OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN

K061159 · Hospira, Inc. · DQE · Jun 26, 2006 · Cardiovascular

Device Facts

• Record ID: K061159
• Device Name: OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN
• Applicant: Hospira, Inc.
• Product Code: DQE · Cardiovascular
• Decision Date: Jun 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1230
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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

OPTICATH® Central Venous Oximetry Probe is a sterile, single-use, disposable fiberoptic probe. Input: reflected light from circulating blood. Principle: reflection spectrophotometry to measure oxyhemoglobin saturation. Output: continuous ScvO2 data displayed on compatible external oximeters/optical modules. Includes Fluidic Seal accessory for insertion into existing central venous catheters, allowing simultaneous pressure monitoring and fluid infusion. Used in clinical settings (e.g., hospitals) by healthcare professionals. Provides real-time hemodynamic status monitoring to assist clinical decision-making during physiological compromise.

Clinical Evidence

Non-clinical in vivo testing performed to evaluate the accuracy of oxygen saturation measurements. Bench testing included fluid flow, fluid leakage, pressure frequency response, plunger activation force, and probe drag force. All results met acceptance criteria.

Technological Characteristics

Fiberoptic probe utilizing reflection spectrophotometry. Includes Fluidic Seal accessory with lateral flush port for pressure monitoring/infusion. Single-use, sterile, non-pyrogenic. Connects to compatible external optical modules/oximeters. No software algorithm details provided.

Indications for Use

Indicated for continuous in vivo monitoring of central venous oxygen saturation (ScvO2) in patients experiencing metabolic, respiratory, cardiovascular, or other physiological system compromise. Also indicated for pressure monitoring and fluid infusion. No specific age or gender contraindications stated.

Regulatory Classification

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.

Predicate Devices

• OPTICATH® Oximetry Catheter (K820674)
• PreSep Central Venous Oximetry Catheter (K053609)

Submission Summary (Full Text)

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K061/159
p.1/2

## 510(k) SUMMARY

| 1. Submitted by: | Hospira, Inc.<br>D-389, Bldg. H2<br>275 N. Field Drive<br>Lake Forest, IL 60045<br>Contact: Thomas Kozma, Ph.D. | Phone: [phone]<br>Fax: [phone] |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| 2. Date Prepared: | June 06, 2006 | JUN 26 2006 |
| 3. Name/Classification<br>of Device: | Fiberoptic Oximetry Catheter, Class II<br>78 DQE, 21 CFR Parts 870.1230 | |
| 4. Trade Name of<br>Proposed Device: | OPTICATH® Central Venous Oximetry Probe with Fluidic<br>Seal | |

- 5. Predicate Devices:

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

#### 6. Proposed 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:

1) 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

2) 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.

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.

## 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 [phone]. 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 [phone] or [phone] 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.

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.

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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