(420 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor and does not mention any AI or ML components or capabilities. The performance studies are based on standard clinical accuracy testing according to ISO 81060-2.
No.
The device is intended to measure blood pressure, which is a diagnostic function, not a therapeutic one. Therapeutic devices are designed to treat or alleviate diseases or conditions.
Yes
Explanation: The device is an electronic blood pressure monitor intended to measure systolic and diastolic blood pressure and pulse, providing quantitative data that aids in the assessment and monitoring of a patient's health status, which is a key function of a diagnostic device.
No
The device description explicitly lists hardware components such as PCBA, crystal oscillator, pump, valve, enclose, LCD, and cuffs, indicating it is a physical device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: This device measures blood pressure and pulse rate by applying a cuff to the upper arm and using oscillation mensuration. This is a non-invasive measurement taken directly from the body, not from a specimen taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse on the upper arm, which is a direct physiological measurement, not an analysis of a biological sample.
Therefore, based on the provided information, this electronic blood pressure monitor is a non-invasive medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia)
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
Electronic blood pressure monitor, model: HTD6602US is a Noninvasive Blood Pressure Measurement System that is intended to measuring blood pressure through oscillation mensuration. The proposed device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited.
It measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The HTD6602US is small, portable and used in home or medical facilities environment. The Electronic blood pressure monitor consists of two parts: main unit and cuffs. The HTD6602US is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 22cm32cm and cuff of size 22cm42cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
over 12 years old
Intended User / Care Setting
household or medical facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The clinical accuracy test report and data analysis followed the requirements of the ISO 81060-2 Third Edition 2018-11.
Total subjects: 85
Male subjects: 38
Female subjects: 47
Age > 12: 100%
Arm circumference in the range of 22-27cm: 31.76%
Arm circumference in the range of 27-32cm: 23.53%
Arm circumference in the range of 32-37cm: 23.53%
Arm circumference in the range of 37-42cm: 21.18%
Arm circumference in the range of 22-24.5cm: 21.18%
Arm circumference in the range of 39.5-42cm: 11.76%
Subjects tested through the cuff with specified (22-32cm): 32.94%
Subjects tested through the cuff with specified (22-42cm): 67.06%
Systolic BP = 160mmHg: 12.94%
Systolic BP >=140mmHg: 30.59%
Diastolic BP = 100mmHg: 10.59%
Diastolic BP >= 85mmHg: 27.06%
Reference equipment used for measurements:
Name: Sphygmomanometer - Stethoscope health box
Model: A Type
Manufacturer: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Measuring Method: Auscultatory
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical accuracy testing
Sample Size: 85 subjects
Key Results: The test data showed the clinical accuracy of the subject device complied with the requirements of ISO 81060-2 Third Edition 2018-11.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 5, 2023
HeTaiDa Technology Co., Ltd. % You Yijie Manager Qimmiq Medical Consulting Service Co., Ltd. RM.406, Building C, Run Science Park, No.18 Shenzhou Road, Huangpu, Guangzhou, Guangdong 510663 China
Re: K223170
Trade/Device Name: Electronic Blood Pressure Monitor, model: HTD6602US Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 14, 2023 Received: November 14, 2023
Dear You Yijie:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
3
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,
Stephen C. Browning -S
LCDR 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
3
Indications for Use
510(k) Number (if known) K223170
Device Name
Electronic Blood Pressure Monitor, model: HTD6602US
Indications for Use (Describe)
This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia)
| 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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Section 5: 510(k) Summary
510(k) Number: K223170
1. Submitter's Information
Establishment Registration Information
Name: Hetaida Technology Co., Ltd.
Address: Room 801,802,803,804,901, 2# Building Scientific Research Center, Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town, Dongquan City, Guangdong Province Dongguan Guangdong, CN 523423.
