The Dyonics Varicose Vein Ablation Blade (proprietary name TBD) is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins.

Device Description

The design of the blades offers required precision for varicose vein ablation by controlling the location and extent of tissue resection. Target tissue is drawn into the cutting window of the blade under suction while the rotating inner blade shears off the tissue. The location and extent of tissue removal is completely controlled by surgeon placement and rotary activation of the blade.

AI/ML Overview

The provided document is a 510(k) summary for the Dyonics Varicose Vein Ablation Blade. It claims substantial equivalence to a predicate device based on "clinical experience submitted with this Premarket Notification Submission." However, it does not contain any information about specific acceptance criteria or a detailed study proving the device meets particular performance metrics.

Therefore, I cannot provide the requested table or detailed study information. The provided text primarily focuses on:

Substantial Equivalence: Stating the device is substantially equivalent to the Medicon Ambulatory Phlebectomy Hook in intended use and procedural outcomes.
Device Description: Explaining how the blade works.
Intended Use: Defining its indication for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins.
FDA Correspondence: The FDA's 510(k) clearance letter.

Based on the provided text, the following aspects of your request cannot be fulfilled:

A table of acceptance criteria and the reported device performance: No such criteria or performance data are presented in the document.
Sample size used for the test set and the data provenance: No information about a test set or its data provenance is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No mention of experts or ground truth establishment for a test set.
Adjudication method for the test set: No information is available.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a surgical tool, not an AI-assisted diagnostic or imaging system, so an MRMC study is not applicable and not mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a surgical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth for device performance is detailed. The "clinical experience" is mentioned as support for substantial equivalence, but not described in detail.
The sample size for the training set: No information about a training set.
How the ground truth for the training set was established: No information about a training set or its ground truth.

In summary, the provided 510(k) summary outlines the regulatory submission for a surgical device based on substantial equivalence, not a detailed performance study with acceptance criteria as one might expect for a diagnostic or imaging algorithm.

Summary

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OCT 5 1399

K990723

Smith & Nephew, Inc. ascomb Road, Andover, MA 01810 U.S.A. hone: 978-749-1000 ax - 978-749-1599

510(k) Summary March 3, 1999 Smith & Nephew, Inc., Endoscopy Division Dyonics Varicose Vein Ablation Blade

th - Nephew

Endoscopy Division

Substantial Equivalence:

The Dyonics Varicose Vein Ablation Blade is substantially eqivalent in intended use and procedural outcomes to the conventional phlebectomy hook as supported by the clinical experience submitted with this Premarket Notification Submission. Patient contacting materials for both devices are surgical stainless steel.

Predicate Device:

The predicate device for the intended use described in this submission is the Medicon Ambulatory Phlebectomy Hook.

Summary of Device Function:

Intended Use of Device:

The Dyonics Varicose Vein Ablation Blade (proprietary name TBD) is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins.

Debmah J. Coss

Deborah J. Connors Senior Regulatory Affairs Specialist

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 1999

Ms. Deborah J. Connors Principal Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, Massachusetts 01810

Re: K990723

Trade Name: Dyonics Varicose Vein Ablation Blade Regulatory Class: II Product Code : GEI Dated: June 30, 1999 Received: July 6, 1999

Dear Ms. Connors:

This letter corrects our substantially equivalent letter of October 5, 1999, regarding the Product Code.

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 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 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.

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Page 2 - Ms. Deborah J. Connors

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- 4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note that the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number : K 99 0723

Device Name : Dyonics Varicose Vein Ablation Blade

Indications for Use :

The Dyonics Varicose Vein Ablation Blade (proprietary name TBD) is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins.

(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use L OR (Per 21 CFR 801.109) (Optional Format 1-2-96)

Over-the-Counter

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Division Sign-Off

(Division Sign-Om)
Division of General Restorative Devices
510(k) Number K490723

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.