(29 days)
The PreSep Oligon Oximetry Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements.
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.
This 510(k) summary describes a medical device, the PreSep Oligon Oximetry Catheters, and demonstrates its substantial equivalence to a predicate device, rather than providing a study proving performance against defined acceptance criteria in the typical sense of an AI/algorithm-driven device.
Therefore, many of the requested categories regarding AI-specific studies and ground truth establishment are not applicable. I will extract the relevant information from the provided text.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document does not explicitly present a table of quantitative acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) with corresponding reported device performance values. Instead, it describes a comparative analysis to a predicate device for safety and effectiveness.
| Performance Aspect (Implied) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance/Functionality | Substantial equivalence to the predicate device in terms of safety and effectiveness. | "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." |
| Functional/Safety | Successful completion of functional and performance testing. | "The PreSep Oligon Oximetry Catheters have successfully undergone functional and performance testing, including bench studies, pre-clinical animal studies and biocompatibility testing." |
| Clinical Impact | Safety and effectiveness for intended use. | "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." |
2. Sample Size Used for the Test Set and Data Provenance
The document states "side-by-side comparative bench and pre-clinical performance testing."
- Sample Size: Not explicitly stated. The term "pre-clinical animal studies" implies a test set of animals, but the number is not provided. "Bench" studies typically involve physical device testing, not data samples in the same way an AI algorithm uses data.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies are described as "pre-clinical animal studies," indicating they were conducted in a controlled, non-human environment. The nature (retrospective/prospective) is not explicitly given, but "pre-clinical" and "bench" studies are typically prospective tests designed for device evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. This device is a physical catheter, not an AI algorithm requiring expert ground truth for image or data interpretation. The "ground truth" would be objective measurements and observations from the bench and animal studies to assess the catheter's physical performance, safety, and functionality.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in human-AI studies involving subjective interpretations. For this device, the "adjudication" would be based on direct measurement, observation, and comparison to the predicate device's measured performance in the bench and animal studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
Not Applicable. This is not an AI/software device whose performance depends on human-in-the-loop interaction. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device (catheter) with associated oximetry monitors. It is not an algorithm, so a standalone algorithm performance study is not relevant. The device itself performs the function.
7. The Type of Ground Truth Used
For a physical device like this, the "ground truth" for the test (verification and validation) would be based on:
- Physical Measurements and Observations: Direct measurements of catheter dimensions, material properties, flow rates, pressure readings, oxygen saturation readings, and observations of device interaction within the test environment (bench models, animal models).
- Biocompatibility Testing: Results from standardized tests to ensure the material is safe for contact with biological tissues.
- Predicate Device Performance: The established and legally marketed performance and safety profile of the predicate device serves as the benchmark against which the new device is compared to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set for an AI algorithm, no ground truth was established for a training set in this context.
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510(k) Summary
K110167
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| Submitter: | Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614-5686FEB 18 2011 |
|---|---|
| Contact Person: | Marguerite Thomlinson, JD, BSMESr. Manager of Regulatory AffairsEdwards Lifesciences LLCPhone: (949) 756-4386Fax: (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 CathetersK100739, 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
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510(k) Summary
K110/67
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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.
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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
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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
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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
§ 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).