(135 days)
Not Found
No
The device description focuses on the mechanical and electrical components of a pressure transducer, with no mention of AI or ML capabilities for data analysis or interpretation.
No
The device is solely for measurement and monitoring of blood pressure, not for treating any condition.
Yes
The device is intended for direct measurement and monitoring of blood pressure to aid in diagnosis and treatment decisions.
No
The device description clearly outlines multiple hardware components, including a transducer module, Luer connectors, a flush valve, a stopcock, and a transducer cable. It is a physical device that converts mechanical pressure into electrical signals.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "direct measurement and monitoring of blood pressure." This involves measuring a physiological parameter within the body (intravascular pressure).
- Device Description: The device description clearly states it's an "extravascular blood pressure transducer" that interfaces between an "intravascular catheter" and a pressure monitor. It converts mechanical pressure changes into electrical signals.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not analyze samples in vitro.
The Disposable Transpac® III Integrated Transducer (IT) is a medical device used for direct physiological monitoring, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The Disposable Transpace III Integrated Transducer (IT) is intended for direct measurement and monitoring of blood pressure. The Disposable Transpace III Integrated Transducer (IT) is intended for one-time use.
Indications for the Disposable Transpac® III Integrated Transducer (IT) include:
Direct arterial blood pressure monitoring - central and peripheral,
Pulmonary artery monitoring,
Venous pressure monitoring,
Left atrial monitoring when used with an air eliminator filter, and Cardiac cathterization
Product codes
DRS
Device Description
The Disposable Transpac® III Integrated Transducer (IT) is an extravascular blood pressure transducer that converts mechanical changes in pressure into electrical currents that can be input into a pressure monitor. The Disposable Transpac® III Integrated Transducer (IT) consists of an extravascular pressure transducer module that interfaces between an intravascular catheter and pressure monitor. The major components of the Disposable Transpace III Integrated Transducer (IT) include:
- the Disposable Transpac® III Integrated Transducer (IT) module that houses a ceramic . transducer,
- a Luer connector with locking collar that can connect to an intravascular catheter, .
- an integrated flush valve and Luer connector that can connect a flushing fluid source to the . intravascular catheter,
- a transducer or nating that can be opened and closed by the three-handled, venting stopcock . to allow equilibration of the transducer with atmospheric pressure, and
- a transducer cable that can connect to a pressure monitor using a hooded RJ-11 connector. .
The Disposable Transpac® III Integrated Transducer (IT) can be pole-mounted or patient mounted and is provided sterile and non-pyrogenic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K052d28
FEB ! ? 2006
Special 510(k) Summary
Name of Submitter:
Hospira, Incorporated 275 North Field Drive Lake Forest, Illinois 60045 Owner/Operator #: 9063339
Manufacturer and Establishment Registration Number:
Manufacturer and Sterilization Site: Abbott - Ireland Ballytivnan, Sligo, IRELAND Establishment Registration #: 9610175
Proprietary or Trade Name of Proposed Device: Disposable Transpace III Integrated Transducer (IT) Extravascular Blood Pressure Transducer Common Name:
Device Classification, Pancode and ProCode: Class II, DRS
Performance Standards: No performance standards have been established under Section 514 of the Food, Drug, and Cosmetic Act for Pressure Monitoring Devices. An Extravascular Blood Pressure Transducer is regulated within 21 CFR 870.2850.
Intended Use / Indications for Use:
The Disposable Transpace III Integrated Transducer (IT) is intended for direct measurement and The Disposable Transpue - The Disposable Transpace Transducer (IT) is intended for one-time use.
Indications for the Disposable Transpac® III Integrated Transducer (IT) include:
Direct arterial blood pressure monitoring - central and peripheral,
Pulmonary artery monitoring,
Venous pressure monitoring,
Left atrial monitoring when used with an air eliminator filter, and Cardiac cathterization
Proposed Device Description:
The Disposable Transpac® III Integrated Transducer (IT) is an extravascular blood pressure transducer that converts mechanical changes in pressure into electrical currents that can be input into a pressure monitor. The Disposable Transpac® III Integrated Transducer (IT) consists of an extravascular pressure transducer module that interfaces between an intravascular catheter and pressure monitor. The major components of the Disposable Transpace III Integrated Transducer (IT) include:
- the Disposable Transpac® III Integrated Transducer (IT) module that houses a ceramic . transducer,
- a Luer connector with locking collar that can connect to an intravascular catheter, .
- an integrated flush valve and Luer connector that can connect a flushing fluid source to the . intravascular catheter,
1
- a transducer or nating that can be opened and closed by the three-handled, venting stopcock . to allow equilibration of the transducer with atmospheric pressure, and
- a transducer cable that can connect to a pressure monitor using a hooded RJ-11 connector. .
