(72 days)
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).
Electronic blood pressure monitor is a Noninvasive Blood Pressure Measurement System that is intended to measure 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 may be revisited. It measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The electronic blood pressure monitor is small, portable and used in home or medical facilities environment. It consists of two parts: main unit and cuffs. The electronic blood pressure monitor is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 22cm32cm and cuff of size 22cm42cm.
The provided text describes the acceptance criteria and the study that proves the device (Electronic Blood Pressure Monitor models D6606US, D6607US) meets these criteria, primarily by demonstrating substantial equivalence to a predicate device (HTD6602US, K223170).
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from international standards and are met by the device. The reported device performance is that it meets these standards.
| Acceptance Criteria (Standard/Parameter) | Reported Device Performance |
|---|---|
| Blood Pressure Indication Range: | |
| DIA: 30 mmHg~195mmHg | Met (Same as predicate) |
| SYS: 60 mmHg~255mmHg | Met (Same as predicate) |
| Measurement Pressure Range: | Met (Same as predicate) |
| 0 | |
| Range Accuracy: | Met (Same as predicate) |
| ±3mmHg (±0.4kPa) | |
| Measurement Pulse Range: | Met (Same as predicate) |
| 40~180 beats/min | |
| Pulse Accuracy: | Met (Same as predicate) |
| ±5% of reading value | |
| Performance Standard: | |
| ISO 81060-2 | Met (Results demonstrated predetermined acceptance criteria were fully met by the predicate device, and these results were transferred to the subject device due to identical critical components and algorithm.) |
| IEC 80601-2-30 | Met (Same as predicate) |
| Biocompatibility: | |
| ISO 10993-1, FDA Guidance | Met (Tests included Cytotoxicity, Sensitization, and Intracutaneous Reactivity. All test results were positive, implying compliance.) |
| Electrical Safety: | Met (Same as predicate - IEC60601-1) |
| IEC60601-1 | |
| EMC: | Met (Same as predicate - IEC60601-1-2) |
| IEC60601-1-2 | |
| Usability: | Met (Same as predicate - IEC 60601-1-6) |
| IEC 60601-1-6 | |
| Home Use: | Met (Same as predicate - IEC 60601-1-11) |
| IEC 60601-1-11 | |
| Alarm Systems: | Met (IEC 60601-1-8) |
| IEC 60601-1-8 | |
| Software Life Cycle: | Met (IEC 62304) |
| IEC 62304 |
2. Sample size used for the test set and the data provenance
The document states that a clinical study was performed on the predicate device (HTD6602US, K223170). The results of this study were transferred to the subject device (D6606US, D6607US) because the subject device has the same specifications, intended use, method of measurement, measurement type, critical components (e.g., air pump, sensor, cuff), and algorithm as the predicate device.
- Sample Size for Clinical Accuracy Testing: The document does not explicitly state the sample size. It only refers to "all the relevant activities were performed by designate individual(s)" as per ISO 81060-2. ISO 81060-2 specifies requirements for clinical investigation of automated non-invasive sphygmomanometers, which includes specific sample size requirements (e.g., typically at least 85 subjects with a distribution across blood pressure ranges). However, the exact number is not provided in this submission summary.
- Data Provenance: The clinical study data originates from the testing done for the predicate device K223170. The country of origin and whether it was retrospective or prospective are not specified in this document, but "clinical investigation" usually implies a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions that for the clinical accuracy testing (performed on the predicate device), "all the relevant activities were performed by designate individual(s)". It does not specify the number of experts or their qualifications for establishing ground truth, but implicitly, highly qualified medical professionals/technicians are required to perform and verify measurements according to ISO 81060-2.
4. Adjudication method for the test set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). For blood pressure measurement studies following ISO 81060-2, ground truth is typically established by trained observers (often two) using a reference sphygmomanometer, with specific protocols for resolving discrepancies, although these details are not provided here.
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
- No MRMC Study: This device is an Electronic Blood Pressure Monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool that requires human interpretation. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done as it is irrelevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was done (implicitly). The primary study cited is the clinical accuracy testing of the predicate device against ISO 81060-2. This standard evaluates the accuracy of the automated device (algorithm only) compared to a reference measurement performed by trained observers, effectively assessing its standalone performance. The results of this standalone performance were deemed acceptable for the predicate and transferred to the subject device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical accuracy testing (following ISO 81060-2) is established by simultaneous or sequential measurements using a standardized reference method (e.g., mercury sphygmomanometer with trained observers) against which the automated device's readings are compared. This is a form of expert measurement/consensus in a controlled clinical setting.
8. The sample size for the training set
This information is not applicable/provided. The device is an Electronic Blood Pressure Monitor based on oscillometric measurement, not a machine learning or AI device that typically requires a "training set" in the conventional sense. The development of its algorithm would involve engineering and calibration, not statistical training on a dataset of labeled cases in the AI context.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reasons as point 8.
