(121 days)
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Not Found
No
The summary describes a standard blood pressure monitor with no mention of AI or ML components or functionalities.
No
Explanation: The device is intended to measure blood pressure and pulse rate, not to treat any medical condition. While the information it provides can be used in a therapeutic context, the device itself is for diagnostic/monitoring purposes.
No
Explanation: The device measures physiological parameters (systolic, diastolic, and pulse rate) but its intended use statement does not indicate that these measurements are used to diagnose a disease, condition, or state of health. It is a measurement device.
No
The device description explicitly lists hardware components such as an inflatable cuff, LCD display, semiconductor sensor, internal air pump, battery/AC/DC power source, and keys for operation. This indicates it is a hardware device with potentially integrated software, not a software-only medical device.
Based on the provided information, 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 the device measures systolic, diastolic, and pulse rate by using an inflating cuff wrapped around the upper arm. This is a non-invasive measurement of physiological parameters directly from the body, not a test performed on a sample taken from the body.
- Lack of IVD Indicators: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are characteristic of IVD devices.
Therefore, the Arm BPM described is a medical device for measuring blood pressure and heart rate, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Arm BPM is intended to measure the systolic, 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
DXN
Device Description
The Arm BPM is designed to measure the systolic, and pulse rate (heart rate) of an individual. The device consists of an inflatable cuff that is wrapped around the upper arm and held in place with Velcro™, a LCD display, a semiconductor sensor, an internal air pump, a battery power or AC/DC 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
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In addition to the conformity standards of the predicate device, this Arm BPM also complies with EN60601-1 (LVD test).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K-jump Health Co., Ltd. Arm Blood Pressure Monitor Models KP-6821, KP-6822
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
ATTACHMENT 4
APR 2 1 2005
510(k) Summary
K-jump's Arm Blood Pressure Monitor, Models KP-6821A, KP-6822A series. Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Daniel Tseng K-jump Health Co., Ltd No. 56 Wu Kung 500 Road Wu Ku Industrial Park Taipei Hsien, Taiwan Phone: +886 2 2299 1378 Facsimile: +886 2 2299 1386 Date Prepared: December 9, 2004
Name of Device and Name/Address of Sponsor
Arm Blood Pressure Monitor, Models KP-6821A and KP-6822A K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien, Taiwan Phone: +886 2 2299 1378 Facsimile: +886 2 2299 1386 Contact person: Daniel Tsenq
| Common or Usual Name: | Blood Pressure Monitor |
|---|---|
| Classification Name: | System, Measurement, Blood Pressure, Non-invasive |
| Predicate Device: | K-jump Health Co., Ltd. Arm Blood Pressure Monitor Models |
| KP-6821, KP-6822 |
Intended Use
The Arm BPM is intended to measure the systolic, 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.
Technological Characteristics
The Arm BPM is designed to measure the systolic, and pulse rate (heart rate) of an individual. The device consists of an inflatable cuff that is wrapped around the upper arm and held in place with Velcro™, a LCD display, a semiconductor sensor, an internal air pump, a battery power or AC/DC power source, and keys for operation.
Performance Data
In addition to the conformity standards of the predicate device, this Arm BPM also complies with EN60601-1 (LVD test).
1
Image /page/1/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2005
K-Jump Health Co., Ltd. c/o Mr. Daniel Tseng President and CEO No.56 Wu Kung 5th Road Wu Ku Industrial Park TaiPei Hsien TAIWAN
Re: K043531
Ko45531
Trade Name: Arm Blood Pressure Monitor, Models, KP-6821A and KP-6822A Regulation Number: 21 CFR 870.1130 Regulation Name: Blood Pressure Monitor Regulatory Class: Class II Product Code: DXN Dated: December 09, 2004 Received: December 21, 2004
Dear Mr. Tseng:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosule) to regists the Medical Device Amendments, or to conninered prof to May 20, 1978, the occordance with the provisions of the Federal Food, DNIg, devices 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, merelore, manel of the Act include requirements for annual registration, listing of general controls provisions of arctice, 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 (500 above) ans. Existing major regulations affecting your device can Inay be subject to suen additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs acements concerning your device in the Federal Register.
2
Page 2 – Mr. Daniel Tseng
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuated or a bevice complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must or any Federal statutes and regariations and admited to: registration and listing (21 Comply with an the 70c s requirements, n.i. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 radiation control provisions (Device as described in your Section 510(k) I ms letter will anow you to begin manicaling of substantial equivalence of your device to a legally premarket notification. The PDA midning of backansal of the 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 advice for your as not the case note the regulation entitled, and Colliact the Orice of Complanes at (21CFR Part 807.97). You may obtain " Misbranding by relefence to premants. Louited in the Act from the Division of Small other general information on your responsible in the 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,
Dmula R. Vochmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
ATTACHMENT 2
Indications for Use Statement
510(k) Number (if known): __ K04353)_
Device Name:
Arm Blood Pressure Monitor models KP-6821A, KP-6822A
Indications for 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 upper arm. The device is indicated for use in adults.
Prescription Use (Per 21 CFR 801 Subpart D)
Over-The Counter Use (21 CFT 807 Subpart C) OR
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Muna R. Mc luner
Concurrence of CDRH, Office
510(k) Number