(96 days)
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.
The KARL STORZ New Generation Trocars provide a port of entry during endoscopic and laparoscopic procedures in pediatric and adult patients. The New Generation Trocars are available in diameters 2.5mm to 13.5mm and consist of a cannula, trocar, and a valve seal. The trocars combine single-use and reusable components since the valve seal is single use while the cannula and trocar are reusable components. The trocars are color coded by size and are available with pyramidal, conical, or conical-blunt tips. Reducers can be used to reduce the size of the trocar to accommodate a smaller instrument without losing pneumoperitoneum.
The 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.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ||
| Seal Leak Test | Adequate sealing to maintain pneumoperitoneum | Bench verification performance testing was performed. |
| Seal Leak Test while Under Torque | Adequate sealing under torque conditions | Bench verification performance testing was performed. |
| Instrument Insertion and Retention Test | Instruments can be inserted smoothly and retained securely | Bench verification performance testing was performed. |
| Penetration Force | Acceptable force required for tissue penetration | Bench verification performance testing was performed. |
| Compression Testing of the Cannula | Cannula withstands compressive forces without failure | Bench verification performance testing was performed. |
| Bending Testing of the Cannula | Cannula withstands bending forces without failure | Bench verification performance testing was performed. |
| Torsional Testing of the Cannula | Cannula withstands torsional forces without failure | Bench verification performance testing was performed. |
| Biocompatibility | ||
| Biocompatibility | Compliant with ISO 10993 standards | Biocompatibility evaluation was performed to ISO 10993. |
| Sterility (Reusable Components) | ||
| Sterility (Reusable Cannula, Trocar, Reducer) | Compliant with ISO 11135 (Steam sterilization) | Sterility of the Reusable Components was validated in accordance with ISO 11135. |
| Sterility (Sterile Single-Use Components) | ||
| Sterility (Sterile Single-Use Valve Seals) | Compliant with ISO 11135 and ISO 10993 | Sterility of the Sterile Single Use Components was validated in accordance with ISO 11135 and ISO 10993. |
| Packaging (Sterile Single-Use Components) | ||
| Packaging (Sterile Single-Use Valve Seals) | Compliant with ISO 11607 and ISO 11737 | Packaging for the Sterile Single Use Components was validated to ISO 11607 and ISO 11737. |
| Clinical Performance | Demonstrate substantial equivalence to predicate device in terms of safety and effectiveness for intended use | Clinical testing was not required; non-clinical bench testing and medical literature review were considered sufficient to assess safety and effectiveness and establish substantial equivalence. |
| Usage in Pediatric Population | Safe and effective for use in pediatric patients | Supported by real-world evidence (medical literature) referencing pediatric minimally invasive surgery effectiveness and safety. |
| Electromagnetic Compatibility (EMC) | Not applicable | The subject device does not require electromagnetic compatibility, electrical safety, or software validation documentation. |
| Electrical Safety | Not applicable | The subject device does not require electromagnetic compatibility, electrical safety, or software validation documentation. |
| Software Validation | Not applicable | The subject device does not require electromagnetic compatibility, electrical safety, or software validation documentation. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each bench test performed. It generally states that "Bench verification performance testing has been performed" for the listed parameters.
- Data Provenance: The studies were bench tests performed by the manufacturer, KARL STORZ Endoscopy-America, Inc. There is no information about the country of origin of the data beyond the manufacturer's location in El Segundo, CA. All testing appears to be retrospective in the sense that it was completed prior to the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for the performance tests was established through direct measurement against pre-defined engineering and regulatory standards (e.g., ISO standards, specific force/leakage thresholds set by the manufacturer for functional performance). There is no mention of human experts establishing ground truth for these objective bench tests.
4. Adjudication Method for the Test Set
Not applicable. For objective bench tests, results are typically determined by measurement against specified criteria, not by human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a mechanical surgical instrument (trocar), not an AI-powered diagnostic or assistive tool that would involve human readers or AI assistance. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a mechanical surgical instrument; it does not involve algorithms or AI.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the bench tests was based on engineering specifications and established regulatory standards (e.g., ISO standards). For example, for biocompatibility, the ground truth was compliance with ISO 10993. For sterility, the ground truth was validation against ISO 11135 and ISO 11737. For mechanical tests, the ground truth would be the defined acceptable ranges for forces, leakage, etc.
For the expansion of indications to include a pediatric population, the "ground truth" was established through medical literature review (real-world evidence) from various peer-reviewed publications covering pediatric minimally invasive surgery.
8. The Sample Size for the Training Set
Not applicable. This device does not use an algorithm that requires a training set. The term "training set" is typically associated with machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no algorithm or AI, there is no training set or ground truth associated with it.
