(186 days)
Not Found
No
The device description focuses on mechanical components and operation, with no mention of AI/ML terms or functions.
Yes
The device is used for the "treatment of vascular disorders" by "excising or disrupting venous valves," which are direct medical interventions aimed at improving a patient's health condition.
No
The device is described as an instrument for excising or disrupting venous valves, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components like a handle, catheter, and cutter head, indicating it is a hardware device.
Based on the provided information, the Valvulotome by Koven is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "excising or disrupting venous valves when performing in-situ vascular procedures, such as lower extremity arterial bypass surgery." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical instrument with cutting blades and guide fins designed for use within a blood vessel. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The Valvulotome is a surgical tool used for a therapeutic purpose (treating vascular disorders by disrupting valves), not for diagnostic testing.
N/A
Intended Use / Indications for Use
The Valvulotome by Koven Valvulotome is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves when performing in-situ vascular procedures, such as lower extremity arterial bypass surgery.
Product codes
MGZ
Device Description
The Valvulotome by Koven is a medical device that has a deployable assembly with multiple deployable cutting blades and guide fins which permit continual centralizing, and alignment of the cutting blades within the lumen of the vein as the valves are being cut. The device includes a handle operatively associated with this deployable assembly through a catheter operated by the handle in a one-handed operation for deploying the guide fins and cutting blades of the deployable assembly having respective outer diameters at each deployment position.
The Valvulotome by Koven consists of three main parts; the handle, the catheter and the cutter head as shown.
-
- The handle is fabricated through injection molded plastics that are assembled using adhesive and mechanical fasteners. The material used is a Medical Grade Acrylic and a Medical Grade Thermoplastic Elastomer.
-
- The catheter is fabricated through an extrusion process and an adhesive bond. The materials used are a Medical Grade Natural Polyetheretherketone and medical grade adhesive.
-
- The cutter head is fabricated through machining, etching, drawing and stamping and assembled using a welding process. All materials in the cutter head are made from 300 series Stainless Steel.
The Valvulotome by Koven are packaged using a Medical Grade Polyethylene Terephthalate Glycol tray and lid. The tray with lid shall be placed inside a sealed Twek pouch, which will be placed, along with an "Instructions for Use" booklet, inside a shelf carton with two protective form pads. The device label will appear on both the pouch and the shelf carton. The device and its packaging will be sterilized using irradiation sterilization method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous valves in blood vessels of the leg
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) / clinical settings only
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)
Testing of the Valvulotome by Koven included laboratory bond strength testing of all joined elements, bench testing for the determination of adequacy and safety of the device for the disruption of valves in blood vessels of the leg.
The Valvulotome by Koven successfully completed all testing with positive end points achieved.
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
KC80178 page lot 3
510(k) (Traditional) Submission Section 5, Summary
Image /page/0/Figure/2 description: The image shows the logo for Koven Technology Incorporated. The words "Vascular Instruments" are at the top of the logo. The word "Koven" is in large font in the middle of the logo, and the words "Technology Incorporated" are at the bottom of the logo.
JUL 2 8 2008
Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the Valvulotome by Koven.
1. Company making the submission:
| Name: | Koven Technology, Inc. |
|---|---|
| Address: | 12125 Woodcrest Executive Drive, |
| St. Louis, MO 63141 | |
| Telephone: | 314-542-2101 Voice |
| 314-542-6020 Fax | |
| Contact: | Heather Bell |
| E-mail: | hbell@koven.com |
| Submission Contact: | J. Harvey Knauss, Delphi Consulting Group |
| Address: | 11874 South Evelyn Circle |
| Houston, Texas 77071-3404 | |
| Telephone: | 713-723-4080 Voice |
| 832-615-3550 Fax | |
| E-mail: | Harvey@delphiconsulting.com |
2. Device Name;
Trade/Proprietary Name: Valvulotome by Koven Common/Usual Name: Valvulotome - External Vein Stripper Classification Name: External Vein Stripper Regulation Number: 870.4885 Product Code: MGZ
3. Predicate Devices:
The Valvulotome by Koven is substantially equivalent to other Valvulotome devices in the market such as the Lemaitre Valvulotome II, K946352, manufactured by Vascutech, Inc., North Andover, MA 01854.