Establishment registration number: 3017493034
Contact Person of applicant:
Name: Tom Chen
Address: Room 801,802,803,804,901, 2# Building Scientific Research Center, Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town, Dongguan City, Guangdong Province Dongguan Guangdong, CN 523423
TEL: +86-769-87036256
Email: tomchen@hetaida.com.cn
Correspondent (510(k) preparer) Information:
Name: You Yijie
Address: RM.406, Building C, Run Science Park, No.18 Shenzhou Road, Huangpu, Guangzhou, Guangdong 510663 P.R.China.
TEL: (+86)020-82245821
FAX: (+86)020-82245821
Email: jet.you@gimmiq-med.com
Date prepared: 11/15/2022
2. Device Information
Device Common Name: Noninvasive Blood Pressure Measurement System
Trade Name: Electronic blood pressure monitor
Model: HTD6602US
Classification name: Noninvasive Blood Pressure Measurement System
Review panel: Cardiovascular
Product code: DXN
5
Regulation Class: II Requlation Number: 870.1130
3. Predicate Device Information
| 510(k) submitter/holder: | Jiangsu Yuyue Medical Equipment & Supply Co., |
|---|---|
| Ltd. | |
| 510(K) Number: | K200939 |
| Trade Name: | Electronic blood pressure monitor |
| Model: | YE680B |
| Classification name: | Noninvasive Blood Pressure Measurement |
| System | |
| Review panel: | Cardiovascular |
| Product code: | DXN |
| Regulation Class: | II |
| Regulation Number: | 870.1130 |
4. Device description
Electronic blood pressure monitor, model: HTD6602US is a Noninvasive Blood Pressure Measurement System that is intended to measuring blood pressure through oscillation mensuration. The proposed device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited.
It measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The HTD6602US is small, portable and used in home or medical facilities environment. The Electronic blood pressure monitor consists of two parts: main unit and cuffs. The HTD6602US is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 22cm32cm and cuff of size 22cm42cm.
Principle of operation:
This product uses the Oscillometric Measuring method to detect blood pressure. When the cuff is fully inflated to reach a pressure above systolic pressure, no blood flow occurs through the artery. As the cuff is deflated below the systolic pressure, the reducing pressure exerted on the artery allows blood to flow through it and sets up a detectable vibration in the arterial wall. When the cuff pressure falls below the patient's diastolic pressure, blood flows smoothly through the artery in the usual pulses, without any vibration being set up in the wall. Vibrations occur at any point where the cuff pressure is sufficiently high that the blood has to push the arterial wall open in order to flow through the artery. The vibrations are transferred from the arterial wall, through the air inside the cuff, into a transducer in the monitor that converts the measurements into electrical signals. Hence when it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations
6
generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and pulse rate.
5. Indications for Use
This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia).
6. Summary of technological characteristics of device compared to the
| SE
Comparisons | Subject device
(Electronic blood pressure monitor,
model: HTD6602US) | Predicate device
(Electronic blood pressure monitor,
Model: YE680B) | Discussion of
difference | | |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------|
| 510K Number | K223170 | K200939 | / | | |
| Model | HTD6602US | YE680B | / | | |
| Classification | 21CFR 870.1130 | 21CFR 870.1130 | Same | | |
| Product Code | DXN | DXN | Same | | |
| FDA Class | II | II | Same | | |
| Indications for
Use | This product is intended to measure
systolic and diastolic blood pressure
and pulse on upper arm. | This product is intended to measure
systolic and diastolic blood pressure and
pulse on upper arm | Same | | |
| Patient
