TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX

K080189 · Trimline Medical Products Corp. · DXQ · Aug 15, 2008 · Cardiovascular

Device Facts

• Record ID: K080189
• Device Name: TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX
• Applicant: Trimline Medical Products Corp.
• Product Code: DXQ · Cardiovascular
• Decision Date: Aug 15, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TRIMLINE Tempa-Kuff Blood Pressure Cuff: - is an accessory used in conjunction with non-invasive blood pressure measuring systems - is non-sterile and may be used on a limited basis : - . may be used with neonatal, pediatric and adult patients

Device Story

TRIMLINE Tempa-Kuff is a non-sterile blood pressure cuff accessory; used with non-invasive blood pressure measuring systems; intended for neonatal, pediatric, and adult patients; limited-use device; operates as a pneumatic interface between patient limb and blood pressure monitor; facilitates oscillometric or auscultatory blood pressure measurement; used in clinical or home settings; aids healthcare providers in monitoring patient cardiovascular status.

Clinical Evidence

Bench testing only.

Technological Characteristics

Non-sterile, limited-use blood pressure cuff; pneumatic cuff design; compatible with standard non-invasive blood pressure monitoring systems; dimensions and materials consistent with predicate cuff designs for neonatal, pediatric, and adult applications.

Indications for Use

Indicated for use as an accessory with non-invasive blood pressure measuring systems for neonatal, pediatric, and adult patients.

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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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2008

TRIMLINE Medical Products Corporation c/o Ms. Nancy Skocypec Regulatory Affairs Manager 34 Columbia Road Branchburg, NJ 08876

Re: K080189

TRIMLINE™ Tempa-Kuff® Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood pressure cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: August 7, 2008 Received: August 11, 2008

Dear Ms. Skocypec:

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.

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.

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Page 2 - Ms. Nancy Skocypec

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,

Qmpl

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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## INDICATIONS FOR USE 4

510(K) Number: K080189

Device Name: TRIMLINE™ Tempa-Kuff® Blood Pressure Cuff

Indications for Use:

"

The TRIMLINE Tempa-Kuff Blood Pressure Cuff:

- is an accessory used in conjunction with non-invasive blood pressure measuring systems
- is non-sterile and may be used on a limited basis :
- . may be used with neonatal, pediatric and adult patients

| Prescription Use | | AND/OR | Over-The Counter Use |
|-----------------------------|--|--------|-------------------------------|
| (Part 21 CFR 801 Subpart D) | | | X (Part 21 CFR 801 Subpart C) |

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | k080189 |