STRYKER VIDEOSCOPE

K082451 · Stryker Endoscopy · HET · Dec 16, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K082451
• Device Name: STRYKER VIDEOSCOPE
• Applicant: Stryker Endoscopy
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Dec 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Intended Use

The Stryker Videoscope is a video endoscope indicated for use in endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.

Device Story

Stryker Videoscope is a reusable video endoscope for visualization during thoracic, abdominal, and gynecological endoscopic surgeries. The device features a 10mm diameter rigid shaft with a distal articulating section controlled by external levers in the handle, allowing a 0° to 110° (±10°) direction of view. It connects to a camera control unit (CCU), light source, and display monitor. Surgeons operate the device to illuminate and observe body cavities. The articulation mechanism uses a pulley-like system with four guide wires. Unlike the predicate, it lacks an inner working channel for insufflation or irrigation. The device provides surgeons with enhanced viewing flexibility through articulation, potentially reducing the need for multiple scopes with fixed angles.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance were validated through mechanical reliability testing, biocompatibility testing per ISO 10993, and sterilization validation (Sterrad and ETO).

Technological Characteristics

Reusable video endoscope; 10mm diameter; 330mm working length. Materials: 304 stainless steel, glass, Viton, 6061-T6 anodized aluminum, silicone rubber. Articulation: 110° (±10°) in four directions. Connectivity: Wired connection to CCU and light source. Sterilization: Sterrad and ETO. Standards: ISO 14971, ISO 10993, IEC 60601-1, IEC 60601-2-18, ISO 8600.

Indications for Use

Indicated for use in endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Predicate Devices

• Olympus Laparo Thoraco Videoscope XLTF-VAW (K053382)

Submission Summary (Full Text)

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

5900 Optical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 2521

K082451

Image /page/0/Picture/2 description: The image shows the word "Stryker" in a bold, sans-serif font. The letters are black, and the background is white. There is a registered trademark symbol in the upper right corner of the word. The word is the logo for Stryker Corporation, a medical technology company.

Endoscopy

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## Device Name

## DEC 1 6 2008

Table 1

| Proprietary Name: | Stryker Videoscope |
|-------------------------|------------------------------------------------------------------------------------------------------------------|
| Common and Usual Names: | Endoscopic Laparoscope, Gynecological Laparoscope,<br>Videoscope |
| Classification Name: | Laparoscope, General & Plastic Surgery - CFR 21 §<br>876.1500, Laparoscope, Gynecological - CFR 21 §<br>884.1720 |

## Product Description:

Device Description and Intended Use: The Stryker Videoscope is a video endoscope indicated for use in endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.

Voluntary Safety and Performance Standards: The Stryker Videoscope will conform to the standards deemed applicable for this device. Please refer to section 5.1 for a list of standards that will be used.

## Predicate Device

## Table 2

| Name | LAPARO THORACO VIDEOSCOPE XLTF-VAW |
|--------------|------------------------------------|
| Manufacturer | Olympus |
| 510(k) | K053382 |

Substantial Equivalence: The indications for use and most technological characteristics are the same for both devices. The few differences in technological characteristics are slight and do not raise new questions of safety and effectiveness, thus demonstrating that the Stryker Videoscope is at least as safe and effective as the Laparo Thoraco Videoscope XLTF - VAW that is currently legally marketed. Please see substantial equivalence table 4 for a detailed comparison.

#### INTRODUCTION 1.0

This 510(k) pre-market notification letter is submitted to notify the FDA of Stryker Endoscopy's intent to market the Stryker Videoscope. The Stryker Videoscope is a video endoscope indicated for use in endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.

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

5900 Optical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 2521

stryker®

Endoscopy

### DEVICE SPONSOR: 2.0

Stryker Endoscopy is the sponsor of this pre-market notification. Stryker Endoscopy has an established history of manufacturing and marketing medical products for endoscopic surgery.

