(286 days)
No
The summary describes a set of physical instruments for neuroendoscopy and does not mention any software, image processing, or AI/ML capabilities.
Yes
The device is described with therapeutic applications such as "cyst fenestration," "shunt placement," "intraventricular coagulation," and "biopsy of lesions."
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "diagnosis" as one of the device's purposes during intracranial procedures.
No
The device description explicitly lists physical components such as a sheath, obturators, telescope, forceps, scissors, electrodes, suction needle, and adapters, indicating it is a hardware device.
Based on the provided information, this device 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 provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a Neuro-Endoscope intended for direct visualization, diagnosis, and therapeutic application during intracranial procedures. It is used inside the body for surgical and diagnostic purposes, not for testing samples outside the body.
- Intended Use: The listed intended uses (cyst fenestration, shunt placement, etc.) are all surgical and interventional procedures performed directly on the patient.
- Device Components: The components (sheath, obturators, telescope, forceps, scissors, electrodes, suction needle) are all instruments used for surgical manipulation and visualization within the body.
Therefore, this device falls under the category of a surgical or interventional device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for use for direct visualization, diagnosis and therapeutic application during intracranial procedures, such as
- cyst fenestration
- shunt placement
- intraventricular coagulation
- ventriculostomy of the 3rd ventricle when the aqueduct is obstructed
- coagulation of small intraventricular lesions
- biopsy of lesions which lead to the stricture of a ventricle
The instrument simultaneously permits visual control and utilization of a working, an irrigation, and an aspiration channel.
The Neuro-Endoscope can be used with or without a stereotactic frame. A special adapter is available to affix the endoscope.
Product codes
GWG
Device Description
The set consists of a sheath, obturators, telescope, forceps, scissors, electrodes, suction needle, and adapters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial
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
To ensure that the user is electrically isolated from the device, the instruments and connection cables . are designed so that the connection instrument/cable overlaps.
Abrasion/Flaking testing was performed to assure the integrity and bonding of the insulation material to the instruments.
Testing was performed to verify thermal safety. Thermal damage is unlikely to occur using the Richard Wolf Neuroendoscopy Set.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
353 Corporate Woods Parkway Vernon Hills, Illinois 60064 Phone: 847.913.1143 Fax: 847.943.1488
OCT 2 9 1997
RICHARD W MEDICAL INSTRUMENTS CORPOR
510(k) Summary of Safety and Effectiveness
| Submitter: | Date of Preparation: | October 8, 1997 | |||||
|---|---|---|---|---|---|---|---|
| Company / Institution name: | FDA establishment registration number: | ||||||
| RICHARD WOLF MEDICAL INSTRUMENTS CORP. | 14 184 79 | ||||||
| Division name (if applicable): | Phone number (include area code): | ||||||
| N.A. | (847) 913-1113 | ||||||
| Street address: | FAX number (include area code): | ||||||
| 353 Corporate Woods Parkway | (847) 913-0924 | ||||||
| City: | Vernon Hills | State/Province: | Illinois | Country: | USA | ZIP / Postal Code: | 60061 |
| Contact name: | |||||||
| Mr. Robert L. Casarsa | |||||||
| Contact title: | |||||||
| Quality Assurance Manager | |||||||
| Product Information: | |||||||
| Trade name: Neurological Endoscope | Model number: 8765.001, 15016.299, 15016.300, | ||||||
| 15016.301, 8989.401/.431, 8765.611, 8765.701 | |||||||
| Common name: | Classification name: | ||||||
| Neuro Endoscope Set | Neurological Endoscope | ||||||
| Information on devices to which substantial equivalence is claimed: |
| 510(k) Number | Trade or proprietary or model name | Manufacturer | ||||
|---|---|---|---|---|---|---|
| 1 | 1 | Gaab Neuroendoscope system Sheath, 83-1521 | 1 Codman | |||
| 2 | 2 | Auero Neuroendoscope system Sheath 28160D | 2 Storz | |||
| 3 | 3 | Sheath Insert W/ Inflow Stopcock Connection 28160 J | 3 Storz | |||
| 4 | 4 | Bougie Guide Obturator | 4 Storz | |||
| 5 | 5 | Telescope Gaab 83-1523 | 5 Codman | |||
| 6 | 6 | Auero system Telescope 27020 A | 6 Storz | |||
| 7 | 7 | Auero Monoplar coagulating Electrode 27160B | 7 Storz | |||
| 8 | 8 | Injection Needle 83-1534 | 8 Codman | |||
| 9 | 9 | Suction Catheter 10468 A | 9 Storz | |||
| 10 | 10 | Neuroendoscope (Ventriculoscope) K941239 | 10 Asculap |
1.0 Description
.
