(252 days)
Not Found
No
The document describes traditional surgical instruments for endoscopic procedures and does not mention any AI or ML components or functionalities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the instruments are intended for "therapeutic surgical procedures" and lists several therapeutic examples like "ablation, incision, coagulation, cauterization of minor bleedings, resection of tissue, vaporization and enucleation." The "Device Description" also refers to it as a "diagnostic and therapeutic resectoscopic system."
Yes
The "Intended Use / Indications for Use" section explicitly states that the instruments are "intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures," and the "Device Description" also mentions they "assemble into and/or work as a diagnostic and therapeutic resectoscopic system."
No
The device description explicitly lists physical components such as rigid working elements, sheaths, obturators, electrodes, and HF cables, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Henke-Sass, Wolf Resection Instruments are used within the body during surgical procedures. They are tools for visualization, manipulation, cutting, and other surgical actions directly on tissue inside the patient.
- Intended Use: The intended use clearly describes surgical procedures performed in vivo (within a living organism), not the analysis of samples in vitro (in a lab setting).
- Device Description: The components listed (working elements, sheaths, obturators, electrodes, cables) are all instruments used for direct surgical intervention.
Therefore, the Henke-Sass, Wolf Resection Instruments are surgical instruments, not IVDs.
N/A
Intended Use / Indications for Use
The Henke-Sass, Wolf Resection Instruments are intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization of anatomy, ablation, incision, coagulation, cauterization of minor bleedings, resection of tissue, vaporization and enucleation, and as the surgeon deems appropriate. The instruments are intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures:
. Dilation of the urethra, and cold-slitting of urethral strictures
. Trans-urethral incision and resection of the prostate
. Trans-urethral removal of bladder tumor
. Trans-cervical resection and ablation of the endometrium
. Trans-cervical resection of fibroids
Product codes (comma separated list FDA assigned to the subject device)
HIH, FAS, FAJ
Device Description
The Henke-Sass, Wolf Resection Instruments consist of various components that assemble into and/or work as a diagnostic and therapeutic resectoscopic system in urology and gynecology.
This submission is comprised of rigid working elements (resectoscopes), sheaths, obturators, electrodes (bipolar and monopolar), and HF cables. With the exception of the electrodes, the subject devices are provided non-sterile and reusable. The electrodes are provided sterile and are single-use.
Examples of use of the product include the visualization and manipulation of anatomy, biopsy, and as the surgeon deems appropriate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological and gynecological surgery
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)
Bench Testing was conducted to verify the performance of the Henke-Sass, Wolf Resection Instruments. Design verification testing was conducted to evaluate the functional and electrical performance of the subject devices, which included:
. Visual inspection
. Resection Setup Mechanical Functionality
. Leakage Test and Flow Measurement
. Functional Test (Monopolar and Bipolar electrodes)
Sterility and Shelf Life: For the sterile electrodes, EtO sterilization validation per ISO 11135:2014 and package integrity testing per ISO 11607-1:2014 - 11 were conducted. In addition, transport validation and accelerated aging testing were performed for the sterile electrodes in order to confirm the five-year shelf life.
In addition, the reusable Henke-Sass, Wolf Resection Instruments were validated for manual and automated cleaning with subsequent steam sterilization to provide a sterility assurance level of 10-6. The reprocessing validation was conducted in accordance with the 2015 FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
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.
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
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA acronym is in a blue square, and the full name, "U.S. Food & Drug Administration," is in blue text.
June 8, 2018
Henke-Sass, Wolf GmbH Anna Reifschneider Regulatory Affairs Manager Keltenstrasse 1 Tuttlingen, 78532 Germany
Re: K173070
Trade/Device Name: HSW Resection Instruments Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH, FAS, FAJ Dated: May 7, 2018 Received: May 11, 2018
Dear Anna Reifschneider:
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. 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.
