(163 days)
KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559, KD-516
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML components, training data, or related performance metrics.
No
The device is described as a "non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate," indicating it is a diagnostic tool, not a therapeutic one.
Yes
The device is described as a "blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate," which are measurements used for diagnostic purposes. It also mentions that "the measurements results can also be classified by the function of blood pressure classification indicator," implying the device aids in classifying the state of blood pressure, a diagnostic function.
No
The device description explicitly states it is a "Fully Automatic Electronic Blood Pressure Monitor" and describes physical components like an "inflatable cuff" and an "LCD," indicating it is a hardware device with integrated software, not a software-only 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: The description clearly states that this device 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 upper arm."
- Non-Invasive: The key term here is "non-invasive." The device measures physiological parameters directly from the body's surface without requiring a sample to be taken and analyzed outside the body.
Therefore, since the device measures blood pressure and pulse rate non-invasively on the body, it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor are 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 upper arm. The cuff circumference is limited to 22cm-48cm.
Product codes
DXN
Device Description
KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-575N. KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor are 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 upper arm. The cuff circumference is limited to 22cm-48cm.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. Achieves its function by an LCD.
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)
KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-575N, KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor will conform to the following standards before marketing:
- IEC60601-1:2005+CORR.1(2006)+CORR.2(2007)/EN60601-1:2006/A11: 2011, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- IEC 60601-1-2:2007/EN 60601-1-2:2007+AC:2010, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Performance - Collateral Standard: Electromagnetic Essential Compatibility - Requirements And Tests
- IEC 80601-2-30: 2009+A1: 2013, Medical Electrical Equipment Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers
- ANSI/AAMI/ISO 81060-2:2009, Non-invasive sphygmomanometer part 2: Clinical validation of automated measurement type
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in promoting the health and well-being of the nation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 10, 2016
Andon Health Co., Ltd Ms. Liu Yi President No.3 Jin Ping Street, Ya An Road, Nankai District Tianjin, 300190 CN
Re: K160565
Trade/Device Name: KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-575N, KD-5917D, KD-5917N, KD- 595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic 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: February 26, 2016 Received: March 4, 2016
Dear Ms. Liu Yi,
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. 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
Page 2 - Ms. Liu Yi
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
M.A. Hillebrenner
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160565
Device Name
KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor
Indications for Use (Describe)
KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor are 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 upper arm. The cuff circumference is limited to 22cm-48cm.
| Type of Use (Select one or both, as applicable) | Residential Use (Rentals of 30+ Days, Sales, etc.). Please call 1-877-391-5261 to set up your account.Short-Term Connection (Under 30 Days). Please call 1-877-391-5261 to set up your account. | Residential Use (Rentals of 30+ Days, Sales, etc.). Please call 1-877-391-5261 to set up your account. | Short-Term Connection (Under 30 Days). Please call 1-877-391-5261 to set up your account. | ||
|---|---|---|---|---|---|
| Residential Use (Rentals of 30+ Days, Sales, etc.). Please call 1-877-391-5261 to set up your account. | |||||
| Short-Term Connection (Under 30 Days). Please call 1-877-391-5261 to set up your account. |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K160565
Page 1 of 4
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.
1.0 submitter's information
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No 3, Jinping Street, Ya An Road, Nankai District, Tianjin, |
| P.R. China | |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 02/26/2016 |
2.0 Device information
- Trade name: KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-575N, KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor
Common name: Noninvasive blood pressure measurement system Classification name: Noninvasive blood pressure measurement system
3.0 Classification
Production code: DXN- Noninvasive blood pressure measurement system. Regulation number: 870.1130 Classification: II Panel: Cardiovascular
4.0 Predicate device information
Manufacturer: Andon Health Co., Ltd. Device: KD-513LU Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K121372
5.0 Device description
KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-575N. KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and
4
K160565 Page 2 of 4
KD-516 Fully Automatic Electronic Blood Pressure Monitor are 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 upper arm. The cuff circumference is limited to 22cm-48cm.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. Achieves its function by an LCD.
6.0 Intended use
KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-575N, KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic 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 upper arm. The cuff circumference is limited to 22cm-48cm.
The intended use and the indication for use of these monitors, as described in their labelings are the same as the predicate device KD-513LU.
| Technological Characteristics | Comparison result |
|---|---|
| Design principle | Identical |
| Appearance | The |
| weight(excluding batteries) and | |
| dimensions are changed. | |
| Patients contact Materials | Identical |
| Function | The memory time, function of display IHB, |
| voice and touch function, averaging | |
| function, time format displayed | |
| are | |
| changed. | |
| Biocompatibility | Identical |
7.0 Summary comparing technological characteristics with predicate device
5
KD-388N, 5031L, 5031N, 5031N, 525EN, 575N, 5917N, 595B, 5961B, 5963NG, 559 and 516 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files
| Mechanical safety | Identical |
|---|---|
| Energy source | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Performance | The cuff pressure range and |
| microprocessor are changed. | |
| Environmental | The temperature and humidity for |
| operation, storage and transport are | |
| changed. |
8.0 Performance summary
KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-575N, KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor will conform to the following standards before marketing:
- IEC60601-1:2005+CORR.1(2006)+CORR.2(2007)/EN60601-1:2006/A11: 2011, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- · IEC 60601-1-2:2007/EN 60601-1-2:2007+AC:2010, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Performance - Collateral Standard: Electromagnetic Essential Compatibility - Requirements And Tests
- IEC 80601-2-30: 2009+A1: 2013, Medical Electrical Equipment Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers
- · ANSI/AAMI/ISO 81060-2:2009, Non-invasive sphygmomanometer part 2: Clinical validation of automated measurement type
9.0 Comparison to the predicate device and the conclusion
Our device KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-575N, KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-513LU whose 510(k) number is K121372.
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K160565 Page 4 of 4
These devices are very similar in the intended use, the design principle, the material, the performance and the applicable standards. Only their appearance, the memory time, and the user interface are different.
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.