(348 days)
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.
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.
The provided document describes a 510(k) premarket notification for the VISTA™ Endoscope and Accessories. It outlines the device's description, indications for use, and a comparison of its technological characteristics with predicate devices. The "Performance Data" section briefly mentions that "Laboratory and performance tests were executed to ensure that the devices functioned as intended and met design specifications" and "Data demonstrated that the VISTA Endoscope and accessories met all performance testing acceptance criteria." However, it does not provide specific details about the acceptance criteria nor the study design, sample sizes, expert qualifications, or ground truth establishment for those performance tests.
Therefore, I can only provide the information that is present in the document.
1. A table of acceptance criteria and the reported device performance
The document states: "Data demonstrated that the VISTA Endoscope and accessories met all performance testing acceptance criteria."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly listed, but implied by compliance with standards: EN 60601-2-18: 1996, EN60601-1:1990, ISO 10993-1:2003, AAMI TIR12:2004, ISO 11137:2006. | The VISTA Endoscope and accessories met all performance testing acceptance criteria and comply with the listed standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Laboratory and performance tests were executed".
- Sample size: Not specified.
- Data provenance: Not specified. It's implied to be laboratory testing, but no details on the origin of the data or whether it was retrospective or prospective are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not specified. The document refers to "performance tests" and "design specifications" but does not mention the involvement of experts to establish a "ground truth" in the context of clinical or diagnostic performance. This is typically a technical performance study, not a clinical diagnostic study with expert review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not specified. This type of adjudication method is relevant for studies involving human interpretation of data, which is not described here.
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 document describes a medical device (endoscope), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document describes a medical device (endoscope), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated using the term "ground truth." For the performance tests, the "ground truth" would be the engineering specifications and standards that the device was designed to meet (e.g., optical properties, flexibility, material biocompatibility, sterility).
8. The sample size for the training set
Not applicable. This document describes a medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This document describes a medical device, not a machine learning model.
{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. AnastasDirector, Regulatory AffairsPhone: 650.362.6136Fax: 650.362.6186Email: janastas@vibrynt.com |
| Date Summary wasPrepared: | February 4, 2011 |
| Device Trade Name | VISTATM EndoscopeSCOUTTM Blunt-tipped Guide |
| Device CommonName: | Endoscope and accessories |
| Device ProductCodes andClassificationNames: | GCJ, Class IIEndoscope 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 forvisualization of the thoracic and abdominal cavities. The deviceis labeled non-sterile and must be sterilized prior to use. TheEndoscope may be used with or without the SCOUTTM Blunt-tipped Guide accessory, which aids in Endoscope advancementand steerability. The Guide also has a fluid channel (cannula)that may be used to deliver saline that may be required forirrigation during an endoscopic procedure. The SCOUTTMGuide is a sterile, single-use device, sterilized by electron beamradiation. |
| Indications for Use: | The VISTATM Endoscope and accessories are intended for usein providing access to, and visualization of, the thoracic andabdominal cavities, to allow for the performance of variousdiagnostic 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 DeviceVISTAEndoscope | Predicate Device(Olympus Laparo-ThoracoVideoscopeXLTF-VAW) | Predicate Device(Hans HermannLaparoscopicInstruments) | Predicate Device(AcclarentMicroEndoscope) |
|---|---|---|---|---|
| Indications forUse | The VISTAEndoscope andaccessories areintended for use inproviding accessto, andvisualization of,the thoracic andabdominalcavities, to allowfor theperformance ofvarious diagnosticand therapeuticsurgicalprocedures. | This instrumenthas been designed. for endoscopicobservation,diagnosis andtreatment withinthe thoracic andabdominal cavities,including femalereproductiveorgans. | The laparoscopesand accessoriesare intended foruse in providingaccess to andvisualization ofbody cavities,organs, and canalsto perform variousdiagnostic andtherapeuticsurgicalprocedures. | TheMicroEndoscope isintended to providean endoscopicmeans to view abody cavity for ear,nose, or throatprocedures. |
| Materialspotentiallycontactingpatient | Stainless steel,glass, epoxyEP42HT-2, blueultem, polyimide,Pebax | Not Known | Surgical gradestainless steel,PTFE, PEEK,several coatings.silicon and brasschromium plated | stainless steel,gradient imageglass, epoxyEP42HT-2, blackultem, polyimide,polyolefin |
| Rigidity | Flexible | Semi-rigid | Rigid | Semi-rigid |
| Viewing Optics | Coherent Fiber | Electronic VideoCCD | 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° (forwardViewing) | 0° (forwardViewing) | 0°,30 °, 45°, 70 ° | 70° |
| Outer Diameter ofDistal 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 DeviceVISTAEndoscope | Predicate Device(Olympus Laparo-ThoracoVideoscopeXLTF-VAW) | Predicate Device(Hans HermannLaparoscopicInstruments) | Predicate Device(AcclarentMicroEndoscope) |
|---|---|---|---|---|
| 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
§ 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.