(142 days)
Not Found
No
The description focuses on standard oscillometric technology and basic data storage/display, with no mention of AI/ML terms or capabilities.
Yes
The device is described as a "non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual" and it also has a "blood pressure level classification" function. These capabilities align with the definition of a therapeutic device designed to monitor a physiological condition for health management.
Yes
The device is intended to measure diastolic and systolic blood pressures and pulse rate, which are physiological parameters used to assess a patient's health status and can indicate the presence of certain conditions.
No
The device description explicitly mentions hardware components such as an inflatable cuff, an internal pump, an LCD, and a silicon integrated pressure sensor, indicating it is a physical device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: This device measures blood pressure and pulse rate by applying a cuff to the wrist and using oscillometric technology. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
- Intended Use: The intended use clearly states it's a "non-invasive blood pressure measurement system."
Therefore, based on the provided information, this Wrist Measurement Electronic Blood Pressure Monitor is a non-IVD medical device.
N/A
Intended Use / Indications for Use
Wrist Measurement 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
Wrist Measurement Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around a wrist automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 60 times measuring result with the day and time. Specially, it has the function of blood pressure level classification.
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)
Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-2002. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-2002.
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
AUG 15 2007
510(k) Summary
ldentification of the submitter:
Submitter: Kodon (Tianjin) Electronic & Electrical Apparatus Co., LTD No 31, Changjiang Road, Nankai District, Tianjin, P.R. China, 300193 Telephone number: 86-22-6052 8012 Fax number: 86-22-6052 6162 Contact: Liu Yi Date of Application: 07/02/2007
ldentification of the product:
| Trade Name: | Wrist Measurement Electronic Blood Pressure Monitor,
Models: KD-791, KD-792, KD-793, KD-795, KD-796,
KD-797, KD-798 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------|
| Common name: | Noninvasive blood pressure measurement
systems |
| Classification name: | Noninvasive blood pressure measurement system
Class per 21 CFR 870.1130 |
Marketed Devices to which equivalence is claimed:
| Device | manufacture | 510(k) number |
|---|---|---|
| KD-726 | Kodon (Tianjin) Electronic and | |
| Electrical Co., Ltd. | K030359 |
Device description:
Wrist Measurement Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around a wrist automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 60 times measuring result with the day and time. Specially, it has the function of blood pressure level classification.
Intended use:
Wrist Measurement Automatic Electronic Blood Pressure Monitor is intended
1
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 wrist according to the instruction in the user's quide manual.
Comparison of technological characteristics of new device to predicate devices:
The design Wrist Measurement Electronic Blood Pressure Monitor utilizes Oscilliometric measurement method, with an electronic interface module and a silicon integrate pressure sensor and a cuff automatically inflated and released by an internal pump over the wrist to obtain blood pressure signals in the same manner as the predicate device.
In addition, we adopt a new technological method in developing the Wrist Memory Automatic Electronic Blood Pressure Monitor so that it has a series of new functions, such as blood pressure level classification and date and time displayed in large screen.
Clinical Tests:
Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-2002. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-2002.
Non-clinical Tests:
All non-clinical tests coincide the following standards, including Electromagnetic Compatibility test Product Safety test and Biocompatibility test.
EN60601-1-2-2001
Medical electrical equipment ---- Part 1-2:General requirements for safety[1] Collateral standards: Electromagnetic compatibility; Requirements and test, IEC60601-1: 1998+A1:1991+A2:1995
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
ISO 10993-5
Biological evaluation of medical device-----part 5: Test for in vitro cytotoxicity. ISO 10993-10
Biological evaluation of medical device --- part 10: Tests for irritation and delayed type hypersensitivity.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2007
Kodon (Tianjin) Electronic & Electrical Apparatus, Co. c/o Mr. Liu Yi No. 31, Changjiang Road, Nankai District Tianjin, China 300193
Re: K070826
Trade Name: Wrist Measurement Electronic Blood Pressure Monitor, Models KD-791, KD-792, KD-793, KD-795, KD-796, KD-797, KD-798 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Date: Not provided Received: July 6, 2007
Dear Mr. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B. Zumimmo for
Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510(k) Number: K070826
Applicant: Kodon (Tianjin) Electronic & Electrical Apparatus Co., LTD
Device name: Wrist Measurement Electronic Blood Pressure Monitor, Models: KD-791, KD-792, KD-793, KD-795 KD-796, KD-797, KD-798
Indications for use:
Wrist Measurement 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
Prescription use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use YES (21 CFR 807 Subpart C)
(Please Do not WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
B/humma
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number Ka 72826
Page 1 of 1