Reprocessed endoscopic electrodes are intended to be used for vaporization, ablation, coagulation and/or resection of soft tissue in the prostate and bladder as well as when ablation and coagulation are required in gynecological and urological surgical procedures.

Device Description

Reprocessed endoscopic electrodes are electrosurgical electrode devices that have a wide variety of tip configurations and sizes. The device is used to cut and cauterize prostate, bladder, gynecological, and urological tissue. They are used in conjunction with an endoscope and are powered by a separate RF generator. The RF generator component is not included in this submission; only the endoscopic electrodes are reprocessed.

AI/ML Overview

This document is a 510(k) summary for reprocessed endoscopic electrodes, not a detailed study report. Therefore, much of the requested information regarding specific acceptance criteria, study methodologies, and performance metrics is not explicitly provided. However, I can extract the available information and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Comments
Functional Characteristics	Representative samples underwent bench testing to demonstrate appropriate functional characteristics.	Specific criteria (e.g., impedance, power output limits, cutting/coagulation effectiveness) are not detailed. Performance results (e.g., pass/fail rates) are also not provided.
Cleaning Procedures	Process validation testing was done to validate the cleaning procedures.	Specific criteria for cleanliness (e.g., residual organic materials, bioburden reduction) are not detailed. Performance results are not provided.
Sterilization Procedures	Process validation testing was done to validate the sterilization procedures.	Specific criteria for sterility (e.g., Sterility Assurance Level (SAL)) are not detailed. Performance results are not provided.
Device Packaging	Process validation testing was done to validate the device's packaging.	Specific criteria for packaging integrity (e.g., seal strength, bacterial barrier) are not detailed. Performance results are not provided.
Manufacturing Process Quality	The manufacturing process includes visual and functional testing of all products produced.	This indicates in-process quality control, but specific performance metrics are not given.
Substantial Equivalence	Reprocessed endoscopic electrodes are substantially equivalent to the KSEA Vaporization Electrodes (K961702) and the Vaportrode Vaporization Electrodes (K890328B).	This is the overarching "acceptance" by the FDA, based on "similarities in functional design, materials, indications for use and methods of construction."

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document mentions "Representative samples of reprocessed endoscopic electrodes underwent bench testing." It does not specify the number of devices or the number of tests performed.
Data Provenance: The document is a 510(k) submission from SterilMed, Inc., located in Minneapolis, MN, USA. The data originates from this company's internal testing as part of their regulatory submission. It is retrospective in the sense that the testing was performed, and the results are reported to the FDA after the fact, but it describes the validation of a manufacturing process for future use.

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

This section is not applicable as the document describes validation testing for medical devices, not a study involving human interpretation of data where "ground truth" would typically be established by expert consensus (e.g., radiology images). The "ground truth" here is adherence to engineering specifications and regulatory requirements for cleaning, sterilization, and functional performance.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as #3. Adjudication methods are typically used in clinical studies or studies involving human assessment of data.

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

Was it done? No, an MRMC comparative effectiveness study was not done. This type of study is relevant to AI or diagnostic imaging devices where human readers interpret data, often with and without AI assistance. This document describes the re-processing and functional validation of physical medical devices (electrosurgical electrodes).
Effect size of human reader improvement: Not applicable.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Was it done? This is not applicable in the context of this device. The devices are physical electrodes used in surgical procedures. There is no "algorithm" or standalone AI performance to evaluate. The testing performed evaluates the physical performance and safety of the reprocessed electrodes.

7. Type of Ground Truth Used

The "ground truth" in this context refers to established engineering standards, regulatory requirements, and validated methods for assessing device performance, cleanliness, and sterility.

Bench Testing: Engineering specifications for functional characteristics (e.g., cutting ability, coagulation, impedance).
Process Validation (Cleaning & Sterilization): Regulatory standards for sterility (e.g., SAL), residual organic material limits, and packaging integrity.
Predicate Device Equivalence: The performance of the original, legally marketed predicate devices serves as the benchmark against which the reprocessed devices must demonstrate substantial equivalence.

8. Sample Size for the Training Set

This section is not applicable. This document describes the validation of a re-processing methodology for physical medical devices. There is no machine learning "training set" involved.

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

This section is not applicable as there is no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, represented by three curved lines.

1 2004 NOV

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bruce Lester, Ph.D. Vice President, Research and Development SterilMed. Inc. 11400 73rd Avenue North MINNEAPOLIS MN 55369

Re: K012685 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: NLW Dated: December 6, 2001 Received: December 7, 2001

Dear Dr. Lester:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on February 14, 2002. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.

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Page 2 - Bruce Lester, Ph.D.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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 http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 3 – Bruce Lester, Ph.D.

Attachment - Reprocessed Endoscopic Electrodes (K012685)

Karl Storz 26050 G 26050 J 26050 N 26050 NK 26050 NX 26050 NW 26050 I 26050 Gr Circon ACMI VE-B VE-F VE-S VE-LG CE-24° CE-26° CE-28° PE-24° PE-26° PE-28° RB-24° RB-26° RE-24° RE-26° RE-28° KE-24° KE-26° KE-28° RAK-24° RAK-26° RAK-28° RKE-24° RKE-26° RKE-28° MLE-24-010 MLE-26-010 MLE-28-010 MLE-24-012 MLE-26-012 MLE-28-012 MLE-24-015

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Page 4 - Bruce Lester, Ph.D.

. . . . . . .

MLE-26-015 MLE-28-015
MLES-24-015 MLES-26-015

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Indications for Use

510(k) Number (if known):

K012685

Device Name:

Reprocessed Endoscopic Electrodes

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Nancy C Brogdon

(Division Sign -OH Division of Reproduc and Radiological Devi 510(k) Number

Page 1 of _ _ _

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FEB 1 4 2002

K012685

SECTION 2. SUMMARY AND CERTIFICATION

510(k) Summary A.

Submitter:

SterilMed, Inc.

August 13, 2001

Contact Person:

Patrick Fleischhacker 11400 73rd Avenue North Minneapolis, MN 55369 Ph: 763-488-3400 Fax: 763-488-3350

Date Prepared:

Trade Name:

Classification Name and Number:

Product Code:

Predicate Device(s):

Device Description:

Intended Use:

Reprocessed Endoscopic Electrodes

Active Electrosungical Electrode Class II, 21 CFR 876.4300, and 21 CFR 884.4120 Panel 85

FAS, and HGI

Reprocessed endoscopic electrodes are substantially equivalent to the KSEA Vaporization Electrodes (K961702) manufactured by Karl Storz Endoscopy, and the Vaportrode Vaporization Electrodes (K890328B) manufactured by Circon/ACMI.

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K612685

Pg 2 of 2

Functional and Safety Testing:

Conclusion:

Representative samples of reprocessed endoscopic electrodes underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced

This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction.

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).