(74 days)
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No
The document describes a standard blood pressure monitor using an inflatable cuff and sensor, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is intended for measurement and monitoring of vital signs (blood pressure and heart rate), not for treatment or therapy.
No
The device is intended to measure vital signs (systolic, diastolic, and pulse rate), not to diagnose a disease or condition. While the measurements can be used for diagnostic purposes by a healthcare professional, the device itself is a measurement tool.
No
The device description explicitly lists hardware components such as an inflatable cuff, LCD display, semiconductor sensor, internal air pump, battery power source, and keys for operation.
No, this device 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 description clearly states that this device measures blood pressure and pulse rate by using an inflating cuff wrapped around the arm. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
- Lack of Sample Analysis: There is no mention of analyzing any biological samples.
Therefore, based on the provided information, the Arm BPM is a non-invasive medical device for measuring vital signs, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The K-Jump Arm Blood Pressure Monitor, Model KP-6821 AND KP-6822 are intended to measure the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm. The device is indicated for use in adults.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Arm BPM is designed to measure the systolic, diastolic, and pulse rate (heart rate) of an individual. The device consists of an inflatable cuff that is wrapped around the arm and held in place with Velcro™, an LCD display, a semiconductor sensor, an internal air pump, a battery power source, and keys for operation.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Arm, upper arm
Indicated Patient Age Range
adults
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
K-Jump conducted a clinical trial in accordance with the ANSI/AAMI SP10A-1996 "Electronic or Automatic Sphygmomanometer" standard. One hundred patients had their blood pressure and heart rate tested with both an Ausculatory Mercurial Sphygmomanometer and the Arm BPM.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
510(k) SUMMARY
K-Jump's Arm Blood Pressure Monitor, Models KP-6821 and KP-6822 series
p. 1/2
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
MAR 5 2002
Daniel 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 22331386
Date Prepared: November 5, 2001
Name of Device and Name/Address of Sponsor
Arm Blood Pressure Monitor, Model KP-6821 and KP-6822
K-Jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: 011 886 2 22991378 Facsimile: 011 886 2 22331386 Contact Person: Daniel Tseng
| Common or Usual Name | Blood Pressure Monitor |
|---|---|
| Classification Name | System, Measurement, Blood Pressure, Non-Invasive |
| Predicate Device | I. A & D Engineering Inc. |
| Arm Blood Pressure Monitor Model UA-779 | |
| II. K-Jump Health Co., Ltd. | |
| Wristwatch Blood Pressure Monitor Model KP-6120 |
Intended Use
The Arm BPM is intended to measure the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the arm. The device is indicated for use in adults.
1
Technological Characteristics
The Arm BPM is designed to measure the systolic, diastolic, and pulse rate (heart rate) of an individual. The device consists of an inflatable cuff that is wrapped around the arm and held in place with Velcro™, an LCD display, a semiconductor sensor, an internal air pump, a battery power source, and keys for operation.
1014204 p. 2/2
Performance Data
The Arm BPM complies with EN 60601-1-2 (1993); EN 55011 (1991), IEC 801-2 (1991); IEC 801-3; EN 1060-1 and EN 1060-3 and the AAMI/ANSI SP10A-1996 standard. "Electronic or Automatic Sphygmomanometer."
K-Jump conducted a clinical trial in accordance with the ANSI/AAMI SP10A-1996 "Electronic or Automatic Sphygmomanometer" standard. One hundred patients had their blood pressure and heart rate tested with both an Ausculatory Mercurial Sphygmomanometer and the Arm BPM.
Substantial Equivalence
The Arm BPM is substantially equivalent to the A & D Engineering Inc.'s Arm BPM Model UA-779 and K-Jump's WristWatch BPM Model 6120. The Arm BPM and its predicate device are all noninvasive blood pressure monitors. Both the Arm BPM and A & D's Arm BPM take readings from the Upper Arm using the oscillometric method. The Arm BPM and A & D UA-779 have the same intended use, principles of operation and virtually identical technological characteristics. With the exception of minor variations in pressure measurement ranges, minimum operational relative humidity, minimum storage temperature and memory capacity, the devices are technologically identical. These minor differences do not raise any new issues of safety or effectiveness because both devices comply with the AAMI/ANSI SP10A-1996 standard "Electronic or Automated Sphygmomanometer".". Thus, the Arm BPM is substantially equivalent to the A & D's UA-779 and the WristWatch BPM. Further, the Arm BPM substantial equivalence is demonstrated by conformance to the ANSI/AAMI SP10A-1996 standard.
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Image /page/2/Picture/1 description: The image shows a black and white circular logo. The logo features the symbol of the Department of Health and Human Services (HHS) in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 5 2002
K-Jump Health Co., Ltd. c/o Mr. Jonathan S. Kahan, Esq. Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004
Re: K014204
Trade Name: Arm Blood Pressure Monitor, Models KP-6821, KP-6822 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: December 21, 2001 Received: December 21, 2001
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreated of the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 2017, 11:24 accordance with the provisions of the Federal Food, Drug, de rices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mererere, maxis of the Act include requirements for annual registration, listing of general controlly profices of tactice, 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 If your device is classified (600 a00 royals. 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. Jonathan S. Kahan
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 that i Drines Internations administered by other Federal agencies. You must or any I catal button and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fat 607); adoning (21 OFF 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) I mis lotter will and in yourse FDA finding of substantial equivalence of your device to a legally promative noticated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 301) 594-4646. Additionally, for questions on the promotion and advertising of Compinance at (301) 59 + + the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general millimantes turers, 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,
signature
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): _
Device Name: K-JUMP Health Co., Ltd. Arm Blood Pressure Monitor, Models KP-6821 and KP-6822 series
Indication for Use:
The K-Jump Arm Blood Pressure Monitor, Model KP-6821 AND KP-6822 are intended to measure the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm. The device 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)
Division of Cardiovascular & Respiratory Devices
510(k) N:
2014 207
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OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________