(168 days)
These shunts are intended for use to shunt blood by the arteriotomy anastomosis site while the surgeon is making the anastomosis.
The Medtronic ClearView® Intravascular Arteriotomy Shunt is a temporary arterial shunt for use during coronary artery bypass grafting procedures (CABG). The device features two teardrop shaped bulbs over-molded onto the ends of a flexible tubular shaft. The device is provided in nine sizes. A tag attached to each device identifies size. The device is radiopaque.
The provided document does not describe the acceptance criteria or a study proving the device meets them in the context of an AI-powered medical device. This document is a 510(k) Summary for a Medtronic ClearView® Intravascular Arteriotomy Shunt, which is a physical medical device (a temporary arterial shunt for use during coronary artery bypass grafting procedures).
Therefore, I cannot provide answers to the requested information (1-9) as they pertain to the evaluation of AI/ML-based medical devices.
The document focuses on non-clinical performance data for a physical device, including:
- Biocompatibility testing: Performed according to ISO 10993-1, testing for cytotoxicity, hemolysis, sensitization, systemic toxicity, and intracutaneous toxicity. All tests were negative.
- Flow Curve testing: Compared the shunt's flow characteristics to a predicate device, showing equivalent or better flow.
- Radiopacity testing: Confirmed that the shunt's radiopaque components were visible via radiographic imaging on a phantom chest device.
- Tensile Strength testing: Demonstrated the device could withstand physical forces exceeding normal usage without failure.
The conclusion states that these non-clinical tests indicate the device is safe and effective for its indicated use and substantially equivalent to the predicate device.
To reiterate, the questions asked (1-9) are specific to the evaluation of AI/ML-driven medical devices (e.g., performance metrics like sensitivity, specificity, use of expert-annotated test sets, MRMC studies), which are not applicable to the physical medical device described in this 510(k) summary.
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APR 1 7 2000
K 9 9 3 6 7 7
Medtronic, Inc.
Medtronic DLP
620 Watson SW, P.O. Box 409
Grand Rapids, MI 49501-0409
Telephone: (616) 242-5200
Toll Free: (800) 253-1540
Fax: (616) 242-5262
510(k) Summary
| Submitter: | Medtronic DLP620 Watson, S.W.Grand Rapids, Michigan 49504 |
|---|---|
| Contact: | Michael Hingson |
| Telephone Number: | 616.356.5518 |
| Facsimile Number: | 616.242.5214 |
| Date 510(k) Summary Prepared: | October 29, 1999 |
| Trade Name of Device: | Medtronic ClearView® Intravascular Arteriotomy Shunt |
| Common Name of Device: | Cardiopulmonary bypass vascular catheter, cannula ortubing (21 CFR 870.4210) |
| Substantially Equivalent Predicate: | Chase Blood Vessel ShuntClass II at 21 CFR 870.4210 |
- Description of Device: The Medtronic ClearView® Intravascular Arteriotomy Shunt is a temporary arterial shunt for use during coronary artery bypass grafting procedures (CABG). The device features two teardrop shaped bulbs over-molded onto the ends of a flexible tubular shaft. The device is provided in nine sizes. A tag attached to each device identifies size. The device is radiopaque.
- Intended Use: These shunts are intended for use to shunt blood by the arteriotomy anastomosis site while the surgeon is making the anastomosis.
Comparison to Predicate Device:
The predicate to which substantial equivalence is claimed is the Chase Blood Vessel Shunt. The ClearView Shunt and the Chase Blood Vessel Shunt are similar in design; manufacturing materials, flow characteristics and physical dimensions. The predicate device's intended use is to internally shunt blood vessels during anastomosis.
510(k) Premarket Notification Medtronic ClearView® Intravascular Arteriotomy Shunt
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Summary of Non-Clinical Performance Data:
Biocompatibility testing was performed in accordance with ISO 10993-1: Biological evaluation of medical devices-- Part 1: Evaluation and Testing. The Medtronic ClearView Intravascular Arteriotomy Shunt is classified under externally communicating devices coming in contact with circulating blood with contact duration of ≤24 hours. The device tested negative for: cytotoxicity, hemolysis, sensitization, systemic toxicity and intracutaneous toxicity.
Performance testing of the device included flow curve, radiopacity and tensile strength testing.
Flow Curve
Flow characterization testing was performed to assure that the ClearView Shunt would perform as described in the device's indications for use. Identical sizes of the Medtronic Clear View Shunt and the predicate device were tested on a flow bench unit. The flow bench unit generates flow curves by plotting pressure differential (mmHg) against water flow rate (mL/min.). Water was directed through the lumen of each device at flow rates ranging from 0-200mL/min., or as needed to characterize the flow of each shunt at and below 80mm/Hg. Flow curves generated from the tested devices demonstrated the ClearView Shunt to have flow curves equivalent to or better than the predicate device. Tests on other sizes of the ClearView Shunt demonstrated measurable flows for all devices tested.
Radiopacity Testing
The ClearView Shunt was tested to determine if the radiopaque components of the device would be visible by radiographic imaging. ClearView Shunts were placed atop a phantom chest device. The phantom chest simulates the tissue and fluid densities that would be present in a closed adult chest. Processed radiographs of the ClearView Shunts on the phantom chest device revealed all ClearView test shunts could be identified.
Tensile Strength Testing
Tensile strength testing of the ClearView Shunt was performed to assure the device would be able to withstand the estimated physical forces it is expected the device would be subjected to when used as indicated. Various attachments and components of the ClearView Shunt were subjected to pull forces exceeding that which would be expected during normal usage (i.e., as indicated). All shunt components and attachments passed tensile strength test requirements.
Conclusions of Non-Clinical Performance Testing
Non-clinical performance testing of the Medtronic ClearView® Intravascular Arteriotomy Shunt indicates the device is safe and effective for its indicated use and the product is substantially equivalent to the claimed predicate Chase Blood Vessel Shunt.
Medtronic ClearView® Intravascular Arteriotomy Shunt
510(k) Premarket Notification
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PREMARKET NOTIFICATION TRUTHFUL AND ACCURATE STATEMENT [As required by 21 CFR 807.87(j)]
I certify that in my capacity as Principal Product Regulations Manager at Medtronic DLP, I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.
Signature
James Balun Typed Name
10/29/99
Date
510(k) Premarket Notification Medtronic ClearView® Intravascular Arteriotomy Shunt
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2000
Mr. Michael Hingson Product Regulation Manager Medtronic Cardiac Surgical Products 620 Watson SW Grand Rapids, MI 49504
Re: K993677 Medtronic ClearView® Intravascular Arteriotomy Shunt Regulatory Class: II Product Code: DWF Dated: March 3, 2000 Received: March 6, 2000
Dear Mr. Hingson:
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 Requlations, 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 regulation (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. Michael Hingson
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,
for Rose & Symperle
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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K 993677 510(k) Number (if known):
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
These shunts are intended for use to shunt blood by the arteriotomy anastomosis site while the surgeon is making the anastomosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
i. Dece L. Conover Ok
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K993677
Prescription Use (Per 21 CFR 801.109)
.
OR
Over-The-Counter Use
(Optional Format 1-2-96) 000005
§ 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).