(29 days)
Not Found
No
The summary describes a catheter for hemodynamic monitoring and oxygen saturation measurement, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is used for monitoring and measuring physiological parameters, not for treating a disease or condition.
Yes
The device is indicated for "oxygen saturation measurements" and "hemodynamic monitoring," both of which involve assessing a patient's physiological state to aid in diagnosis and treatment.
No
The device description clearly states it is a catheter, which is a physical hardware component, and mentions guidewires. It also describes bench and pre-clinical testing of the physical device.
Based on the provided text, the PreSep Oligon Oximetry Catheters are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device as being used for "hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements." These are measurements taken in vivo (within the living body) or from blood samples taken from the body, but the device itself is not performing a diagnostic test on the blood sample in a laboratory setting.
- Device Description: The description reinforces its use for continuous oxygen saturation measurements (taken in vivo), infusion, pressure measurement, and blood sampling. It doesn't describe any components or functions related to analyzing biological samples in vitro to diagnose a condition.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as reagents, assays, or analysis of biological samples outside of the body for diagnostic purposes.
Therefore, the PreSep Oligon Oximetry Catheters are a medical device used for monitoring and accessing the circulatory system, not an IVD.
N/A
Intended Use / Indications for Use
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 (K060093) are used with Edwards oximetry monitors to continuously measure oxygen saturation. The catheters also provide the means for infusion of solutions, measuring pressure and taking blood samples. The PreSep Oligon Oximetry Catheters can be used with an uncoated stainless steel guidewire or a PTFE-coated Nitinol core guidewire, which are included in kits or as separately packaged components.
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)
Verification and validation testing was conducted to compare the performance and functionality of the PreSep Oligon Oximetry Catheters to the predicate device. This testing regimen included side-by-side comparative bench and pre-clinical performance testing of the pending and predicate devices. The results show that the performance functionality of the pending guidewire is substantially equivalent to the predicate device, and provides a marked improvement in the ease of use of the pending device in comparison to the predicate device. Thus, the PreSep Oligon Oximetry Catheters have been demonstrated to be safe and effective and substantially equivalent to the predicate device for their intended use.
The PreSep Oligon Oximetry Catheters have successfully undergone functional and performance testing, including bench studies, pre-clinical animal studies and biocompatibility testing. The PreSep Oligon Oximetry Catheters have been shown to be safe and effective and substantially equivalent to the cited predicate device 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.
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
510(k) Summary
K110167
p 1/2
| Submitter: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614-5686
FEB 18 2011 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Marguerite Thomlinson, JD, BSME
Sr. Manager of Regulatory Affairs
Edwards Lifesciences LLC
Phone: (949) 756-4386
Fax: (949) 809-5676 |
| Date Prepared: | February 17, 2011 |
| Trade Name: | PreSep Oligon Oximetry Catheters |
| Classification Name: | Catheter, Oximeter, Fiberoptic (21 CFR Part 870.1230) |
| Product Class/ Code: | Class II/ DQE |
| Predicate Devices: | K060093, PreSep Oligon Oximetry Catheters
K100739, VolumeView System |
Device Description:
The PreSep Oligon Oximetry Catheters (K060093) are used with Edwards oximetry monitors to continuously measure oxygen saturation. The catheters also provide the means for infusion of solutions, measuring pressure and taking blood samples. The PreSep Oligon Oximetry Catheters can be used with an uncoated stainless steel guidewire or a PTFE-coated Nitinol core guidewire, which are included in kits or as separately packaged components.
Indications for Use:
The PreSep Oligon Oximetry Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements.
Comparative Analysis:
Verification and validation testing was conducted to compare the performance and functionality of the PreSep Oligon Oximetry Catheters to the predicate device. This testing regimen included side-by-side comparative bench and pre-clinical performance testing of the pending and predicate devices. The results show that the
1
510(k) Summary
K110/67
p 2/2
performance functionality of the pending guidewire is substantially equivalent to the predicate device, and provides a marked improvement in the ease of use of the pending device in comparison to the predicate device. Thus, the PreSep Oligon Oximetry Catheters have been demonstrated to be safe and effective and substantially equivalent to the predicate device for their intended use.
Functional/Safety Testing:
The PreSep Oligon Oximetry Catheters have successfully undergone functional and performance testing, including bench studies, pre-clinical animal studies and biocompatibility testing. The PreSep Oligon Oximetry Catheters have been shown to be safe and effective and substantially equivalent to the cited predicate device for their intended use.
Conclusion:
The PreSep Oligon Oximetry Catheters are safe and effective and are substantially equivalent to the cited predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Edwards Lifesciences, LLC C/O Ms. Marguerite Thomlinson Sr. Manager of Regulatory Affairs, Critical Care One Edwards Way Irvine. CA 92614
FEB 18 201
Re: K110167
Trade/Device Name: PreSep Oligon Oximetry Catheters Regulation Number: 21 CFR 870.1230 Regulation Name: Catheter, Oximetry, Fiberoptic Regulatory Class: Class II Product Code: DQE Dated: January 18, 2011 Received: January 20, 2011
Dear Ms. Thomlinson:
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
3
Page 2 - Ms. Thomlinson
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803): 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Pari 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K 110167
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.
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M.
vision Sign-Off) ivision of Cardiovascular Devices 510(k) Number