(68 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.
These coronary Cannulae consist of basket-style tip, soft (silicone) tip, or spherical tip which is attached to a malleable stainless steel tube, or a soft bulb beveled tip with an integral silicone body. The Cannulae terminate with a locking female luer fitting. The French diameter is measured at the base of the tip adjacent to the sealing flange or across the diameter for the soft bulb beveled tip style. The Cannulae are nonpyrogenic, single use, and sterile.
The provided text describes a 510(k) summary for the Medtronic DLP® Coronary Ostial Perfusion Cannulae, focusing on its substantial equivalence to predicate devices rather than a study proving performance against acceptance criteria in the context of an AI/ML device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies, as typically found for AI/ML medical devices, is not present in this document. This document pertains to a medical device where the primary evaluation is based on material and design changes compared to a previously cleared device.
However, I can extract the closest analogous information available, interpreting "acceptance criteria" as performance tests to demonstrate substantial equivalence following modifications.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Test) | Reported Device Performance (Results) |
|---|---|
| Burst strength relative to predicate material | Pass |
| Tip component tested for tensile pull-off force | Pass |
| Biocompatibility Assessment (for organic to synthetic barium sulfate change) | Pass - no impact to biocompatibility |
| Hub tested for Tensile Pull-Off Force and Torsional Twist-Off Force | Pass |
| Biocompatibility Assessment (for polypropylene material change) | Pass - no impact to biocompatibility |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the verification and validation tests. The data provenance is implied to be internal testing conducted by Medtronic, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document is for a physical medical device and its predicate equivalence, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for clinical studies involving human readers, which this submission does not describe.
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. No MRMC study was conducted or described, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is based on engineering and material science performance standards and specifications, as demonstrated by the "Pass" results in the table. For biocompatibility, it refers to industry-standard assessments that show "no impact."
8. The sample size for the training set
Not applicable. There is no AI/ML model necessitating a training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model necessitating a training set or its associated ground truth establishment.
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510(k) Summary
| Date Prepared: | May 2, 2013 | JUL 1 0 2013 |
|---|---|---|
| Submitter: | Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establishment Registration Number: 2184009 | |
| Contact Person: | Kevin T. LamSenior Regulatory Affairs SpecialistMedtronic Perfusion SystemsPhone: 763.526.2360Fax: 763.367.8360Email: kevin.t.lam@medtronic.com | |
| Alternate Contact: | Susan FidlerSenior Regulatory Affairs ManagerMedtronic Perfusion SystemsPhone: 763.514.9839Fax: 763.367.8360Email: susan.c.fidler@medtronic.com | |
| Device Name and Classification | ||
| Trade Name: | DLP® Coronary Ostial Perfusion Cannulae | |
| Trade Name: | DLF Coronary Ostial Perfusion Cannulae | |
| Models: 30010, 30011, 30012, 30014, 30050, 30055, 30315,30317, 30320, 30110, 30112, 30114, 30155, 30212, and 30255. | ||
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing | |
| Regulation Number: | 21 CFR 870.4210 | |
| Product Code: | DWF | |
| Product Classification: | Class II |
Predicate Devices
Spherical Tip Coronary Ostial Cannulae
Device Description
These coronary Cannulae consist of basket-style tip, soft (silicone) tip, or spherical tip which is attached to a malleable stainless steel tube, or a soft bulb beveled tip with an integral silicone body. The Cannulae terminate with a locking female luer fitting. The French diameter is
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measured at the base of the tip adjacent to the sealing flange or across the diameter for the soft bulb beveled tip style. 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 modified product to the currently marketed predicate products (K034058) indicates the following similarities:
- Same intended use ■
- Same technological characteristics
- Same operating principle
- 트 Same design features
- 트 Same base materials (Polyviny) Chloride (PVC), Polypropyiene, and Stainless steel)
- P Same shelf life
Summary of Performance Data
Verification and validation testing has demonstrated that the DLP Coronary Ostial Perfusion Cannula are substantially equivalent to the predicates.
| Modifications | Verification/Validation | Results |
|---|---|---|
| Silicone to new Silicone due tosupplier obsolescence. | Burst strength relative to predicatematerial. | Pass |
| Organic to synthetic bariumsulfate. | Tip component tested for tensilepull-off force. | Pass |
| Organic to synthetic bariumsulfate. | Biocompatibility Assessment. | Pass - no impact tobiocompatibility |
| Polypropylene to newPolypropylene due to supplierobsolescence. | Hub tested for Tensile Pull-OffForce and Torsional Twist-OffForce. | Pass |
| Polypropylene to newPolypropylene due to supplierobsolescence. | Biocompatibility Assessment. | Pass - no impact tobiocompatibility |
The following performance tests were conducted:
Conclusion
Medtronic has demonstrated that the modifications made to the DLP® Coronary Ostial Perfusion Cannulae product family described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate devices.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
July 10, 2013
Medtronic CardioVascular, Inc. c/o Kevin Lam 8200 Coral Street NE Mailstop MVS83 Mounds View, MN 55112
K131269 Re:
Trade/Device Name: DLP Coronary Ostial Perfusion Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II Product Code: DWF Dated: June 13, 2013 Received: June 14, 2013
Dear Mr. Lam:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Kevin Lam
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M. A. Hillemann
for
Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number: K131269
Device Name: DLP® Coronary Ostial Perfusion Cannulae
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Lillehamm
§ 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).