(144 days)
The Fully Automatic Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age.
The Arm-Type series use an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg. An irregular heartbeats rhythm is defined as a rhythm that varies by 25% less or more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure. AND, these subject device can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the "JOYTECH healthcare" APP through the embed a 2.4GHz BLE module that allow users to connect with nearby BT receiving terminal. Once measurement is over, the LCD of the device displays results. And the device will start to transmit data to the pair-up terminal automatically. This app is only intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate, does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by the user.
The provided text is a 510(k) Summary for a blood pressure monitor and does not contain detailed information about a specific study proving the device meets acceptance criteria. Instead, it states that clinical testing was not required because the device is considered equivalent to a previously cleared predicate device (Joytech DBP-1307, K173024) due to having the same core algorithm and cuff circumference.
However, the summary does list the standards that were utilized for testing to demonstrate safety and effectiveness. The most relevant standard for performance claims is ISO 81060-2:2013, which covers the clinical validation of automated non-invasive sphygmomanometers. The document states that the clinical validation was performed according to ISO 81060-2:2013 for the predicate device.
Therefore, the information I can extract regarding the acceptance criteria and a study demonstrating compliance is limited. I will present the information available based on the provided text, primarily focusing on what ISO 81060-2:2013 generally entails for blood pressure monitors, as the detailed study specific to this device is not present but is referenced through the predicate.
Here's the breakdown of the information requested, based on the provided text and general knowledge of ISO 81060-2:2013:
1. Table of acceptance criteria and the reported device performance
Since the document states "clinical testing was not required to establish equivalency of the device" because it is based on the predicate device's validation per ISO 81060-2:2013, the acceptance criteria and performance would be those defined by this standard. The document does provide performance specifications for the device, which are implicitly stated to meet the requirements of the standards listed, including ISO 81060-2:2013 via the predicate.
| Acceptance Criteria (from ISO 81060-2:2013 for clinical validation) | Reported Device Performance (from this device's specifications) |
|---|---|
| Systolic Blood Pressure (SBP) & Diastolic Blood Pressure (DBP) Accuracy (mean difference): Mean difference between device measurement and auscultatory reference method for SBP and DBP should be ≤ ±5 mmHg. | Static Pressure: ±3 mmHg |
| Systolic Blood Pressure (SBP) & Diastolic Blood Pressure (DBP) Accuracy (standard deviation): Standard deviation of the differences should be ≤ 8 mmHg. | Not explicitly stated with comparison to auscultatory reference, but implied to meet standard through static pressure accuracy. |
| Pulse Rate Accuracy: Accuracy within a specified range (typically ±5% or ±5 beats/min) | Pulse: ±5% |
| Maximum Cuff Pressure: Safety limit for inflation pressure | 300 mmHg |
2. Sample size used for the test set and the data provenance
The document explicitly states that "clinical testing was not required" for the new device because it is considered equivalent to the predicate device K173024 (Joytech DBP-1307), which had undergone clinical validation.
- Test Set Sample Size: Not provided in the document for the new device. For the predicate device, a clinical validation study adhering to ISO 81060-2:2013 would typically require a minimum of 85 subjects with specific distributions of age, sex, and blood pressure ranges.
- Data Provenance: Not provided for the new device. For the predicate device's clinical validation, it would have been prospective clinical data. The country of origin is not specified but is typically mentioned in clinical study reports.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information pertains to the clinical validation of the predicate device (DBP-1307, K173024) under ISO 81060-2:2013.
- Number of Experts: For ISO 81060-2:2013, ground truth is typically established by three trained observers taking sequential auscultatory measurements according to a defined protocol.
- Qualifications of Experts: The standard requires trained observers who are blinded to the device readings and are experienced in taking auscultatory blood pressure measurements. Specific medical qualifications (e.g., cardiologist, certified BP measurement technician) are usually detailed in the study protocol. The document does not specify their exact qualifications but implies they meet the standard's requirements.
