(29 days)
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.
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.
The provided document is a 510(k) Premarket Notification from the FDA regarding the Medtronic DLP™ Silicone Coronary Artery Ostial Cannulae. It details the substantial equivalence review process for a change made to the device's packaging material, specifically from a Surlyn film pouch to a Nylon film pouch.
Based on the document, this is not a study demonstrating the performance of an AI/ML powered device. Instead, it's a submission for a packaging material change for a physical medical device. Therefore, many of the requested criteria related to AI/ML device performance, ground truth, expert adjudication, and MRMC studies are not applicable to this document.
However, I can extract the relevant information regarding the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" in the context of this specific packaging change.
Here's the breakdown:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (in the context of packaging change) | Reported Device Performance |
|---|---|
| Product functional testing results | All results pass |
| Biocompatibility assessment results | All results pass |
| Product shelf life study results | All results pass |
| Maintain the pre-existing 3-year shelf life | Maintained 3-year shelf life |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for the functional testing, biocompatibility assessment, or shelf-life study. It also does not specify the provenance of this data (e.g., country of origin, retrospective/prospective). This information would typically be detailed in the full test reports, not usually summarized in this high-level 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is a medical device packaging change, not an AI/ML performance study. The "ground truth" here would be the physical and biological properties meeting specifications, evaluated by standard engineering and laboratory methods, not expert human interpretation of data like medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to human interpretation of data, typically in AI/ML performance studies to establish a consensus ground truth. For materials testing, the results are objectively measured against pre-defined specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device; it's a physical medical device (cannula) with a packaging change.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on objective measurements and established standards for:
- Product Functional Testing: Ensuring the device still operates as intended (e.g., fluid flow, connection integrity). This would involve engineering specifications and validated test methods.
- Biocompatibility Assessment: Ensuring the new packaging material does not cause adverse biological reactions. This is established by ISO standards (e.g., ISO 10993 series) and specific laboratory tests (e.g., cytotoxicity, sensitization).
- Shelf Life Study: Ensuring the device maintains its sterility and functional integrity over its claimed shelf life. This is established through accelerated and/or real-time aging studies and performance testing at various time points.
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/ML product.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
Summary from the document regarding the "study" for the packaging change:
The "study" or rather, the design verification and validation activities performed to prove the device (with the new packaging) meets the acceptance criteria are summarized as:
- Risk-based testing and evaluations
- Product functional testing
- Biocompatibility assessment
- Completion of a product shelf life study
The conclusion explicitly states: "All results pass," thereby demonstrating that the modified DLP™ Silicone Coronary Artery Ostial Cannulae are substantially equivalent to the predicate devices and meet the necessary performance and safety standards despite the packaging change.
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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
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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
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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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510(k) Summary
| Date Prepared: | April 04, 2023 |
|---|---|
| Applicant: | Medtronic, IncMedtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establishment Registration No. 2184009 |
| Contact Person: | Stephen BeierPrincipal Regulatory Affairs SpecialistPhone: (763) 526-6751Fax: (763) 367-8361Email: stephen.beier2@medtronic.com |
| Alternate Contact: | Diane HowellRegulatory Affairs ManagerPhone: (651) 214-2693Email: 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 |
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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).
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| Component | Material Changes | Design Verification andValidation | Results |
|---|---|---|---|
| Form-fill-seal (FFS)pouch material | The pouch material used inthe FFS packaging processhas undergone a changefrom a Surlyn film pouch toa Nylon film pouch. | Risk-based testing and evaluations toqualify this change included productfunctional testing, a biocompatibilityassessment and completion of a productshelf life study. | All resultspass |
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.
§ 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).