(85 days)
Aesculap'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.
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.
The Aesculap MINOP System is a medical device intended for endoscope-assisted microneurosurgery and pure neuroendoscopy (ventriculoscopy) for direct visualization, diagnostic, and/or therapeutic procedures (e.g., ventriculostomies, biopsies, removal of cysts, tumors, and other obstructions).
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Performance Standards | No applicable performance standards promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. | The MINOP System complies with the requirements of IEC 601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment). |
| Safety Testing | Evaluation for electrical safety | Underwent evaluation to ensure safety for intended use. |
| Evaluation for thermal safety | Underwent evaluation to ensure safety for intended use. | |
| Evaluation for irrigation safety | Underwent evaluation to ensure safety for intended use. | |
| Sterilization | Ability to be sterilized prior to use | Provided non-sterile and can be sterilized by steam sterilization. |
| Substantial Equivalence | Similar features and function to legally marketed predicate devices. | Shares similar features and function with corresponding devices distributed by: Aesculap (Ventriculoscope, Angled Neuroendoscopes), Codman (Neuroendoscopes), Neuro Navigational (Neuroview), Richard Wolf (Neuro-Endoscope). |
2. Sample size used for the test set and the data provenance:
The provided document does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for proving the device's performance against the stated criteria. The compliance with IEC 601-2-18 and safety evaluations would have been conducted through engineering tests and possibly bench testing, rather than a clinical 'test set' in the typical sense of a patient study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. Given that the acceptance criteria are related to compliance with an electrical safety standard (IEC 601-2-18) and general safety evaluations, it's unlikely that "experts" in the context of ground truth for a clinical test set were used. Rather, the evaluations would involve qualified engineers and technicians.
4. Adjudication method for the test set:
This information is not provided in the document. An adjudication method, typically associated with clinical trials or expert reviews, is not mentioned for the safety and performance evaluations described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable and not provided. The Aesculap MINOP System is a physical neuroendoscopic system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. As mentioned above, the device is a physical endoscopic system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance criteria appears to be compliance with an international standard (IEC 601-2-18) and successful completion of internal safety evaluations (electrical, thermal, irrigation). For substantial equivalence, the ground truth is the existence and characteristics of predicate devices already on the market. This is not "ground truth" derived from patient data like pathology or outcomes.
8. The sample size for the training set:
This information is not provided and is not applicable. The MINOP System is a hardware device; it does not involve a "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established:
This information is not provided and is not applicable for the reasons stated in point 8.
{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.
{3}------------------------------------------------
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)
§ 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).