(73 days)
No
The description focuses on the physical design, optical transmission, and working channels of the endoscope. There is no mention of AI, ML, image processing, or any data analysis beyond transmitting stereoscopic images to an external display.
No
The device is described as an endoscope intended for viewing internal surgical sites and does not perform any therapeutic function.
No
The device is described as an endoscope intended for viewing internal surgical sites during surgical procedures, not for diagnosing conditions.
No
The device description explicitly details a rigid metal shaft, a proximal sensor module, optical transmission, fiber optic threads, and working channels, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for viewing internal surgical sites during various surgical procedures. This is a direct visualization tool used during a medical procedure on a patient.
- Device Description: The description details a rigid endoscope with optical transmission and working channels. This aligns with a surgical instrument used for direct observation within the body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing information about a patient's health status based on the analysis of biological samples.
- Performing tests in vitro (outside the living body).
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical visualization tool used in vivo (within the living body).
N/A
Intended Use / Indications for Use
The 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, and foraminotomy, and shoulder and large joint arthroscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
HRX, GWG
Device Description
The VS3 ETV endoscope is the same endoscope as the predicate VS3 with the addition of 3 working channels. The endoscope is designed and manufactured the same way. The endoscope is a rigid metal shaft that uses a proximal sensor module which is mounted onto a camera block on the proximal side of the endoscope (the handle). The endoscope uses stereoscopic images which are transmitted from the visual field at the distal end of the scope through an optical transmission (for left and right channels). The endoscope camera sensor module picks up the left and right images of the scene inside the body and delivers them to the external display. The endoscope incorporates fiber optic threads that transfer the light from the illumination unit to the surgical scene. The VS3 ETV endoscope contains 3 working channels. The endoscope utilizes the same principle of operation, software, system architecture, camera and visual viewing technologies, illumination sources, display monitors, carts, CCU and couplers as the predicate VS3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical transmission
Anatomical Site
internal surgical sites during general surgical procedures, ventricles and structures within the brain during neurological surgical procedures, internal surgical sites during anterior and posterior spinal procedures, shoulder and large joint arthroscopic procedures.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance testing consisting of reuse validation, cleaning and disinfection validation, autoclave and sterilization were performed to demonstrate the additional working channels do not present changes in reuse handling and processing compared to the predicate device.
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles incorporated into the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2016
Visionsense Ltd % Raymond Kelly Licensale Inc 57 Lazy Brook Rd Monroe, Connecticut 06468
Re: K153548
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: December 25, 2015 Received: January 8, 2016
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 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 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.
1
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
2
Indications for Use
510(k) Number (if known)
Device Name
VS3-ETV
Indications for Use (Describe)
The 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, and foraminotomy, and shoulder and large joint 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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) Summary Visionsense VS3-ETV
Submitter's Name, Address, Telephone Number,
Visionsense Ltd. 20 Hamagshimim Street, Petach Tikva 49348 Israel Phone: 972-3-9244339 Facsimile: +972-3-9244-335
Contact Person and Date Prepared
Raymond Kelly 57 Lazy Brook Rd Monroe, CT 06468 USA Phone: (203) 880-4091
Date Prepared: October 25, 2015
Name of Device
VS3-ETV
Common or Usual Name / Classification Name Neurological Endoscope / Arthroscope
| Product Code / | Regulation Number |
|---|---|
| GWG / HRX | 882.1480 / 888.1100 |
Review Panel Neurology / Orthopedic
Device Class: Class II
Predicate Device
VS3 Stereoscopic High Definition Vision System, Model VS3 (K141002)
Intended Use / Indications for Use
The 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 large joint arthroscopic procedures.
Principles of Operation / Conditions of Use
The VS3 ETV endoscope is the same endoscope as the predicate VS3 with the addition of 3 working channels. The endoscope is designed and manufactured the same way. The endoscope is a rigid metal shaft that uses a proximal sensor module which is mounted onto a camera block on the proximal side of the endoscope (the handle). The endoscope uses stereoscopic images which are transmitted from the visual field at the distal end of the scope through an optical transmission (for left and right channels). The endoscope camera sensor module picks up the left and right images of the scene inside the body and delivers them to the external display. The endoscope incorporates fiber optic threads that transfer the light from the illumination unit to the surgical scene. The VS3 ETV endoscope contains 3 working channels. The endoscope utilizes the same principle of operation, software, system architecture, camera and visual viewing technologies, illumination sources, display monitors, carts, CCU and couplers as the predicate VS3.
4
Technological Characteristics / Performance Data
| Standards
No. | Standards
Organization | Standards Title |
|------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 60601-1-2 | IEC | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance -
collateral standard: electromagnetic compatibility -
requirements and tests (Edition 3). |
| 60601-1 | IEC | Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance. |
| 60601-1-4 | IEC | Medical electrical equipment - Part 1: General requirements
for safety, Collateral standard: Programmable electrical
medical systems. |
The subject device conforms to the following recognized standards:
Performance testing consisting of reuse validation, cleaning and disinfection validation, autoclave and sterilization were performed to demonstrate the additional working channels do not present changes in reuse handling and processing compared to the predicate device. No new biocompatibility assessments or electrical safety or EMC testing was required as the only modification to the VS3 system was the addition of 3 working channels.
| Feature/Parameter | Proposed VS3-ETV | Predicate VS3 (K141002) |
|---|---|---|
| Able to function with no | ||
| camera | No | No |
| Working distance range | 8mm - 70mm | 8mm - 70mm |
| Field Of View | 70° - 95° | 70° - 95° |
| Direction of view | 0º - 70º | 0° - 70° |
| Horizontal resolution | >199 Ipf | >199 Ipf |
| Vertical resolution | >199 lpf | >199 lpf |
| Identification | Support functionality to permit | |
| the system to identify scope | Support functionality to permit | |
| the system to identify scope | ||
| Irrigation Sheath | Support an optional irrigation | |
| sheath with a standard Storz- | ||
| style connector | Support an optional irrigation | |
| sheath with a standard Storz- | ||
| style connector | ||
| Endoscope diameter | 4 - 5.5 mm | 4 - 5.5 mm |
| Endoscope length | 175 - 300 mm (±5 mm) | 175 - 300 mm (±5 mm) |
| Depth of field | 7 - 30mm and 15 - 60mm | 7 - 30mm and 15 - 60mm |
| Working Channels | yes | no |
Substantial Equivalence
Working/Irrigation Channels Reference Device
K983365 (Aesculap Minop System) cleared December 1998 is used as reference device to show precedence of the irrigation and working channels.
Conclusions
The VS3-ETV is substantially equivalent to the predicate device. Performance testing demonstrates that the modified device performs substantially equivalent to the predicate device, and any differences in technological characteristics do not raise different questions of safety or efficacy compared to the predicate device.