(213 days)
Not Found
No
The summary describes standard endoscopic and urological instruments for visualization and manipulation, with no mention of AI, ML, or advanced image processing beyond basic visualization. The performance studies focus on mechanical, optical, illumination, cleaning, and sterilization aspects, not algorithmic performance.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state the device is for "therapeutic surgical procedures" and "therapeutic procedures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the endoscopes and urology instruments are indicated for "endoscopic diagnostic" procedures and for "examination, diagnosis and therapy". The "Device Description" also mentions "endoscopic diagnostic and therapeutic procedures".
No
The device description explicitly states it is composed of physical components like cystoscopes, hysteroscopes, and accessories, which are hardware. The performance studies also focus on mechanical, optical, and illumination performance, and cleaning/sterilization, all related to physical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is an endoscope (Cystoscope/Hysteroscope) and associated instruments used for visualization and manipulation of anatomy during surgical procedures. It is used in vivo (within the body) to directly view and interact with the surgical site.
- Lack of Sample Analysis: There is no mention of the device being used to analyze samples taken from the body. Its purpose is direct observation and intervention.
The device is a surgical instrument used for direct visualization and manipulation within the body, which falls under the category of surgical or endoscopic devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
a. Endoscopes: The Henke-Sass, Wolf Cystoscopes are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the devices include the visualization and manipulation of the anatomy, as the surgeon deems appropriate. The Henke-Sass, Wolf Cystoscopes are intended to be used in general urological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site. b. Urology Instruments: The Henke-Sass, Wolf Urology Instruments in combination with endoscopes are intended to provide the user with the means for endoscopic visualization during examination, diagnosis and therapy of the lower urinary tract in conjunction with endoscopic accessories, or as the surgeon deems appropriate. The intended for use in urological procedures through the minimally invasive approach, by utilizing natural orifices to access the surgical site.
Product codes (comma separated list FDA assigned to the subject device)
FAJ, HIH
Device Description
The Henke-Sass, Wolf Cystoscopes, Hysteroscopes and Accessories are composed of cystoscopes, hysteroscopes and cystoscopic accessories, which provide the user with the means for endoscopic diagnostic and therapeutic procedures. 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
general urological surgery, lower urinary tract, general 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 Cystoscopes, Hysteroscopes, and Accessories. Design verification testing was conducted to evaluate the mechanical, optical, and illumination performance. The cleaning instructions were also validated. The Henke-Sass, Wolf Cystoscopes, Hysteroscopes, and Accessories has been validated for manual and automated cleaning as well as steam sterilization to provide a sterility assurance of 106. The devices are provided non-sterile. The risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971. Results show that the subject device has met pre-defined design and performance acceptance Results of all non-clinical testing support the safety and effectiveness of the subject criteria. devices.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 7, 2017
Henke-Sass, Wolf GmbH Anna Reifschneider, RAC Regulatory Affairs Manager Keltenstrasse 1 Tuttlingen, 78532 De Germany
Re: K171336
Trade/Device Name: Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr .; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ, HIH Dated: October 27, 2017 Received: October 27, 2017
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K171336
Device Name
Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm; Cysto-Urethroscope Sheath 19 Fr .; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath
Indications for Use (Describe)
Indications for Use
a. Endoscopes
The Henke-Sass, Wolf Cystoscopes are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the devices include the visualization and manipulation of the anatomy, as the surgeon deems appropriate. The Henke-Sass, Wolf Cystoscopes are intended to be used in general urological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.
b. Urology Instruments
The Henke-Sass, Wolf Urology Instruments in combination with endoscopes are intended to provide the user with the means for endoscopic visualization during examination, diagnosis and therapy of the lower urinary tract in conjunction with endoscopic accessories, or as the surgeon deems appropriate. The intended for use in urological procedures through the minimally invasive approach, by utilizing natural orifices to access the surgical site.
| 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 FDA 3881 (7/17)
3
510(k) Summary
510(k) Number: 171336
5.1 Sponsor Information
| Date Prepared: | December 7th, 2017 |
|---|---|
| Company Name and Address: | Henke-Sass, Wolf GmbH |
| Keltenstrasse 1 | |
| 78532 Tuttlingen | |
| Germany | |
| Contact Person: | Anna Reifschneider, RAC |
| Regulatory Affairs Manager |
5.2 Device Information
| Device Type: | Cystoscopes, Hysteroscopes and Accessories |
|---|---|
| Regulation Description: | Endoscope and Accessories |
| Review Panel: | Gastroenterology/Urology, Obstetrics/Gynecology |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | FAJ, HIH |
| Device Class: | II |
| Device Name: | Cystoscope 4.0mm autoclavable 0° WL 302mm; |
| Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto- | |
| Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto- | |
| Urethroscope Sheath |
5.3 Predicate Device
The legally marketed device to which substantial equivalence is being claimed is:
| 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 |
4
5.4 Device Description
The Henke-Sass, Wolf Cystoscopes, Hysteroscopes and Accessories are composed of cystoscopes, hysteroscopes and cystoscopic accessories, which provide the user with the means for endoscopic diagnostic and therapeutic procedures. Examples of use of the product include the visualization and manipulation of anatomy, biopsy, and as the surgeon deems appropriate.
