(90 days)
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No
The summary only describes a standard sphygmomanometer for measuring blood pressure and contains no mention of AI, ML, or related concepts.
No
The device measures blood pressure, which is a diagnostic function, not a therapeutic one.
No
The device measures blood pressure, which is a physiological parameter. While blood pressure measurements can be used in diagnosis, the device itself is described as a sphygmomanometer, which is a measurement tool and not inherently a diagnostic device that performs a diagnosis.
No
The summary describes a sphygmomanometer, which is a hardware device used to measure blood pressure. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "measure the blood pressure." This is a physiological measurement taken directly from the patient's body, not a test performed on a sample of bodily fluid or tissue outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances within those samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis
Sphygmomanometers are considered medical devices, but they fall under a different category than IVDs. They are used for direct physiological measurement.
N/A
Intended Use / Indications for Use
Big Ben Square and Big Ben Round models are sphygmomanomter and are intended to measure the blood pressure.
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
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Indicated Patient Age Range
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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
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Key Metrics
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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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
SEP 17 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Patricia Riester Freudenmann Rudolf Riester GmbH & Co. KG P.O. Box 35 Bruckstraße 31 D-72417 Jungingen GERMANY
Re: K972301 Big Ben Round and Big Ben Square Requlatory Class: II Product Code: DXQ Dated: September 17, 1997 Received: June 19, 1997
Dear Ms. Freudenmann:
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 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation 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.
1
This letter will allow you to begin marketing your device as described in your 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 requlation (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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| 870. 1120 | |
|---|---|
| Blood | |
| Pressure | |
| Co44 |
DXQ []
510(k) Number (if known):_ -・K972301
Big Ben Square, Big Ben Round Device Name:
Indications For Use:
Big Ben Square and Big Ben Round models are sphygmomanomter and are intended to measure the blood pressure.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bea V. Demperle
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number 972301
Prescription Use (Per 21 CFR 801.109
OR
Over-The-Counter Use
(Optional Formal 1-2-96)