(184 days)
K961702, K890328B
Not Found
No
The document describes a reprocessed electrosurgical electrode and its intended use, focusing on the physical device and its reprocessing. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is used to cut and cauterize tissue, which are therapeutic actions.
No
Explanation: The device description clearly states its intended use is for "vaporization, ablation, coagulation and/or resection of soft tissue," and it functions to "cut and cauterize" tissue. These are therapeutic, interventional actions, not diagnostic ones.
No
The device description explicitly states that the device is "electrosurgical electrode devices" with "a wide variety of tip configurations and sizes," which are physical hardware components. The submission is for the reprocessing of these physical electrodes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for surgical procedures (vaporization, ablation, coagulation, resection of soft tissue) directly on the patient's body.
- Device Description: The device description confirms it's an electrosurgical electrode used to cut and cauterize tissue in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly treat or alter tissue within the body. This device clearly falls under the category of a surgical or therapeutic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NLW, FAS, HGI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate and bladder, gynecological and urological surgical procedures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
KSEA Vaporization Electrodes (K961702), Vaportrode Vaporization Electrodes (K890328B)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
3
Page 4 - Bruce Lester, Ph.D.
·
. . . . . . .
MLE-26-015 MLE-28-015
MLES-24-015 MLES-26-015
4
Indications for Use
510(k) Number (if known):
Device Name:
Reprocessed Endoscopic Electrodes
Indications For Use:
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.
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 _ _ _
5
FEB 1 4 2002
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.
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.
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.
6
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
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.
This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction.