The VSII System is intended for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, as well as 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.

Device Description

Visionsense Stereoscopic Vision System (VSn) consists of a proprietary CCD camera, embedded in the distal end of a rigid metal arthroscope. An array of miniature lenses - the Lenticular Arrav (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 eyes 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.

AI/ML Overview

The provided text is a 510(k) summary for the Visionsense Stereoscopic Vision System (VSn). It describes the device, its intended use, and substantial equivalence to predicate devices. However, the document does not contain explicit acceptance criteria or detailed study results demonstrating performance against such criteria.

The section titled "Performance" states: "No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FDC Act") for arthroscopes. However, the VSn System and its components comply with international standards for electrical safety, electromagnetic compatibility, and biocompatibility."

This indicates that the submission primarily relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a performance study with defined acceptance criteria.

Therefore, many of the requested details cannot be extracted from the provided document.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in the document for product performance. The document mentions compliance with "international standards for electrical safety, electromagnetic compatibility, and biocompatibility," which serve as regulatory acceptance criteria for device components, but not performance criteria related to its imaging capabilities or clinical effectiveness.
Reported Device Performance: Not detailed in terms of a clinical or technical performance study with specific metrics. The document focuses on the system's ability to provide "stereo vision" by capturing images from slightly different angles and processing them for display.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable/Not provided. The document does not describe a clinical or technical performance study with a test set.

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 applicable/Not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not provided.

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/Not provided. This device is a vision system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable/Not provided. This device is a vision system for human use, not an automated algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable/Not provided.

8. The sample size for the training set:

Not applicable/Not provided. The document does not describe a machine learning model requiring a training set.

9. How the ground truth for the training set was established:

Not applicable/Not provided.

Summary of available information related to performance/equivalence:

Device: Visionsense Stereoscopic Vision System (VSn)
Intended Use: Viewing internal surgical sites during anterior and posterior spinal procedures (nucleotomy, discectomy, foraminotomy), general surgical procedures, and visualization of ventricles and structures within the brain during neurological surgical procedures.
Technological Characteristics: Proprietary CCD camera with a Lenticular Array to capture images from slightly different angles, mimicking natural human stereo vision. Images are processed and presented on a stereoscopic display panel.
Basis for Clearance: Substantial Equivalence to predicate devices (K081102, K073279, K990635, K051827) and compliance with international standards for electrical safety, electromagnetic compatibility, and biocompatibility. The current submission expands the indications for use based on similarity to previously cleared versions and other endoscopes.
Performance Standards: No specific performance standards or special controls under Section 514 for arthroscopes.

Summary

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K082355

Page ① of ②

510(k) Summary

VI-HOUSENSE

Submitter

DEC 1 5 2008

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@hhlaw.com

Date Prepared

December 10, 2008 1

Device Information

Trade name: VSu Common name: Visionsense Stereoscopic Vision System Classification Name: Arthroscope Review Panel: Orthopedic Product Code: HRX Device Class: Class II

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K082355

Page (2) of (6)

Predicate Devices

510(k) number	Trade or propriety name	Manufacturer
K081102, K073279	VSII - Visionsense StereoscopicVision System	Visionsense Ltd.
K990635	Vista Stereoscope System	Vista MedicalTechnologies
K051827	THESSYS Multiscope	Joimax GmbH

Intended Use/Indications for Use

Technological Characteristics/Principles of Operation

Substantial Equivalence

Visionsense's VSn was previously cleared by FDA 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 (K081102, K073279). The subject device is technologically similar to the one for which FDA has granted marketing clearance, except Visionsense is now expanding the indication to include diagnostic and surgical procedures, such as nucleotomy, discectomy, and foraminotomy.

Visionsense's VSn System is also substantially equivalent to other endoscopes, namely the Joimax THESSYS Multiscope (K051827) and the Vista Stereoscope System (K990635). Performance data to support this claim is included in the body of the submission file. Thus, the VSm System is substantially equivalent to the identified predicate devices.

Performance

No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FDC Act") for arthroscopes. However, the VSn System and its components comply with international standards for electrical safety, electromagnetic compatibility, and biocompatibility.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 2008

Visionsense, Ltd. % Hogan & Hartson, LLP Mr. Gerard J. Prud'homme 555 Thirteenth Street, Northwest Washington, District of Columbia 20004

Re: K082355

Trade/Device Name: VSn Visionsense Stereoscopic Vision System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX, GWG Dated: November 25, 2008 Received: November 25, 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.

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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 N. Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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082335-

Indications for Use

510(k) Number:

Device Name:

VSu - Visionsense Stereoscopic Vision System

Indications for Use:

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)

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Neil R. Onken for mkn

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K082355

\\DC - 082456/000001 - 2829350 v1

Regulation Number and Section

§ 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.