1
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 device-related 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.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173070
Device Name HSW Resection Instruments
Indications for Use (Describe)
The Henke-Sass, Wolf Resection Instruments are intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization of anatomy, ablation, incision, coagulation, cauterization of minor bleedings, resection of tissue, vaporization and enucleation, and as the surgeon deems appropriate. The instruments are intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures:
- . Dilation of the urethra, and cold-slitting of urethral strictures
- . Trans-urethral incision and resection of the prostate
- . Trans-urethral removal of bladder tumor
- . Trans-cervical resection and ablation of the endometrium
- . Trans-cervical resection of fibroids
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 201 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Number: K173070
1. Applicant Information
| Date Prepared: | June 5, 2018 |
|---|---|
| Company Name and Address: | Henke-Sass, Wolf GmbH |
| Keltenstrasse 1 | |
| 78532 Tuttlingen | |
| Germany | |
| Ph: +49 (7462) 946-6147 | |
| Contact Person: | Ms. Anna Reifschneider, RAC |
| Regulatory Affairs Manager |
2. Device Information
| Common Name: | Resectoscopic Accessories | |
|---|---|---|
| Regulation Name: | Hysteroscope and accessories | |
| Regulation Number: | 21 CFR 884.1690 | |
| Product Code: | HIH (Hysteroscope (And Accessories)), FAJ (Cystoscope | |
| Accessories, Flexible/Rigid), FAS (Electrode, | ||
| and | ||
| Electrosurgical, Active, Urological) | ||
| Device Class: | II | |
| Device Name: | HSW Resection Instruments |
3. Predicate Devices
The legally marketed devices to which substantial equivalence is being claimed are:
| 510(k) Number: | K040390 |
|---|---|
| Applicant: | Stryker Endoscopy |
| Device Name: | Stryker Urology and Gynecology Hardware System |
| Regulation Number: | 21 CFR 884.1690 |
| Product Code: | HIH, FAJ, FAS, and KQT |
| Device Class: | II |
The predicate device has not been subject to a design related recall.
4
4. Device Description
The Henke-Sass, Wolf Resection Instruments consist of various components that assemble into and/or work as a diagnostic and therapeutic resectoscopic system in urology and gynecology.
This submission is comprised of rigid working elements (resectoscopes), sheaths, obturators, electrodes (bipolar and monopolar), and HF cables. With the exception of the electrodes, the subject devices are provided non-sterile and reusable. The electrodes are provided sterile and are single-use.
Examples of use of the product include the visualization and manipulation of anatomy, biopsy, and as the surgeon deems appropriate.
The following table provides a descriptive list of each of the subject device components: Working Elements
| Description (model) | Model Number |
|---|---|
| Resectoscope working element active, for 2.9mm scope, handle open, monopolar | 8300032281 |
| Resectoscope working element active, for 2.9mm scope, handle closed, monopolar | 8300032501 |
| Resectoscope working element active, for 4.0mm scope, monopolar | 8300032481 |
| Resectoscope working element active, for 4.0mm scope, monopolar | 8300032483 |
| Resectoscope working element active, for 4.0mm scope, handle closed, monopolar | 8300032485 |
| Resectoscope working element active, for 4.0mm scope, handle open, monopolar | 8300032486 |
| Resectoscope working element passive, for 2.9mm scope, handle open, monopolar | 8300032280 |
| Resectoscope working element passive, for 2.9mm scope, handle closed, monopolar | 8300032500 |
