(139 days)
These devices are intended for the perfusion of anticoagulated arterial blood to an ischemic area of the heart.
These devices are intended for the perfusion of anticoagulated arterial blood from the aorta to coronary vessels to supply an ischemic area of the heart during beating heart CABG procedures.
The Medtronic AortoCoronary Shunt includes an Aortic Root Cannula Assembly, a Y-Tubing Connector Assembly and a set of Arteriotomy Cannulae (2 mm, 3 mm and 4 mm sizes). The Arteriotomy Cannula Assemblies are also available separately for user convenience. The user assembles the components into the final product configuration immediately prior to use. The assembled device diverts oxygenated, arterial blood from the patient's aorta directly to one or two coronary arteries, thereby providing perfusion of an ischemic area of the heart during cardiac surgical procedures
The Medtronic AortoCoronary Shunt and Arteriotomy Cannulae are medical devices intended for the perfusion of anticoagulated arterial blood to an ischemic area of the heart during cardiac surgical procedures. The provided 510(k) summary outlines the non-clinical performance data used to assert substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Negative (non-toxic) results in a battery of tests per ISO 10993-1. | - Cytotoxicity (MEM Elution Method): Negative results- Sensitization (Guinea Pig Maximization Method): Negative results- Intracutaneous Reactivity (in rabbits): Negative results- Acute Systemic Toxicity (in mice): Negative results- Genotoxicity (Ames Salmonella typhimurium / Escherichia coli Mutation Reversion Method): Negative results- Hemocompatibility (material-mediated Hemolysis and Thrombogenicity): Negative results |
| Tensile and Hydrostatic Burst Testing | Acceptable strength and integrity of all device segments. | Yielded acceptable results on all segments of the fully assembled AortoCoronary Shunt. |
| Resistance to Fluid Flow | Capable of delivering blood to target coronary arteries at flow rates higher than normally observed. | Demonstrated that the product is capable of delivering blood to target coronary arteries at flow rates that are higher than are normally observed in those coronary arteries. Evaluated for both Arteriotomy Cannulae alone and the fully assembled AortoCoronary Shunt. |
| Resistance to Kinking and Damage due to Clamping | Acceptable resistance to kinking and damage. | Yielded acceptable results. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical performance data, meaning these are laboratory or bench tests, not tests on human subjects. Therefore, the concept of a "test set" with human data is not applicable in this context.
- Sample Size: Not explicitly stated for each test (e.g., number of devices tested for tensile strength). However, the document implies that a sufficient number of samples were tested to demonstrate acceptable performance for each criterion.
- Data Provenance: The tests are explicitly described as "non-clinical" performance data, conducted in a laboratory setting. Country of origin of data is not specified but is implicitly associated with the submitter, Medtronic Cardiac Surgical Products, Grand Rapids, MI, USA. The data is prospective in the sense that the tests were conducted specifically to evaluate the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As this involves non-clinical bench testing, the concept of "ground truth" established by medical experts (e.g., radiologists) for a test set is not relevant. The "ground truth" here is the physical and biological characteristics measured by the laboratory tests against established scientific and regulatory standards (e.g., ISO 10993-1).
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human reader studies or clinical trials to resolve discrepancies in expert opinions. For non-clinical bench testing, the results are typically quantitative measurements or qualitative observations directly compared against pre-defined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical performance data to demonstrate substantial equivalence to predicate devices, not on comparing the effectiveness of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This submission is for a physical medical device (AortoCoronary Shunt and Arteriotomy Cannulae), not for an artificial intelligence/machine learning algorithm.
7. The Type of Ground Truth Used
The "ground truth" for these non-clinical tests is based on:
- International Standards: Specifically, ISO 10993-1 for biocompatibility.
- Engineering Principles and Benchmarks: For functional tests like tensile strength, burst pressure, fluid flow resistance, and kinking resistance, the ground truth is established by physical measurements and comparison against expected physiological performance (e.g., flow rates higher than normally observed in coronary arteries) and engineering specifications for device integrity.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/ML device. The tests described are for a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circle with a stylized human figure inside, and the word "Medtronic" written in a bold, sans-serif font below the circle. The human figure appears to be in motion, with multiple overlapping outlines suggesting movement. The logo is black and white.
