Indicated for the assessment of the hemodynamic status of a patient, including but not restricted to the following: Venous Pressures, Cardiac Output, Oxyhemoglobin Saturation, and Venous Blood Sampling, A secondary indication is for the therapeutic infusion of solutions.

Hospira Latex-Free Critical Care Catheters:

Indicated for the assessment of hemodynamic status through right ventricular, and pulmonary artery and / or wedge pressure monitoring for patients including the following: acute heart failure; differentiating ruptured ventricular septum from mitral regurgitation; diagnosis of tamponade; severe hypovolemia; complex circulatory situations (e.g., fluid management with acute burn patients); medical emergencies; adult respiratory distress syndrome; gram negative sepsis; drug intoxication; acute renal failure; hemorrhagic pancreatitis; intra- and postoperative management of high risk patients; history of pulmonary or cardiac disease; fluid shifts (such as extensive intra-abdominal operations); management of high risk obstetrical patients; known cardiac disease; toxemia; premature separation of placenta; cardiac output determination by thermodilution method; and blood sampling.

Additional indication for Hospira Latex-Free Critical Care Pacing Lead Catheters:

Indicated for temporary transluminal ventricular pacing a temporary ventricular pacing lead.

Device Description

The HOSPIRA Latex-Free Critical Care and Advanced Sensor Catheters have multi-Iumens that incorporate some or all of the following components and features: a distal balloon for positioning the catheter tip via blood flow within the pulmonary artery, a heater coil for determining continuous cardiac output, a thermistor for monitoring core temperature and cardiac output, fiber optics for monitoring mixed venous oxygen saturation (SvO2), and access ports for drug delivery or blood sampling. In addition, the HOSPIRA Latex-Free Critical Care Pacing Lead Catheters include an access port for use with Transluminal Right Ventricular Pacing Leads. The catheters also incorporate insertion distance markings and are provided with a syringe for inflating the latex-free balloon.

AI/ML Overview

The provided text describes a 510(k) summary for the HOSPIRA Latex-Free Critical Care and Advanced Sensor Catheters. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study of the proposed device itself. The key study mentioned relates to the material of the new balloon.

Here's an analysis of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific device performance acceptance criteria for the overall catheter system with corresponding reported results. Instead, it describes tests performed on the gamma sterilized Polyisoprene-Polyurethane balloon material.

Acceptance Criteria (for the balloon)	Reported Performance (for the balloon)
Biocompatibility	Passed
Expansion Symmetry	Passed
Over Inflation	Passed
Multiple Inflations	Passed
Deflation Time	Passed
Burst Strength	Passed

The overall device is stated to "meet the functional claims and intended use as described in the product labeling, and are as safe and effective in terms of substantial equivalence as the predicate catheters." This statement implies an equivalency review rather than a direct performance study against novel criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the tests conducted on the Polyisoprene-Polyurethane balloon.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), but these would typically be lab-based, pre-clinical tests for a material change, not human clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the described tests are laboratory/material performance tests, not clinical evaluations requiring expert interpretation for ground truth.

4. Adjudication Method

This information is not applicable as the described tests are laboratory/material performance tests, not clinical evaluations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of an MRMC comparative effectiveness study involving human readers. This type of study is not relevant for the described material and device equivalency assessment.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

There is no mention of a standalone performance study. This type of study is typically relevant for AI/software devices, which this is not. The described tests are material/physical performance tests.

7. Type of Ground Truth Used

For the balloon material tests, the ground truth would be based on engineering specifications and established test methodologies for biocompatibility, mechanical properties (expansion symmetry, over inflation, multiple inflations, deflation time, burst strength). There is no "expert consensus," "pathology," or "outcomes data" in the traditional clinical sense for these specific tests as described.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The tests are for material and device physical integrity.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" to establish ground truth for.

In summary, the provided 510(k) notification focuses on demonstrating substantial equivalence of the new latex-free catheters to previously cleared predicate devices, primarily by showing that the new balloon material (Polyisoprene-Polyurethane) meets established performance and safety criteria, and that manufacturing process changes (gamma sterilization) are acceptable. The study highlighted is a set of laboratory tests on the balloon component, not a clinical study of the entire device's performance in humans against specific numerical clinical efficacy acceptance criteria.

Summary

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HOSPIRA Latex-Free Critical Care and Advanced Sensor Catheters

1061450

510(k) Summary

Name of Submitter: Hospira, Incorporated 275 North Field Drive Lake Forest, Illinois 60045 Owner/Operator #: 9063339

AUG - 4 2006

Manufacturer and Establishment Registration Number:

Manufacturer:	Sterilization Site:
ICU MEDICAL (UTAH), INC.4455 Atherton Dr.Salt Lake City, UT 84123	Isomedix Operations Inc.9120 South 150 EastSandy, UT 84070
Establishment Registration #: 1713468	Establishment Registration #: 1720929

Proprietary or Trade Name of Proposed Device: HOSPIRA Latex-Free Critical Care and Advanced Sensor Catheters

Common Name: Flow-Directed Catheter

Device Classification, Pancode and ProCode: Class II, 74 - DYG

Performance Standards: No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for Flow-Directed Catheters regulated within 21 CFR 870.1240.

