(207 days)
Not Found
No
The summary does not mention any AI or ML capabilities, image processing, or provide details about training or test sets, which are typical indicators of AI/ML use in medical devices.
Yes.
The "Intended Use / Indications for Use" states 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... endoscopic procedures of urinary tract".
No
The device description explicitly lists multiple hardware components, including a flexible video scope, LUER ports, a suction valve, and a CCU with specific model numbers. This indicates it is a system with significant hardware elements, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that 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 imaging and surgical intervention.
- Device Description: The description details a flexible endoscope with components like a scope, ports, and a camera control unit (CCU). These are all components of a system used for direct visualization and access within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide diagnostic information. IVDs are typically used in laboratories or point-of-care settings to analyze biological 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 used in vivo (within the living body), not in vitro (in glass/outside the body).
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 Cysto-Urethroscope (Part Number: 11272VH(U)), the LUER ports (Part Number: 11014L(U)), the Suction Valve (Part Number: 091011-20), 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).
The Flexible HD Cysto-Urethroscope (Part Number: 11272VH(U)) is a reusable, flexible video scope with an insertion shaft OD of 5.5 mm and length of 37 cm, a working channel OD of 2.3 mm, and a suction channel. Users can choose to attach either a LUER port with stopcocks (Part Number: 11014L) or a double LUER port (Part Number: 11014LU) to the working channel port. In terms of optics, it has direction of view of 0° and field of view of 100°.
Mentions image processing
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: Electrical Safety and Electromagnetic Compatibility Summary The electrical safety and EMC data included in the submission is in compliance with the following FDA recognized standards: ANSI/AAMI ES:60601-1:2005 IEC 60601-1-2:2007 The performance data submitted in the submission is in compliance with the following FDA recognized standards: IEC 62471:2006 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 and sterilization 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
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.
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.
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Image /page/0/Picture/0 description: The image shows 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 23, 2019
KARL STORZ Endoscopy-America, Inc. Nozomi Yagi, MAS, RAC Sr. Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245
Re: K182723
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: March 13, 2019 Received: March 14, 2019
Dear Nozomi Yagi:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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,
for 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) K182723
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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/1 description: The image contains 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 font.
KARL STORZ Premarket Notification Flexible HD Cysto-Urethroscope System 007_510(k) Summary
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.
| Submitter: | KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Avenue
EI Segundo, CA 90245 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nozomi Yagi
Sr. Regulatory Affairs Specialist
Phone: (424) 218-8351
Fax: (424) 218-8519 |
| Date of
Preparation: | April 10, 2019 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: Flexible HD Cysto-Urethroscope System
Classification Name: Endoscope and accessories (21 CFR Part
876.1500) |
| Regulatory
Class: | II |
| Product Code: | FAJ (Cystoscope and accessories, flexible/rigid)
FBO (Cystourethroscope) |
| Guidance
Document: | Not Applicable for FAJ/FBO product codes |
| Recognized
Consensus
Standards: | Not Applicable for FAJ/FBO product codes |
| Predicate
Device(s): | Primary Predicate Device: Olympus Corporation of the America's
VISERA Cysto-Nephroscope (K133538)
Secondary Predicate Device: KARL STORZ Endoscopy-America's
Flexible CMOS-Video-Cysto-Urethroscope (K131364) |
| Device
Description: | The components subject of this submission are: the Flexible HD
Cysto-Urethroscope (Part Number: 11272VH(U)), the LUER ports
(Part Number: 11014L(U)), the Suction Valve (Part Number:
091011-20), and the IMAGE1 S CCU. The CCU consists of the |
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Image /page/4/Picture/1 description: The image is a logo for Karl Storz Endoskope. The logo features the word "STORZ" in large, bold, blue letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller, blue letters. The logo is simple and professional, and it is likely used to represent the company on its products and marketing materials.
| IMAGE1 S Connect Module (Model Number: TC200US) and
| IMAGE1 S X-Link (Model Number: TC301US). | |||
|---|---|---|---|
| The Flexible HD Cysto-Urethroscope (Part Number: 11272VH(U)) | |||
| is a reusable, flexible video scope with an insertion shaft OD of 5.5 | |||
| mm and length of 37 cm, a working channel OD of 2.3 mm, and a | |||
| suction channel. Users can choose to attach either a LUER port with | |||
| stopcocks (Part Number: 11014L) or a double LUER port (Part | |||
| Number: 11014LU) to the working channel port. In terms of optics, it | |||
| has direction of view of 0° and field of view of 100°. | |||
| 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: | Comparison Table: Subject vs. Primary and Secondary Predicate Devices | ||
| Subject Device | Primary Predicate Device, K133538 Secondary Predicate Device, K131364 | ||
| Physical Characteristics | |||
| Type of Scope | Flexible | Same as the subject device Same as the subject device | |
| Insertion Shaft Diameter | 5.5 mm | Same as the subject device Same as the subject device | |
| Insertion Shaft Length | 37 cm | 38 cm Same as the subject device | |
| Deflection | 210° Up, 140° Down | 220° Up, 130° Down Same as the subject device | |
| Optical Characteristics | |||
| Type of Imager | CMOS | CCD Same as the subject device | |
| Direction of View | 0° | Same as the subject device Same as the subject device | |
| Light Source | Internal LED | External Xenon Same as the subject device | |
| Cleaning and Sterilization Methods | |||
| Cleaning | Yes | Same as the subject device Same as the subject device | |
| Sterilization | Yes | Same as the subject device Same as the subject device | |
| Non-Clinical | |||
| Performance | |||
| Data: | Electrical Safety and Electromagnetic Compatibility Summary | ||
| The electrical safety and EMC data included in the submission is in compliance | |||
| with the following FDA recognized standards: | |||
| ANSI/AAMI ES:60601-1:2005 | |||
| IEC 60601-1-2:2007 |
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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 phrase "KARL STORZ - ENDOSKOPE" in smaller, bold letters.
KARL STORZ Premarket Notification Flexible HD Cysto-Urethroscope System 007_510(k) Summary
| The performance data submitted in the submission is in compliance with the following FDA recognized standards: IEC 62471:2006 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 and sterilization 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 | |
|---|---|
| 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 devices |