(42 days)
No
The description mentions image processing but does not include any terms or concepts related to AI or ML, such as neural networks, algorithms trained on data, or adaptive learning.
No.
The device is used for viewing anatomical sites and does not provide any therapy.
No
The device is intended for viewing and visualization of anatomical sites during surgical procedures, not for identifying diseases or conditions. The "further analysis" mentioned for recorded images does not explicitly indicate diagnostic use.
No
The device description explicitly states it consists of a proprietary CCD camera embedded in a rigid metal endoscope, which are hardware components. While it includes image processing software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures." This describes a device used in vivo (within the living body) for visualization during surgery.
- Device Description: The description details a system for capturing and displaying stereoscopic images from within the body using an endoscope and camera. This is consistent with a surgical visualization device.
- Lack of IVD Characteristics: An IVD device is intended for use in vitro (outside the living body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any analysis of biological specimens.
Therefore, the VSn system is a surgical visualization device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VSn system is intended for viewing internal surgical sites during general surgical procedures and and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.
Product codes
GWG
Device Description
Visionsense Stereoscopic Vision System (VSu) consists of a proprietary CCD camera, embedded in the distal end of a rigid metal endoscope. An array of miniature lenses - the Lenticular Array (LA) - built onto the CCD surface during the wafer fabrication process, captures the image from slightly different angles, thus mimicking the natural human 'Stereo vision' obtained when the cycs simultaneously pick up two different images of the same object (right and left). The captured image is subsequently transmitted to a PC workstation, processed and presented on a stereoscopic display panel. Images are recorded and may be later downloaded for further analysis.
Mentions image processing
The captured image is subsequently transmitted to a PC workstation, processed and presented on a stereoscopic display panel.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal surgical sites, ventricles and structures within the brain
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)
No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FDC Act") for endoscopes. However, the VS;j system and its components comply with international standards for electrical safety, electromagnetic compatibility, and biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).
0
KOSILOZ
:
………
SECTION 5: 510(k) Summary
VISIONSENSE
MAY 2 9 2008
Submitter
Visionsense Ltd (Previously known as Envision Advanced Medical Systems) 20 Hamagshimim Street P.O. Box 7149 Petach Tikva 49348 Israel Owner/Operator Number: 9042467 Establishment Registration Number: 9616637
Contact Person(s)
Gerard J. Prud'homme Partner Hogan & Hartson LLP 555 13th Street, NW Washington, DC 20004-1108 Tel: (202) 637-5735 Fax: (202) 637-5910 E-mail: GJPrudhomme@hhhlaw.com
OR
Benny Arazy Arazy Group Mizpe Aviv, Industrial Park 13 M. P. Misgav 20187, ISRAEL Tel: +972 (4) 994-7880 Fax: +972 (4) 994-4224 E-mail: benny(@arazygroup.com
Date Prepared
April 15, 2008
1
Device Information
Trade name: VSH Common name: Visionsense Stereoscopic Vision System Classification Name: Neurological Endoscope Review Panel: Neurology Product Code: GWG Device Class: Class II
Predicate Devices
| 510(k) number | Trade or propriety name | Manufacturer |
|---|---|---|
| K073279 | VSII (General Surgery) | Visionsense Ltd. |
| K964281 | Aesculap Angled Neuroendoscopes | Aesculap Inc. |
Intended Use/Indications for Use
The VSn system is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.
- »J
Technological Characteristics/Principles of Operation
Visionsense Stereoscopic Vision System (VSu) consists of a proprietary CCD camera, embedded in the distal end of a rigid metal endoscope. An array of miniature lenses - the Lenticular Array (LA) - built onto the CCD surface during the wafer fabrication process, captures the image from slightly different angles, thus mimicking the natural human 'Stereo vision' obtained when the cycs simultaneously pick up two different images of the same object (right and left). The captured image is subsequently transmitted to a PC workstation, processed and presented on a stereoscopic display panel. Images are recorded and may be later downloaded for further analysis.
Substantial Equivalence
Visionsense's VS1 was previously cleared by FDA for general surgery (K073279). The subject device is technologically similar to the one for which FDA has granted marketing clearance, except -- Visionsense is now seeking to expand the indication so it includes neurosurgical procedures as well.
Visionsense's VSu system is also substantially equivalent to other neurosurgical endoscopic devices, namely the Aesculap Angled Neuroendoscopes (K964281). Performance data, to support this claim, is included in the body of the submission file. Thus, the VSn System is substantially equivalent to the identified predicate devices.
2
Performance
No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FDC Act") for endoscopes. However, the VS;j system and its components comply with international standards for electrical safety, electromagnetic compatibility, and biocompatibility.
- 4 - ৮৮
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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 2008
Visionsense Ltd % Hogan & Hartson LLP Mr. Gerard J. Prud'homme 555 13th Street, Northwest Washington, District of Columbia 20004-1108
Rc: K081102
Trade/Device Name: VSn-Visionsense Stereoscopic Vision System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG Dated: April 17, 2008 Received: April 17, 2008
Dear Mr. Prud'homme:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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
Page 2 - Mr. Gerard J. Prud'homme
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Mulhearn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
KOSHOZ 510(k) Number:
Device Name:
VSII - Visionsense Stereoscopic Vision System
Indications for Use:
The VSu system is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.
Prescription Use __ V (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (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)
Page 1 of 1
Neil Koch for mkn
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number_