(261 days)
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No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities.
No
The device is a blood pressure monitor used for monitoring, not for treating a disease or condition. Therefore, it is a diagnostic/monitoring device, not a therapeutic one.
No
Explanation: The device is a "Blood Pressure Monitor" which measures blood pressure and pulse rate. While these measurements can be used by a healthcare professional for diagnosis, the device itself is for "Home Health Care" and "monitor[ing]" these vital signs, not for diagnosing conditions. It also explicitly states "The KLOCK is not intended to be used by people who have circulatory problems, such as arrhythmia," which suggests it's not designed to diagnose or manage such conditions.
No
The device description explicitly states "Watch Style Wrist Digital Blood Pressure Monitor," indicating a hardware component (the watch/monitor itself) is integral to the device's function of obtaining blood pressure measurements via the oscillometric method.
Based on the provided information, the KLOCK Blood Pressure Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The KLOCK Blood Pressure Monitor directly measures physiological parameters (blood pressure and pulse rate) from the body itself, not from a specimen. It uses the oscillometric method to detect blood movement within the artery.
Therefore, the KLOCK Blood Pressure Monitor falls under the category of a non-IVD medical device used for monitoring physiological signs.
N/A
Intended Use / Indications for Use
The KLOCK Blood Pressure Monitor is to be used by adults as a Home Health Care device to monitor Blood Pressure (systolic and diastolic) and the Pulse rate at home. The Blood Pressure Measurement is obtained by the use of the oscillometric method, meaning that the monitor detects the blood's movement through the artery in the wrist and converts the movements into digital readings. The KLOCK is not intended to be used by people who have circulatory problems, such as arrhythmia, or if pregnant.
Product codes
DXQ
Device Description
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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
wrist
Indicated Patient Age Range
adults
Intended User / Care Setting
Home Health Care
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
JAN 1 9 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Guenter Ginsberg President Media Trade Corporation Industrielle Entwicklung Medizinttechnik 11641 Red Hibiscus Drive Bonita Springs, FL 34135
Re: K991545 Watch Style Wrist Digital Blood Pressure Monitor Regulatory Class: II Product Code: DXQ Dated: October 27, 1999 Received: November 1, 1999
Dear Mr. Ginsberg:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of The general controls provisions of the Act include the Act. 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 (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice reguirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, the Food and Druq Administration (FDA) may publish further announcements concerning your device in the Federal Please note: this response to your premarket Register. notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to continue marketing your device as described in your 510(k) premarket notification. The FDA finding
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Page 2 - Mr. Guenter Ginsberg
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
for/Bora R. Lemperle
Celia M. Witten, Ph.D. Acting Director Division of Cardiovascular Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indication for Use Statement
510(k) Number: K991545 Device Name: Watch Style Wrist Digital Blood Pressure Monitor
The KLOCK Blood Pressure Monitor is to be used by adults as a Home Health Care device to monitor Blood Pressure (systolic and diastolic) and the Pulse rate at home. The Blood Pressure Measurement is obtained by the use of the oscillometric method, meaning that the monitor detects the blood's movement through the artery in the wrist and converts the movements into digital readings. The KLOCK is not intended to be used by people who have circulatory problems, such as arrhythmia, or if pregnant.
Segre G. Kemperle
(Division Sign Off)
Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurologic . Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________
X over-the-counter