BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193

K032568 · Med Textile, LLC · DXQ · Apr 29, 2004 · Cardiovascular

Device Facts

• Record ID: K032568
• Device Name: BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193
• Applicant: Med Textile, LLC
• Product Code: DXQ · Cardiovascular
• Decision Date: Apr 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2

Intended 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.

Device Story

Disposable BP Cuff Barrier is a non-sterile, single-use protective sleeve; functions as a physical barrier between patient skin and blood pressure cuff; prevents cross-contamination during clinical blood pressure monitoring; used in clinical settings; applied by healthcare providers; simple mechanical design; no electronic or software components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Disposable, non-sterile, plastic-coated barrier; physical sleeve form factor; no energy source; no software; no specific material standards cited.

Indications for Use

Indicated for patients requiring blood pressure monitoring to serve as a protective barrier between the patient's skin and the blood pressure cuff to prevent cross-contamination.

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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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 [phone]. 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 [phone] or [phone] 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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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