(72 days)
No
The description focuses on standard oscillometric blood pressure measurement technology and does not mention any AI or ML components or algorithms. The performance study relies on the predicate device's algorithm, which is not described as AI/ML.
No
This device is intended to measure blood pressure, not to provide therapy or treatment for a condition.
Yes
Explanation: The device is intended to measure systolic and diastolic blood pressure, which are key physiological parameters used to diagnose conditions like hypertension.
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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- 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 performed directly on the body, not on a sample taken from the body.
- Intended Use: The intended use clearly states it measures blood pressure and pulse on the upper arm.
Therefore, this device falls under the category of a non-invasive medical device rather than an in vitro diagnostic device.
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
DXN
Device Description
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.
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
Population over 12 years old. (Not suitable for neonate, pregnancy or pre-eclampsia).
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
In ISO 81060-2 Third edition 2018-11 [Including: Amendment 1 (2020)] Non-invasive 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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)
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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, Dongguan | |
| City, Guangdong Province, P.R.China | |
| Tel: +86-0769-83326886 | |
| E-mail: tomchen@hetaida.com.cn | |
| Contactor: | Tom Chen |
| Hetaida Technology Co., Ltd. | |
| Room 801, 802, 803, 804, 901, 2# Building Scientific Research Center, | |
| Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town, Dongguan | |
| City, Guangdong Province, P.R.China | |
| E-mail: tomchen@hetaida.com.cn | |
| Tel: +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 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). | |
| Device Description: | 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 22cm~32cm and cuff of size | |
| 22cm~42cm. |
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. | Marketing | |||
| clearance | ||||
| date | Applying | December 5, 2023 | -- | |
| 3. | Device Name | Electronic Blood Pressure | ||
| Monitor | Electronic Blood Pressure | |||
| Monitor | -- | |||
| 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 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). | 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). | 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~32cm; | ||
| 22cm~42cm. | 22cm~32cm; | |||
| 22cm~42cm. | Same | |||
| 16. | Inflation Method | Automatic by electronic pump | Automatic by electronic pump | Same |
| 17. | Deflation Method | Automatic Pressure Release | ||
| Valve | Automatic Pressure Release | |||
| Valve | Same | |||
| 18. | Display | Backlight LCD | ||
| Digital Display | Backlight LCD | |||
| Digital Display | Same | |||
| 19. | Memory Size | Two users, 2 × 99 groups | 180 groups | Different |
| Note 1 | ||||
| 20. | Blood | |||
| Pressure | ||||
| Indication Range | DIA: 30 mmHg~195mmHg | |||
| SYS: 60 mmHg~255mmHg | DIA: 30 mmHg~195mmHg | |||
| SYS: 60 mmHg~255mmHg | Same | |||
| 21. | Measurement | |||
| Pressure Range | 0 | 0 | Same | |
| 22. | Range Accuracy | ±3mmHg (±0.4kPa) | ±3mmHg (±0.4kPa) | Same |
| 23. | Measurement | |||
| Pulse | ||||
| Range | 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. | Operating | |||
| Environment | Ambient temperature: | |||
| +5°C ~+40°C | ||||
| Relative humidity (RH): ≤85% | ||||
| Atmospheric pressure: | ||||
| 800hPa~1050hPa | Ambient temperature: | |||
| +5°C ~+40°C | ||||
| Relative humidity (RH): ≤85% | ||||
| Atmospheric pressure: | ||||
| 800hPa~1050hPa | Same | |||
| 28. | Storage Environment | Ambient temperature: | ||
| -20°C~+55°C | ||||
| Relative humidity (RH): | ||||
| 10%~93% | ||||
| Atmospheric pressure: | Ambient temperature: | |||
| -20°C~+55°C | ||||
| Relative humidity (RH): | ||||
| 10%~93% | ||||
| Atmospheric pressure: | Same | |||
| Atmospheric pressure: |
6
| 29. | Energy Source | Internal power supply DC 6V
(4X1.5V (AA) Alkaline
battery/ IEC Type LR06);
External power supply: USB
interface DC 5V 1A | Internal power supply DC 6V
(4X1.5V (AA) Alkaline
battery/ IEC Type LR06);
External power supply: USB
interface DC 5V 1A | Same | | | | | |
|-----|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|----------------|----------------------------------------|---------------|------------------|--|
| 30. | Display Content | 1, User 1 icon, User 2 icon
2, Over pressure Alarm
3, Low battery symbol
4, Unit mmHg
5, WHO (icon)
6, Pulse Rate
7, Unit kPa
8, Memory
9, Average of last 3 measurements
10, Pulse signal
11, Body movement
12, Cuff inflation abnormal
13, Irregular pulse icon
14, Diastolic pressure
15, Systolic pressure
16. Memory group
17. Voice on/off icon | 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 | Different Note 2 | | | | | |
| 31. | Controls | Set button
Start/Stop button
Memory button | Set button
Start/Stop button
Memory button | Same | | | | | |
| 32. | Performance | ISO 81060-2
IEC 80601-2-30 | ISO 81060-2
IEC 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 Patient
contact components | Bottom Cover: ABS757
Battery door: ABS757
Window cover: PMMA
Female connector: ABS757
Start/Stop button: ABS757
Set button: ABS757
Memory button: ABS757
Cuff connector: ABS757
Cuff: 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: 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 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 Patient
contact components | Bottom Cover: ABS757
Battery door: ABS757
Window cover: PMMA
Female connector: ABS757
Start/Stop button: ABS757
Set button: ABS757
Memory button: ABS757
Cuff connector: ABS757
Cuff: 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: 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
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) | Approximate 323g.
(Without battery) | Different
Note 5 | | | | | |
| 42. | Principle of operation | Oscillometric Measuring
method | Oscillometric Measuring
method | 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.