Population | population over 12 years old | Adult | Different
(Discussion is
indicated in D1) | | |
| Environment of
Use | Home or medical facilities | Home or medical facilities | Same | | |
| Design | table type | table type | Same | | |
| Design Method | Oscillometric | Oscillometric | Same | | |
| Measurement
Site | Upper Arm | Upper Arm | Same | | |
| Cuff
Circumference | 22cm32cm;42cm. | 22cm
22cm32cm;45cm. | Different
22
(Discussion is
indicated in D2) | | |
| Inflation Method | Inflation Method | Inflation Method | Same | | |
| Deflation Method | Automatic Pressure Release Valve | Automatic Pressure Release Valve | Same | | |
| Display | Backlight LCD
Digital Display | Backlight LCD
Digital Display | Same | | |
| Memory Size | 180 groups | Up to 99x2 sets of data | Different
(Discussion is
indicated in D3) | | |
| Blood Pressure
Indication
Range | DIA: 30 mmHg195mmHg255mmHg | Diastolic:20
SYS: 60 mmHg210 mmHg260 mmHg | Different
Systolic:40
(Discussion is
indicated in D4) | | |
| Measurement
Pressure Range | 0299mmHg (039.9kPa) | 0 ~ 300 mmHg (0 kPa ~ 40 kPa) | Same | | |
| Range
Accuracy | ±3 mmHg (±0.4kPa) | ±3 mmHg (±0.4kPa) | Same | | |
| Measurement
Pulse Range | 40180 beats/min | 40 ~ 200 beats/min | Different1050
(Discussion is
indicated in D5) | | |
| Pulse Accuracy | ±5% of reading value | ±5% of reading value | Same | | |
| Pressurization
Source | Automatic Internal Pump | Automatic Internal Pump | Same | | |
| Pressure
Sensor | Semiconductor Pressure Sensor | Semiconductor Pressure Sensor | Same | | |
| Operating
Environment | Ambient temperature: +5°C ~ +40°C
Relative humidity (RH): ≤85%
Atmospheric pressure: 800 hPa
hPa | Temperature: +5℃ ~ +40 ℃
Humidity: 15% RH ~ 90% RH (no
condensation) | Different
(Discussion is
indicated in D6) | | |
| Storage
Environment | Ambient temperature: -20 °C ~+55 °C
Relative humidity (RH): 10%93%1050
Atmospheric pressure: 800 hPa
hPa | Temperature: -20 °C ~ +55 °C
Humidity: 15% RH ~ 90% RH (no
condensation) | Different
(Discussion is
indicated in D7) | | |
| Energy Source | Internal power supply DC 6V (4X1.5V
(AA) Alkaline battery/ IEC Type LR06);
External power supply: USB interface
DC 5V 1A | 4 AA batteries or 6V/600mA AC adapter | Different
(Discussion is
indicated in D8) | | |
| Display Content | 1, User Group
2,Over pressure Alarm
3, Low battery symbol
4, Unit mmHg
5, WHO (icon)
6, Pulse Rate (Measuring mode)
Memory group (Memory mode)
7, Unit kPa
8, Memory
9, Average of last 3 measurements
10, Pulse signal
11, Body movement
12, Cuff inflation abnormal
13, Pulse Rate (Memory mode)
14, Diastolic pressure
15, Systolic pressure | Cuff Pressure,
Pulse, Date,
Time,
Systolic/Diastolic
Pressure, error
message,
measurements
results in
memory,
Irregular Heart
Beat Feature,
Body movement
detection, Cuff
Wrapping
Detection, Dual
user switching | Different
(Discussion is
indicated in D9) | | |
| Controls | Set button
Start/Stop button
Memory button | Memory Button,
START/PULSE Button,
Member Button | Different
(Discussion is
indicated in D10) | | |
| Performance | ANSI/IAAMI/ISO81060-2:2013 | ANSI/IAAMI/ISO81060-2:2013 | Same | | |
| Performance | IEC80601-2-30 | IEC80601-2-30 | Same | | |
| | Biocompatibility | ISO 10993-1, FDA Guidance, Tests
included Cytotoxicity, Sensitization and
Intracutaneous Reactivity | ISO 10993-1, FDA Guidance, Tests
included Cytotoxicity, Sensitization and
Intracutaneous Reactivity | Same | |
| Electrical
Safety | | IEC60601-1 | IEC60601-1 | Same | |
| EMC | | IEC60601-1-2 | IEC60601-1-2 | Same | |
| Usability | | IEC 60601-1-6 | IEC 60601-1-6 | Same | |
| Home Use | | IEC 60601-1-11 | IEC 60601-1-11 | Same | |
| Material of
Patient contact
components | | Top Cover: ABS757
Bottom Cover: ABS757
Battery door: ABS757
Window cover: PMMA
Female connector: ABS757
Start/Stop button: ABS757
Set button: ABS757
Memory button: ABS757
Decoration ring(button): ABS757
Cuff connector: ABS757
Cuff: 1. cuff: Two layers of 420D
Polyester;
2.air bag: PVC.
