(157 days)
Not Found
No
The provided text describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities. The operational principle is based on established pressure sensing technology and classification based on a blood pressure classification indicator, which is a standard feature. There is no mention of AI/ML in the device description, intended use, or performance studies.
No
The device is a blood pressure monitor intended for measurement and diagnostic purposes, not for treating any condition.
Yes
The device is a blood pressure monitor intended to measure diastolic and systolic blood pressures and pulse rate, which are used to diagnose and monitor cardiovascular conditions.
No
The device description explicitly mentions an "inflatable cuff" and "silicon integrates pressure sensor technology," indicating physical hardware components are integral to its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are 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 description clearly states that this device is a "non-invasive blood pressure measurement system" that measures blood pressure and pulse rate by wrapping a cuff 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, which is a physiological measurement taken directly from the body, not an analysis of a sample.
Therefore, this device falls under the category of a non-invasive medical device for physiological measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
KD-726N, KD-737, KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-7961N, KD-797M, KD-798B and KD-798M 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 wrist. The cuff circumference is limited to 14cm-25cm.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
KD-726N. KD-737. KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-7961N, KD-797M, KD-798B and KD-798M 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 wrist. The cuff circumference is limited to 14cm-25cm.
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
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)
KD-726N, KD-737, KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-7961N, KD-797M, KD-798B and KD-798M 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 Essential Performance - Collateral Standard: Electromagnetic 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): 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three overlapping human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2016
Andon Health Co., Ltd Ms. Liu Yi President No.3 Jin Ping Street, Ya An Road, Nankai District Tianjin, 300190 CN
Re: K160563
Trade/Device Name: KD-726N, KD-737, KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-7961N, KD-797M, KD-798B and KD-798M 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.
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
1
Page 2 - Ms. Liu Yi
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 vours.
Mude Jellman
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) K160563
Device Name
KD-726N, KD-737, KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-797M, KD-798B and KD-798M Fully Automatic Electronic Blood Pressure Monitor
Indications for Use (Describe)
KD-726N, KD-737, KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-7961N, KD-797M, KD-798B and KD-798M 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 wrist. The cuff circumference is limited to 14cm-25cm.
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
K160563
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
- KD-726N, KD-737, KD-7902B, KD-7902BT, KD-7903W, Trade name: KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-7961N, KD-797M, KD-798B and KD-798M 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-7966 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K111830
5.0 Device description
KD-726N. KD-737. KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-7961N, KD-797M, KD-798B and
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K160563 Page 2 of 4
KD-798M 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 wrist. The cuff circumference is limited to 14cm-25cm.
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-726N, KD-737, KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-7961N, KD-797M, KD-798B and KD-798M 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 wrist. The cuff circumference is limited to 14cm-25cm.
The intended use and the indication for use of these monitors, as described in their labeling are the same as the predicate device KD-7966.
| 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-726N, 737, 7902B, 7902BT, 7903W, 791(V1), 7941B, 795B, 795M, 7961N, 797M, 798B and 798M 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-726N, KD-737, KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-7961N, KD-797M, KD-798B and KD-798M 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 Essential Performance - Collateral Standard: Electromagnetic 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
device KD-726N, KD-737, KD-7902B, KD-7902BT, KD-7903W, Our KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-7961N, KD-797M, KD-798B and KD-798M Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-7966 whose 510(k) number is K111830.
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K160563 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.