(71 days)
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No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard blood pressure cuff functionality.
No
The device is used for measurement and monitoring of blood pressure, not for treating a condition.
Yes
A blood pressure cuff is used to measure blood pressure, which is a key vital sign used in diagnosing various medical conditions.
No
The device description explicitly mentions a "Blood Pressure Cuff," which is a hardware component. The intended use also describes "complete inflation systems," further indicating hardware.
Based on the provided information, the ClearMedical Blood Pressure Cuff 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.
- ClearMedical Blood Pressure Cuff Function: The intended use describes the device as being used for manual and automatic non-invasive blood pressure monitoring. This involves measuring a physiological parameter directly from the body (blood pressure) without analyzing a sample taken from the body.
Therefore, the ClearMedical Blood Pressure Cuff falls under the category of a non-invasive medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ClearMedical Blood Pressure Cuff is indicated for use in manual measurement and automatic non-invasive blood pressure (BP) monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual BP measurement. The ClearMedical Blood Pressure Cuff is intended as a single patient use item.
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
properly trained personnel
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): 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.
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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.
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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
Image /page/0/Picture/1 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, arranged in a way that they also resemble a bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2003
Clear Medical, Inc. c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, PA 19462
Re: K031416
Trade Name: ClearMedical Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood pressure cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: June 27, 2003 Received: June 30, 2003
Dear Mr. Mosenkis:
This letter corrects our substantially equivalent letter of July 15, 2003 regarding the incorrect address.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 3 rotty premier is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the Citiestic) to regars manetical Device Amendments or to Conimeres prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, alla Cosmedic Act (Act) that do fict required controls provisions of the Act. The general therefore, market the devices and genere to generation, listing of devices, controls provisions of the receined requirences against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc above) into the regulations affecting your device can be
1
Page 2 - Mr. Robert Mosenkis
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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loaso be actived a a determination that your device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must or any I odetar bullated and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFA rat 607), adoning (21 OFF Part 820); and if applicable, the electronic forth in the quality by bound (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) This letter will anow you to common ting of substantial equivalence of your device to a legally premated notineation. The 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 11 you dolly Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance additionally For 00110 isonally, 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, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Statement of Indications for Use
510(k) Number:
KD31416
Device:
7 #
ClearMedical Blood Pressure Cuff
The ClearMedical Blood Pressure Cuff is indicated for use in manual measurement and automatic non-invasive blood pressure (BP) monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual BP measurement The for ass with manometers sure Cuff is intended as a single patient use item.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number