(199 days)
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device measures blood pressure and pulse rate, which are diagnostic measurements for monitoring a physiological condition, not for treating a disease or condition.
Yes
The device measures physiological parameters (blood pressure and pulse rate) which provide data for medical professionals to assess a patient's health status, which is a diagnostic function.
No
The device description explicitly states it is a "battery driven automatic non-invasive blood pressure meter" and mentions components like an "inflatable cuff" and "inflation, deflation and measurement," indicating it is a hardware device with integrated software, not a software-only 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: The Automatic Wrist Blood Pressure Monitor measures blood pressure and pulse rate non-invasively by using a cuff wrapped around the wrist. It does not analyze any specimens taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate directly from the individual, not to analyze samples.
Therefore, based on the provided information, this device falls under the category of a non-invasive medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5 cm~19.5 cm.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
Automatic Wrist Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
Adult
Intended User / Care Setting
medical professionals or at home
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 whole product and manufacturing used for the Automatic Upper Wrist Blood Pressure Monitor are identical to those of the predicate device, which were demonstrated to conform with the following standards:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 2005 + A1:2012
- IEC 60601-1-2. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements and tests, 2014
- IEC 60601-1-11, Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment [Including: Technical Corrigendum 1 (2011)]
- IEC 80601-2-30. Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers
- ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, 2010
- AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type. (Cardiovascular)
Summary of new tests on subject device:
- IEC 60601-1-2: 2014, Medical electrical equipment Part 1-2: General requirements for basic safety A and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements and tests
- Mechanical test according to ANSI/AAMI ES60601-1 (2005/(R)2012 + A 1:2012, C1:2009/(R)2012 + A A2:2010/(R)2012) - Amendment 1 - Revision Date 2012/08/21 and IEC 60601-1-11:2015
Key results: The subject device noninvasive sphygmomanometer (Automatic Upper Wrist Blood Pressure Monitor) (Model: BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613) has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pressure: ± 3mmHg
Pulse: ±5%
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 contains 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.
July 12, 2020
Dongguan E-Test Technology Co., Ltd % Cassie Lee, Manager Dongguan E-Test Technology Co., Ltd Room 201,301. Building 1, Changping Section No.1, Dongshen Road Dongguan City, Guangdong, China 523588
Re: K193628
Trade/Device Name: Automatic Wrist Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: December 24, 2019 Received: December 26, 2019
Dear Cassie Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193628
Device Name Automatic Wrist Blood Pressure Monitor
Indications for Use (Describe)
Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5 cm~19.5 cm.
Type of Use (Select one or both, as applicable)
| ☐ Production Use: For 505, 506, or 510(k) Clearance | ☑ Same Use: Corresponding to 505, 506, or 510(k) Clearance |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------ |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: DONGGUAN E-TEST TECHNOLOGY CO., LTD Establishment Registration Number: Applying Address: Room 201,301. Building 1, Changping Section No.1, Dongshen Road, Changping Town, Dongguan City, Guangdong, China. Tel: +86-0769-81158038 Contact Person (including title): Victor Wan (Vice-president) E-mail: victor@agelh.com
Application Correspondent:
Contact Person: Ms. Cassie Lee DONGGUAN E-TEST TECHNOLOGY CO., LTD Address: Room 201.301, Building 1, Changping Section No.1, Dongshen Road, Changping Town, Dongguan City, Guangdong, China. Tel: +86-0769-81158038 Email: regulatory@glomed-info.com
2. Subject Device Information
Type of 510(k): Traditional Common Name: Noninvasive blood pressure measurement systems Classification Name: System, Measurement, Blood-Pressure, Non-Invasive Trade Name: Automatic Wrist Blood Pressure Monitor Model Name: BW-601, BW-602, BW-603, BW-605, BW-611, BW-612, BW-613 Review Panel: Cardiovascular Product Code: DXN Regulation Number: 870.1130 Requlatory Class: 2
3. Predicate Device Information
| Sponsor | Dongguan Ageless Health Industrial Co., Ltd |
|---|---|
| Device Name and Model | AGE Automatic Wrist Blood Pressure Monitor |
| Models: BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613 | |
| 510(k) Number | K151281 |
| Product Code | DXN |
| Regulation Number | 870.1130 |
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| Regulation Class | II |
|---|---|
| ------------------ | ---- |
4. Device Description
Automatic Wrist Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. lt can automatically conduct the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the batterv is low.
5. Intended Use / Indications for Use
Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a noninvasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5 cm.