4. Indications for Use Statement
The Valvulotome by Koven Valvulotome is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves when performing in-situ vascular procedures, such as lower extremity arterial bypass surgery.
Summary Rey B don Houston, TX 7707
1
Korelitz page 2 of 3
510(k) (Traditional) Submission Section 5, Summary
5. Description of Device:
The Valvulotome by Koven is a medical device that has a deployable assembly with multiple deployable cutting blades and guide fins which permit continual centralizing, and alignment of the cutting blades within the lumen of the vein as the valves are being cut. The device includes a handle operatively associated with this deployable assembly through a catheter operated by the handle in a one-handed operation for deploying the guide fins and cutting blades of the deployable assembly having respective outer diameters at each deployment position.
The Valvulotome by Koven consists of three main parts; the handle, the catheter and the cutter head as shown.
-
- The handle is fabricated through injection molded plastics that are assembled using adhesive and mechanical fasteners. The material used is a Medical Grade Acrylic and a Medical Grade Thermoplastic Elastomer.
-
- The catheter is fabricated through an extrusion process and an adhesive bond. The materials used are a Medical Grade Natural Polyetheretherketone and
medical grade adhesive.
KOVEN
-
- The cutter head is fabricated through machining, etching, drawing and stamping and assembled using a welding process. All materials in the cutter head are made from 300 series Stainless Steel.
Image /page/1/Figure/9 description: The image shows a diagram of a medical instrument with several measurements labeled. The total length of the instrument is 94 cm, and the handle is 16 cm long. The diameter of the shaft is 0.8 mm, and the diameter of the tip ranges from 2.6 to 5.5 mm.
- The cutter head is fabricated through machining, etching, drawing and stamping and assembled using a welding process. All materials in the cutter head are made from 300 series Stainless Steel.
Section 11 510(k) Submission Page #
Summary Rev R day Houston, TX 77071
2
The Valvulotome by Koven are packaged using a Medical Grade Polyethylene Terephthalate Glycol tray and lid. The tray with lid shall be placed inside a sealed Twek pouch, which will be placed, along with an "Instructions for Use" booklet, inside a shelf carton with two protective form pads. The device label will appear on both the pouch and the shelf carton. The device and its packaging will be sterilized using irradiation sterilization method.
6. Summary of the technological characteristics of the device compared to predicate device:
Differences in technology - None.
The basic method of construction and materials is very similar. The methods of operation and indications for use are the same for each device.
7. Testing:
Testing of the Valvulotome by Koven included laboratory bond strength testing of all joined elements, bench testing for the determination of adequacy and safety of the device for the disruption of valves in blood vessels of the leg.
The Valvulotome by Koven successfully completed all testing with positive end points achieved.
8. Rx or OTC:
The Valvulotome by Koven is a Rx prescription device per 21 CFR Subpart D. The device is labeled for clinical settings only. Federal Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
9. Conclusions:
Based upon the testing and comparison to the predicts device the Valvulotome by Koven has the same intended use, with similar technological characteristics. Koven Technology, Inc., therefore posits that its device is substantiality equivalent to predicate devices.
Koven Technology. Inc.
D.R. Bell
President Koven Technology, Inc
Date: 7-17-08
Houston, TX 7707
3
Image /page/3/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 bars representing the department's three main goals. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 8 2008
Koven Technology c/o Mr. Harvey Knauss Consultant Delphi Consulting Group 11874 South Evelyn Circle Houston, TX 77071
Rc: K080178
Trade/Device Namc: Valvulotome by Koven Regulation Number: 21 CFR 870.4885 Regulation Name: External Vein Stripper Regulatory Class: Class II Product Code: MGZ Dated: July 1, 2008 Received: July 8, 2008
Dear Mr. Knauss:
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 mav publish further announcements concerning your device in the Federal Register.
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
4
Page 2 Mr. Harvey Knauss
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) promarket 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.
una R. V. Auner
Bram Zuckerman Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) (Traditional) Submission Section 3, 510(k) Cover Letter
Indications for Use Statement
510(k) Number K080178 Device Name: Valvulotome by Koven
The Valvulotome by Koven is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves when performing in-situ vascular procedures, such as lower extremity arterial bypass surgery.
Prescription Use Yes (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (Part 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)
Anna P. Mc James
Division Sign-Off) on of Cardiovascula
510(k) Number K080178