(90 days)
No reference devices were used in this submission.
No
The summary describes a set of electrosurgical electrodes and their intended use with a resectoscope system. There is no mention of any computational processing, algorithms, or learning capabilities associated with the electrodes themselves or the system they are part of, beyond the basic electrical characteristics for cutting, coagulation, etc. The performance studies focus on biocompatibility, electrical/thermal safety, and mechanical/electrical performance, not on any data-driven or AI/ML-based functionality.
Yes
The device is used for therapeutic purposes such as cutting, ablation, resection, vaporization, and coagulation of tissue in both urological and gynecological applications, specifically mentioned for treating conditions like myomas and polyps.
Yes
The description explicitly states, "Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications" and "Transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium." The term "diagnosis" clearly indicates a diagnostic function.
No
The device description clearly outlines physical components like active tips, tubes, insulators, and clips, and the performance studies include testing of mechanical and electrical performance, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that these electrodes are part of a resectoscope system used for endoscopic diagnosis and treatment within the body (urological and gynecological applications). They are used for cutting, ablation, resection, vaporization, and coagulation of tissue using HF current.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to directly interact with and modify tissue within the body.
Therefore, this device falls under the category of a surgical instrument or electrosurgical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting, ablation, resection, vaporization and coagulation with HF current.
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, cutting and coagulation of tissue in the uterus in non-conducting irrigation fluid.
Specific intended use
Gynecology
- Transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium
- Lysis of intrauterine septa
- Endometrial ablation
Product codes (comma separated list FDA assigned to the subject device)
FAS, HIH, FJL
Device Description
The Olympus Resection Electrodes that are subject to this submission are either monopolar or for application in saline. The main difference between monopolar electrosurgery and electrosurgery in saline is that while in monopolar electrosurgery a neutral electrode is required, whereas in electrosurgery in saline the (neutral) return electrode is part of the surgical device.
Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporisation and cutting.
The subject HF-Resection Electrodes consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft).
The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, bands, rollers, needles or buttons.
All subject Resection Electrodes are single-use electrodes and are delivered sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urological applications, gynecological applications (uterus)
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)
The following performance data was provided in support of the substantial equivalence determination. All standards applied are FDA recognized international standards.
Biocompatibility testing: All biocompatibility testing has been conducted according to ISO 10993-1 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing. Additionally, the FDA guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'' was followed.
Testing included the following tests: Cytotoxicity, Irritation, Sensitization, Chemical Analysis, Biological-toxicological evaluation.
Electrical safety and electromagnetic compatibility (EMC): Electrical Safety was tested according to AAMI/ANSI ES 60601-1:2005 + A1:2012, C1:2009 and A2:2010 (Medical Electrical Equipment - Part 1.1 General requirements for safety and essential performance), AAMI/ANSI/IEC 60601-2-2 2009 (Medical Electrical Equipment - Part 2-2: Particular Requirements for the Basic Safety And Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories), IEC 60601-2-18:2009 (Medical electrical equipment - Part 2-18: Medical Electrical Equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment).
Electromagnetic compatibility (EMC) testing according to IEC 60601-1-2 and IEC 60601-2-2 was conducted for the resectoscope system, but not for the standalone Resection Electrodes. EMC testing demonstrates that the compatible resectoscope system complies with all requirements of IEC 60601-1-2 and IEC 60601-2-2.
Thermal Safety: Tested according to AAMI/ANSVIEC 60601-2-2 2009, Medical Electrical Equipment - Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories.
Clinical Evaluation: Clinical and animal studies were not necessary. A clinical evaluation has been conducted containing a comprehensive literature review.
Software: Not applicable as the Resection Electrodes do not contain any software.
Performance Testing Bench: Conducted tests include mechanical and electrical performance testing, resection/coagulation testing, durability testing, and transport/packaging testing.
