(113 days)
Not Found
No
The description focuses on the mechanical articulation of the scope and does not mention any software or processing capabilities that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No.
The device is an endoscope used for observation and illumination during surgical procedures, not for treating a disease or condition.
No
The device is described as a video endoscope used for observation during surgery, not for diagnosing conditions. Its purpose is to illuminate and allow observation of body cavities.
No
The device description clearly describes a physical endoscope with a distal articulating section, working length, and outer diameter, indicating it is a hardware device. The performance studies also focus on mechanical reliability, biocompatibility, and sterilization, which are relevant to a physical medical device.
Based on the provided information, the Stryker Videoscope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs." This involves direct visualization and surgical procedures within the body.
- Device Description: The description details a video endoscope designed to illuminate and allow observation of body cavities. It's a tool for direct visual examination and surgical manipulation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. The Stryker Videoscope does not perform this function. It's used in vivo (within a living organism).
Therefore, the Stryker Videoscope is a surgical endoscope, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
GCJ, HET
Device Description
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. The Stryker Videoscope is intended to illuminate and allow observation of body cavities relating to general endoscopic, laparoscopic and gynecological surgeries. 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 of the scope. The Videoscope will have a working length of 330mm, with an outer diameter of 10mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and abdominal cavities, including female reproductive organs.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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 § 884.9.
0
5900 Optical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 2521
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, |
| Videoscope | |
| Classification Name: | Laparoscope, General & Plastic Surgery - CFR 21 § |
| 876.1500, Laparoscope, Gynecological - CFR 21 § | |
| 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
5900 Optical Court
San Jose, CA 95138
FDA Registration # 2936485 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Owner: | Stryker Corporation
2725 Fairfield Road
Kalamazoo, MI 49002
FDA Registration # 1811755 |
| Manufacturer of Videoscope | Henke-Sass, Wolf, GMBH
Keltenstrasse 1
Tuttlingen, Germany D-78532
FDA Registration # 8010418 |
| Manufacturer of Camera
Control Unit (CCU) | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138
FDA Registration # 2936485 |
| Correspondence Regarding
this 510(k): | Desiree Crisolo
Sr. Regulatory Representative
Stryker Endoscopy
5900 Optical Ct.
San Jose, CA 95138
Phone: 408-754-2784
Fax: 408-754-2521
Email: Desiree.Crisolo@Stryker.com |
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 |
| Laparoscope, Videoscope |
3.2 Predicate Device Name
Table 5
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Name | Manufacturer | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
10/17 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ADARO THORACO | And Advertising on the discussion of the contribution
Book Andrew
lympus | A Print of Children And Children
KAS3287 |
| VIDEOSCODE VI TE
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |
4.0 CLASSIFICATION AND PRODUCT CODE
Table 6
| Classification Name | Product
Code | Product
Class | Regulation
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
| Standard | Title of Standard |
|---|---|
| EN 550: 1994 | Sterilization of Medical Devices: Validation and routine Control of |
| 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 |
| cytotoxicity |
'T'shle 7
3
| ISO 10993-7:1995 | Biological evaluation of medical devices - Part 7: Ethylene oxide
sterilization residuals |
|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-10:2002 | Biological evaluation of medical devices - Part 10: Tests for irritation
and delayed-type hypersensitivity |
| ISO 10993-11:2006 | Biological evaluation of medical devices - Part 11: Tests for systemic
toxicity |
| Required
Biocompatibility
Training and
Toxicology Profiles
for Evaluation of
Medical Devices (G
95-1) | Use of International Standard ISO-10993, "Biological Evaluation of
Medical Devices Part 1: Evaluation and Testing" |
| IEC 60601-1:2005 | Medical Electrical Equipment - Part 1: General Requirements for Basic
Safety and Essential Performance |
| IEC
60601-1-
1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety
- Collateral standard: Safety requirements for medical electrical systems |
| IEC 60601-1-
2:2001 + A1:2004 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety Requirements for Medical Electrical
Systems |
| IEC 60601-1-
4:2000 +A1:1999 | Medical Electrical Equipment - Part 1-4: General Requirements for
Safety Collateral Standard: Programmable Medical Devices |
| IEC
60601-2-
18:1996 | Medical Electrical Equipment - Part 2: Particular Requirements for the
safety of endoscopic equipment |
| ISO 8600-1:2005 | Optics and Photonics - Medical Endoscopes and Endotherapy Devices
Part 1: General Requirements |
| ISO 8600-3:1997 | Optics and optical instruments - Medical Endoscopes and endoscopic
accessories Part 3: Determination of field of view and direction of view
of endoscopes with optics |
| ISO 8600-4 | Optics and optical instruments - Medical endoscopes and endoscopic
accessories - Part 4: Determination of maximum width of insertion
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/ | |
| Articulation Levers | 304 Stainless Steel | |
| Distal Tip Cover | Glass | |
| Articulating Section | Viton | |
| Housing | 6061 - T6 Aluminum | |
| 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
Stryker Videoscope | Predicate Device
Olympus Laparo Thoraco
Videoscope XLTF-VAW
(K053382) | Same or
Different | Equivalence |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-------------|
| Characteristics | | | | |
| Intended Use | The Stryker
Videoscope is a video
endoscope intended
for use in endoscopy
and endoscopic
surgery within the
thoracic and
abdominal cavities,
including female
reproductive organs. | LAPARO-THORACO
VIDEOSCOPE XLTF-VAW
is designed for endoscopy and
endoscopic surgery within the
thoracic and abdominal
cavities including female
reproductive organs. | Same | Equivalent |
| Field of View(FOV),
(Degree) | 75° +/- 5° | 90° | Different | Equivalent |
| Direction of View
(degree) | 0° Forward Viewing | 0° Forward Viewing | Same | Equivalent |
| Outer Diameter of
Distal End | 10mm | 10.5mm | Different | Equivalent |
| Bending Section
Angulations
(UP/DOWN/
LEFT/RIGHT),
(degree) | 110°/110°/110°/110°,
± 10 | 100°/100°/60°/60° | Different | Equivalent |
| Working Length
(mm) | 330mm | 330mm | Same | Equivalent |
| Inner Working
Channel | None | Provided | Different | Equivalent |
.
:
. . . .
.
:
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 (800) 638-2041 or (240) 276-3150 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.