(90 days)
The LeMaitre Vascular Disposable Vein Stripper is designed for the removal of the long saphenous vein (LSV) by invagination stripping from the knee to the groin, without a distal incision for the treatment of varicose veins.
Not Found
I apologize, but the provided text from the FDA 510(k) approval letter for the LeMaitre Vascular Disposable Vein Stripper does not contain the specific information needed to answer your request regarding acceptance criteria and a study proving the device meets those criteria.
This document is a letter confirming the substantial equivalence of the device to a predicate device, allowing it to be marketed. It focuses on regulatory classification, general controls, and compliance requirements.
The document does NOT include the following information you requested:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
Medical device clearance letters like this typically refer to information provided in the 510(k) submission, but they do not reproduce the detailed study results or performance data within the letter itself. To find the information you're looking for, you would generally need to consult the full 510(k) submission document, which is often not publicly available in its entirety in an easily searchable format.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LeMaitre Vascular, Inc. James Ashby Ouality Assurance Specialist 26 Ray Avenue Burlington, Massachusetts 01803
JAN 3 0 2003
Re: K023688
Trade/Device Name: LeMaitre Vascular Disposable Vein Stripper Regulation Number: 878.4800 Regulation Name: Stripper, Vein, Disposable Regulatory Class: Class I Exempt Product Code: GAF Dated: October 30. 2002 Received: November 1, 2002
Dear Mr. Ashby:
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). You may, therefore, market the device, subiect to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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 - Mr. James Ashby
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 (21 CFR Part 807); 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 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 the labeling regulation, please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Miriam C. Provost
+0 Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K023688 510(k) Number (if known):
LeMaitre Vascular Disposable Veîn Stripper Device Name:
Indications For Use:
The LeMaitre Vascular Disposable Vein Stripper is designed for the removal of the long saphenous vein (LSV) by invagination stripping from the knee to the groin, without a distal incision for the treatment of varicose veins.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
- Miriam l' Provost
Ivision of Get 1 Restorative A Neurologi
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.