K232370 · Karl Storz SE & CO. KG · FGA · May 1, 2024 · Gastroenterology, Urology
Device Facts
Record ID
K232370
Device Name
Percutaneous Nephroscope System
Applicant
Karl Storz SE & CO. KG
Product Code
FGA · Gastroenterology, Urology
Decision Date
May 1, 2024
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic, Real-World Evidence, Pediatric
Real-World Evidence
Submission
Device
Sponsor
RWD Sources
RWE Use Summary
Key Tags
K232370 · May 1, 2024
Percutaneous Nephroscope System
Karl Storz SE & CO. KG
Published clinical literature
Published literature was used to support the safety and effectiveness of the Percutaneous Nephroscope System for use in pediatric patients older than one month.
Pediatric use; Literature review
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
Published literature review
Pediatric patients >1 month of age
Not applicable for this study
Safety and effectiveness
Indications for Use
The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults. The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults and pediatrics >1month of age.
Device Story
Percutaneous Nephroscope System facilitates minimally invasive percutaneous nephrolithotomy (PCNL). System components include MIP nephroscopes, HOPKINS telescopes, operating sheaths, dilators, and various surgical instruments (forceps, scissors, knives, laser hand instruments). Device inputs are visual signals captured via rod lens/fiber-optic optics; surgeon operates device in clinical setting (OR) to visualize kidney interior. Surgeon introduces instruments through working channels or ports to fragment and remove stones; suction tubes allow removal of fragments. System provides continuous flow irrigation. Output is direct visualization for the physician, enabling stone fragmentation and extraction. Benefits include minimally invasive access to kidney stones, reducing trauma compared to open surgery.
Clinical Evidence
No clinical trials were conducted. Safety and effectiveness for the pediatric population (>1 month of age) were supported by a review of published literature.
Technological Characteristics
Rigid, rod lens and fiber-optic endoscopes; 3.3mm-7.5mm outer diameter; 6°-10° direction of view. Materials biocompatible per ISO 10993-5, -11, -23, -10. Thermal safety per IEC 60601-2-18. Reprocessing per AAMI TIR12, TIR30, ST77, ST79, and ISO 14937. Continuous flow irrigation and suction capability.
Indications for Use
Indicated for percutaneous removal of kidney stones in adults and pediatric patients >1 month of age.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
KARL STORZ Adult and Pediatric Nephroscope (K940594)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 1, 2024
Karl Storz SE & Co. Kg Alita McElroy Senior Specialist, Regulatory Affairs Dr.-Karl-Storz-Straße 34 Baden-Wurttemberg Tuttlingen, 78532 GERMANY
Re: K232370
Trade/Device Name: Percutaneous Nephroscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGA Received: March 29, 2024
Dear Alita McElroy:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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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 -S
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
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## Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
K232370
Device Name
Percutaneous Nephroscope System
Indications for Use (Describe)
Percutaneous System for adults The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults.
Percutaneous System for adults and pediatrics
The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults and pediatrics >1month of age.
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.
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#### *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:
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Image /page/4/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.
K232370 Page 1 of 5
KARL STORZ Premarket Notification Percutaneous Nephroscope System 510(k) Summary
## 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.<br>2151 E. Grand Avenue<br>El Segundo, CA 90245 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Alita McElroy<br>Senior Regulatory Affairs Specialist<br>Phone: (424) 218-8376<br>Email: Alita.McElroy@karlstorz.com |
| Date of<br>Preparation: | August 7, 2023 |
| Type of 510(k)<br>Submission: | Traditional |
| Device<br>Identification: | Trade Name: Percutaneous Nephroscope System<br>Classification Name: Kit, Nephroscope (21 CFR 876.1500) |
| Regulatory Class: | II |
| Product Code: | FGA |
| Classification<br>Panel: | Gastroenterology/Urology |
| Predicate<br>Device(s): | KARL STORZ Adult and Pediatric Nephroscope (K940594) |
| Device<br>Description: | The Percutaneous Nephroscope System consists of the following:<br>- Minimally Invasive Percutaneous Nephrolithopaxy (MIP) Nephroscopes<br>- HOPKINS Telescopes for Percutaneous Nephrolithotomy (PCNL)<br>- Operating Sheaths<br>- One-Step Dilators<br>- Telescope Bougie Set<br>- Hollow Obturator and Fascial Dilator Applicators<br>- Biopsy and Grasping forceps<br>- Scissors<br>- Knives |
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Image /page/5/Picture/0 description: The image shows the logo for STORZ. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font. The logo is simple and professional.
