(199 days)
Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure 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. with the left upper arm according to the instruction in the user's guide manual(Cuff size 220 ~ 420 mm).
Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor (Model:FDBP-A7B、FDBP-A7BL、FDBP-A7BT、FDBP-A7BLT、FDBP-A8B、 FDBP-A8BL、FDBP-A8BT、FDBP-A8BLT、FDBP-A9B、FDBP-A9BL、FDBP-A9BT、 FDBP-A9BLT、FDBP-A10B、FDBP-A10BL、FDBP-A10BT、FDBP-A10BLT) 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, , wireless function 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 filter signal 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/deflation module to release the pressure after receive measurements; in the meanwhile, display the measurements results then stored the values with memory module.
The provided text describes the 510(k) submission for the Famidoc Technology Company Limited Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. The information below is extracted from the provided text to fulfill the request.
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance, particularly its clinical accuracy, is evaluated against the standards outlined in ISO 81060-2.
| Acceptance Criteria (Standard) | Device Performance (Metric) |
|---|---|
| Accuracy (Pressure) | ±3 mmHg (±0.4kPa) |
| Accuracy (Pulse) | ±5% |
| Measuring Range (Systolic) | 60-250mmHg |
| Measuring Range (Diastolic) | 30-195mmHg |
| Measuring Range (Pulse) | 40-199 beats/min |
The document states: "The results showed the accuracy of the subject device is within acceptable scope specified in ISO 81060-2."
2. Sample size used for the test set and data provenance
- Sample Size: 85 patients (43 males)
- Data Provenance: The document does not explicitly state the country of origin but implies a clinical study was performed. It also does not specify if the study was retrospective or prospective, but clinical studies are generally prospective in nature.
3. Number of experts used to establish the ground truth for the test set and their qualifications
The document mentions "manual Mercury Sphygmomanometer was used as a reference sphygmomanometer." It does not specify the number of experts or their qualifications for establishing the ground truth, but implicitly, trained medical professionals would be operating the reference device.
4. Adjudication method for the test set
The document states, "Same arm sequential method was adopted during the clinical study." This refers to how measurements were taken, not an adjudication method for conflicting readings. No explicit adjudication method for the test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This is an automated blood pressure monitor, not an AI-assisted diagnostic device for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the device operates as a standalone automated blood pressure monitor. Its performance was tested directly against a reference standard in a clinical setting. The clinical study details describe the device's performance in measuring blood pressure and pulse rate without human-in-the-loop assistance in the measurement process itself, beyond initiation and observation.
7. The type of ground truth used
The ground truth for blood pressure and pulse rate measurements was established using a manual Mercury Sphygmomanometer. This is considered a clinical reference standard.
8. The sample size for the training set
The document does not provide a specific sample size for a training set. This is typical for medical devices that rely on established physical measurement principles (oscillometric method) and are validated against existing standards rather than necessarily "training" a machine learning algorithm in the same way an AI diagnostic tool would. If an algorithm within the device was developed using data, that information is not detailed here.
9. How the ground truth for the training set was established
As no explicit training set is mentioned in the context of machine learning, the ground truth establishment for such a set is not described. The device's underlying principles are based on oscillometric measurements, for which the fundamental accuracy is validated against clinical standards like mercury sphygmomanometers.
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April 10, 2023
Famidoc Technology Company Limited Amos Zou Management Representative No. 212 Yilong Road, Hexi Industrial Zone Jinxia. Changan Town Dongguan, Guangdong 523853 China
Re: K222887
Trade/Device Name: Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 6, 2023 Received: April 7, 2023
Dear Amos Zou:
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.
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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 mediation-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.
Aneesh S. Deoras -S
for
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) K22887
Device Name
Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor
Indications for Use (Describe)
Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure 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. with the left upper arm according to the instruction in the user's guide manual(Cuff size 220 ~ 420 mm).
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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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.