| Resectoscope working element, passive, monopolar for 2.9mm scope | 8300032419 |
| Resectoscope working element passive, for 4.0mm scope, monopolar | 8300032480 |
| Resectoscope working element passive, for 4.0mm scope, monopolar | 8300032482 |
| Resectoscope working element passive, for 4.0mm scope, handle closed, monopolar | 8300032484 |
| Resectoscope working element passive, for4.0mm scope, handle open, monopolar | 8300032256 |
| Resectoscope working element passive, for 2.0mm scope, monopolar | 8300032503 |
| Resectoscope working element passive, for 2.7mm scope, monopolar | 8300032506 |
| Resectoscope working element passive, for 2.9mm scope, bipolar (saline) | 8300032327 |
| Resectoscope working element passive, for 4mm scope, bipolar (saline) | 8300032344 |
| Resectoscope working element active, for 4mm scope, bipolar (saline) | 8300032345 |
| Laser resectoscope working element passive, for 2.9mm scope, with guiding channel | |
| for laser probe up to 0.8mm | 8300032254 |
| Laser resectoscope working element passive, for 2.9mm scope, with guiding channel | |
| for laser probe up to 1.2mm | 8300032255 |
| Laser resectoscope working element passive, for 4mm scope, with guiding channel for | |
| laser probe up to 0.8mm | 8300032240 |
| Laser resectoscope working element passive, for 4mm scope, with guiding channel for | |
| laser probe up to 1.2mm | 8300032241 |
| Laser resectoscope working element passive, for 4mm scope, with interchangeable | |
| guiding channel for laser probe | 8300035301 |
| Laser resectoscope adapter for laser probe, rotatable | 8300032243 |
| Laser resectoscope adapter for laser probe, rotatable, long | 8300032244 |
| TB laser resectoscope adapter for laser probe | 8300039283 |
| Laser resectoscope guiding channel for laser probe up to 0.8mm | 8300032246 |
| Laser resectoscope guiding channel for laser probe up to 1.0mm | 8300032247 |
| Laser resectoscope guiding channel for laser probe up to 1.2mm | 8300032248 |
5
| Laser resectoscope guiding channel for laser probe up to 1.4mm | 8300032249 |
|---|---|
| Laser resectoscope guiding channel for laser probe up to 0.8mm with retractor | 8300032250 |
| Laser resectoscope guiding channel for laser probe up to 1.0mm with retractor | 8300032251 |
| Laser resectoscope guiding channel for laser probe up to 1.2mm with retractor | 8300032252 |
| Laser resectoscope guiding channel for laser probe up to 1.4mm with retractor | 8300032253 |
Sheaths
| Description (model) | Model Number |
|---|---|
| Resectoscope standard sheath 11Fr. | 8300032502 |
| Resectoscope standard sheath 13 Fr. | 8300032504 |
| Resectoscope standard sheath 17.5 Fr. | 8300032323 |
| Resectoscope standard sheath 19Fr. | 8300032282 |
| Resectoscope standard sheath 24Fr. | 8300032260 |
| Resectoscope standard sheath 27Fr. | 8300032261 |
| Resectoscope standard sheath 24Fr. with central valve | 8300032489 |
| Resectoscope standard sheath 27Fr. with central valve | 8300032490 |
| Resectoscope inner sheath 17.5 Fr. quick lock | 8300032325 |
| Resectoscope inner sheath 19Fr. with oblique distal tip, fixed stopcock | 8300032283 |
| Resectoscope inner sheath 19Fr. with oblique distal tip, rotatablestopcocks | 8300032286 |
| Resectoscope inner sheath 24Fr., fixed stopcock | 8300032262 |
| Resectoscope inner sheath 27Fr., fixed stopcock | 8300032265 |
| Resectoscope inner sheath 24Fr., rotatable stopcocks | 8300032270 |
| Resectoscope inner sheath 27Fr., rotatable stopcocks | 8300032272 |
| Resectoscope inner sheath 24 Fr., quick lock, rotatable stopcocks | 8300032335 |
| Resectoscope outer sheath 22Fr., fixed stopcock, all aroundperforation | 8300032284 |
