(132 days)
Not Found
No
The device description and performance studies focus on the physical properties and performance of a medical cannula, with no mention of AI or ML technologies.
No
The device is used for perfusion during surgical procedures, specifically for short-term (
No
The device is an Aortic Perfusion Cannula, used for perfusing the aorta during cardiopulmonary bypass procedures. Its function is to facilitate blood flow, not to diagnose conditions or diseases.
No
The device description clearly states it is made of flexible and non-flexible polymeric materials and includes physical components like tips, connectors, and wire reinforcement. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the Aortic Perfusion Cannulae are used for "perfusion of the aorta during short-term cardiopulmonary bypass procedures." This involves directly interacting with the patient's circulatory system inside the body (in vivo) to facilitate blood flow during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, performing tests on samples, or providing diagnostic information based on laboratory analysis.
The device is a surgical instrument used to support a physiological process during a medical procedure, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Aortic perfusion cannulae are Intended for perfusion of the aorta during short-term (≤ 6 hours) cardiopulmonary bypass procedures.
Aortic Perfusion Cannulae may be used in pediatric or adult populations based on the flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates.
Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Product codes
DWF
Device Description
Edwards Aortic Perfusion Cannulae are sterile, non-pyrogenic, single-use cannulae made of flexible and non-flexible polymeric materials. They are intended for perfusion of the ascending aorta during cardiopulmonary bypass procedures.
Edwards' Aortic Perfusion Cannulae are available in a range of sizes with a variety of tip and hole configurations, including straight, angled, stainless steel, and plastic tips. They terminate in a connector or connector acceptance of 3/8" (9.5 mm) or 1/4" (6.3 mm), and are available in non-wire-reinforced and stainless steel wire-reinforced configurations to help prevent kinking and twisting of the cannulae. Edwards Aortic Perfusion Cannulae are also available with Duraflo™ coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Aorta, ascending aorta
Indicated Patient Age Range
pediatric or adult populations
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)
Bench and laboratory testing was performed and assures that the product meets its specifications per the table below. The performance testing met the acceptance criteria.
Testing included: Sterility, Ethylene oxide sterilization residuals, Biocompatibility, Conical Fittings, Assembly Leak, Kink, Cannula Crush, Tip Crush, Vent Plug Crush, Cap Removal Force, Corrosion, Assembly Tensile, Hemolysis, Pressure Drop.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary
| Submitter: | Edwards Lifesciences LLC |
|---|---|
| Contact Person: | Karen Jones, Senior Manager, Regulatory Affairs |
| 12050 Lone Peak Pkwy | |
| Draper, UT 84020 | |
| (801) 565-6231 | |
| MAR 13 2013 | |
| Date Prepared: | October 31, 2012 |
| Trade Name: | Edwards Lifesciences® Aortic Perfusion Cannulae |
| Classification Name: | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary |
| Bypass | |
| 21 CFR Part 870.4210, Product Code DWF, Class II | |
| Predicate Device: | K831769 - Aortic Perfusion Cannulae |
| K033463 - Aortic Perfusion Pediatric Cannulae |
Device Description:
Edwards Aortic Perfusion Cannulae are sterile, non-pyrogenic, single-use cannulae made of flexible and non-flexible polymeric materials. They are intended for perfusion of the ascending aorta during cardiopulmonary bypass procedures.
Edwards' Aortic Perfusion Cannulae are available in a range of sizes with a variety of tip and hole configurations, including straight, angled, stainless steel, and plastic tips. They terminate in a connector or connector acceptance of 3/8" (9.5 mm) or 1/4" (6.3 mm), and are available in non-wire-reinforced and stainless steel wire-reinforced configurations to help prevent kinking and twisting of the cannulae. Edwards Aortic Perfusion Cannulae are also available with Duraflo™ coating.
1
Indications for Use:
Aortic perfusion cannulae are Intended for perfusion of the aorta during short-term (≤ 6 hours) cardiopulmonary bypass procedures.