1. Submitter of 510(K):
| Date of Prepared: | 17/1/2023 |
|---|---|
| Submitter's Name: | Famidoc Technology Company Limited |
| Address: | No.212 Yilong Road, Hexi Industrial Zone, Jinxia, Changan TownDongguan Guangdong 523853 CN |
| Contact person: | Amos zou |
| TEL: | +(86) -769-8927-2488 |
| FAX: | +(86) -769-8927-2498 |
| E-mail: | qa@famidoc.com |
2.Proposed Device and code:
| Device Trade Name: | Arm Blood Pressure Monitor/Automatic Wireless Smart BloodPressure monitor(Model:FDBP-A7B、FDBP-A7BL、FDBP-A7BT、FDBP-A7BLT、FDBP-A8B、FDBP-A8BL、FDBP-A8BT、FDBP-A8BLT、FDBP-A9B、FDBP-A9BL、FDBP-A9BT、FDBP-A9BLT、FDBP-A10B、FDBP-A10BL、FDBP-A10BT、FDBP-A10BLT) |
|---|---|
| Regulation MedicalSpecialty | Noninvasive blood pressure measurement system. |
| Product Code: | DXN |
| Regulation number | 21 CRF 870.1130 |
| Device Class | 2 |
3. Predicate Device:
| 510(K) | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K210770 | Fully Automatic ElectronicBlood Pressure Monitor | Andon Health Co,.Ltd. |
4. Description of Proposed Device:
Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor(Model:FDBP-A7B、FDBP-A7BL、FDBP-A7BT、FDBP-A7BLT、FDBP-A8B、 FDBP-A8BL、FDBP-A8BT、FDBP-A8BLT、FDBP-A9B、FDBP-A9BL、FDBP-A9BT、
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FDBP-A9BLT、FDBP-A10B、FDBP-A10BL、FDBP-A10BT、FDBP-A10BLT)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, , wireless function 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/deflation 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
Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure 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. with the cuff around the left upper arm according to the instruction in the user's guide manual(Cuff size 220 ~ 420 mm).
6. Technical and Performance
The following table compares the device to the predicate device with basic technological characteristics.
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7.Comparison of Technological Characteristics with Predicate Device
| Elements ofComparison | Subject Devices | Predicate Device | ComparisonResult | |||
|---|---|---|---|---|---|---|
| Device Name | Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor | Fully Automatic ElectronicBlood Pressure Monitor | / | |||
| Device Model | FDBP-A7BL | FDBP-A7BT | FDBP-A10BL | FDBP-A10BT | KD-5810, KD5810B,KD-5811, KD-5920TL,KD-552 | / |
| 510 (k) Number | K222887 | K222887 | K222887 | K222887 | K210770 | / |
| 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 | Arm Blood PressureMonitor/AutomaticWireless Smart BloodPressure is intended tomeasure the bloodpressure and pulse rate ofadults and children atleast 12 years of age, athousehold or medicalcenter. with the cuffaround the left upper armaccording to theinstruction in the user'sguide manual(Cuff size220 ~ 420 mm). | Arm Blood PressureMonitor/AutomaticWireless Smart BloodPressure is intended tomeasure the bloodpressure and pulse rate ofadults and children atleast 12 years of age, athousehold or medicalcenter. with the cuffaround the left upper armaccording to theinstruction in the user'sguide manual(Cuff size220 ~ 420 mm). | Arm Blood PressureMonitor/AutomaticWireless Smart BloodPressure is intended tomeasure the bloodpressure and pulse rate ofadults and children atleast 12 years of age, athousehold or medicalcenter. with the cuffaround the left upper armaccording to theinstruction in the user'sguide manual(Cuff size220 ~ 420 mm). | Arm Blood PressureMonitor/AutomaticWireless Smart BloodPressure is intended tomeasure the bloodpressure and pulse rate ofadults and children atleast 12 years of age, athousehold or medicalcenter. with the cuffaround the left upper armaccording to theinstruction in the user'sguide manual(Cuff size220 ~ 420 mm). | Fully Automatic ElectronicBlood Pressure Monitor isfor use by medicalprofessionalsor at home and is anon-invasive bloodpressure measurementsystem intended tomeasure the diastolic andsystolic blood pressuresand pulse rate of an adultindividualby using a non-invasivetechnique in which aninflatable cuff is wrapped | SE |
| upper arm. The cuffcircumference is limited to22cm-48cm. | ||||||
| Performance Specification | ||||||
| MeasuringMethod | Oscillometric Method | Oscillometric Method | Oscillometric Method | Oscillometric Method | Oscillometric Method | SE |