| | - | Insertion Aid | |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - | Laser Hand Instrument | |
| | - | Suction tube | |
| | - | Adaptors | |
| | - | Luer-Lock tube connectors | |
| Intended Use and<br>Indications for<br>Use: | The dilators are used to dilate the access tract to the punctured kidney. The<br>operating sheath is inserted in the pre-expanded tract and facilitates insertion<br>of the MIP Nephroscopes or the HOPKINS Telescopes for PCNL. The desired<br>instrument (e.g forceps, scissors, knives) for stone removal is introduced<br>through the working channel of the HOPKINS Telescopes or into the MIP<br>Nephroscopes via an instrument port. A suction tube can alternatively be used<br>via the working channel of the MIP Nephroscopes to suction stone fragments.<br>The laser hand instrument or an insertion aid is used to guide a laser fiber for<br>stone fragmentation. Applicators are used to seal the access tract of the kidney.<br>Percutaneous System for adults<br>The KARL STORZ Percutaneous System is intended to be used during<br>percutaneous removal of kidney stones in adults.<br>Percutaneous System for adults and pediatrics<br>The KARL STORZ Percutaneous System is intended to be used during<br>percutaneous removal of kidney stones in adults and pediatrics >1month of<br>age. | | |
| Technological<br>Characteristics. | | Percutaneous<br>Nephroscope System<br>Subject Device | KARL STORZ Adult and<br>Pediatric Nephroscope<br>System<br>Predicate Device<br>K940594 |
| | Components | MIP Nephroscopes<br>HOPKINS Telescopes<br>Operating Sheaths<br>Hollow Obturator<br>Fascial Dilator<br>Telescope Bougie Set<br>One-Step Dilators<br>Grasping Forceps<br>Biopsy Forceps<br>Knives<br>Scissors | Nephroscopes with<br>instrument channel<br>Telescopes without<br>instrument channel and<br>luer-lock connector tubes<br>Operating Sheaths<br>Dilation Set<br>Hollow Obturator Fascial<br>Dilator<br>Grasping Forceps<br>Biopsy Forceps |
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Image /page/6/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 letters.
KARL STORZ Premarket Notification Percutaneous Nephroscope System 510(k) Summary
| | Applicator | Knives | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| | Insertion Aid | Scissors | |
| | Laser Hand Instrument | Triradiate Graspers | |
| | Suction tube | Kidney Stone crushers | |
| | Adaptors | | |
| | Luer-lock connector<br>tubes | | |
| Scope Type | Rigid, rod lens and<br>fiber-optic | Rigid, rod lens | |
| Scope Outer<br>Diameter | 3.3mm- 7.5mm | 2.7mm- 6mm, 5 x 3mm | |
| Scope<br>Working<br>Length | 20cm- 26cm | 10cm -30cm | |
| Instrument<br>channel<br>width | 0.8- 5mm | 2.5mm- 4.7mm | |
| Scope<br>Direction of<br>View | 6°, 7.5°, 10° | 0° | |
| Scope Field<br>of View | 72°- 102° | 65°- 118° | |
| Depth of<br>Field | 4mm- 200mm | 4mm- 200mm | |
| | 5.5mm- 200mm | 5.1mm- 200mm | |
| | 6.6mm- 200mm | | |
| | 7.6mm- 200mm | | |
| | 8.0mm- 200mm | | |
| Irrigation<br>and Suction | Continuous Flow | Continuous Flow | |
| Vacuum-<br>Cleaner<br>effect | Yes | No | |
| Operating<br>Sheath<br>dimensions | Diameter: 11/12 Fr- 26<br>Fr<br>Working Length:<br>7.5cm- 22.8cm | Diameter: 17 Fr- 33 Fr<br>Working Length: 10cm<br>-20cm | |
| Telescope | Dilation Cannula | Dilation/Puncture Cannula | |
| Bougie/Dilati<br>on Set | Diameter: 3.8mm | Diameter: 4mm | |
