Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard blood pressure monitor using a "unique algorithm" for pressure and pulse calculation, but there is no mention of AI, ML, or related concepts like neural networks, training data, or performance metrics typically associated with AI/ML devices.

Therapeutic

No.
The device is intended to measure blood pressure and pulse, which are diagnostic indicators, not therapeutic interventions. While monitoring is important for health management, the device itself does not treat or cure a condition.

Diagnostic

Yes

The device is intended to measure blood pressure and pulse, which are physiological parameters used to assess a patient's health status. While it doesn't diagnose a specific disease, the measurement of these parameters falls under the general definition of a diagnostic device as it provides information used in the detection or assessment of medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as a single-chipped microcomputer, pneumatic flow control module, cuff module, pressure detection module, inflation module, and memory module, indicating it is a physical device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
Device Function: The FDBP A series Upper Arm Blood Pressure Monitor measures blood pressure and pulse by applying and releasing pressure to the upper arm and detecting the resulting pressure and pulse signals. This is a non-invasive measurement taken directly from the body, not from a specimen taken from the body.
Intended Use: The intended use is to measure blood pressure and pulse, which are physiological parameters measured directly from the patient.

Therefore, based on the provided information, the FDBP A series Upper Arm Blood Pressure Monitor is a non-invasive medical device for measuring vital signs, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

FDBP A series Upper Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse and children at least 12 years of age, at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia). with the cuff around the left upper arm according to the instruction in the user's guide manual.

Product codes

DXN

Device Description

FDBP A series Upper Arm Blood Pressure Monitor (Model:FDBP-A8,FDBP-A11,FDBP-A12,FDBP-A14 )includes utilize modular design method, It consists of nine main modules:

power-on self-test module, system initialization module,sampling data processing and pressure, pulse rate calculation module, display processing module, power detection processing module, data storage module, key scanning processing module, sampling processing module, voice broadcast processing module, and each module communicates through a message queue.
The blood pressure monitor controls the pneumatic flow control module through singlechipped microcomputer to pressurize the cuff module in order to exceed the lower pressure of patients, the blood being pushed against the artery walls;
Pneumatic Flow Control Module being directed to release the pressure, while the pressure detection module collect pulse pressure signal and amplify filter;
amplified filtersignal being read by single-chipped microcomputer for pressure and pulse signal,through unique algorithm to obtain the systolic and diastolic pressure with pulse;
Single-chipped microcomputer will control the inflation module to release the pressure after receive measurements;
in the meanwhile, display the measurements results then stored the values with memory module.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Upper Arm

Indicated Patient Age Range

children at least 12 years of age. (Not suitable for neonate, pregnancy or pre-eclampsia).

Intended User / Care Setting

household or medical center.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance data includes "Non-Clinical Data" and "Clinical Data".
Non-Clinical Data:

Biocompatibility testing: conducted in accordance with ISO 10993-1, including Cytotoxicity, Skin Sensitization, and Skin Irritation tests.
Electrical safety and electromagnetic compatibility (EMC): complies with IEC 60601-1: 2012 and IEC 60601-1-2: 2014.
Bench Testing: complies with IEC 60601-1-11: 2015 and ISO 80601-2-30: 2009 for performance effectiveness.
Software Verification and Validation Testing: conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered a "Moderate" level of concern.
Usability Testing: conducted according to FDA Guidance 1757, "Applying Human Factors and Usability Engineering to Optimize Medical Device Design".
Clinical data: Clinical testing is conducted per ISO 81060-2: 2013 "Non-invasive sphygmomanometers -Part 2: Clinical validation of automated measurement type".
Summary: "Based on the non-clinical and clinical performance as documented in the device development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device."

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy:
Pressure: ±3 mmHg ( ±0.4 kPa)
Pulse: ±5 %

Predicate Device(s)

K172895

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font in blue.

November 27, 2019

Famidoc Technology Company Limited Leon Cao General Manager No. 212 Yilong Road, Hexi Industrial Zone Jinxia. Changan Town Dongguan, Guangdong 523853 CHINA

Re: K191673

Trade/Device Name: FDBP A Series Upper Arm Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: October 28, 2019 Received: November 6, 2019

Dear Leon Cao:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 (OS) 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 Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K191673

Device Name

FDBP A Series Upper Arm Blood Pressure Monitor

Indications for Use (Describe)

FDBP A series Upper Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse and children at least 12 years of age, at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia). with the cuff around the left upper arm according to the instruction in the user's guide manual.

