(224 days)
H141951
Not Found
No
The summary describes a physical medical device (cannulae) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used to deliver cardioplegia solutions during cardiopulmonary bypass surgery, which is a therapeutic intervention aimed at protecting the heart.
No
Explanation: The device is intended for the delivery of cardioplegia solutions during cardiopulmonary bypass surgery, which is a therapeutic function, not a diagnostic one. It is used to administer a substance, not to identify or measure a condition or disease.
No
The device description clearly describes a physical medical device made of silicone with a beveled tip and luer fitting, intended for surgical use. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for delivering cardioplegia solutions directly to the coronary arteries during cardiopulmonary bypass surgery. This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical cannula designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used for direct treatment.
N/A
Intended Use / Indications for Use
The DLP Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 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 (comma separated list FDA assigned to the subject device)
DWF
Device Description
The DLP™ Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Risk-based testing and evaluations to qualify this change included product functional testing and a biocompatibility assessment. All results pass.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
December 7, 2023
Medtronic, Inc. Stephen Beier Principal Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, Minnesota 55428
Re: K231206
Trade/Device Name: DLP Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, 30320 Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: April 27, 2023 Received: April 27, 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 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).
Sincerely,
Nicole M. Gillette -S
Nicole Gillette 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
2
Indications for Use
510(k) Number (if known) K231206
Device Name
DLP Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320
Indications for Use (Describe)
The DLP Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Date Prepared: | December 6, 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 | DLPTM Silicone Coronary Artery Ostial Cannulae, Models 30315,
30317, 30320 |
4
Device Description
The DLP™ Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 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
The DLP™ Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 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 equivalent with the following similarities:
- . Same intended use and labeling
- Same technological characteristics
- Same operating principle ●
- Same design features
- . Same sterilization requirements, methods, and parameters
- Same 3-year shelf life ●
- Same packaging materials and configuration ●
The following device modification was made to the predicate device:
- Adhesive material formulation 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 Change | Design Verification and
Validation | Results |
|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Adhesive used to
encapsulate the bulb tip
of the DLPTM Silicone
Coronary Artery Ostial
Cannulae, Models
30315, 30317, and
30320 | The adhesive used in the
design of the Cannulae has
undergone a raw material
formulation change. | Risk-based testing and evaluations to
qualify this change included product
functional testing and a biocompatibility
assessment. | 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, Models 30315, 30317, and 30320 are substantially equivalent to the predicate device. Table 5-1 defines the material change that has been made to the predicate device and the design verification and validation activities that were completed to evaluate the updated adhesive formulation.
Conclusion
Medtronic has demonstrated that the modified DLP™ Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 are substantially equivalent to the predicate device based on the fundamental scientific principles, operating principles, design features and intended use being unchanged from the predicate device.