| MeasuringRange | Systolic: 60-250mmHgDiastolic: 30-195mmHgPulse: 40-199beats/min | Systolic: 60-250mmHgDiastolic: 30-195mmHgPulse: 40-199beats/min | Systolic: 60-250mmHgDiastolic: 30-195mmHgPulse: 40-199beats/min | Systolic: 60-250mmHgDiastolic: 30-195mmHgPulse: 40-199beats/min | Systolic: 60-260mmHgDiastolic: 40-199mmHgPulse rate: 40-180beats/min | SimilarNote 1 |
| Pressureresolution | 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 (±0.4kPa)Pulse:±5% | Pressure:±3 mmHg (±0.4kPa)Pulse:±5% | Pressure:±3 mmHg (±0.4kPa)Pulse:±5% | Pressure:±3 mmHg (±0.4kPa)Pulse:±5% | Pressure: ±3mmHgPulse rate:Less than 60: ±3bpmMore than 60 (incl.) : ±5% | SimilarNote 2 |
| PatientPopulation | Adult | Adult | Adult | Adult | Adult | SE |
| MeasurementSite of Body | Upper Arm | Upper Arm | Upper Arm | Upper Arm | Upper Arm | SE |
| Inflation andDeflation | Automatic | Automatic | Automatic | Automatic | Automatic | SE |
| Memory Size | 2x60 sets record | 2x60 sets record | 2x60 sets record | 2x60 sets record | 4×60 times with time anddate stamp | SimilarNote 3 |
| Indicators | Blood Pressure (Systolicand Diastolic), Pulse,Date, Time, WHO BPClassification IndicatingBar, Low Battery Icon,Heart Icon, Memory | Blood Pressure (Systolicand Diastolic), Pulse,Date, Time, WHO BPClassification IndicatingBar, Low Battery Icon,Heart Icon, Memory | Blood Pressure (Systolicand Diastolic), Pulse,Date, Time, WHO BPClassification IndicatingBar, Low Battery Icon,Heart Icon, Memory | Blood Pressure (Systolicand Diastolic), Pulse,Date, Time, WHO BPClassification IndicatingBar, Low Battery Icon,Heart Icon, Memory | Blood Pressure (Systolicand Diastolic), Pulse,Date, Time, WHO BPClassification IndicatingBar, Low Battery Icon,Heart Icon, Memory | SE |
| K222887 510(k) Summary | ||||||
| RecordNumber,Bluetoothsymbol | RecordNumber,Bluetoothsymbol | RecordNumber,Bluetoothsymbol | Record Number,Bluetoothsymbol | Record Number,Bluetoothsymbol | ||
| CuffCircumference | 220mm ~420mm | 220mm ~420mm | 220mm ~420mm | 220mm ~420mm | 22cm-30cm,30cm-42cm(Optional),42cm-48cm(Optional),22cm-42cm (Optional) | SimilarNote 4 |
| Power Battery | 3.7V lithium battery orUSB 5V adapter | 4xAAA 1.5V alkalinebatteries or USB 5Vadapter | 3.7V lithium battery orUSB 5V adapter | 4xAAA 1.5V alkalinebatteries or USB 5Vadapter | 4xAA 1.5V alkalinebatteries or DC 6Vadapter | SimilarNote 5 |
| Display | LED Digital Display | LED Digital Display | LCD Digital Display | LCD Digital Display | LCD Digital Display | SimilarNote 6 |
| OPERATING&STORAGE CONDITIONS | ||||||
| OperatingEnvironment | Temperature: 5°C | Temperature: 5°C | Temperature: 5°C | Temperature: 5°C | Temperature: 10°C | SimilarNote 7 |
| StorageEnvironment | Temperature: -25°C | Temperature: -25°C | Temperature: -25°C | Temperature: -25°C | Temperature: -20°C | SimilarNote 8 |
| COMPLIANCE STANDARDS | ||||||
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | Safety Engineering |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Safety Engineering |
| Home Use | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | Safety Engineering |
| Performance | IEC 80601-2-30 | IEC 80601-2-30 | IEC 80601-2-30 | IEC 80601-2-30 | IEC 80601-2-30 | Safety Engineering |
| Biocompatibility | All the patient | All the patient | All the patient | All the patient | All the patient | Safety Engineering |
| contracting materialsare evaluated by thebiocompatibilitystandard ISO10993 -5, -10. | contracting materialsare evaluated by thebiocompatibilitystandard ISO10993 -5, -10. | contracting materialsare evaluated by thebiocompatibilitystandard ISO10993 -5, -10. | contracting materialsare evaluated by thebiocompatibilitystandard ISO10993 -5, -10. | contracting materialsare evaluated by thebiocompatibilitystandard ISO10993 -5, -10. | ||
| Performance | ANSI/AAMI/ISO81060-2 | ANSI/AAMI/ISO81060-2 | ANSI/AAMI/ISO81060-2 | ANSI/AAMI/ISO81060-2 | ANSI/AAMI/ISO81060-2 | SE |
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K222887 510(k) Summary
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K222887 510(k) Summary
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K222887 510(k) Summary
Note 1 and 2
The Measuring Range and Accuracy 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 Measuring Range and Acuracy of proposed device they are both compliance with IEC 8001 -2-30 Standard Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.
