(197 days)
No
The description details the use of the oscillometric method, a standard technique for blood pressure measurement, and mentions analyzing signals from a pressure sensor. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies summary.
No
The device is intended to monitor blood pressure and pulse rate, not to treat a condition or disease.
No
A diagnostic device identifies a disease or condition. This device monitors blood pressure and pulse rate, which are physiological parameters, not a diagnosis of a disease.
No
The device description explicitly mentions an "inflatable cuff," "electronic capacitive pressure sensor," and "battery," all of which are hardware components. The device is described as a physical blood pressure monitor, not solely software.
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: The Automatic Upper Arm Blood Pressure Monitor measures blood pressure and pulse rate by applying a cuff to the upper arm and using the oscillometric method. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
- Intended Use: The intended use is to monitor and display blood pressure and pulse rate, which is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
Product codes
DXN
Device Description
Automatic Upper Arm Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable cuff is wrapped around upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but using an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic and calculating pulse rate is a well-known technique in the market so called "oscillometric method". 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
Upper Arm
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 Arm 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)
All hardware and software of the subject device are based on that of the predicate device (K172895), since no new testing is presented in the submission.
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 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 10, 2020
Dongguan E-Test Technology Co., Ltd % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, 510000 CHINA
Re: K193624
Trade/Device Name: Automatic Upper Arm Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 25, 2020 Received: April 13, 2020
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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-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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193624
Device Name
Automatic Upper Arm Blood Pressure Monitor
Indications for Use (Describe)
Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
| 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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3
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: 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 Upper Arm Blood Pressure Monitor
Model Name: BA-815, BA-816
Review Panel: Cardiovascular
Product Code: DXN
4
Regulation Number: 870.1130
Requlatory Class: 2
3. Predicate Device Information
| Sponsor | Dongguan Ageless Health Industrial Co., Ltd |
|---|---|
| Device Name and | |
| Model | AGE Automatic Upper Arm Blood Pressure Monitor |
| Models: BA-815, BA-816, BA-818, BA-819 | |
| 510(k) Number | K172895 |
| Product Code | DXN |
| Regulation | |
| Number | 870.1130 |
| Regulation Class | II |
4. Device Description
Automatic Upper Arm Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable cuff is wrapped around upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but using an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic and calculating pulse rate is a well-known technique in the market so called "oscillometric method". The device also has low voltage indication, which will be triggered when the battery is low.
5. Intended Use / Indications for Use
Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
6. Test Summary
5
K193624
The whole product and manufacturing used for the Automatic Upper Arm 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)
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Automatic Upper Arm 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.
6
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict | |
|---|---|---|---|---|
| Company | DONGGUAN E-TEST | |||
| TECHNOLOGY CO., LTD | Dongguan Ageless Health | |||
| Industrial Co., Ltd | -- | |||
| Product Name | Automatic Upper Arm Blood | |||
| Pressure Monitor | AGE Automatic Upper Arm Blood | |||
| Pressure Monitor | -- | |||
| Model Name | BA-815, BA-816 | BA-815, BA-816, BA-818, BA-819 | -- | |
| Classification | ||||
| Name | System, Measurement, Blood- | |||
| Pressure, Non-Invasive | System, Measurement, Blood- | |||
| Pressure, Non-Invasive | SE | |||
| 510(k) Number | Applying | K172895 | -- | |
| Product Code | DXN | DXN | SE | |
| Intended Use / | ||||
| Indications for | ||||
| Use | Automatic Upper Arm Blood | |||
| Pressure Monitor is intended for | ||||
| use by medical professionals or | ||||
| at home to monitor and display | ||||
| diastolic, systolic blood pressure | ||||
| and pulse rate on adult each | ||||
| time, with an air cuff buckled | ||||
| around one's arm according to | ||||
| the instruction in the user's | ||||
| guide manual. | AGE Automatic Upper Arm Blood | |||
| Pressure Monitor is intended for | ||||
| use by medical professionals or | ||||
| at home to monitor and display | ||||
| diastolic, systolic blood pressure | ||||
| and pulse rate on adult each time, | ||||
| with an air cuff buckled around | ||||
| one's arm according to the | ||||
| instruction in the user's guide | ||||
| manual. | SE | |||
| Energy source | DC 6V (4 X AA 1.5V alkaline | |||
| batteries) | DC 6V (4 X AA 1.5V alkaline | |||
| batteries) | SE | |||
| Design | ||||
| Software | Same version software | SE | ||
| ign | ||||
| hardware | Same version hardware | |||
| Material | ABS plastic, Nylon, Latex | ABS plastic, Nylon, Latex | SE | |
| Measurement | ||||
| Site | Upper Arm | Upper Arm | SE | |
| Measuring range | Pressure: 0~280 mmHg | |||
| Pulse: 40~199 beats/minute | Pressure: 0~280 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 | |||
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Verdict | |
| Cuff | ||||
| Circumference | For BA-815: 22-34 cm; | For BA-815: 22-34 cm; | SE | |
| For BA-816: 28-42 cm; | For BA-816: 28-42 cm; | |||
| For BA-818 and BA-819, there | ||||
| are 6 size: | ||||
| size A: 17cm--22cm (SMALL | ||||
| ADULT CUFF) | ||||
| size B: 22cm--30cm (ADULT | ||||
| CUFF-1) | ||||
| size C: 24cm--34cm (ADULT | ||||
| CUFF-2) | ||||
| size D: 22cm--42cm (L-LARGE | ||||
| ADULT CUFF) | ||||
| size E: 30cm--42cm (LARGE | ||||
| ADULT CUFF) | ||||
| size F: 42cm--50cm (EXTRA | ||||
| LARGE ADULT CUFF) | ||||
| Size and Weight | ||||
| of model BA-815 | About 1150g (not include | |||
| battery) | ||||
| (L) 235mm X (D)182mm X | ||||
| (H)210mm | About 1150g (not include battery) | |||
| (L) 235mm X (D)182mm X | ||||
| (H)210mm | SE | |||
| Size and Weight | ||||
| of model BA-816 | About 1150g (not include | |||
| battery) | ||||
| (L) 255mm X (D)201mm X | ||||
| (H)228mm | About 1150g (not include battery) | |||
| (L) 255mm X (D)201mm X | ||||
| (H)228mm | 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, | Blood Pressure (Systolic and | |||
| Diastolic), Pulse, Date, Time, | ||||
| WHO BP Classification Indicating | ||||
| Bar, Low Battery Icon, Heart Icon, | ||||
| Memory Record Number | SE | |||
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Verdict | |
| Heart Icon, Memory Record | ||||
| Number | ||||
| Software | ||||
| Version | V01 | V01 | SE | |
| 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/storage environment | Temperature: -20°C ~ +65°C | |||
| Humidity: 10~95%RH | ||||
| Atmospheric Pressure:86 kPa~106 kPa | Temperature: -20°C ~ +65°C | |||
| Humidity: 10~95%RH | ||||
| Atmospheric Pressure:86 kPa~106 kPa | 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 | ISO 10993 series | ISO 10993 series | SE |
7
8
Comparison in Detail(s):
Final Conclusion:
The subject device noninvasive sphygmomanometer (Automatic Upper Arm Blood Pressure Monitor) (Model: BA-815, BA-816) 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.
All hardware and software of the subject device are based on that of the predicate device (K172895), since no new testing is presented in the submission.