{0}------------------------------------------------
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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 7, 2025
Hetaida Technology Co., Ltd. Tom Chen General Manager Rm 801, 802, 803, 804, 901, 2# Bldg Scientific Research Ctr Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town Dongguan City, Guangdong 523423 China
Re: K243661
Trade/Device Name: Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 13, 2025 Received: January 13, 2025
Dear Tom Chen:
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.
{1}------------------------------------------------
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" (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 (OS) 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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
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-regulatory
{2}------------------------------------------------
assistance/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,
Robert T. Kazmierski -S
for
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
Submission Number (if known)
Device Name
Electronic Blood Pressure Monitor
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
K243661
510(k) Summary
[As required by 21 CFR 807.92]
| 1. Submission Information | |
|---|---|
| 510(k) Number: | K243661 |
| Date: | November 26th, 2024 |
| Type of 510(k) Submission: | Special 510(k) |
| Submitter/Manufacturer: | Hetaida Technology Co., Ltd.Room 801, 802, 803, 804, 901, 2# Building Scientific Research Center,Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town, DongguanCity, Guangdong Province, P.R.ChinaTel: +86-0769-83326886E-mail: tomchen@hetaida.com.cn |
| Contactor: | Tom ChenHetaida Technology Co., Ltd.Room 801, 802, 803, 804, 901, 2# Building Scientific Research Center,Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town, DongguanCity, Guangdong Province, P.R.ChinaE-mail: tomchen@hetaida.com.cnTel: +86-0769-83326886 |
| 2. Device Description | |
| Proprietary Name: | Electronic Blood Pressure Monitor |
| Model Name: | D6606US, D6607US |
| Classification Name: | Noninvasive Blood Pressure Measurement System |
| Product Code: | DXN |
| Device Class: | 2 |
| Regulation Number: | 21 CFR § 870.1130 |
| Review Panel: | Cardiovascular |
| Indications for use: | This product is intended to measure systolic and diastolic blood pressureand pulse on upper arm of population over 12 years old in household ormedical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia). |
| Device Description: | Electronic blood pressure monitor is a Noninvasive Blood PressureMeasurement System that is intended to measure blood pressure throughoscillation mensuration. The proposed device will automatically start totake measurements after the inflation of the cuff is finished, the results willshow the systolic pressure and diastolic pressure with pulse rate. The bloodpressure monitor will store the measurements automatically; The recordmay be revisited.It measures blood pressure and pulse rate through inflating cuff whichrounding the upper arm of patients. The electronic blood pressure monitoris small, portable and used in home or medical facilities environment. Itconsists of two parts: main unit and cuffs. The electronic blood pressuremonitor is composed of PCBA, crystal oscillator, pump, valve, enclose,and LCD. Cuffs including cuff of size 22cm |
3. Predicate Device Identification
| 510(k) Number: | K223170 |
|---|---|
| Product Name: | Electronic Blood Pressure Monitor |
| Model Name: | HTD6602US |
| Submitter: | Hetaida Technology Co., Ltd. |
{5}------------------------------------------------
4. Substantially Equivalent Comparison
| Parameters | Subject Device | Predicate Device | Remark | |
|---|---|---|---|---|
| 1. | 510(k) Number: | K243661 | K223170 | -- |
| 2. | Marketingclearancedate | Applying | December 5, 2023 | -- |
| 3. | Device Name | Electronic Blood PressureMonitor | Electronic Blood PressureMonitor | -- |
| 4. | Model | D6606US, D6607US | HTD6602US | -- |
| 5. | 510(k) Owner | Hetaida Technology Co., Ltd. | Hetaida Technology Co., Ltd. | Same |
| 6. | Classification | Class II Device, DXN (21 CFR§ 870.1130) | Class II Device, DXN (21 CFR§ 870.1130) | Same |
| 7. | Classification Panel | Cardiovascular | Cardiovascular | Same |
| 8. | Type of use | Over-The-Counter Use | Over-The-Counter Use | Same |
| 9. | Indications for Use | This product is intended tomeasure systolic and diastolicblood pressure and pulse onupper arm of population over12 years old in household ormedical facilities. (Not suitablefor neonate, pregnancy or pre-eclampsia). | This product is intended tomeasure systolic and diastolicblood pressure and pulse onupper arm of population over12 years old in household ormedical facilities. (Not suitablefor neonate, pregnancy or pre-eclampsia). | Same |