| Sponsor of 510(k): | Stryker Endoscopy<br>5900 Optical Court<br>San Jose, CA 95138<br>FDA Registration # 2936485 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Owner: | Stryker Corporation<br>2725 Fairfield Road<br>Kalamazoo, MI 49002<br>FDA Registration # 1811755 |
| Manufacturer of Videoscope | Henke-Sass, Wolf, GMBH<br>Keltenstrasse 1<br>Tuttlingen, Germany D-78532<br>FDA Registration # 8010418 |
| Manufacturer of Camera<br>Control Unit (CCU) | Stryker Endoscopy<br>5900 Optical Court<br>San Jose, CA 95138<br>FDA Registration # 2936485 |
| Correspondence Regarding<br>this 510(k): | Desiree Crisolo<br>Sr. Regulatory Representative<br>Stryker Endoscopy<br>5900 Optical Ct.<br>San Jose, CA 95138<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

## Table 3

STRYKER VIDEOSCOPE 510(K) SUBMISSION

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

#### DEVICE IDENTIFICATION 3.0

#### 3.1 Proposed Device Name

## Table 4

| Proprietary Name: | Stryker Videoscope |
|------------------------|------------------------------------------------------------------|
| Common and Usual Name: | Endoscopic Laparoscope, Gynecological<br>Laparoscope, Videoscope |

#### 3.2 Predicate Device Name

Table 5

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Name | Manufacturer | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>10/17 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ADARO THORACO | And Advertising on the discussion of the contribution<br>Book Andrew<br>lympus | A Print of Children And Children<br>KAS3287 |
| VIDEOSCODE VI TE<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |

#### 4.0 CLASSIFICATION AND PRODUCT CODE

## Table 6

| Classification Name | Product<br>Code | Product<br>Class | Regulation<br>Number |
|------------------------------------------|-----------------|------------------|----------------------|
| Laparoscope, General and Plastic Surgery | GCJ | II | 876.1500 |
| Laparoscope, Gynecologic | HET | II | 884.1720 |

4.1. Advisory Committee General & Plastic Surgery Obstetrics/Gynecology

#### 5.0 SECTION 514 SPECIAL CONTROLS

No performance standards or special controls have been established under section 514 of the Federal Food, Drug, and Cosmetic Act.

However, Stryker Endoscopy has chosen to comply with the following voluntary standards:

#### 5.1. Voluntary Standards

| Table 7<br>Standard | Title of Standard |
|---------------------|-----------------------------------------------------------------------------------------------------|
| EN 550: 1994 | Sterilization of Medical Devices: Validation and routine Control of<br>Ethylene Oxide Sterilization |
| ISO 14971:2007 | Medical Devices- Application of risk management to medical devices. |
| ISO 10993-1:2003 | Biological evaluation of medical devices- Part 1: Evaluation and testing. |
| ISO 10993-5:1999 | Biological evaluation of medical devices - Part 5: Tests for in vitro<br>cytotoxicity |

## 'T'shle 7

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

| ISO 10993-7:1995 | Biological evaluation of medical devices - Part 7: Ethylene oxide<br>sterilization residuals |
|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-10:2002 | Biological evaluation of medical devices - Part 10: Tests for irritation<br>and delayed-type hypersensitivity |
| ISO 10993-11:2006 | Biological evaluation of medical devices - Part 11: Tests for systemic<br>toxicity |
| Required<br>Biocompatibility<br>Training and<br>Toxicology Profiles<br>for Evaluation of<br>Medical Devices (G<br>95-1) | Use of International Standard ISO-10993, "Biological Evaluation of<br>Medical Devices Part 1: Evaluation and Testing" |
| IEC 60601-1:2005 | Medical Electrical Equipment - Part 1: General Requirements for Basic<br>Safety and Essential Performance |
| IEC<br>60601-1-<br>1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety<br>- Collateral standard: Safety requirements for medical electrical systems |
| IEC 60601-1-<br>2:2001 + A1:2004 | Medical electrical equipment - Part 1-1: General requirements for safety<br>- Collateral standard: Safety Requirements for Medical Electrical<br>Systems |
| IEC 60601-1-<br>4:2000 +A1:1999 | Medical Electrical Equipment - Part 1-4: General Requirements for<br>Safety Collateral Standard: Programmable Medical Devices |
| IEC<br>60601-2-<br>18:1996 | Medical Electrical Equipment - Part 2: Particular Requirements for the<br>safety of endoscopic equipment |
| ISO 8600-1:2005 | Optics and Photonics - Medical Endoscopes and Endotherapy Devices<br>Part 1: General Requirements |
| ISO 8600-3:1997 | Optics and optical instruments - Medical Endoscopes and endoscopic<br>accessories Part 3: Determination of field of view and direction of view<br>of endoscopes with optics |
| ISO 8600-4 | Optics and optical instruments - Medical endoscopes and endoscopic<br>accessories - Part 4: Determination of maximum width of insertion<br>portion |

.

