(105 days)
Not Found
No
The description focuses on the physical design and function of a temporary blood conduit, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is a temporary conduit used to restore blood flow during carotid endarterectomy, which is a medical procedure to treat a condition. This function aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device, a carotid shunt, is described as a temporary blood conduit used during surgery to maintain blood flow. It does not perform any diagnostic function such as detecting, monitoring, or analyzing medical conditions or bodily functions.
No
The device description clearly states it is a "Flexcel™ Carotid Shunt," which is a physical, implantable device designed to serve as a temporary blood conduit. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Flexcel™ Carotid Shunt is a temporary conduit used during surgery to maintain blood flow within the patient's body. It does not analyze or test specimens taken from the body.
The device description clearly indicates it's a surgical tool used in vivo (within the living body) during a carotid endarterectomy procedure.
N/A
Intended Use / Indications for Use
The Flexcel™ Carotid Shunt is indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.
Product codes
MJN
Device Description
The Flexcel™ Carotid Shunt is designed to serve as a temporary blood conduit connecting one section of a vessel to a second area of the same vessel. This allows blood to continuously flow to the patient's brain during an endarterectomy procedure. The Flexcel Carotid Shunt is a straight design shunt packaged in 5-unit packages providing a variety of sizes from 8-14 French.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carotid arteries
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness of the Flexcel™ Carotid Shunt has been demonstrated through data collected from bench tests and analyses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo for LeMaitre Vascular. The logo consists of a stylized, rounded square shape on the left, with a white, curved line running through it. To the right of the shape is the word "LeMaitre" in a bold, sans-serif font, with a registered trademark symbol next to it. Below "LeMaitre" is the word "VASCULAR" in a smaller, sans-serif font.
Jre Than The Valvulotome.
KD71367
p. 1 of 1
AUG 2 9 2007
510(k) SUMMARY SAFETY and EFFECTIVENESS INFORMATION
as required by Safe Medical Devices Act of 1990 and codified in 21 CFR Part 807.92 upon which
substantial equivalence is based.
| Flexcel® Carotid Shunt (inlying) | |
|---|---|
| Date Prepared: | 05/15/2007 |
| Submitter's Name: | LeMaitre Vascular, Inc. |
| Address: | 63 Second Avenue |
| Burlington, MA 01803 | |
| Company Contact: | Minnie Mildwoff, RAC |
| Sr. Regulatory Affairs Specialist | |
| Tel: (781) 221-2266 | |
| Fax:(781) 425-5049 | |
| Device Name | |
| Trade Name: | Flexcel® Carotid Shunt (inlying) |
| Device Common Name: | Carotid Shunt |
| Device Classification Name: | Catheter, Intravascular Occluding, Temporary |
Summary of Substantial Equivalence:
The design, materials, method of delivery and intended use features of Flexcel™ Carotid Shunt (inlying) is substantially equivalent with regard to these features in the predicate device, the Pruitt F3 Carotid Shunt (K051067) and LeMaitre Vascular Straight Carotid Shunt (K033159)
Device Description:
The Flexcel™ Carotid Shunt is designed to serve as a temporary blood conduit connecting one section of a vessel to a second area of the same vessel. This allows blood to continuously flow to the patient's brain during an endarterectomy procedure. The Flexcel Carotid Shunt is a straight design shunt packaged in 5-unit packages providing a variety of sizes from 8-14 French.
Intended Use:
The Flexcel™ Carotid Shunt is indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.
Performance Data:
The safety and effectiveness of the Flexcel™ Carotid Shunt has been demonstrated through data collected from bench tests and analyses.
United States LeMaitre Vascular, Inc. 63 Second Avenue Burlington, MA 01803
Germany LeMaitre Vascular GmbH Otto-Volger-Str. 5a/b 65843, Sulzbach/Ts
Tel: 781 221-2266 Fax: 781 221-2223
Tel: +49-(0)6196-659230 Fax: +49-(0)6196-527072 Japan LeMaitre Vascular, KK 1F Kubodera Twin Tower Bldg. 2-9-4 Kudan-minami, Chiyoda-ku Tokyo, 102-0074
Tel: +81-(0)3-5215-5681 Fax: +81-(0)3-5215-5682 www.lemaitre.com
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2007
LeMaitre Vascular, Inc. c/o Ms. Minnie Mildwoff Senior Regulatory Affairs Specialist 63 Second Avenue Burlington, MA 01803
Re: K071367 Flexcel Carotid Shunt (Inlying) Regulation Number: 21 C.F.R. § 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II Product Code: MJN Dated: August 16, 2007 Received: August 22, 2007
Dear Ms. Mildwoff:
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 - Ms. Minnie Mildwoff
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); labcling (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 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 regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dmina R. Vachnes
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the logo for LeMaitre Vascular. The logo consists of a stylized, abstract shape on the left, followed by the words "LeMaitre" in a bold, sans-serif font. Below "LeMaitre" is the word "VASCULAR" in a smaller, sans-serif font. A registered trademark symbol is present to the right of the word "LeMaitre".
دre Than The Valvulotome.
Indications for Use
510(k) Number (if known): $07_1367
Device Name: Flexcel Carotid Shunt (inlying)
Indications For Use:
Carotid Shunts are indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid 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 THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uma R. Vachner
Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K071367
Page 1 of 1
United States LeMaitre Vascular, Inc. 63 Second Avenue Burlington, MA 01803
Tel: 781 221-2266 Fax: 781 221-2223
1: +81-(0)3-5215-568 Fax: +81-(0)3-5215-5682