Aortic Perfusion Cannulae may be used in pediatric or adult populations based on the flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates.
Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Comparative Analysis:
The Aortic Perfusion Cannulae have the same fundamental scientific technology and principles of operation as the predicate devices. Minor differences in features relate to customer reference rather than the clinical performance of the device. The product range of sizes now includes 6 to 24 French and 6 to 14.8 inches in length. Tips are open or slotted; straight, bent or curved; metal or plastic. Devices have vent caps or vent plugs, connectors or standard acceptance for connecting to the circuit. Several models are offered with a heparin coating. It has been demonstrated that the subject Aortic Perfusion Cannulae are comparable to the predicate devices in fundamental scientific technology, material types, principles of operation, and functional performance evaluations. No new issues of safety or efficacy have been raised. Additionally, the polymeric material formulations in the devices have evolved, but material types remain the same as those originally cleared in predicate submissions. All configurations may be considered for pediatric use based on the physical needs of the pediatric patient.
Non Clinical Testing:
Bench and laboratory testing was performed and assures that the product meets its specifications per the table below. The performance testing met the acceptance criteria.
2
Edwards Lifesciences LLC Traditional 510(k) Premarket Notification Aortic Perfusion Cannula
| Testing | Criteria |
|---|---|
| Sterility | Per ISO11135-1, Sterilization of health care products - Ethylene oxide |
- Part 1: |
| Ethylene oxide
sterilization residuals | ISO 10993-7, Biological evaluation of medical devices - Part 7: |
| Biocompatibility | Per ISO 10993-1 for External communicating device, direct circulating
blood path, duration ≤ 24 hours. |
| Conical Fittings | Fittings must be compatible with standard connections. |
| Assembly Leak | Pressure drop must meet minimum requirement. |
| Kink | The cannulae shall not kink at a pre-determined diameter. |
| Cannula Crush | Cannula shall not crush when a pre-determined compression is
applied. |
| Tip Crush | Distal tip of cannula shall withstand a minimum weight without
cracking or breaking |
| Vent Plug Crush | Must withstand pre-determined compressive force without breaking or
crumbling |
| Cap Removal Force | Removal force meets a pre-determined axial force |
| Corrosion | Metallic components shall show no signs of corrosion. |
| Assembly Tensile | Confirmation of the bond strength of the catheter assembly must meet |
| | pre-determined loads. |
| Hemolysis | Dynamic hemolysis testing must show that devices are non-hemolytic. |
| Pressure Drop | Pressure drop testing to confirm flow rate values for product labeling |
The Aortic Perfusion Cannulae conform to the following standards:
- · ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing.
- · ISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- ISO11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- · ISO14971, Medical devices Application of risk management to medical devices
Conclusion:
The Aortic Perfusion Cannulae are substantially equivalent to the cited predicate devices. The nonclinical tests demonstrate that the devices are as safe and as effective as the legally marketed devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2013
Edwards Lifesciences LLC C/O Karen Jones 12050 Lone Peak Pkwy. Draper, UT 84020
Re: K123370
Trade/Device Name: Aortic Perfusion Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula or tubing Regulatory Class: Class II Product Code: DWF Dated: January 21, 2013 Received: January 22, 2013
Dear Ms. Jones:
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 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
4
Page 2 - Ms. Karen Jones
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 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,
Matthew Gັ퀘訓llebrenner
Bram D. Zuckerman, M.D.
for
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Statement of Indications for Use
510(k) Number (if known): K123370
Edwards Lifesciences® Aortic Perfusion Cannula Device Name:
Indications for Use:
Aortic perfusion cannulae are Intended for perfusion of the aorta during short-term (≤ 6 hours) cardiopulmonary bypass procedures.
Aortic Perfusion Cannulae may be used in pediatric or adult populations based on the flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates.
Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Prescription Use X (Per 21 CFR 801.109)
OR Over-The-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)