PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR

Q: Who is the manufacturer of PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR?

Edwards Lifesciences, LLC filed the 510(k) submission for PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR (K053609).

Q: What is the FDA product code for PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR?

DQE. It is classified under 21 CFR 870.1230 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR?

Central Venous Oximetry Probe Catheter and Probe; Multi-Med Multi-Lumen Central Venous Catheter; Edslab Dual Lumen Regional Saturation Oximetry Catheter; Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor; SDM Percuglide.

Q: Who can help prepare an FDA 510(k) submission like PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K053609 · Edwards Lifesciences, LLC · DQE · Feb 28, 2006 · Cardiovascular

Device Facts

Record ID	K053609
Device Name	PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
Applicant	Edwards Lifesciences, LLC
Product Code	DQE · Cardiovascular
Decision Date	Feb 28, 2006
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1230
Device Class	Class 2
Attributes	Pediatric

Intended Use

The PreSep Oximetry and PediaSat Oximetry Catheters are intended to provide in adults and pediatrics the means for infusion of solutions, measuring pressure and taking blood samples through the distal, proximal and medial lumens. The PreSep Oximetry and PediaSat Oximetry Catheters also provide the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor. The dilator included with either the PreSep Oximetry or PediaSat Oximetry Catheter is intended to be used in adults and pediatric patients for enlarging the opening in a vessel for preparation of percutaneous entry of the catheter. The Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor is intended to measure arterial pressure cardiac output and oximetry. The monitor also calculates hemodynamic and oxygenation parameters. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics.

Device Story

System comprises PreSep/PediaSat Oximetry Catheters and Vigileo APCO/Oximetry Monitor. Catheters provide venous access for infusion, pressure measurement, blood sampling, and continuous oxygen saturation monitoring via fiberoptic technology. Monitor is a microprocessor-based instrument; connects to dual disposable pressure transducer (DDPT) for arterial pressure cardiac output (APCO) measurement; connects to oximetry catheters for oxygen saturation. Monitor calculates derived parameters: cardiac index, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, and systemic vascular resistance index. Used in clinical settings by healthcare professionals to assess hemodynamic status and oxygenation. Output displayed on monitor for clinical decision-making regarding patient oxygen delivery and consumption.

Clinical Evidence

Bench testing only. No clinical data provided. Functional testing confirmed equivalence to predicate devices.

Technological Characteristics

Fiberoptic oximetry catheters; microprocessor-based monitor; dual disposable pressure transducer (DDPT). Connectivity: monitor interfaces with catheters and pressure transducers. Software: microprocessor-based algorithm for hemodynamic parameter calculation. Sterilization: not specified.

Indications for Use

Indicated for hemodynamic monitoring and oxygen saturation measurement in adults and pediatric patients via blood sampling and catheter-based monitoring. The dilator is indicated for enlarging vessel openings for percutaneous catheter entry. The monitor is indicated for measuring arterial pressure cardiac output and oximetry to assess oxygen delivery and consumption.

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
Multi-Med Multi-Lumen Central Venous Catheter
Edslab Dual Lumen Regional Saturation Oximetry Catheter
Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor
SDM Percuglide

Related Devices

K043065 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P · Edwards Lifesciences, LLC · Jan 26, 2005
K082308 — MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR · Edwards Lifesciences, LLC · Dec 9, 2008
K062134 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR · Edwards Lifesciences, LLC · Aug 22, 2006
K131588 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR · Edwards Lifesciences, LLC · May 22, 2014
K103094 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR · Edwards Lifesciences, LLC · May 17, 2011

Submission Summary (Full Text)

