(28 days)
No
The document describes a standard endoscopic system for visualization and operative access. While it mentions image processing, there is no mention of AI, ML, deep learning, or any related concepts in the device description, intended use, or performance studies. The focus is on the optical and mechanical aspects of the scope and the basic image processing by the CCU.
Yes
The intended use states that the device is used for "diagnostic and therapeutic endoscopic procedures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used "during diagnostic and therapeutic endoscopic procedures."
No
The device description clearly states that the system consists of physical components, including cysto-urethroscopes and camera control units (CCUs), which are hardware. The software component is part of the CCU for image processing, but the device as a whole is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide visualization and operative access during endoscopic procedures of the urinary tract. This is a direct medical procedure performed on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a flexible endoscope system used for visualization and surgical access. It processes video signals from within the body.
- Anatomical Site: The device is used within the urinary tract (urethra, bladder, ureters, kidneys), which are internal organs of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to provide visual information and access for procedures.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.
Product codes
FAJ, FBO
Device Description
The Flexible HD Cysto-Urethroscope System (Part Number: 11272VH(U)-TL) is intended to be used with the IMAGE1 S CCU consisting of Connect / Connect II and X-Link modules (cleared in K201135). Identical to the predicates, the scope cannot be operated on its own because it produces image data output in the form of video signals which require external processing and display. When the scope is used with the compatible CCU, it becomes the Flexible HD Cysto-Urethroscope System, which can then be operated as intended and indicated.
The Flexible HD Cysto-Urethroscope System consists of the following key components:
11272VH-TL / 11272VHU-TL – Cysto-Urethroscopes with positive (VH-TL) / contra-positive (VHU-TL) deflection control and permanent T-Luer affixed to working channel TC200US / TC201US / TC301US – Connect/Connect II/Link camera control unit (CCU) modules for image processing
The subject device is a lower cost alternative to the primary predicate and incorporates the following differences. Housing Plug: Due to lack of clinical need, the subject device replaces the suction channel of the primary predicate device with a permanent stainless steel housing plug. Fixed LUER: The subject device uses a removable T-Luer whereas the primary predicate supported a removable T-Luer or Stopcock.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract including the urethra, bladder, ureters, and kidneys.
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
Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Comparative analysis is sufficient to establish substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Flexible HD Cysto-Urethroscope System (K191357), Flexible Video Cysto-Urethroscope (C-View) (K202957)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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September 3, 2021
KARL STORZ Endoscopy America, Inc. Thomas Ostrowski Senior Regulatory Affairs Specialist 2151 E. Grand Ave El Segundo, CA 90245
Re: K212476
Trade/Device Name: Flexible HD Cysto-Urethroscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ, FBO Dated: August 5, 2021 Received: August 6, 2021
Dear Thomas Ostrowski:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K212476
Device Name Flexible HD Cysto-Urethroscope System
Indications for Use (Describe)
The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.
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) |
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Image /page/3/Picture/0 description: The image shows the logo for KARL STORZ–ENDOSKOPE. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ–ENDOSKOPE" are in smaller, blue letters.
8. 510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | KARL STORZ Endoscopy-America, Inc
2151 E. Grand Avenue
EI Segundo, CA 90245 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Thomas Ostrowski
Senior Regulatory Affairs Specialist
781-910-8508 (phone) |
| Date of Preparation: | August 27th, 2021 |
| Type of 510(k)
Submission: | Special |
| Device Identification: | Trade Name: Flexible HD Cysto-Urethroscope System |
| Common Name: | Cystoscope and accessories, Flexible/Rigid (FAJ)
Cystourethroscope (FBO) |
| Product Code: | FAJ, FBO |
| Regulation Name /
Number: | Endoscope and Accessories (21 CFR 876.1500) |
| Predicate Device(s): | Flexible HD Cysto-Urethroscope System (K191357) – Primary
Flexible Video Cysto-Urethroscope (C-View) (K202957) - Secondary
The above predicate devices have not been subject to any recall |
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| Device Description: | The Flexible HD Cysto-Urethroscope System (Part Number: 11272VH(U)-TL) is intended to be used with the IMAGE1 S CCU consisting of Connect / Connect II and X-Link modules (cleared in K201135). Identical to the predicates, the scope cannot be operated on its own because it produces image data output in the form of video signals which require external processing and display. When the scope is used with the compatible CCU, it becomes the Flexible HD Cysto-Urethroscope System, which can then be operated as intended and indicated. | ||||
