(184 days)
K-6210, K-6821, K-6822
Not Found
No
The summary describes a standard electronic blood pressure monitor with basic irregular pulse detection, and there are no mentions of AI, ML, or related concepts.
No.
The device is a blood pressure monitor intended for measurement and detection, not for treating any condition.
Yes
The device is described as measuring systolic and diastolic blood pressure and pulse rate, and it performs irregular pulse detection. These functions involve the detection and measurement of physiological parameters to assess health conditions, which aligns with the definition of a diagnostic device.
No
The device description explicitly lists multiple hardware components including an inflating cuff, LCD display, bellows sensor, internal air pump, valves, battery, and keys for operation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure systolic and diastolic blood pressure and pulse rate by using an inflating cuff wrapped around the arm. This is a direct physiological measurement taken from the body.
- Device Description: The components described (inflating cuff, LCD display, bellows sensor, air pump, valves, battery, keys) are all consistent with a non-invasive physiological monitoring device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or performing tests in vitro (outside the body).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The device is intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff. The device is indicated for use with adults.
The device displays irregular pulse detection (IPD) icon on LCD screen when irregular pulse is detected during blood pressure measurement.
Product codes
DXN
Device Description
The device is an electronic blood pressure monitor. The device consists of an inflating cuff, a LCD display, a bellows sensor, an internal air pump, a leakage valve, an exhaust valve, a battery power resource, and keys for operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arm
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
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)
In accordance with AAMI/ANSI SP10, a clinical trial also was performed to verify the accuracy of in vivo measurement. The results demonstrate that the KP-7500 and KP-7500D accurately measures the patient's blood pressure and pulse rate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K-jump Health Co., Ltd.'s Wristwatch BPM Blood Pressure Monitor Model KP-6210, K-jump Health Co., Ltd.'s Arm BPM Blood Pressure Monitor Model KP-6821 and KP-6822, MicroLife's Upper Arm Blood Pressure Monitor Model BP-3BT0-AP.
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
Ko83753
510(k) Summary
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Mr. Daniel C.M. Tseng K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386
JUN 19 2009
Name of Device
Arm Blood Pressure Monitor Smartlogic Model KP-7500 and Fuzzylogic Model KP-7500D
Name/Address of Sponsor
K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386 Contact Person: Jason Cheng
Common or Usual Name
Arm Blood Pressure Monitor
Classification Name
Class II § 870.1130; System, Measurement, Blood Pressure, Non-Invasive
Predicate Device
- I. K jump Health Co., Ltd.'s Wristwatch BPM Blood Pressure Monitor Model KP-6210.
- II. K-jump Health Co., Ltd.'s Arm BPM Blood Pressure Monitor Model KP-6821 and KP-6822.
- III. MicroLife's Upper Arm Blood Pressure Monitor Model BP-3BT0-AP.
1
Intended Use/Indications for Use
The device is intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff. The device is indicated for use with adults.
The device displays irregular pulse detection (IPD) icon on LCD screen when irregular pulse is detected during blood pressure measurement.
Technological Characteristics
The device is an electronic blood pressure monitor. The device consists of an inflating cuff, a LCD display, a bellows sensor, an internal air pump, a leakage valve, an exhaust valve, a battery power resource, and keys for operation.
Performance Data
The Arm Blood Pressure Monitor Model KP-7500 and KP-7500D complies with the following FDA recognized consensus standards, to the extent that these standards are applicable to this device:
- AAMI/ANSI SP10 (2002 / A1:2003); .
- IEC 60601-1 (1988); and �
- IEC 60601-1-2 (2002). .
The KP-7500 and KP-7500D also complies with the following additional
2
standards:
- . EN61000-4-2 (1995); and
- EN61000-4-3 (2002). .
In accordance with AAMI/ANSI SP10, a clinical trial also was performed to verify the accuracy of in vivo measurement. The results demonstrate that the KP-7500 and KP-7500D accurately measures the patient's blood pressure and pulse rate.
Substantial Equivalence
The KP-7500 and KP-7500D have the same intended use and indications for use as K-Jump's Arm Blood Pressure Monitor Model KP-6210, K-Jump's Wristwatch Blood Pressure Monitor Model KP-6821 and MicroLife's Model BP-3BT0-AP.
The KP-7500 has the same technological characteristics as the KP-6210 except: (1) that the KP-7500 uses a bellows sensor; and (2) the KP-7500 is used on the upper arm rather than on the wrist.
The KP-7500D has the same technological characteristics as the KP-6821 except: (1) that the KP-7500D uses a bellows sensor; and (2) the KP-7500D displays blood pressure and heart rate on the same screen simultaneously rather than on subsequent, alternating screens.
3
Microlife's Model BP-3BT0-AP also uses a bellows sensor same as the KP-7500 and KP-7500D. Both devices include an irregular pulse detection function.
Thus, the minor differences between the KP-7500, KP-7500D and the predicate devices are not new technological characteristics for arm blood pressure monitors. The modification of the device's LCD display was made for user convenience. Therefore, these minor technological differences do not raise any new questions of safety or effectiveness. Accordingly, the KP-7500 and KP-7500D are substantially equivalent to its predicate devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background. The overall design is simple and professional, reflecting the department's role in public health and human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 19 2009
K-jump Health Co., Ltd. c/o Mr. Jason Cheng Regulatory Affairs No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien 248 Taiwan
Re: K083753
Trade/Device Name: Arm Blood Pressure Monitor Smartlogic Model KP-7500 and Fuzzylogic Model KP-7500D Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Monitoring System Regulatory Class: Class II (Two) Product Code: DXN Dated: June 12, 2009 Received: June 16, 2009
Dear Mr. Cheng:
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.
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Page 2 - Mr. Jason Cheng
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
or Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if Known): K083753
Device Name: Arm Blood Pressure Monitor Smartlogic Model KP-7500 and Fuzzylogic Model KP-7500D
Indication for Use:
The KP-7500 and KP-7500D are intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff which is wrapped around the arm. It is indicated for use in adults.
The devices display irregular pulse detection (IPD) icon on LCD screen when irregular pulse is detected during blood pressure measurement.
Prescription Use -------(Per 21 C.F.R. 801.109) -Over-The-Counter-Use-X-(Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
-OR-
of Cardiovascula
510(k) Number K 08373