(163 days)
No
The device description focuses on mechanical components and manual operation, with no mention of AI or ML.
Yes
The device is intended to be used in the disruption of venous valves, which is a medical procedure aimed at improving physiological function (blood flow) in patients undergoing bypass graft procedures. This aligns with the definition of a therapeutic device.
No.
The Fogarty® Valvulotome is described as a device used to disrupt venous valves, which is a therapeutic intervention, not a diagnostic one. It is used in surgical procedures to alter the function of valves, rather than to identify or characterize a disease state.
No
The device description clearly outlines physical components like a flexible shaft, cutting blade, handle, and irrigation lumen, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to disrupt venous valves during surgical procedures (in situ or autologous bypass graft procedures). This is a direct intervention on the patient's body.
- Device Description: The device is a surgical tool with a cutting blade designed to physically alter the structure of venous valves.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) outside of the body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a surgical instrument used for a therapeutic procedure.
N/A
Intended Use / Indications for Use
The Fogarty® Valvulotome is indicated for use in veins during in situ or autologous bypass graft procedures.
Product codes
MGZ
Device Description
The modified Fogarty® Valvulotome, like the predicate device, consists of a flexible shaft with a cutting blade at the distal tip and a handle at the proximal end. The mode of operation for both devices is the same. The device is inserted into the vessel in an antegrade direction until the blade is located above the cusp of a venous valve. The location of the valve is visualized via an angioscope or is directly visualized through the vein wall in an open procedure. The blade is withdrawn retrograde through the cusp, thereby rendering it incompetent. After the blade disrupts one cusp, it is then rotated 180° to disrupt the adjoining cusp segment.
The Fogarty® Valvulotome, like the predicate device, contains an irrigation lumen that provides irrigation/fluid flow during the valvulotomy procedure.
The predicate valvulotome was available in two sizes, 3.8 mm or 4.6 mm, with a shaft length of 90 cm. The modified device is available in one size that accommodates various vessel sizes and a usable length of 81 cm.
A modification to the Fogarty® Valvulotome was implemented that enhanced the strength of the attachment of the blade holder to the stop.
Other modifications to the device that have occurred since FDA clearance of the original valvulotome (Intramed Valvulotome, K925283) are also included in this submission and include:
- The blade is on the modified Fogarty® Valvulotome is retractable whereas the . blade on the predicate device was not. The size and shape of the blade have been changed to accommodate retractability.
- The material used for the shaft and handle have been changed; the modified . materials have been determined to be biocompatible.
- . The handle now includes a control button for extension and retraction of the blade and guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
veins
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 following non-clinical testing was performed on the Fogarty® Valvulotome:
- biocompatibility testing and .
- functional/bench testing.
Biocompatibility testing was performed on valvulotome samples in accordance with the requirements specified in International Standards Organization (ISO) 10993-1-1994 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests and the FDA General Program Memorandum No. G95-1. The valvulotome was found to be biocompatible and nontoxic and acceptable for its intended use.
Functional testing was performed on the Fogarty® Valvulotome to evaluate the integrity and performance of the device. The testing demonstrated that the product meets its performance requirements for its intended use.
In addition. Baxter conducted a clinical evaluation of the Fogarty® Valvulotome which demonstrated that the product is capable of disrupting venous valves during in situ saphenous vein grafting procedures.
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
§ 870.4885 External vein stripper.
(a)
Identification. An external vein stripper is an extravascular device used to remove a section of a vein.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 510(k) Notification for the Fogarty® Valvulotome
K96513)
JUN - 4 1997
510(k) Summary
A. Determination of Substantial Equivalence
The Fogarty® Valvulotome is substantially equivalent to the Intramed® Valvulotome, which was cleared for marketing under premarket notification K925283.
B. Device Name
Fogarty Valvulotome, Model 700091
C. Predicate Device
The claim of substantial equivalence is based on the following device:
- Intramed® Valvulotome, 510(k) No. K925283 .
D. Device Description
The modified Fogarty® Valvulotome, like the predicate device, consists of a flexible shaft with a cutting blade at the distal tip and a handle at the proximal end. The mode of operation for both devices is the same. The device is inserted into the vessel in an antegrade direction until the blade is located above the cusp of a venous valve. The location of the valve is visualized via an angioscope or is directly visualized through the vein wall in an open procedure. The blade is withdrawn retrograde through the cusp, thereby rendering it incompetent. After the blade disrupts one cusp, it is then rotated 180° to disrupt the adjoining cusp segment.