4. Adjudication method for the test set
For the clinical validation of the predicate device under ISO 81060-2:2013:
- Adjudication Method: The standard specifies a method where the three observers conduct measurements. The ground truth (reference blood pressure) is derived from the average of the two closest readings among the three observers, or if there's a significant disagreement, specific rules are followed for exclusion or further measurement. This is a form of consensus-based ground truth.
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
- MRMC Study: No, an MRMC comparative effectiveness study is not applicable to this device. This is a standalone blood pressure monitor, not an AI-assisted diagnostic imaging device requiring human reader interpretation. The device provides automatic blood pressure readings.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the fundamental performance of the blood pressure measurement algorithm is evaluated in standalone mode as part of the clinical validation process (for the predicate device). The device itself performs the measurement and displays the result without direct human interpretation of waveforms for diagnosis. While a human initiates the measurement and reads the display, the accuracy assessment is of the device's algorithmic output against a reference.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the clinical validation of the predicate device (following ISO 81060-2:2013), the ground truth for blood pressure measurements is established by expert auscultatory measurements (Korotkoff sounds) by trained observers, as stated in point 3. This is a form of expert consensus derived from a gold standard manual method.
8. The sample size for the training set
- Training Set Sample Size: Not applicable/Not provided. The document describes a medical device leveraging an established oscillometric method for blood pressure measurement, not a machine learning or AI model that requires a distinct training set in the conventional sense. The "core algorithm" of the device is validated against the predicate and established standards, rather than "trained" on a dataset in the way an AI model would be.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As mentioned, this is not an AI/ML device that uses a distinct training set. The underlying oscillometric algorithm's principles are based on known physiological responses and signal processing, not on labeled training data. The validation of its performance (for the predicate device) uses auscultatory reference measurements as ground truth.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
August 3, 2020
Joytech Healthcare Co., Ltd Ren Yunhua General Manager No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City, Hangzhou, Zhejiang, China 311100
Re: K200649
Trade/Device Name: Arm-Type Fully Automatic Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 28, 2020 Received: July 6, 2020
Dear Ren Yunhua:
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.
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
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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,
LT 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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510(k) Summary
The assigned 510(k) number is:
2.1 Subiectter's Identification:
Name: JOYTECH Healthcare Co., Ltd.
Add.: No. 365. Wuzhou Road, Yuhang Economic Development Zone, Hangzhou,311100, China.
Contact Person: Yunhua Ren
Phone: +86-571-81957767
Fax: +86-571-81957750
Email: renyh@sejoy.com
2.2 Name of the Device:
Trade Name: Arm-type Fully Automatic Digital Blood Pressure Monitor
Including: DBP-1307b,DBP-1305b,DBP-1318b,DBP-1332b,DBP-1333b,DBP-1257b,
DBP-1358b,DBP-1359b
Common Name: Blood Pressure Monitor
Classification name: Non-invasive blood pressure measurement System
21 CFR 870-1130, Class II, 74-DXN.
2.3 Classification Information:
Regulation Number: 870.1130
Product Code: DXN
Device Class: II
Panel: 74 Cardiovascular
2.4 Predicate Device Information:
The Arm-Type Fully Automatic Digital Blood Pressure Monitors are substantially equivalent to the following devices:
| 510(k) number | model | Product code | Manufacturer |
|---|---|---|---|
| K173024 | DBP-1307 | DXN | JOYTECH HEALTHCARE CO., LTD. |
| K161886 | H-BP100SBP | DXN | Guangdong Transtek Medical ElectronicsCo.,Ltd |
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2.5 Device Description:
The Arm-Type series use an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg.
An irregular heartbeats rhythm is defined as a rhythm that varies by 25% less or more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.
