(28 days)
KP-6120
Not Found
No
The summary describes a standard electronic blood pressure monitor with no mention of AI or ML components or capabilities.
No
The device is intended for measurement, not treatment or diagnosis, and is described as a monitor.
Yes
The device is described as measuring "systolic and diastolic blood pressure and pulse rate," and a "clinical trial... was performed to verify the accuracy of in-vivo measurement" of these vital signs. This process of measuring and characterizing a physiological state to assess health or disease indicates a diagnostic function.
No
The device description explicitly lists multiple hardware components (inflating cuff, LCD display, bellows sensor, internal air pump, etc.), indicating it is a physical medical device, not software-only.
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 blood pressure and pulse rate using an inflating cuff. This is a direct physiological measurement taken on the patient, not a test performed on a sample of bodily fluid or tissue outside the body.
- Device Description: The components described (cuff, display, sensor, pump, valves, battery, keys) are consistent with a non-invasive physiological monitoring device, not an IVD which would typically involve components for handling and analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The KP-7000 is intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff which is wrapped around the wrist. It is indicated for use in adults.
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
wrist
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
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-7000 accurately measures the patient's blood pressure and pulse rate.
Key Metrics
Not Found
Predicate Device(s)
K-jump Health Co., Ltd.'s Wristwatch BPM Blood Pressure Monitor Model I. KP-6120., MicroLife's Wrist Watch Blood Pressure Monitor Model BP-3BU1-3.
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
SEP = 9 2003
510(k) Summary
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Mr. C.M. Daniel Tseng K-iump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386
Date Prepared: August 11, 2003
Name of Device
Wristwatch Blood Pressure Monitor Model KP-7000
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: T.T. Lin
Common or Usual Name
Wrist Blood Pressure Monitor
Classification Name
Class II § 870.1130; System, Measurement, Blood Pressure, Non-Invasive
Predicate Device
- K-jump Health Co., Ltd.'s Wristwatch BPM Blood Pressure Monitor Model I. KP-6120.
- II. MicroLife's Wrist Watch Blood Pressure Monitor Model BP-3BU1-3.
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.
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 Wristwatch Blood Pressure Monitor Model KP-7000 complies with the following FDA-recognized consensus standards, to the extent that these standards are applicable to this device:
- AAMI/ANSI SP10 (1992 / A1:1996); ●
- IEC 60601-1-1 (2000); and .
- IEC 60601-1-2 (2002). ●
The KP-7000 also complies with the following additional 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-7000 accurately measures the patient's blood pressure and pulse rate.
Substantial Equivalence
The KP-7000 has the same intended use and indications for use as K-Jump's Wristwatch Blood Pressure Monitor Model KP-6120 and MicroLife's Model BP-3BU1. The KP-7000 has the same technological characteristics as the the KP6120 except: (1) that the KP-7000 uses a bellows sensor; (2) the KP-7000 has a lower maximum storage temperature; and (3) the KP-7000 displays blood pressure
2
and heart rate on the same screen simultaneously rather than on subsequent, alternating screens. Microlife's Model BP-3BU1 also uses a bellows sensor and has the same maximum storage temperature as the KP-7000. Thus, the minor differences between the KP-7000 and the predicate devices are not new technological characteristics for wrist watch 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-7000 is substantially equivalent to its predicate devices.
3
Public Health Service
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2003
K-Jump Health Co., Ltd c/o Mr. Jonathan S. Kahan Hogan & Hartson L.L.P. 555 Thirteen Street, N.W. Washington, D.C. 20004-1109
Re: K032492
Trade Name: Wristwatch Blood Pressure Monitor Model KP-7000 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure monitor Regulatory Class: Class II (two) Product Code: DXN Dated: August 12, 2003 Received: August 12, 2003
Dear Mr. Kahan:
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 or any Federal statutes and regulations administered by other Federal agencies. You must
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Page 2 - Mr. Jonathan S. Kahan
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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
K. Dalton Tull
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if Known):
K432492 ______________________________________________________________________________________________________________________________________________________________________
Device Name: KP-7000
Wristwatch Blood Pressure Monitor Model
Indication for Use:
The KP-7000 is intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff which is wrapped around the wrist. It is indicated for use in adults.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use X (Optional Format 1-2-96)
N. Deaton
510(k) Number K032492