(61 days)
Not Found
Not Found
No
The summary does not mention AI, ML, deep learning, image processing, or any related concepts. The device description and performance study sections are also not found, which would typically contain information about such technologies if present.
No.
The device is described as a blood pressure measurement device used for monitoring and archiving readings, not for treating a medical condition.
No
The device is described as a "non-invasive blood pressure measurement device" to measure "systolic, diastolic BP" and "pulse rate." While these measurements can be used in diagnosis, the current text only describes it as a measurement tool, not as a device that provides a diagnosis.
No
The description explicitly states the device is a "non-invasive blood pressure measurement device" that uses a "non-invasive blood pressure and pulse rate cuff managed around the upper arm." This indicates the device includes hardware components (the cuff and the measurement mechanism) in addition to any potential software for data transmission and archiving.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "non-invasive blood pressure measurement device" that measures blood pressure and pulse rate. This is a physiological measurement taken directly from the body, not a test performed on a sample (like blood, urine, or tissue) outside of the body.
- Device Description: While the description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Mentions image processing, AI, DNN, or ML: These are not mentioned, which is common for non-IVD devices like blood pressure monitors.
- Input Imaging Modality: "Not Applicable" further supports that it's not an imaging-based IVD.
- Anatomical Site: The measurement is taken from the "upper arm," which is a direct physiological measurement site.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This blood pressure monitor does not fit that description.
N/A
Intended Use / Indications for Use
BP 700-WF is a non-invasive blood pressure measurement device intended to measure systolic, diastolic BP 700-Wr is a non-invasive blood pressure modult individual over age 18, at home by using a non-invasive blood pressure and puise rate of an addit managed around the upper arm. The cuff circumference is limited to 9"-13" for Arm type.
The device can transmit the readings through wireless communication for record archiving and review.
Product codes
DXN, DRG
Device Description
BP 700-WF is a non-invasive blood pressure measurement device intended to measure systolic, diastolic BP 700-Wr is a non-invasive blood pressure modult individual over age 18, at home by using a non-invasive blood pressure and puise rate of an addit managed around the upper arm. The cuff circumference is limited to 9"-13" for Arm type.
The device can transmit the readings through wireless communication for record archiving and review.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
over age 18
Intended User / Care Setting
at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NOV 2 8 2012
Carematix Inc. c/o Mr. Sukhwant Khanuja 209 W. Jackson Blvd, Suite 800 Chicago, IL 60606
Re: K123020
Trade/Device Name: Blip model bp-700wf Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN, DRG Dated: October 31, 2012 Received: November 1, 2012
Dear Mr. Khanuja:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
Page 2 - Mr. Sukhwant Khanuja
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/Resourcesfor You/Industry/default.htm.
Sincerely yours r
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Special 510(k) Notification
Indications for Use
510(k) Number_ K123020
Device Name: BP-700WF
Indications for Use:
BP 700-WF is a non-invasive blood pressure measurement device intended to measure systolic, diastolic BP 700-Wr is a non-invasive blood pressure modult individual over age 18, at home by using a non-invasive blood pressure and puise rate of an addit managed around the upper arm. The cuff circumference is limited to 9"-13" for Arm type.
The device can transmit the readings through wireless communication for record archiving and review.
Prescription Use (21 CFR 801 Subpart D) and/or
Over-the-counter Use X (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
vision Sign-Off) Mision Sign-Om)
vision of Cardiovascular Devices
510(k) Number K123020
Page 5 of 170
Carematix Inc.