(120 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related concepts in the device description, intended use, or performance studies.
Yes
The device is described as being used for "diagnostic and therapeutic endoscopic procedures."
Yes
The "Intended Use / Indications for Use" states that the system is used during "diagnostic and therapeutic endoscopic procedures."
No
The device description explicitly lists hardware components such as the Flexible HD Cysto-Urethroscope, LUER ports, Suction Valve, and the IMAGE1 S CCU (which includes Connect and X-Link modules).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract". This describes a device used directly on the patient for visualization and intervention, not for testing samples outside the body.
- Device Description: The components listed are physical instruments used for endoscopy (scope, ports, valve, camera control unit). These are not reagents, calibrators, or other components typically associated with IVD tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to perform tests on these types of samples.
In summary, this device is an endoscopic system used for direct visualization and procedures within the urinary tract, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
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 (comma separated list FDA assigned to the subject device)
FAJ, FBO
Device Description
The components subject of this submission are: the Flexible HD CystoUrethroscope (Part Number: 11272VH(U)), the LUER ports (Part Number: 11014L(U)), the Suction Valve (Part Number: 11301CE1/20), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: Biocompatibility Summary: The biocompatibility evaluation for the patient contacting components of the neuroscope was performed according to ISO 10993-1 and FDA Guidance. The following tests were conducted based contact type and duration: ISO 10993-5:2009/(R) 2014 ISO 10993-10:2010 ISO 10993-11:2006/(R) 2010. Reprocessing Validation Summary: The Flexible HD Cysto-Urethroscope (Part Number: 11272V(H)) is provided non-sterile and is reusable. The users are required to reprocess it for initial and after each use. The subject device contacts intact mucosal membranes so it is a semi-critical device per Spaulding Classification. We performed validation activities for cleaning sterilization and HLD according to the FDA Guidance. The reprocessing data submitted is in compliance with the following standards: AAMI TIR 12:2010 ISO 15883-5:2005 AAMI TIR 30:2011 AAMI/ANSI/ISO 11737-1:2006/(R)2011 ASTM E1837-96:2014.
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
September 18, 2019
KARL STORZ Endoscopy-America, Inc. Irina Fedorov Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245
Re: K191357
Trade/Device Name: Flexible HD Cysto-Urethroscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FAJ, FBO Dated: August 14, 2019 Received: August 19, 2019
Dear Irina Fedorov:
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. 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
1
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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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,
Sharon M. Andrews Acting 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) K191357
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 kicheys.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
3
K191357 Page 1 of 3
KARL STORZ Premarket Notification Flexible HD Cysto-Urethroscope System 007 510(k) Summarv
7. 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.
KARL-STORZ Endoscopy-America is submitting this 510(k) to seek clearance for a change to add Sterilization V PRO-60 and High Level Disinfection (HLD) for the currently cleared Flexible HD Cysto-Urethroscope System (K182723). This submission is traditional 510(K) as since we are including two reports to supports the additions.
| Submitter: | KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Avenue
EI Segundo, CA 90245 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Irina Fedorov
Regulatory Affairs Specialist
Phone: (508) 248-1275
Fax: (508) 248-9017 |
| Date of
Preparation: | May 17, 2019 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: HD View
Common Name: Flexible HD Cysto-Urethroscope System
Classification Name: Endoscope and accessories (21 CFR Part
876.1500) |
| Regulatory
Class: | II |
| Product Code: | FAJ, FBO |
| Guidance
Document: | Not Applicable for FAJ/FBO product codes |
| Recognized
Consensus
Standards: | Not Applicable for FAJ/FBO product codes |
| Predicate
Device(s): | Predicate Device: KARL STORZ Flexible HD Cysto-Urethroscope
(K182723) |
| Device
Description: | The components subject of this submission are: the Flexible HD Cysto-
Urethroscope (Part Number: 11272VH(U)), the LUER ports (Part |
4
K191357 Page 2 of 3
| Number: 11014L(U)), the Suction Valve (Part Number: 11301CE1/20), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US). | |||
|---|---|---|---|
| Intended Use: | The Flexible HD Cysto-Urethroscope System is intended for visualization purposes during urological diagnostic and therapeutic procedures. | ||
| 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. | ||
| Technological | |||
| Characteristics: | Subject Device | Predicate Device, K182723 | |
| Cleaning and Sterilization Methods | |||
| Cleaning | Manual | Same as the subject device | |
| Sterilization | STERRAD 100NX (FLEX and DUO Cycles) STERRAD NX (Advanced Cycle) V-PRO maX (Flexible Cycle) SS1E (Standard Cycle) V-PRO 60 Resert XL | STERRAD 100NX (FLEX and DUO Cycles) STERRAD NX (Advanced Cycle) V-PRO maX (Flexible Cycle) SS1E (Standard Cycle) None | |
| Non-Clinical | |||
| Performance | |||
| Data: | Biocompatibility Summary | ||
| The biocompatibility evaluation for the patient contacting components of the neuroscope was performed according to ISO 10993-1 and FDA Guidance. The following tests were conducted based contact type and duration: ISO 10993-5:2009/(R) 2014 ISO 10993-10:2010 ISO 10993-11:2006/(R) 2010 Reprocessing Validation Summary | |||
| The Flexible HD Cysto-Urethroscope (Part Number: 11272V(H)) is provided non-sterile and is reusable. The users are required to reprocess it for initial and after each use. The subject device contacts intact mucosal membranes so it is a semi-critical device per Spaulding Classification. We performed validation activities for cleaning sterilization and HLD according to the FDA Guidance. The reprocessing data submitted is in compliance with the following standards: AAMI TIR 12:2010 ISO 15883-5:2005 AAMI TIR 30:2011 AAMI/ANSI/ISO 11737-1:2006/(R)2011 |
5
K191357
Page 3 of 3
Image /page/5/Picture/1 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller, less bold font.
KARL STORZ Premarket Notification Flexible HD Cysto-Urethroscope System 007_510(k) Summary
| • ASTM E1837-96:2014 | |
|---|---|
| Clinical | |
| Performance | |
| Data: | Clinical testing was not required to demonstrate the substantial |
| equivalence to the predicate devices. Non-clinical bench testing was | |
| sufficient to establish the substantial equivalence of the modifications. | |
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that the |
| subject device, the Flexible HD Cysto-Urethroscope System performs | |
| as well as or better than the legally marketed predicate device. |