(29 days)
Not Found
No
The summary describes a physical medical device (cannulae) with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device is described as cannulae intended for use in conjunction with cardiopulmonary bypass surgery for delivery of cardioplegia solutions. It does not exert a therapeutic effect on the patient's body directly, but rather facilitates a medical procedure.
No
The device is described as a cannula intended for delivery of solutions during surgery, not for diagnosing conditions or diseases.
No
The device description clearly states it is a physical medical device (cannulae) made of silicone with a luer fitting, intended for surgical use. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for delivering solutions directly to the coronary arteries during cardiopulmonary bypass surgery. This is an in vivo application (within a living organism).
- Device Description: The description details a physical cannula designed for insertion into the body.
- 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 screening.
IVD devices are used to perform tests on samples taken from the body, not to deliver substances into the body.
N/A
Intended Use / Indications for Use
These Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.
Product codes
DWF
Device Description
The DLP™ Silicone Coronary Artery Ostial Cannulae feature a soft bulb beveled tip with a silicone body. The Cannulae terminate with a locking female luer fitting. The Cannulae are nonpyrogenic, single use, and sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary arteries
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
Risk-based testing and evaluations to qualify this change included product functional testing, a biocompatibility assessment and completion of a product shelf life study. All results pass.
Key Metrics
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 4, 2023 Medtronic, Inc. Stephen Beier Principal Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, Minnesota 55428
Re: K230960
Trade/Device Name: DLP™ Silicone Coronary Artery Ostial Cannulae Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: April 4, 2023 Received: April 5, 2023
Dear Stephen Beier:
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/cfpmn/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 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
1
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (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).
Sincerelv.
Kathleen M. Grunder -S
Kathleen Grunder Acting 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
2
Indications for Use
510(k) Number (if known) K230960
Device Name
DLP Silicone Coronary Artery Ostial Cannulae
Indications for Use (Describe)
These Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.
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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| FORM FDA 3881 (6/20) | ||
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510(k) Summary
| Date Prepared: | April 04, 2023 |
|---|---|
| Applicant: | Medtronic, Inc |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establishment Registration No. 2184009 | |
| Contact Person: | Stephen Beier |
| Principal Regulatory Affairs Specialist | |
| Phone: (763) 526-6751 | |
| Fax: (763) 367-8361 | |
| Email: stephen.beier2@medtronic.com | |
| Alternate Contact: | Diane Howell |
| Regulatory Affairs Manager | |
| Phone: (651) 214-2693 | |
| Email: diane.d.howell@medtronic.com |
Device Name and Classification
| Trade Names: | DLPTM Silicone Coronary Artery Ostial Cannulae
(Models: 30315, 30317, and 30320) |
|--------------------|-------------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or tubing |
| Regulation Number: | 21 CFR 870.4210 |
| Product Code: | DWF |
| Classification: | Class II |
| Predicate Device | |
| K141951 | DLP Silicone Coronary Artery Ostial Cannulae |
4
Device Description
The DLP™ Silicone Coronary Artery Ostial Cannulae feature a soft bulb beveled tip with a silicone body. The Cannulae terminate with a locking female luer fitting. The Cannulae are nonpyrogenic, single use, and sterile.
Indications for Use
These Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.
Comparison to Predicate Devices
A comparison of the of the modified devices to the currently marketed predicate device (K141951) indicates the subject devices are substantially equivalent11 with the following similarities:
- Same intended use and labeling ●
- Same technological characteristics
- Same operating principle ●
- Same design features and device materials
- Same sterilization requirements, methods, and parameters ●
- Same 3-year shelf life
- Same packaging configuration o
The following device modifications were made to the predicate device:
- Packaging material change ●
1 The term 'substantially equivalent' as used herein is intended to be a determination of substantial equivalency under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits or other patent matters." (Federal Register, Vol. 42, No. 163, Aug. 23, 1977, page 42525 and 42529).
5
| Component | Material Changes | Design Verification and
Validation | Results |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Form-fill-seal (FFS)
pouch material | The pouch material used in
the FFS packaging process
has undergone a change
from a Surlyn film pouch to
a Nylon film pouch. | Risk-based testing and evaluations to
qualify this change included product
functional testing, a biocompatibility
assessment and completion of a product
shelf life study. | All results
pass |
Table 5-1: Summary of Changes from Predicate Device
Summary of Performance Data
Testing has demonstrated that the DLP™ Silicone Coronary Artery Ostial Cannulae are substantially equivalent to their predicate devices. Table 5-1 describes the change that has been made to the predicate devices' packaging and the design verification and validation activities that were completed to evaluate the new packaging material.
Conclusion
Medtronic has demonstrated that the modified DLP™ Silicone Coronary Artery Ostial Cannulae are substantially equivalent to the predicate devices based on the fundamental scientific principles, operating principles, design features and intended use being unchanged from the predicate devices.