(335 days)
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No
The description details a purely mechanical device (manually inflatable cuff, analog gauge) with no mention of digital processing, algorithms, or any terms related to AI/ML.
No
The device is described as a non-invasive medical device intended to measure blood pressure, which is a diagnostic function, not a therapeutic one.
No
Explanation: The device is described as a non-invasive medical device intended to measure blood pressure. While measuring blood pressure can be part of a diagnostic process, the device itself is a measurement tool, not a diagnostic one that performs analysis or interpretation to identify a disease or condition.
No
The device description explicitly states it includes a "manually inflatable cuff and a manometer analog gauge," which are hardware components.
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 for measuring systolic and diastolic blood pressure. This is a physiological measurement taken directly from the patient's body.
- Device Description: The description reinforces that it's a non-invasive medical device using a cuff and manometer.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
Therefore, an Aneroid Sphygmomanometer is a non-invasive medical device used for direct physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure the systolic and diastolic blood pressures by means of a manually inflatable cuff and a manometer analog gauge.
Product codes
DXQ
Device Description
An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure the systolic and diastolic blood pressures by means of a manually inflatable cuff and a manometer analog gauge.
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 (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
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
JUL 7 1998
Mr. Anthony L. Giaccio Director Quality Systems/Regulatory Affairs Cypress Medical Products 1202 South Route 31 McHenry, IL 60050
Re: K972899 Cypress Medical Products Aneroid Sphygmomanometer Regulatory Class: II (Two) Product Code: DXQ Dated: April 27, 1998 Received: April 28, 1998
Dear Mr. Giaccio:
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 leqally 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, Druq, 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 aqainst 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 requlation may result in requlatory 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 requlations.
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Page 2 - Mr. Anthony L. Giaccio
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 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. 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/dsma/dsmamain.html."
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K 9 7 レ8 9 9
Device Name: Aneroid Sphygmomanometer
An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure the systolic and diastolic blood pressures by means of a manually inflatable cuff and a manometer analog gauge.
(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, Respiratory, and Neurological Devices | |
| 510(k) Number | K972899 |
Prescription Use_V (Per 21 CFR 801.109) OR Over-The-Counter Use_
(Optional Format 1-2-96)