(169 days)
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No
The summary describes a standard endoscope for visualization and material removal, with no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML devices.
No
The device is an endoscope used for visualization and aiding in the search and removal of material, which are diagnostic and procedural functions, not therapeutic in nature.
No
Explanation: The device is an endoscope used for visualization and removal of material, which are interventional procedures, not diagnostic ones. While visualization can aid in diagnosis, the primary indicated uses are therapeutic (removal of material) and for aiding in search, not for providing a diagnosis itself.
No
The device is described as an "Endius Spine Endoscope," which is a physical instrument used for visualization and removal of tissue. The description of its intended use in various anatomical sites further confirms it is a hardware device.
Based on the provided information, the Endius Spine Endoscope is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description clearly states the Endius Spine Endoscope is used for "aiding in the search and removal of nucleus material and for visualization of lumbar herniated discs," and for "visualizing the tissues of the brain and for use in the knee, shoulder, wrist, and the temporomandibular joint (TMJ)." This involves direct visualization and manipulation within the body.
Therefore, the Endius Spine Endoscope is an in vivo device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Endius Spine 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 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
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
lumbar spine, brain, knee, shoulder, wrist, temporomandibular joint (TMJ)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/10 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 27 1999
Mr. Joseph Ress Authorized Representative Medical Device Regulatory Consultants 45 Pontiac Road Newton, Massachusetts 02468
Re: K982819 Trade Name: Endius Spine Endoscope Regulatory Class: II Product Code: GWG Dated: October 28, 1998 Received: November 3, 1998
Dear Mr. Ress:
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 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 (Premarket Approval), 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 895. A 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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.
1
Page 2 - Mr. Joseph Ress
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,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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Appendix K - Indications for Use
STATEMENT FOR INDICATIONS FOR USE
510 (K) Number: K 9828 19
Device Name: Endius Spine Endoscope
Indications for Use:
The Endius Spine 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 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 )
Concurrance of CDRH, Office of Device Evaluation (ODE)
Perscription Use YES
OR Over-The-Counter Use NO
(Division Division of General Restorative De 510k) Num