The OPTICATH® Central Venous Oximetry Catheter is indicated for central venous pressure monitoring, drug and fluid administration, vascular access, venous blood sampling and 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 OPTICATH® Central Venous Oximetry Catheter is intended for onetime use.

Device Description

The OPTICATH® Central Venous Oximetry Catheter is a disposable single use central venous catheter with integrated fiber optics for measurement of blood oxyhemoglobin levels. It is compatible with existing Oximetrix 3, Q2 or Q2 Plus SO₂ oxylicmographili lovols: 1015 computactured by Philips, GE Medical and Spacelabs. The Central Venous Oximetry – Integrated Catheter is a component within a Hospira Central Venous Catheter (CVC) kit.

AI/ML Overview

The provided text describes a 510(k) summary for the OPTICATH® Central Venous Oximetry Catheter but does not contain detailed information about the acceptance criteria or a specific study designed to prove the device meets those criteria.

However, the closest information regarding performance and evaluation is in the following statement:

"The proposed modifications have been evaluated using bench testing as well as in-vivo non-clinical studies of which the results met the acceptance criteria and do not raise new issues of safety and/or effectiveness."

This statement confirms that studies were performed, and acceptance criteria were met, but it does not specify what those criteria were, the reported device performance, or the details of the studies themselves. As a result, I cannot populate the requested table or provide detailed answers to many of the specific questions.

Here's an attempt to answer what can be inferred or directly stated from the provided document, with many fields marked as "Not specified in the provided text":

Acceptance Criteria and Study Details for OPTICATH® Central Venous Oximetry Catheter

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred/Generic)	Reported Device Performance
Device modifications do not raise new issues of safety and/or effectiveness.	Results of bench testing and in-vivo non-clinical studies met "the acceptance criteria."
Performance similar to predicate devices for:	- Measuring central venous oxygen saturation
	- Central venous pressure monitoring
	- Drug and fluid administration
	- Vascular access
	- Venous blood sampling
Device is non-pyrogenic and sterile.	Not explicitly stated as "performance" but implied by "materials of construction" and "method of sterilization."
Technology and operating principles are the same as predicate.	Confirmed as a similarity.
Materials of construction are the same as predicate.	Confirmed as a similarity.
Method of sterilization is the same as the OPTICATH® Oximetry Catheter predicate.	Confirmed as a similarity.
(Specific quantitative criteria for accuracy, drift, interference, etc.)	Not specified in the provided text.

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

Sample Size for Test Set: Not specified in the provided text. The document only states "bench testing as well as in-vivo non-clinical studies."
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The term "in-vivo non-clinical studies" suggests animal studies or simulated human models, but details are lacking.

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

Not specified in the provided text.

4. Adjudication method for the test set

Not specified in the provided text.

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

Not applicable. This device is a medical catheter with integrated fiber optics for continuous in-vivo measurement, not an AI-assisted diagnostic imaging device or software that involves "human readers."

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

Not applicable in the context of an "algorithm only" study. The device performs a measurement, which is then used by clinicians for monitoring. The performance evaluation would focus on the accuracy and reliability of the measurement itself, which is inherently "standalone" in its measurement function, but then integrated into a human workflow. The text refers to "bench testing as well as in-vivo non-clinical studies" to evaluate the device.

7. The type of ground truth used

Not explicitly stated. For a device measuring oxyhemoglobin saturation, the "ground truth" for the in-vivo non-clinical studies would likely involve established reference methods for blood gas analysis or oximetry. For bench testing, it would involve controlled conditions with known reference values.

8. The sample size for the training set

Not applicable. This is a hardware medical device, not a machine learning algorithm that requires a "training set."

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

Not applicable (as above).

