(552 days)
Not Found
Not Found
No
The summary describes a standard endoscopic system with optical fibers and an image transmitting fiber bundle. There is no mention of AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices.
No
The device is an endoscope primarily used for visualization and aiding in surgical procedures (search and removal), not for directly treating a disease or condition itself.
No
The INCLUSIVE® Endoscope is indicated for aiding in the search and removal of nucleus material, viewing herniated disc material, and visualizing tissues. These are interventional and visualization uses, not diagnostic uses.
No
The device description explicitly states it is an "endoscopic system and ancillary equipment" and describes physical components like "light transmitting optical fibers and an image transmitting fiber bundle contained within the scope." This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside of the body (in vitro).
- Device Function: The INCLUSIVE® Endoscope is used inside the body (in vivo) to visualize anatomical structures and aid in surgical procedures. It directly interacts with tissues within the patient.
- Intended Use: The intended use clearly describes a surgical tool for viewing and removing material within the body, not for testing bodily specimens.
Therefore, based on the provided information, the INCLUSIVE® Endoscope is a surgical endoscope, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The INCLUSIVE® Endoscope is indicated for aiding in the search and removal of nucleus material and for viewing herniated disc material in the lumbar spine via a percutaneous surgical approach. The endoscope is also indicated for visualizing the tissues of the brain and for use in the knee, shoulder, wrist and the temporomandibular joint (TMJ).
Product codes
GWG
Device Description
This submission describes an endoscopic system and ancillary equipment. The endoscope consists of light transmitting optical fibers and an image transmitting fiber bundle contained within the scope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic
Anatomical Site
lumbar spine, brain, knee, shoulder, wrist, temporomandibular joint (TMJ)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).
0
510(k) Summary INCLUSIVE® Endoscopic System K963642 January 16, 1998
- l. Company: Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
- INCLUSIVE® Endoscopic System II. Product Name:
- III. This submission describes an endoscopic system and ancillary equipment. The endoscope consists of light transmitting optical fibers and an image transmitting fiber bundle contained within the scope.
- IV. The INCLUSIVE Endoscope is indicated for aiding in the search and removal of nucleus material and for visualization of lumbar herniated discs. It is intended to be used percutaneously in the lumbar spine. The endoscope is also intended for visualizing the tissues of the brain and for use in the knee, shoulder, wrist and the temporomandibular joint (TMJ).
- V. The INCLUSIVE Endoscope Device was claimed to be substantially equivalent to various commercially available arthroscopic and endoscopic systems. Information pertaining to these systems was provided in the submission.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid with three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 1998
Mr. Richard W. Treharne Vice President, Research and Regulatory Affairs Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K963642 Inclusive Endoscopic System Trade Name: Requlatory Class: II Product Code: GWG Dated: January 16, 1998 Received: January 16, 1998
Dear Mr. Treharne:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Treharne
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Stephen Rhodes
Lee Solid, M. Witten, Ph.D., M.
M. Witten, Ph.D., M.D. Director ivision of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 _ of _ 1 _
January 16, 1998
510(k) Number (if known): K963642
Device Name: INCLUSIVE® Endoscope
Indications for Use:
The INCLUSIVE® Endoscope is indicated for aiding in the search and removal of nucleus material and for viewing herniated disc material in the lumbar spine via a percutaneous surgical approach. The endoscope is also indicated for visualizing the tissues of the brain and for use in the knee, shoulder, wrist and the temporomandibular joint (TMJ).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of General Restorative Devices | |
| Prescription Use (Per 21 CFR 801.109) | X OR Over-The-Counter Use 510(k) Number K963642 |
(Optional Format 1-2-96)