| Resectoscope outer sheath 26Fr. fixed stopcock, all aroundperforation | 8300032263 |
| Resectoscope outer sheath 26Fr. fixed stopcock, top and bottom perforation | 8300032495 |
| Resectoscope outer sheath 26Fr. fixed stopcock, all around slot hole perforation | 8300032586 |
| Resectoscope outer sheath 28.5Fr., fixed stopcock, all aroundperforation | 8300032266 |
| Resectoscope outer sheath 18.5Fr. with rotatable stopcocks | 8300032324 |
| Resectoscope outer sheath 22Fr., all around perforation, rotatable stopcocks | 8300032287 |
| Resectoscope outer sheath 26Fr., all around perforation, rotatable stopcocks | 8300032271 |
| Resectoscope outer sheath 26Fr., top and bottom perforation, rotatablestopcocks | 8300032496 |
| Resectoscope outer sheath 26Fr., top perforation, rotatablestopcocks | 8300032497 |
| Resectoscope outer sheath 26Fr., all around slot hole perforation, rotatable stopcocks | 8300032587 |
| Resectoscope outer sheath 26Fr., top slot hole perforation, rotatablestopcocks | 8300032588 |
| Resectoscope outer sheath 26Fr. quick lock, all around perforation, rotatable stopcocks | 8300032333 |
| Resectoscope outer sheath 28.5 Fr. all around perforation, rotatablestopcocks | 8300032273 |
Electrodes
| Description (model) | Model Number |
|---|---|
| Loop electrode 11Fr., angled, monopolar, for 2.0mm scope | 8300039108 |
| Loop electrode 11Fr., angled, monopolar, for 2.0mm 0°C scope, small | 8300039110 |
| Ball electrode 11Fr., monopolar, for 2.0mm scope | 8300041000 |
| Knife electrode 11Fr., monopolar, for 2.0mm scope | 8300039114 |
| Hook-like electrode 11Fr., monopolar, for 2.0mm scope | 8300039116 |
| Loop electrode 13Fr., angled, monopolar, for 2.7mm scope | 8300039109 |
| Loop electrode 13Fr., angled, monopolar, for 2.7mm scope, small | 8300039111 |
| Ball electrode 13Fr., monopolar, for 2.7mm scope | 8300039112 |
| Knife electrode 13Fr., monopolar, for 2.7mm scope | 8300039115 |
| Hook-like electrode 13Fr., monopolar, for 2.7mm scope | 8300039117 |
| Loop electrode 19Fr. monopolar, for 2.9mm 12° scope | 8300039074 |
| Loop electrode 19Fr. monopolar, straight, for 2.9mm scope | 8300039075 |
| Knife electrode 19Fr. monopolar, for 2.9mm scope | 8300039076 |
| Ball electrode 19Fr. monopolar, for 2.9mm scope | 8300039077 |
| Roller electrode 19Fr. monopolar, for 2.9mm scope | 8300039078 |
| HF roller electrode, 19Fr., monopolar scope, for 2.9mm scope | 8300039079 |
| Loop electrode 24Fr. angled 30°, monopolar, for 4mm scope | 8300039081 |
| Loop Electrode 24Fr. angled 30°, monopolar, cutting wire 0,40 mm | 8300039256 |
| Loop electrode 24Fr. straight, monopolar, for 4mm scope | 8300039083 |
| Knife electrode 24Fr. monopolar, for 4mm scope | 8300039088 |
| Ball electrode 3mm 24Fr. monopolar, for 4mm scope | 8300039090 |
| Ball electrode 5mm 24Fr. monopolar, for 4mm scope | 8300039092 |
| Roller electrode 3mm 24Fr. monopolar, for 4mm scope | 8300039094 |
| Roller electrode 5mm 24Fr. monopolar, for 4mm scope | 8300039096 |
| Conical electrode 24Fr. monopolar, for 4mm scope | 8300039098 |
| Loop electrode 24Fr. 90°, monopolar, for 4mm 0° scope | 8300039264 |
| Spiked Vaporisation electrode 3mm, monopolar, for 4mm scope | 8300039099 |
| Spiked Vaporisation electrode 5mm, monopolar, for 4mm scope | 8300039100 |
| Vaporisation electrode 3mm, monopolar, for 4mm scope | 8300039101 |
| Vaporisation electrode 5mm, monopolar, for 4mm scope | 8300039102 |
| Band vaporisation electrode monopolar, for 4mm scope | 8300039106 |
| Band electrode monopolar, for 4mm 0°scope | 8300039104 |
| Band electrode monopolar, for 4mm 30°scope | 8300039476 |
| Loop electrode 27Fr. angled 30°, monopolar, for 4mm scope | 8300039082 |
| Loop electrode 27Fr. straight, monopolar, for 4mm scope | 8300039084 |