.

:

:

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

#### DEVICE DESCRIPTION 6.0

- Intended Use: The Stryker Videoscope is a video endoscope indicated for use in 6.1. endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.
#### System Description and Diagrams 6.2.

## Figure 1: Stryker Videoscope System Block Diagram

Image /page/4/Figure/4 description: The image shows a diagram of a videoscopic system. The system includes a sterile field, a videoscope, a videoscope camera control unit (CCU), a light source, and a display monitor. The videoscope is connected to the videoscope camera control unit (CCU) and the light source. The videoscope camera control unit (CCU) is connected to the display monitor.

#### 6.2.1. Stryker Videoscope

The Stryker Videoscope is intended to illuminate and allow observation of body cavities relating to general endoscopic, laparoscopic and gynecological surgeries. Traditionally, surgeons would need multiple scopes with varying direction of view angles (such as 0°, 30°, and 45°) to have a wide range of view. The Stryker Videoscope can provide varying angles all in one scope through a distal articulating section that changes the direction of view between 0° and 110° (±10°) from the axis The Videoscope will have a working length of 330mm, of the scope. with an outer diameter of 10mm.

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

Image /page/5/Figure/0 description: The image is labeled as "Figure 2: Stryker Videoscope" and shows a Stryker videoscope with several labeled parts. The distal tip housing/cover, articulating section/rigid shaft, keypad, articulation levers, handle/housing, cable to CCU and LS, and video connector are all labeled with arrows pointing to the corresponding parts of the videoscope. The videoscope has a long, thin rigid shaft with an articulating section near the distal tip.

6.2.2.2.

## Table 8: Patient Contacting Materials

| Component | Device Component | Material |
|------------|--------------------------------------------------------|--------------------------------|
| Videoscope | Distal Tip Housing/Rigid Shaft/<br>Articulation Levers | 304 Stainless Steel |
| | Distal Tip Cover | Glass |
| | Articulating Section | Viton |
| | Housing | 6061 - T6 Aluminum<br>Anodized |
| | Keypad | Silicone Rubber |
| | Cable | Silicone Rubber |

{6}------------------------------------------------

#### Safety and Performance Testing 6.3.

#### Mechanics/Articulating mechanism and controls: The Stryker 6.3.1.

Videoscope has an articulating distal tip to allow the user to view the surgical area. The articulating section is made up of several links that are attached to four guide wires. These guide wires run from the distal tip up into the handle where the control levers are located. The external control handles, when moved, drive the internal articulating mechanism to push and pull the bending section in four directions and operates similarly to a pulley system. A mechanical reliability test will be conducted to ensure optimal performance and reliability.

#### Biocompatibility 6.3.2.

All patient contacting materials are validated for biocompatibility in accordance with the requirements of ISO 10993-1:2003 and FDA Blue Book Memorandum #G95-1. Additionally, patient-contacting and usercontacting materials do not contain natural rubber or latex. Refer to Section 6.2.2 or Table 3 for patient contacting materials.

- Sterilization: The Stryker Videoscope will be a reusable device. As 6.3.3. such, it will undergo Sterility Assurance Validation testing to ensure it is able to be sterilized to a SAL =10 - . The two methods of sterilization that will be available to the users are Sterrad and ETO. ETO Residuals will be tested according to ISO10993-7.
#### SUBSTANTIAL ROUTHAL BROOM COMPARISON 7.0

The Stryker Videoscope described in this 510(k) notification is substantially equivalent to the currently marketed predicate device; the Olympus Laparo-Thoraco Videoscope XLTF-VAW. The fundamental technology and intended use is similar for both the Stryker Videoscope and Olympus Laparo Thoraco Videscope XLTF-VAW. In the following sections, the proposed device's characteristics are compared with the predicate device and the differences with respect to their impact on safety and effectiveness are discussed.

{7}------------------------------------------------

# Table 9: Substantial Equivalence Table

:

.

