(253 days)
Not Found
Not Found
No
The device description and intended use clearly define a simple physical barrier. There is no mention of any computational or analytical functions that would require AI/ML.
No
The device acts as a barrier to prevent contamination, not to treat or diagnose a medical condition.
No
Explanation: The device is described as a "barrier to prevent contamination" between a patient and a blood pressure cuff. It does not perform any assessment, diagnosis, or monitoring of a medical condition, which are characteristic functions of a diagnostic device.
No
The device description clearly states it is a "disposable non-sterile device" and "Plastic Coated," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to act as a physical barrier between a patient and a blood pressure cuff to prevent contamination. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description mentions a "Plastic Coated" barrier, which aligns with a physical barrier and not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the BP Cuff Barrier is a medical device, but it falls under a different classification than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BP Cuff Barrier is a disposable non-sterile device with a medical purpose, worn by the patient as a barrier to prevent contamination between patient and blood pressure cuff.
Product codes
DXQ
Device Description
Disposable BP Cuff Barrier 1081789, Disposable BP Cuff Barrier, Plastic Coated, 1030193
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
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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.
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).
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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/11 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three stripes emanating from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2004
MedTextile, LLC c/o Ms. Brittney Gill Chicf Executive Officer P.O. Box 2301 Glen Allen, VA 23058
Re: K032568
R032300
Trade Name: Disposable BP Cuff Barrier 1081789, Disposable BP Cuff Barrier, Plastic Coated, 1030193 Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: II (two) Product Code: DXQ Dated: April 12, 2004 Received: April 15, 2004
Dear Ms.Gill:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your becamined the device 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 encreated of the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de necs mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mere revelsions of the Act include requirements for annual registration, listing of general controls provincitire, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Codc 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 - Ms. Brittney Gill
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); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna R. Vachner
( Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _Disposable BP Cuff Barrier 1081789, Disposable BP Cuff Barrier, Plastic Coated, 1030193
Indications For Use:
The BP Cuff Barrier is a disposable non-sterile device with a medical purpose, worn by the patient as a barrier to prevent contamination between patient and blood pressure cuff.
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 3-10-98)
Duana R. Vachenes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k 0 3 2568