3.Velcro: nylon.
4.Ring: metal.
5.air tube: PVC. | Not public | Different
(Discussion is
indicated in D11) | |
| | Patient
Interface | | Cuff, button | Cuff, button | Same |
| | Dimensions | | 141mm×106mm×70mm
(Length×Width×Height) | 127x93x74 (mm) | Different
(Discussion is
indicated in D12) |
| | Weight | | Approximate 323g. (Without battery) | Approx.330g | Different
(Discussion is
indicated in D13) |
| | Principle of
operation | | Oscillometric Measuring method | Oscillometric Measuring method | Same |
| | User Interface | | Cuff, button | Cuff, button | Same |
| | Software | | Embedded | Embedded | Same |
predicate devices (K200939)
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The discussion of differences exist between the subject and predicate devices is listed in following:
- D1: The difference of Patient Population between subject device and predicate device is that the intended age range of subject device is over 12 years old and predicate device is intended for adults, this difference is addressed through clinical trial conducted with subject device and contains population over 12 years old according to ISO 81060-2 Third Edition 2018-11, the results of clinical trial meet the requirements of ISO 81060-2 Third Edition 2018-11, therefore, the difference of subject device with predicate device YE680B (K200939) will not affect the safety and effectiveness.
9
- D2: The difference of Cuff Circumference between subject device and predicate device is that the intended Cuff Circumference range of subject device is 22
42cm and predicate device is 2245cm, the Cuff Circumference range of subject device is in the range of predicate device, and this difference is also addressed through clinical trial conducted with subject device according to ISO 81060-2 Third Edition 2018-11, the results of clinical trial meet the requirements of ISO 81060-2 Third Edition 2018-11, therefore, the difference of subject device with predicate device YE680B (K200939) will not affect the safety and effectiveness. - D3: The Memory Size of subject device is different with predicate device predicate device YE680B (K200939) will not affect the safety and effectiveness.
- D4: The difference of Blood Pressure Indication Range between subject device and predicate device is that the Blood Pressure Indication Range of subject device is DIA: 30 mmHq
195mmHq & SYS: 60 mmHg255mmHg and predicate device is Diastolic:20210 mmHg & Systolic:40260 mmHg, the Blood Pressure Indication Range of subject device is in the range of predicate device and meets the IEC 80601-2-30: Edition 2.0 2018-03, and this difference is also addressed through requirements of clinical trial conducted with subject device according to ISO 81060-2 Third Edition 2018-11, the results of clinical trial meet the requirements of ISO 81060-2 Third Edition 2018-11, therefore, the difference of subject device with predicate device YE680B (K200939) will not affect the safety and effectiveness. - D5: The Measurement Pulse Range of subject device is in the range of predicate device, and this difference is also addressed through clinical trial conducted with subject device according to ISO 81060-2 Third Edition 2018-11, therefore, the difference of subject device with predicate device YE680B (K200939) will not affect the safety and effectiveness.
- D6: The operating Environment of subject device are different with predicate device YE680B (K20033), the difference introduces risks mitigated by testing in accordance with IEC 60601-1-11 and ANSI AAMI ES60601-1 provided in this submission, therefore the difference does not raise new questions of safety and effectiveness.
- D7: The Storage Environment of subject device is different with predicate device YE680B (K200939), the difference introduces risks mitigated by testing in accordance with IEC 60601-1-11 and ANSI AAMI ES60601-1 provided in this submission, therefore the difference does not raise new questions of safety and effectiveness.
