(62 days)
The EMBOL-X Access Device / Aortic Cannula is indicated for the perfusion of the ascending aorta during short-term (≤ 6 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.
The Edwards Lifesciences EMBOL-X Access Device / Aortic Cannulae are polymeric tubes intended to provide a means of returning oxygenated blood from the oxygenator to the patient during cardiopulmonary bypass procedures. A port is included for optional insertion of the EMBOL-X filter device. The cannulae are available in three configurations. Variants include one code with an open tip and two codes with an alternate tip hole configuration. Cannulae bodies are reinforced by means of a stainless steel wire entirely encapsulated within the wall of the cannula to minimize the potential for cannula kinking. The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.
The provided document describes a 510(k) premarket notification for the Edwards Lifesciences® EMBOL-X® Access Device / Aortic Cannula. This is a medical device and the study described is a functional/safety test, not typically a diagnostic algorithm requiring multi-reader, multi-case studies or large expert ground-truthing efforts as one would expect for AI/ML devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Pre-established) | Reported Device Performance |
|---|---|
| Cannula / Tip Bending: No defects after manipulation | Met pre-established acceptance criteria |
| Static Pressure (6 hrs): No defects after exposure to static air pressure and manipulation | Met pre-established acceptance criteria |
| Dynamic Pressure (6 hrs): No defects after exposure to dynamic water flow and manipulation | Met pre-established acceptance criteria |
| Tip/Cannula Bond Strength: Adherence to tensile test requirements | Met pre-established acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each functional test.
The data provenance is also not explicitly stated beyond the fact that these are functional tests performed to evaluate the physical components of the device. It's implicitly prospective, as these are tests conducted on the newly manufactured device variants. Country of origin not specified for the tests themselves, but the manufacturer is Edwards Lifesciences® LLC (USA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This type of information is not applicable to the functional performance tests described. Ground truth for these tests is based on objective physical measurements and visual inspections against defined engineering specifications, not expert interpretation of complex data.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided and is generally not applicable to the functional performance testing of a physical medical device like a cannula. Adjudication methods are typically relevant for studies involving subjective human interpretation, such as image-based diagnostics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic algorithms or systems where human readers interpret medical data (e.g., images) and their performance is being compared with and without AI assistance. The EMBOL-X Access Device / Aortic Cannula is a physical medical device, not a diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is not an algorithm. The "standalone" performance here refers to the device's functional performance on its own, which is described by the "Functional/Safety Testing."
7. The Type of Ground Truth Used
The ground truth used for these functional/safety tests is based on engineering specifications and objective physical measurements/inspections. For example, a bond strength test would have a pre-defined minimum tensile strength (a factual, measurable criterion). Inspections for defects would be against defined visual or tactile standards.
8. The Sample Size for the Training Set
This document describes a premarket notification for a physical medical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of an AI/ML algorithm. The device's design and manufacturing rely on established engineering principles and material science.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an AI/ML algorithm, this question is not applicable. The functional performance of the device is assessed against predetermined engineering and safety standards, which are derived from industry best practices, regulatory requirements, and the device's intended use.
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K10.2420
510(k) Summary
| Submitter: | Edwards Lifesciences® LLC | OCT 26 2010 |
|---|---|---|
| Contact Person: | Dannette Crooms, Regulatory Affairs Associate12050 Lone Peak PkwyDraper, UT 84020 | |
| Date Prepared: | October 25, 2010 | |
| Trade Name: | Edwards Lifesciences® EMBOL-X® Access Device / Aortic Cannula | |
| Classification Name: | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass21 CFR Part 870.4210, Product Code DWF, Class II | |
| Predicate Device: | EMBOL-X® Aortic Cannula |
Device Description:
The Edwards Lifesciences EMBOL-X Access Device / Aortic Cannulae are polymeric tubes intended to provide a means of returning oxygenated blood from the oxygenator to the patient during cardiopulmonary bypass procedures. A port is included for optional insertion of the EMBOL-X filter device.
The cannulae are available in three configurations. Variants include one code with an open tip and two codes with an alternate tip hole configuration. Cannulae bodies are reinforced by means of a stainless steel wire entirely encapsulated within the wall of the cannula to minimize the potential for cannula kinking. The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.
Intended Use:
The EMBOL-X Access Device/Aortic Cannula is indicated for the ascending aota during cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.
Comparative Analysis:
lt has been demonstrated that the EMBOL-X Access Device / Aortic Cannula is comparable to the predicate device in intended use and other labeling, fundamental scientific technology, material types, principles of operation and functional performance evaluations.
Functional/Safety Testing:
The functional data indicate that the EMBOL-X Access Device / Aortic Cannula performs in a substantially equivalent manner when compared with the predicate device. The following functional tests were performed. All data met pre-established acceptance criteria.
- Cannula / Tip Bending Inspection for defects after manipulation of the cannula / tip. .
- . Static Pressure (6hrs) - Inspection for defects after exposure to static air pressure and manipulation of the cannula/tip.
- Dynamic Pressure (6 hrs) Inspection for defects after exposure to dynamic water flow and . manipulation of the cannula/tip.
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- Tip/Cannula Bond Strength Tensile test of the tip / cannula bond. .
Conclusion:
The EMBOL-X Access Device / Aortic Cannula is substantially equivalent to the cited predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Edwards Lifesciences, LLC. c/o Ms. Dannette Crooms Regulatory Affairs Associate 12050 Lone Peak Parkway Draper, UT 84020
OCT 2 6 2010
Re: K102420 EMBOL-X® Access Device/Aortic Cannula EMBOL-X® Slim Access Device/Aortic Cannula EMBOL-X® Glide Access Device/Aortic Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DWF Dated: September 24, 2010 Received: September 27, 2010
Dear Ms. Crooms:
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.
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Page 2 - Ms. Dannette Crooms
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 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/CDRH0ffices/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 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 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,
er R. Vachner
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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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Statement of Indications for Use
Indications for Use
510(k) Number (if known): K102420
OCT 2 6 2010
Device Name: Edwards Lifesciences EMBOL-X® Access Device / Aortic Cannula
The EMBOL-X Access Device / Aortic Cannula is indicated for the perfusion of the ascending aorta during short-term (≤ 6 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office Of Device Evaluation (ODE)
una D. V. kline
on Sign-Off) Division of Cardiovascular Devices
510(k) Number_K102420
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).