Note 3
The Menory Size of proposed device and predication is clearly indicated in user manual and outer carton. Therefore, this officence will not result in any safety and effectiveness issue of the proposed device.
Note 4
The Cuti Circumference of proposed device is complance with EC 8060 -2-30 Standard,this difference will not result in any safety and effectivers issue of the proposed device.
Note 5 and Note 6
The Power Battery and Display of proposed device are compliance with IEC 60601-2-30 Standard.these difference will not realt in any safety and effectiveness issue of the proposed device.
Note 7 and Note 8
The Temperature, Relative Humidty and Atmospheric pressure of Operation and storage environment of subject devices is difference with predicate
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device,and they are both compliance with IEC 60601-1-11 standard,it will not raise any safety or effectiveness issue.
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8.Subject Devices Different Table
| model | FDBP-A7BL | FDBP-A8BL | FDBP-A7B | FDBP-A8B |
|---|---|---|---|---|
| Powersource | Rechargeable 3.7V lithiumbattery/USB 5V | Rechargeable 3.7V lithiumbattery/USB 5V | 4* AAA battery/USB 5V | 4* AAA battery/USB 5V |
| Number of keys | Three | Three | Three | Three |
| Display module | LED (No backlight) | LED (No backlight) | LED (No backlight) | LED (No backlight) |
| Intended Use andindications for Use | See chapter 7 | Same | Same | Same |
| Performance Specification | See chapter 7 | Same | Same | Same |
| OPERATING&STORANECONDITIONS | See chapter 7 | Same | Same | Same |
| MeasuringMethod | See chapter 7 | Same | Same | Same |
| COMPLIANCESTANDARDS | See chapter 7 | Same | Same | Same |
FDBP-Axyy
"x"= 7, 8, 9, 10"yy"=L, B, BL, T, LT,BT, BLT or blank.
"x" 7, 9 are identical except the display, "x" 8, 10 are identical except the display.
"x" 7, 8 use the LED display, "x" 9, 10 use the LCD display.
"tyy" had "L" mean the device use the lithium battery to offer the power. If not, mean use the internal circuit no charging carcuit.
"yy" had "B" mean the device had Bluetooth and Wifi function. If not, mean no this function.
"yy" had "T" mean no setting button, only memory and start/stop button. If not, mean had an extra settingsbutton.
- All models can use USB cable to power. If it is a lithing batter the power provided by the USB cable can only charge the lithing battle one one one one one over will not work properly during the charging process. If tis a 4* A A battery devided by the USB cable will power the device and the device and the never an work nomally.
| Model | FDBP-A7BT | FDBP-A8BT | FDBP-A8BLT | FDBP-A7BLT |
|---|---|---|---|---|
| Power | 4*AAA battery | 4*AAA battery | Rechargeable 3.7V lithium | Rechargeable 3.7V lithium |
| source | /USB 5V | /USB 5V | battery/USB 5V | battery/USB 5V |
| Number of keys | Two | Two | Two | Two |
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K222887 510(k) Summary
| Display module | LED (No backlight) | LED (No backlight) | LED (No backlight) | LED (No backlight) |
|---|---|---|---|---|
| Intended Use andindications for Use | See chapter 7 | Same | Same | Same |
| Performance Specification | See chapter 7 | Same | Same | |
| OPERATING&STORANECONDITIONS | See chapter 7 | Same | Same | Same |
| MeasuringMethod | See chapter 7 | Same | Same | |
| COMPLIANCESTANDARDS | See chapter 7 | Same | Same |
FDBP-Axyy
"x"= 7, 8, 9, 10"yy"=L, B, BL, T, LT,BT, BLT or blank.
"x" 7, 9 are identical except the display, "x" 8, 10 are identical except the display.
"x" 7, 8 use the LED display, "x" 9, 10 use the LCD display.
"tyy" had "L" mean the device use the lithium battery to offer the power. If not, mean use the internal circuit no charging circuit.
"yy" had "B" mean the device had Bluetooth and Wifi function. If not, mean no this function.
"yy" had "T" mean no setting button, only memory and start/stop button. If not, mean had an extra settingsbutton.
