The DYONICS Electroblade Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft and osseous tissues. The DYONICS EletroBlade Resector is effective in tissue resection and hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringer's lactate or other conductive solutions as an irrigant under direct or video-assisted fiber-optic visualization.

Device Description

The DYONICS ElectroBlade Resector combines the rotary cutting technology of Dyonics Arthroscopic Surgery Blades with the electrosurgical capabilities of a bipolar electrosurgery probe. The inner rotational blade is electrified by connection to a standard generator. Insulation on the outer blade isolates the electrical energy to the inner tube where it is exposed to tissue at the cutting window of the blade. The DYONICS ElectroBlade Resector operates in conjunction with the standard Dyonics shaver system and standard electrosurgical generator systems.

AI/ML Overview

This 510(k) summary is for the DYONICS ElectroBlade Resector, a device combining rotary cutting technology with electrosurgical capabilities. The submission establishes substantial equivalence to the DYONICS ElectroBlade (K994365).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain a table of acceptance criteria or specific quantitative performance metrics for the DYONICS ElectroBlade Resector. The submission focuses on demonstrating substantial equivalence to a predicate device (DYONICS ElectroBlade) based on intended use, materials, and method of operation rather than presenting a detailed performance study with predefined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not mention any specific test set, sample size, or data provenance because the submission appears to be a substantial equivalence claim based on comparison to an existing predicate device rather than a de novo marketing application requiring extensive clinical performance data with a separate test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

As there is no mention of a specific test set or a study requiring ground truth establishment, there is no information on the number or qualifications of experts.

4. Adjudication Method for the Test Set

Again, with no description of a test set, there is no mention of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The submission is a 510(k) seeking substantial equivalence, not typically requiring such a study to demonstrate improvement with AI assistance (which is not relevant here as the device is not an AI diagnostic).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the DYONICS ElectroBlade Resector is a surgical tool, not an AI algorithm. Therefore, "standalone" algorithm performance is not a concept pertinent to this device.

7. Type of Ground Truth Used

As there is no mention of a clinical study generating specific performance data that required ground truth, this information is not available. The determination of substantial equivalence relies on comparison of design, materials, and intended use, not on a detailed clinical performance study with established ground truth.

8. Sample Size for the Training Set

This is not applicable. The DYONICS ElectroBlade Resector is a physical surgical device, not a machine learning model, so there is no concept of a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as the device is not an AI algorithm and therefore does not have a training set or associated ground truth.

Summary

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K012314

510(k) Summary DYONICS ElectroBlade Resector™ Date Prepared: July 20, 2001

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

FEB 0 1 2002

Submitter A.

Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01810

B. Company Contact

Tim Crabtree Regulatory Affairs Specialist

C. Device Name

Trade Name: DYONICS EletroBlade Resector Common Name: Arthroscopic Surgery Blade / Electrosurgical Probe Classification Name: Electrosurgical Probe

D. Predicate Devices

DYONICS ElectroBlade (K994365)

E. Description of Device

D. Intended Use

్ట్రాల్యాల్లో ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ఆరోగ్య కేంద్రం, ప్రాథమిక ఆరోగ్య కేంద్రం, ప్రాథమిక ఆరోగ్య కేంద్రం, ప్రాథమిక ఆరోగ్య కేంద్

The DYONICS Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The DYONICS Electroblade Resector is effective in soft and osseous tissue resection and in hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringer's lactate or other conductive solutions as an irrigant under direct or video assisted fiberoptic visualization.

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Comparison of Technological Characteristics E.

The DYONICS Electroblade Resector is a combination of both bipolar RF and mechanical resector technologies. The design reflects this combination of these technologies. The resection and coagulation capabilities are features that are also found in the DYONICS Electroblade. The modified DYONICS Electroblade Resector is substantially equivalent to the DYONICS Electroblade in intended use, materials and method of operation.

Tim Licht

ాజ్యాల్లో

Tim Crabtree Regulatory Affairs Specialist

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with the profiles overlapping each other. The profiles are simple and abstract, and they are arranged in a way that suggests movement or progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 01 2002

Mr. Tim Crabtree Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover. Massachusetts 01810

Re: K012314

Trade/Device Name: DYONICS Electroblade Resector™ Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulating device and accessories Regulatory Class: II Product Code: GEI Dated: November 2, 2001 Received: November 5, 2001

Dear Mr. Crabtree:

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.

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 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.

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Page 2 - Mr. Tim Crabtree

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 our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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 the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Muriam C. Provost

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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510(k) Number : KO123/4

Device Name: DYONICS Electroblade Resector™

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use سك (Per 21 CFR 801.109)

Over-the-Counter ------

(Optional Format 1-2-96)

Miriam C. Provost

on of General, Restorative and Neurological Devices

510(k) Number K012314

Smith & Nephew Electroblade Resector Page 18 of 57

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.