(209 days)
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Not Found
No
The summary describes a standard wrist blood pressure monitor and does not mention any AI or ML capabilities.
No
The device is a blood pressure monitor used for measurement and monitoring, not for treating or rehabilitating a condition.
Yes
Explanation: The device measures diastolic and systolic blood pressure and pulse rate, which are physiological parameters used to assess the health status of an individual. This falls under the definition of a diagnostic device.
No
The device description explicitly states it is a "Wrist Type Blood Pressure Monitor" and mentions an "inflatable cuff wrapped around the wrist," indicating it includes hardware components for blood pressure measurement.
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 this device is a "non-invasive blood pressure measurement system" that measures blood pressure and pulse rate by using a cuff wrapped around the wrist. This is a direct measurement of physiological parameters from the body, not an analysis of a sample taken from the body.
Therefore, the Wrist Type Blood Pressure Monitor falls under the category of a non-invasive medical device used for monitoring physiological signs, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Wrist Type Blood Pressure Monitor is for use at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The theoretical range of cuff circumference is limited to 14-19.5cm.
Product codes
DXN
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
adult
Intended User / Care Setting
use at home
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Harvard Medical Devices Ltd. c/o Mr. Martin Ma Unit 1301-2, 13th Floor, Railway Plaza 39 Chatam Road South Tsimshatsui, Kowloon
Re: K092558
Hong Kong
Trade Name: Wrist Type Blood Pressure Monitor, HMBPM-005/Kinetik Branded BPM2 Series Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Monitors Regulatory Class: Class II (two) Product Code: DXN Dated: undated Received: February 26, 2010
Dear Mr. Ma:
This letter corrects our substantially equivalent letter of March 17, 2010.
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 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.
APR 2 9 2010
1
Page 2 - Mr. Martin Ma
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indication for Use
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________ K092558
Device Name:
Wrist Type Blood Pressure Monitor, HMBPM-005/Kinetik Branded BPM2 Series
Indication For Use
Wrist Type Blood Pressure Monitor is for use at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The theoretical range of cuff circumference is limited to 14-19.5cm.
Prescription Use_
AND/OR Over-The-Counter Use_ YES
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M.A.
Page 1 of 1
vision of Car
(k) Number K092555