LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX

K092604 · Trimline Medical Products Corp. · DXQ · Oct 21, 2009 · Cardiovascular

Device Facts

• Record ID: K092604
• Device Name: LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX
• Applicant: Trimline Medical Products Corp.
• Product Code: DXQ · Cardiovascular
• Decision Date: Oct 21, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TRIMLINE Large Face Aneroid Sphygmomanometer: is a non-automated, mechanical blood pressure sphygmomanometer that is used for the non-invasive indication of blood pressure. may be used with neonatal, pediatric and adult patients

Device Story

TRIMLINE Large Face Aneroid Sphygmomanometer is a non-automated, mechanical device for non-invasive blood pressure measurement. Operated by clinicians in clinical settings; device utilizes manual inflation of a cuff and visual observation of an aneroid gauge to determine systolic and diastolic pressure. Provides immediate visual output for healthcare provider assessment; aids in patient hemodynamic monitoring and clinical decision-making.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical aneroid sphygmomanometer; non-automated; manual inflation/deflation system; large face analog gauge; non-invasive cuff-based measurement.

Indications for Use

Indicated for non-invasive blood pressure measurement in 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

TRIMELINE Medical Products Corporation c/o Ms. Nancy Skopec Regulatory Affairs Specialist 34 Columbia Road Branchburg, NJ 08876

OCT 2 1 2009

Re: K092604

> Trade/Device Name: TRIMELINE Large Face Aneroid Sphygmomanometer Regulatory Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: II (two) Product Code: 74 DXQ Dated: August 6, 2009 Received: August 25, 2009

Dear Ms. Skopec

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 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 Skopec

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

STATE SERVER BER SERVER PLAND SERVER SELLERS SELLER SELLE

bunu R. lahner

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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## TRIMLINE Medical Products Corporation

## 510(k) Premarket Notification

092604

## INDICATIONS FOR USE 4

K092604 510(K) Number:

Device Name: TRIMLINE™ Large Face Aneroid Sphygmomanometer

Indications for Use:

The TRIMLINE Large Face Aneroid Sphygmomanometer:

is a non-automated, mechanical blood pressure sphygmomanometer that is used for the non-invasive indication of blood pressure.

may be used with neonatal, pediatric and adult patients

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

2.1 DU MANS

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K097604