| Knife electrode 27Fr. monopolar, for 4mm scope | 8300039089 |
| Ball electrode 3mm 27Fr. monopolar, for 4mm scope | 8300039091 |
| Ball electrode 5mm 27Fr. monopolar, for 4mm scope | 8300039093 |
| Roller electrode 3mm 27Fr. monopolar, for 4mm scope | 8300039095 |
| Roller electrode 5mm 27Fr. monopolar, for 4mm scope | 8300039097 |
| Loop electrode 27Fr. 90°, monopolar, for 4mm 0° scope | 8300039086 |
| Knife electrode 27Fr., monopolar, for 4mm scope | 8300039089 |
| Spiked Vaporisation electrode 3mm, 27Fr. monopolar, for 4mm scope | 8300039268 |
| Spiked Vaporisation electrode 5mm, 27Fr. monopolar, for 4mm scope | 8300039270 |
| Vaporisation electrode 3mm, 27Fr. monopolar, for 4mm scope | 8300039272 |
| Vaporisation electrode 5mm, 27Fr. monopolar, for 4mm scope | 8300039273 |
| Loop electrode 17Fr., 30°, bipolar (saline), for 2.9mm | 8300039118 |
| Loop electrode 17Fr., bipolar (saline), for 2.9mm scope | 8300039122 |
| Knife electrode 17Fr., bipolar (saline), for 2.9mm scope | 8300039119 |
| Ball electrode 2mm 17Fr., bipolar (saline), for 2.9mm scope | 8300039120 |
| Roller electrode 2mm 17Fr., bipolar (saline), for 2.9mm scope | 8300039121 |
| Loop electrode 24Fr., bipolar (saline), for 4mm scope | 8300039127 |
| Knife electrode 24Fr., bipolar (saline), for 4mm scope | 8300039124 |
| Coagulation ball electrode 24Fr., bipolar (saline), for 4mm scope | 8300039125 |
| Coagulation roller electrode 24Fr., bipolar (saline), for 4mm scope | 8300039126 |
| Loop electrode 90° 24Fr., bipolar (saline), for 4mm scope | 8300039128 |
6
Henke-Sass,WolfGmbH
HSW Resection Instruments
7
Henke-Sass, Wolf GmbH HSW Resection Instruments
Obturators
| Description (model) | Model number |
|---|---|
| Obturator for 13 Fr. Resectoscope sheath | 8300032505 |
| Obturator for 11 Fr. Resectoscope sheath | 8300032422 |
| Obturator for 17.5 Fr. Resectoscope sheath | 8300032326 |
| Obturator for 19 Fr. Resectoscope sheath | 8300032285 |
| Obturator for 24 Fr. Resectoscope sheath | 8300032264 |
| Obturator for 24Fr. Resectoscope sheath, quick lock | 8300032343 |
| Obturator for 27 Fr. Resectoscope sheath | 8300032267 |
| Visual obturator for 19 Fr. Resectoscope sheath | 8300032288 |
| Visual obturator for 24 Fr. Resectoscope sheath | 8300032279 |
| Visual obturator for 27 Fr. Resectoscope sheath | 8300032276 |
| Visual obturator with 6Fr. working channel for 24 Fr. Resectoscopesheath | 8300032277 |
| Visual obturator with 9Fr. working channel for 27 Fr. Resectoscopesheath | 8300032278 |
| Timberlake obturator for 24 Fr. Resectoscope sheath | 8300032274 |
| Timberlake obturator for 27 Fr. Resectoscope sheath | 8300032275 |
HF Cables
| Description (model) | Model number |
|---|---|
| HF connection cable Martin, 3 m length | 8300040170 |
| HF connection cable Storz/Erbe, 3 m length | 8300040172 |
| HF connection cable Valleylab-Bovie, 3m length | 8300040171 |
| HF connection cable, Valleylap, 4.5m length | 8300032353 |
5. Indications for Use
The Henke-Sass, Wolf Resection Instruments are intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, incision, coagulation,
8
cauterization of minor bleedings, resection of tissue, vaporization and enucleation, and as the surgeon deems appropriate. The instruments are intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures:
- . Dilation of the urethra, and cold-slitting of urethral strictures
- . Trans-urethral incision and resection of the prostate
- . Trans-urethral removal of bladder tumor
- . Trans-cervical resection and ablation of the endometrium
- . Trans-cervical resection of fibroids
The subject and predicate devices have the same intended use and the same indications for use.