| 10. | Patient Population | Population over 12 years old | Population over 12 years old | Same |
| 11. | Intended Environment | Home or medical facilities | Home or medical facilities | Same |
| 12. | Design | Table type | Table type | Same |
| 13. | Design Method | Oscillometric | Oscillometric | Same |
| 14. | Measurement Site | Upper Arm | Upper Arm | Same |
| 15. | Cuff Circumference | 22cm | 22cm | Same |
| 16. | Inflation Method | Automatic by electronic pump | Automatic by electronic pump | Same |
| 17. | Deflation Method | Automatic Pressure ReleaseValve | Automatic Pressure ReleaseValve | Same |
| 18. | Display | Backlight LCDDigital Display | Backlight LCDDigital Display | Same |
| 19. | Memory Size | Two users, 2 × 99 groups | 180 groups | DifferentNote 1 |
| 20. | BloodPressureIndication Range | DIA: 30 mmHg | DIA: 30 mmHg | Same |
| 21. | MeasurementPressure Range | 0 | 0 | Same |
| 22. | Range Accuracy | ±3mmHg (±0.4kPa) | ±3mmHg (±0.4kPa) | Same |
| 23. | MeasurementPulseRange | 40~180 beats/min | 40~180 beats/min | Same |
| 24. | Pulse Accuracy | ±5% of reading value | ±5% of reading value | Same |
| 25. | Pressurization Source | Automatic Internal Pump | Automatic Internal Pump | Same |
| 26. | Pressure Sensor | Semiconductor Pressure Sensor | Semiconductor Pressure Sensor | Same |
| 27. | OperatingEnvironment | Ambient temperature:+5°C | Ambient temperature:+5°C | Same |
| 28. | Storage Environment | Ambient temperature:-20°C~+55°CRelative humidity (RH):10%~93%Atmospheric pressure: | Ambient temperature:-20°C~+55°CRelative humidity (RH):10%~93%Atmospheric pressure: | SameAtmospheric pressure: |
{6}------------------------------------------------
| 29. | Energy Source | Internal power supply DC 6V(4X1.5V (AA) Alkalinebattery/ IEC Type LR06);External power supply: USBinterface DC 5V 1A | Internal power supply DC 6V(4X1.5V (AA) Alkalinebattery/ IEC Type LR06);External power supply: USBinterface DC 5V 1A | Same | |||||
|---|---|---|---|---|---|---|---|---|---|
| 30. | Display Content | 1, User 1 icon, User 2 icon2, Over pressure Alarm3, Low battery symbol4, Unit mmHg5, WHO (icon)6, Pulse Rate7, Unit kPa8, Memory9, Average of last 3 measurements10, Pulse signal11, Body movement12, Cuff inflation abnormal13, Irregular pulse icon14, Diastolic pressure15, Systolic pressure16. Memory group17. Voice on/off icon | 1. User Group2. Over pressure Alarm3. Low battery symbol4. Unit mmHg5. WHO (icon)6. Pulse Rate (Measuring mode), Memory group (Memory mode)7. Unit kPa8. Memory9. Average of last 3 measurements10. Pulse signal11. Body movement12. Cuff inflation abnormal13. Pulse Rate (Memory mode)14. Diastolic pressure15. Systolic pressure | Different Note 2 | |||||
| 31. | Controls | Set buttonStart/Stop buttonMemory button | Set buttonStart/Stop buttonMemory button | Same | |||||
| 32. | Performance | ISO 81060-2IEC 80601-2-30 | ISO 81060-2IEC 80601-2-30 | Same | |||||
| 33. | 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 | |||||
| 34. | Electrical Safety | IEC60601-1 | IEC60601-1 | Same | |||||
| 35. | EMC | IEC60601-1-2 | IEC60601-1-2 | Same | |||||
| 36. | Usability | IEC 60601-1-6 | IEC 60601-1-6 | Same | |||||
| 37. | Home Use | IEC 60601-1-11 | IEC 60601-1-11 | Same | |||||
| 38. | Material of Patientcontact components | Bottom Cover: ABS757Battery door: ABS757Window cover: PMMAFemale connector: ABS757Start/Stop button: ABS757Set button: ABS757Memory button: ABS757Cuff connector: ABS757Cuff: 1. cuff: Two layers of 210D raw silk cloth;2.air bag: PVC;3.Velcro: nylon;4.Ring: metal;5.air tube: PVC. | Top Cover: ABS757Bottom Cover: ABS757Battery door: ABS757Window cover: PMMAFemale connector: ABS757Start/Stop button: ABS757Set button: ABS757Memory button: ABS757Decoration ring(button): ABS757Cuff connector: ABS757Cuff: 1. cuff: Two layers of 420D1 Polyester;2.air bag: PVC;3.Velcro: nylon;4.Ring: metal;5.air tube: PVC. | Different Note 3 | |||||
| 39. | Patient Interface | Cuff, button | Cuff, button | Same | |||||
| 40. | Dimensions | $116mm \times 110mm \times 50mm$(Length×Width×Height) | $141mm \times 106mm \times 70mm$(Length×Width×Height) | Different Note 4 | |||||
| 41. | Weight | Approximate 278g.(Without battery) | IEC 60601-1-11 | Approximate 323g.(Without battery) | IEC 60601-1-6 | Different Note 5 | |||
| 37. | Home Use | Same | |||||||
| 38. | Material of Patientcontact components | Bottom Cover: ABS757Battery door: ABS757Window cover: PMMAFemale connector: ABS757Start/Stop button: ABS757Set button: ABS757Memory button: ABS757Cuff connector: ABS757Cuff: 1. cuff: Two layersof 210D raw silk cloth;2.air bag: PVC;3.Velcro: nylon;4.Ring: metal;5.air tube: PVC. | Top Cover: ABS757Bottom Cover: ABS757Battery door: ABS757Window cover: PMMAFemale connector: ABS757Start/Stop button: ABS757Set button: ABS757Memory button: ABS757Decoration ring(button):ABS757Cuff connector: ABS757Cuff: 1. cuff: Two layers of420D1 Polyester;2.air bag: PVC;3.Velcro: nylon;4.Ring: metal;5.air tube: PVC. | DifferentNote 3 | |||||
