(121 days)
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.
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.
The provided document is a 510(k) summary for the K-jump Arm Blood Pressure Monitor, Models KP-6821A and KP-6822A. It describes the device's intended use and technological characteristics, and references conformity to EN60601-1 (LVD test) in addition to the predicate device's standards. However, it does not contain detailed information regarding specific acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance data.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's a breakdown of what can be reported and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states: "In addition to the conformity standards of the predicate device, this Arm BPM also complies with EN60601-1 (LVD test)." It does not provide specific numerical acceptance criteria (e.g., accuracy ranges for blood pressure measurements) or actual device performance values against such criteria. EN60601-1 is a general standard for the safety of medical electrical equipment, not specifically for blood pressure measurement accuracy.
Therefore, a table cannot be populated as requested.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For blood pressure monitors, ground truth typically comes from reference sphygmomanometers operated by trained personnel, not necessarily "experts" in the same way as medical image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
MRMC studies and AI assistance are not relevant to this type of device (a blood pressure monitor). This information is not provided and would not be expected for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone blood pressure monitor. Performance tests would inherently be "standalone" in the sense that the device measures blood pressure without continuous human interpretation of its output in a diagnostic context. However, the details of such performance tests are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The specific method for establishing ground truth for blood pressure measurements is not explicitly stated, but it would typically involve comparison to readings from a validated reference sphygmomanometer (e.g., mercurial or oscillometric) operated by trained individuals, following established protocols (e.g., AAMI or ISO standards).
8. The sample size for the training set
This information is not provided in the document. Blood pressure monitors typically do not involve statistical "training sets" in the same way machine learning algorithms do; their calibration and validation are based on comparison to reference devices.
9. How the ground truth for the training set was established
This information is not provided in the document.
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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).
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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.
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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
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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 < 043531
§ 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).