KARL STORZ ShuntScope

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, creating a sense of depth and unity. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 16, 2017 Karl Storz Endoscopy-America, Inc. Leigh Spotten Regulatory Director 2151 E. Grand Avenue El Segundo, California 90245 Re: K170462 Trade/Device Name: KARL STORZ ShuntScope Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: February 14, 2017 Received: February 15, 2017 Dear Leigh Spotten: 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 practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. 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 {1}------------------------------------------------ related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Michael 原田offmann -S for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K170462 Device Name KARL STORZ ShuntScope #### Indications for Use (Describe) The KARL STORZ ShuntScope is indicated to provide visualization and access during cranial diagnostic and therapeutic procedures such as shunt placement, tumor biopsy and resection, hydrocephalus treatment, endoscopic third ventriculostomy with choroid plexus cauterization (ETV/CPC), endoscopic third ventriculostomy, cyst fenestration, and aqueduct exploration in pediatrics and adult population. | 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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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: | Nozomi Yagi<br>Regulatory Affairs Specialist<br>Phone: (424) 218-8351<br>Fax: (424) 218-8519 | | Date of<br>Preparation: | May 15, 2017 | | Type of 510(k)<br>Submission: | Traditional | | Device<br>Identification: | Trade Name: KARL STORZ ShuntScope<br>Classification Name: Endoscope, Neurological (21 CFR Part 882.1480) | | Regulatory<br>Class: | II | | Product Code: | GWG | | Guidance<br>Document: | Not Applicable for GWG product code | | Recognized<br>Consensus<br>Standards: | Not Applicable for GWG product code | | Predicate<br>Device(s): | Primary Predicate Device: Medtronic PS Medical's NeuroPEN Endoscope<br>and Optical Accessories (K003914)<br>Secondary Predicate Device: KARL STORZ Endoscopy-America's Neuro-<br>Fiberscope (K002788)<br>Reference Device: KARL STORZ Endoscopy-America's KSEA | | | Sialendoscopes and Accessories (K012527) | | Device<br>Description: | The components subject of this submission are: (1) the KARL STORZ<br>ShuntScope (Model Number: 28164SSA), (2) the examination sheath<br>(Model Number: 11577KA) and (3) operating sheath (Model Number:<br>11577KE) | {4}------------------------------------------------ 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, in smaller blue letters, is the text "KARL STORZ - ENDOSKOPE". | Intended Use: | The KARL STORZ ShuntScope is intended for visualization purposes during cranial diagnostic and therapeutic procedures. | | | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | Indications For Use: | The KARL STORZ ShuntScope is indicated to provide visualization and access during cranial diagnostic and therapeutic procedures such as shunt placement, tumor biopsy and resection, hydrocephalus treatment, endoscopic third ventriculostomy with choroid plexus cauterization (ETV/CPC), endoscopic third ventriculostomy, cyst fenestration, and aqueduct exploration in pediatrics and adult population. | | | | Technological Characteristics: | Comparison Table: Subject vs. Primary and Secondary Predicate Devices | | | | | Subject Device | Primary Predicate Device, K003914 | Secondary Predicate Device, K002788<br>Reference Device, K012527 | | | KARL STORZ Shuntscope | Medtronic NeuroPEN | KSEA Neuro-Fiberscope<br>Marchal Mini Sialendoscope 0° | | | Physical Characteristics | | | | | Type of Scope | Same as the subject device | Flexible<br>Same as the subject device | | | Insertion Shaft Diameter | 1 mm (wo sheath)<br>1.3 mm (w 11577KA)<br>N/A | 1.14 mm<br>N/A<br>Same as the subject device | | | | 2.6 mm (w 11577KE) | 3.7 mm<br>Same as the subject device | | | Insertion Shaft Length | 161.8 mm | 155 or 190 mm<br>340 mm<br>Same as the subject device | | | Working Channel Diameter | 1.3 mm (w 11577KE) | N/A, No working channel<br>1.2 mm<br>Same as the subject device | | | Optical Characteristics | | | | | Type of Imager | Fiberoptic | Same as the subject device<br>Same as the subject device | | | Direction of View | 0° | Information not publicly available<br>Same as the subject device | | | Pixel Fibers | 10,000 | Same as the subject device<br>7,000<br>Same as the subject device | | | Light Source | External | Same as the subject device<br>Same as the subject device | | | Cleaning and Sterilization Methods | | | | | Cleaning | Manual | Single-use<br>Same as the subject device | | | Sterilization | Steam | Sterile<br>Same as the subject device | | Non-Clinical Performance Data: | Bench Testing Summary | | | | | Verification Test | Test Method Summary | | | | Surface and Edges | The surface of the ShuntScope shall be free of pores, cracks, and remainders of tooling agents. | | | | Maximum insertion portion width | The maximum insertion portion width shall not be larger than 1 mm, stated in the instruction manual. | | | | Field of view | The deviation of field of view shall not be greater than 15%. | | | | Direction of view | The deviation of direction of view shall not be greater than 0° ± 10°. | | | | Resolution | Characterization only. | | | | | Result | | | | | Pass | | | | | Pass | | | | | Pass | | | | | Pass | | | | | Pass | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for STORZ. The word "STORZ" is written in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters. | <b>Biocompatibility Summary</b><br>The biocompatibility evaluation for the patient contacting components of the neuroscope<br>was performed according to ISO 10993-1 and FDA Guidance. The following tests were<br>conducted based contact type and duration:<br>Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-11) Irritation (ISO 10993-11) Systemic Toxicity (ISO 10993-10) The biological-toxicological safety of the patient is not affected by the materials used in the<br>tested items. | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | <b>Sterilization Validation Summary</b> | | | | Test | Test Method Summary | Result | | Steam | SAL=10-6, Half cycle method | Pass | | <b>Bibliography</b> | The following published literature was provided to support the pediatric use<br>of the subject device:<br>1. Kulkarni, Abhaya V., et al. "International Infant Hydrocephalus Study: initial results<br>of a prospective, multicenter comparison of endoscopic third ventriculostomy (ETV)<br>and shunt for infant hydrocephalus." Child's Nervous System 32.6 (2016): 1039-1048.<br>2. Depreitere, Bart, et al. "Endoscopic biopsy for intraventricular tumors in children."<br>Journal of Neurosurgery: Pediatrics 106.5 (2007): 340-346.<br>3. Stone, Scellig SD, and Benjamin C. Warf. "Combined endoscopic third<br>ventriculostomy and choroid plexus cauterization as primary treatment for infant<br>hydrocephalus: a prospective North American series: Clinical article." Journal of<br>Neurosurgery: Pediatrics 14.5 (2014): 439-446.<br>4. Zada, Gabriel, et al. "Pathogenesis and treatment of intracranial arachnoid cysts in<br>pediatric patients younger than 2 years of age." Neurosurgical focus 22.2 (2007): 1-5. | | | <b>Clinical<br/>Performance<br/>Data:</b> | Clinical testing was not required to demonstrate the substantial equivalence<br>to the predicate devices. Non-clinical bench testing was sufficient to<br>establish the substantial equivalence of the modifications. | | | <b>Conclusion:</b> | The conclusions drawn from the nonclinical tests demonstrate that the<br>subject device, KARL STORZ ShuntScope performs as well as or better than<br>the legally marketed predicate devices. | |