(30 days)
Not Found
No
The device description and performance studies focus on the physical components and functional performance of the cardioplegia delivery sets, with no mention of AI or ML.
No.
The device is described as an "adapter" for connecting tubing to catheters and "extracorporeal circuit components." Its function is to facilitate the delivery of cardioplegia and improve blood compatibility within an extracorporeal circuit, not to directly treat a disease or condition itself.
No
The device is described as an adapter for connecting tubing and "extracorporeal circuit components." Its purpose is to deliver cardioplegia or improve blood compatibility in a circuit, not to diagnose a condition or disease. The performance studies section lists functional/safety testing, not diagnostic performance metrics.
No
The device description clearly outlines physical components like manifolds, tubing, adapters, and clamps, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "connecting cardioplegia administration tubing to cardioplegia delivery catheters" and for use in "cardiopulmonary surgery". This describes a device used in vivo (within the body) during a surgical procedure, not a device used in vitro (outside the body) to examine specimens like blood or tissue for diagnostic purposes.
- Device Description: The description details physical components like tubing, connectors, and coatings designed for use in an extracorporeal circuit during surgery. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
- Measuring analytes
Therefore, the Cardioplegia Delivery Sets are medical devices used in a surgical setting, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
Cardioplegia Delivery Sets with and without Duraflo coating are intended for use as adapters for connecting cardioplegia administration tubing to cardioplegia delivery catheters.
Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Product codes
DTL
Device Description
Edwards Lifesciences cardioplegia delivery sets are comprised of various configurations of clear manifold connections in either straight, Y-shaped, or 4-way connections which are joined by appropriate lengths of clear, flexible tubing. Depending upon configuration, the cardioplegia delivery set may contain a vent port adapter with female luer lock, a tapered tubing adapter, tubing clamps, and/ or male and/ or female luer lock connectors.
The exterior and/ or inner-luminal cannula surfaces of product codes containing a "D" or "DII" are coated with Duraflo TM (heparin) coating.
When used on devices for cardiopulmonary surgery, the Duraflo coating improves the blood compatibility of non-biological surfaces in the extracorporeal circuit.
Each Edwards Lifesciences device is packaged sterile and non-pyrogenic in a sealed, peel-type pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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/Safety Testing:
The functional data indicate that the Cardioplegia Delivery sets perform in a substantially equivalent manner when compared to the predicate device. The following functional tests were performed.
- Pressure vs. flow .
- Clamp closure .
- . Kink
- . Assembly tensile
All data met acceptance criteria.
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
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
510(k) Summarv
JAN 1 2 2012
| Submitter: | Edwards Lifesciences LLC |
|---|---|
| Contact Person: | Karen Jones, Senior Manager, Regulatory Affairs |
| 12050 Lone Peak Pkwy | |
| Draper, UT 84020 | |
| (801) 565-6231 | |
| Date Prepared: | December 12, 2011 |
| Trade Name: | Edwards Lifesciences™ Cardioplegia Delivery Sets |
| Classification Name: | Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting |
| 21 CFR Part 870.4290, Product Code DTL, Class II | |
| Predicate Device: | K892368 Cardioplegia Delivery Sets |
Device Description:
Edwards Lifesciences cardioplegia delivery sets are comprised of various configurations of clear manifold connections in either straight, Y-shaped, or 4-way connections which are joined by appropriate lengths of clear, flexible tubing. Depending upon configuration, the cardioplegia delivery set may contain a vent port adapter with female luer lock, a tapered tubing adapter, tubing clamps, and/ or male and/ or female luer lock connectors.
The exterior and/ or inner-luminal cannula surfaces of product codes containing a "D" or "DII" are coated with Duraflo TM (heparin) coating.
When used on devices for cardiopulmonary surgery, the Duraflo coating improves the blood compatibility of non-biological surfaces in the extracorporeal circuit.
Each Edwards Lifesciences device is packaged sterile and non-pyrogenic in a sealed, peel-type pouch.
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences, LLC.
1
Indications for Use:
Cardioplegia Delivery Sets with and without Duraflo coating are intended for use as adapters for connecting cardioplegia administration tubing to cardioplegia delivery catheters.
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 subject devices have the same intended use and technological characteristics (i.e., design, material, chemical composition) as the predicate devices. It has been demonstrated that the subject Cardioplegia Delivery Sets 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.
Functional/Safety Testing:
The functional data indicate that the Cardioplegia Delivery sets perform in a substantially equivalent manner when compared to the predicate device. The following functional tests were performed.
- Pressure vs. flow .
- Clamp closure .
- . Kink
- . Assembly tensile
All data met acceptance criteria.
i
Conclusion:
Testing conducted to qualify the subject changes shows that devices in this product family have met all predetermined acceptance criteria and have been shown to be safe and effective for their intended use. The subject change does not affect the intended use or alter the fundamental scientific technology of the device.
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences, LLC.
2
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 features a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 2 2012
Edwards Lifesciences LLC c/o Ms. Karen Jones Sr. Principal Project Manager, Regulatory Affairs 12050 Lone Peak Parkway Draper, UT 84020
Re: K113667 Edwards Lifesciences™ Cardioplegia Delivery Sets Regulation Number: 21 CFR 870.4290 Regulation Name: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTL Dated: December 12, 2011 Received: December 13, 2011
Firman to wa
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 (Act do not require approval of a provisions of the Pederal Food, Drug, 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Karen Jones
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M. A. Hillemann
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
510(k) Number (if known): K|| 366 7
Cardioplegia Delivery Sets Device Name:
Indications for Use:
Cardioplegia Delivery Sets are intended for use as adapters for connecting cardioplegia administration tubing to cardioplegia delivery catheters.
Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Prescription Use × (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)
M.S. Willelenn
rdiovascular Devices
510(k) Number K113667
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences, LLC.