PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)

K110167 · Edwards Lifesciences, LLC · DQE · Feb 18, 2011 · Cardiovascular

Device Facts

• Record ID: K110167
• Device Name: PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
• Applicant: Edwards Lifesciences, LLC
• Product Code: DQE · Cardiovascular
• Decision Date: Feb 18, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1230
• Device Class: Class 2

Intended Use

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

Device Story

PreSep Oligon Oximetry Catheters are fiberoptic catheters used with Edwards oximetry monitors for continuous oxygen saturation measurement. The device facilitates hemodynamic monitoring, including blood sampling and pressure monitoring. It is compatible with either uncoated stainless steel guidewires or PTFE-coated Nitinol core guidewires. Used in clinical settings by healthcare professionals, the catheter provides real-time physiological data to support clinical decision-making regarding patient hemodynamic status. The primary benefit is the integration of oximetry with standard catheter functions, allowing for continuous monitoring and diagnostic sampling.

Clinical Evidence

Bench testing and pre-clinical animal studies were conducted to compare the performance and functionality of the subject device against the predicate. No human clinical trial data was required or presented. Testing confirmed that the device is safe, effective, and performs substantially equivalent to the predicate.

Technological Characteristics

Fiberoptic oximetry catheter; materials include stainless steel or PTFE-coated Nitinol core guidewires. Functions as a multi-lumen catheter for pressure monitoring, blood sampling, and optical oxygen saturation sensing. Designed for use with Edwards oximetry monitors. Sterilization and specific ASTM standards are not explicitly detailed in the provided text.

Indications for Use

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

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

• PreSep Oligon Oximetry Catheters (K060093)
• VolumeView System (K100739)

Submission Summary (Full Text)

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# 510(k) Summary

K110167
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| Submitter: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614-5686<br>FEB 18 2011 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Marguerite Thomlinson, JD, BSME<br>Sr. Manager of Regulatory Affairs<br>Edwards Lifesciences LLC<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | February 17, 2011 |
| Trade Name: | PreSep Oligon Oximetry Catheters |
| Classification Name: | Catheter, Oximeter, Fiberoptic (21 CFR Part 870.1230) |
| Product Class/ Code: | Class II/ DQE |
| Predicate Devices: | K060093, PreSep Oligon Oximetry Catheters<br>K100739, VolumeView System |

### Device Description:

The PreSep Oligon Oximetry Catheters (K060093) are used with Edwards oximetry monitors to continuously measure oxygen saturation. The catheters also provide the means for infusion of solutions, measuring pressure and taking blood samples. The PreSep Oligon Oximetry Catheters can be used with an uncoated stainless steel guidewire or a PTFE-coated Nitinol core guidewire, which are included in kits or as separately packaged components.

### Indications for Use:

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

## Comparative Analysis:

Verification and validation testing was conducted to compare the performance and functionality of the PreSep Oligon Oximetry Catheters to the predicate device. This testing regimen included side-by-side comparative bench and pre-clinical performance testing of the pending and predicate devices. The results show that the

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# 510(k) Summary

K110/67
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performance functionality of the pending guidewire is substantially equivalent to the predicate device, and provides a marked improvement in the ease of use of the pending device in comparison to the predicate device. Thus, the PreSep Oligon Oximetry Catheters have been demonstrated to be safe and effective and substantially equivalent to the predicate device for their intended use.

## Functional/Safety Testing:

The PreSep Oligon Oximetry Catheters have successfully undergone functional and performance testing, including bench studies, pre-clinical animal studies and biocompatibility testing. The PreSep Oligon Oximetry Catheters have been shown to be safe and effective and substantially equivalent to the cited predicate device for their intended use.

### Conclusion:

The PreSep Oligon Oximetry Catheters are safe and effective and are substantially equivalent to the cited predicate device.

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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 & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Edwards Lifesciences, LLC C/O Ms. Marguerite Thomlinson Sr. Manager of Regulatory Affairs, Critical Care One Edwards Way Irvine. CA 92614

FEB 18 201

Re: K110167

Trade/Device Name: PreSep Oligon Oximetry Catheters Regulation Number: 21 CFR 870.1230 Regulation Name: Catheter, Oximetry, Fiberoptic Regulatory Class: Class II Product Code: DQE Dated: January 18, 2011 Received: January 20, 2011

Dear Ms. Thomlinson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Thomlinson

CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803): 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Pari 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

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 (if known): K 110167

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.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.

vision Sign-Off) ivision of Cardiovascular Devices 510(k) Number