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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3

Image /page/3/Picture/0 description: The image shows the logo for FAMIDOC, a company that appears to be based in China. The logo consists of the word "FAMIDOC" in a bold, sans-serif font, with a blue plus sign inside of a circle in the middle of the word. To the right of the English word is the Chinese translation of the company name, "费米博士", and the number "K191673" is in the upper right corner of the image.

Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section

510(K) SUMMARY

This summary of 510(K) safety and effective information is being submitted in accordance with the requirement SMDA and 21 CFR 807.92.

Submitter of 510(K): 1.

Date of Prepared:	11/27/2019
Submitter's Name:	Famidoc Technology Company Limited
Address:	No.212 Yilong Road, Hexi Industrial Zone, Jinxia, Changan
Town Dongguan Guangdong 523853 CN
Contact person:	Mr. Leon Cao
TEL:	+(86) -769-8927-2488
FAX:	+(86) -769-8927-2498
E-mail:	leon@famidoc.com

2. Proposed Device and code:

| Device Trade Name: | FDBP A series Upper Arm Blood Pressure Monitor
(Model:FDBP-A8,FDBP-A11,FDBP-A12,FDBP-A14 ) |
|------------------------------|-----------------------------------------------------------------------------------------------|
| Regulation Medical Specialty | Noninvasive blood pressure measurement system. |
| Product Code: | DXN |
| Regulation number | 21 CRF 870.1130 |
| Device Class | 2 |

4

Predicate Device:

001 510 (k) Summary Version: 1.1

510(K)	Trade or Proprietary or Model Name	Manufacturer
	K172895 GE Automatic Upper Arm Blood Pressure Monitor Ageless Health Industrial Co.,
	with Models BA-815, BA-816, BA-818 and BA-819	Ltd.

Description of Proposed Device: 4.

FDBP A series Upper Arm Blood Pressure Monitor (Model:FDBP-A8,FDBP-A11,FDBP-A12,FDBP-A14 )includes utilize modular design method, It consists of nine main modules:

power-on self-test module, system initialization module,sampling data processing and pressure, pulse rate calculation module, display processing module, power detection processing module, data storage module, key scanning processing module, sampling processing module, voice broadcast processing module, and each module communicates through a message queue.
The blood pressure monitor controls the pneumatic flow control module through singlechipped microcomputer to pressurize the cuff module in order to exceed the lower pressure of patients, the blood being pushed against the artery walls;
Pneumatic Flow Control Module being directed to release the pressure, while the pressure detection module collect pulse pressure signal and amplify filter;
amplified filtersignal being read by single-chipped microcomputer for pressure and pulse signal,through unique algorithm to obtain the systolic and diastolic pressure with pulse;
Single-chipped microcomputer will control the inflation module to release the pressure after receive measurements;
in the meanwhile, display the measurements results then stored the values with memory module.

5. Intended for Use

FDBP A series Upper Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adults and children at least 12 years of age, at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia). with the cuff around the left upper arm according to the instruction in the user's guide manual.

6. Technical and Performance

The following table compares the device to the predicate device with basic technological characteristics.

5

Image /page/5/Picture/1 description: The image shows the logo for FAMIDOC, a healthcare company. The logo consists of the word "FAMIDOC" in a sans-serif font, with the "+" symbol in a circle. To the right of the English name is the Chinese name "费米博士" in a similar sans-serif font. The English name is in gray and blue, while the Chinese name is in gray.

| Elements of

Comparison	Subject Devices				Predicate Device	Verdoc
Device Name	Upper Arm Blood Pressure Monitor				AGE Automatic Upper
Arm Blood Pressure	/
Device Model	FDBP-A8	FDBP-A12	FDBP-A14	FDBP-A11	BA-815, BA-816, BA-818,
BA-819	/
510 (k) Number	N/A	N/A	N/A	N/A	K172895	/
Product Code	DXN	DXN	DXN	DXN	DXN	SE
Regulation No.	870.1130	870.1130	870.1130	870.1130	870.1130	SE
Classification	II	II	II	II	II	SE
Intended Use and indications for Use