AND, these subject device can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the "JOYTECH healthcare" APP through the embed a 2.4GHz BLE module that allow users to connect with nearby BT receiving terminal. Once measurement is over, the LCD of the device displays results. And the device will start to transmit data to the pair-up terminal automatically. This app is only intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate, does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by the user.
| FeaturesModels | A | B | C | D | E | F | G | H | I (mm) | J (cm) | K(mm) | L | M | N | O |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DBP-1307b | Y | Y | 60 Memories×2 | Y | Y | Y | N | Y | 166×114× 72 | 22-36 | 102.1×68.9 | O | O | N | Y |
| DBP-1305b | Y | Y | 60 Memories×2 | Y | N | Y | Y | Y | 166×114×72 | 22-36 | 84.1×55.1 | O | O | N | Y |
| DBP-1318b | Y | Y | 60 Memories×2 | Y | N | Y | Y | Y | 139× 88× 43 | 22-36 | 66×43 | N | N | N | Y |
| DBP-1319b | Y | Y | 60 Memories×2 | Y | N | Y | Y | Y | 166×114× 72 | 22-36 | 102×68.9 | O | O | N | Y |
| DBP-1332b | Y | Y | 60 Memories×2 | Y | N | Y | Y | Y | 148×100× 56 | 22-36 | 84.1×55.1 | O | O | N | Y |
| DBP-1333b | Y | Y | 60 Memories×2 | Y | N | Y | Y | Y | 164×111× 60 | 22-36 | 102.1×68.9 | O | O | N | Y |
| DBP-1257b | Y | Y | 120Memories×1 | Y | N | Y | N | N | 131×102×44 | 22-36 | 45 × 30 | N | N | N | Y |
| DBP-1358b | Y | Y | 60 Memories×2 | Y | N | Y | Y | Y | 131×102×44 | 22-36 | 45.7 × 62 | N | O | N | Y |
| DBP-1359b | Y | Y | 60 Memories×2 | Y | N | Y | Y | Y | 131×102×44 | 22-36 | 69 × 67 | O | O | N | Y |
The detail comparisons among the Arm-Type series are listed in table below:
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A = Powered by 4 AA size batteries B= Powered by AC adaptor C = Memory Size D = Time & Date E = Results Average in Three way F = WHO (World Health Organization) Classification Indicator G = Last 3 Results Average H = Irregular Heartbeat Detection I = Outside Demission (L x W x H in unit mm) J = Cuff Size K = LCD Size (Viewing Area in unit mm) L = LCD Backlight M= Voice N=Music O=Bluetooth Function Y= Yes N= No O= Optional function depending on clients' needs
The devices are all designed and manufactured according to AAMI/ANSI/IEC80601-2-30:2009/A1:2013, medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.
2.6 Intended Use:
The Fully Automatic Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age.
| Comparison item | Subject device in present application | Predicate device 1K173024(model:DBP-1307) | Predicate device 2K161886(model:H-BP100SBP) | Comparison result / Explanation |
|---|---|---|---|---|
| The trade name | Arm-type Fully Automatic Blood Pressure Monitor | Arm-type Fully Automatic Digital Blood Pressure Monitor | Welch Allyn Blood Pressure Device | / |
| Recommended classification on regulation | 21CFR 870.1130, Noninvasive Blood Pressure Measurement System | 21CFR 870.1130, Noninvasive Blood Pressure Measurement System | 21CFR 870.1130, Noninvasive Blood Pressure Measurement System | Identical |
| Regulatory class | II | II | II | Identical |
| Panel | 74 Cardiovascular | 74 Cardiovascular | 74 Cardiovascular | Identical |
| Product code | DXN | DXN | DXN | Identical |
| Intended | The Fully | The Fully Automatic | Welch Allyn Blood | Similar |
| 2.7 Comparison of Technological Characteristics with predicate device: | ||||
|---|---|---|---|---|
| use | AutomaticBlood | BloodPressure | Pressure Device H- | |
| Pressure Monitors | Monitors are | BP100SBP is digital | ||
| are intended to | intended to measure | monitor intended for | ||
| measure blood | blood pressure | use in measuring | ||
| pressure (systolic | (systolic and | blood pressure and | ||
| and diastolic) and | diastolic) and pulse | heartbeat rate in adult | ||
| pulse rate of adults | rate of adults and | patient population | ||