Sterilization and Shelf Life: Sterilization is performed according to ISO 11135 and packaging conforms with AAMI ANSI ISO 11607-1:2006. The EtO sterilization cycle has been validated. A sterility assurance level (SAL) of 10-6 was reached during validation and will be used for routine sterilization in compliance with regulations in force for sterile medical devices. The EtO residuals are within the limits after tunnel degassing time. Shelf Life testing was conducted, including performance testing and package integrity testing, to support a shelf life of 5 years for the resection electrodes.
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.
K897003, K903323, K931764, K954488, K931763, K100275
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.
No reference devices were used in this submission.
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 seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 26, 2015
Olympus Winter & Ibe Gmbh % Graham Baillie Manager, Regulatory Affairs Gyrus Acmi, Inc. 136 Turnpike Rd. Southborough, Massachusetts 01772
Re: K152092
Trade/Device Name:
Electrodes for resection in saline (WA22302S, WA22306S, WA22332S. WA22351S. WA22355S. WA22503S. WA22507S, WA22521S, WA22523S, WA22537S, WA22538S, WA22539S, WA22557S, WA22558S, and WA22559S)
Monopolar Electrodes (WA22201S, WA22202S, WA22203S, WA22210S, WA22211S, WA22221S, WA22222S, WABD09MS, WABD10MS, WACL21MS, WACL27MS, WACL28MS, WALP03MS, WALP04MS, WALP06MS, WALP08MS, WALP13MS, WALP14MS, WALP31MS, WALP35MS, WAND18MS, WAND20MS, WARL16MS, WARL23MS, WARL33MS, WARN25MS)
Slim Resection Electrodes (WA47050S, WA47051S, WA47052S, WA47053S, WA47054S, WA47055S, WA47056S)
Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit And Accessories Regulatory Class: Class II Product Code: FAS, FJL, HIH Dated: July 27, 2015 Received: July 28, 2015
Dear Graham Baillie:
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).
1
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours.
Herbert P. Lerner -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation
2
Page 3 - Graham Baillie
Center for Devices and Radiological Health
Enclosure
3
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
510(k) Number (if known)
Device Name
Electrodes for resection in saline (WA22302S, WA22306S, WA22351S, WA22355S, WA22503S, WA22507S, WA22521S, WA22533S, WA22538S, WA22538S, WA22557S, WA22558S, and WA22559S)
Indications for Use (Describe)
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting. ablation, resection, vaporization and coagulation with HF current.
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Monopolar Electrodes (WA22202S, WA22203S, WA22210S, WA22211S, WA2221S, WA22222S, WABD09MS, WABD10MS, WACL21MS, WACL28MS, WACL28MS, WALP03MS, WALP06MS, WALP06MS, WALP13MS, WALP14MS, WALP31MS, WALP35MS, WAND18MS, WAND20MS, WARL16MS, WARL33MS, WARL33MS, WARN25MS)
Indications for Use (Describe) General intended use
Urology
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting, ablation, resection, vaporization and coagulation with HF current.
Gynecology
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, cutting and coagulation of tissue in the uterus in non-conducting irrigation fluid.
The following products are not intended to be used in gynecology: WA22202S, WA22222S, WABD10MS, WALP06MS, WALP08MS
Specific intended use
Gynecology
-
Transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium
-
Lysis of intrauterine septa
-
Endometrial ablation
The following products are not intended to be used in gynecology: WA22203S, WA22222S, WABD10MS, WALP06MS, WALP08MS
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
5
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Indications for Use
510(k) Number (if known)
Device Name
Slim Resection Electrodes (WA47051S, WA47052S, WA47052S, WA47054S, WA47055S, WA47056S)
Indications for Use (Describe) General intended use
Urology
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting, ablation, resection, vaporization and coagulation with HF current.
The following product is not intended to be used in urology: WA47056S
Gynecology
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, cutting and coagulation of tissue in the uterus in non-conducting irrigation fluid.