- D8: The Energy Source of subject device are different with predicate devices, the difference introduces risks mitigated by the electromagnetic compatibility and electrical safety testing in accordance with IEC 60601-1-2 and ANSI AAMI ES60601-1 provided in this submission, therefore the difference does not raise new questions of safety and effectiveness.
- D9: The Display Content between subject device and predicate device is that excluding the same parts, the Display Content of subject device additionally includes "User Group and Average of last 3 measurements" which are not included by predicate device, and the predicate device additionally includes "Cuff Pressure, Date, Time, Irreqular Heart, Beat Feature, Dual user switching" which are not included by predicate device, since the subject device meets the requirements of IEC 80601-2-30: Edition 2.0 2018-03 and ISO 81060-2 Third Edition 2018-11, therefore, the difference of subject device with predicate device YE680B (K200939) will not affect the safety and effectiveness.
- D10: The Controls of subject device are different with predicate device, the difference does not raise new questions of safety and effectiveness.
10
- D11: The Material of Patient contact components of subject device has been validated for Cytotoxicity though testing against ISO 10993- 5, for Sensitization though testing against ISO 10993-10 tested and all test results are positive, the difference of subject device with predicate device YE680B (K200939) do not raise new questions of safety and effectiveness.
- D12: The Dimensions of subject device is different with predicate device predicate device YE680B (K200939) will not affect the safety and effectiveness.
- D13: The Weight of subject device is different with predicate device YE680B (K200939) will not affect the safety and effectiveness.
7. Discussion of Non-Clinical Tests Performed are as follows
The recognized consensus standards for safety of medical electrical equipment: ANSI AAM ES 60601- 1: 2005 / (R) 2012 and A1: 2012, IEC 60601-1-11 Edition 2.0 2015-01. IEC 60601-1-8 Edition 2.1 2012-11 for safety, IEC 60601-1-2: 2014 for electromagnetic compatibility, IEC 80601-2-30: Edition 2.0 2018-03, ISO 81060-2 Third Edition 2018-11 for performance, IEC 62304 Edition 1.1 2015-06 for software verification, IEC 62366-1 Edition 1.0 2015-02, IEC 60601-1-6 Edition 3.1 usability and 2013-10 for for ട്രി 10993-10:2010 for Sensitization and Irritation endpoints are complied. See below table for details:
| Standards | Standards Name |
|---|---|
| ANSI AAMI ES60601- | |
| 1:2005/(R)2012 and A1:2012 | Medical Electrical Equipment - Part 1: General Requirements For |
| Basic Safety And Essential Performance | |
| 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 | |
| IEC 60601-1-11 Edition 2.0 | |
| 2015-01 | Medical Electrical Equipment - Part 1-2: General Requirements For |
| Basic Safety And Essential Performance - Collateral Standard: | |
| Electromagnetic Disturbances - Requirements And Tests | |
| IEC 60601-1-8 Edition 2.1 | |
| 2012-11 | Medical electrical equipment - Part 1-8: General requirements for |
| basic safety and essential performance - Collateral Standard: | |
| General requirements, tests and guidance for alarm systems in | |
| medical electrical equipment and medical electrical systems | |
| IEC 80601-2-30: Edition 2.0 | |
| 2018-03 | Medical electrical equipment - Part 2-30: Particular requirements for |
| the basic safety and essential performance of automated non- | |
| invasive sphygmomanometers | |
| ISO 81060-2 Third Edition | |
| 2018-11 | Non-invasive sphygmomanometers - Part 2: Clinical investigation of |
| intermittent automated measurement type | |
| IEC 62366-1 Edition 1.0 | |
| 2015-02 | Medical devices - Part 1: Application of usability engineering to |
| medical devices | |
| IEC 60601-1-6 Edition 3.1 | |
| 2013-10 | Medical electrical equipment - Part 1-6: General requirements for |
| basic safety and essential performance - Collateral standard: | |
| Usability |
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| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
|---|---|
| ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
| IEC 62304 Edition 1.1 2015- | |
| 06 | Medical device software - Software life cycle processes |
● Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject device HTD6602US. The system complies with the AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, IEC 80601-2-30: Edition 2.0 2018-03, ISO 81060-2 Third Edition 2018-11, standards for electrical safety and the IEC 60601-1-2 standard for EMC.
