The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal is indicated for the continuous in vivo measurement of the oxyhemoglobin saturation of blood in the central venous system (ScvO2) for monitoring hemodynamic status during metabolic, respiratory, cardiovascular, and/or other physiological system(s) compromise in accordance with hospital protocols or current Clinical Standards of Practice. The probe with fluidic seal is also indicated for pressure monitoring and infusion of fluids.

Device Description

The OPTICATH® Central Venous Oximetry Probe is a sterile, non-pyrogenic, single use, disposable probe for use with compatible optical modules/oximeters and central venous catheters. The probe incorporates optic fibers that enable continuous in vivo monitoring of oxyhemoglobin saturation within circulating blood using the principle of reflection spectrophotometry.

The Fluidic Seal is a non-pyrogenic, sterile, single use accessory to the OPTICATH® Probe that facilitates the introduction of the Probe into any sizecompatible central venous catheter and maintains the insertion position of the probe tip. The Fluidic Seal has a lateral flush port for pressure monitoring or for infusion of fluids.

The subject device is a modification of the predicate OPTICATH® Oximetry Catheter (K820674). The modifications include:

reducing the usable length of the probe and removing the guiding balloon since the probe is intended to monitor the oxyhemoglobin saturation of blood in the superior vena cava (central venous oxygen). (i.e., the additional length and balloon that facilitate placement of the predicate catheter into the pulmonary artery are not required) and
addition of a Fluidic Seal, which is an accessory to the OPTICATH® Probe, that facilitates placement of the probe into a previously-inserted central catheter and maintains the position of the probe tip.

AI/ML Overview

This document describes a 510(k) submission for the OPTICATH® Central Venous Oximetry Probe with Fluidic Seal. The submission primarily focuses on demonstrating substantial equivalence to predicate devices through bench testing and in vivo non-clinical testing. While the general nature of the testing is mentioned, detailed acceptance criteria and performance data in a format typically seen for modern AI/ML device submissions are not present.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific numerical acceptance criteria or performance metrics for the device. It generally states that "Results of all non-clinical testing met associated acceptance criteria" but without detailing what those criteria were or the exact performance achieved against them.

Acceptance Criteria	Reported Device Performance
Not specified for individual tests.	"met associated acceptance criteria"
Bench Testing:
Fluid flow	Met criteria
Fluid leakage	Met criteria
Pressure frequency response	Met criteria
Plunger activation force	Met criteria
Probe drag force	Met criteria
In vivo non-clinical testing:
Accuracy of oxygen saturation measurements	Met criteria

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

The document does not specify the sample size for the test set used in either the bench testing or the in vivo non-clinical testing. It also does not mention the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided. The study appears to be focused on device functionality and accuracy rather than clinical interpretation by experts.

4. Adjudication Method

Not applicable as there is no mention of expert review or adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is not an AI/ML diagnostic tool, but rather a medical probe for continuous physiological monitoring.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a hardware probe with an optical measurement principle, not a standalone algorithm.

7. Type of Ground Truth Used

For the in vivo non-clinical testing for accuracy of oxygen saturation measurements, the ground truth would have been derived from a reference method for measuring oxyhemoglobin saturation. The specific reference method is not stated, but typically involves laboratory-based blood gas analysis or a highly accurate research oximeter. For the bench testing, the ground truth would be based on engineering specifications and measurement standards.

8. Sample Size for the Training Set

Not applicable. This device does not involve training a machine learning model.

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

Not applicable. This device does not involve a training set for machine learning.

Summary of Study and Device Evidence:

The provided document describes a 510(k) submission for a modified medical device, specifically an oximetry probe. The study conducted to support its substantial equivalence involved bench testing (fluid flow, fluid leakage, pressure frequency response, plunger activation force, probe drag force) and in vivo non-clinical testing (accuracy of oxygen saturation measurements). The general conclusion is that all testing "met associated acceptance criteria," but the specific criteria and quantitative results are not detailed. This type of submission predates the common requirements for detailed AI/ML device performance reporting, and therefore many of the requested categories (like expert involvement, MRMC studies, or training data) are not relevant to this specific device and its regulatory pathway.

Summary

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K061/159
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510(k) SUMMARY

1. Submitted by:	Hospira, Inc.D-389, Bldg. H2275 N. Field DriveLake Forest, IL 60045Contact: Thomas Kozma, Ph.D.	Phone: (224) 212-4803Fax: (224) 212-5401
2. Date Prepared:	June 06, 2006	JUN 26 2006
3. Name/Classificationof Device:	Fiberoptic Oximetry Catheter, Class II78 DQE, 21 CFR Parts 870.1230
4. Trade Name ofProposed Device:	OPTICATH® Central Venous Oximetry Probe with FluidicSeal

1. Predicate Devices:

Device Name	510(k) Number
OPTICATH® Oximetry Catheter(ICU Medical, Hospira, Inc.)	K820674
PreSep Central Venous OximetryCatheter (Edwards Lifesciences)	K053609

6. Proposed Device Description:

The subject device is a modification of the predicate OPTICATH® Oximetry Catheter (K820674). The modifications include:

reducing the usable length of the probe and removing the guiding balloon since the probe is intended to monitor the oxyhemoglobin saturation of blood in the superior vena cava (central venous oxygen). (i.e., the additional length and

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balloon that facilitate placement of the predicate catheter into the pulmonary artery are not required) and

addition of a Fluidic Seal, which is an accessory to the OPTICATH® Probe, that facilitates placement of the probe into a previously-inserted central catheter and maintains the position of the probe tip.

7. Statement of Intended Use:

The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal is intended for measuring the oxygen saturation of blood.

8. Summary of Technological Characteristics of New Device Compared to Predicate Devices

The subject and predicate devices are similar in design, principle of operation, materials of construction, intended use, labeling and manufacturing processes. All modifications were evaluated by bench testing that included testing fluid flow. fluid leakage, pressure frequency response, plunger activation force, and probe drag force. In vivo non-clinical testing was also performed to evaluate the accuracy of oxygen saturation measurements obtained by the probe. Results of all non-clinical testing met associated acceptance criteria and did not raise new issues of safety and/or effectiveness. Therefore, the OPTICATH® Central Venous Oximetry Probe with Fluidic Seal is substantially equivalent to the predicate Oximetry Catheters.

The claim for substantial equivalence is supported by the information provided in the 510(k) submission.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2006

Hospira. Inc. c/o Daniel W. Lehtonen Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 Twinsburg, OH 44087

Re: K061159

Trade Name: OPTICATH® Central Venous Oximetry Probe with Fluidic Scal Regulation Number: 21 CFR 870.1230 Regulation Name: Fiberoptic Oximeter Catheter Regulatory Class: II (two) Product Code: DQF Dated: June 7, 2006 Received: June 9, 2006

Dear Mr. Lehtonen:

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 10 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. Ilisting 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 vour device in the Federal Register.

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

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Page 2 - Mr. Daniel W. Lehtonen

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); 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. 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/cdrl/industry/support/index.html.

Sincerely yours.

Phnumar 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: K061159

OPTICATH® Central Venous Oximetry Probe with Fluidic Seal Device Name:

Indications for Use:

The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal is intended for measuring the oxygen saturation of blood.

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)

K. Williame
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fon Sign-Off Vision of Cardlovascular Devices 510(k) Number

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).