(106 days)
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.
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.
This is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to establish de novo performance criteria. Therefore, the traditional concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as would be seen in a clinical trial for a novel device, is not explicitly present in the provided text.
Instead, the submission focuses on demonstrating that the PreSep Oligon Oximetry Catheters are as safe and effective as the predicate devices through comparative analysis and functional/safety testing.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Compared to Predicate Devices: "The PreSep Oligon Oximetry Catheters have been demonstrated to be as safe and effective as the predicate devices for their intended use." |
| Functional Equivalence | "The PreSep Oligon Oximetry Catheters have successfully undergone functional testing. These products have been shown to be equivalent to the predicate devices." |
Note: The document
does not specify quantitative acceptance criteria (e.g., specific thresholds for accuracy, precision, or durability). The acceptance is based on demonstrating equivalence to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission states "functional testing" was performed, but no specifics about the testing methodology or data are given.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. Given that this is a 510(k) for an oximetry catheter, "ground truth" would likely refer to established methods for measuring oxygen saturation or relevant physiological parameters, and not typically involve a panel of experts reviewing images or clinical cases in the way an AI-based diagnostic device might.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. MRMC studies are typically used to assess the impact of medical imaging devices or AI algorithms on human reader performance, which doesn't directly apply to an oximetry catheter for continuous physiological monitoring. The comparative analysis focused on device characteristics and performance against predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The PreSep Oligon Oximetry Catheter is a physical medical device for continuous physiological monitoring, not an algorithm, and therefore does not have "standalone" algorithmic performance in the context of AI.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. For an oximetry catheter, "ground truth" would generally refer to established, validated methods for measuring oxygen saturation (e.g., co-oximetry of blood samples) or other physiological parameters measured by the catheter (pressure, blood sampling). The functional testing would compare the device's measurements against these established methods or against the performance of the predicate devices.
8. The Sample Size for the Training Set
This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.
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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 LLCOne Edwards WayIrvine, CA 92614-5686 |
|---|---|
| Contact Person: | Jason SmithProject Manager, Regulatory Affairs |
| Date Prepared: | January 10, 2006 |
| Trade name: | PreSep Oligon Oximetry Catheters |
| ClassificationName: | Catheter, Oximeter, Fiberoptic (21 CFR 870.1230) |
| PredicateDevices: | Central Venous Oximetry Probe Catheter and Probe,Vantex Central Venous Catheters with Oligon material,Edslab Dual Lumen Regional Saturation OximetryCatheter |
| DeviceDescription: | The PreSep Oligon Oximetry Catheters are used withEdwards oximetry monitors to continuously measureoxygen saturation. These catheters also provide themeans for infusion of solutions, measuring pressure andtaking blood samples. |
| Intended Use: | The PreSep Oligon Oximetry Catheters are intended toprovide the means for infusion of solutions, measuringpressure and taking blood samples through the distal,proximal and medial lumens. The PreSep OligonOximetry Catheters also provide the means forcontinuously monitoring oxygen saturation using anEdwards Lifesciences oximetry monitor. |
| ComparativeAnalysis: | The PreSep Oligon Oximetry Catheters have beendemonstrated to be as safe and effective as thepredicate devices for their intended use. |
| Functional/SafetyTesting: | The PreSep Oligon Oximetry Catheters havesuccessfully undergone functional testing. Theseproducts have been shown to be equivalent to thepredicate devices. |
| Conclusion: | The PreSep Oligon Oximetry Catheters aresubstantially equivalent to the predicate devices. |
January 10, 2006 510(k) Notification for PreSep Oligon Oximetry Catheters CONFIDENTIAL
Page 12
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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.
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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
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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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§ 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).