(62 days)
Not Found
Not Found
No
The description focuses on the physical structure and function of a cannula for cardiopulmonary bypass, with no mention of AI or ML capabilities.
No
The device aids in blood circulation during bypass surgery, but it does not directly treat a disease or medical condition.
No
The device is described as an "Access Device / Aortic Cannula" indicated for "perfusion of the ascending aorta during short-term cardiopulmonary bypass (CPB) surgery." Its purpose is to return oxygenated blood to the patient. This functionality is therapeutic, not diagnostic.
No
The device description clearly states it is a polymeric tube with a stainless steel wire reinforcement, indicating it is a physical hardware device, not software. The performance studies also focus on physical properties like bending, pressure, and bond strength.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the perfusion of the ascending aorta during cardiopulmonary bypass surgery. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a polymeric tube intended to return oxygenated blood to the patient. This is a medical device used for direct patient treatment and support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is clearly used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DWF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ascending aota
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)
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.
- Tip/Cannula Bond Strength Tensile test of the tip / cannula bond. .
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.
EMBOL-X® Aortic Cannula
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
§ 870.4210 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
K10.2420
510(k) Summary
| Submitter: | Edwards Lifesciences® LLC | OCT 26 2010 |
|---|---|---|
| Contact Person: | Dannette Crooms, Regulatory Affairs Associate | |
| 12050 Lone Peak Pkwy | ||
| Draper, 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 Bypass | |
| 21 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.
1
- 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
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.
3
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
Image /page/3/Picture/7 description: The image contains a simple free-hand drawing of a symbol or logo. The symbol appears to be a stylized representation of a letter, possibly a 'W' or a similar character, with curved lines and sharp angles. The drawing is in black and white and has a somewhat rough or unfinished appearance.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
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