(101 days)
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.
The PreSep Oligon Oximetry Catheter is a pressure injectable antimicrobrial catheter intended to provide the means for infusion of solutions, measuring pressure, delivering contrast media and taking blood samples through the distal, proximal and medial lumens. The PreSep Oligon Oximetry Catheter also provides the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor.
The PreSep Oligon Oximetry Catheter is a 3 lumen catheter available in 8.5 French, 16 and 20cm lengths. The lumens exit at the tip of the catheter for the distal; medial and proximal exit at the ports. The catheter is manufactured from a base material of barium sulfate-filled polyurethane. Barium sulfate makes the material more radiopaque. Carbon, silver, and platinum are added to the base material. The silver and platinum render the polymer antimicrobial, by oligodynamic iontophoresis. The antimicrobial agent is silver, which is ionized and electrochemically released from the inside and outside surfaces of the catheter material into the lumens and subcutaneous space. The Oligon polymer technology provides antimicrobial protection on both the inside and outside of the catheter.
With the use of the Oligon material, the catheter has demonstrated significant antimicrobial activity, within 48 hours after inoculation, against the following organisms: Staphylococcus epidermidis, Staphylococcus aureus, Enterococcus faecalis, Candida albicans, Escherichia coli, Serratia marcescens, Acinetobacter calcoaceticus, Corynebacterium diptheriae, Enterobacter aerogenes, Klebsiella pneumoniae, Staphylococcus aureus Gentamicin and Methicillin resistant (GMRSa), Pseudomonas aeruginosa, Candida glabrata, and VRE (Enterococcus faecium)
The provided text describes the 510(k) summary for the PreSep Oligon Oximetry Catheter (K160645). However, it does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML-based medical device.
The document discusses:
- The device's trade name, regulation, and classification.
- Indications for Use, which are for hemodynamic monitoring, blood sampling, infusion, continuous oxygen saturation monitoring, pressure injection of contrast media, and central venous pressure monitoring for short-term use (<30 days).
- A comparison to predicate devices, noting the specific difference being an indication expansion to include pressure injection of contrast media and MR Safe labeling.
- Functional and safety testing performed: blood oxygenation, tensile, fatigue, flow rate, tip buckling, radiopacity, pressure, silver release, and MRI testing.
There is no mention of:
- Acceptance criteria in a quantitative sense with reported performance values.
- Sample sizes for test sets (beyond the generic list of functional tests).
- Data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for an AI/ML context.
- Training set details.
This document pertains to a physical medical device (catheter) and its substantial equivalence to a predicate device, focusing on its physical and functional properties, not an AI/ML software device. Therefore, it cannot be used to answer the prompt's specific requirements geared towards AI/ML device validation.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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/DQE |
| Predicate Device(s) | K060093: PreSep Oligon Oximetry CathetersK071538: Arrow G+ Blue Plus Pressure Injectable Central Venous Catheter |
| Device Description | The PreSep Oligon Oximetry Catheter is a pressure injectable antimicrobrialcatheter intended to provide the means for infusion of solutions, measuringpressure, delivering contrast media and taking blood samples through thedistal, proximal and medial lumens. The PreSep Oligon Oximetry Catheteralso provides the means for continuously monitoring oxygen saturationusing an Edwards Lifesciences oximetry monitor.The PreSep Oligon Oximetry Catheter is a 3 lumen catheter available in 8.5French, 16 and 20cm lengths. The lumens exit at the tip of the catheter forthe distal; medial and proximal exit at the ports. The catheter ismanufactured from a base material of barium sulfate-filled polyurethane.Barium sulfate makes the material more radiopaque. Carbon, silver, andplatinum are added to the base material. The silver and platinum render thepolymer antimicrobial, by oligodynamic iontophoresis. The antimicrobialagent is silver, which is ionized and electrochemically released from theinside and outside surfaces of the catheter material into the lumens andsubcutaneous space. The Oligon polymer technology providesantimicrobial protection on both the inside and outside of the catheter.With the use of the Oligon material, the catheter has demonstratedsignificant antimicrobial activity, within 48 hours after inoculation, againstthe following organisms: Staphylococcus epidermidis, Staphylococcusaureus, Enterococcus faecalis, Candida albicans, Escherichia coli, Serratiamarcescens, Acinetobacter calcoaceticus, Corynebacterium diptheriae,Enterobacter aerogenes, Klebsiella pneumoniae, Staphylococcus aureusGentamicin and Methicillin resistant (GMRSa), Pseudomonas aeruginosa,Candida glabrata, and VRE (Enterococcus faecium) |
| Indications for Use/Intended Use | The pressure injectable PreSep Oligon Oximetry Catheters are indicated forshort 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. | |
| ComparativeAnalysis | 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/ SafetyTesting | 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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§ 870.1230 Fiberoptic oximeter catheter.
(a)
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.(b)
Classification. Class II (performance standards).