VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028,

Q: Who is the manufacturer of VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028,?

Vibrynt, Inc. filed the 510(k) submission for VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028, (K100533).

Q: What is the FDA product code for VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028,?

GCJ. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

Q: What is the regulatory pathway for VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028,?

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

Q: What are the predicate devices for VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028,?

Olympus Laparo-Thoraco Videoscope (K053382); Hans Hermann Laparoscopes and Accessories (K051610); Acclarent MicroEndoscope (K063078).

Q: Who can help prepare an FDA 510(k) submission like VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028,?

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.

K100533 · Vibrynt, Inc. · GCJ · Feb 8, 2011 · Gastroenterology, Urology

Device Facts

Record ID	K100533
Device Name	VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028,
Applicant	Vibrynt, Inc.
Product Code	GCJ · Gastroenterology, Urology
Decision Date	Feb 8, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The VISTA™ Endoscope and accessories are intended for use in providing access to, and visualization of, the thoracic and abdominal cavities, to allow for the performance of various diagnostic and therapeutic surgical procedures.

Device Story

VISTA Endoscope is a flexible fiberscope for visualization of thoracic and abdominal cavities. Device inputs include light and optical images transmitted via internal fibers from distal to proximal end. Output is visual image viewed through eyepiece or via attached endoscopic camera on video monitor. Used by physicians in surgical settings. SCOUT Blunt-tipped Guide accessory aids advancement and steerability; includes fluid channel for saline irrigation. Guide features transparent polycarbonate tip; flexible PVC sheath; adjustable stylet. Endoscope is non-sterile (requires reprocessing); Guide is sterile, single-use (e-beam sterilized). Device provides access and visualization to facilitate surgical procedures; benefits include improved steerability and support for difficult-to-reach anatomy.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included compliance with EN 60601-2-18 (safety of endoscopic equipment), EN 60601-1 (general safety), ISO 10993-1 (biocompatibility), AAMI TIR12 (reprocessing), and ISO 11137 (sterilization).

Technological Characteristics

Flexible fiberscope; illumination and image fibers. Materials: stainless steel, glass, epoxy EP42HT-2, blue/black ultem, polyimide, Pebax, polyolefin. 5.0 mm distal diameter; 56.4-109.7 cm working length. 50,000 pixel coherent fiber optics; 70° field of view; 5mm-infinity depth of field. 0° direction of view. Connectivity: optical eyepiece or external camera/monitor. Sterilization: non-sterile (reusable endoscope), e-beam (single-use guide).

Indications for Use

Indicated for patients requiring access to and visualization of thoracic and abdominal cavities for diagnostic and therapeutic surgical procedures. No specific age or gender contraindications stated.

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

Olympus Laparo-Thoraco Videoscope (K053382)
Hans Hermann Laparoscopes and Accessories (K051610)
Acclarent MicroEndoscope (K063078)

