VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM

K141002 · Visionsense, Ltd. · HRX · Jun 26, 2014 · Orthopedic

Device Facts

• Record ID: K141002
• Device Name: VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
• Applicant: Visionsense, Ltd.
• Product Code: HRX · Orthopedic
• Decision Date: Jun 26, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Indications for Use

The VS3-OT system is intended for viewing internal surgical procedures, visualization of ventricles and structures within the brain during neurological procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and shoulder and knee arthroscopic procedures.

Device Story

VS3-OT is a stereoscopic high-definition (3DHD) vision system for surgical visualization. System components include a rigid stainless steel endoscope, light source, camera control unit (CCU), camera, and display monitors. Operation involves inserting the endoscope into the surgical site; internal illumination provides light. The proximal stereoscopic camera block captures right and left images from different angles via an optical array. The CCU processes these inputs to generate a stereoscopic video signal for display. Used in OR settings by surgeons to view internal anatomy; facilitates surgical navigation and decision-making. Includes 2D coupler for compatibility with third-party 2D endoscopes. Provides high-resolution 3D visualization to assist in surgical precision.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance validated through adherence to consensus standards including AAMI/ANSI ES60601-1 (electrical safety), AAMI/ANSI/IEC 60601-1-2 (EMC), IEC 60601-2-18 (endoscopic equipment safety), ISO 14971 (risk management), and AAMI/ANSI/ISO 10993-1 (biocompatibility).

Technological Characteristics

Rigid stainless steel endoscope (4-5.5mm diameter, 175-300mm length); proximal HD stereoscopic camera block; internal illumination; CCU for signal processing; 2D coupler for third-party scope compatibility. Standards: AAMI/ANSI ES60601-1, AAMI/ANSI/IEC 60601-1-2, IEC 60601-2-18, ISO 14971, AAMI/ANSI/ISO 10993-1. Connectivity: Video output to display monitors.

Indications for Use

Indicated for patients undergoing general, neurological, spinal (nucleotomy, discectomy, foraminotomy), shoulder, or knee arthroscopic surgical procedures requiring internal visualization.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Visionsense Ltd VS3 for Neurosurgery (K131434)
• Visionsense Ltd VSii Arthroscope (K082355)
• Karl Storz C-Mount Arthroscope (K983142)

Submission Summary (Full Text)

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#### 510(k) Summary K141002

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: April 11, 2014

Applicant Visionsense Ltd 20 Hamagshimim Street Petach Tikva 49348 Israel

Contact Person Raymond Kelly Licensale Inc. 57 Lazy Brook Rd Monroe, CT 06468 USA Phone: [phone]

Alternate Contact Azi Ben-Yishai 20 Hamagshimim Street Petach, Tikva 49348 Israel [phone] Phone: Facsimile: [phone]

Device Information Trade name: VS3 Stereoscopic High Definition Vision System, Model VS3-OT Common name: Endoscope, Arthroscope Classification Name: Arthroscope Review Panel: General and Plastic Surgery Product Code: HRX Device Class: Class II Regulation: 21 C.F.R. §888.1100

Predicate Device Information Visionsense Ltd VS3 for Neurosurgery (K131434) Visionsense Ltd VSii Arthroscope (K082355) Karl Storz C-Mount Arthroscope (K983142)

#### Intended Use/Indications for Use

The VS3-OT system is intended for viewing internal surgical sites during general surgical procedures, visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures.

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## Technological Characteristics

The VS3 Stereoscopic High Definition Vision System, Model VS3-OT consists of the following components:

- > Endoscope
- > Light source
- > Camera Control Unit (CCU)
- > Camera
- > Display monitors
- > 2D Endoscope coupler

The VS3 Stereoscopic High Definition ("3DHD") Vision System, Model VS3-0T is based on the proximal HD camera concept with a stereoscopic camera block located on the proximal side of the endoscope (the handle). This allows high resolution capture of the 3D video stream. The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block containing the HD sensor module. The VS3 Stereoscopic High Definition Vision System. Model VS3-OT allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housing optical relay components and light fibers. The VS3 Stereoscopic High Definition Vision System, Model VS3-OT also includes 2D coupler capability that allows the VS3 Stereoscopic High Definition Vision System, Model VS3-OT to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.

### Principles of Operation

During surgical procedures, the surgeon inserts the endoscope into the surgical site, which is illuminated using the internal illumination source. The optical array then functions by capturing both right and left images of the surgical site from different angles. Both images are detected by the camera and transmitted to the CCU. Once the images are received by the CCU, the VS3 Stereoscopic High Definition Vision System, Model VS3-OT generates a stereoscopic signal of both the right and left images that can be sent to the display monitor.