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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.2151 E. Grand AvenueEI Segundo, CA 90245 |
|---|---|
| Contact: | AnnaLisa SmullinRegulatory EngineerPhone: (424) 218-8376Fax: (424) 218-8519 |
| Date ofPreparation: | July 9, 2018 |
| Type of 510(k)Submission: | Traditional |
| DeviceIdentification: | Trade Name: KARL STORZ New Generation TrocarsClassification Name: Laparoscope, General & Plastic Surgery |
| RegulatoryClass: | II |
| Product Code: | GCJ |
| Regulation: | 21 CFR 876.1500 |
| PredicateDevice: | Primary Predicate Device: KARL STORZ Trocars (K940347)The predicate device has not been subject to a design-related recall. |
| DeviceDescription: | The KARL STORZ New Generation Trocars provide a port of entry duringendoscopic and laparoscopic procedures in pediatric and adult patients. TheNew Generation Trocars are available in diameters 2.5mm to 13.5mm andconsist of a cannula, trocar, and a valve seal. The trocars combine single-use and reusable components since the valve seal is single use while thecannula and trocar are reusable components. The trocars are color coded bysize and are available with pyramidal, conical, or conical-blunt tips.Reducers can be used to reduce the size of the trocar to accommodate asmaller instrument without losing pneumoperitoneum. |
| Intended Use: | To create and maintain a port of entry. |
| Indications ForUse: | KARL STORZ New Generation Trocars are intended to be used duringendoscopic and laparoscopic procedures in general surgery andthoracoscopy in adult and pediatric patients to create and maintain a port ofentry. |
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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.
| TechnologicalCharacteristics: | Comparison Table: Subject vs. Predicate Device | ||
|---|---|---|---|
| Subject Device | Predicate Device, K940347 | ||
| KARL STORZ NewGeneration Trocars | KARL STORZ Trocars | ||
| Indication for Use | Indication for Use | ||
| Indications for Use | Intended to be used duringendoscopic and laparoscopicprocedures in general surgeryand thoracoscopy in adult andpediatric patients to create andmaintain a port of entry. | Intended to be used duringendoscopic and laparoscopicprocedures in general surgeryand thoracoscopy to createand maintain a port of entry. | |
| Product Code | GCJ | GCJ | |
| Target Population | Adult and pediatric generalpopulation | Adult and pediatric generalpopulation | |
| 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 HousingMaterial | PEEK (Polyether EtherKetone) | Stainless Steel | |
| Cleaning and Sterilization Methods | |||
| Reusable Components | Trocar, Cannula, Reducer | Trocar, Cannula, Valve,Reducer | |
| Cleaning | Manual | Manual | |
| Sterilization | Steam | Steam, EtO | |
| Sterile Single-UseComponents | Valve Seals | None | |
| Non-ClinicalPerformanceData: | Bench verification performance testing has been performed for thefollowing parameters:• Seal Leak Test• Seal Leak Test while Under Torque• Instrument Insertion and Retention Test• Penetration Force• Compression Testing of the Cannula• Bending Testing of the Cannula• Torsional Testing of the CannulaBiocompatibility evaluation was performed to:• ISO 10993Sterility of the Reusable Components was validated in accordance with:• ISO 11135Sterility of the Sterile Single Use Components was validated in accordancewith:• ISO 11135• 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 11737Packaging for the Sterile Single Use Components was validated to: ISO 11607 The subject device does not require electromagnetic compatibility, electricalsafety, or software validation documentation. | |
|---|---|
| ClinicalPerformanceData: | Clinical testing was not required to demonstrate substantial equivalence tothe predicate device. Non-clinical bench testing was sufficient to assesssafety and effectiveness and to establish the substantial equivalence. |
| MedicalLiterature: | The following real world evidence (literature) was used to support the useof the KARL STORZ New Generation Trocars in a pediatric population aswell as to demonstrate the safety and effectiveness of the subject device andits substantial equivalence to the predicate: Blinman, T. & Ponsky, T. Pediatric Minimally Invasive Surgery:Laparoscopy and Thoracoscopy in Infants and Children. Pediatrics 130,539-549 (2012). Mitul, A. R. & Sarin, Y. K. Minimal Access Surgery in Neonates. J.Neonatal Surg. 6, (2017). Slater, B. J. & Rothenberg, S. S. Minimally Invasive Approaches toGERD and Hiatal Hernia in Children. The SAGES Manual of PediatricMinimally Invasive Surgery 315-326 (Springer, Cham, 2017). Bruns, N. E. & DeRoss, A. L. Laparoscopic Management ofIntussusception. In The SAGES Manual of Pediatric MinimallyInvasive Surgery 443–450 (Springer, Cham, 2017). Wei, J. & Feng, J. Laparoscopic treatment of liver diseases in children.Front. Med. 5, 388-394 (2011). Ishimaru, T. & Iwanaka, T. Laparoscopy and Thoracoscopy. OperativeGen Surgery in Neonates and Infants 21–29 (Springer, Tokyo, 2016). Hanna, G. B. & Cuschieri, A. Ergonomics of Task Performance inEndoscopic Surgery. 12 Kurtz, Steven M., and John N. Devine. "PEEK Biomaterials inTrauma, Orthopedic, and Spinal Implants.” Biomaterials, vol. 28, no.32, 2007, pp. 4845-4869. Wei, Jia, and Jiexiong Feng. “Laparoscopic Treatment of LiverDiseases in Children." Frontiers of Medicine, vol. 5, no. 4, 2011, pp.388-394. Bharathi, Ramanathan Saranga, et al. “Minimal Access Surgery ofPediatric Inguinal Hernias: a Review." Surgical Endoscopy, vol. 22,no. 8, 2008, pp. 1751–1762. Mattei, Peter. "Minimally Invasive Surgery in the Diagnosis andTreatment of Abdominal Pain in Children." Current Opinion inPediatrics, vol. 19, no. 3, 2007, pp. 338-343. |
| Conclusion: | The conclusions drawn from the non-clinical tests demonstrate that thesubject device, KARL STORZ New Generation Trocars, performs as wellas or better than the legally marketed predicate device. |
§ 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.