MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF

K071244 · Medline Industries, Inc. · DXQ · Mar 5, 2008 · Cardiovascular

Device Facts

• Record ID: K071244
• Device Name: MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF
• Applicant: Medline Industries, Inc.
• Product Code: DXQ · Cardiovascular
• Decision Date: Mar 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Medline Single Patient Use Blood Pressure Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The device is non-sterile and disposable. It is available in neonatal, infant, and adult sizes.

Device Story

Medline Single Patient Use Blood Pressure Cuffs are disposable, non-sterile accessories for non-invasive blood pressure monitoring systems. Available in neonatal, infant, and adult sizes with single or double tube configurations. Used in clinical settings by healthcare professionals to facilitate blood pressure measurement. Device functions as a pneumatic cuff to occlude and release blood flow, allowing the monitoring system to detect oscillations or sounds for pressure determination. Benefits include reduced risk of cross-contamination due to single-patient use design.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Pneumatic blood pressure cuff; single or double tube configuration; disposable; non-sterile; available in neonatal, infant, and adult sizes. Operates via mechanical occlusion of blood flow for use with non-invasive blood pressure monitoring systems.

Indications for Use

Indicated for use with non-invasive blood pressure monitoring systems to determine blood pressure in neonatal, infant, and adult patient populations.

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)

{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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 2008

Medline Industries, Inc. c/o Mr. Matt Clausen Regulatory Specialist One Medline Place Mundelein, IL 60060

## Re: K071244

Trade/Device Name: Medline Single Patient Use Blood Pressure Cuffs:

| Description | Part Numbers |
|----------------------------------------|----------------------------------|
| Neonatal, single tube | MDS9741/9742/9743/9744/9745 |
| Neonatal, double tube | MDS9751/9752/9753/9754/9755 |
| Infant - Adult, Disposable double tube | MDS9710/9711/9712/9713/9714/9715 |
| Infant - Adult, Disposable single tube | MDS9720/9721/9722/9723/9724/9725 |

Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuffs Regulatory Class: Class II (Two) Product Code: DXO Dated: February 1, 2008 Received: February 4, 2008

Dear Mr. Clausen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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.

{1}------------------------------------------------

## Page 2 - Mr. Matt Clausen

If your device is classified (see 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 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 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/industry/support/index.html.

Sincerely yours.

B.Bermmurafe

Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:__Medline Single Patient Use Blood Pressure Cuff

Indications For Use:

The Medline Single Patient Use Blood Pressure Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The device is non-sterile and disposable. It is available in neonatal, infant, and adult sizes.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhummer

Diction of Cardiovascular Deviçes 516.kg Number

Page 1 of ____________________________________________________________________________________________________________________________________________________________________