The Fogarty® Valvulotome, like the predicate device, contains an irrigation lumen that provides irrigation/fluid flow during the valvulotomy procedure.
The predicate valvulotome was available in two sizes, 3.8 mm or 4.6 mm, with a shaft length of 90 cm. The modified device is available in one size that accommodates various vessel sizes and a usable length of 81 cm.
A modification to the Fogarty® Valvulotome was implemented that enhanced the strength of the attachment of the blade holder to the stop.
Other modifications to the device that have occurred since FDA clearance of the original valvulotome (Intramed Valvulotome, K925283) are also included in this submission and include:
- The blade is on the modified Fogarty® Valvulotome is retractable whereas the . blade on the predicate device was not. The size and shape of the blade have been changed to accommodate retractability.
1
Food and Drug Administration 510(k) Notification for the Fogarty® Valvulotome
- The material used for the shaft and handle have been changed; the modified . materials have been determined to be biocompatible.
- . The handle now includes a control button for extension and retraction of the blade and guidewire.
E. Intended Use of Device
The Fogarty® Valvulotome, like the predicate device, is intended to be used in the disruption of venous valves.
F. Intended Use of Predicate Device
The Intramed® Valvulotome is intended to be used in the disruption of venous valves.
G. Technological Comparison of the Fogarty Valvulotome and the Predicate Device
The modified Fogarty® Valvulotome, like the predicate device, consists of a flexible shaft with a stainless steel cutting blade at the distal tip and a handle at the proximal end. Both contain an irrigation lumen that provides irrigation/fluid flow during the valvulotomy procedure. The mode of operation for both devices is the same as is the intended use. Therefore, the technological characteristics of Fogarty Valvulotome are equivalent to those of the Intramed® Valvulotome.
H. Discussion of Non-Clinical Tests, Clinical Evaluations and Conclusions
The following non-clinical testing was performed on the Fogarty® Valvulotome:
- biocompatibility testing and .
- functional/bench testing. �
Biocompatibility testing was performed on valvulotome samples in accordance with the requirements specified in International Standards Organization (ISO) 10993-1-1994 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests and the FDA General Program Memorandum No. G95-1. The valvulotome was found to be biocompatible and nontoxic and acceptable for its intended use.
Functional testing was performed on the Fogarty® Valvulotome to evaluate the integrity and performance of the device. The testing demonstrated that the product meets its performance requirements for its intended use.
In addition. Baxter conducted a clinical evaluation of the Fogarty® Valvulotome which demonstrated that the product is capable of disrupting venous valves during in situ saphenous vein grafting procedures.
2
11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 -
Food and Drug Administration 510(k) Notification for the Fogarty® Valvulotome
Summary of Safety and Effectiveness i.
The above testing demonstrates that the Fogarty® Valvulotome is safe and effective for its intended use.
Patricia K. Garvey
Patricia L. Garvey, Ph.D. Director, Regulatory Affairs and Clinical Studies CardioVascular Group
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of a bird-like figure, possibly representing an eagle or other national symbol. The bird figure is stylized with flowing lines, giving it a sense of movement.
11 2011 - 31
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 1997
Ms. Paula A. Torrianni Senior Clinical Affairs Spēcialist Baxter Healthcare Corporation 17221 Red Hill Avenue P.O. Box 11150 Santa Ana, California 92711-1150
K965137 Re: Baxter Fogarty® Valvulotome Requlatory Class: II (two) Product Code: MGZ Dated: April 4, 1997 Received: April 7, 1997
Dear Ms. Torrianni:
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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 620) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions.
4
requlatory 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.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket motification" (21 CFR 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 at (301) 443-6597.
Sincerely yours,
Thomas J. Collechon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page of
510(k) Number (if known): K965/37
Device Name: Baxter Fogarty® Valvulot
Indications For Use
Food and Drug Administration 510(k) Notification for the Fogarty® Valvulotome December 20, 1996 Page iii # Indications for Use
510(k) Notification for the Baxter Fogarty® Valvulotome Reference:
The Fogarty® Valvulotome is indicated for use in veins during in situ or autologous bypass graft procedures.
(PLEASE DO NOT WRITE: BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bette L. Cooperle
(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use_X (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)