K180977 · KARL STORZ Endoscopy-America, Inc. · GCJ · Jul 18, 2018 · Gastroenterology, Urology
Device Facts
Record ID
K180977
Device Name
KARL STORZ New Generation Trocars
Applicant
KARL STORZ Endoscopy-America, Inc.
Product Code
GCJ · Gastroenterology, Urology
Decision Date
Jul 18, 2018
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Real-World Evidence, Pediatric
Real-World Evidence
Submission
Device
Sponsor
RWD Sources
RWE Use Summary
Key Tags
K180977 · Jul 18, 2018
KARL STORZ New Generation Trocars
KARL STORZ Endoscopy-America, Inc.
Peer-reviewed medical literature (clinical reviews and studies of pediatric minimally invasive surgery)
The literature was used to support the intended use of the device in a pediatric population and to provide evidence of safety and effectiveness in clinical practice.
Pediatric population; Minimally invasive surgery; Literature review
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
Compilation of pediatric minimally invasive surgery literature; Literature review / Clinical practice summary; Study Period: Various (2007-2017)
Pediatric patients (infants and children)
Not applicable for this study
Safety and effectiveness of minimally invasive surgical procedures in pediatric patients
Indications for Use
KARL STORZ New Generation Trocars are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry.
Device Story
KARL STORZ New Generation Trocars provide port of entry for endoscopic/laparoscopic procedures. System comprises cannula, trocar, and valve seal; available in 2.5mm–13.5mm diameters with pyramidal, conical, or conical-blunt tips. Cannula and trocar are reusable stainless steel; valve seal is single-use. Reducers allow instrument size adjustment while maintaining pneumoperitoneum. Used in general surgery and thoracoscopy; operated by surgeons. Manual insertion creates access; valve maintains insufflation. Benefits include reliable access and instrument exchange during minimally invasive surgery.
Clinical Evidence
No clinical data. Substantial equivalence established via non-clinical bench testing, including seal leak tests, instrument insertion/retention, penetration force, and mechanical stress testing (compression, bending, torsion) of the cannula. Biocompatibility evaluated per ISO 10993. Sterility validated per ISO 11135 and ISO 11737. Packaging validated per ISO 11607.
Technological Characteristics
Materials: Stainless steel (cannula, trocar), PEEK (housing). Dimensions: 2.5-13.5 mm diameter, 5 or 10 cm length. Tip designs: Pyramidal, conical, blunt. Manual insertion. Reusable components (cannula, trocar, reducer) sterilized via steam; single-use valve seals. No electrical, electromagnetic, or software components.
Indications for Use
Indicated for adult and pediatric patients undergoing endoscopic and laparoscopic procedures in general surgery and thoracoscopy to create and maintain a port of entry.
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.
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Image /page/0/Picture/0 description: The image contains 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 in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
July 18, 2018
KARL STORZ Endoscopy-America, Inc. AnnaLisa Smullin Regulatory Engineer 2151 E. Grand Avenue El Segundo, California 90245
Re: K180977
Trade/Device Name: KARL STORZ New Generation Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: June 8, 2018 Received: June 11, 2018
Dear AnnaLisa Smullin:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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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 medical devices and radiation-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, Jennifer R. Stevenson For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K180977
Device Name KARL STORZ New Generation Trocars
Indications for Use (Describe)
KARL STORZ New Generation Trocars are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry.
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)
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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters on the top line. The words "KARL STORZ - ENDOSKOPE" are in smaller, bold, blue letters on the second line.
## 510(k) Summary K180977
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>EI Segundo, CA 90245 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | AnnaLisa Smullin<br>Regulatory Engineer<br>Phone: (424) 218-8376<br>Fax: (424) 218-8519 |
| Date of<br>Preparation: | July 9, 2018 |
| Type of 510(k)<br>Submission: | Traditional |
| Device<br>Identification: | Trade Name: KARL STORZ New Generation Trocars<br>Classification Name: Laparoscope, General & Plastic Surgery |
| Regulatory<br>Class: | II |
| Product Code: | GCJ |
| Regulation: | 21 CFR 876.1500 |
| Predicate<br>Device: | Primary Predicate Device: KARL STORZ Trocars (K940347)<br>The predicate device has not been subject to a design-related recall. |
| Device<br>Description: | The KARL STORZ New Generation Trocars provide a port of entry during<br>endoscopic and laparoscopic procedures in pediatric and adult patients. The<br>New Generation Trocars are available in diameters 2.5mm to 13.5mm and<br>consist of a cannula, trocar, and a valve seal. The trocars combine single-<br>use and reusable components since the valve seal is single use while the<br>cannula and trocar are reusable components. The trocars are color coded by<br>size and are available with pyramidal, conical, or conical-blunt tips.<br>Reducers can be used to reduce the size of the trocar to accommodate a<br>smaller instrument without losing pneumoperitoneum. |
| Intended Use: | To create and maintain a port of entry. |
| Indications For<br>Use: | KARL STORZ New Generation Trocars are intended to be used during<br>endoscopic and laparoscopic procedures in general surgery and<br>thoracoscopy in adult and pediatric patients to create and maintain a port of<br>entry. |
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Image /page/4/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.
