← Product Code [GCJ](/productcode/GCJ) · K100533
# VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028, (K100533)
_Vibrynt, Inc. · GCJ · Feb 8, 2011 · Gastroenterology, Urology · SESE_
**Canonical URL:** https://fda.innolitics.com/device/K100533
## Device Facts
- **Applicant:** Vibrynt, Inc.
- **Product Code:** [GCJ](/productcode/GCJ.md)
- **Decision Date:** Feb 8, 2011
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Therapeutic
## 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.
## 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).
## Regulatory 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.
## Predicate Devices
- Olympus Laparo-Thoraco Videoscope ([K053382](/device/K053382.md))
- Hans Hermann Laparoscopes and Accessories ([K051610](/device/K051610.md))
- Acclarent MicroEndoscope ([K063078](/device/K063078.md))
## Submission Summary (Full Text)
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>
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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
---
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