| and adolescents age | adolescents age 12 | with arm | ||
| 12 through 21 years | through 21 years of | circumference ranging | ||
| of age. | age. | from 15 cm to 54 cm(about 6-21 inches). | ||
| These devices detect | ||||
| the appearance of | ||||
| irregular heartbeats | ||||
| during measurement | ||||
| and give a warning | ||||
| signal with readings. | ||||
| Measuringprinciple | Oscillometricmethod | Oscillometricmethod | Oscillometric method | Identical |
| Cufflocation | Upper arm | Upper arm | Upper arm | Identical |
| Performance Attributes | ||||
| Measuringrange | Systolic Pressure:60mmHg ~ 280mmHg | Systolic Pressure:60mmHg ~ 280mmHg | Systolic Pressure:50mmHg ~ 260mmHg | Identical aspredicatedevice 1 |
| Diastolic Pressure:30mmHg ~ 200mmHg | Diastolic Pressure:30mmHg ~ 200mmHg | Diastolic Pressure:25mmHg ~ 220mmHg | ||
| Pulse:30~180Beats/Minute | Pulse:30~180Beats/Minute | Pulse:40~199Beats/Minute | ||
| Max cuffpressure | 300mmHg | 300mmHg | 300mmHg | Identical |
| Accuracy | Static Pressure: ±3mmHgPulse: ± 5% | Static Pressure: ±3mmHgPulse: ± 5% | Pressure: ± 0.4kPa(3mmHg)Pulse value: ± 5% | Identical |
| Physical Attributes | ||||
| BloodPressurecategories | WHO classification | WHO classification | None | Identical |
| Displaycomponent | 1.Device LCD;2.iOS device orAndroid device | Device LCD | 1.Device LCD;2.iOS device orAndroid device | Identical aspredicatedevice 2 |
| Inflation | By air pump | By air pump | By air pump | Identical |
| Pressurerelease | By solenoid valve | By solenoid valve | By solenoid valve | Identical |
| Cuffcircumference | Fits armcircumference 22-36 | Fits armcircumference 22-36 | The three preformedcuff units, which are | Identical aspredicatedevice 1 |
| BluetoothModuleversion | v5.0 | None | circumferencebetween 15-24cm, 22-42cm and 40-54cm tomeet differentPopulation's need.V4.0 | Different |
| Systemrequirement | Bluetooth 4.0 orlater/Android 5.0 or later/IOS 9.0 or later | None | Platform whichsupport Bluetooth 4.0technology | Similar |
| Bluetoothfeatures | Transmit data tosmart phone viaBluetooth | None | Transmit data tosmart phone viaBluetooth | Identical aspredicatedevice 2 |
| PCB orElectricalscheme | BP07BT PCB | BP07 PCB | Unknow | Similar |
| Apps on smart deviceFuntion onAPP | Storage test result/Announce testresult/Readmemories in App/Empty memories inapp/ Draw curve/Set the personalinformation in app | None | Unknow | Different,The changein thespecificationisdocumented,thecybersecurity risk hasbeenconsideredand theoverallresidual riskisacceptable.The changedoes notaffect theintended useor thefundamentalscientifictechnology. |
| Environmental | ||||
| OperatingTemp. &humidity | Temp.: 10℃ | Temp.: 10℃ | Temp.:5℃~40℃Relative humidity85%RH | Identical aspredicatedevice 1 |
| 700hPa~1060hPa | 700hPa~1060hPa | pressure:86kPa to 106kPa | ||
| StorageTemp.&humidity | Temp.: -25°C~55°CHumidity:≤90% RH | Temp.: -25°C~70°CHumidity:≤90% RH | Temp.:-20°C~60℃Relative Humidity:10% RH - 93% RHAtmosphericPressure: 50kPa to106 kPa | Similar |
| Electrical Power | ||||
| Supplypowersource | For models DBP-1318b,DBP-1257b,DBP-1358b,DBP-1359b:4x1.5V AAA batteryor Medical ACadapter (DC 6V,600mA)(recommended, not provided)For other models:4x1.5V AA batteryor Medical ACadapter (DC 6V,600mA)(recommended, not provided) | 4x1.5V AA batteryor Medical AC adapter (DC 6V, 600mA)(recommended, not provided) | powered by four AA alkaline batteries or by a AC adapter(DC 6V,1A)(not include) | EquivalentThedifferent inthespecificationisdocumentedand tested |
| Other Attributes | ||||
| Sterilization | Not applicable | Not applicable | Not applicable | Identical |