The set consists of a sheath, obturators, telescope, forceps, scissors, electrodes, suction needle, and adapters.
1
2.0 Intended Use
The device is intended for use for direct visualization, diagnosis and therapeutic application during intracranial procedures, such as
- cyst fenestration �
- shunt placement �
- � intraventricular coagulation
- � ventriculostomy of the 3rd ventricle when the aqueduct is obstructed
- � coagulation of small intraventricular lesions
- ◆ biopsy of lesions which lead to the stricture of a ventricle
The instrument simultaneously permits visual control and utilization of a working, an irrigation, and an aspiration channel.
The Neuro-Endoscope can be used with or without a stereotactic frame. A special adapter is available to affix the endoscope.
/3.0 Technological Characteristics
- · Procedure can be performed through one single burr hole.
- · Uses a small flexible endoscope able to pass through the working channel and the possibility of using different rigid telescopes with various viewing angles.
- · Rigid telescopes can be advanced in a second stage beyond the tip of the sheath to penetrate small openings or channels and to "look around the corner".
Substantial Equivalence 4.0
The Richard Wolf Neuroendoscopy Set is substantially equivalent to the following devices:
- Codman and Shurtleff, Inc.'s Gaab Neuroendoscope System .
- · Karl Storz Auero Neuro-Endoscope System
- · Aesculap. Inc. Neuroendoscope
All devices have the same intended use.
5.0 Performance Data
- To ensure that the user is electrically isolated from the device, the instruments and connection cables . are designed so that the connection instrument/cable overlaps.
- · Abrasion/Flaking testing was performed to assure the integrity and bonding of the insulation material to the instruments.
- · Testing was performed to verify thermal safety. Thermal damage is unlikely to occur using the Richard Wolf Neuroendoscopy Set.
6.0 Clinical Tests
Clinical tests were performed by Eric Weber, MD, PhD, at the University of South Alabama under protocol # 92-105.
2
得
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual.
By: Robert J. Casares
Robert L. Casarsa Quality Assurance Manager
Date: Oct 97
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
OCT 2 9 1997
Re: K970162 Trade Name: Neurological Endoscope Regulatory Class: II. achines : Common an Product Code: GWG Dated: October 8, 1997
Received: October 9, 1997
Dear Mr. Casarsa:
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 requirements , as set forth in the Quality System Regulation (OS) 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.
4
Page 2 - Mr. Robert L. Casarsa
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 vour 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,
t. Oellefa
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
5
| Page | of |
|---|---|
| ------ | ---- |
| 510(k) Number (if known): | K970162 |
|---|---|
| Device Name: | Neurological Endoscope |
Indications For Use:
The device is intended for use for direct visualization, diagnosis and therapeutic application during intracranial procedures, such as
- cyst fenestration �
- ్లా shunt placement
- � intraventricular coagulation
- � ventriculostomy of the 3th ventricle when the aqueduct is obstructed and more a
- � coagulation of small intraventricular lesions
- � biopsy of lesions which lead to the stricture of a ventricle
The instrument simultaneously permits visual control and utilization of a working, an irrigation, and an aspiration channel.
The Neuro-Endoscope can be used with or without a stereotactic frame. A special adapter is available to affix the endoscope.
(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 | |
| 510(k) Number | K970162 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Formal 1-2-96)