(85 days)
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Not Found
No
The device description focuses on mechanical components and direct visualization, with no mention of AI/ML terms or image processing capabilities that would typically utilize such technologies.
Yes
Explanation: The intended use explicitly states "diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions," indicating its use in treating medical conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states "diagnostic and/or therapeutic procedures".
No
The device description explicitly lists physical components such as trocars, neuroendoscopes, instruments, electrodes, and an optional holding device, all made of stainless steel or titanium. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Aesculap's MINOP System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "direct visualization, diagnostic and/or therapeutic procedures" performed within the body (endoscope-assisted microneurosurgery and pure neuroendoscopy). IVD devices are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: The description details surgical instruments like trocars, neuroendoscopes, and electrodes, which are used for direct intervention and visualization during surgery. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the MINOP System is a surgical device used for direct visualization and intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Aesculab's MINOP System is intended for use in endoscope-assisted microneurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for direct visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.
Product codes (comma separated list FDA assigned to the subject device)
GWG
Device Description
The MINOP System consists of trocars (cannulas with blunt obturators). neuroendoscopes, instruments and electrodes. There are three different styles of operating cannulas which function as the base for the device system. The MINOP System operating cannulas have either 1, 3, or 4 working channels.
The Neuroendoscopes for the MINOP System are rigid, rod-lens neuroendoscopes with either 0° or 30° direction of view. The lens evepiece is angled at 90° to allow an unobstructed view when used in conjunction with a surgical microscope. The MINOP System consists of reusable devices composed primarily of stainless steel.
An optional holding device, Aesculap's Flexible Titanium Support Arm, can be used to position and hold the neuroendoscopes. With use of the flexible support arm, the surgeon can freely operate with both hands.
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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/0 description: The image shows the text "DEC 18 1998" in a light gray font at the top. Below this text is the word "AESCULAP" in a large, bold, black font. The word is followed by a period.
Aesculan, Inc 000 Gateway Blvd. San Francisco. CA 94080-7028 (650) 876-7000 650) 876-7028
.aesculap.com
510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990
Aesculap MINOP System
December 15, 1998
Aesculap®, Inc. Submitted by: 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Mary Ellen Holden (650) 876-7000 x5072 Phone: Direct line: (650) 624-5072 (650) 589-3007 FAX:
Product: Aesculap MINOP System Common Name: Neuroendoscopes
Intended Use
Aesculab's MINOP System is intended for use in endoscope-assisted microneurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for direct visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.
Technological Characteristics
The MINOP System consists of trocars (cannulas with blunt obturators). neuroendoscopes, instruments and electrodes. There are three different styles of operating cannulas which function as the base for the device system. The MINOP System operating cannulas have either 1, 3, or 4 working channels.
The Neuroendoscopes for the MINOP System are rigid, rod-lens neuroendoscopes with either 0° or 30° direction of view. The lens evepiece is angled at 90° to allow an unobstructed view when used in conjunction with a surgical microscope. The MINOP System consists of reusable devices composed primarily of stainless steel.
An optional holding device, Aesculap's Flexible Titanium Support Arm, can be used to position and hold the neuroendoscopes. With use of the flexible support arm, the surgeon can freely operate with both hands.
B BRAUN
1
Performance Standards
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Aesculap's MINOP System complies with the requirements of IEC 601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment.) The MINOP System has undergone evaluation for electrical, thermal and irrigation safety to ensure the system is safe for the intended use.
Sterilization
The MINOP System is provided non-sterile and must be sterilized prior to use. The devices may be sterilized by steam sterilization.
Substantial Equivalence
Aesculap's MINOP System shares similar features and function with corresponding devices distributed by:
- Aesculap (Ventriculopscope, Angled Neuroendoscopes) の
- Codman (Neuroendoscopes) 0
- Neuro Navigational (Neuroview) 0
- o Richard Wolf (Neuro-Endoscope)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 1998
Ms. Mary Ellen Holden Senior Regulatory Associate Aesculap, Inc. 1000 Gateway Boulevard South San Francisco, California 94080-7030
Re: K983365 Trade Name: Aesculap MINOP System Regulatory Class: II Product Code: GWG Dated: September 23, 1998 Received: September 24, 1998
Dear Ms. Holden:
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 (OS) 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.
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Page 2 -- Ms. Mary Ellen Holden
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.
pcolle
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
4
INDICATION FOR USE STATEMENT
983365 510(k) Number (if known):
Device Name:
Aesculap MINOP System
Indication for Use:
Aesculap's MINOP System is indicated for use in endoscope-assisted microneurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for direct visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
t.coelloto
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 12983365
Prescription Use
(Per 21 CFR 801.109)