Related Devices

K961536 — FLEXSCOPE · Matrix Medica, Inc. · Sep 18, 1996
K080780 — ANCHORAGE SCOPE, MODEL 000003 · Epitek, Inc. · Jul 30, 2008
K013617 — LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS · Olympus Optical Co., Ltd. · Jan 30, 2002
K193161 — Pristine Scope · Pristine Surgical · Apr 21, 2020
K020310 — DAVLITE MICROENDOSCOPE & ACCESSORIES · Davlite Technologies · Mar 20, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ K100533 R. 10f3 ## Vibrynt, Inc. . ﺗ # VISTA™ Endoscope and Accessories # 510(K) SUMMARY .EEB = 8 254 | Sponsor/Submitter: | Vibrynt, Inc. 701 Galveston Dr. Redwood City, CA 94063 | |---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Julia S. Anastas Director, Regulatory Affairs Phone: 650.362.6136 Fax: 650.362.6186 Email: janastas@vibrynt.com | | Date Summary was Prepared: | February 4, 2011 | | Device Trade Name | VISTATM Endoscope SCOUTTM Blunt-tipped Guide | | Device Common Name: | Endoscope and accessories | | Device Product Codes and Classification Names: | GCJ, Class II Endoscope and accessories (21 CFR 876.1500) | | Predicate Devices: | Olympus Laparo-Thoraco Videoscope (K053382) Hans Hermann Laparoscopes and Accessories (K051610) Acclarent MicroEndoscope (K063078) | | Device Description: | The VISTA Endoscope is a flexible fiberscope that allows for visualization of the thoracic and abdominal cavities. The device is labeled non-sterile and must be sterilized prior to use. The Endoscope may be used with or without the SCOUTTM Blunt- tipped Guide accessory, which aids in Endoscope advancement and steerability. The Guide also has a fluid channel (cannula) that may be used to deliver saline that may be required for irrigation during an endoscopic procedure. The SCOUTTM Guide is a sterile, single-use device, sterilized by electron beam radiation. | | Indications for Use: | The VISTATM Endoscope and accessories are intended for use in providing access to, and visualization of, the thoracic and abdominal cavities, to allow for the performance of various diagnostic and therapeutic surgical procedures. | {1}------------------------------------------------ Vibrynt, Inc. #### VISTA™ Endoscope and Accessories ## 510(K) SUMMARY Technological Characteristics: The VISTA Endoscope contains illumination and image fibers that transmit an image from the distal to the proximal end of the device. The image may be viewed through the eyepiece or by attaching a standard endoscopic camera and viewed using a video monitor. The Guide's transparent polycarbonate tip enables visibility during the procedure, while the flexible PVC sheath and adjustable stylet increase steerability and support for difficult-to-reach anatomy. The table below compares the technological characteristics of the VISTA Endoscope to those of the predicate devices. | Attribute | Subject Device VISTA Endoscope | Predicate Device (Olympus Laparo- Thoraco Videoscope XLTF-VAW) | Predicate Device (Hans Hermann Laparoscopic Instruments) | Predicate Device (Acclarent MicroEndoscope) | |---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The VISTA Endoscope and accessories are intended for use in providing access to, and visualization of, the thoracic and abdominal cavities, to allow for the performance of various diagnostic and therapeutic surgical procedures. | This instrument has been designed . for endoscopic observation, diagnosis and treatment within the thoracic and abdominal cavities, including female reproductive organs. | The laparoscopes and accessories are intended for use in providing access to and visualization of body cavities, organs, and canals to perform various diagnostic and therapeutic surgical procedures. | The MicroEndoscope is intended to provide an endoscopic means to view a body cavity for ear, nose, or throat procedures. | | Materials potentially contacting patient | Stainless steel, glass, epoxy EP42HT-2, blue ultem, polyimide, Pebax | Not Known | Surgical grade stainless steel, PTFE, PEEK, several coatings. silicon and brass chromium plated | stainless steel, gradient image glass, epoxy EP42HT-2, black ultem, polyimide, polyolefin | | Rigidity | Flexible | Semi-rigid | Rigid | Semi-rigid | | Viewing Optics | Coherent Fiber | Electronic Video CCD | Rigid rod-lens | Coherent Fiber | | Number of Pixels | 50,000 | N/A | N/A | 10,000 | | Depth of Field | 5mm - infinity | 15-100 mm | Not known | 3-25 mm | | Field of View | 70° | 80° -90° | Not known | 70° | | Direction of View | 0° (forward Viewing) | 0° (forward Viewing) | 0°,30 °, 45°, 70 ° | 70° | | Outer Diameter of Distal End | 5.0 mm | 5.4 - 10.5 mm | 5-10 mm | 0.9 mm | {2}------------------------------------------------ Vibrynt, Inc. #### VISTA™ Endoscope and Accessories ### 510(K) SUMMARY | Attribute | Subject Device VISTA Endoscope | Predicate Device (Olympus Laparo- Thoraco Videoscope XLTF-VAW) | Predicate Device (Hans Hermann Laparoscopic Instruments) | Predicate Device (Acclarent MicroEndoscope) | |-----------------|--------------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------| | Jacket Material | Pebax | Not Known | Stainless steel | Polyimide | | Working Length | 56.4 - 109.7 cm | 33.0 – 37.0 cm | 30.0-33.0 cm | 60.9 cm | Performance Data: Laboratory and performance tests were executed to ensure that the devices functioned as intended and met design specifications. Data demonstrated that the VISTA Endoscope and accessories met all performance testing acceptance criteria and comply with the following standards / guidance documents: EN 60601-2-18: 1996, Medical Electrical Equipment Part . 2: Particular requirements for the safety of endoscopic equipment and the corresponding general standard, EN60601-1:1990 Medical Electrical Equipment, Part 1: General Requirements for Safety ISO 10993-1:2003, Biological evaluation of medical . devices - Part 1: Evaluation and testing AAMI TIR12:2004 - Designing, testing, and labeling . reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers (VISTA Endoscope) . ISO 11137:2006, Sterilization of health care products -Radiation (parts 1 and 2) (SCOUT Guide) Conclusions: When compared to the predicate devices, the VISTA Endoscope and accessories do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Vibrynt. Inc. % Ms. Julia S. Anastas Director, Regulatory Affairs 701 Galveston Drive Redwood City, California 94063 FEB - 8 1 .: Re: K100533 Trade/Device Name: VISTA™ Endoscope; SCOUT™ Blunt-tipped Guide Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: February 01, 2011 Received: February 03, 2011 Dear Ms. Anastas: 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 {4}------------------------------------------------ Page 2 - Ms. Julia S. Anastas 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 (reporting of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours, Ky. B. R. for. Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K-100533 1.6 Vibrynt, Inc. VISTA™ Endoscope and Accessories Traditional 510(k) ### INDICATIONS FOR USE STATEMENT 510(k) Number (if known): .K100533 Trade Name: VISTA™ Endoscope SCOUT TM Blunt-tipped Guide Common Name: Endoscope and Accessories Indications For Use: The VISTA™ Endoscope and accessories are intended for use in providing access to, and visualization of, the thoracic and abdominal cavities, to. allow for the performance of various diagnostic and therapeutic surgical procedures. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Neil B. Boyle for mka (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K100533