Specific intended use
Gynecology
-
Transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium
-
Lysis of intrauterine septa
-
Endometrial ablation
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
6
510(k) Summary of Safety and Effectiveness
1. General Information
| Manufacturer: | Olympus Winter & Ibe GmbH
Kuehnstr. 61
22045 Hamburg
Germany |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 9610773 |
| Official Correspondent: | Graham A.L. Baillie
Manager, Regulatory Affairs
Gyrus ACMI, Inc.
136 Turnpike Rd.
Southborough, MA 01772-2104
Phone: 508.804.2738
Fax: 508. 804.2624
Email: Graham.baillie@olympus-osta.com |
| Establishment
Registration No | 3003790304 |
| 2. Device Identification | |
| Common Name: | - Electrode, Electrosurgical, Active, Urological |
| Regulation Number: | 876.4300 |
| Classification | - Endoscopic electrosurgical unit and accessories |
| Device Class: | II |
| Product Code: | FAS / HIH / FJL |
| Review Panel: | Gastroenterology/Urology |
| Proprietary/Trade Name: | Electrodes for resection in saline (WA22302S, WA22306S,
WA22332S, WA22351S, WA22355S, WA22503S,
WA22507S, WA22521S, WA22523S, WA22537S,
WA22538S, WA22539S, WA22557S, WA22558S, and
WA22559S), |
| | Monopolar Electrodes (WA22201S, WA22202S,
WA22203S, WA22210S, WA22211S, WA22221S,
WA22222S, WABD09MS, WABD10MS, WACL21MS,
WACL27MS, WACL28MS, WALP03MS, WALP04MS, |
7
WALP06MS, WALP08MS, WALP13MS, WALP14MS, WALP31MS, WALP35MS, WAND18MS, WAND20MS, WARL16MS, WARL23MS, WARL33MS, WARN25MS)
Slim Resection Electrodes (WA47050S, WA47051S, WA47052S, WA47053S, WA47054S, WA47055S, WA47056S)
3. Predicate Devices
For each electrode model the respective predicate device was chosen from the following predicate 510(k)s:
| 510(k)
No. | Name | Predicate Model No. | Product code /
Reg No. |
|---------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| K897003 | Olympus
Hysteroresectoscope | A2184, A2189, A2193, A4516 | HIH / 884.1690 |
| K903323 | Resectoscope Loops | A2183S, A2184S, A2185S, A2189S, A2193S, A2195S, A2203S, A2204S, A2205S, A4513S, A4514S, A4515S, A4513US, A4514US | KNS / 876.4300 |
| K931764 | HF Resection Electrode,
Loop w/runner
Hyster/Acces | A2186, A2228 | HIH / 884.1690 |
| K954488 | Roller Electrode | A2158S | HIH / 884.1690 |
| K931763 | HF-Resection Electrode,
Loop w/runner
Hyster/Acces | A2186 | FAS / 876.4300
FJL / 876.1500 |
| K100275 | Resection Button Electrode
for Plasma Vaporization,
HF-Resection Electrode
Loops and Band | WA22302D, WA22306D, WA22332D, WA22351C, WA22355C, WA22503D, WA22507D, WA22521C, WA22523C, WA22537D, WA22538C, WA22539D, WA22557C, WA22558C | FAS / 876.4300
GEI / 878.4400 |
These predicates have not been subject to a design-related recall.
No reference devices were used in this submission.
8
4. Product Description
The Olympus Resection Electrodes that are subject to this submission are either monopolar or for application in saline. The main difference between monopolar electrosurgery and electrosurgery in saline is that while in monopolar electrosurgery a neutral electrode is required, whereas in electrosurgery in saline the (neutral) return electrode is part of the surgical device.
Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporisation and cutting.
The subject HF-Resection Electrodes consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft).
