Who is the manufacturer of ViziShot 2 FLEX?

Olympus Surgical Technologies America filed the 510(k) submission for ViziShot 2 FLEX (K193517).

What is the FDA product code for ViziShot 2 FLEX?

KTI. It is classified under 21 CFR 874.4680 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for ViziShot 2 FLEX?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ViziShot 2 FLEX?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ViziShot 2 FLEX

K193517 · Olympus Surgical Technologies America · KTI · Mar 18, 2020 · Ear, Nose, Throat

Device Facts

Record ID	K193517
Device Name	ViziShot 2 FLEX
Applicant	Olympus Surgical Technologies America
Product Code	KTI · Ear, Nose, Throat
Decision Date	Mar 18, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4680
Device Class	Class 2

Intended Use

The ViziShot 2 FLEX has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use.

Device Story

ViziShot 2 FLEX is a single-use, manual aspiration needle used with ultrasound endoscopes for tissue sampling. The device comprises a handle, sheath, needle, and removable stylet. During a procedure, the catheter is inserted into a bronchoscope's working channel and locked to the adapter biopsy valve. The clinician advances the needle to the target lesion under real-time ultrasound visualization. Suction is applied via a syringe at the handle's proximal end to obtain tissue samples. The device is used in surgical, endoscopy, or bronchoscopy suites by physicians. The output is a tissue sample for cytopathological or microbiological examination. The device benefits patients by enabling minimally invasive biopsy of tracheobronchial lesions.

Clinical Evidence

No clinical or animal studies were performed. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993 series), sterilization validation (ISO 11135-1), and mechanical performance testing (insertion/withdrawal forces, angulation, durability, echogenicity). A GLP bench study compared the ViziShot 2 FLEX 19G needle to the predicate, confirming similar tissue sampling metrics (weight, length, quality) for histologic and core analysis.

Technological Characteristics

Single-use aspiration needle (19G). Materials: Stainless Steel, PTFE, PEBAX, Nitinol. Manual operation. Dimensions: 70cm catheter length, 2.08mm working OD. Sterilization: Ethylene Oxide (EO) per ANSI/AAMI/ISO 11135-1. Packaging validated per ANSI/AAMI/ISO 11607-1. Shelf life: 3 years (accelerated aging per ASTM F1980-16).

Indications for Use

Indicated for patients requiring ultrasound-guided fine needle aspiration (FNA) or fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree.

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Predicate Devices

Cook Ireland, Ltd Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle (K160229)

Reference Devices

Gyrus ACMI ViziShot 2 FLEX (K163469)

