(418 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement technology using an MCU and analog circuits, with no mention of AI or ML terms, training/test sets, or performance metrics typically associated with AI/ML.
No.
The device is for measuring blood pressure and pulse rate, not for treating any medical condition.
Yes
The device measures physiological parameters (blood pressure and pulse rate) to assess an individual's health status, which is a diagnostic function.
No
The device description explicitly states it consists of "external hardwares (such as cuff), analog circuit, and MCU," indicating it includes physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an "Arm Electronic Sphygmomanometer" that measures "diastolic and systolic blood pressures and pulse rate" using a "non-invasive oscillometric technique" by wrapping a cuff around the arm.
- No Sample Analysis: The device does not involve taking any samples from the body or performing any analysis on biological specimens. It directly measures physiological parameters from the body's surface.
Therefore, this device falls under the category of a non-invasive medical device for measuring vital signs, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Arm Electronic Sphygmomanometer 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 oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm~32 cm. It is intended to be used in hospital environment or at home.
Product codes
DXN
Device Description
The proposed devices are battery driven automatic non-invasive blood pressure Monitor. It is used for automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at upper arm within its claimed range and accuracy by oscillometry technique. Devices are consisted of three main parts: external hardwares (such as cuff), analog circuit, and MCU. The devices have the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time.
The proposed devices are intended to be used in medical facilities or at home and provided non-sterile.
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
It is intended to be used in hospital environment 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)
Arm Electronic Sphygmomanometer has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 80601-2-30 standards
- Electromagnetic compatibility test according to IEC 60601-1-2 standard
- Electromagnetic compatibility test according to IEC 60601-1-6 standard
- Performance according to AAMI / ANSI / ISO 81060-2 standard
- Lithium battery report in accordance with IEC62133
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- Usability test according to IEC62366 standard
- Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pressure: ± 3mmHg
Pulse: ±5%
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). 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.
January 27, 2021
ShenZhen Changkun 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: K193387
Trade/Device Name: Arm Electronic Sphygmomanometer Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 27, 2020 Received: December 31, 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.
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
1
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,
for 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
2
Indications for Use
510(k) Number (if known) K193387
Device Name Arm Electronic Sphygmomanometer
Indications for Use (Describe)
Arm Electronic Sphygmomanometer 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 oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm-32 cm. It is intended to be used in hospital environment or at home.
Type of Use (Select one or both, as applicable)
| ☑ Own-The-Counter Use (21 CFR 201.66) |
|---|
| ☐ Prescription Use (Part 201 CFR 201 Subpart D) |
__ 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."
3
| Sponsor: | ShenZhen Changkun Technology CO., LTD. |
|---|---|
| Subject: | Arm Electronic Sphygmomanometer, Models: CK-A120,CK-A136,CK-A138,CK-A139,CK-A155,CK-A155 |
| Device: | A156, CK-A158, CK-A168 |
| Document: | FDA 510(k) Submission Report |
| Name: |
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: ShenZhen Changkun Technology CO., LTD. Establishment Registration Number: Applying Address: 801, 3 floor 4floor 6floor 7floor, B building, NO.69 ,zhenbi road, biling community, biling street, pingshan district, Shenzhen city, Guangdong, China Tel: +86-0755-29100487 Fax: +86-0755-23463480 Contact Person (including title): Steve Li (Manger Representative) E-mail: changkunkj@163.com
Application Correspondent:
Contact Person: Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
2. Subject Device Information
Type of 510(k): Traditional Common Name: Non-invasive blood pressure measurement systems Classification Name: System, Measurement, Blood-Pressure, Non-Invasive Trade Name:Arm Electronic Sphygmomanometer Model Name: CK-A120, CK-A136, CK-A138, CK-A155, CK-A156, CK-A156, CK-A158, CK-A168 Review Panel: Cardiovascular Product Code: DXN Regulation Number: 870.1130 Regulatory Class: 2
3. Predicate Device Information
| Sponsor | Shenzhen BSX Technology Electronics Co., Ltd. |
|---|---|
| Device Name | |
| and Model | Arm-type Electronic Blood Pressure Monitor |
| Model: BSX516, BSX523, BSX525, BSX583, BSX593, BSX595 | |
| 510(k) Number | K183058 |
| Product Code | DXN |
4
ShenZhen Chanqkun Technoloqy CO., LTD. Sponsor: Subject Arm Electronic Sphygmomanometer, Models: CK-A120,CK-A136,CK-A138,CK-A139,CK-A155,CK-Device: A156. CK-A158.CK-A168 Document FDA 510(k) Submission Report Name:
| Regulation
| Number | 870.1130 |
|---|---|
| Regulation | |
| Class | II |
4. Device Description
The proposed devices are battery driven automatic non-invasive blood pressure Monitor. It is used for automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at upper arm within its claimed range and accuracy by oscillometry technique. Devices are consisted of three main parts: external hardwares (such as cuff), analog circuit, and MCU. The devices have the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time.
The proposed devices are intended to be used in medical facilities or at home and provided non-sterile.
5. Intended Use / Indications for Use
Arm Electronic Sphygmomanometer 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 oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm~32 cm. It is intended to be used in hospital environment or at home.
