SURGVIEW INTEGRATED VISUALIZATION SYSTEM
Device Facts
| Record ID | K082293 |
|---|---|
| Device Name | SURGVIEW INTEGRATED VISUALIZATION SYSTEM |
| Applicant | Biovision Technologies, LLC |
| Product Code | HRX · Orthopedic |
| Decision Date | Sep 9, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.1100 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Indications for Use
The SurgView™ Integrated Visualization System is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.
Device Story
SurgView™ Integrated Visualization System provides illumination and visualization for diagnostic and operative arthroscopic/endoscopic procedures. System components: light source/display/image capture unit (monitor, processor, Xenon light source, camera unit, handpiece with integrated fiberoptic cable); semi-rigid, single-use fiberoptic scope (various diameters/lengths/angles); supplemental instruments (cannula, trocar, obturator, plug); and procedural kit. Operated by trained physicians in clinical settings. Device captures internal cavity images via fiberoptic scope, processes signals, and displays real-time video on integrated monitor to assist surgical navigation and decision-making. Benefits include improved visualization of internal anatomy during minimally invasive procedures.
Clinical Evidence
No clinical data was used to establish substantial equivalence. Equivalence is supported by non-clinical performance and safety testing, including compliance with UL/CSA/EN60601-1 (general safety), UL/CSA/EN60601-2-18 (endoscopic equipment safety), EN60601-1-2 (electromagnetic compatibility), and 47 CFR Part 15.
Technological Characteristics
System includes Xenon light source, camera unit, monitor, and semi-rigid fiberoptic scope. Complies with UL/CSA/EN60601-1:1990, UL/CSA/EN60601-2-18:1996, and EN60601-1-2. Connectivity is integrated within the console. Single-use scope design.
Indications for Use
Indicated for use by trained physicians for illumination and visualization of interior body cavities via natural or surgical openings during diagnostic and operative arthroscopic and endoscopic procedures (e.g., knee, shoulder, ankle, elbow, wrist, TMJ, spinal, ophthalmic, ENT, cervix, urethra).
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
- InnerVue Diagnostic Scope System (K07287)
- Video Arthroscope (K04339)
- Arthrex Arthroscopes (K03009)
- METRx System (K00293)
- Davlite Microendoscope (K02031)
Submission Summary (Full Text)
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 emblem of an eagle with its wings stylized into three curved lines.
SEP 0 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BioVision Technologies, LLC % TÜV SÜD America Inc. Ms. Dawn Tibodeau 1775 Old Highway 8 NW, Suite 104 New Brighton, Minnesota 55112-1891
Re: K082293
Trade/Device Name: SurgView™ Integrated Visualization System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX, GCJ Dated: August 22, 2008 Received: August 25, 2008
Dear Ms. Tibodeau:
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.
{1}------------------------------------------------
Page 2 - Ms. Dawn Tibodeau
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. Millerson
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Enclosure
{2}------------------------------------------------
Ko82293
## Indications for Use
510(k) Number (if known): K082293
Device Name: SurgView™ Integrated Visualization System
Indications for Use:
The SurgView™ Integrated Visualization System is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.
Daniel Krane for Nixon
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K082293
Prescription Use ✔ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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
PAGE 2.1
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for BioVision Technologies, LLC. The logo is in black and white and features the word "BIOVISION" in a stylized font. The word "Technologies, LLC" is written in a smaller font to the right of "BIOVISION" and is underlined. The logo is simple and professional.
## 510(k) Summary of Safety and Effectiveness SurgView™ Integrated Visualization System
| Date: | June 3, 2008 |
|--------------------|-------------------------------------------------------|
| Applicant/Sponsor: | BioVision Technologies, L.L.C. |
| Address: | 221 Corporate Circle Unit H<br>Golden, Colorado 80401 |
| Telephone Number: | (303) 237-9608 |
| Facsimile Number: | (303) 237-0757 |
| Contact Person: | David Sanso<br>President |
| Proprietary Name: | SurgView™ Integrated Visualization System |
| Regulation Name: | Arthroscope<br>Endoscope |
| Regulation Number: | 21 CFR §888.1100, HRX<br>21 CFR §876.1500, GCJ |
Regulatory Class: II
## Information on devices to which substantial equivalence is claimed:
| COMPANY | DEVICE | 510(k) |
|-------------------------|----------------------------------|--------|
| Biomet Sports Medicine | InnerVue Diagnostic Scope System | K07287 |
| Smith & Nephew | Video Arthroscope | K04339 |
| Arthrex, Inc | Arthrex Arthroscopes | K03009 |
| Medtronic Sofamor Danek | METRx System | K00293 |
| Davlite Technologies | Davlite Microendoscope | K02031 |
## Device Description:
The SurgView™ Integrated Imaging System is a video endoscope/arthroscope imaging system consisting of the following components:
- 1. A Light Source/Display/Image Capture device that includes a monitor, image processor, Xenon light source, camera unit, and a camera hand piece with integrated fiberoptic cable.
2. A semi-rigid Fiberoptic Scope designed for one time use, in a variety of diameters, lengths, and viewing angles.
All trademarks are property of BioVision Technologies, LLC
{4}------------------------------------------------
3. Supplemental Instruments that can be used interchangeably throughout the procedure. They include a cannula, trocar, obturator, and cannula plug.
4. Procedural Kit that contains a variety of sterile items used to aid in the procedure.
Indications for Use: The SurgView™ Integrated Visualization System is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use are included but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, shoulder, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, cervix, and the urethra.
Summary of Technologies: The SurgView™ Integrated Visualization System technological characteristics are similar to predicate devices.
Non-Clinical Testing: Establishment of equivalence is based on similarities of intended use, design, and materials, physical characteristics and geometry between the SurgView™ Integrated Visualization System and predicate devices.
Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.
Performance and Safety Testing: The SurgView™ Integrated Visualization System complies with UL/CSA/EN60601-1:1990 Medical electrical equipment - Part 1. General requirements for safety; UL/CSA/EN60601-2-18:1996 Medical electrical equipment -Part 2. Particular requirements for the safety of endoscopic equipment; EN60601-1-2, Group 2, Class B. Collateral standard electromagnetic compatibility; 47 CFR Part 15.
280
510(K) SUMMARY PAGE 2.2
