PRESEP OLIGON OXIMETRY CATHETERS

K060093 · Edwards Lifesciences, LLC · DQE · Apr 28, 2006 · Cardiovascular

Device Facts

• Record ID: K060093
• Device Name: PRESEP OLIGON OXIMETRY CATHETERS
• Applicant: Edwards Lifesciences, LLC
• Product Code: DQE · Cardiovascular
• Decision Date: Apr 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1230
• Device Class: Class 2

Intended Use

The PreSep Oligon Oximetry Catheters are intended to provide the means for infusion of solutions, measuring pressure and taking blood samples through the distal, proximal and medial lumens. The PreSep Oligon Oximetry Catheters also provide the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor.

Device Story

PreSep Oligon Oximetry Catheters are multi-lumen catheters used for hemodynamic monitoring; they provide infusion of solutions, pressure measurement, and blood sampling. The device integrates with Edwards Lifesciences oximetry monitors to provide continuous oxygen saturation measurements via fiberoptic technology. Used in clinical settings by healthcare professionals, the catheter provides real-time data to assist in patient management and clinical decision-making. The inclusion of Oligon material is a feature for the catheter construction.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Multi-lumen catheter featuring Oligon material; fiberoptic sensing for oxygen saturation; compatible with Edwards Lifesciences oximetry monitors for continuous data output.

Indications for Use

Indicated for hemodynamic monitoring in patients requiring blood sampling, pressure monitoring, and continuous oxygen saturation measurements.

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

• Central Venous Oximetry Probe Catheter and Probe
• Vantex Central Venous Catheters with Oligon material
• Edslab Dual Lumen Regional Saturation Oximetry Catheter

Submission Summary (Full Text)

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K060093

Image /page/0/Picture/1 description: The image shows the logo for Edwards Lifesciences. The logo consists of a square grid pattern on the left and the company name "Edwards Lifesciences" on the right. The text is in a serif font and is black.

One Edwards Way • Irvine, CA USA • 92614
Phone: [phone] • Fax: [phone] www.edwards.com

## 5 510(k) Summary

| Submitter: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614-5686 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jason Smith<br>Project Manager, Regulatory Affairs |
| Date Prepared: | January 10, 2006 |
| Trade name: | PreSep Oligon Oximetry Catheters |
| Classification<br>Name: | Catheter, Oximeter, Fiberoptic (21 CFR 870.1230) |
| Predicate<br>Devices: | Central Venous Oximetry Probe Catheter and Probe,<br>Vantex Central Venous Catheters with Oligon material,<br>Edslab Dual Lumen Regional Saturation Oximetry<br>Catheter |
| Device<br>Description: | The PreSep Oligon Oximetry Catheters are used with<br>Edwards oximetry monitors to continuously measure<br>oxygen saturation. These catheters also provide the<br>means for infusion of solutions, measuring pressure and<br>taking blood samples. |
| Intended Use: | The PreSep Oligon Oximetry Catheters are intended to<br>provide the means for infusion of solutions, measuring<br>pressure and taking blood samples through the distal,<br>proximal and medial lumens. The PreSep Oligon<br>Oximetry Catheters also provide the means for<br>continuously monitoring oxygen saturation using an<br>Edwards Lifesciences oximetry monitor. |
| Comparative<br>Analysis: | The PreSep Oligon Oximetry Catheters have been<br>demonstrated to be as safe and effective as the<br>predicate devices for their intended use. |
| Functional/Safety<br>Testing: | The PreSep Oligon Oximetry Catheters have<br>successfully undergone functional testing. These<br>products have been shown to be equivalent to the<br>predicate devices. |
| Conclusion: | The PreSep Oligon Oximetry Catheters are<br>substantially equivalent to the predicate devices. |

January 10, 2006 510(k) Notification for PreSep Oligon Oximetry Catheters CONFIDENTIAL

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2006

Edwars Lifesciences LLC c/o Mr. Jason Smith Project Manager, Regulatory Affairs One Edwards Way Irvine, CA 92614-5686

Re: K060093

Trade Name: PreSep Oligon Oximetry Catheters Regulation Number: 21 CFR 870.1230 Regulation Name: Fiberoptic Oximeter Catheter Regulatory Class: Class II (two) Product Code: DQE Dated: March 29, 2006 Received: March 31, 2006

Dear Mr. Smith:

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 - Mr. Jason Smith

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 [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 vours.

er R. Lochner

- (1 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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Koboog3

Image /page/3/Picture/1 description: The image shows the logo for Edwards Lifesciences. The logo consists of a stylized graphic on the left and the text "Edwards Lifesciences" on the right. The graphic is a grid-like pattern with a mix of solid and patterned squares. The text is in a serif font and is horizontally aligned with the graphic.

One Edwards Way · Irvine, C Phone: [phone] · Fax: 949-250 www.edwards.com

## Indications for Use Statement 4

510(k) Number (if known): K060093

Device Name: PreSep Oligon Oximetry Catheters

Indications for Use:

The PreSep Oligon Oximetry Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dunch R. Holmes

ular Devices

510(k) Number

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