The Disposable Transpac® III Integrated Transducer (IT) is intended for direct measurement and monitoring of blood pressure. The Disposable Transpac® III 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.

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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Disposable Transpac III Integrated Transducer (IT)". It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study on specific acceptance criteria and performance metrics. Therefore, much of the requested information, particularly quantitative data from a study, is not present in the document.

Here's an analysis of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from "Summary of Substantial Equivalence")	Reported Device Performance (Inferred from "Statement of Safety and Effectiveness")
Intended Use: Direct measurement and monitoring of blood pressure.	Meets the functional claims and intended use as described in the product labeling.
Sterility: Provided sterile.	Safe and effective in terms of substantial equivalence.
Pyrogenicity: Provided non-pyrogenic.	Safe and effective in terms of substantial equivalence.
Single-Use: Intended for one-time use.	Safe and effective in terms of substantial equivalence.
Technology/Operating Principles: Extravascular transducer coupled to an intravascular catheter for pressure conversion into electrical currents.	The technology and operating principles are the same as the predicate device.
Biocompatibility: All fluid/blood contacting materials are biocompatible.	Biocompatibility based on the results of biocompatibility testing.
Functional Equivalence to Predicate Device (K831506): Similar measurement capabilities and accuracy as the predicate.	Meets the functional claims and intended use, and is as safe and effective as the predicate.

Missing:

Specific numerical performance metrics (e.g., accuracy, precision, drift over time, frequency response) which would typically be present in a detailed performance study. The document primarily focuses on equivalence in function, rather than absolute performance numbers against predefined criteria.

2. Sample size used for the test set and the data provenance

Missing: The document does not describe a specific test set or study with a sample size for evaluating acceptance criteria. The information provided is a 510(k) summary, which primarily establishes substantial equivalence based on design, materials, and intended use, often leveraging previous predicate device data or internal testing without detailing the specific statistical methods, sample sizes, and provenance of a rigorous performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Missing: This information is not relevant to the content provided. The document does not describe a study involving expert assessment or ground truth establishment in the context of diagnostic accuracy.

4. Adjudication method for the test set

Missing: Not applicable, as no described test set or study requiring adjudication is present.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Missing: Not applicable. This device is a physical transducer for physiological measurement, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Missing: Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used

Missing: Ground truth in the context of a diagnostic or algorithmic study is not applicable here. The "ground truth" for a physical device like this would typically be established by comparing its measurements against a highly accurate reference standard (e.g., a calibrated pressure manometer). The document implies that the ground truth for its performance is its functional equivalence to the predicate device, which presumably also demonstrated its performance against such reference standards.

8. The sample size for the training set

Missing: Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Missing: Not applicable. As there's no training set, there's no ground truth for it.

In summary:

This 510(k) summary focuses on demonstrating substantial equivalence to an existing predicate device (Transpac® Disposable Transducer with Monitoring Kit, K831506). It highlights similarities in intended use, technology, operating principles, sterility, pyrogenicity, and biocompatibility. The "Statement of Safety and Effectiveness" asserts that the device "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."

The document does not describe a new, independent performance study with defined acceptance criteria and quantitative results, sample sizes, expert involvement, or adjudication methods in the way one would for a novel diagnostic device or AI application. Instead, the "proof" the device meets acceptance criteria is primarily inferred from its demonstrated substantial equivalence to a device already cleared by the FDA.

Summary

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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) 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,

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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:

1. 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.
1. The devices are provided as non-pyrogenic and sterile and are intended for one-time use.
1. 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.
1. The transducers are supplied individually or packaged within Cardiovascular Monitoring Kit.
1. 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:

1. Several of the materials of composition have been changed from the predicate devices.
1. 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.

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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.

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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

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Indications for Use

510(k) Number (if known)

K052828

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_

Page 1 of 1

Regulation Number and Section

§ 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).