(104 days)
Not Found
No
The device description and performance studies focus on the physical and electrical properties of a pressure transducer, with no mention of AI or ML capabilities.
No
The device is described as a pressure transducer that converts pressure changes into electrical currents for monitoring, not for treating a condition.
Yes
The device measures and monitors fluid pressure (e.g., intracranial, arterial, venous pressure), which provides information used to aid in the diagnosis and management of various medical conditions.
No
The device description clearly outlines multiple hardware components, including a transducer module, luer connector, transducer cable, and stopcock, which are physical parts of the device and not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Transpac® III Disposable Straight Pressure Transducer is designed to directly measure and monitor fluid pressure within the body (intracranial, intrauterine, intramuscular, arterial, venous, etc.). It interfaces with catheters and converts pressure changes into electrical signals for a monitor.
- Lack of Sample Analysis: The device does not analyze a sample taken from the body. It is directly connected to the body's fluid systems to measure pressure in real-time.
Therefore, the Transpac® III Disposable Straight Pressure Transducer falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Transpac® III Disposable Straight Pressure Transducer (DSPT) is intended for direct measurement and monitoring of fluid pressure.
Indications for the Transpac® III DSPT include: Intracranial Pressure Monitoring. Intrauterine Pressure Monitoring, or Compartmental (Intramuscular) Pressure Monitoring.
In addition, indications for the Transpac® III DSPT 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, or Cardiac catheterization.
Product codes (comma separated list FDA assigned to the subject device)
DRS, GWM
Device Description
The Transpac III DSPT is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The major components of the Transpac® III DSPT include:
- the Transpac® III Disposable Straight Pressure Transducer module that houses a ceramic . transducer,
- . a luer connector with locking collar that can connect to an intravascular catheter,
- a transducer cable that can connect to a compatible pressure monitor using a hooded RJ-11 . connector,
- . A stopcock for altering direction of fluid flow.
The Transpac® III DSPT can be pole-mounted or patient mounted and is provided sterile and nonpyrogenic and is intended for one-time use.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Transpace III DSPT has been tested for biocompatibility and physical and electrical requirements and has passed all acceptance criteria. The Transpac® III DSPT 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® II Disposable Transducer and predicate Disposable Transpac® III IT devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
SEP 1 9 2006
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:
Transpac® III Disposable Straight Pressure Transducer (DSPT)
Common Name: Pressure Transducer (Intracranial and Extravascular Blood) Device Classification, Pancode and ProCode: Class II, GWM and DRS
Performance Standards: No performance standards have been established under Section 514 of the Food, Drug, and Cosmetic Act for Intracranial Pressure Monitoring Devices. An Intracranial Pressure Monitoring Device is regulated within 21 CFR 882.1620 and an Extravascular Blood Pressure . Transducer is regulated within 21 CFR 870.2850.
Intended Use / Indications for Use:
The Transpac® III Disposable Straight Pressure Transducer (DSPT) is intended for direct measurement and monitoring of fluid pressure.
Indications for the Transpac® III DSPT include: Intracranial Pressure Monitoring. Intrauterine Pressure Monitoring, or Compartmental (Intramuscular) Pressure Monitoring.
In addition, indications for the Transpac® III DSPT 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, or Cardiac catheterization.
Proposed Device Description:
The Transpac III DSPT is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The major components of the Transpac® III DSPT include:
- the Transpac® III Disposable Straight Pressure Transducer module that houses a ceramic . transducer,
- . a luer connector with locking collar that can connect to an intravascular catheter,
1
-
a transducer cable that can connect to a compatible pressure monitor using a hooded RJ-11 . connector,
KOL 1573 p2/2 -
. A stopcock for altering direction of fluid flow.
The Transpac® III DSPT can be pole-mounted or patient mounted and is provided sterile and nonpyrogenic and is intended for one-time use.
Summary of Substantial Equivalence
The Transpace III DSPT is substantially equivalent to the predicate Transpace II Disposable Transducer (K884823) and Disposable Transpac® III Integrated Transducer (IT) (K052828) with respect to the following characteristics:
Similarities:
-
- The Transpac III DSPT and predicate devices are intended for direct measurement and monitoring of pressure.
-
- Indications for Use of the Transpac® III DSPT include the same Indications for Use as the predicate Transpac® II Disposable Transducer (K884823).
-
- Indications for Use of the Transpac® III DSPT include the same Indications for Use as the predicate Transpac® III IT (K052828).
-
- The Transpac® III DSPT and both predicate devices are provided as non-pyrogenic and sterile devices that 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 compatible pressure monitor) are the same.
-
- The transducers are supplied individually or packaged within a catheter-based kit.
-
- The materials of construction of the Transpac® III DSPT are the same as the predicate Transpac® III IT (K052828), and all fluid/blood contacting materials are biocompatible based on the results of biocompatibility testing.
Differences:
-
- The size of the Transpac® III DSPT is smaller than the predicate Transpac® II Disposable Transducer but is similar to the size of the predicate Transpac® III IT (K052828).
-
- The physical appearance of the non-integrated stopcock of the Transpac® III DSPT is different from the non-integrated stopcock of the Transpac® II Disposable Transducer.
Statement of Safety and Effectiveness
The Transpace III DSPT has been tested for biocompatibility and physical and electrical requirements and has passed all acceptance criteria. The Transpac® III DSPT 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® II Disposable Transducer and predicate Disposable Transpac® III IT devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2006
Hospira, Inc. c/o Thomas Kozma, Ph.D. Associate Director, Global Regulatory Affairs 275 North Field Drive Lake Forest, Illinois 60045
Re: K061573
Trade Name: Transpac® III Disposable Straight Pressure Transducer (DSPT) Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II (two) Product Code: DRS Dated: August 23, 2006 Received: August 28, 2006
Dear Dr. Kozma:
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.
3
Page 2 - Thomas Kozma, Ph.D.
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 or any I 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 (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product taxable 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 premated 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 If you a t the Office of Compliance at (240) 276-0120. 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 Mass Eacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimmon 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
K061573 510(k) Number (if known)
Device Name: Transpac® III Disposable Straight Pressure Transducer (DSPT)
Indications for Use:
The Transpac® III Disposable Straight Pressure Transducer (DSPT) is intended for direct measurement and monitoring of fluid pressure.
Indications for the Transpac® III DSPT include:
- Intracranial Pressure Monitoring, .
- Intrauterine Pressure Monitoring, or .
- Compartmental (Intramuscular) Pressure Monitoring. .
In addition, indications for the Transpac® III DSPT 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 catheterization. .
Prescription Use X (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)
Bhumima
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Bivision Sign-Off) Division of Cardiovascular Devigas 510(k) Number