Intended Use / Indications for Use:

Hospira Latex-Free Advanced Sensor Catheters:

Hospira Latex-Free Critical Care Catheters:

Additional indication for Hospira Latex-Free Critical Care Pacing Lead Catheters:

Indicated for temporary transluminal ventricular pacing a temporary ventricular pacing lead.

Proposed Device Description:

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HOSPIRA Latex-Free Critical Care and Advanced Sensor Catheters

output, a thermistor for monitoring core temperature and cardiac output, fiber optics for monitoring mixed venous oxygen saturation (SvO2), and access ports for drug delivery or blood sampling. In addition, the HOSPIRA Latex-Free Critical Care Pacing Lead Catheters include an access port for use with Transluminal Right Ventricular Pacing Leads. The catheters also incorporate insertion distance markings and are provided with a syringe for inflating the latex-free balloon.

Summary of Substantial Equivalence

The HOSPIRA Latex-Free Critical Care and Advanced Sensor Catheters as described in this submission are substantially equivalent to the predicate Flow Directed Thermal-Dilution Infusion Catheter (821057), OptiCath Heparin Coated Flow-Directed Catheter (K823007), and Sorenson Thermo Flow-Directed Transluminal Pacing Catheter (K874465) with respect to the following characteristics:

Similarities:

1. The catheters have the same intended use and indications for use.
1. The catheters contain the same type of components.
1. The method of sterilization of Hospira Latex-Free Advanced Sensor Catheters is the same.

Differences:

1. The material used to manufacture the balloon in both the Critical Care Catheters and Advanced Sensor Catheters is Polyisoprene-Polyurethane compound rather than Latex Rubber.
1. Critical Care catheters will be sterilized using gamma radiation rather than EtO sterilization.

Statement of Safety and Effectiveness

The gamma sterilized Polyisoprene-Polyurethane balloon has been tested for biocompatibility and for expansion symmetry, over inflation, multiple inflations, deflation time, and burst strength and has passed all acceptance criteria. The HOSPIRA Latex-Free Critical Care and Advanced Sensor Catheters meet the functional claims and intended use as described in the product labeling, and are as safe and effective in terms of substantial equivalence as the predicate catheters described in this document.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three lines forming the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the top half of the seal, while "DEPARTMENT OF HEALTH AND HUMAN SERVICES" is arranged in a circular pattern around the bottom half of the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 2006

Hospira, Inc. c/o Mr. Thomas P. Sampogna Director Global Regulatory Affairs 275 North Field Drive Dept. 389, Bldg. H2 Lake Forest, IL 60045

Re: K061450

Trade Names: Hospira Latex-Free Advanced Sensor Catheters Hospira Latex-Free Critical Care Catheters Regulation Number: 21 CFR 870.1230, 21 CFR 870.1240; and, 21 CFR 870.1915 Regulation Name: Fiberoptic Oximeter Catheter, Flow-Directed Catheter; and, Thermodilution Probe Regulatory Class: Class II (two) Product Code: DQE, DYG; and, KRB Dated: June 23, 2006 Received: June 26, 2006

Dear Mr. Sampogna:

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 rr your de rise is onabilional 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. Thomas P. Sampogna

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 mr) vith 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 (21 CFR & uality 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. This letter 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 marketed 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 contact 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 Manufacturers, 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,

Въпиство вос

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)

KOG1450

Device Name: HOSPIRA Latex-Free Critical Care and Advanced Sensor Catheters

Indications for Use:

Hospira Latex-Free Advanced Sensor Catheters:

Indicated for the assessment of the hemodynamic status of a patient, including but not restricted to the following: Venous Pressures, Cardiac Output, Oxyhemoglobin Saturation, and Venous Blood Sampling. A secondary indication is for the therapeutic infusion of solutions.

Hospira Latex-Free Critical Care Catheters:

Indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and / or wedge pressure monitoring for patients including the following: acute heart failure; differentiating ruptured ventricular septum from mitral regurgitation; diagnosis of tamponade; severe hypovolemia; complex circulatory situations (e.g., fluid management with acute burn patients); medical emergencies; adult respiratory distress syndrome; gram negative sepsis; drug intoxication; acute renal failure; hemorrhagic pancreatitis; intra- and postoperative management of high risk patients; history of pulmonary or cardiac disease; fluid shifte (setch as extensive intra-abdominal operations); management of high risk obstetrical patients; known cardiac disease; toxemia; premature separation of placenta; cardiac output determination by thermodilution method; and blood sampling.

Additional indication for Hospira Latex-Free Critical Care Pacing Lead Catheters:

Indicated for temporary transluminal ventricular pacing using a temporary ventricular pacing lead.

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)

	B/ymanina
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(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Cardiovascular Devices

510(k) Number	K$\alpha$1450
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PAGE 1 of 1

Regulation Number and Section

§ 870.1230 Fiberoptic oximeter catheter.

(a)
Identification. A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.(b)
Classification. Class II (performance standards).