(22 days)
Not Found
No
The summary describes a physical medical device (carotid shunt and biologic patch) and its intended use in surgical procedures. There is no mention of software, algorithms, image processing, AI, or ML.
Yes
The device, specifically the Pruitt F3 carotid shunt and XenoSure Biologic Patch, is used for surgical repair and reconstruction of arteries and tissues, which are therapeutic interventions.
No
The device is described as a "temporary conduit" and "surgical patch material" used in surgery, indicating therapeutic and reconstructive purposes rather than diagnostic ones.
No
The device description clearly states it is a "convenience kit composed of Pruitt F3 carotid shunt and XenoSure (Peripatch) biologic patch," which are physical medical devices, not software.
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.
- Device Description and Intended Use: The description clearly states that the device is a kit containing a carotid shunt and a biologic patch. The intended uses are for surgical procedures (carotid endarterectomy, cardiac and vascular reconstruction, soft tissue repair). These are all procedures performed on the body, not tests performed on samples taken from the body.
Therefore, the Pruitt Carotid Kit falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Pruitt F3 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. The size 8 French Shunt is intended for use on those patients whose vasculature is too small to accommodate a size 9 French Shunt.
The patch is intended for use as a surgical patch material for: cardiac and vascular re-construction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.
Product codes
MJN, FTM
Device Description
The Pruitt Carotid Kit is a convenience kit composed of Pruitt F3 carotid shunt and XenoSure (Peripatch) biologic patch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carotid arteries, cardiac, vascular, soft tissue
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)
Not Found
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
K103356 page 1 of 1
DEC - 8 2010
SECTION 6: 510(K) Summary
| Submitter: | LeMaitre Vascular, Inc.
63 Second Avenue
Burlington, MA 01803 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Vic Zhang
Sr. Regulatory Affairs Specialist
Phone: 781-221-2266 x162
Fax: 781-425-5049
Email: xzhang@lemaitre.com |
| Date Prepared: | November 12, 2010 |
| Trade Name: | Pruitt Carotid Kit |
| Common Name: | Carotid Kit |
| Classification Name: | N/A |
| Predicate Device: | Pruitt F3 Carotid Shunt (K051067)
Peripatch Biologic Patch (K040835) |
| Device Description: | The Pruitt Carotid Kit is a convenience kit composed of Pruitt F3 carotid shunt and XenoSure (Peripatch) biologic patch. |
| Intended Use: | The Pruitt F3 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. The size 8 French Shunt is intended for use on those patients whose vasculature is too small to accommodate a size 9 French Shunt.
The patch is intended for use as a surgical patch material for: cardiac and vascular re-construction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures. |
| Summary of Technological
Characteristics: | The Pruitt Carotid Kit is a convenience kit composed of the Pruitt F3 carotid shunt and XenoSure (Peripatch) biologic patch. |
| Summary of Product
Testing: | N/A |
| Conclusion: | LeMaitre Vascular has demonstrated that the Pruitt Carotid Kit is substantially equivalent to the predicate devices based on its indications for use and fundamental scientific technology. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
LeMaitre Vascular Inc. c/o Vic Zhang Sr. Regulatory Affairs Specialist 63 2nd Ave. Burlington, MA 01803
DEC - 8 2010
Re: K103356
Trade/Device Name: Pruitt Carotid Kit Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: MJN, FTM Dated: November 12, 2010 Received: November 16, 2010
Dear Mr. Zhang:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Vic Zhang
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
buna R. v. chmis
Image /page/2/Picture/7 description: The image shows a handwritten word "Branch" above the word "Direct". To the left of the words is a curved line with an arrow pointing to the right. The image is in black and white.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K103356 page
SECTION 5: INDICATION FOR USE STATEMENT
510(k) Number (if known): K403356
DEC - 8 2010
Device Name: Pruitt Carotid Kit
Indications for Use:
For Pruitt F3 Carotid Shunts:
The Pruitt F3 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. The size 8 French Shunt is intended for use on those patients whose vasculature is too small to accommodate a size 9 French Shunt.
For XenoSure Biologic Patch:
The patch is intended for use as a surgical patch material for: cardiac and vascular reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.
Prescription Use X
(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE ID NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
b.k.hmer
(Division Sign-Off) Division of Cardiovascular Devices
K103356 510(k) Number_