(101 days)
Not Found
No
The document describes a catheter for hemodynamic monitoring and infusion, focusing on material properties and functional performance. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device facilitates continuous monitoring of oxygen saturation and other hemodynamic parameters, but it does not directly treat a disease or condition itself. Its antimicrobial properties are preventative, not therapeutic.
Yes
The device continuously monitors oxygen saturation measurements, which is a diagnostic function, and allows for blood sampling for further analysis.
No
The device description clearly details a physical catheter made of polyurethane with added materials like barium sulfate, carbon, silver, and platinum. It is a hardware device intended for insertion into the body.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this catheter is used for direct interaction with the patient's circulatory system (blood sampling, infusion, pressure monitoring, contrast injection, oxygen saturation monitoring). It is not used to test samples outside of the body.
- The functions described are related to patient monitoring and treatment. Blood sampling is for obtaining samples, but the device itself isn't performing the diagnostic test on the sample. The other functions are directly related to patient care and monitoring in vivo.
Therefore, the PreSep Oligon Oximetry Catheter is a medical device used for patient monitoring and treatment, not an IVD.
N/A
Intended Use / Indications for Use
The pressure injectable PreSep Oligon Oximetry Catheters are indicated for short term (
§ 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).
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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 ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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 Catheters |
| K071538: Arrow G+ Blue Plus Pressure Injectable Central Venous Catheter | |
| Device Description | 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) |
| Indications for Use/Intended Use | The pressure injectable PreSep Oligon Oximetry Catheters are indicated for
short term (