The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, bands, rollers, needles or buttons.
| 1. Subject electrodes for Hystero-Resectoscope System with 4mm Telescope (OES Pro) | |
|---|---|
| 1.1 Monopolar electrodes standard length | |
| WA22201S | HF-resection electrode, loop 24 Fr., 0.35 wire, 12°/16° |
| WA22210S | HF-resection electrode, loop, 24 – 28 Fr., 0.2 wire, 12°/16° |
| WALP03MS | HF-resection electrode, loop 24 Fr., 0.35 wire, 12° - 30° |
| WALP04MS | HF-resection electrode, loop, 24 – 28 Fr., 0.2 wire, 12° - 30° |
| WARN25MS | HF-resection electrode, loop with runner, 24 Fr., 12° - 30° |
| WALP13MS | HF-resection electrode, angled loop, 24 - 28 Fr., 0.35 wire, 12° - 30° |
| WALP14MS | HF-resection electrode, angled loop, 24-28 Fr., 0.2 wire, 12° - 30° |
| WARL16MS | HF-resection electrode, roller, 24 - 28 Fr., 12° - 30° |
| WARL23MS | HF-resection electrode, large roller, 24 - 28 Fr., 12° - 30° |
| WACL27MS | HF-resection electrode, cylinder, 24 - 28 Fr., 12° - 30° |
| WAND18MS | HF-resection electrode, needle 90°, 24 - 28 Fr., 12°/16° |
| WAND20MS | HF-resection electrode, angled needle, 24 - 28 Fr., 12° - 30° |
| WACL21MS | HF-resection electrode, cylinder with grooves, 24 - 28 Fr., 12° - 30° |
| WA22211S | HF-resection electrode, loop with runner, 24 Fr., 12°/16° |
| WA22221S | HF-resection electrode, band 24 Fr., 12°/16° |
| WABD09MS | HF-resection electrode, band 24 Fr., 12° - 30° |
| WACL28MS | HF-resection electrode, cylinder with spikes, 24 - 28 Fr., 12° - 30° |
| 1.2 Electrodes for resection in saline - standard length (Urology only) | |
| WA22302S | HF-resection electrode, loop, 24 Fr., 0.2 wire, standard, 12°/16° |
| WA22503S | HF-resection electrode, large loop, 24 Fr., 0.2 wire, 12°/16° |
| WA22306S | HF-resection electrode, loop, 24 Fr., 0.2 wire, standard, 12° - 30° |
| WA22507S | HF-resection electrode, large loop, 24 Fr., 0.2 wire, 12° - 30° |
| WA22521S | HF-resection electrode, band, 24 Fr., standard, 12°/16° |
| WA22523S | HF-resection electrode, band, 24 Fr., standard, 12° - 30° |
| WA22332S | HF-resection electrode, angled loop, 24 Fr., 0.2 wire, standard, 12° - 30° |
| WA22351S | HF-resection electrode, roller, 24 Fr., 12° - 30° |
| WA22355S | HF-resection electrode, angled needle, 24 Fr., 12° - 30° |
| WA22557S | HF-resection electrode, button, 24 Fr., 12° - 30° |
| 2. Subject electrodes for long Resectoscope OES Pro with 4mm Telescope | |
| 2.1 Monopolar electrodes long | |
| WALP31MS | HF-resection electrode, long loop, 24 Fr., 12° |
| WARL33MS | HF-resection electrode, long roller, 24 - 28 Fr., 12° - 30° |
| WALP35MS | HF-resection electrode, long angled loop, 24 - 28 Fr., 12° - 30° |
| 2.2 Electrodes for resection in saline - long (Urology only) | |
| WA22537S | HF-resection electrode, long loop, 24 Fr., 0.2 wire, standard, 12° |
| WA22538S | HF-resection electrode, long roller, 24 Fr., 12° - 30° |
| WA22539S | HF-resection electrode, long angled loop , 24 Fr., 0.2 wire, standard, 12° - 30° |
| 3. Subject electrodes for Hystero-Resectoscope System with 3mm Telescope | |
| 3.1 Monopolar slim electrodes standard length | |
| WA47050S | HF-resection electrode, loop, 22.5 Fr., 0.35 wire, 12° |
| WA47051S | HF-resection electrode, angled loop, 22.5 Fr., 0.35 wire, 12° |