|---|---|---|---|---|---|
| The Flexible HD Cysto-Urethroscope System consists of the following key components: | |||||
| 11272VH-TL / 11272VHU-TL – Cysto-Urethroscopes with positive (VH-TL) / contra-positive (VHU-TL) deflection control and permanent T-Luer affixed to working channel TC200US / TC201US / TC301US – Connect/Connect II/Link camera control unit (CCU) modules for image processing | |||||
| The subject device is a lower cost alternative to the primary predicate and incorporates the following differences. Housing Plug: Due to lack of clinical need, the subject device replaces the suction channel of the primary predicate device with a permanent stainless steel housing plug. Fixed LUER: The subject device uses a removable T-Luer whereas the primary predicate supported a removable T-Luer or Stopcock. | |||||
| Intended Use and Indications for use: | The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys. The minor modifications to the Flexible HD Cysto-Urethroscope System do not change the intended use and indications for use. The intended use / indications for use are identical between the proposed device and the predicate devices. | ||||
| Technological Characteristics: | The subject device is a modification of the primary predicate, 11272VH/VHU, cleared via K191357 and also incorporates design features of the secondary predicate device, 11272VE/VUE, cleared via K202957. A comparison between the proposed device and primary predicate device is included in the table below: | ||||
| Proposed Device | Primary Predicate | ||||
| K191357 | Secondary Predicate | ||||
| K202957 | |||||
| Physical Characteristics | |||||
| Type of scope | Flexible | Same | Same | ||
| Insertion Shaft Diameter | 5.5 mm | Same | 5.2 mm | ||
| Insertion Shaft | |||||
| Length | 37 cm | Same | Same | ||
| Working Channel | |||||
| Diameter | 2.3 mm | Same | Same | ||
| Deflection (°) | Up: 210° | ||||
| Down: 140° | Same | Same | |||
| Optical Characteristics | |||||
| Type of Imager | CMOS | Same | Same | ||
| Field of View | 100° | Same | Same | ||
| Direction of View | 0° | Same | Same | ||
| Depth of Field | 3-50 mm | Same | 5-50 mm | ||
| On-axis Resolution | |||||
| (minimal) | 40 lp/mm @ 3 mm | ||||
| 2.5 lp/mm @ 50 mm | Same | 16 lp/mm @ 5 mm | |||
| 1.8 lp/mm @ 50 mm | |||||
| Light Source | Internal LED | Same | Same | ||
| Material / Design Characteristics | |||||
| Suction Port / | |||||
| Channel | No | Yes | No | ||
| Luer Type | Permanent T-Luer | Bayonet with | |||
| removable T-Luer | |||||
| or Stopcock | |||||
| assembly | Same as proposed | ||||
| device | |||||
| Cleaning, Disinfection and Sterilization Methods | |||||
| Cleaning | Manual | Same | Same | ||
| Sterilization | STERRAD 100NX | ||||
| (FLEX and DUO | |||||
| cycles), | |||||
| STERRAD NX | |||||
| (Advanced Cycle), | |||||
| V-PRO maX | |||||
| (Flexible Cycle), | |||||
| V-PRO 60 | Same with | ||||
| additional support | |||||
| for SSIE (Standard | |||||
| Cycle) | Same as proposed | ||||
| device | |||||
| High Level | |||||
| Disinfection | Revital-Ox | ||||
| RESERT | Same | Same | |||
| Non-Clinical | |||||
| Performance Data: | There are no performance standards or special controls developed under Section | ||||
| 514 of the FD&C Act for endoscopes, however, the subject device follows FDA | |||||
| recognized consensus standards identified in the primary and secondary | |||||
| predicate device submissions: |
• Electrical Safety and EMC
o IEC 60601-1:2005/(R)2012, Ed. 3.1
o IEC 60601-1-2:2014, 4th Ed.
o IEC 60601-2-18:2009, Ed. 3.0
• Optical/Mechanical Performance
o IEC 62471:2006
o ISO 8600 | | | | |
5
6
| Biocompatibility ISO 10993-1:2009/(R) 2013 ISO 10993-5:2009/(R) 2014 ISO 10993-10:2010 ISO 10993-11:2006/(R) 2010 Reprocessing AAMI TIR 12:2010 ISO 15883-5:2005 AAMI TIR 30:2011 AAMI/ANSI/ISO 11737-1:2006/ (R)2011 ASTM E1837-96:2014 | |
|---|---|
| Substantial | |
| Equivalence: | The intended use, operating principles, technological characteristics and features |
| are similar, if not identical, between that subject device and the predicate | |
| devices, Flexible HD Cysto-Ureteroscope System (K191357) and Flexible | |
| Video Cysto-Uretheroscope (C-View) (K202957). The minor difference | |
| between the subject and predicate devices that does not raise new or different | |
| questions or safety and effectiveness are listed above in Technological | |
| Characteristics section. |
As proven by the comparisons, the differences do not raise different questions of
safety and effectiveness because the intended use, operating principles,
technological characteristics, and features are similar, if not identical. Both
systems also comply with identical standards and safety testing, where
applicable.
Substantial equivalence to the effectiveness of the subject device is supported by
the comparison of the images and standard image quality characteristics
including, but not limited to the performance testing listed above. |
| Clinical Performance
Data: | Clinical performance is not required to demonstrate substantial equivalence to
the predicate devices. Comparative analysis is sufficient to establish substantial
equivalence. |
| Conclusion: | The Flexible HD Cysto-Urethroscope System is substantially equivalent to its
predicate devices. The comparative analysis demonstrates that the device is as
safe and effective as the legally marketed devices. |