(218 days)
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No
The summary describes a disposable blood pressure transducer, a purely physical device for measuring pressure. There is no mention of software, algorithms, or any computational processing that would suggest AI/ML.
No
The device is used for monitoring blood pressure, which is a diagnostic function, not a therapeutic one. It measures and monitors physiological parameters but does not provide treatment or alter the body's function in a therapeutic way.
No
Explanation: The device is a "Blood Pressure Transducer" intended for direct measurement and monitoring of blood pressure. While monitoring is a component of diagnosis, the device itself is a transducer that measures a parameter (blood pressure), which does not inherently make it a diagnostic device that interprets or identifies a disease or condition. It provides data for diagnosticians.
No
The device description explicitly states "Medline Blood Pressure Transducer" and describes it as a "disposable transducer," indicating a physical hardware component for measuring blood pressure.
Based on the provided information, the Medline Blood Pressure Transducer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "direct measurement and monitoring of blood pressure." This involves measuring a physiological parameter within the body (in vivo), not analyzing samples outside the body (in vitro).
- Device Description: The description is for a "Blood Pressure Transducer," which is a device used to convert physical pressure into an electrical signal for monitoring. This aligns with in vivo measurement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside the body, which are hallmarks of IVD devices.
Therefore, the Medline Blood Pressure Transducer is a medical device used for in vivo physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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 .
Product codes
DRS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 870.2850 Extravascular blood pressure transducer.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with outstretched wings, with a wavy line underneath the bird.
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.
1
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 (800) 638-2041 or (301) 796-7100 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
2
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'
3-i
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