6. Test Summarv
6.1 The whole product and manufacturing used for the Automatic Upper Wrist Blood Pressure Monitor are identical to those of the predicate device, which were demonstrated to conform with the following standards:
- ♦ IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 2005 + A1:2012
- � IEC 60601-1-2. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements and tests, 2014
- � IEC 60601-1-11, Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment [Including: Technical Corrigendum 1 (2011)]
- � IEC 80601-2-30. Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers
- � ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009
- � ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, 2010
- � AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type. (Cardiovascular)
5
6.2 Summary of new tests on subject device
- IEC 60601-1-2: 2014, Medical electrical equipment Part 1-2: General requirements for basic safety A and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements and tests
- Mechanical test according to ANSI/AAMI ES60601-1 (2005/(R)2012 + A 1:2012, C1:2009/(R)2012 + A A2:2010/(R)2012) - Amendment 1 - Revision Date 2012/08/21 and IEC 60601-1-11:2015
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Automatic Wrist Blood Pressure Monitor is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Company | DONGGUAN E-TEST | ||
| TECHNOLOGY CO., LTD | Dongguan Ageless Health | ||
| Industrial Co., Ltd | -- | ||
| Product Name | Automatic Wrist Blood Pressure | ||
| Monitor | AGE Automatic Wrist Blood | ||
| Pressure Monitor | -- | ||
| Model Name | BW-601, BW-602, BW-603, BW- | ||
| 605, BW-606, BW-611, BW-612, | |||
| BW-613 | BW-601, BW-602, BW-603, BW- | ||
| 605, BW-606, BW-611, BW-612, | |||
| BW-613 | -- | ||
| Classification | |||
| Name | System, Measurement, Blood- | ||
| Pressure, Non-Invasive | System, Measurement, Blood- | ||
| Pressure, Non-Invasive | SE | ||
| 510(k) Number | Applying | K151281 | -- |
| Product Code | DXN | DXN | SE |
| Intended Use / | |||
| Indications for | |||
| Use | Automatic Wrist Blood Pressure | ||
| Monitor is for use by medical | |||
| professionals or at | |||
| home and is a non-invasive | |||
| blood pressure measurement | |||
| system intended to measure the | |||
| diastolic and systolic blood | |||
| pressures and pulse rate of an | |||
| adult individual by using a | |||
| non-invasive technique in which | |||
| an inflatable cuff is wrapped | |||
| around the wrist. The cuff | |||
| circumference is limited to 13.5 | |||
| cm~19.5 cm. | AGE Automatic Wrist Blood | ||
| Pressure Monitor is for use by | |||
| medical professionals or at | |||
| home and is a non-invasive | |||
| blood pressure measurement | |||
| system intended to measure the | |||
| diastolic and systolic blood | |||
| pressures and pulse rate of an | |||
| adult individual by using a | |||
| non-invasive technique in which | |||
| an inflatable cuff is wrapped | |||
| around the wrist. The cuff | |||
| circumference is limited to 13.5 | |||
| cm~19.5 cm. | SE | ||
| Energy source | 3Vdc (2 "AAA" batteries) | 3Vdc (2 "AAA" batteries) | SE |
| Software | Same version software | SE | |
| hardware | Same version hardware | SE | |
| Material | ABS plastic, Nylon, Latex | ABS plastic, Nylon, Latex | SE |
| Measurement | |||
| Site | Wrist | Wrist | SE |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Verdict |
| Measuring | |||
| range | Pressure: 0~294 mmHg | ||
| Pulse: 40~199 beats/minute | Pressure: 0~294 mmHg | ||
| Pulse: 40~199 beats/minute | SE | ||
| Pressure | |||
| resolution | 1 mmHg or 0.1kPa | 1 mmHg or 0.1kPa | SE |
| Measuring | |||
| accuracy | Pressure: ± 3mmHg | ||
| Pulse: ±5% | Pressure: ± 3mmHg | ||
| Pulse: ±5% | SE | ||
| Cuff | |||
| Circumference | 13.5~19.5cm | 13.5~19.5cm | SE |
| Inflation and | |||
