VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES

K101734 · Visionscope Technologies, LLC · HRX · Sep 8, 2010 · Orthopedic

Device Facts

• Record ID: K101734
• Device Name: VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES
• Applicant: Visionscope Technologies, LLC
• Product Code: HRX · Orthopedic
• Decision Date: Sep 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Intended Use

The VisionScope High Definition Endoscopy Camera System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization and capture of still and motion pictures of an interior cavity of the body through a natural or surgical opening. Examples of generic surgical use include imaging of articular cavities, body cavities, hollow organs and canals. Additionally, when used in conjunction with an appropriately indicated and FDA 510(k)-cleared endoscope and light source, the VisionScope High Definition Endoscopy Camera Control Unit and Camera Handpiece are indicated for use in arthroscopic and endoscopic surgical procedures to provide illumination, visualization and capture of still and motion pictures of articular cavities, body cavities, hollow organs and canals.

Device Story

VisionScope High Definition Endoscopy Camera System provides illumination and visualization for diagnostic/operative arthroscopic and endoscopic procedures. System components: Camera Control Unit (CCU) with integrated light source and image capture electronics; Camera Handpiece; endoscopes (four lengths); sterile procedure kits. Device captures still/motion images of articular cavities, body cavities, hollow organs, and canals. Used in clinical settings by healthcare providers. CCU processes optical inputs from endoscope for display and recording. System supports visualization of interior body structures to assist clinical decision-making and surgical guidance. Benefits include high-definition imaging for minimally invasive procedures.

Clinical Evidence

Bench testing only. Verification and validation testing performed to demonstrate safety, effectiveness, and substantial equivalence. Device conforms to ANSI/AAMI/ISO 11135-1:2007, ISO 10993 series (biocompatibility), and various IEC/EN 60601 standards for electrical safety and electromagnetic compatibility.

Technological Characteristics

High-definition endoscopy camera system. Components: CCU (integrated light source, image capture), handpiece, endoscopes, sterile kits. Standards: ANSI/AAMI/ISO 11135-1:2007 (sterilization), ISO 10993-5/7/10/11 (biocompatibility), UL/IEC/EN 60601-1 (electrical safety), IEC 60601-2-18 (endoscopic equipment).

Indications for Use

Indicated for diagnostic and operative arthroscopic and endoscopic procedures requiring illumination, visualization, and image/video capture of interior body cavities, hollow organs, and canals via natural or surgical openings.

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 (K072879)
• Smith & Nephew HD Camera System (K070266)
• Smith & Nephew Arthroscope (K072675)
• Stryker LED Light Source (L9000) (K082813)
• EndoSheath (K990354)
• Smith & Nephew 660HD Image Management System (K060777)

Submission Summary (Full Text)

{0}------------------------------------------------

K10734

Image /page/0/Picture/1 description: The image shows the word "VISIONScope" in a stylized font. The "V" is large and has a circle with a dot inside, resembling an eye. The rest of the word is in a sans-serif font, with "VISION" in bold and "Scope" in a lighter weight.

VisionScope Technologies LLC 2352 Main Street, Suite 303 Concord, MA 01742 USA T: 1-978-776-9512 F: 1-978-776-9511

SEP 0 3 2010

# 510(k) Summary of Safety and Effectiveness as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which Substantial Equivalence is based

#### 1. Date Prepared: June 15, 2010

#### 2. 510(k) Owner's Name:

VisionScope Technologies, LLC 2352 Main Street, Suite 303 Concord, MA 01742, USA

### 3. Contact Information:

Lim Cheung, Ph.D. General Manager & CTO Telephone: [phone] Fax: [phone] Email: [e-mail]

## 4. Device Name

| Trade Name: | VisionScope High Definition Endoscopy Camera System with:<br>• Camera Control Unit<br>• Camera Handpiece<br>• Endoscopes (Accessories in four lengths)<br>• Sterile Procedure Kits (Accessories in four lengths) |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Endoscopes and Accessories: Video Systems, Image Capture, Light<br>Source, Endoscopes, Fiber Optic |
| Classification Name: | Endoscopes And/Or Accessories (21 CFR §876.1500): Video System<br>Image Capture, Light source, Endoscope, Fiber Optic<br>Arthroscope (21 CFR §888.1100) |

## 5. Predicate Devices:

| Primary: | | |
|-------------------------------------------------|---------|--------------------------|
| InnerVue Diagnostic Scope System | K072879 | Arthrotek Inc. (Biomet) |
| Secondary: | | |
| Smith & Nephew HD Camera System | K070266 | Smith & Nephew Endoscopy |
| Smith & Nephew Arthroscope | K072675 | Smith & Nephew Endoscopy |
| Stryker LED Light Source (L9000) | K082813 | Stryker Endoscopy |
| EndoSheath | K990354 | Vision Sciences Inc. |
| Smith & Nephew 660HD Image<br>Management System | K060777 | Smith & Nephew Endoscopy |