| 39. | Patient Interface | Cuff, button | Cuff, button | Same | |||||
| 40. | Dimensions | $116mm \times 110mm \times 50mm$(Length×Width×Height) | $141mm \times 106mm \times 70mm$(Length×Width×Height) | DifferentNote 4 | |||||
| 41. | Weight | Approximate 278g.(Without battery) | Approximate 323g.(Without battery) | DifferentNote 5 | |||||
| 42. | Principle of operation | Oscillometric Measuringmethod | Oscillometric Measuringmethod | Same | |||||
| 43. | Software | Embedded | Embedded | Same |
{7}------------------------------------------------
K243661
The discussion of differences exist between the subject device and predicate devices is listed as follows:
Note 1: The Memory Size of subject device is different with predicate device HTD6602US (K223170) will not affect the safety and effectiveness.
Note 2: The Display Content between subject device and predicate device is that excluding the same parts, the Display Content of subject device additionally includes "User 1 icon, Irregular pulse icon, Voice on/off icon" which are not included by predicate device, since the subject device meets the requirements of IEC 80601-2-30:2018, therefore, the difference of subject device with predicate device HTD6602US (K223170) will not affect the safety and effectiveness.
Note 3: The Material of Patient contact components of subject device is same as predicate device, only the cuff has changed the cuff fabric, and the cuff has been validated for Cytotoxicity though testing against ISO 10993- 5, for Sensitization and Irritation though testing against ISO 10993-10 tested, and all test results are positive, the difference of subject device with predicate device HTD6602US (K223170) do not raise new questions of safety and effectiveness.
Note 4: The Dimensions of subject device is different with predicate device HTD6602US (K223170) will not affect the safety and effectiveness.
Note 5: The Weight of subject device is different with predicate device HTD6602US (K223170) will not affect the safety and effectiveness.
5. Discussion of Non-Clinical Tests Performed are as follows:
To demonstrate safety and effectiveness of Electronic Blood Pressure Monitor: D6606US, D6607US and to show substantial equivalence to the predicate device, Hetaida Technology Co., Ltd completed the following non-clinical tests. Results confirm that the design inputs, acceptance criteria for the device are met. The device passed the testing in accordance with internal requirements, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:
-
ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009(R)2012 And A2:2010(R)2012+A2:2021 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)];
-
ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)];
-
ANSI AAMI HA60601-1-11:2015 [Including AMD1:2021] Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment] (2021)];
-
IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION 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 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-
6: General requirements for basic safety and essential performance - Collateral standard: Usability;
-
IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes:
-
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;
{8}------------------------------------------------
-
ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization,
6. Discussion of Clinical Accuracy Testing Performed
The subject device has the same specification as predicated device HTD6602US (K223170), including: intended use, method of measurement, measure type, critical components (ex. Air pump, sensor, cuff...) and algorithm etc., so clinical study results can be transferred from the predicated device HTD6602US (K223170) to the subject device.
81060-2 Third edition 2018-11 [Including: Amendment 1 (2020)] Non-invasive In ISO sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type, all the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met. Therefore, repeated clinical testing in accordance with the standard ISO 81060-2 Third edition 2018-11 [Including: Amendment 1 (2020)] for subject device is not warranted.
7. Conclusion
The subject device has the same indication for use as the predicate device as well as technical characteristics, and the minor differences do not raise new or different questions of safety and effectiveness, as determined through a risk assessment and well-established test methods. The D6606US and D6607US of subject device are same, only the model number is different. The subject device is substantially equivalent 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).