MEDLINE BLOOD PRESSURE TRANSDUCER

K123095 · Medline Industries, Inc. · DRS · May 8, 2013 · Cardiovascular

Device Facts

• Record ID: K123095
• Device Name: MEDLINE BLOOD PRESSURE TRANSDUCER
• Applicant: Medline Industries, Inc.
• Product Code: DRS · Cardiovascular
• Decision Date: May 8, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2850
• Device Class: Class 2

Intended Use

Medine Blood Pressure Transducer is intended for direct measurement and monitoring of blood pressure. This disposable transducer is intended for single use only. Indications for use include: - Direct arterial blood pressure monitoring - central and peripheral - Pulmonary artery monitoring (PA distal) - Venous pressure monitoring (RA Proximal) - Left atrial monitoring when used with an air eliminator - Cardiac catheterization

Device Story

Medline Blood Pressure Transducer is a disposable, single-use device for invasive hemodynamic monitoring. It interfaces with patient vasculature to measure blood pressure directly. The transducer converts physiological pressure signals into electrical signals for display on compatible bedside monitors. Used in clinical settings such as ORs, ICUs, or cardiac catheterization labs by physicians or trained clinical staff. The output provides real-time pressure waveforms and numerical values, enabling clinicians to assess patient hemodynamic status and guide therapeutic interventions. The device is intended for single use to prevent cross-contamination.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and technological comparison.

Technological Characteristics

Extravascular blood pressure transducer; disposable, single-use design. Operates via pressure-sensing diaphragm converting physiological pressure to electrical signals. Compatible with standard hemodynamic monitoring systems. Class II device (21 CFR 870.2850).

Indications for Use

Indicated for direct arterial, pulmonary artery, venous, and left atrial blood pressure monitoring, and cardiac catheterization in patients requiring invasive hemodynamic monitoring.

Regulatory Classification

Identification

An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 8, 2013

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

Re: K123095

Trade/Device Names: Medline Blood Pressure Transducer Regulatory Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II (Two) Product Code: DRS Dated: March 5, 2013 Received: March 8, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 - Mr. Matt Clausen

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 n&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/ucc1118800 //p/plfast the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 3 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFF) 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 ne [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

OwenPFaris-S

for

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

Enclosure

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## K123095 Indications for Use

510(k) Number (if known):

Device Name: Medline Blood Pressure Transducer

Medine Blood Pressure Transducer is intended for direct measurement and monitoring of blood pressure.

This disposable transducer is intended for single use only.

Indications for use include:

- . Direct arterial blood pressure monitoring - central and peripheral
- Pulmonary artery monitoring (PA distal) .
- Venous pressure monitoring (RA Proximal) ●
- Left atrial monitoring when used with an air eliminator .
- Cardiac catheterization .

Prescription Use X (Part 21 CFR 801 Subpart D)

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)

Owen P. Faris -S
2013.05.08 08:40:44
-04'00'

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