Percutaneous Nephroscope System

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, Pediatric

Intended 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.

Predicate Devices

• KARL STORZ Adult and Pediatric Nephroscope (K940594)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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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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: [phone]<br>Email: [e-mail] |
| 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.