5.5 Indications for Use
a. Endoscopes:
The Henke-Sass, Wolf Cystoscopes/Hysteroscopes are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of the anatomy, as the surgeon deems appropriate. The Henke-Sass, Wolf Cystoscopes/Hysteroscopes are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.
b. Urology Instruments:
The Henke-Sass, Wolf Urology Instruments in combination with endoscopes are intended to provide the user with the means for endoscopic visualization during examination, diagnosis and therapy of the lower urinary tract in conjunction with endoscopic accessories, or as the surgeon deems appropriate. The instruments are intended for use in urological procedures through the minimally invasive approach, by utilizing natural orifices to access the surgical site.
5.6 Summary of Substantial Equivalence
The Henke-Sass, Wolf Cystoscopes, Hysteroscopes and Accessories are substantially equivalent to the existing 510(k) cleared devices under the predicate Stryker Urology and Gynecology Hardware System (K040390). The indications for use of the Henke-Sass, Wolf Cystoscopes, Hysteroscopes and Accessories are substantially equivalent to the predicate device. The Henke-Sass, Wolf Cystoscopes, Hysteroscopes and Accessories do not incorporate any special technology or characteristics when compared to its predicate device.
5.7 Non-Clinical Performance Data
Bench testing was conducted to verify the performance of the Henke-Sass, Wolf Cystoscopes, Hysteroscopes, and Accessories. Design verification testing was conducted to evaluate the mechanical, optical, and illumination performance.
5
The cleaning instructions were also validated. The Henke-Sass, Wolf Cystoscopes, Hysteroscopes, and Accessories has been validated for manual and automated cleaning as well as steam sterilization to provide a sterility assurance of 106. The devices are provided non-sterile. The risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971.
The subject devices demonstrate conformance with the following recognized standards and guidances:
- 510(k) submission guidance for Hysteroscopes and Gynecology Laparoscopes; ●
- IEC 60601-2-18, Sec. 201.11.1.2.2 ●
- ISO 8600-1;
- ISO 8600-3;
- ISO 8600-4; ●
- . ISO 8600-5;
- . ISO 8600-6.
Results show that the subject device has met pre-defined design and performance acceptance Results of all non-clinical testing support the safety and effectiveness of the subject criteria. devices.
6
5.8 Technological Characteristics
| The subject device compares to the legally marketed device as follows: | |
|---|---|
| Device | Subject Device:
Henke-Sass, Wolf Cystoscopes,
Hysteroscopes, and Accessories | Predicate Device:
K040390 - Stryker Urology and Gynecology
Hardware System |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Henke-Sass, Wolf | Stryker Endoscopy |
| 510(k) number | Not yet assigned | K040390 |
| Indications for Use | a. Endoscopes:
The Henke-Sass, Wolf
Cystoscopes/Hysteroscopes are indicated to
provide the user with the means for endoscopic
diagnostic and therapeutic surgical procedures.
Examples for the use of the devices include the
visualization and manipulation of the anatomy,
as the surgeon deems appropriate. The Henke-
Sass, Wolf Cystoscopes/Hysteroscopes are
intended to be used in general urological and
gynecological surgery through a minimally
invasive approach by utilizing natural orifices
to access the surgical site. | The Stryker Urology and Gynecology Hardware
System is 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, biopsy, incision, and
resection of tissue, and/or as the surgeon deems
appropriate. The system is 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: |
| | b. Urology Instruments: | • Dilation of the urethra, and cold-slitting of
urethral strictures |
| | The Henke-Sass, Wolf Urology Instruments in
combination with endoscopes are intended to
provide the user with the means for endoscopic | • Trans-urethral incision and resection of the
prostate |
| | visualization during examination, diagnosis and
therapy of the lower urinary tract in | • Trans-urethral removal of bladder tumors |
| | conjunction with endoscopic accessories, or as | • Trans-cervical resection and ablation of the
endometrium |
| | | • Trans-cervical resection of fibroids |
| Device | Subject Device:
Henke-Sass, Wolf Cystoscopes,
Hysteroscopes, and Accessories | Predicate Device:
K040390 - Stryker Urology and Gynecology
Hardware System |
| | the surgeon deems appropriate. The
instruments are intended for use in urological
procedures through the minimally invasive
approach, by utilizing natural orifices to access
the surgical site. | |
| Regulation Number | 884.1690, 876.1500 | 884.1690 |
| Product Code | FAJ, HIH | HIH, FAJ, FAS, KQT |
| Working length (± 0.5mm) | 269mm - 302mm | 269mm - 302mm |
| Outer diameter (± 0.2mm) | 2.7mm - 4.0mm | 2.7mm - 4.0mm |
| Light Source | Xenon, LED | Xenon, LED |
| Distal tip (outer diameter) | 2.7mm - 4.0mm | 2.7mm - 4.0mm |
| Deflection (°) | 0°- 70° | 0°- 70° |
7
5.8 Conclusion
Based on the above information and all data provided in this submisson of intended uses, technological characteristics, and non-clinical performance that the subject devices are substantially equivalent to the predicate device identified in this submission.