(168 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and function of a temporary arterial shunt, with no mention of AI or ML.
Yes.
This device is used to shunt blood at the arteriotomy anastomosis site during bypass grafting procedures, which is a therapeutic intervention.
No
This device is a temporary arterial shunt used during surgery to maintain blood flow, not to diagnose a condition or disease.
No
The device description clearly describes a physical, temporary arterial shunt with bulbs and a tubular shaft, provided in various sizes. It also mentions radiopacity and includes performance studies related to physical properties like flow curve, radiopacity, and tensile strength, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Medtronic ClearView® Intravascular Arteriotomy Shunt is a temporary physical device used during a surgical procedure (coronary artery bypass grafting). Its purpose is to maintain blood flow while the surgeon is working on the anastomosis site. It does not analyze or test any biological samples.
- Intended Use: The intended use clearly states it's for "use to shunt blood by the arteriotomy anastomosis site while the surgeon is making the anastomosis." This is a mechanical function within the body, not an in vitro diagnostic test.
Therefore, this device falls under the category of a surgical instrument or implantable device, not an IVD.
N/A
Intended Use / Indications for Use
These shunts are intended for use to shunt blood by the arteriotomy anastomosis site while the surgeon is making the anastomosis.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic imaging
Anatomical Site
Arteriotomy anastomosis site (during coronary artery bypass grafting procedures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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
Flow Curve: Identical sizes of the Medtronic Clear View Shunt and the predicate device were tested on a flow bench unit. 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.
Radiopacity Testing: 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: 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).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing: Performed in accordance with ISO 10993-1: Biological evaluation of medical devices-- Part 1: Evaluation and Testing. The device tested negative for: cytotoxicity, hemolysis, sensitization, systemic toxicity and intracutaneous toxicity.
Flow Curve: Flow characterization testing was performed to assure that the ClearView Shunt would perform as described in the device's indications for use. 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. Processed radiographs of the ClearView Shunts on the phantom chest device revealed all ClearView test shunts could be identified.
Tensile Strength Testing: 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. All shunt components and attachments passed tensile strength test requirements.
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.
Chase Blood Vessel Shunt
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).
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Image /page/0/Picture/0 description: The image shows the word "Medtronic" in a bold, sans-serif font, followed by a square logo. The logo contains a stylized design with curved lines and a central dot, enclosed within a square border. The text and logo are both in black, contrasting with the white background.
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 DLP
620 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 or
tubing (21 CFR 870.4210) |
| Substantially Equivalent Predicate: | Chase Blood Vessel Shunt
Class 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
Image /page/0/Picture/10 description: The image shows a sequence of numbers, specifically "000002". The numbers are printed in a clear, sans-serif font, and they appear to be part of a larger code or identifier. There are some black shapes above the numbers, which are obscuring the numbers.
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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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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned above the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which are arranged in a circular pattern around the top half of the logo.
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.
4
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
5
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