| WA47052S | HF-resection electrode, roller, 22.5 Fr., 12° and 30° |
| WA47053S | HF-resection electrode, cylinder, 22.5 Fr., 12° and 30° |
| WA47054S | HF-resection electrode, angled needle, 22.5 Fr., 12° |
| WA47055S | HF-resection electrode, cylinder with grooves, 22.5 Fr., 12° and 30° |
| WA47056S | HF-resection electrode, cylinder with spikes, 22.5 Fr., 12° and 30° (gyn only) |
| 4. Subject electrodes for urology-only | |
| 4.1 Monopolar electrodes standard length (Urology only) | |
| WA22202S | HF-resection electrode, loop 26 Fr., 0.35 wire, 12°/16° |
| WA22203S | HF-resection electrode, loop 28 Fr., 0.35 wire, 12°/16° |
| WA22222S | HF-resection electrode, band 26 Fr., 12°/16° |
| WABD10MS | HF-resection electrode, band 26 Fr., 12° - 30° |
| WALP06MS | HF-resection electrode, loop 26 Fr., 0.35 wire, 12° - 30° |
| WALP08MS | HF-resection electrode, loop 28 Fr., 0.35 wire, 12° - 30° |
| 4.2 Electrodes for resection in saline - standard length (Urology only) | |
| WA22558S | HF-resection electrode, TUEB angled loop , 24 Fr., 12° - 30° |
| WA22559S | HF-resection electrode, TUEB loop, 24 Fr., 12° - 30° |
All subject Resection Electrodes are single-use electrodes and are delivered sterile.
9
5. Indications for Use
The subject device resection electrodes have essentially the same intended use as the predicate resection electrodes (K897003, K903323, K931764, K954488, or K100275, respectively).
Subject Monopolar Electrodes
(WA22201S, WA22202S, WA22203S, WA22210S, WA22211S, WA22221S, WA2222S, WABD09MS, WABD10MS, WACL21MS, WACL27MS, WACL28MS, WALP03MS, WALP04MS, WALP06MS, WALP08MS, WALP13MS, WALP14MS, WALP31MS, WALP35MS, WAND18MS,
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WAND20MS, WARL16MS, WARL23MS, WARL33MS, WARN25MS)
General intended use
Urology
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting, ablation, resection, vaporization and coagulation with HF current.
Gynecology
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in nonconducting irrigation fluid.
The following products are not intended to be used in gynecology: WA22202S, WA22203S, WA22222S, WABD10MS, WALP06MS, WALP08MS
Specific intended use
Gynecology
- -Transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium
- -Lysis of intrauterine septa
- -Endometrial ablation
The following products are not intended to be used in gynecology: WA22202S, WA22203S, WA22222S, WABD10MS, WALP06MS, WALP08MS
Subject Electrodes for Resection in Saline
(WA22302S, WA22306S, WA22332S, WA22351S, WA22355S, WA22503S, WA22507S, WA22521S, WA22523S, WA22537S, WA22538S, WA22539S, WA22557S, WA22558S, WA22559S)
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting, ablation, resection, vaporization and coagulation with HF current.
Slim Electrodes
(WA47050S, WA47051S, WA47052S, WA47053S, WA47054S, WA47055S, WA47056S)
General intended use
Urology
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting, ablation, resection, vaporization and coagulation with HF current.
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The following product is not intended to be used in urology: WA47056S
Gynecology
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in nonconducting irrigation fluid.