Related Devices

K163469 — ViziShot 2 FLEX · Olympus Surgical Technologies America · Apr 6, 2017
K152922 — ViziShot FLEX · Spiration, Inc. · Feb 19, 2016
K160098 — Single Use Aspiration Needle NA-U401SX · Olympus Medical Systems Corp. · Mar 22, 2016
K142909 — Flexible 19G EBUS Needle · Spiration, Inc. · Apr 24, 2015
K213060 — AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle · Micro-Tech (Nanjing) Co., Ltd. · Jul 20, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. March 18, 2020 Olympus Surgical Technologies America Mary Patella Senior Specialist, Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts 01772-2104 # Re: K193517 Trade/Device Name: ViziShot 2 FLEX Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: KTI Dated: December 18, 2019 Received: December 19, 2019 ### Dear Mary Patella: 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. 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 located 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; 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 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 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, James J. Lee Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K193517 Device Name ViziShot 2 FLEX Indications for Use (Describe) The ViziShot 2 FLEX has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use. 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary Gyrus ACMI ViziShot 2 FLEX # General Information | Manufacturer: | Olympus Surgical Technologies America Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772-2104 Phone: 508-804-2600 Fax: 508-804-2624 | |-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment Registration Number: | 3003790304 | | Contact Person: | Mary Anne Patella Senior Specialist, Regulatory Affairs 508-804-2771 Maryanne.patella@olympus-osta.com) | | Date Prepared: | December 18, 2019 | | Device Description | | | Classification Name: CFR Citation Number: Product Code: Classification: Review Panel Trade Name: Generic/Common Name: | Bronchoscope (flexible or rigid) and accessories 21 CFR 874.4680 KTI Class II Ear Nose & Throat Gyrus ACMI ViziShot 2 FLEX Aspiration Needle | | Predicate Device | | | Cook Ireland, Ltd Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle | K160229 | | Reference Device | | | Gyrus ACMI ViziShot 2 FLEX | K163469 | {4}------------------------------------------------ ### Product Description The subject device, ViziShot 2 FLEX is a single use aspiration needle to be used in conjunction with compatible ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree. The subject device consists of a handle, sheath, needle, and stylet. The sheath and needle are attached to the handle, and the removable stylet is located within the needle. Note that although, the device has a component called a needle, the device is often referred to as a needle as well. The device is a single-use sterile device. Prior to a procedure, the flexible catheter portion is inserted into a bronchoscope's working channel (2.2mm) and advanced forward until fully inserted. The handle is then affixed to the channel port of the endoscope via a lever mechanism that locks onto the Adapter Biopsy Valve. The needle is advanced through the bronchoscope to the sampling site while visualizing both the target and the needle in real time with ultrasound. The handle facilitates advancement of the needle during puncture of the targeted biopsy site. The sample is obtained by penetrating the lesion with the needle while applying suction at the proximal end of the handle. After completing the sampling, the vacuum from the syringe is released to atmosphere, the handle unlocked from the bronchoscope, and the catheter and needle pulled out from the working channel. The removed tissue can then be prepared for cytopathological or microbiological examination and testing. The ViziShot 2 FLEX is available in one model only (NA-U403SX-4019), with a needle size of 19 gauge (19G). The two required accessories, the Adapter Biopsy Valve and the Merit Syringe with Stopcock, are packaged with the ViziShot 2 FLEX. ### Intended Use The ViziShot 2 FLEX has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use. Comparison of Proposed and Predicate DeviceThe proposed addition of "fine needle biopsy (FNB)" to the Indications for Use is the same as the primary predicate Cook Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle cleared via K160229. The ViziShot 2 FLEX has the same technological characteristics and design as the as the reference predicate ViziShot 2 FLEX cleared under K163469. The subject and predicate device operate in the same manner to obtain a tissue biopsy using an ultrasound endoscope. Please refer to the following Substantial Equivalence Table. {5}------------------------------------------------ - | | Proposed Device | Predicate Device (K160229) | Reference Device (K163469) | | |------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------| | Device Name/ Characteristics | Gyrus ACMI ViziShot 2 FLEX | Cook Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle | Gyrus ACMI ViziShot FLEX | Comment | | Indications for Use | The ViziShot 2 FLEX has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use. | Echotip Procore® Endobronchial High Definition Ultrasound Biopsy Needle for use with Olympus EBUS scopes: This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract. | The ViziShot FLEX has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use. | Similar to the Cook Predicate. | | Use Conditions | Surgical suite, endoscopy or bronchoscopy suite, used with a bronchoscope | Surgical suite, endoscopy or bronchoscopy suite, used with a bronchoscope | Surgical suite, endoscopy or bronchoscopy suite, used with a bronchoscope | Identical | | Mechanics of Action | Manual | Manual | Manual | Identical | | Mode of Action | Single/multiple puncture and aspirate | Single/multiple puncture and aspirate | Single/multiple puncture and aspirate | Identical | | General design | Handle, Sheath, Needle, Stylet | Handle, Sheath, Needle, Stylet | Handle, Sheath, Needle, Stylet | Identical | | Patient Contacting Materials | Stainless Steel, PTFE, PEBAX, Nitinol | Unknown | Stainless Steel, PTFE, PEBAX, Nitinol | Identical to reference ViziShot 2 FLEX | | Biocompatible | Yes | Yes | Yes | Identical | | Single Use Only | Yes | Yes | Yes | Identical | | Working OD (mm) | 2.08 | Unknown | 2.08 | Identical to reference ViziShot 2 FLEX | | Catheter Length (cm) | 70 | Unknown | 70 | Identical to reference ViziShot 2 FLEX | | Needle Gauge | 19G | 22G, 25G | 19G | Identical to | | | Table 5.1 Comparison of Proposed and Predicate Device | | |--|-------------------------------------------------------|--| | | | | {6}------------------------------------------------ | | Proposed Device | Predicate Device (K160229) | Reference Device (K163469) | | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | Device Name/ Characteristics | Gyrus ACMI ViziShot 2 FLEX | Cook Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle | Gyrus ACMI ViziShot FLEX | Comment | | | | | | reference ViziShot 2 FLEX | | Typical Needle Length (mm) | 20 | Unknown | 20 | Identical to reference ViziShot 2 FLEX | | Max Needle Length (mm) | 40 | Unknown | 40 | Identical to reference ViziShot 2 FLEX | | Stylet OD (in) | 0.0204 | Unknown | 0.0204 | Identical to reference ViziShot 2 FLEX | | Stylet Surface Finish | Polished | Unknown | Polished | Identical to reference ViziShot 2 FLEX | | Accessories | Syringe with stopcock and Adapter biopsy valve are provided with device | Syringe with stopcock and Device adapter/ biopsy valve are provided with device | Syringe with stopcock and Adapter biopsy valve are provided with device | Identical | | Packaging | Needle assembly, syringe, adapter placed in tray with snap downs and Tyvek lid. Tray placed in shelf box prior to sterilization. | Needle assembly, syringe, adapter placed in tray with snap downs and lid. | Needle assembly, syringe, adapter placed in tray with snap downs and Tyvek lid. Tray placed in shelf box prior to sterilization. | Identical | | Sterilization | EO | EO | EO | Identical | | Shelf Life | 3 Year at launch | Unknown | 1 Year at launch | Reference device subsequent to launch achieved 3 Year Shelf Life | # Summary of Perfomance Testing The proposed ViziShot 2 FLEX in its final finished form is identical to the reference ViziShot 2 FLEX (previously marketed device) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents). {7}------------------------------------------------ The following performance data were provided in support of the substantial equivalence determination. ### Biocompatibility testing: Biocompatibility testing on all patient contacting surfaces has been performed in Accordance with the FDA Guidance Document "Use of International Standard ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Biocompatibility testing included the following tests: - ISO 10993-4: 2002 Biological evaluation of medical devices Part 4: ● Selection of tests for interactions with blood - . ISO 10993-5: 2009 Biological evaluation of medical devices - Part5: Tests for in vitro cytotoxicity - ISO 10993-10: 2010 Biological evaluation of medical devices. Tests for . irritation and sensitization - ISO 10993-11:2006. Biological evaluation of medical devices. Tests for ● systemic toxicity - United States Pharmacopeia 39, National Formulary 34, 2016 <151> Pyrogen ● Test - United States Pharmacopeia 39, National Formulary 34, 2016 <85> Bacterial ● Endotoxins Test ViziShot 2 FLEX is external communicating, blood path, indirect, and limited duration (<24 hour). ### Sterilization/Shelf Life testing: The ViziShot 2 FLEX will be delivered in a sterile state and is intended for single patient use only. Sterilization (ethylene oxide) and packaging of the device was validated using the following standards: - ANSI/AAMI/ISO 11607-1:2006 Packaging for terminally sterilized medical ● devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - ANSI/AAMI/ISO 11135-1:2014 Sterilization of health-care products ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices Packaging integrity and performance testing on devices that had undergone accelerated aging support a labeled three year shelf life. Accelerated aging tests for the ViziShot 2 FLEX was conducted in accordance with ASTM F1980-16. Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. {8}------------------------------------------------ #### Performance testing - Bench During design verification, the output of the design process was evaluated against the physical and performance specifications. The following performance tests were conducted: - · Sheath and Needle Insertion and Withdrawal Force - · Stylet Insertion and Withdrawal Force - Bronchoscope Angulation - · Activation Force - Plastic Deformation Angle - · Penetration Force - · Transmission Force - Device Durability/Handle Durability - Bronchoscope Adapter Sliding Force - · Handle Durability - · Sheath to Handle Joint Strength - · Echogenicity A GLP Comparison of the ViziShot 2 FLEX to the Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle was performed. The purpose of this study was to evaluate the test article. ViziShot 2 FLEX 19G Needle, and a predicate control article to determine if the needles obtain sufficient tissue samples for histologic and core sample analysis and that the test article needle provided similar quality of samples as the predicate. The performance testing in this study included observations on ease of needle passage through the tissue, and tissue sampling metrics to include weight, length, number of segments and quality of the tissues obtained for microscopic evaluation. ### Performance testing - Animal No animal study was performed to demonstrate substantial equivalence. #### Performance testing - Clinical No clinical study was performed to demonstrate substantial equivalence. #### Conclusion: In summary, the Olympus ViziShot 2 FLEX is substantially equivalent to the predicate devices and presents no new questions of safety or effectiveness.