(77 days)
Not Found
Not Found
No
The summary describes a physical medical device (a shunt) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is described as a temporary conduit that allows blood flow between the common and internal carotid arteries during carotid endarterectomies, which is a therapeutic surgical procedure.
No
The device description indicates it is a "tapered shunt used to divert blood flow," which describes a therapeutic or interventional device, not one used for diagnosis. Its purpose is to facilitate blood flow during surgery, not to identify or characterize a disease or condition.
No
The device description clearly states it is a "tapered shunt," which is a physical, hardware component used to divert blood flow. There is no mention of software as the primary or sole function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a surgical tool (a shunt) used during a surgical procedure (carotid endarterectomy) to manage blood flow within the patient's body. It does not analyze specimens in vitro.
The description clearly indicates its function as a temporary conduit for blood flow within the patient's circulatory system during surgery. This is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
This device is used during carotid endarterectomies as a temporary conduit, to allow for blood flow between the common and internal carotid arteries.
Product codes
DXC
Device Description
A tapered shunt used to divert blood flow from the common carotid artery to the internal carotid during carotid endarterectomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carotid artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Sundt Shunt, Pruitt-Inhara Shunt, Smithwick Shunt, Javid Shunt, Vascuflo Shunt and Modified Carotid Shunt by Uresil Corp.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
510(k) Safety and Effectiveness Summary
| Date: | Feb. 23, 2006 | |
|---|---|---|
| Prepared By: | Cheryl Curry | NOV - 9 2006 |
| Common/Usual Name: | Carotid Shunt | |
| Proprietary Name: | Implantable Devices Shunt | |
| Classification: | Class II 870.1200 | |
| Description: | A tapered shunt used to divert blood flow from the | |
| common carotid artery to the internal carotid during carotid | ||
| endarterectomy. | ||
| Indications for Use: | Carotid Endarterectomy | |
| Substantial Equivalence: | Sundt Shunt, Pruitt-Inhara Shunt, Smithwick Shunt, Javid | |
| Shunt, Vascuflo Shunt and Modified Carotid Shunt by | ||
| Uresil Corp. | ||
| Conclusion: | The Implantable Devices Shunt is safe and effective for | |
| carotid endarterectomy. |
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 9 2006
McPherson Enterprises, Inc. c/o Mr. William E. McPherson 3851 62nd Avenue N. Suite A Pinellas Park, EL 33781
Re: K062474
Smithwick Carotid Shunt Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (Two) Product Code: DXC Dated: August 22, 2006 Received: August 29, 2006
Dear Mr. McPherson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. William E. McPherson
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); good manufacturing practice requirements as set 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legal|y marketed predicate device results in a classification for your device and thus, perreits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note (24 Cr re an over), proc "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon ontain 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) 633-2011 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
R. Wulner
Image /page/2/Picture/5 description: The image contains a handwritten letter 'S' in a cursive style. The letter is written in black ink on a white background. The 'S' has a flowing, elegant shape with a distinct curve at the top and a loop at the bottom.
\ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K062474
Device Name: Smithwick Carotid Shunt Models WR1409SB DWR1409SB Models WR1409DB DWR1409DB
Indications For Use:
This device is used during carotid endarterectomies as a temporary conduit, to allow for blood flow between the common and internal carotid arteries.
Prescription Use XXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma P. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
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510(k) Number Ko62474