:

| | Proposed Device<br>Stryker Videoscope | Predicate Device<br>Olympus Laparo Thoraco<br>Videoscope XLTF-VAW<br>(K053382) | Same or<br>Different | Equivalence |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-------------|
| Characteristics | | | | |
| Intended Use | The Stryker<br>Videoscope is a video<br>endoscope intended<br>for use in endoscopy<br>and endoscopic<br>surgery within the<br>thoracic and<br>abdominal cavities,<br>including female<br>reproductive organs. | LAPARO-THORACO<br>VIDEOSCOPE XLTF-VAW<br>is designed for endoscopy and<br>endoscopic surgery within the<br>thoracic and abdominal<br>cavities including female<br>reproductive organs. | Same | Equivalent |
| Field of View(FOV),<br>(Degree) | 75° +/- 5° | 90° | Different | Equivalent |
| Direction of View<br>(degree) | 0° Forward Viewing | 0° Forward Viewing | Same | Equivalent |
| Outer Diameter of<br>Distal End | 10mm | 10.5mm | Different | Equivalent |
| Bending Section<br>Angulations<br>(UP/DOWN/<br>LEFT/RIGHT),<br>(degree) | 110°/110°/110°/110°,<br>± 10 | 100°/100°/60°/60° | Different | Equivalent |
| Working Length<br>(mm) | 330mm | 330mm | Same | Equivalent |
| Inner Working<br>Channel | None | Provided | Different | Equivalent |

.

:

. . . .

.

:

1. 1. 1. 1.

{8}------------------------------------------------

#### DISCUSSION OF DIFFERENCES 7.1.

- Outer Diameter: The diameter of the Stryker Videoscope is .5mm 7.1.1. smaller than the Olympus Laparo Thoraco Videoscope XLTF-VAW. Laparoscopes generally come in 5mm and 10 - 11mm. Both the Stryker and Olympus Videoscopes fall within the 10-11mm range. The slight difference in diameter will not significantly affect the optical image or the incision created when used in surgery.
- Bending Section Angulations/FOV: The Stryker Videoscope will have 7.1.2. a bending articulation of 110° (±10°) up, down, left and right with a field of view (FOV) of 75 degrees. The Olympus Laparo Thoraco Videoscope XLTF-VAW has a bending articulation of 100° up and down, 60° left and right with a FOV of 90 degrees. The bending section angulations allow the user to vary the direction of view; while the FOV dictates how much the user sees within the image. In general, as the FOV gets bigger, the image quality tends to get reduced. By keeping a smaller FOV, the Stryker Videoscope may maintain a greater degree of image quality. The device will have the ability to articulate at 110° all around, so that although the FOV is smaller than the Olympus Videoscope, the direction of view can be varied 50° more to the left and right. The surgeon will have the convenience of articulating 110° (±10°) all around, allowing more flexibility through articulation while minimizing the movement of the scope handle.
- Inner Working Channel: An inner working channel will not be 7.1.3. provided with the Stryker Videoscope. The predicate device uses the inner working channel to perform insufflation and irrigation, both of which are not indicated in the Stryker Videoscope.

#### 8.0 CONCLUSION

As demonstrated through comparisons between the predicate device Olympus Laparo Thoraco Videoscope XLTF-VAW and the proposed, the Stryker Videoscope, no significant differences exist in the indications for use, surgical procedures, constructions, performance specifications and labeling of these devices. As there are no significant differences, there are no new questions raised regarding safety and effectiveness. Therefore, the Stryker Videoscope is considered, in terms of safety and effectiveness, substantially equivalent to the currently marketed device.

{9}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, serif font. The text is black and the background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Desiree Mae Crisolo Sr. Regulatory Representative Stryker® Endoscopy 5900 Optical Court SAN JOSE CA 95138

K082451 Re:

Trade/Device Name: Stryker Videoscope Regulation Number: 21 CFR §884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Codes: HET and GCJ Dated: November 25, 2008 Received: November 28, 2008

## Dear Ms. Crisolo:

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.

{10}------------------------------------------------

## Page 2

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.

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 Biometrics' (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jorgu M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{11}------------------------------------------------

## INDICATIONS FOR USE

Device Name: Stryker Videoscope

510(k) Number:_KO82451

The Stryker Videoscope is a video endoscope indicated for use in endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.

Prescription Use X (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)

Hulut Reimer

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number.