| Technological<br>Characteristics: | Comparison Table: Subject vs. Predicate Device | | |
|--------------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device, K940347 | |
| | KARL STORZ New<br>Generation Trocars | KARL STORZ Trocars | |
| | Indication for Use | Indication for Use | |
| | Indications for Use | Intended to be used during<br>endoscopic and laparoscopic<br>procedures in general surgery<br>and thoracoscopy in adult and<br>pediatric patients to create andmaintain a port of entry. | Intended to be used during<br>endoscopic and laparoscopic<br>procedures in general surgery<br>and thoracoscopy to create<br>and maintain a port of entry. |
| | Product Code | GCJ | GCJ |
| | Target Population | Adult and pediatric general<br>population | Adult and pediatric general<br>population |
| | Physical Characteristics | | |
| | Diameter | 2.5-13.5 mm | 3.3-15 mm |
| | Length | 5 or 10 cm | 5-16 cm |
| | Tip Design | Pyramidal, conical, blunt | Pyramidal, conical, blunt |
| | Method of Action | Manual Insertion | Manual Insertion |
| | Trocar Material | Stainless Steel | Stainless Steel |
| | Cannula Material | Stainless Steel | Stainless Steel |
| | Trocar Housing<br>Material | PEEK (Polyether Ether<br>Ketone) | Stainless Steel |
| | Cleaning and Sterilization Methods | | |
| | Reusable Components | Trocar, Cannula, Reducer | Trocar, Cannula, Valve,<br>Reducer |
| | Cleaning | Manual | Manual |
| | Sterilization | Steam | Steam, EtO |
| | Sterile Single-Use<br>Components | Valve Seals | None |
| Non-Clinical<br>Performance<br>Data: | | Bench verification performance testing has been performed for the<br>following parameters:<br>• Seal Leak Test<br>• Seal Leak Test while Under Torque<br>• Instrument Insertion and Retention Test<br>• Penetration Force<br>• Compression Testing of the Cannula<br>• Bending Testing of the Cannula<br>• Torsional Testing of the Cannula<br>Biocompatibility evaluation was performed to:<br>• ISO 10993<br>Sterility of the Reusable Components was validated in accordance with:<br>• ISO 11135<br>Sterility of the Sterile Single Use Components was validated in accordance<br>with:<br>• ISO 11135<br>• ISO 10993 | |
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Image /page/5/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters on the top line. The words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters on the bottom line.
| | ISO 11737<br>Packaging for the Sterile Single Use Components was validated to: ISO 11607 The subject device does not require electromagnetic compatibility, electrical<br>safety, or software validation documentation. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical<br>Performance<br>Data: | Clinical testing was not required to demonstrate substantial equivalence to<br>the predicate device. Non-clinical bench testing was sufficient to assess<br>safety and effectiveness and to establish the substantial equivalence. |
| Medical<br>Literature: | The following real world evidence (literature) was used to support the use<br>of the KARL STORZ New Generation Trocars in a pediatric population as<br>well as to demonstrate the safety and effectiveness of the subject device and<br>its substantial equivalence to the predicate: Blinman, T. & Ponsky, T. Pediatric Minimally Invasive Surgery:<br>Laparoscopy and Thoracoscopy in Infants and Children. Pediatrics 130,<br>539-549 (2012). Mitul, A. R. & Sarin, Y. K. Minimal Access Surgery in Neonates. J.<br>Neonatal Surg. 6, (2017). Slater, B. J. & Rothenberg, S. S. Minimally Invasive Approaches to<br>GERD and Hiatal Hernia in Children. The SAGES Manual of Pediatric<br>Minimally Invasive Surgery 315-326 (Springer, Cham, 2017). Bruns, N. E. & DeRoss, A. L. Laparoscopic Management of<br>Intussusception. In The SAGES Manual of Pediatric Minimally<br>Invasive Surgery 443–450 (Springer, Cham, 2017). Wei, J. & Feng, J. Laparoscopic treatment of liver diseases in children.<br>Front. Med. 5, 388-394 (2011). Ishimaru, T. & Iwanaka, T. Laparoscopy and Thoracoscopy. Operative<br>Gen Surgery in Neonates and Infants 21–29 (Springer, Tokyo, 2016). Hanna, G. B. & Cuschieri, A. Ergonomics of Task Performance in<br>Endoscopic Surgery. 12 Kurtz, Steven M., and John N. Devine. "PEEK Biomaterials in<br>Trauma, Orthopedic, and Spinal Implants.” Biomaterials, vol. 28, no.<br>32, 2007, pp. 4845-4869. Wei, Jia, and Jiexiong Feng. “Laparoscopic Treatment of Liver<br>Diseases in Children." Frontiers of Medicine, vol. 5, no. 4, 2011, pp.<br>388-394. Bharathi, Ramanathan Saranga, et al. “Minimal Access Surgery of<br>Pediatric Inguinal Hernias: a Review." Surgical Endoscopy, vol. 22,<br>no. 8, 2008, pp. 1751–1762. Mattei, Peter. "Minimally Invasive Surgery in the Diagnosis and<br>Treatment of Abdominal Pain in Children." Current Opinion in<br>Pediatrics, vol. 19, no. 3, 2007, pp. 338-343. |
| Conclusion: | The conclusions drawn from the non-clinical tests demonstrate that the<br>subject device, KARL STORZ New Generation Trocars, performs as well<br>as or better than the legally marketed predicate device. |