6. Test Summary
Arm Electronic Sphygmomanometer has been evaluated the safety and performance by lab bench testing as following:
- � Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 80601-2-30 standards
- Electromagnetic compatibility test according to IEC 60601-1-2 standard �
- � Electromagnetic compatibility test according to IEC 60601-1-6 standard
- � Performance according to AAMI / ANSI / ISO 81060-2 standard
- � Lithium battery report in accordance with IEC62133
- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- � Usability test according to IEC62366 standard
- � Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Arm Electronic Sphygmomanometer 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 1 | Remark |
|---|---|---|---|
| Elements of | |||
| Comparison | Subject Device | Predicate Device 1 | Remark |
| Company | ShenZhen Changkun Technology | ||
| CO., LTD. | Shenzhen BSX Technology | ||
| Electronics Co., Ltd. | -- | ||
| Product Name | Arm Electronic | ||
| Sphygmomanometer | Arm-type Electronic Blood Pressure | ||
| Monitor | -- | ||
| Model Name | CK-A120, CK-A136, CK-A138, CK- | ||
| A139, CK-A155, CK-A156, CK- | |||
| A158,CK-A168 | BSX516, BSX523, | ||
| BSX525, BSX583, BSX593 and | |||
| BSX595 | -- | ||
| Classification | |||
| Name | systems,measurement,blood | ||
| pressure, Non-invasive | systems,measurement,blood | ||
| pressure, Non-invasive | SE | ||
| 510(k) Number | Applying | K183058 | -- |
| Product Code | DXN | DXN | SE |
| Intended Use and Indications for Use | |||
| Intended Use / | |||
| Indications for | |||
| Use | Arm Electronic | ||
| Sphygmomanometer 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 oscillometric technique in | |||
| which an inflatable CUFF is | |||
| wrapped around the arm of which | |||
| the circumference includes 22 | |||
| cm~32 cm. It is intended to be | |||
| used in hospital environment or at | |||
| home. | The blood pressure monitor 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 oscillometric technique in | |||
| which an inflatable CUFF is | |||
| wrapped around the arm of which | |||
| the circumference includes 22 | |||
| cm~32 cm. It is intended to be used | |||
| in hospital environment or at home. | SE | ||
| Electrical requirement | |||
| Power Supply | 4x1.5V AA Alkaline Battery (CK- | ||
| A138, CK-A139) | |||
| 4x1.5V AAA Alkaline Battery (CK- | |||
| A120, CK-A136) | |||
| 3.7V 400mAh Li-ion Battery (CK- | |||
| A155, CK-A156, CK-A158, CK- | |||
| A168) | 4x1.5V AAA Alkaline Battery | ||
| (BSX516, BSX525, BSX583, | |||
| BSX593 and BSX595) | |||
| 3.7V 400mAh Li-ion Battery | |||
| (BSX523) | SE | ||
| Note 1 | |||
| Performance specification | |||
| Measurement Site | Upper Arm | Upper Arm | SE |
| Measuring range | Pressure: 0mmHg~299 mmHg: | ||
| Pulse: 40 bpm~199 bpm | Pressure: 0mmHg~299 mmHg | ||
| Pulse: 40 bpm ~180 bpm | SE | ||
| Note | |||
| 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 | 22~32cm | 22~32cm | SE |
| Inflation and | Automatic | Automatic | SE |
| Elements of | |||
| Comparison | Subject Device | Predicate Device 1 | Remark |
| Deflation | SE | ||
| Measuring | |||
| Method | Non-invasive Oscillometric | Non-invasive Oscillometric | SE |
| Patient Population | Adult | Adult | SE |
| Display | LCD | LCD | SE |
| Operation | |||
| condition | Temperature: +5 to +40 °C, | ||
| Humidity: 15 to 90% | |||
| Atmospheric Pressure: 80 kPa~106 kPa | Temperature: +5 to +40 °C, | ||
| Humidity: 15 to 85% | |||
| Atmospheric Pressure: 80 kPa~106 kPa | SE | ||
| Note 2 | |||
| Transport/storage | |||
| environment | Temperature: -25°C to +70°C, | ||
| Humidity: ≤93%R.H. | |||
| Atmospheric Pressure: 70 kPa~106 kPa | Temperature: -20°C to +55 °C, | ||
| Humidity: 10 to 93% | |||
| Atmospheric Pressure: 70 kPa~106 kPa | SE | ||
| Note 2 | |||
| 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 | ISO 10993 | SE |
5
Sponsor: ShenZhen Changkun Technology CO., LTD. Arm Electronic Sphygmomanometer, Models: CK-A120,CK-A136,CK-A138,CK-A139,CK-A155,CK-Subject Device: A156, CK-A158,CK-A168 Document FDA 510(k) Submission Report Name:
6
ShenZhen Chanqkun Technoloqy CO., LTD. Sponsor: Subject Arm Electronic Sphygmomanometer, Models: CK-A120,CK-A136,CK-A138,CK-A139,CK-A155,CK-Device: A156, CK-A158,CK-A168 FDA 510(k) Submission Report Document Name:
Comparison
Note 1:
Although the "Power Supply" of the subject device is a little different from the predicate device, they all complied with the requirements of safety standards as IEC 60601-1, IEC 60601-1-2, IEC 80601-2-30 required. So this difference will not raise any safety or effectiveness issue,
Note 2:
Although "Measuring scope", "Operation condition" and "Transport/storage environment" of the subject device are a little different from the predicate devices, but the difference of subject device is very similar with the K183058. So these parameters' differences will not raise any safety or effectiveness issue.
Final Conclusion :
The subject device Non-invasive Sphygmomanometer (Arm Electronic Sphygmomanometer) (Model: CK-A120, CK-A136, CK-A138, CK-A139, CK-A155, CK-A158, CK-A168) 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 K183058.