Intended Use	FDBP A series Upper
Arm Blood Pressure
Monitor is intended to
measure the blood
pressure and pulse rate
of adult at household or
medical center. (Not
suitable for neonate,
pregnancy or pre-
eclampsia). with the
cuff around the left
upper arm according to
the instruction in the
user's guide manual.	FDBP A series Upper
Arm Blood Pressure
Monitor is intended to
measure the blood
pressure and pulse rate
of adult at household or
medical center. (Not
suitable for neonate,
pregnancy or pre-
eclampsia). with the
cuff around the left
upper arm according to
the instruction in the
user's guide manual.	FDBP A series Upper Arm
Blood Pressure Monitor is
intended to measure the
blood pressure and pulse
rate of adult at household
or medical center. (Not
suitable for neonate,
pregnancy or pre-
eclampsia). with the cuff
around the left upper arm
according to the
instruction in the user's
guide manual.	FDBP A series Upper
Arm Blood Pressure
Monitor is intended to
measure the blood
pressure and pulse rate
of adult at household or
medical center. (Not
suitable for neonate,
pregnancy or pre-
eclampsia). with the
cuff around the left
upper arm according to
the instruction in the
user's guide manual.	AGE Automatic Upper
Arm Blood Pressure
Monitor is intended for
use by medical
professionals or at home
to monitor and display
diastolic, systolic blood
pressure and pulse rate
on adult each time, with
the cuff around the left
upper arm according to
the instruction in the
user's guide manual.	SE

Performance Specification

Measuring
Method	Oscillometric
Method	Oscillometric
Method	Oscillometric
Method	Oscillometric
Method	Oscillometric
Method	SE
Measuring
Range	Pressure: 0~280 mmHg
Pulse: 40~200 beats/minute
SYS(systolic pressure ): 60-
255mmHg
DIA (diastolic pressure): 40-
200mmHg	Pressure: 0~280 mmHg
Pulse: 40~200 beats/minute
SYS(systolic pressure ): 60-
255mmHg
DIA (diastolic pressure): 40-
200mmHg	Pressure: 0~280 mmHg
Pulse: 40~200 beats/minute
SYS(systolic pressure ): 60-
255mmHg
DIA (diastolic pressure): 40-
200mmHg	Pressure: 0~280 mmHg
Pulse: 40~200 beats/minute
SYS(systolic pressure ): 60-
255mmHg
DIA (diastolic pressure): 40-
200mmHg	Pressure: 0~280 mmHg
Pulse: 40~199 beats/minute
SYS(systolic pressure ): 60-
255mmHg
DIA (diastolic pressure): 40-
200mmHg	SE
Pressure
resolution	1 mmHg or 0.1 kPa	1 mmHg or 0.1 kPa	1 mmHg or 0.1 kPa	1 mmHg or 0.1 kPa	1 mmHg or 0.1 kPa	SE
Accuracy	Pressure:
$±3$ mmHg ( $±0.4$ kPa)
Pulse: $±5$ %	Pressure:
$±3$ mmHg ( $±0.4$ kPa)
Pulse: $±5$ %	Pressure:
$±3$ mmHg( $±0.4$ kPa)
Pulse: $±5$ %	Pressure:
$±3$ mmHg( $±0.4$ kPa)
Pulse: $±5$ %	Pressure:
$±3$ mmHg
Pulse: $±5$ %	SE

6

Image /page/6/Picture/1 description: The image shows the logo for FAMIDOC 菱米博士. The logo is composed of the word "FAMIDOC" in gray, with a blue plus sign in the middle of the "O". To the right of the English word is the Chinese characters "菱米博士" in gray. The logo is simple and modern, and the use of blue and gray gives it a professional look.

7

Image /page/7/Picture/1 description: The image shows the logo for FAMIDOC, a company that appears to be based in China. The logo consists of the word "FAMIDOC" in a dark gray sans-serif font, with a blue plus sign inside of a circle. To the right of the English text is the company name in Chinese characters, which translates to "Fei Mi Bo Shi".