Summary

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Hospira, Inc

510(k) SUMMARY

1. Submitted by:	Hospira, Inc.D-389 Bldg. H2275 N. Field DriveLake Forest, IL 60045
	Contact: Nicohl R. WildingPhone:(224) 212-5270Fax: (224) 212-5401

1. Date Prepared:

Name/Classification of Device:

1. Trade Name of Proposed Device:
1. Predicate Devices:
5 2006

Fax: (224) 212-5401 June 5, 2006

Fiberoptic Oximetry Catheter, Class II 78 DQE - 21 CFR Parts 870.1230
OPTICATH® Central Venous Oximetry Catheter OPTICATH® Oximetry Catheter (K820674) CVP Polyurethane Catheter (K961552)

PreSep Central Venous Oximetry Catheter (Edwards Lifesciences) (K053609)

6. Manufacturer and Establishment Registration Number:

Manufacturer Site:	Sterilization Site:
ICU Medical (UTAH), Inc.4455 Atherton DriveSalt Lake City, UT 84123Establishment Registration #: 1713468	Isomedix Operations, Inc., Steris Corporation9120 South 150 EastSandy, UT 84070Establishment Registration #: 1720929
	Isomedix Operations, Inc., Steris Corporation
	7685 St. Andrews Ave.San Diego, CA 92154Establishment Registration #: 2032112

7. Performance Standards:

No performance standards have been established under Section 514 of the Food, Drug, and Cosmetic Act for Pressure Monitoring Devices. Cardiovascular Devices are regulated within 21 CFR 870.1230.

8. Intended Use / Indications for Use:

The intended use is the same as for the predicate devices.

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Hospira, Inc

9. Proposed Device Description:

10. Summary of Substantial Equivalence

The OPTICATH® Central Venous Oximetry Catheter is substantially equivalent to the predicate OPTICATH® Oximetry Catheter, K820674 and Central Venous Catheter K961552 with respect to the following characteristics:

Similarities:

1. The OPTICATH® Central Venous Oximetry Catheter and predicates are intended for measuring central venous oxygen saturation, central venous intenture monitoring, drug and fluid administration, vascular access and venous blood sampling. The device is provided as non-pyrogenic and sterile and is intended for one-time use.
1. The OPTICATH® Central Venous Oximetry Catheter has 4 lumens and is 8 French where the CVP Polyurethane predicate has 2 or 3 lumens and is 7 French and the Opticath Oximetry Catheter has 5 lumens and is 7.5 or 8 French.
1. The technology and operating principles are the same.
1. The catheters are packaged within Central Venous Catheter Kit.
1. The materials of construction are the same.
1. The method of sterilization is the same as the OPTICATH® Oximetry Catheter.

Differences:

1. The OPTICATH® Central Venous Oximetry Catheter is 8 French where as the CVP Polyurethane predicate catheters are 7 French.
1. The method of sterilization is different from the CVP Polyurethane catheter.

Statement of Safety and Effectiveness 11.

The subject and predicate devices are similar in design, materials of construction, components, intended use, labeling and manufacturing processes. The proposed modifications have been evaluated using bench testing as well as in-vivo non-clinical studies of which the results met the acceptance criteria and do not raise new issues of safety and/or effectiveness. TTherefore, the OPTICATH® Central Venous Oximetry Catheter is substantially equivalent to the predicate Oximetry Catheter and the Central Venous Pressure Catheters.

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

pg 2 of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 wing segments, representing health, services, and people. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 5 2006

Hospira, Inc. c/o Ms. Nicohl R. Wilding Manager Global Device Regulatory Affairs 275 N. Field Drive H2-2 Lake Forest, IL 60045

Re: K061585

Trade Name: OPTICATH® Central Venous Oximetry Catheter Regulation Number: 21 CFR 870.1230 Regulation Name: Fiberoptic oximetry catheter Regulatory Class: Class II (two) Product Code: DOE Dated: August 30, 2006 Received: September 11, 2006

Dear Ms. Wilding:

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.

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Page 2 - Ms. Nicohl Wilding

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 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/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

K061585 510(k) Number (if known)

Device Name: OPTICATH® Central Venous Oximetry Catheter

Indications for Use:

The OPTICATH® Central Venous Oximetry Catheter is indicated for central venous The OF HOATH® Ochirar Venodo Oximistration, vascular access, venous blood pressure monitoning, drug and liaid administration, resistemoglobin saturation of Sampling and the contral venous system (ScvO₂) for monitoring hemodynamic status during blood in the central venous system (Govern) (Gorog) relaxions of the stime in the melabolic, respiratory, cardiovaoodian, and on current Clinical Standards of Practice.. The in accordance with nospital protesses of Catheter is intended for one-time use.

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)

Bhumima

(Division Sign-Off) Division of Cardiovascular 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).