the | A mathematical<br>formula is<br>established making<br>use of<br>Lambert Beer Law<br>according to<br>Spectrum Absorption<br>Characteristics of<br>Reductive<br>hemoglobin (RHb)<br>and<br>Oxyhemoglobin<br>(HbO2) in red and<br>near-infrared<br>zones. Operation<br>principle of the<br>instrument:<br>Photoelectric<br>Oxyhemoglobin<br>Inspection<br>Technology is<br>adopted in<br>accordance with<br>Capacity Pulse<br>Scanning and<br>Recording<br>Technology, so that<br>two beams of<br>different wavelength<br>of lights can be<br>focused<br>onto a human nail tip<br>through a clamping<br>finger-type sensor. A<br>measured signal<br>obtained by a<br>photosensitive<br>element, is shown on<br>the Oximeter's<br>display through<br>process in electronic<br>circuits and<br>microprocessor. | A mathematical<br>formula is<br>established making<br>use of<br>Lambert Beer Law<br>according to<br>Spectrum Absorption<br>Characteristics of<br>Reductive<br>hemoglobin (RHb)<br>and<br>Oxyhemoglobin<br>(HbO2) in red and<br>near-infrared<br>zones. Operation<br>principle of the<br>instrument:<br>Photoelectric<br>Oxyhemoglobin<br>Inspection<br>Technology is<br>adopted in<br>accordance with<br>Capacity Pulse<br>Scanning and<br>Recording<br>Technology, so that<br>two beams of<br>different wavelength<br>of lights can be<br>focused<br>onto a human nail tip<br>through a clamping<br>finger-type sensor. A<br>measured signal<br>obtained by a<br>photosensitive<br>element, is shown on<br>the Oximeter's<br>display through<br>process in electronic<br>circuits and<br>microprocessor. |

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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)<br>1.2 mW for IR (905nm) | 1.5 mW for red light (660nm)<br>1.2 mW for IR (905nm) | 1.5 mW for red light (660nm)<br>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%:<br>(70%~100%)<br>Unspecified:<br>(0%~69%) | ±2%: (70%~100%)<br>Unspecified:<br>(0%~69%) | ±2%: (70%~100%)<br>No definition:<br>(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.<br>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<br>batteries (Li-Polymer<br>3.7V, 850 mAh) and<br>DC power 5V, 2A | 2*AAA…