(69 days)
Not Found
No
The summary describes a stereoscopic vision system for surgical visualization, focusing on optical components, image capture, and display. There is no mention of AI or ML algorithms for image analysis, processing beyond basic stereoscopic signal generation, or any other function.
No.
The device is described as a vision system intended for viewing internal surgical sites and does not perform any therapeutic function.
No
Explanation: The device is intended for viewing internal surgical sites and does not perform any analysis or interpretation of medical data to diagnose a condition.
No
The device description explicitly lists multiple hardware components (Endoscope, Light source, Camera Control Unit, Camera, Display monitors, 2D Endoscope coupler) that are part of the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for viewing internal surgical sites during various surgical procedures. This is a direct visualization tool used in vivo (within the living body) during surgery.
- Device Description: The components listed (endoscope, light source, camera, display monitors, etc.) are all consistent with a surgical visualization system, not a device that analyzes biological samples in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, urine, etc.), performing tests on samples, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to provide visual access to internal anatomy during surgery.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
HRX, GWG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal surgical sites, ventricles and structures within the brain, anterior and posterior spinal, shoulder, knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, surgical procedures, neurological procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
-
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.1100 Arthroscope.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
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: (203) 880-4091
Alternate Contact Azi Ben-Yishai 20 Hamagshimim Street Petach, Tikva 49348 Israel +972 (3) 9244339 Phone: Facsimile: +972 (3) 9244335
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.
1
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.
2
-
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
(subject device) | VS3 Neurosurgery
(K131434) | VSii Arthroscope
(K082355) | Karl Storz C-Mount
Arthroscope
(K983142) |
|---------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Manufacturer | Visionsense Ltd. | Visionsense Ltd. | Visionsense Ltd. | Karl Storz |
| Classification | Arthroscope
21.C.F.R. §888.1100
Product code HRX | Endoscope,
Neurological
21 C.F.R. §882.1480
Product code GWG | Arthroscope
21 C.F.R. §888.1100
Product code HRX | Arthroscope
21 C.F.R. §888.1100
Product code HRX |
| Indications for
Use | Intended for viewing
internal surgical sites
during surgical
procedures | Intended for viewing
internal surgical sites
during surgical
procedures | Intended for viewing
internal surgical sites
during surgical
procedures | Intended for viewing
internal surgical sites
during surgical
procedures |
| Endoscope type | Rigid Stainless Steel | Rigid Stainless Steel | Rigid Stainless Steel | Rigid Stainless Steel |
| Endoscope
diameter | 4 – 5.5mm | 4 - 5.5 mm | 4 - 5 mm | 4mm |
| Endoscope
length | 175 - 300 mm
(±5 mm) | 175 - 300 mm
(±5 mm) | 175 - 300 mm
(±5 mm) | 175mm |
| Working
distance range | 7 - 70mm | 7 - 70mm | 7 - 60mm | 7 - 70mm |
| Field of view | 70°-95° | 70°-95° | 70° | 95° |
| Direction of
View | 0° - 70° | 0° - 70° | 0° - 70° | 0° - 70° |
| Horizontal
Resolution | >199 lpf | >199 lpf | >150 Ipf | >199 lpf |
| Vertical
Resolution | >199 lpf | >199 lpf | >140 lpf | >199 Ipf |
| Depth of Field | 7 - 30mm and
15 - 60mm | 7 - 30mm and
15 - 60mm | 7 - 30mm and
15 - 60mm | 7 - 30mm and
15 - 60mm |
The following table shows the similarities between the VS3-OT and predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
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.
4
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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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
5
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FDA USE ONLY CONLY CONTRACT CANABLE OF CASE OF Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."