6. Comparison of Technological Characteristics
| Device & Predicate Device(s): | Subject Device (K173070) | Predicate (K040390) |
|---|---|---|
| General Device Characteristics | ||
| Manufacturer | Henke-Sass, Wolf GmbH | Same |
| Features | Resectoscope sheath, handle, | |
| receptacles for HF cables, and | ||
| guiding tubes for electrodes/laser | ||
| fibers | Same | |
| Working Elements | ||
| Materials | Stainless steel, PTFE | Same |
| Diameter | 2.0 - 4.0 mm scopes | Same |
| Types | Active, passive | Same |
| HF ports (#) | 2 | Same |
| Electrosurgical mode | Monopolar and Bipolar | Same |
| Electrodes | ||
| Shapes | Loops, Knives (needles), Balls, and | |
| Rollers | Same | |
| Sterile | Provided sterile (EtO) | Provided non-sterile |
| Materials | Stainless steel, PTFE | Same |
| Insulation Material | PTFE | Same |
| Diameter | 11 Fr. - 27 Fr. | 19 Fr. - 27 Fr. |
| Electrosurgical mode | Monopolar and Bipolar | Same |
| Sheaths | ||
| Materials | Stainless steel, Ceramic (ZrO2) | Same |
| Diameter | 19 Fr. - 27 Fr. (inner) | |
| 22 Fr. - 28.5 Fr. (outer) | ||
| 11 Fr. - 27 Fr. (standard) | 22 Fr. - 27 Fr. (inner) | |
| 24 Fr. - 28 Fr. (outer) | ||
| 24 Fr. - 27 Fr. | ||
| (standard) | ||
| Outer sheath tip design | Round drilled flushing holes | Same |
9
Henke-Sass, Wolf GmbH HSW Resection Instruments
| | Stop Cocks | 2, above and below (outer)
1, below (standard) | Same |
|------------|------------|---------------------------------------------------|-----------------|
| Obturators | | | |
| | Materials | Stainless steel | Same |
| | Diameter | 11 Fr. - 27 Fr. | 22 Fr. - 27 Fr. |
| | Tip design | Rounded tip | Same |
The HSW Resection Instruments have differences in technological characteristics (see above table) when compared to the predicate device. These technological differences do not raise different questions of safety or effectiveness.
7. Non-Clinical Performance Data
The risk analysis was carried out in accordance with ISO 14971.
Bench Testing
Bench testing was conducted to verify the performance of the Henke-Sass, Wolf Resection Instruments. Design verification testing was conducted to evaluate the functional and electrical performance of the subject devices, which included:
- . Visual inspection
- Resection Setup Mechanical Functionality
- Leakage Test and Flow Measurement
- Functional Test (Monopolar and Bipolar electrodes)
Sterility and Shelf Life
For the sterile electrodes, EtO sterilization validation per ISO 11135:2014and package integrity testing per ISO 11607-1:2014 - 11 were conducted. In addition, transport validation and accelerated aging testing were performed for the sterile electrodes in order to confirm the five-year shelf life.
In addition, the reusable Henke-Sass, Wolf Resection Instruments were validated for manual and automated cleaning with subsequent steam sterilization to provide a sterility assurance level of 10-6. The reprocessing validation was conducted in accordance with the 2015 FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
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Henke-Sass, Wolf GmbH HSW Resection Instruments
The subject devices demonstrate conformance with the following recognized standards:
Electrical Safety and performance requirements:
- IEC 60601-1:2005 + A1:2012, C1:2009 + A2:2010 Medical Electrical Equipment Part 1.1 ● General requirements for safety and essential performance.
- IEC 60601-2-2 Edition 5.0 2009-02 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 [Including: Technical Corrigendum 1 (2014)]
- IEC 60601-1-6:2010 (Third Edition) + A1:2013 Medical electrical equipment Part 1-6: ● Particular requirements for the basic safety and essential performance: Usability
- IEC 60601-2-18 Edition 3.0 2009-08 Medical electrical equipment Part 2-18: Particular ● requirements for the basic safety and essential performance of endoscopic equipment.
Biocompatibility:
- Cytotoxicity ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for ● in vitro cytotoxicity
- Sensitization ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests ● for irritation and skin sensitization
- . Irritation - ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
The results of the non-clinical performance testing demonstrated that the subject devices meet predefined design and performance criteria. Results of all non-clinical testing support the safety and effectiveness of the subject device.
8. Conclusion
The performance data support the safety and effectiveness of the subject device and demonstrate that the subject device is substantially equivalent to the predicate device.