The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal (Heparin Coated) 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 Central Venous Oximetry Probes (Heparin Coated) are non-pyrogenic, sterile, single patient use, disposable oxygenation monitoring sets for use with central venous catheters for continuous monitoring of central venous oxygen saturation. The probes are manufactured from medical-grade polymers and incorporate a closed-ended fiber optic lumen at the tip to measure central venous oxygen saturation. The exterior of the proposed device is coated with Heparin using the same Heparin agent and coating method used on Oximetry Catheters being marketed by Hospira today. The method of operation is the same as the predicate OPTICATH® Central Venous Oximetry Probe with Fluidic Seal.

The Fluidic Seal is a non-pyrogenic, sterile, single patient use device that facilitates the introduction of a Central Venous Oximetry Probe into any size-compatible central venous catheter. The Fluidic Seal also maintains the relative insertion of the oximetry probe within the central venous catheter. The Fluidic Seal consists of a lateral flush port for the administration of fluids and/or for pressure monitoring.

The subject devices are modifications of the predicate OPTICATH® Central Venous Oximetry Probe with Fluidic Seal.

The modification is to add Heparin coating to the probe and change the lead tubing material to a PE-lined polyvinyl chloride.

Both the predicate and the proposed devices can be used with marketed central venous catheters for obtaining critical cardiac performance parameters.

AI/ML Overview

The provided 510(k) summary (K062999) describes a device modification rather than a new device and does not include detailed performance studies with acceptance criteria in the manner typically seen for complex diagnostic algorithms. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.

Therefore, the information requested for acceptance criteria and a detailed study proving device performance is not present in the provided text.

The document states:

"The subject devices are modifications of the predicate OPTICATH® Central Venous Oximetry Probe with Fluidic Seal."
"The modification is to add Heparin coating to the probe and change the lead tubing material to a PE-lined polyvinyl chloride."
"The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal (Heparin Coated) 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 OPTICATH® Central Venous Oximetry Probe with Fluidic Seal."

This indicates that the primary method for demonstrating safety and effectiveness was through showing that the modified device is substantially equivalent to the previously cleared predicate device, rather than through a new, comprehensive performance study with specific acceptance criteria.

To directly answer your questions based only on the provided text, most of the information is not available:

A table of acceptance criteria and the reported device performance: Not provided. The submission relies on substantial equivalence to the predicate device.
Sample size used for the test set and the data provenance: Not provided. No specific test set data is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
Adjudication method for the test set: Not provided.
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: Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. No training set is mentioned.

Summary

{0}------------------------------------------------

K062999 page 1/2

510(k) Summary

Name of Submitter:

HOSPIRA. Incorporated 275 North Field Drive Lake Forest, Illinois 60045 Owner/Operator #: 9063339

Nilly - 3 2005

Manufacturer and Establishment Registration Number:

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

Proprietary or Trade Name of Proposed Device: Opticath® Central Venous Oximetry Probe with Fluidic Seal (Heparin Coated)

Common Name: Fiberoptic Oximetry Catheter

Device Classification, Pancode and ProCode: Class II, 78-DQE

Performance Standards: No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for Fiberoptic Oximetry Catheters. Fiberoptic oximeter catheters are regulated within 21 CFR 870.1230.

Intended Use / Indications for Use:

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

Proposed Device Description:

{1}------------------------------------------------

K062999 page 2/2

The subject devices are modifications of the predicate OPTICATH® Central Venous Oximetry Probe with Fluidic Seal.

The modification is to add Heparin coating to the probe and change the lead tubing material to a PE-lined polyvinyl chloride.

Both the predicate and the proposed devices can be used with marketed central venous catheters for obtaining critical cardiac performance parameters.

Summary of Substantial Equivalence

imary of Substantial Equivalence
The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal (Heparis Crums) Version Cormers The OPTICATH - Central Venous Oximely Prooe Micate OPTICATH® Central Venous Oximetry ans Judineston is Seal with respect to the following characteristics:

Similarities:

1. Both devices have the same intended use
1. Doth devices have the banting principles are the same for both devices
1. The materials used to manufacture the device and the sterilization is the same.

Difference:

The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal (Heparin Coated) is heparin coated

Statement of Safety and Effectiveness

ethen of Salery and Bircetry Probe with Fluidic Seal (Heparin Coated) meets the The OF I ICA I I Central Venous Oximed in the product labeling, and is as safe and effective in tunctional claims and michded use as deseriods in the producting.
terms of substantial equivalence as the predicate OPTICATH® Central Venous Oximetry Probe with Fluidic Seal.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2006

Hospira, Inc. c/o Ms. Diane Rennpferd Sr. Associate, Global Regulatory Affairs - Devices Dept 389 Bldg H2 275 N Field Drive Lake Forest IL 60045-5046

Re: K062999

Trade/Device Name: OPTICATH Central Venous Oximetry Probe with Seal with Heparin Regulation Number: 21 CFR 870.1230 Regulation Name: Fiberoptic Oximeter Catheter Regulatory Class: Class II (performance standards) Product Code: DQE Dated: September 29, 2006 Received: October 2, 2006

Dear Ms. Rennpferd:

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.

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

{3}------------------------------------------------

Page 2 – Ms. Diane Rennpferd

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 Ictter 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B. Zimmer for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known) K062999

Device Name:	Central Venous Oximetry Probe with Fluidic Seal (Heparin Coated)
--------------	------------------------------------------------------------------

Indications for Use:

The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal (Heparin Coated) 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)

Bimmlema

7 -1010-1 ascular Devices

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).