APR 2 7 2000
Medtronic c Surgical Products 620 Watson, S.W. Grand Rapids, MI 49504 U.S.A. Phone (616) 643 5200
FAX (616) 643 1095
510(k) Summary [As Required by 21 CFR 807.92]
| Submitter: | James BalunMedtronic Cardiac Surgical Products620 Watson, S.W.Grand Rapids, Michigan 49504 |
|---|---|
| Telephone Number: | (616) 643 5283 |
| FAX Number: | (616) 643 5214 |
| Date Summary Prepared: | December 7, 1999 |
| Trade Name of Device: | Medtronic AortoCoronary Shunt and separately packaged Arteriotomy Cannulae |
| Common Name of Device: | Cardiovascular cannula and tubing |
| Classification Name of Device: | "Cardiopulmonary bypass vascular cannula and tubing",Class II at 21 CFR 870.4210 |
| Predicate Substantially Equivalent Devices: | Medtronic DLP Aortic Root CannulaClass II at 21 CFR 870.4210Medtronic DLP Y-Type Coronary Perfusion AdapterClass II at 21 CFR 870.4210Medtronic DLP Coronary CannulaClass II at 21 CFR 870.4210 |
| Description of Device: | The Medtronic AortoCoronary Shunt includes an Aortic Root CannulaAssembly, a Y-Tubing Connector Assembly and a set of Arteriotomy Cannulae(2 mm, 3 mm and 4 mm sizes). The Arteriotomy Cannula Assemblies are alsoavailable separately for user convenience. The user assembles the componentsinto the final product configuration immediately prior to use. The assembleddevice diverts oxygenated, arterial blood from the patient's aorta directly to oneor two coronary arteries, thereby providing perfusion of an ischemic area of theheart during cardiac surgical procedures |
| Intended Use of Device: | These devices are intended for the perfusion of anticoagulated arterial bloodto an ischemic area of the heart. |
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Comparison to Predicate Devices:
The Aortic Root Cannula Assembly used in the new Medtronic AortoCoronary Shunt is identical to the predicate Medtronic DLP 10014 Aortic Root Cannula except for the substitution of a more flexible material that is used to fabricate the cannula body. The Y-Tubing Connector Assembly used in the new Medtronic AortoCoronary Shunt is very similar to the predicate Medtronic DLP 10004 Y-Type Coronary Perfusion Adapter except for material substitutions. which permit increased flexibility of this assembly as well. Finally the Arteriotomy Cannula Assemblies used in the new Medtronic AortoCoronary Shunt are substantially equivalent to the predicate Medtronic DLP 30010 and 30012 Coronary Cannula in that both the new and predicate devices are intended to deliver protective fluid (blood or cardioplegia solution) to myocardial tissue via direct cannulation of the coronary arteries.
Summary of Non-Clinical Performance Data:
Material biocompatibility testing was conducted in accordance with the ISO 10993-1 standard. Under this standard the AortoCoronary Shunt and Arteriotomy Cannulae are categorized as externally communicating devices in contact with circulating blood for a limited (<24 hour) contact duration. The battery of biocompatibility tests performed yielded negative (non-toxic) results in Cytotoxicity (MEM Elution Method), Sensitization (Guinea Pig Maximization Method), Intracutaneous Reactivity (in rabbits), Acute Systemic Toxicity (in mice), Genotoxicity (Ames Salmonella tvphimurium / Escherichia coli Mutation Reversion Method) and Hemocompatibility (material-mediated Hemolysis and Thrombogenicity) assessments.
Tensile and hydrostatic burst testing were performed on all segments of the fully assembled AortoCoronary Shunt. These tests vielded acceptable results. Resistance to fluid flow, determined by measuring the rate of flow from the end of the device as a function of the fluid pressure head at the inlet of the device, was assessed as well. This parameter was evaluated for both the Arteriotomy Cannulae alone as well as for the fully assembled AortoCoronary Shunt. These tests demonstrated that the product is capable of delivering blood to target coronary arteries at flow rates that are higher than are normally observed in those coronary arteries. Finally the resistance of the product to kinking and damage due to clamping the sections of tubing was assessed. This testing vielded acceptable results as well.
Conclusions of Non-Clinical Tests:
The results of the non-clinical tests summarized above support an assertion that the Medtronic AortoCoronary Shunt and Arteriotomy Cannulae are as safe and effective as the three predicate legally marketed medical devices itemized above.
Section 2
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2000
Mr. James Balun Principal Product Regulations Manager Medtronic Cardiac Surgical Products 620 Watson SW 49504 Grand Rapids, MI
Re: K994171/S1 Medtronic AortoCoronary Shunt and Arteriotomy Cannulae Requlatory Class: II Product Code: DWF March 27, 2000 Dated: Received: March 28, 2000
Dear Mr. Balun:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. James Balun
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4692. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Bura L. Lymperle
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K994171 5 10(k) Number (if known):
Medtronic AortoCoronary Shunt and separately packaged Arteriotomy Cannulae Device Name:
Indications For Use:
These devices are intended for the perfusion of anticoagulated arterial blood from the aorta to coronary vessels to supply an ischemic area of the heart during beating heart CABG procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Betri L. Guspiz C
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________ K gal 417
Prescription Use (Per 21 CFR 801.109)
.
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).