#### Performance

No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") for endoscopes. However, the VS3 Stereoscopic High Definition Vision System, Model VS3-OT and its components follow FDA recognized consensus standards for electrical safety, electromagnetic compatibility, and biocompatibility:

- > AAMI/ANSI ES60601-1:2005:A1:2012 Medical electrical equipment part 1: general requirements for basic safety and essential performance.
- > AAMI/ANSI/IEC 60601-1-2:2007 Medical electrical equipment part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.

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- > IEC 60601-2-18:2009 Medical electrical equipment part 2-18: particular requirements for the basic safety and essential performance of endoscopic equipment
- > ISO 14971:2007 Medical devices application of risk management to medical devices.
- > AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of medical devices -part 1: evaluation and testing within a risk management process.

#### Substantial Equivalence

The Visionsense VS3 Stereoscopic High Definition Vision System, Model VS3-OT has the same intended use and similar indications, principles of operation, and technological characteristics as the cleared VS3 for Neurosurgery (K131434), VSii Arthroscope (K082355), and Karl Storz Arthroscope (K983142). Thus, the VS3 Stereoscopic High Definition Vision System, Model VS3-OT is substantially equivalent to its predicate devices.

| | VS3-OT<br>(subject device) | VS3 Neurosurgery<br>(K131434) | VSii Arthroscope<br>(K082355) | Karl Storz C-Mount<br>Arthroscope<br>(K983142) |
|---------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Manufacturer | Visionsense Ltd. | Visionsense Ltd. | Visionsense Ltd. | Karl Storz |
| Classification | Arthroscope<br>21.C.F.R. §888.1100<br>Product code HRX | Endoscope,<br>Neurological<br>21 C.F.R. §882.1480<br>Product code GWG | Arthroscope<br>21 C.F.R. §888.1100<br>Product code HRX | Arthroscope<br>21 C.F.R. §888.1100<br>Product code HRX |
| Indications for<br>Use | Intended for viewing<br>internal surgical sites<br>during surgical<br>procedures | Intended for viewing<br>internal surgical sites<br>during surgical<br>procedures | Intended for viewing<br>internal surgical sites<br>during surgical<br>procedures | Intended for viewing<br>internal surgical sites<br>during surgical<br>procedures |
| Endoscope type | Rigid Stainless Steel | Rigid Stainless Steel | Rigid Stainless Steel | Rigid Stainless Steel |
| Endoscope<br>diameter | 4 – 5.5mm | 4 - 5.5 mm | 4 - 5 mm | 4mm |
| Endoscope<br>length | 175 - 300 mm<br>(±5 mm) | 175 - 300 mm<br>(±5 mm) | 175 - 300 mm<br>(±5 mm) | 175mm |
| Working<br>distance range | 7 - 70mm | 7 - 70mm | 7 - 60mm | 7 - 70mm |
| Field of view | 70°-95° | 70°-95° | 70° | 95° |
| Direction of<br>View | 0° - 70° | 0° - 70° | 0° - 70° | 0° - 70° |
| Horizontal<br>Resolution | >199 lpf | >199 lpf | >150 Ipf | >199 lpf |
| Vertical<br>Resolution | >199 lpf | >199 lpf | >140 lpf | >199 Ipf |
| Depth of Field | 7 - 30mm and<br>15 - 60mm | 7 - 30mm and<br>15 - 60mm | 7 - 30mm and<br>15 - 60mm | 7 - 30mm and<br>15 - 60mm |

The following table shows the similarities between the VS3-OT and predicate devices.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

June 26, 2014

Visionsense Ltd. % Ravmond Kelly Licensale Inc. 57 Lazy Brook Road Monroe, Connecticut 06468

Re: K141002

> Trade/Device Name: Vs3 stereoscopic high definition vision system Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX. GWG Dated: April 7, 2014 Received: April 18, 2014

Dear Mr. Kelly.

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 mav, 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 cither 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 (reporting of medical devicerelated 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.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# David Krause - S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K141002

Device Name

VS3 Stereoscopic High Definition Vision System, Model VS3-OT

#### Indications for Use (Describe)

The VS3-OT system is intended for viewing internal surgical procedures, visualization of ventricles and structures within the brain during neurological procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectorny, and shoulder and knee arthroscopic procedures.

#### Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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