- All models can use USB cable to power. If it is a lithing battery device, the USB cable can only charge the lithing battle covice will not work properly during the charging process. If tis a 4* AA battery devided by the USB cable will power the device and the device and the never an work nomally.
| Model | FDBP-A10BL | FDBP-A9BL | FDBP-A9B | FDBP-A10B |
|---|---|---|---|---|
| Powersource | Rechargeable 3.7V lithiumbattery/USB 5V | Rechargeable 3.7V lithiumbattery/USB 5V | 4*AAA battery/USB 5V | 4*AAA battery/USB 5V |
| Number of keys | Three | Three | Three | Three |
| Display module | LCD (backlight) | LCD (backlight) | LCD (backlight) | LCD (backlight) |
| Intended Use andindications for Use | See chapter 7 | Same | Same | Same |
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| Performance Specification | See chapter 7 | Same | Same | Same |
|---|---|---|---|---|
| OPERATING&STORANECONDITIONS | See chapter 7 | Same | Same | Same |
| MeasuringMethod | See chapter 7 | Same | Same | Same |
| COMPLIANCESTANDARDS | See chapter 7 | Same | Same | Same |
FDBP-Axyy
"x"= 7, 8, 9, 10"yy"=L, B, BL, T, LT,BT, BLT or blank.
"x" 7, 9 are identical except the display, "x" 8, 10 are identical except the display.
"x" 7, 8 use the LED display, "x" 9, 10 use the LCD display.
"tyy" had "L" mean the device use the lithium battery to offer the power. If not, mean use the internal circuit no charging circuit
"yy" had "B" mean the device had Bluetooth and Wifi function. If not, mean no this function.
"yy" had "T" mean no setting button, only memory and start/stop button. If not, mean had an extra settingsbutton.
- All models can use USB cable to power. If it is a lithing batter the power provided by the USB cable can only charge the lithing battle one one one one one over will not work properly during the charging process. If t is a 4* AA battery devided by the USB cable will power the device and the device and work nomally.
| Model | FDBP-A10BT | FDBP-A98T | FDBP-A9BLT | FDBP-A10BLT |
|---|---|---|---|---|
| Powersource | 4*AAA battery/USB 5V | 4* AAA battery/USB 5V | Rechargeable 3.7V lithiumbattery/USB 5V | Rechargeable 3.7V lithiumbattery/USB 5V |
| Number of keys | Two | Two | Two | Two |
| Display module | LCD (backlight) | LCD (backlight) | LCD (backlight) | LCD (backlight) |
| Intended Use andindications for Use | See chapter 7 | Same | Same | Same |
| Performance Specification | See chapter 7 | Same | Same | Same |
| OPERATING&STORANECONDITIONS | See chapter 7 | Same | Same | Same |
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| MeasuringMethod | See chapter 7 | Same | Same | Same |
|---|---|---|---|---|
| COMPLIANCESTANDARDS | See chapter 7 | Same | Same | Same |
FDBP-Axyy
"x"= 7, 8, 9, 10"yy"=L, B, BL, T, LT,BT, BLT or blank.
"x" 7, 9 are identical except the display, "x" 8, 10 are identical except the display.
"x" 7, 8 use the LED display, "x" 9, 10 use the LCD display.
"tyy" had "L" mean the device use the lithium battery to offer the power. If not, mean use the internal circuit no charging circuit.
"yy" had "B" mean the device had Bluetooth and Wifi function. If not, mean no this function.
"yy" had "T" mean no setting button, only memory and start/stop button. If not, mean had an extra settingsbutton.
- All models can use USB cable to pover. It is a lithing battery device, the power provided by the USB cable can only charge the lithing battlery, and the device will not work properly during the charging process. If ti s a 4* A A battery devided by the USB cable will power the device and the device and the device and work nomally.
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9. Performance
Testing:
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
9.1 Non-Clinical Data:
The following performance data were provided in support of the substantial equivalence determination.
9.2 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
9.3 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.
9.4 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, IEC 80601-2-30: 2018 Medical electrical equipment — Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers standards for performance effectiveness.
9.5 Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was 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.
9.6 Usability Testing
Usability testing according to following FDA Guidance 1757, Applying Human Factors and Usability Engineering to Optimize Medical Device Design, was conducted.
9.7 Clinical data:
Clinical testing is conducted per ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type.
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K222887 510(k) Summary
Based on the same product principle, and the clinical validation data on the FDBP-A7BL can cover all the models included in this submission.
In this clinical study, 85 patients(43 males) participated in the clinical study. Same arm sequentialmethod was adopted during the clinical study. The manual MercurySphygmomanometer was used as a reference sphygmomanometer. All the subjectswere volunter to take part in the clinical study, all the subjects completed theclinical study without any AE or side-effect. The results showed the accuracy of thesubject device is within acceptable scope specified in ISO 81060-2.
9.8 Summary
Based on the non-clinical and clinical performance as documented in the device devices were found to have a safety and effectiveness profile that is similar to the predicate device.
10. 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 KD-5810, KD5811, KD-5920TL and KD-552(K210770) 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
§ 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).