| Deflation | Automatic | Automatic | SE |
| Measuring | |||
| Method | Oscillometry | Oscillometry | SE |
| Patient | |||
| Population | Adult | Adult | SE |
| Display | Blood Pressure (Systolic and | ||
| Diastolic), Pulse, Date, Time, | |||
| WHO BP Classification | |||
| Indicating Bar, Low Battery Icon, | |||
| Heart Icon, Memory Record | |||
| Number | Blood Pressure (Systolic and | ||
| Diastolic), Pulse, Date, Time, | |||
| WHO BP Classification | |||
| Indicating Bar, Low Battery Icon, | |||
| Heart Icon, Memory Record | |||
| Number | SE | ||
| Software | |||
| Version | V01 | V01 | SE |
| Size and | |||
| Weight of | |||
| model BW-601 | 73.5mm(L) | ||
| 73.2mm(W) | |||
| 30.9mm(H) | |||
| 270g | 73.5mm(L) | ||
| 73.2mm(W) | |||
| 30.9mm(H) | |||
| 270g | SE | ||
| Size and | |||
| Weight of | |||
| model BW-602 | 72.69mm(L) | ||
| 64.0mm(W) | |||
| 28.0mm(H) | |||
| 150g | 73.5mm(L) | ||
| 73.2mm(W) | |||
| 30.9mm(H) | |||
| 270g | SE | ||
| Size and | |||
| Weight of | |||
| model BW-603 | 76.0mm(L) | ||
| 60.5mm(W) | |||
| 27.1mm(H) | |||
| 260g | 87mm(L) | ||
| 67.9mm(W) | |||
| 31mm(H) | |||
| 262g | SE | ||
| Size and | |||
| Weight of | |||
| model BW-605 | 73.5mm(L) | ||
| 60.5mm(W) | |||
| 30.9mm(H) | |||
| 270g | 87mm(L) | ||
| 64mm(W) | |||
| 31mm(H) | |||
| 265g | SE | ||
| Note 1 | |||
| Size and | |||
| Weight of | |||
| model BW-606 | 75.0mm(L) | ||
| 70.0mm(W) | |||
| 32.6mm(H) | |||
| 280g | 87mm(L) | ||
| 63.4mm(W) | |||
| 31mm(H) | |||
| 265g | SE | ||
| Size and | |||
| Weight of | |||
| model BW-611 | 75.0mm(L) | ||
| 70.0mm(W) | |||
| 32.6mm(H) | |||
| 280g | 87mm(L) | ||
| 62mm(W) | |||
| 30mm(H) | |||
| 245g | SE | ||
| Note 1 | |||
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Verdict |
| Size and | |||
| Weight of | |||
| model BW-612 | 73.5mm(L) | ||
| 73.2mm(W) | |||
| 30.9mm(H) | |||
| 270g | 78mm(L) | ||
| 72mm(W) | |||
| 29mm(H) | |||
| 255g | SE | ||
| Note 1 | |||
| Size and | |||
| Weight of | |||
| model BW-613 | 76.0mm(L) | ||
| 60.5mm(W) | |||
| 27.1mm(H) | |||
| 260g | 78mm(L) | ||
| 72mm(W) | |||
| 29.6mm(H) | |||
| 260g | SE | ||
| Note 1 | |||
| Operation | |||
| condition | Temperature: 5°C ~ 40°C | ||
| Humidity: 15~90%RH | |||
| Atmospheric Pressure: 86 | |||
| kPa~106 kPa | Temperature: 5°C ~ 40°C | ||
| Humidity: 15~90%RH | |||
| Atmospheric Pressure: 86 | |||
| kPa~106 kPa | SE | ||
| Transport/stora | |||
| ge environment | Temperature: -20°C ~ +65°C | ||
| Humidity: 15~95%RH | |||
| Atmospheric Pressure: 86 | |||
| kPa~106kPa | Temperature: -20°C ~ +65°C | ||
| Humidity: 15~95%RH | |||
| Atmospheric Pressure: 86 | |||
| kPa~106kPa | SE | ||
| Safety | IEC 60601-1 | ||
| IEC 60601-1-11 | |||
| IEC 80601-2-30 | IEC 60601-1 | ||
| IEC 60601-1-11 | |||
| IEC 80601-2-30 | SE | ||
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | SE |
| Biocompatibility | All the patient contracting | ||
| materials are evaluated by the | |||
| biocompatibility standard ISO | |||
| 10993-5, -10. | All the patient contracting | ||
| materials are evaluated by the | |||
| biocompatibility standard ISO | |||
| 10993-5, -10. | SE |
Comparison table:
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Comparison in Detail(s):
Note 1:
Although there is a little difference for "appearance", "Physical Dimensions" and "Weight" from the predicate devices, but it will not affect the main function and the intended use of the device.
Final Conclusion:
The subject device noninvasive sphygmomanometer (Automatic Upper Wrist Blood Pressure Monitor) (Model: BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613) has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.
Except for new tests mentioned in section 6.2 above, all hardware and software of the subject device are based on that of the predicate device K151281.