(156 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Level (from Predicate Device/Standards) | Reported Device Performance (FDBP A Series) | Met? |
|---|---|---|---|
| Measuring Range | Pressure: 0~280 mmHg | Pressure: 0~280 mmHg | Yes |
| Pulse: 40~199 beats/minute | Pulse: 40~200 beats/minute | Yes | |
| SYS (systolic pressure): 60-255 mmHg | SYS (systolic pressure): 60-255 mmHg | Yes | |
| DIA (diastolic pressure): 40-200 mmHg | DIA (diastolic pressure): 40-200 mmHg | Yes | |
| Pressure Resolution | 1 mmHg or 0.1 kPa | 1 mmHg or 0.1 kPa | Yes |
| Accuracy | Pressure: ±3 mmHg (±0.4 kPa) | Pressure: ±3 mmHg (±0.4 kPa) | Yes |
| Pulse: ±5 % | Pulse: ±5 % | Yes | |
| Performance Standard | ANSI/AAMI/ISO 81060-2 | Complies with ANSI/AAMI/ISO 81060-2 | Yes |
| Electrical Safety Standard | IEC 60601-1 | Complies with IEC 60601-1 | Yes |
| EMC Standard | IEC 60601-1-2 | Complies with IEC 60601-1-2 | Yes |
| Home Use Standard | IEC 60601-1-11 | Complies with IEC 60601-1-11 | Yes |
| Performance Standard | IEC 80601-2-30 | Complies with IEC 80601-2-30 | Yes |
| Biocompatibility Standard | ISO 10993-5, -10 | Complies with ISO 10993-5, -10 | Yes |
Study Proving Acceptance Criteria:
The studies conducted for the FDBP A Series Upper Arm Blood Pressure Monitor are divided into "Non-Clinical Data" and "Clinical Data."
2. Sample Size Used for the Test Set and Data Provenance:
- Non-Clinical Data:
- The document does not explicitly state the sample size for individual biocompatibility, electrical safety, EMC, or bench testing. However, it indicates these tests were conducted on "all the modules and accessories in the system" and "all the patient contracting materials."
- Data Provenance: Not specified, but given the manufacturer is Famidoc Technology Company Limited (China), it's highly probable the testing was conducted in China or by labs contracted by the Chinese manufacturer. The document doesn't specify if it's retrospective or prospective for non-clinical testing.
- Clinical Data:
- The document states: "Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers -Part 2: Clinical validation of automated measurement type."
- ISO 81060-2: 2013 typically requires a specific number of subjects for clinical validation. While the exact number is not provided in this document, the standard generally mandates a minimum of 85 subjects for validation in a mixed population.
- Data Provenance: Not explicitly stated, but likely from a clinical study conducted either within China or a region where compliance with ISO 81060-2 is standard. The document doesn't specify if it's retrospective or prospective, but clinical validation studies are inherently prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- For the clinical validation (per ISO 81060-2):
- ISO 81060-2 requires that the reference blood pressure measurements (the "ground truth") be obtained by at least two trained observers using a mercury sphygmomanometer or an equivalent validated reference device.
- Qualifications of Experts: These observers must be specifically trained and certified to perform accurate auscultatory blood pressure measurements, adhering to strict protocols outlined in the standard. The document does not provide specific details on the individual qualifications of the "two trained observers" used in this particular study, but it is a prerequisite of the standard cited.
4. Adjudication Method for the Test Set:
- For the clinical validation (per ISO 81060-2):
- The standard dictates a specific methodology where simultaneous (or near-simultaneous) measurements are taken by the device under test and the two trained observers. The average of the two observers' measurements typically serves as the reference (ground truth). Discrepancies between the observers' measurements might trigger re-measurements or specific rules for reconciliation, but a formal "adjudication" in the sense of a third expert resolving disagreements is not always explicitly a primary step unless the initial agreement criteria are not met. The document does not specify the exact adjudication method (e.g., 2+1, 3+1) beyond compliance with ISO 81060-2.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance:
- Not applicable. This device is an automated blood pressure monitor for direct blood pressure measurement, not an AI-assisted diagnostic imaging device or an interpretation tool involving human "readers." Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this type of medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, this is a standalone device. The FDBP A Series Upper Arm Blood Pressure Monitor is an automated device designed to measure blood pressure without human intervention in the measurement process (once the cuff is applied and the device activated). The "algorithm only" performance is the core function of such a device. The clinical validation conducted under ISO 81060-2 is precisely a standalone performance evaluation against a human-read auscultatory reference.