● Software Verification and Validation Testing
Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005.
Software Description:
The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could result in Minor Injury, either to a patient or to a user of the device. The software of the system, on the whole, is accountable for the system scheduler of the device, including Pressure and pulse signal acquisition, calculation and display, the button presses of end user, display the result of the measurement data storage and average calculation, memory data query, prompt of error message, low battery voltage detection and prompt, measurement Unit conversion, user Account Switching.
- V Programming language C Programming Language.
Hardware Requirements A Microprocessors: HME062
8. Discussion of Clinical Accuracy Testing Performed
The clinical accuracy test report and data analysis followed the requirements of the ISO 81060-2 Third Edition 2018-11.
| Subjects requirement | Number specified in ISO
81060-2 Third edition 2018-
11 Amendment 1 2020-01 | Actual number |
|----------------------|----------------------------------------------------------------------------------|---------------|
| Total | A minimum of 85 | 85 |
| Male | At least 26 | 38 |
| Female | At least 26 | 47 |
| Age > 12 | 100% | 100% |
The clinical accuracy testing evaluated 85 of subjects, division of all subjects:
12
| arm circumference in the range of 22-
| 27cm; | ≥20% | 31.76% |
|---|---|---|
| arm circumference in the range of 27- | ||
| 32cm; | ≥20% | 23.53% |
| arm circumference in the range of 32- | ||
| 37cm; | ≥20% | 23.53% |
| arm circumference in the range of 37- | ||
| 42cm; | ≥20% | 21.18% |
| arm circumference in the range of 22- | ||
| 24.5cm; | ≥10% | 21.18% |
| arm circumference in the range of 39.5- | ||
| 42cm | ≥10% | 11.76% |
| subjects shall be tested through the cuff | ||
| with specified (22-32cm) | At least 25% | 32.94% |
| subjects shall be tested through the cuff | ||
| with specified (22-42cm) | At least 50% | 67.06% |
| Systolic BP ≤ 100mmHg | ≥5% | 17.65% |
| Systolic BP ≥ 160mmHg | ≥5% | 12.94% |
| Systolic BP ≥140mmHg | ≥20% | 30.59% |
| Diastolic BP ≤ 60mmHg | ≥5% | 14.12% |
| Diastolic BP ≥ 100mmHg | ≥5% | 10.59% |
| Diastolic BP ≥ 85mmHg | ≥20% | 27.06% |
The test data showed the clinical accuracy of the subject device complied with the requirements of ISO 81060-2 Third Edition 2018-11.
| Name | Sphygmomanometer - Stethoscope health box |
|---|---|
| Model | A Type |
| Manufacturer | Jiangsu Yuyue Medical Equipment & Supply |
| Co., Ltd. | |
| Measuring Method | Auscultatory |
Reference equipment used for measurements:
9. Conclusions
The Electronic blood pressure monitor, model: HTD6602US, have the same intended use and similar characteristics as the cleared predicate device Electronic Blood Pressure Monitor, Model: YE680B. Moreover, bench testing contained in this submission supplied demonstrate that the differences existed between HTD6602US and YE680B do not raise any new questions of safety or effectiveness.
The non-clinical tests support the safety of the device and the hardware and software verification and validation demonstrate that the Electronic blood pressure monitor, model: HTD6602US performs as intended in the specified use conditions are same with predicate device. The clinical performance tests demonstrate that the Electronic blood pressure monitor, model: HTD6602US performs comparably to the predicate device that is currently marketed for the same intended use. Thus, the Electronic blood pressure monitor, model: HTD6602US is Substantially Equivalent (SE) to the predicate device.