(409 days)
The Minature Neuro-Endoscope System by Hopf allows visual observation of the operating site while using working channels, supply and drain channels. They are used for diagnosis and therapy in neurosurgery, in connection with endoscopic accessories, during intracranial procedures.
The EANS System (Endoscopic Assisted Neuro Surgery) allows a visualization of cerebral structures not visible through the microscope and at the same time offers the option of supplying and draining irrigation fluid, for examination and diagnosis of microsurgical brain operation.
The submitted neuroendoscope sets are adaptable and therefore suitable for a variety of surgical manipulations. The set consists of sheaths with working channels respectively working inserts, obturators, endoscopes, forceps, electrodes and an articulated arm.
This submission pertains to the Miniature Neuro-Endoscope System by Hopf and Endoscopic Assisted Neuro Surgery-System (EANS).
Based on the provided 510(k) summary, there is no information about acceptance criteria or a study demonstrating device performance against such criteria in the traditional sense of a clinical trial or performance study with defined metrics like sensitivity, specificity, or accuracy.
The document states:
- "No clinical tests performed." (Section 6.0 Clinical Tests)
- The performance data provided is limited to conformance to international electrical safety and electromagnetic compatibility standards, and precautions regarding light sources to avoid heat accumulation. (Section 5.0 Performance Data).
- The conclusion drawn is that the devices are "designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." (Section 7.0 Conclusions Drawn).
- The submission focuses on establishing substantial equivalence to existing predicate devices (K970162) by Richard Wolf.
Therefore, the following information cannot be provided as it is not present in the given document:
- Table of acceptance criteria and reported device performance: Not available.
- Sample size used for the test set and data provenance: Not applicable as no such test set or study is described.
- Number of experts used to establish the ground truth and qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not done.
- Standalone (algorithm only) performance: Not applicable as this is a medical device, not an algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of what is provided regarding "performance":
- Acceptance Criteria: Not explicitly stated as performance metrics. Instead, "acceptance" appears to be based on adherence to safety standards and the claim of substantial equivalence.
- Specific Standards Mentioned: IEC 601-1, IEC 601-2-2, and IEC 601-2-18 (electrical safety and electromagnetic compatibility for medical devices).
- Heat Accumulation Precaution: "To avoid accumulation of heat due to high light energy, only halogen light sources of up to 250 W or other light sources, such as gas discharge lamps, Xenon, of up to max. 180 W must be used, fluid light cables are not allowed to be used." This acts as an operational guideline to ensure safety.
- Reported Device Performance: The primary "performance" discussed is the device's conformance to the aforementioned international safety standards. There are no quantitative performance numbers (e.g., in terms of imaging quality, success rates, complication rates) provided. The key claim is substantial equivalence to a predicate device, meaning it performs as safely and effectively as a legally marketed device.
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Image /page/0/Picture/1 description: The image contains a handwritten string of alphanumeric characters. The string appears to read 'K031858'. The characters are written in a cursive style, with some connections between the letters and numbers. The handwriting is somewhat uneven, but the characters are generally legible.
13 510(k) Summary of Safety and Effectiveness
| Submitter: | Date of Preparation:19. September 2003 | |
|---|---|---|
| Company / Institution name:RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FDA establishment registrationnumber:14 184 79 | |
| Division name (if applicable):N.A. | Phone number (include area code):( 847 ) 913 1113 | |
| Street address: | FAX number (include area code):( 847 ) 913 0924 | |
| City:Vernon Hills | State/Province:Illinois | Country:USA ZIP / Postal Code:IL 60061 |
| Contact name:Mr. Robert L. Casarsa | ||
| Contact title:Quality Assurance Manager | ||
| Product Information: | ||
| Trade name: | Model number: | |
| Miniature Neuro-Endoscope System by HopfandEndoscopic Assisted Neuro Surgery-System | 8672.xxx,8768.xxx,and others | |
| Common name:Neurological Endoscopy Set | Classification name:Neurological endoscope | |
| Information on devices to which substantial equivalence is claimed: | ||
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
| 1 K970162 | 1 Neurological Endoscope Set | 1 Richard Wolf |
1.0 Description
The submitted neuroendoscope sets are adaptable and therefore suitable for a variety of surgical manipulations. The set consists of sheaths with working channels respectively working inserts, obturators, endoscopes, forceps, electrodes and an articulated arm.
2.0 Intended Use
The Miniature Neuro-Endoscope System by Hopf allows visual observation of the operating site while using working channels, supply and drain channels. They are used for diagnosis and therapy in neurosurgery, in connection with endoscopic accessories, during intracranial procedures.
The EANS System (Endoscopic Assisted Neuro Surgery) allows a visualization of cerebral structures not visible through the microscope and at the same time offers the option of supplying and draining irrigation fluid, for examination and diagnosis of microsurgical brain operation.
Rev 12/03
13-1
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Technological Characteristics 3.0
The new sets are used with an articulated arm instead of the stereotactic frame, so that they become shorter. The smaller outer diameter and the convenient working length make the endoscope system especially valuable for intraventricular endoscopic procedures in newborn and children, as well as in adults if anatomical situation allows it.
Substantial Equivalence 4.0
The submitted devices pose the same type of questions about safety or effectiveness as the compared devices and the new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k)-devices sold by Richard Wolf and competitors.
5.0 Performance Data
The neuroscopy sets are conforming to the international standards IEC 601-1, IEC 601-2-2, and IEC 601-2-18.
To avoid accumulation of heat due to high light energy, only halogen light sources of up to 250 W or other light sources, such as gas discharge lamps, Xenon, of up to max. 180 W must be used, fluid light cables are not allowed to be used.
6.0 Clinical Tests
No clinical tests performed.
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual.
By: Robert J. Casarsa
Robert L. Casarsa Quality Assurance Manager
Date: Dec 15, 2003
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three wavy lines, resembling an abstract representation of the American flag or a flowing ribbon.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2004
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061-3110
Re: K031858
Trade/Device Name: Neuro-Endoscope System by Hopf EANS-System (Endoscopic Assisted Neuro Surgery) Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG Dated: May 28, 2004 Received: June 1, 2004
Dear Mr. Casarsa:
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 10 mos based or 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 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.
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Page 2 - Mr. Robert L. Casarsa
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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
R. Mark A. Melkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K031858 |
|---|---|
| Device Name: | Neuro-Endoscope System by HopfEANS-System (Endoscope Assisted Neuro Surgery) |
| Indications For Use: | The Minature Neuro-Endoscope System by Hopf allowsvisual observation of the operating site while using workingchannels, supply and drain channels. They are used fordiagnosis and therapy in neurosurgery, in connection withendoscopic accessories, during intracranial procedures.The EANS System (Endoscopic Assisted Neuro Surgery)allows a visualization of cerebral structures not visiblethrough the microscope and at the same time offers theoption of supplying and draining irrigation fluid, forexamination and diagnosis of microsurgical brain operation. |
Prescription Use V (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)
Mark N. Millman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K031858
§ 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).