| Material | PC and ABS for thecase and plastic foilfor the labels of thedevice.Biocompatiblematerials are usedfor the applied parts(Cuff containing ainteral bladder) | PC and ABS for thecase and plastic foilfor the labels of thedevice.Biocompatiblematerials are usedfor the applied parts(Cuff containing ainteral bladder) | ABS is used to outerhousing of the mainunit. | Identical aspredicatedevice 1 |
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Image /page/6/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. To the right of the word JOYTECH is two Chinese characters.
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Image /page/7/Picture/0 description: The image shows the logo for JOYTEC-I. The logo is in blue and red. The text is in a sans-serif font. The logo is simple and modern.
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Image /page/8/Picture/0 description: The image shows the text 'K200649' in a simple, sans-serif font. The text is black against a white background. The letters and numbers are evenly spaced and clearly legible.
2.8. Performance Data:
Testing information demonstrating safety and effectiveness of the device in the intended environment of use is supported by testing that was conducted.
The following testing was conducted to prove safety and effectiveness as well as substantial equivalence to the predicate devices.
The following National and International Standards were utilized for testing the subject
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device.
Electrical Safety and performance requirements:
- AAMI ● A2:2010/(R)2012 Medical Electrical Equipment.
- IEC 80601-2-30:2009(First Edition) and A1:2013, medical electrical equipment part 2-● 30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.
Home-used medical equipment requirements and environmental test:
-
IEC 60601-1-11:2015 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
Electromagnetic compatibility requirements: -
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
-
EN300328:Electromagnetic compatibility and Radio spectrum Matters (ERM); . Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques;
-
ETSI Radio spectrum Matters(ERM);ElectroMagnetic Compatibility (EMC)standard for radio equipment and services;Part 1:Common technical requirements;
-
ETSI EN 301489-17: Electromagnetic compatibility and Radio spectrum Matters (ERM);ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions or Broadband Data Transmission Systems;
Bio-compatibility Evaluation for patient contacting components:
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for ● irritation and skin sensitization
FCC Test
- FCC Part15 Subpart C
- RF Exposure Evaluation
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Guidance Document:
The software/firmware verification and validation was provided in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
The test result all meet or exceed the requirement of these standards.
2.10. Discussion of Clinical Tests Performed:
Clinical Validation:
- ISO81060-2:2013 Non-invasive sphygmomanometers -- Part 2: Clinical validation of automated measurement type.
Based on the core algorithm and same cuff circumference are completely equivalent to the Predicate device of Joytech, DBP-1307 (K Number: K173024), clinical testing was not required to establish equivalency of the device.
2.11. Conclusions:
This submitted Arm-type series have been found to be substantially equivalent to the predicate device. Based on the information provided in this submission, differences between the subject device and predicate device have been tested and documented, it has been demonstrated that the subject devices are as safe and effective as the predicate device.
In the other words, the difference between the subject and the predicate devices does not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device, and the new models as mentioned on this submission are considered substantial equivalent to the predicate devices.
--- End of this 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).