| Patient

Population	Adult	Adult	Adult	Adult	Adult	SE
Measurement
Site of Body	Upper Arm	Upper Arm	Upper Arm	Upper Arm	Upper Arm	SE
Inflation and
Deflation	Automatic	Automatic	Automatic	Automatic	Automatic	SE
Memory Size	2x60 sets record	2x60 sets record	2x60 sets record	2x60 sets record	2x90 sets record	Similar
Note 1
Indicators	Blood Pressure (Systolic
and Diastolic), Pulse,
Date, Time, WHO BP
Classification Indicating
Bar, Low Battery Icon,
Heart Icon, Memory
Record Number	Blood Pressure (Systolic
and Diastolic), Pulse,
Date, Time, WHO BP
Classification Indicating
Bar, Low Battery Icon,
Heart Icon, Memory
Record Number	Blood Pressure (Systolic
and Diastolic), Pulse, Date,
Time, WHO BP
Classification Indicating
Bar, Low Battery Icon,
Heart Icon, Memory
Record Number	Blood Pressure (Systolic
and Diastolic), Pulse,
Date, Time, WHO BP
Classification Indicating
Bar, Low Battery Icon,
Heart Icon, Memory
Record Number	Blood Pressure (Systolic
and Diastolic), Pulse,
Date, Time, WHO BP
Classification Indicating
Bar, Low Battery Icon,
Heart Icon, Memory
Record Number	SE

8

Image /page/8/Picture/1 description: The image shows the logo for FAMIDOC, a company that appears to be based in China. The logo consists of the word "FAMIDOC" in a combination of gray and blue colors, with a plus sign inside a blue circle. To the right of the English name is the Chinese translation of the company name, "费米博士", which is also in gray.

| Cuff
Circumference | 220mm~~320mm | 220mm~~320mm | 220mm~~320mm | 220mm~~320mm | For BA-815: 22-34 cm;
For BA-816: 28-42 cm;
For BA-818 and BA-819, there are 6 size:
size A: 17cm--22cm (SMALL ADULT CUFF)
size B: 22cm--30cm (ADULT CUFF-1)
size C: 24cm--34cm (ADULT CUFF-2)
size D: 22cm--42cm (L-LARGE ADULT CUFF)
size E: 30cm--42cm (LARGE ADULT CUFF)
size F: 42cm--50cm (EXTRA LARGE ADULT CUFF) | SE |
|------------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Power Battery | DC 6V (4xAA 1.5V
alkaline batteries or DC
Adaputer) | DC 6V (4xAA 1.5V
alkaline batteries or DC
Adaputer) | DC 6V (4xAAA 1.5V alkaline
batteries or DC Adaputer) | DC 6V (4xAAA 1.5V
alkaline batteries or DC
Adaputer) | DC 6V (4xAA 1.5V alkaline
batteries ) | Similar
Note 2 |
| Display | LCD Digital Display | LCD Digital Display | LCD Digital Display | LED Digital Display | LCD Digital Display | Similar
Note 3 |
| OPERATING&STORAGE CONDITIONS | | | | | | |
| Operating
Environment | Temperature:
5 °C-40 °C | Temperature:
5 °C -40 °C | Temperature:
5 °C -40 °C | Temperature:
5 °C -40 °C | Temperature:
5°C ~ 40°C
Humidity: 1590%RH
Atmospheric Pressure:
86 kPa106 kPa | Similar
Note 4 |
| | Humidity:
15%RH-90%RH,
No condensation
Atmospheric pressure
70kPa106kPa | Humidity :
15%RH-90%RH,
No condensation
Atmospheric pressure
70kPa106kPa | Humidity:
15%RH-90%RH,
No condensation
Atmospheric pressure
70kPa106kPa | Humidity:
15%RH-90%RH,
No condensation
Atmospheric pressure
70kPa106kPa | | |

9

Image /page/9/Picture/1 description: The image shows the logo for FAMIDOC, a company that appears to be based in China. The logo consists of the company name in English, "FAMIDOC," followed by the Chinese characters "费米博士". The English portion of the logo is in a dark gray font, while the "+" symbol in the middle of the name is in blue. The Chinese characters are also in dark gray.

