(199 days)
No
The description focuses on standard oscillometric blood pressure measurement technology and does not mention any AI or ML components.
No
This device is a blood pressure monitor intended for measurement and monitoring, not for treating or curing a medical condition.
No
The device measures blood pressure and pulse rate, which are physiological parameters, but it does not analyze or interpret these measurements to provide a diagnosis of a disease or condition. It simply displays the results.
No
The device description explicitly mentions hardware components such as an inflatable cuff, internal pump, LCD, and electronic interface module, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the KD-575 Memory Automatic Electronic Blood Pressure Monitor 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 KD-575 measures blood pressure and pulse rate by applying a cuff to the upper arm and using an oscillometric technique. This is a non-invasive method that does not involve analyzing samples taken from the body.
The device description clearly states it's a "Non-invasive blood pressure measurement system." This directly contradicts the definition of an IVD.
N/A
Intended Use / Indications for Use
The KD-575 Memory 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 8.6614 inches to 13.78 inches
Product codes
DXN
Device Description
KD-575 Fuily Automatic Electronic 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, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results. It can storage and show 120 times measuring result with the month, day, time of measuring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left upper arm
Indicated Patient Age Range
except infants and unconscious people, with the air cuff around the left upper arm according to the instruction in the user's guide manual. / 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/AAMISP10-1992. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-1992.
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
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510(k) Summary
Identification of the submitter:
| Submitter: | Kodon (Tianjin) Electronic & Electrical Apparatus
Co., LTD
No 31, Changjiang Road, Nankai District, Tianjin,
P.R. China, 300193 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone number: | 86-22-60526082 |
| Fax number: | 86-22-60526162 |
| Contact: | Liu Yi |
| Date of Application: | 08/25/04 |
Identification of the product:
| Device proprietary Name: | KD-575 Memory Automatic Electronic Blood
Pressure Monitor |
|--------------------------|-------------------------------------------------------------------------------|
| Common name: | Noninvasive blood pressure measurement systems |
| Classification name: | Noninvasive blood pressure measurement system
Class II per 21 CFR 870.1130 |
Marketed Devices to which equivalence is claimed:
| Device | manufacture | 510(k) number |
|---|---|---|
| KD-622 | Kodon (Tianjin) Electronic and Electrical | |
| Apparatus Co., Ltd. | K030358 |
Device description:
KD-575 Fuily Automatic Electronic 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, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results. It can storage and show 120 times measuring result with the month, day, time of measuring.
Intended use:
1
use by medical professionals or at home to monitor and display d systolic blood pressure and pulse rate on anyone each time, except infants and unconscious people, with the air cuff around the left upper arm according to the instruction in the user's guide manual.
Comparison of technological characteristics of new device to predicate devices:
KD-575 Memory Automatic Electronic Blood Pressure Monitor can storage and show 120 times measuring results with the month, day, time of measuring. It can help patients to memorize the measuring data of their measuring results. Therefore the patients can analyze the measuring data and inspect their physical conditions. The time and the date are the advantages of KD-575 compare with the predicate device.
Clinical Tests:
Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-1992. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-1992.
Non-clinical Tests:
tests the following standards, including non-clinical coincide All Electromagnetic Compatibility test.
IEC601-1 (1988)
Medical electrical equipment --- Part 1:General requirements for safety IEC601-1 (1988)
Amendment 2
IEC 60602-2-30: 1995
Medical electrical equipment-part2: Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment. GB9706.1-1995 ISO 1833-1977
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three curved lines representing its wings or feathers.
MAR 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kondon (Tianjin) Electronic & Electrical Apparatus Co., Ltd. c/o Mr. Liu Yi President, Board of Directors No. 31. Changjiang Road Tianjin CHINA 300193
Re: K042418
Trade/Device Name: KD-575 Fully Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 18, 2005 Received: January 21, 2005
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.
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
3
Page 2 - Mr. Liu Yi
or any Federal statutes and regulations administered by other Federal agencies. You must or ally Federal statutes and regulations and admited to: registration and listing (21 comply with an the Act 3 requirements, morealing, were and 800 manufacturing as set 80 miles of as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radianon control provisions (Declons of I device as described in your Section 5 10(k) I his letter will anow you to obgin maneting your antial equivalence of your device to a legally premits notification. THC PDA miding of castomination 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 If you desire specific acrive ior your as (240) 276-0120. Also, please note the regulation entitled, Contact the Online of Comphane at (210) 21 Top Part 807.97). You may obtain Misoranding by reference to premanteering in the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimmarfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K042418
Device Name: KD-575 Fully Automatic Electronic Blood Pressure Monitor
Indications For Use:
The KD-575 Memory 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 8.6614 inches to 13.78 inches
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhummer
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K042418
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Yes