| | dimensions | Working length: 12.6cm | Working Length: 15cm |
| | | Guide wire<br>diameter: 1.9mm, ball<br>end: 3mm<br>working length: 57cm | Guide wire<br>diameter: 1.9mm, ball end:<br>2.9mm<br>working length: 57.5cm |
| | | Dilators<br>Diameter: 9, 12, 15, 18,<br>21, 24, 27, 30Fr<br>Working Length: 27-<br>29cm | Dilators<br>Diameter: 9, 12, 15, 18, 21,<br>24, 27, 30Fr<br>Working Length: 10-<br>18cm |
| Hollow<br>Obturator<br>and Fascial<br>Dilator<br>dimensions | | Diameter: 6.7mm- 8mm<br>Working Length:<br>20.8cm - 27cm | Diameter: 5mm- 7mm<br>Working Length: 10cm-<br>15cm |
| Biopsy<br>Forceps<br>dimensions | | Diameter: 1.67mm -<br>3.5mm<br>Working Length:<br>39cm - 40cm | Diameter: 1.67- 3.5mm<br>Working Length: 12cm-<br>31cm |
| Grasping<br>Forceps<br>dimensions | | Diameter: 1.67mm -<br>3.5mm<br>Working Length:<br>40cm | Diameter: 1.67mm- 3.5mm<br>Working Length: 12cm-<br>31cm |
| Scissors<br>dimensions | | Diameter: 1.7mm -<br>3.5mm<br>Working Length:<br>40cm | Diameter: not included in<br>510k<br>Working Length: 31cm |
| Knives<br>dimensions | | Diameter: 3.5mm<br>Working Length:<br>38cm | Diameter: not included in<br>510k<br>Working Length: 31cm |
| 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 Percutaneous Nephroscope System is tested in accordance with the following standards and FDA Guidance: | | | |
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Image /page/7/Picture/0 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 font.
K232370
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KARL STORZ Premarket Notification Percutaneous Nephroscope System 510(k) Summary
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Image /page/8/Picture/1 description: The image is a logo for Karl Storz Endoskope. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
KARL STORZ Premarket Notification Percutaneous Nephroscope System 510(k) Summary
## SO Endoscopic Standards
- ISO 8600-1
- ISO 8600-3
- ISO 8600-5
- ISO 8600-6
## Biocompatibility Summary
- Cytotoxicity (ISO 10993-5:2009) ●
- Acute Systemic Toxicity (ISO 10993-11:2017) ●
- Irritation (ISO 10993-23:2021)
- Maximization Sensitization (ISO 10993-10:2021) ●
## Thermal Safety
- IEC 60601-2-18:2009 (3RD Edition) ●
## Reprocessing (Cleaning and Sterilization)
- AAMI TIR12: 2010 ●
- AAMI TIR30: 2011 ●
- ANSI/AAMI ST77:2013/(R)2018 ●
- ANSI/AAMI ST79:2017 ●
- AAMI/ISO 14937:2009
- DIN EN ISO 11138-1:2017
- ANSI/AAMI/ISO 17655-1:2006/(R)2013 ●
- Reprocessing Medical Device in Health Care Settings: Validation ● Methods and Labeling
Comparative bench testing between the subject and predicate DEVICES demonstrated that the endoscopes in the Percutaneous Nephroscope System meets all its design specification and is substantially equivalent to its predicate device. Additional bench testing was performed for the subject device instruments
(forceps and scissors) to ensure the device met its design specifications and is substantially equivalent to the predicate.
| Clinical | Published literature was provided to support the safety and effectiveness of |
|-------------------|------------------------------------------------------------------------------|
| Performance Data: | the Percutaneous Nephroscope system for use in pediatrics >1month of age. |
The conclusions drawn from the nonclinical test demonstrate that the Conclusion: subject device is as safe and effective as the predicate device.