7. The Type of Ground Truth Used:
- Expert Consensus (Auscultatory Reference): For the clinical validation, the ground truth for blood pressure measurements is established by trained human observers using the auscultatory method (typically with a mercury sphygmomanometer or a validated equivalent), following the protocols defined in ISO 81060-2. This is considered an "expert consensus" in the context of blood pressure measurement.
8. The Sample Size for the Training Set:
- Not applicable/Not explicitly stated. As an automated blood pressure monitor, the device's core functionality relies on a pre-defined oscillometric algorithm rather than a "training set" in the context of machine learning or AI models. While the algorithm itself would have been developed and refined using data (which could be loosely considered "training"), the document does not provide details on such a training dataset or its size. The primary validation focuses on its clinical performance against expert-derived ground truth.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not explicitly stated. Similar to point 8, the document does not detail a "training set" for an AI algorithm. If an algorithm development process involved data, the ground truth for that development would likely have been established through a combination of simulated data, data from calibration devices, and potentially earlier validation studies against auscultatory measurements. However, the document does not provide these specifics.
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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.
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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 (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
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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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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, ChanganTown 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 |
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- 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.
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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 ofComparison | Subject Devices | Predicate Device | Verdoc | ||||
|---|---|---|---|---|---|---|---|
| Device Name | Upper Arm Blood Pressure Monitor | AGE Automatic UpperArm 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 UpperArm Blood PressureMonitor is intended tomeasure the bloodpressure and pulse rateof adult at household ormedical center. (Notsuitable for neonate,pregnancy or pre-eclampsia). with thecuff around the leftupper arm according tothe instruction in theuser's guide manual. | FDBP A series UpperArm Blood PressureMonitor is intended tomeasure the bloodpressure and pulse rateof adult at household ormedical center. (Notsuitable for neonate,pregnancy or pre-eclampsia). with thecuff around the leftupper arm according tothe instruction in theuser's guide manual. | FDBP A series Upper ArmBlood Pressure Monitor isintended to measure theblood pressure and pulserate of adult at householdor medical center. (Notsuitable for neonate,pregnancy or pre-eclampsia). with the cuffaround the left upper armaccording to theinstruction in the user'sguide manual. | FDBP A series UpperArm Blood PressureMonitor is intended tomeasure the bloodpressure and pulse rateof adult at household ormedical center. (Notsuitable for neonate,pregnancy or pre-eclampsia). with thecuff around the leftupper arm according tothe instruction in theuser's guide manual. | AGE Automatic UpperArm Blood PressureMonitor is intended foruse by medicalprofessionals or at hometo monitor and displaydiastolic, systolic bloodpressure and pulse rateon adult each time, withthe cuff around the leftupper arm according tothe instruction in theuser's guide manual. | SE | |
| Performance Specification | |||||||
| MeasuringMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod | SE | |
| MeasuringRange | Pressure: 0 | Pressure: 0 | Pressure: 0 | Pressure: 0 | Pressure: 0 | SE | |
| 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 ( $±0.4$ 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:$±3$ mmHgPulse: $±5$ % | SE | |
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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.
