PreSep Oligon Oximetry Catheter

K160645 · Edwards Lifesciences, LLC · DQE · Jun 16, 2016 · Cardiovascular

Device Facts

• Record ID: K160645
• Device Name: PreSep Oligon Oximetry Catheter
• Applicant: Edwards Lifesciences, LLC
• Product Code: DQE · Cardiovascular
• Decision Date: Jun 16, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1230
• Device Class: Class 2

Intended Use

The pressure injectable PreSep Oligon Oximetry Catheters are indicated for short term (< 30 days) hemodynamic monitoring through blood sampling, infusion of solutions, continuous monitoring of oxygen saturation measurements, pressure injection of contrast media and central venous pressure monitoring. When used for pressure injection of contrast media do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable PreSep Oligon Oximetry Catheter may not exceed 400psi.

Device Story

PreSep Oligon Oximetry Catheter is a 3-lumen, pressure-injectable, antimicrobial central venous catheter; available in 8.5 French, 16cm and 20cm lengths. Catheter inputs include venous blood for oxygen saturation monitoring via fiberoptic technology; outputs include continuous oxygen saturation data displayed on an Edwards Lifesciences oximetry monitor. Used in clinical settings (e.g., ICU, OR) by physicians/nurses for hemodynamic monitoring, fluid infusion, and contrast media delivery. Antimicrobial properties provided by silver/platinum ions released via oligodynamic iontophoresis from catheter surfaces. Healthcare providers use oxygen saturation data to assess patient hemodynamic status and guide clinical interventions. Benefits include reduced risk of catheter-related infection and integrated monitoring capabilities.

Clinical Evidence

Bench testing only. Performance testing included blood oxygenation, tensile strength, fatigue, flow rate, tip buckling, radiopacity, pressure testing, silver release, and MRI compatibility. No clinical data presented.

Technological Characteristics

3-lumen catheter; material: barium sulfate-filled polyurethane with carbon, silver, and platinum. Antimicrobial mechanism: oligodynamic iontophoresis (silver ion release). Fiberoptic sensing for oxygen saturation. Pressure injectable up to 400 psi. Radiopaque. MR Safe.

Indications for Use

Indicated for short-term (<30 days) hemodynamic monitoring, blood sampling, infusion of solutions, continuous oxygen saturation monitoring, contrast media pressure injection, and central venous pressure monitoring in patients requiring central venous access.

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)
• Arrow G+ Blue Plus Pressure Injectable Central Venous Catheter (K071538)

Submission Summary (Full Text)

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Public Health Service

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

June 16, 2016

Edwards Lifesciences, LLC Deana Boushell Senior Manager, RA 1 Edwards Way Irvine, California 92614

Re: K160645

Trade/Device Name: Presep Oligon Oximetry Catheter Regulation Number: 21 CFR 870.1230 Regulation Name: Fiberoptic Oximeter Catheter Regulatory Class: Class II Product Code: DQE Dated: March 4, 2016 Received: March 7, 2016

Dear Deana Boushell:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stein

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K160645

Device Name

PreSep Oligon Oximetry Catheter

### Indications for Use (Describe)

The pressure injectable PreSep Oligon Oximetry Catheters are indicated for short term (< 30 days) hemodynamic monitoring through blood sampling, infusion of solutions, continuous monitoring of oxygen saturation measurements, pressure injection of contrast media and central venous pressure monitoring.

When used for pressure injection of contrast media do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable PreSep Oligon Oximetry Catheter may not exceed 400psi.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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# SECTION 5 - 510(k) SUMMARY

| 510(k) Submitter | Edwards Lifesciences, LLC |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Deana Boushell |
| Date Prepared | June 15, 2016 |
| Trade Name | PreSep Oligon Oximetry Catheter |
| Classification Name | Catheter, Oximeter, Fiberoptic (21 CFR 870.1230) |
| Regulation Class/Product Code | Class II/<br>DQE |
| Predicate Device(s) | K060093: PreSep Oligon Oximetry Catheters<br>K071538: Arrow G+ Blue Plus Pressure Injectable Central Venous Catheter |
| Device Description | The PreSep Oligon Oximetry Catheter is a pressure injectable antimicrobrial<br>catheter intended to provide the means for infusion of solutions, measuring<br>pressure, delivering contrast media and taking blood samples through the<br>distal, proximal and medial lumens. The PreSep Oligon Oximetry Catheter<br>also provides the means for continuously monitoring oxygen saturation<br>using an Edwards Lifesciences oximetry monitor.<br><br>The PreSep Oligon Oximetry Catheter is a 3 lumen catheter available in 8.5<br>French, 16 and 20cm lengths. The lumens exit at the tip of the catheter for<br>the distal; medial and proximal exit at the ports. The catheter is<br>manufactured from a base material of barium sulfate-filled polyurethane.<br>Barium sulfate makes the material more radiopaque. Carbon, silver, and<br>platinum are added to the base material. The silver and platinum render the<br>polymer antimicrobial, by oligodynamic iontophoresis. The antimicrobial<br>agent is silver, which is ionized and electrochemically released from the<br>inside and outside surfaces of the catheter material into the lumens and<br>subcutaneous space. The Oligon polymer technology provides<br>antimicrobial protection on both the inside and outside of the catheter.<br><br>With the use of the Oligon material, the catheter has demonstrated<br>significant antimicrobial activity, within 48 hours after inoculation, against<br>the following organisms: Staphylococcus epidermidis, Staphylococcus<br>aureus, Enterococcus faecalis, Candida albicans, Escherichia coli, Serratia<br>marcescens, Acinetobacter calcoaceticus, Corynebacterium diptheriae,<br>Enterobacter aerogenes, Klebsiella pneumoniae, Staphylococcus aureus<br>Gentamicin and Methicillin resistant (GMRSa), Pseudomonas aeruginosa,<br>Candida glabrata, and VRE (Enterococcus faecium) |
| Indications for Use/Intended Use | The pressure injectable PreSep Oligon Oximetry Catheters are indicated for<br>short term (< 30 days) hemodynamic monitoring through blood sampling |
| | measurements, pressure injection of contrast media and central venous pressure monitoring. |
| | When used for pressure injection of contrast media do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable PreSep Oligon Oximetry Catheter may not exceed 400psi. |
| Comparative<br>Analysis | Testing was conducted to confirm the performance and functionality of the PreSep Oligon Oximetry Catheter as comparted to the predicate device. There are no design differences between the two devices. The only difference is in the labeling, specifically an indication expansion to include the pressure injection of contrast media and the addition of MR Safe labeling. The PreSep Oligon Oximetry Catheter was shown to be safe, effective, and substantially equivalent to the predicate device for its intended use. |
| Functional/ Safety<br>Testing | PreSep Oligon Oximetry Catheter has successfully passed functional and performance testing, including blood oxygenation, tensile, fatigue, flow rate, tip buckling, radiopacity, pressure, silver release and MRI testing. |
| Conclusion | PreSep Oligon Oximetry Catheter has been shown to be safe, effective, and is substantially equivalent to the predicate for its intended use. |

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