{1}------------------------------------------------

K101734

VisionSCOPE

VisionScope Technologies LLC 2352 Main Street, Suite 3 Concord, MA 01742 T: 1-978-776-9512 F: 1-978-776-9511

#### 6. Description of Device

The VisionScope High Definition Endoscopy Camera System is made up of the following components:

- · Integrated Camera Control Unit containing the camera control electronics, light source and image capture electronics
- Camera Handpiece .
- . VisionScope line of four Endoscopes of identical design except for the lengths
- . VisionScope Disposable Sterile Procedure Kits in four matched lengths as the endoscopes

#### 7. Indications for Use

The VisionScope High Definition Endoscopy Camera System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization and capture of still and motion pictures of an interior cavity of the body through a natural or surgical opening. Examples of generic surgical use include imaging of articular cavities, body cavities, hollow organs and canals.

Additionally, when used in conjunction with an appropriately indicated and FDA 510(k)-cleared endoscope and light source, the VisionScope High Definition Endoscopy Camera Control Unit and Camera Handpiece are indicated for use in arthroscopic surgical procedures to provide illumination, visualization and capture of still and motion pictures of articular cavities, body cavities, hollow organs and canals.

#### Comparison of Technological Characteristics 8.

The VisionScope System similarities to the predicate devices are:

- Has the same intended use and indications for use .
- . Utilizes the same operating principle
- Incorporates the same basic design .
- . Incorporates the same technological characteristics
- Tested to the same electrical and electromagnetic safety standards for medical electrical . equipment
- Manufactured under a quality system .

#### 9. Summary Performance Data

VisionScope conducted the verification and validation testing with the VisionScope High Definition Endoscopy Camera System to demonstrate safety and effectiveness and substantial equivalence to the predicate devices listed above. All verification and validation data demonstrate that the device is safe and effective and performs as intended.

The VisionScope System conforms to the following voluntary standards:

- ANSI/AAMI/ISO 11135-1:2007 ●
- ISO 10993-7:2008 .
- ISO 10993-5:2009 .

{2}------------------------------------------------

loh34

Image /page/2/Picture/1 description: The image shows the word "VISIONSCOPE" in a stylized font. The "V" is large and bold, with a circle containing a smaller circle and some dots inside it, placed in the upper part of the "V". The rest of the word is in a thinner, sans-serif font, with each letter clearly spaced. The overall impression is of a logo or brand name.

VisionScope Technologies LLC 2352 Main Street, Suite 303 Concord, MA 01742 USA T: 1-978-776-9512 F: 1-978-776-9511

- ISO·10993-10:2002
- . ISO 10993-11:2006
- UL 60601-1:2003 R4.06 .
- IEC 60601-1:1988 + A1:1991 + A2:1995, .
- EN 60601-1:1990 + A1 + A2 + A13 .
- . CAN/CSA 22.2 No. 601.1
- . IEC 60601-1- 4 / EN60601-1-4:2000
- IEC 60601-1-6: 2004 (First Edition) for use in conjunction with IEC 60601-1:1988 + A1:1991 . + A2:1995
- . EN 60601-1-2:2007
- . IEC 60601-2-18:1996 Second Edition + A1:2000

{3}------------------------------------------------

Image /page/3/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" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or other bird-like figure with three wing-like shapes extending from its body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

VisionScope Technologies, LLC % Lim Cheung, Ph.D. General Manager & CTO 2352 Main Street, Suite 303 Concord, Massachusetts 01742

SEP 0 g 2010

Re: K101734

Trade/Device Name: VisionScope High Definition Endoscopy Camera System with:

- Camera Control Unit �
- Camera Handpiece
- Endoscopes (Accessories in four lengths)
- Sterile Procedure Kits (Accessories in four lengths)

Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, GCJ Dated: June 15, 2010 Received: June 21, 2010

Dear Dr. Cheung:

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

{4}------------------------------------------------

Page 2 - Lim Cheung, Ph.D.

Enclosure

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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number ... [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

{5}------------------------------------------------

# Indications for Use

510(k) Number (if known): K101734

Device Name:

VisionScope High Definition Endoscopy Camera System with:

- Camera Control Unit .
- . Camera Handpiece
- Endoscopes (Accessories in four lengths) .
- Sterile Procedure Kits (Accessories in four lengths) .

## Indications for Use:

The VisionScope High Definition Endoscopy Camera System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization and capture of still and motion pictures of an interior cavity of the body through a natural or surgical opening. Examples of generic surgical use include imaging of articular cavities, body cavities, hollow organs and canals.

Additionally, when used in conjunction with an appropriately indicated and FDA 510(k)cleared endoscope and light source, the VisionScope High Definition Endoscopy Camera Control Unit and Camera Handpiece are indicated for use in arthroscopic and endoscopic surgical procedures to provide illumination, visualization and capture of still and motion pictures of articular cavities, body cavities, hollow organs and canals.

Prescription Use Yes (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Qulen firman
Director Sign Off

Division Sign-Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101734

SEP 0 8 2010

K101734

Page 1 of 1