| Storage
Environment | Temperature:
-25 °C-55 °C
Humidity:
15%RH-95%RH,
No condensation
Atmospheric pressure
700hPa1060hPa | Temperature:
-25 °C-55 °C
Humidity:
15%RH-95%RH,
No condensation
Atmospheric pressure
700hPa1060hPa | Temperature:
-25 °C-55 °C
Humidity:
15%RH-95%RH,
No condensation
Atmospheric pressure
700hPa1060hPa | Temperature:
-25 °C-55 °C
Humidity:
15%RH-95%RH,
No condensation
Atmospheric pressure
700hPa1060hPa | Temperature:
-20°C ~ +65°C
Humidity: 1095%RH
Atmospheric Pressure:
86 kPa106 kPa | Similar
Note 5 |
|------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------|
| COMPLIANCE STANDARDS | | | | | | |
| Performance | ANSI/AAMI/ISO
81060-2 | ANSI/AAMI/ISO
81060-2 | ANSI/AAMI/ISO
81060-2 | ANSI/AAMI/ISO
81060-2 | ANSI/AAMI/ISO
81060-2 | SE |
| Electrical Safety | IEC
60601-1 | IEC
60601-1 | IEC
60601-1 | IEC
60601-1 | IEC
60601-1 | SE |
| EMC | IEC
60601-1-2 | IEC
60601-1-2 | IEC
60601-1-2 | IEC
60601-1-2 | IEC
60601-1-2 | SE |
| Home Use | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | SE |
| Performance | IEC
80601-2-30 | IEC
80601-2-30 | IEC
80601-2-30 | IEC
80601-2-30 | IEC
80601-2-30 | SE |
| Biocompatibility | All the patient
contracting materials
are evaluated by the
biocompatibility
standard ISO
10993 -5, -10. | All the patient
contracting materials
are evaluated by the
biocompatibility
standard ISO
10993 -5, -10. | All the patient
contracting materials
are evaluated by the
biocompatibility
standard ISO
10993 -5, -10. | All the patient
contracting materials
are evaluated by the
biocompatibility
standard ISO
10993 -5, -10. | All the patient
contracting materials
are evaluated by the
biocompatibility
standard ISO
10993 -5, -10. | SE |

Note 1 and 2

The Memory Size, Power Battery of proposed device are different. But the difference is very slight,it will not affect the main function and the intended use of the device. and Memory Size,Power Battery of proposed device is clearly indicated in user manual and outer carton. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.

Note 3

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Image /page/10/Picture/1 description: The image shows the logo for FAMIDOC, a company that appears to be based in China. The logo consists of the word "FAMIDOC" in gray and blue letters, followed by the trademark symbol. To the right of the English name is the Chinese translation of the company name, "费米博士", which is also in gray.

The Display of proposed device and predicate device are difference is very slight,it will not affect the main function and the intended use of the device. And they are both compliance with IEC 60601-1-2 Standard. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.

Note 4 and 5:

The Temperature, Relative Humidity and Atmospheric pressure of Operation and storage environment of subject devices is difference with predicate device,and they are both compliance with IEC 60601-1-11 standard,it will not raise any safety or effectiveness issue.

Conclusion:

The subject device AGE Automatic Upper Arm Blood Pressure Monitor has all features of the differences between them do not affect the safety and effectiveness. Thus, the subject device is substantially equivalent to the predicate device.

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7. Performance

Testing:

Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as

below.

7.1 Non-Clinical Data:

The following performance data were provided in support of the substantial equivalence determination.

7.2 Biocompatibility testing

The biocompatibility evaluation for the FDBP A series Upper arm Blood Pressure Monitor and

the NIBP CUFF were conducted in accordance with the International Standard ISO 10993-1 "Biological

Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as

recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less

than 24 hours. And the testing included the following tests:

Cytotoxicity
Skin Sensitization
Skin Irritation

7.3 Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the FDBP A series Upper arm Blood Pressure Monitor, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2014 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance - Collateral Standard:Electromagnetic disturbances -Requirements and tests standard for EMC.

7.4 Bench Testing

Bench testing was conducted on the FDBP A series Upper arm Blood Pressure Monitor,consisting of all the accessories in the system. The system complies with the IEC 60601-1-11: 2015 MEDICAL ELECTRICAL EQUIPMENT –Part 1-11: General requirements for basic safety and essential performance –Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, ISO 80601-2-30: 2009 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers standards for performance effectiveness.

7.5 Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was

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provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.

7.6 Usability Testing

Usability testing according to following FDA Guidance 1757, Applying Human Factors and Usability

Engineering to Optimize Medical Device Design, was conducted.

7.7 Clinical data:

Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers -Part 2: Clinical

validation of automated measurement type.

7.7 Summary

Based on the non-clinical and clinical performance as documented in the device development, the subject

devices were found to have a safety and effectiveness profile that is similar to the predicate device.

8. Conclusions:

The proposed device has the same intended use and similar characteristics as the predicate device, AGE Automatic Upper Arm Blood Pressure Monitor with Models BA-815, BA-816, BA-818 and BA-819(K172895) Meanwhile, performance testing, bench testing, and safety report documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Based on performance testing, the proposed device is Substantially Equivalent (SE) to the predicate device.