(31 days)
Not Found
No
The description focuses on the mechanical function and design of a physical medical device (a carotid shunt) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a temporary conduit to allow for blood flow, which performs a physiological function by moving blood, thus it is a therapeutic device.
No.
The device is a temporary conduit for blood flow during surgery, not a diagnostic tool. It does not identify or characterize a disease or condition.
No
The device description clearly describes a physical, sterile conduit with balloons, indicating it is a hardware device, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Pruitt® F3 carotid shunts are used as a "temporary conduit to allow for blood flow between the common and internal carotid arteries" during a surgical procedure (carotid endarterectomy). This is a device that is physically inserted into the body to facilitate a surgical intervention.
- No Sample Analysis: There is no mention of the device analyzing any biological samples or providing diagnostic information based on such analysis. Its function is purely mechanical and supportive during surgery.
Therefore, the device falls under the category of a surgical or interventional device, not an in vitro diagnostic.
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.
Product codes (comma separated list FDA assigned to the subject device)
MJN
Device Description
The proposed Pruitt® F3 Shunts are designed to serve as temporary blood conduits 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 device is manufactured using a clear, plastic, sterile conduit, which is held in place by a stabilization technique on both ends of the conduit.
The Pruitt® F3 Shunts are tri-lumen devices with balloons on both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the shunt when it is placed within the common and internal carotid arteries. An external safety balloon, located on the inflation arm internal ourbild afternal carotid) balloon, acts as a mechanism to relieve pressure on the internal carotid balloon in the event it inflates above the maximum stated volume. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage.
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 proposed Pruitt® F3 Shunts has been demonstrated through data collected from bench tests and analyses.
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.
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
§ 870.4450 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
MAY 2 7 2005
510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR Part 807.92.
| Submitter's Name: | LeMaitre Vascular, Inc. |
|---|---|
| Submitter's Address: | 63 Second Avenue |
| Burlington, MA 01803 | |
| Telephone: | 781/221-2266 |
| Fax: | 781/221-2223 |
| Contact Person: | Amy Watzke |
| Date Prepared: | 04/04/05 |
| Device Trade Names: | Pruitt® F3 Outlying Carotid Shunt |
| (without T-Port) | |
| Pruitt® F3 Outlying Carotid Shunt (with T-Port) | |
| Pruitt® F3 Inlying Carotid Shunt (with T-Port) | |
| Pruitt® F3 Inlying Carotid Shunt | |
| (without T-Port) | |
| Device Common Name: | Carotid Shunt |
| Device Classification Name: | Catheter, Intravascular Occluding, Temporary |
| Device Classification: | Class II |
Summary of Substantial Equivalence:
The design, materials, method of delivery and intended use features of the Pruitt® F3 Outlying Carotid Shunt without T-port, the Pruitt® F3 Outlying Carotid Frant with T-port, the Pruitt® F3 Inlying Carotid Shunt with T-port and the Pruitt® Onlying Carotid Shunt without T-port (the Pruitt® F3 Shunts) are substantially equivalent with regard to these features in the predicate device, the Next Generation Pruitt-Inahara® Outlying Carotid Shunt (K043023, December 3, 2004).
Device Description:
The proposed Pruitt® F3 Shunts are designed to serve as temporary blood conduits 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 device is manufactured using a clear, plastic,
1
sterile conduit, which is held in place by a stabilization technique on both ends of the conduit.
The Pruitt® F3 Shunts are tri-lumen devices with balloons on both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the shunt when it is placed within the common and internal carotid arteries. An external safety balloon, located on the inflation arm internal ourbild afternal carotid) balloon, acts as a mechanism to relieve pressure on the internal carotid balloon in the event it inflates above the maximum stated volume. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage.
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.
Technoloqical Characteristics:
Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization and packaging of the proposed devices are substantially equivalent ടterilization and pashaging of the new Pruitt® F3 Shunts compared to that of the predicate carotid shunt are:
- . Physical Changes
- Removal of the T-Port (for Outlying without T-Port and Inlying without o T-Port versions)
- o Reduction in the length of the shunt body (for Inlying versions)
- o Reduction in French size from 10.5F to 10F
Performance Data:
The safety and effectiveness of the proposed Pruitt® F3 Shunts has been demonstrated through data collected from bench tests and analyses.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
MAY 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LeMaitre Vascular, Inc. c/o Ms. Amy Watzke International Regulatory Affairs Specialist 63 Second Avenue Burlington, MA 01803
Re: K051067
Pruitt® F3 Outlying and Inlying Carotid Shunts with and without T-Port Regulation Number: 21 CFR 870.4450 Regulation Name: Catheter, Intravascular Occluding, Temporary Regulatory Class: Class II (Two) Product Code: MJN Dated: April 4, 2005 Received: April 26, 2005
Dear Ms. Watzke:
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 11 your de ree to such additional controls. Existing major regulations affecting your device can may or bayers tode of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Amy Watzke
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I Dr a wean that your device complies with other requirements of the Act that I Dri has made a aond regulations administered by other Federal agencies. You must of any it cach statutes and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the Hot of CFR Part 801); good manufacturing practice requirements as set CI K Part 607); mooning (D. CFR Part 820); and if applicable. the electronic forul in the quant) by sell provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product faction of to begin marketing your device as described in your Section 5 (0(k) 1 ms letter will and w yours of substantial equivalence of your device to a legally prematics notification: "The Britismation 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 11 you abon office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Duma R. Lochner
Image /page/3/Picture/5 description: The image shows a signature. The signature is composed of a series of curved and angular lines. The lines are dark and appear to be written with a pen or marker. The signature is illegible and does not resemble any recognizable letters or words.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number (if known): | K051067 |
|---|---|
| Device Name: | Pruitt® F3 Outlying Carotid Shunt (without T-Port) |
| Pruitt® F3 Outlying Carotid Shunt (with T-Port) | |
| Pruitt® F3 Inlying Carotid Shunt (without T-Port) | |
| Pruitt® F3 Inlying Carotid Shunt (with T-Port) |
Indications For Use:
-
- The Pruitt-Inahara®, Inahara-Pruitt® and 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.
| Prescription Use | X |
|---|---|
| ------------------ | --- |
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(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)
Duna R. Vochner
'Division Sign-Off) Ivision of Cardiovascular Devices
ت مل بال (k) Number _ F مل تاريخ ج تبارك ج م