(30 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device drains blood for cardiopulmonary bypass, which is a life support procedure, but the cannula itself does not treat a disease or condition.
No
The device is a venous cannula used to drain blood during cardiopulmonary bypass. Its function is to facilitate a medical procedure, not to diagnose a condition or disease.
No
The device description clearly lists multiple hardware components including a wirewound cannula, introducer(s), guidewire, connector hub, and percutaneous insertion components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to drain blood from the venae cavae and/or right atrium during cardiopulmonary bypass. This is a direct intervention on the patient's circulatory system, not a test performed on a sample taken from the body.
- Device Description: The description details a cannula, introducers, guidewire, and other components for insertion into a vein. These are all tools for a surgical or medical procedure, not for analyzing a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or any other biological sample. There are no reagents, test strips, or analytical components described.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used on the body during a procedure.
N/A
Intended Use / Indications for Use
The QuickDraw venous cannula is indicated for use in patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae and/or right atrium during cardiopulmonary bypass.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The Edwards Lifesciences QuickDraw venous cannula kit includes a wirewound cannula, introducer(s), guidewire, connector hub, and percutaneous insertion components. The cannula and introducer(s) have tapered tips to aid in insertion and advancement into the femoral vein. The cannula is marked at 5 cm intervals from the first marker band to indicate the depth of insertion. The soft, clear tubing near the barbed end of the cannula allows visualization of air and blood and provides a non-reinforced clamp site. The cannula connector is a 3/8 in. (9.5 mm) barbed connector. The introducers accept a 0.038 in. (0.97 mm) guidewire for assistance in cannula insertion. The connector hub secures and immobilizes the introducer within the cannula for easier, one-person insertion of the cannula/introducer assembly. For percutaneous insertion, percutaneous insertion components are provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venae and/or right atrium, femoral vein
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)
Functional and safety testing were not applicable for this changed device as the change is only adding a contraindication and warning to the Instructions for Use.
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.
Not Found
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 29, 2020
Edwards Lifesciences LLC Diem Nguyen Specialist, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K200499
Trade/Device Name: QuickDraw Venous Cannula (models QD22 and QD25) Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: February 25, 2020 Received: February 28, 2020
Dear Diem Nguyen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200499
Device Name
QuickDrawTM Venous Cannula, models QD22 and QD25
Indications for Use (Describe)
The QuickDraw venous cannula is indicated for use in patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae and/or right atrium during cardiopulmonary bypass.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows a logo with the letter 'E' in white, superimposed on a gray square with a grid pattern. The letter 'E' is stylized with geometric shapes, including circles and lines. Below the logo, the word 'Edwards' is written in a serif typeface.
510(k) Summary
| Submitter: | Edwards Lifesciences LLC |
|---|---|
| Contact Person: | Diem My Nguyen |
| Specialist, Regulatory Affairs | |
| One Edwards Way | |
| Irvine, CA 92614 | |
| (949) 250-5124 | |
| Date Prepared: | February 25, 2020 |
| Trade Name: | QuickDraw™ Venous Cannula, models QD22 and QD25 |
| Classification Name: | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Predicate Device: | QuickDraw™ Venous Cannula, models QD22 and QD25 |
| Device Description: | The Edwards Lifesciences QuickDraw venous cannula kit includes a |
| wirewound cannula, introducer(s), guidewire, connector hub, and | |
| percutaneous insertion components. The cannula and introducer(s) have | |
| tapered tips to aid in insertion and advancement into the femoral vein. | |
| The cannula is marked at 5 cm intervals from the first marker band to | |
| indicate the depth of insertion. The soft, clear tubing near the barbed end | |
| of the cannula allows visualization of air and blood and provides a non- | |
| reinforced clamp site. The cannula connector is a 3/8 in. (9.5 mm) barbed | |
| connector. The introducers accept a 0.038 in. (0.97 mm) guidewire for | |
| assistance in cannula insertion. The connector hub secures and | |
| immobilizes the introducer within the cannula for easier, one-person | |
| insertion of the cannula/introducer assembly. For percutaneous insertion, | |
| percutaneous insertion components are provided. | |
| Indications For Use: | The QuickDraw venous cannula is indicated for use in patients |
| undergoing cardiopulmonary bypass. The QuickDraw venous cannula | |
| serves to drain non-oxygenated blood from the venae cavae and/or right | |
| atrium during cardiopulmonary bypass. | |
| Comparative Analysis: | The subject device is identical as the predicate device with only the |
| addition of a contraindication and a warning to the Instructions for Use. | |
| The QuickDraw venous cannula is substantially equivalent to the | |
| predicate QuickDraw venous cannula as the device has the same | |
| intended use, indications for use, patient population, fundamental | |
| scientific technology, operating principle, and performance specifications. | |
| Functional/Safety | |
| Testing: | Functional and safety testing were not applicable for this changed device |
| as the change is only adding a contraindication and warning to the | |
| Instructions for Use. | |
| Conclusion: | The QuickDraw Venous Cannula is substantially equivalent to the named |
| predicate device based on technological comparison, principle of |
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Image /page/4/Picture/0 description: The image shows a logo with the letter 'E' in white, overlaid on a grid of squares and circles. The background of the grid is a light brown color. Below the grid, the word 'Edwards' is written in a serif font.
| operation, indications for use, and intended use. There are no new |
|---|
| questions of safety and effectiveness. |