(106 days)
Not Found
Not Found
No
The summary describes a catheter for monitoring oxygen saturation and other physiological parameters, with no mention of AI or ML in its function or analysis.
No
The device is primarily for monitoring and diagnostic purposes (measuring pressure, taking blood samples, monitoring oxygen saturation) and for infusion of solutions, not for directly treating a disease or condition.
Yes
Explanation: The device is used for "continuously monitoring oxygen saturation," "hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements," and "measuring pressure and taking blood samples." These actions are diagnostic in nature as they provide information about a patient's health status.
No
The device description clearly states it is a catheter, which is a physical hardware component. The summary also mentions "functional testing" of the catheters, further indicating a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The primary intended uses are for infusion, pressure measurement, blood sampling, and continuous oxygen saturation monitoring. These are all performed in vivo (within the living body).
- Device Description: The description reinforces the in vivo nature of the device, highlighting its use with an oximetry monitor to measure oxygen saturation continuously.
- Lack of mention of in vitro testing: There is no mention of analyzing samples outside the body for diagnostic purposes.
IVD devices are specifically designed to examine specimens (like blood, urine, tissue) in vitro to provide information for diagnosis, monitoring, or screening. This device operates directly within the patient's circulatory system.
N/A
Intended Use / Indications for Use
The PreSep Oligon Oximetry Catheters are intended to provide the means for infusion of solutions, measuring pressure and taking blood samples through the distal, proximal and medial lumens. The PreSep Oligon Oximetry Catheters also provide the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor.
The PreSep Oligon Oximetry Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements.
Product codes (comma separated list FDA assigned to the subject device)
DQE
Device Description
The PreSep Oligon Oximetry Catheters are used with Edwards oximetry monitors to continuously measure oxygen saturation. These catheters also provide the means for infusion of solutions, measuring pressure and taking blood samples.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The PreSep Oligon Oximetry Catheters have successfully undergone functional testing. These products have been shown to be equivalent to the predicate devices.
The PreSep Oligon Oximetry Catheters have been demonstrated to be as safe and effective as the predicate devices for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Central Venous Oximetry Probe Catheter and Probe, Vantex Central Venous Catheters with Oligon material, Edslab Dual Lumen Regional Saturation Oximetry Catheter
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for Edwards Lifesciences. The logo consists of a square grid pattern on the left and the company name "Edwards Lifesciences" on the right. The text is in a serif font and is black.
One Edwards Way • Irvine, CA USA • 92614
Phone: 949-250-2500 • Fax: 949-250-2525 www.edwards.com
5 510(k) Summary
| Submitter: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614-5686 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jason Smith
Project Manager, Regulatory Affairs |
| Date Prepared: | January 10, 2006 |
| Trade name: | PreSep Oligon Oximetry Catheters |
| Classification
Name: | Catheter, Oximeter, Fiberoptic (21 CFR 870.1230) |
| Predicate
Devices: | Central Venous Oximetry Probe Catheter and Probe,
Vantex Central Venous Catheters with Oligon material,
Edslab Dual Lumen Regional Saturation Oximetry
Catheter |
| Device
Description: | The PreSep Oligon Oximetry Catheters are used with
Edwards oximetry monitors to continuously measure
oxygen saturation. These catheters also provide the
means for infusion of solutions, measuring pressure and
taking blood samples. |
| Intended Use: | The PreSep Oligon Oximetry Catheters are intended to
provide the means for infusion of solutions, measuring
pressure and taking blood samples through the distal,
proximal and medial lumens. The PreSep Oligon
Oximetry Catheters also provide the means for
continuously monitoring oxygen saturation using an
Edwards Lifesciences oximetry monitor. |
| Comparative
Analysis: | The PreSep Oligon Oximetry Catheters have been
demonstrated to be as safe and effective as the
predicate devices for their intended use. |
| Functional/Safety
Testing: | The PreSep Oligon Oximetry Catheters have
successfully undergone functional testing. These
products have been shown to be equivalent to the
predicate devices. |
| Conclusion: | The PreSep Oligon Oximetry Catheters are
substantially equivalent to the predicate devices. |
January 10, 2006 510(k) Notification for PreSep Oligon Oximetry Catheters CONFIDENTIAL
Page 12
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1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2006
Edwars Lifesciences LLC c/o Mr. Jason Smith Project Manager, Regulatory Affairs One Edwards Way Irvine, CA 92614-5686
Re: K060093
Trade Name: PreSep Oligon Oximetry Catheters Regulation Number: 21 CFR 870.1230 Regulation Name: Fiberoptic Oximeter Catheter Regulatory Class: Class II (two) Product Code: DQE Dated: March 29, 2006 Received: March 31, 2006
Dear Mr. Smith:
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.
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.
2
Page 2 - Mr. Jason Smith
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
er R. Lochner
- (1 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Koboog3
Image /page/3/Picture/1 description: The image shows the logo for Edwards Lifesciences. The logo consists of a stylized graphic on the left and the text "Edwards Lifesciences" on the right. The graphic is a grid-like pattern with a mix of solid and patterned squares. The text is in a serif font and is horizontally aligned with the graphic.
One Edwards Way · Irvine, C Phone: 949-250-2500 · Fax: 949-250 www.edwards.com
Indications for Use Statement 4
510(k) Number (if known): K060093
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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter 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)
Dunch R. Holmes
ular Devices
510(k) Number
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