The Disposable Transpac® III Integrated Transducer (IT) can be pole-mounted or patient mounted and is provided sterile and non-pyrogenic.
Summary of Substantial Equivalence
The Disposable Transpac® III Integrated Transducer (IT) is substantially equivalent to the predicate Transpac Disposable Transducer with Monitoring Kit (K831506) with respect to the following characteristics:
Similarities:
.
-
- The Disposable Transpac® III Integrated Transducer (IT) and predicate Transpac® Disposable Transducer with Monitoring Kit are intended for direct measurement and monitoring of blood pressure.
-
- The devices are provided as non-pyrogenic and sterile and are intended for one-time use.
-
- The technology and operating principles (i.e., extravascular transducer that is coupled to an intravascular pressure-monitoring catheter for converting mechanical changes in pressure into electrical currents that can be input into a pressure monitor) are the same.
-
- The transducers are supplied individually or packaged within Cardiovascular Monitoring Kit.
-
- Several of the materials of construction are the same, and all fluid/blood contacting materials are biocompatible based on the results of biocompatibility testing.
Differences:
-
- Several of the materials of composition have been changed from the predicate devices.
-
- The flush device and stopcock that were separate components of the predicate Transpace Disposable Transducer with Monitoring Kit (K831506) have been integrated into the transducer housing of the Disposable Transpac® III Integrated Transducer (IT).
Statement of Safety and Effectiveness
The Disposable Transpace III Integrated Transducer (IT) meets the functional claims and intended use as described in the product labeling, and is as safe and effective in terms of substantial equivalence as the predicate Transpac Disposable Transducer with Monitoring Kit device.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2006
Hospira, Inc. c/o Thomas Kozma, Ph.D. Associate Director Global Regulatory Affairs- Devices 275 North Field Drive Lake Forest, IL 60045
K052828 Re:
K052620
Trade Name: Disposable Transpac III Integrated Transducer (IT) Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II (two) Product Code: DRS Dated: January 23, 2006 Received: January 24, 2006
Dear Dr. Kozma:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premaince in substantially equivalent (for the indications
referenced above and have determined the device is substance in interstate referenced above and nave determined the actived predicate devices marketed in interstate for use stated in the encrosule) to regally manced provide in the Medical Device Amendments, or to commerce prior to May 28, 1776, the enactities with the provisions of the Federal Food. Drug. devices that have been reclassified in accordance with approval applications (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval increase of th and Cosmetic Act (Act) that do not require approvis in the general controls provisions of the Act. The You may, therefore, mance the devices, soojeer of the more of the more of the port general controls provisions of the Fiel letteres, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mis exister and or regulations affecting your device can
may be subject to such additional controls. Existing major register of Mark may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of reasts concerning your device in the Federal Register.
3
Page 2 - Thomas Kozma, Ph.D.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a backan in ther requirements of the Act
that FDA has made a determination that your device complies with other requirements of the A that FDA has made a determination and Journer Federal agencies. You must or any Federal statutes and regulations administered of not limited to: registration and listing (21) CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set a CFK Part 807), labeling (21 CFR Part 820); and 1f applicable, the electronic forth in the quality systems (QD) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.
Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000product radiation control provisions (occions of re-e-sectibed in your Section 510(k)
This letter will allow you to begin marketing your device as described in your device to I his letter will anow you to ocgin marketing your avree quivalence of your device to a legally premarket nothealth. The PDA Intaling of backantal eque 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 If you desire specific advice for your ac not and and memor and the regulation entitled, Colliact the Office of Comphanes at (21 t 7 = 1 = 1 = 1 = 1 807.97). You may obtain "Misbranding by reference to premanteericaliteas and er the Act from the Division of Soual other general Information on your responsible in the toll-free number (800) 638-2041 or html Mindracturers, International and Oblisa.http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimmar for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known)
Disposable Transpac® III Integrated Transducer (IT) Device Name:
Indications for Use:
The Disposable Transpac III Integrated Transducer (IT) is intended for direct The Disposable Transpac - In "Integrated" (1) } } } } } } } } } } } } } } } } } } } } } } } } } } } incended for "anspac" {{I iT is intended for one-time use.
Indications for the Disposable Transpac® III IT include:
Direct arterial blood pressure monitoring - central and peripheral,
Pulmonary artery monitoring,
Venous pressure monitoring,
Left atrial monitoring when used with an air eliminator filter, and Cardiac cathterization.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhimmina
Avision Sign-Off cular Devices ardlo ivision of C ි i 0(k) Number_
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