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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".
| 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 | 2x90 sets record | SimilarNote 1 |
| Indicators | Blood Pressure (Systolicand Diastolic), Pulse,Date, Time, WHO BPClassification IndicatingBar, Low Battery Icon,Heart Icon, MemoryRecord Number | Blood Pressure (Systolicand Diastolic), Pulse,Date, Time, WHO BPClassification IndicatingBar, Low Battery Icon,Heart Icon, MemoryRecord Number | Blood Pressure (Systolicand Diastolic), Pulse, Date,Time, WHO BPClassification IndicatingBar, Low Battery Icon,Heart Icon, MemoryRecord Number | Blood Pressure (Systolicand Diastolic), Pulse,Date, Time, WHO BPClassification IndicatingBar, Low Battery Icon,Heart Icon, MemoryRecord Number | Blood Pressure (Systolicand Diastolic), Pulse,Date, Time, WHO BPClassification IndicatingBar, Low Battery Icon,Heart Icon, MemoryRecord Number | SE |
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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.
| CuffCircumference | 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 1.5Valkaline batteries or DCAdaputer) | DC 6V (4xAA 1.5Valkaline batteries or DCAdaputer) | DC 6V (4xAAA 1.5V alkalinebatteries or DC Adaputer) | DC 6V (4xAAA 1.5Valkaline batteries or DCAdaputer) | DC 6V (4xAA 1.5V alkalinebatteries ) | SimilarNote 2 |
| Display | LCD Digital Display | LCD Digital Display | LCD Digital Display | LED Digital Display | LCD Digital Display | SimilarNote 3 |
| OPERATING&STORAGE CONDITIONS | ||||||
| OperatingEnvironment | Temperature:5 °C-40 °C | Temperature:5 °C -40 °C | Temperature:5 °C -40 °C | Temperature:5 °C -40 °C | Temperature:5°C ~ 40°CHumidity: 15 | SimilarNote 4 |
| Humidity:15%RH-90%RH,No condensationAtmospheric pressure70kPa~106kPa | Humidity :15%RH-90%RH,No condensationAtmospheric pressure70kPa~106kPa | Humidity:15%RH-90%RH,No condensationAtmospheric pressure70kPa~106kPa | Humidity:15%RH-90%RH,No condensationAtmospheric pressure70kPa~106kPa |
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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.
| StorageEnvironment | Temperature:-25 °C-55 °CHumidity:15%RH-95%RH,No condensationAtmospheric pressure700hPa~1060hPa | Temperature:-25 °C-55 °CHumidity:15%RH-95%RH,No condensationAtmospheric pressure700hPa~1060hPa | Temperature:-25 °C-55 °CHumidity:15%RH-95%RH,No condensationAtmospheric pressure700hPa~1060hPa | Temperature:-25 °C-55 °CHumidity:15%RH-95%RH,No condensationAtmospheric pressure700hPa~1060hPa | Temperature:-20°C ~ +65°CHumidity: 10 | SimilarNote 5 |
|---|---|---|---|---|---|---|
| COMPLIANCE STANDARDS | ||||||
| Performance | ANSI/AAMI/ISO81060-2 | ANSI/AAMI/ISO81060-2 | ANSI/AAMI/ISO81060-2 | ANSI/AAMI/ISO81060-2 | ANSI/AAMI/ISO81060-2 | SE |
| Electrical Safety | IEC60601-1 | IEC60601-1 | IEC60601-1 | IEC60601-1 | IEC60601-1 | SE |
| EMC | IEC60601-1-2 | IEC60601-1-2 | IEC60601-1-2 | IEC60601-1-2 | IEC60601-1-2 | 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 | IEC80601-2-30 | IEC80601-2-30 | IEC80601-2-30 | IEC80601-2-30 | IEC80601-2-30 | SE |
| Biocompatibility | All the patientcontracting materialsare evaluated by thebiocompatibilitystandard ISO10993 -5, -10. | All the patientcontracting materialsare evaluated by thebiocompatibilitystandard ISO10993 -5, -10. | All the patientcontracting materialsare evaluated by thebiocompatibilitystandard ISO10993 -5, -10. | All the patientcontracting materialsare evaluated by thebiocompatibilitystandard ISO10993 -5, -10. | All the patientcontracting materialsare evaluated by thebiocompatibilitystandard ISO10993 -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.
§ 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).