Specific intended use
Gynecology
- Transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium
- Lysis of intrauterine septa -
- -Endometrial ablation
6. Comparison of Technological characteristics
At a high level, the subject and predicate devices are based on similar technological principles with similar elements:
- . Resection electrodes consisting of an active (distal) tip, PTFE color code identification at the distal and proximal ends, an insulator between the electrode and electrode tube, a stabilizing (guiding) tube, and arm (shaft)
- Used in combination with a resectoscope system
- I Like the predicate electrodes, the subject device resection electrode series features loops, bands, needles, rollers, and a button as active tip shapes
- . Utilizing either monopolar mode of ablation or for resection in saline (dependent on model)
- Respectively identical or similar outer dimensions
- . Design changes of the electrodes are minor and do not negatively impact safety or effectiveness of the subject devices
- . The same or similar materials in patient contact are used in predicate and subject device and have all been successfully tested for biocompatibility.
As stated above, the subject and predicate devices have similar design characteristics and performance specifications. The primary technological differences between the subject and predicate devices are related to the patient contacting materials. These minor differences, however, do not raise different questions of safety or effectiveness. As demonstrated in the non-clinical testing (e.g., biocompatibility), the different technological characteristics do not affect the safety and effectiveness of the subject devices.
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7. Performance Data
The following performance data was provided in support of the substantial equivalence determination. All standards applied are FDA recognized international standards.
Biocompatibility testing
All biocompatibility testing has been conducted according to ISO 10993-1 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing. Additionally, the FDA guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'' was followed.
Testing included the following tests:
- Cytotoxicity -
- Irritation -
- Sensitization -
- Chemical Analysis -
- Biological-toxicological evaluation -
Electrical safety and electromagnetic compatibility (EMC)
Electrical Safety was tested according to
| AAMI/ANSI ES 60601-
1:2005 + A1:2012, C1:2009
and A2:2010 | Medical Electrical Equipment - Part 1.1 General
requirements for safety and essential performance. |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AAMI/ANSI/IEC 60601-2-2
2009 | Medical Electrical Equipment - Part 2-2: Particular
Requirements for the Basic Safety And Essential
Performance of High Frequency Surgical Equipment
and High Frequency Surgical Accessories |
| IEC 60601-2-18:2009 | Medical electrical equipment - Part 2-18: Medical
Electrical Equipment - Part 2-18: Particular
requirements for the basic safety and essential
performance of endoscopic equipment. |
Electromagnetic compatibility (EMC) testing according to IEC 60601-1-2 and IEC 60601-2-2 was conducted for the resectoscope system, but not for the standalone Resection Electrodes. EMC testing demonstrates that the compatible resectoscope system complies with all requirements of IEC 60601-1-2 and IEC 60601-2-2. Since all resection electrodes are made of similar conductive materials, there is no reason to expect that different electrodes would affect the electrical properties of the resectoscope system. They do not contain
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any electrical components that can be influenced by electromagnetic emission as well as electrostatic discharge.
Thermal Safety
Tested according to AAMI/ANSVIEC 60601-2-2 2009, Medical Electrical Equipment - Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories.
Clinical Evaluation
Clinical and animal studies were not necessary.
A clinical evaluation has been conducted containing a comprehensive literature review.
Software
Not applicable as the Resection Electrodes do not contain any software.
Performance Testing Bench
Conducted tests include mechanical and electrical performance testing. resection/coagulation testing, durability testing, and transport/packaging testing.
8. Sterilization and Shelf Life
Sterilization is performed according to ISO 11135 and packaging conforms with AAMI ANSI ISO 11607-1:2006. The EtO sterilization cycle has been validated.
A sterility assurance level (SAL) of 106 was reached during validation and will be used for routine sterilization in compliance with regulations in force for sterile medical devices.
The EtO residuals are within the limits after tunnel degassing time.
Shelf Life testing was conducted, including performance testing and package integrity testing, to support a shelf life of 5 years for the resection electrodes.
9. Conclusion
The performance data support the safety of the device and demonstrate that the subject devices comply with the intended use as specified.
In summary, we believe the Resection Electrodes are substantially equivalent with the predicate devices with respect to the general design approach, function, and the intended use. The Resection Electrodes raise no new concerns of safety or effectiveness when compared to the predicate devices.