(51 days)
The Smith & Nephew Tumescent Catheter Inversion System is intended to provide a system for removal of incompetent greater saphenous veins.
The Smith & Nephew Tumescent Catheter Inversion System provides a system for removal of incompetent greater saphenous veins. The system also provides the capability to flush the tunnel left behind from the removal of the vein with tumescent solution.
The provided text is a 510(k) summary for the Smith & Nephew Tumescent Catheter Inversion System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, or any of the detailed performance metrics commonly associated with such studies (like sample sizes, ground truth establishment, or expert qualifications).
The document explicitly states:
H. Summary Performance Data
"There are no known performance standards or special controls promulgated under section 514 of the Act for this device has been tested and found to be in compliance with ISO 10993-1 and at the time of commercialization will be in compliance with applicable sterilization standards. This device has been tested and found to be safe and effective for its intended use."
This statement indicates that while the device was tested for safety and effectiveness and compliance with ISO 10993-1 (biocompatibility) and sterilization standards, the submission does not include a detailed study with acceptance criteria and reported performance data in the manner typically seen for complex diagnostic or AI-based devices.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details because that information is not present in the provided text. The submission focuses on demonstrating substantial equivalence to a pre-amendment device based on similar design, materials, function, and intended use, rather than presenting a detailed performance study against quantified acceptance criteria.
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JUL 22 2004
Endoscopy Shoith & Nephow, Inc 150 Minuteman Road Andever, MA 01810
UUUL (177 (1977) 149 1599 Fax w smilh-nephew.com
>> We are smith&nephew
SECTION IV
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
Date Prepared: May 28, 2004
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact:
Karen Provencher Regulatory Affairs Specialist Phone: 978-749-1365 Fax: 978-749-1443
C. Device Name
| Trade Name: | Smith & Nephew Tumescent Catheter Inversion System |
|---|---|
| Common Name: | External Vein Stripper |
| Classification Name: | External Vein Stripper |
D. Predicate Devices
The Smith & Nephew Tumescent Catheter Inversion System is substantially equivalent in intended use and fundamental scientific technology to the following
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legally marketed device in commercial distribution: Codman® Disposable Vein Stripper (pre-amendment device).
Description of Device E.
The Smith & Nephew Tumescent Catheter Inversion System provides a system for removal of incompetent greater saphenous veins. The system also provides the capability to flush the tunnel left behind from the removal of the vein with tumescent solution.
F. Intended Use
The Smith & Nephew Tumescent Catheter Inversion System is intended to provide a system for removal of incompetent greater saphenous veins.
G. Companson of Technological Characteristics
The Smith & Nephew Tumescent Catheter Inversion System is substantially equivalent in design, materials, function and intended use to the following device cleared for commercial distribution: Codman® Disposable Vein Stripper - legally marketed preamendment device.
H. Summary Performance Data
There are no known performance standards or special controls promulgated under section 514 of the Act for this device has been tested and found to be in compliance with ISO 10993-1 and at the time of commercialization will be in compliance with applicable sterilization standards. This device has been tested and found to be safe and effective for its intended use.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 22 2004
Smith & Nephew, Inc. c/o Ms. Karen Provencher Regulatory Affairs Specialist 150 Minuteman Road Andover, MA 01810
Re: K041453
Tumescent Catheter Inversion System Regulation Number: 21 CFR 870.4885 Regulation Name: External Vein Stripper Regulatory Class: Class II (two) Product Code: DWQ Dated: May 28, 2004 Received: June 1, 2004
Dear Ms. Provencher:
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.
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Page 2 - Ms. Karen Provencher
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I four of action and i termination 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); 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 premaince nevice 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 Office of Compliance at (301) 594-4646. 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
(501) : //www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna R. Holmes
Bran
Direc
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
(041453
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Smith & Nephew Tumescent Catheter Inversion System is intended to provide a system for removal of incompetent greater saphenous veins.
Prescription Use _ ✔ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duana R. Kirchner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K041453
§ 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).