(53 days)
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No
The summary describes a standard blood pressure monitor using an inflatable cuff and sensor, with no mention of AI or ML terms, image processing, or data sets typically associated with AI/ML development.
No
The device is intended to measure blood pressure and pulse rate, which are diagnostic measurements, not therapeutic interventions.
No.
The "Intended Use / Indications for Use" states that the device is "intended to measure the systolic, diastolic, and pulse rate (heart rate)". This indicates it is a measurement device for vital signs, not a diagnostic device. Diagnostic devices are typically used to identify or confirm the presence of a disease or condition, which is not stated as an intended use here.
No
The device description explicitly lists hardware components such as an inflatable cuff, LCD display, semiconductor sensor, internal air pump, and power source.
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 Arm BPM measures blood pressure and pulse rate directly from the body (specifically, the upper arm) using a physical method (inflating cuff). It does not analyze samples taken from the body.
Therefore, the Arm BPM falls under the category of a non-invasive medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / 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.
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 Dot-matrix 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
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
K-jump Health Co., Ltd. Arm Blood Pressure Monitor Models KP-6821A & KP-6822A series
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
Kobi
pi/
nd Date Prepared
K-jump's Arm Blood Pressure Monitor, Model KP-7600 series. Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Daniel Tseng K-jump Health Co., Ltd
No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien, Taiwan Phone: +886 2 2299 1378 Facsimile: +885 2 2299 1386 Date Prepared: June 16, 2006
AUG 1 4 2006
Name of Device and Name/Address of Sponsor
Arm Blood Pressure Monitor, Model KP-7600 series 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: Danny Wanq Email: danny.wang@kjump.com.tw
| 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-6821A & KP-6822A series |
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 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 Dot-matrix LCD display, a semiconductor sensor, an internal air pump, a battery power or ac/dc power source, and keys for operation.
Performance Data
1
K061760
P2/2
In addition to the conformity standards, ANSI/AAMI SP10:2002 Manual, Electronic or Automated Sphygmomanometers, of the predicate device. This Arm BPM also complies with the electrical safety standards 60601-1 Medical Electrical Equipment- Part 1: General Requirements For Safety & 60601-1-2:2001 Medical Electrical Equipment- Part 1-2: General Requirements For Safety- Collateral Standard: Electromagnetic Compatibility-Requirements and Tests.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2006
K-Jump Health Co., Ltd. c/o Mr. Danny Wang Quality Representative No. 56 Wu Kung 5th Rd., Taipei Hsien, Taiwan 248
Re: · K061760
Trade/Device Name: Arm Blood Pressure Monitor, Model KP-7600 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 21, 2006 Received: August 1, 2006
Dear Mr. Wang:
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.
3
Page 2 -- Mr. Danny Wang
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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name:
Arm Blood Pressure Monitor model KP-7600 series
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 arm. The device is indicated for use in adults.
Prescription Use (Per 21 CFR 801 Subpart D)
Over-The Counter Use OR (21 CFT 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K061760 |