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K053609 page 1 of 3 ## 510(k) Summary 5 | Submitter: | Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614-5686 | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Diane Peterson | | | Project Manager, Regulatory Affairs | | Date Prepared: | December 21, 2005 | | Trade name: | PreSep Oximetry and PediaSat Oximetry Catheters | | | Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor | | Classification | Catheter, Oximeter, Fiberoptic (21 CFR 870.1230) | | Name: | Single-Function, Preprogrammed Diagnostic Computer (21 CFR 870.1435) | | | Dilator, Vessel, For Percutaneous Catheterization (21 CFR 870.1310) | | Predicate | Central Venous Oximetry Probe Catheter and Probe | | Devices: | Multi-Med Multi-Lumen Central Venous Catheter | | | Edslab Dual Lumen Regional Saturation Oximetry Catheter | | | Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor | | | SDM Percuglide | | Device Description: | The PreSep Oximetry and PediaSat Oximetry Catheters are used with Edwards oximetry monitors to continuously measure oxygen saturation in adults and pediatrics. These catheters also provide the means for infusion of solutions, measuring pressure and taking blood samples. The dilator included with either the PreSep Oximetry or PediaSat Oximetry Catheter is used to enlarge the | {1}------------------------------------------------ 053609 page 2 of 3 Image /page/1/Picture/1 description: The image shows a close-up of a letter 'E' superimposed on a grid pattern. The letter 'E' is partially obscured by circular shapes, creating a layered effect. The grid pattern provides a structured background, while the letter and circles add visual complexity to the composition. Edwards opening in a vessel for preparation of percutaneous entry of the catheter. The Vigileo APCO/Oximetry monitor is a microprocessor-based instrument which, when connected to a dual disposable pressure transducer (DDPT), continuously measures arterial pressure cardiac output (APCO). When connected to an Edwards oximetry catheter, the monitor measures oxygen saturation (oximetry) in adults or pediatrics. The monitor also calculates other derived parameters including cardiac index, stroke volume, stroke volume index, stroke volume variation, system vascular resistance, and systemic vascular resistance index. The PreSep Oximetry and PediaSat Oximetry Catheters i Intended Use: are intended to provide in adults and pediatrics the means for infusion of solutions, measuring pressure and taking blood samples through the distal, proximal and medial lumens. The PreSep Oximetry and PediaSat Oximetry Catheters also provide the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor. > The dilator included with either the PreSep Oximetry or i PediaSat Oximetry Catheter is intended to be used in adults and pediatric patients for enlarging the opening in a vessel for preparation of percutaneous entry of the catheter. > The Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor is intended to measure arterial pressure cardiac output and oximetry. The monitor also calculates hemodynamic and oxygenation parameters. When i connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The PreSep Oximetry and PediaSat Oximetry Comparative Catheters, dilator and the Vigileo Arterial Pressure Analysis: Cardiac Output/Oximetry Monitor have been demonstrated to be as safe and effective as the predicate devices for their intended use i Page 14 {2}------------------------------------------------ 059609 3 of 3 Image /page/2/Picture/1 description: The image shows a logo with the word "Edwards" written below it. The logo consists of a large letter "E" with a design inside of it. The design appears to be a combination of circles and lines, creating a complex and abstract pattern within the letter. The logo and the word "Edwards" are both in black and white. The PreSep Oximetry and PediaSat Oximetry Functional/Safety Catheters, dilator and the Vigileo Arterial Pressure Testing: Cardiac Output/Oximetry Monitor have successfully undergone functional testing. These products have been shown to be equivalent to the predicate devices. The PreSep Oximetry and PediaSat Oximetry Conclusion: Catheters, dilator and the Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor are substantially equivalent to the predicate devices. {3}------------------------------------------------ Public Health Service Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol of three abstract human figures. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 8 2006 Edwards Lifesciences LLC c/o Ms. Diane Peterson Project Manager, Regulatory Affairs One Edwards Way Irvine, CA 92614 ## Re: K053609 Trade Name: Vigileo APCO/Oximetry Monitor (MIHM1 & MIHM1P), PediaSat Oximetry Catheter Kit, and PreSep - Central Venous Oximetry Catheter Kit Regulation Number: 21 CFR § 870.1230, 21 CFR § 870.1310, and 21 CFR §870.1435 Regulation Name: Fiberoptic Oximeter Catheter, Vessel Dilator for Percutaneous Vessel Dilation, and Single-Function, Preprogrammed Diagnostic Computer Regulatory Class: II (two) Product Code: DQE, DRE, and DXG Dated: December 21, 2005 Received: December 27, 2005 ## Dear Ms. Peterson: We have reviewed your Section 510(k) premarket notification of intent to market the device w & nove 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, do nots that hat t (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. {4}------------------------------------------------ Page 2 - Ms. Diane Peterson Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri- 3 issuation of a build with other requirements of the Act that IDA has made a decermination administered by other Federal agencies. You must of any it catal statutes and regalations and limited to: registration and listing (21 Comply with an the Her e requirements)01); good manufacturing practice requirements as set CFN in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (beting your device as described in your Section 510(k) This letter will anow you to begin manical equivalence of your device of your device to a legally prematicated 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 If you desire specific acrise at (240) 276-0120. Also, please note the regulation entitled, eonading by reference to premarket notification" (21CFR Part 807.97). You may obtain Whisoranding of reference to premassionsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, B/Zimmerman for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Edwards Lifesciences. The logo consists of a square graphic on the left and the company name "Edwards Lifesciences" on the right. The text is in a simple, sans-serif font and is horizontally aligned. ## Indications for Use Statement 4 510(k) Number (if known): KOS3609 Device Name: PreSep Oximetry Catheters PediaSat Oximetry Catheters PediaSal Oximetry Gatheloro Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor Indications for Use: The PreSep Oximetry and PediaSat Oximetry Catheters are indicated for The PreSep Oximelly and I Calabat Oximony of Ediatrics through blood sampling. hemodynamic monitoring in adults and pediatrics through blood sampling. nemodynamio monitoring and oxygen saturation measurement. The dilator, included with each catheter, is indicated for enlarging the opening in The difator, included wn of percutaneous entry of the catheter. The Vigileo Arterial Pressure Cardiac Output /Oximetry Monitor is indicated for i he Vigiled Altenal Fressure Oardiae Output Foximal output and continuously measuring nemouynamic parsumption. When connected to an oximetry to assess oxygen delivery and consumption. When end oximelly to assess oxygen doll. By and or monitor measures oximetry in adults and pediatrics. Over-The-Counter Use AND/OR Prescription 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) Bhummana Witness Sign Off Page 1 of