(43 days)
Not Found
No
The summary describes a new size of an existing endoscope and mentions video processing equipment, but there is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
No.
The device is described as an endoscopic viewing system intended for visualizing internal surgery sites, not for directly treating or diagnosing a medical condition.
No
Explanation: The device is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery to assist with surgical procedures, not for diagnosis.
No
The device description clearly states it is an "8.5mm sized 3D Stereo Endoscope," which is a physical hardware component. While it is used with a system that includes "video processing equipment," the device itself is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "endoscopic viewing of internal surgery sites during minimally invasive surgery". This describes a device used in vivo (within the body) for visualization during a surgical procedure.
- Device Description: The description focuses on the physical characteristics of an endoscope (size, stereo view capabilities) and its use with surgical systems.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device is a surgical tool for visualization during surgery.
N/A
Intended Use / Indications for Use
The Intuitive Surgical® Stereo View Endoscopic System is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with the Intuitive Surgical® Endoscopic Instrument Control system during laparoscopic and thoracoscopic surgical procedures.
Product codes
GCJ
Device Description
This Special 510(k) is being submitted to include an additional 8.5mm sized 3D Stereo Endoscope as an additional accessory model to the currently cleared 12mm 3D Stereo Endoscope. Both endoscopic models are for use with the Intuitive Surgical® Stereo View Endoscopic System and Intuitive Surgical da Vinci® and da VinciS™ Surgical Systems.
The 8.5mm 3D Stereo Endoscope was developed to provide an option for use of a smaller patient access port than the currently cleared 12mm 3D Stereo Endoscope, while maintaining stereo view capabilities.
There are no changes in the basic design, technology, materials or manufacturing processes for the 8.5mm Endoscope. The intended use for the subject device in conjunction with the Intuitive Surgical® Stereo View Endoscopic System (i.e., cameras, illumination sources, video processing equipment) is identical to the previously cleared intended use for the 12mm Endoscope in conjunction with the Intuitive Surgical® Stereo View Endoscopic System.
Mentions image processing
video processing equipment
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic viewing
Anatomical Site
peritoneal cavity, thoracic cavity, and peritoneum
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
Design analysis and comparison, as well as bench testing, have been conducted to confirm that basic functional characteristics of the subject device are substantially equivalent to the predicate device cited, and that design output meets the design input requirements.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Section II
MAR - 6 2008
କ୍ଷରୁ
5
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number:
| Date | January 21, 2008 |
|---|---|
| Submitter | Intuitive Surgical, Inc. |
| 950 Kifer Road | |
| Sunnyvale, CA 94086 | |
| ER Number | 2955842 |
| Contact | Michael Yramategui |
| Sr. Director, Regulatory Affairs | |
| Telephone: (408) 523 - 2145 | |
| Fax: (408) 523 - 1390 | |
| E-mail: mike.yramategui@intusurg.com | |
| Subject | |
| Device | Trade Name(s): |
| 8.5mm 3D Stereo Endoscope | |
| Classification Name: | |
| Endoscope and Accessories (21 CFR 876.1500) | |
| Rigid Endoscope (21 CFR 876.1500) | |
| Gynecologic Laparoscope / Accessories (21 CFR 884.1720) | |
| Common Name: | |
| 3-D Endoscope and Accessories | |
| Device Class: | |
| Class II, GCJ, Laparoscope, General & Plastic Surgery | |
| Predicate | |
| Devices | 12mm 3D Stereo Endoscope |
| (FDA clearance under K001666) |
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K080155 Pg 2 of 3
9
| Device
Description | This Special 510(k) is being submitted to include an additional
8.5mm sized 3D Stereo Endoscope as an additional accessory
model to the currently cleared 12mm 3D Stereo Endoscope. Both
endoscopic models are for use with the Intuitive Surgical® Stereo
View Endoscopic System and Intuitive Surgical da Vinci® and da
VinciS™ Surgical Systems. |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The 8.5mm 3D Stereo Endoscope was developed to provide an
option for use of a smaller patient access port than the currently
cleared 12mm 3D Stereo Endoscope, while maintaining stereo view
capabilities. |
| | There are no changes in the basic design, technology, materials or
manufacturing processes for the 8.5mm Endoscope. The intended
use for the subject device in conjunction with the Intuitive
Surgical®
Stereo View Endoscopic System (i.e., cameras,
illumination sources, video processing equipment) is identical to
the previously cleared intended use for the 12mm Endoscope in
conjunction with the Intuitive Surgical® Stereo View Endoscopic
System. |
| Intended
Use | The Intuitive Surgical® Stereo View Endoscopic System is intended
for endoscopic viewing of internal surgery sites during minimally
invasive surgery in the peritoneal cavity, thoracic cavity, and
peritoneum. It is designed for use with the Intuitive Surgical®
Endoscopic Instrument Control system during laparoscopic and
thoracoscopic surgical procedures. |
| Comparison to
Predicate
Device | The basic design and function of the subject 8.5mm Endoscope in
conjunction with the Intuitive Surgical® Stereo View Endoscopic
System is identical to the predicate system, except that an 8.5mm
Endoscope is an available option to the 12mm Endoscope currently
cleared. The reduced diameter shaft of the endoscope is also
shorter in length, but there are no changes in the compatibility of
the 8.5mm Endoscope with the cameras, illumination sources or
other components of the video processing system. It is built by the
same manufacturer as the 12mm endoscope, with the same
materials and manufacturing processes. |
| Technological
Characteristics | The technological characteristics of the subject device are identical
to the predicate device. |
| Performance
Data | Design analysis and comparison, as well as bench testing, have
been conducted to confirm that basic functional characteristics of
the subject device are substantially equivalent to the predicate
device cited, and that design output meets the design input
requirements. |
| Conclusion | Based upon the technical information, intended use and
performance information provided in this Special 510(k), the
8.5mm 3D Stereo Endoscope) described herein has been shown to
be substantially equivalent to current legally marketed predicate
devices. |
2
K080155 PG 3 of 3
10
3
Image /page/3/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Intuitive Surgical, Inc. % Mr. Michael H. Yramategui VP of Clinical and Regulatory Affairs 950 Kifer Road Sunnyvale, California 94086
MAR - 6 2008
Re: K080155
Trade/Device Name: Intuitive Sugical® Stereo View Endoscopic System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: February 21, 2008 Received: February 22, 2008
Dear Mr. Yramategui:
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
4
Page 2 - Mr. Michael H. Yramategui
forth in the quality systems (OS) 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 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 vours.
Mark M. Wilkerson
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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K080155 pg 1 of 11
Section III
Indications for Use
510(k) Number (if known):
Intuitive Surgical® Stereo View Endoscopic System Device Name:
Indications For Use:
The Intuitive Surgical® Stereo View Endoscopic System is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with the Intuitive Surgical® Endoscopic Instrument Control system during laparoscopic and thoracoscopic surgical procedures.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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
Neil Re. Oehl for mxm
Division of General, Restorative and Neurological Devices
510(k) Number K080155
Intuitive Surgical® 8.5mm 3D Stereo Endoscope