(74 days)
The Mitaka Point Setter is intended for use by qualified surgeons for holding rigid and flexible endoscopes during diagnostic and therapeutic neurologic procedures.
The Mitaka Point Setter is a manual/pneumatic surgical device composed of materials commonly used in medical devices for a wide range of applications.
The provided document is a 510(k) summary for a medical device called the "Mitaka Point Setter," an endoscope holder. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling strict performance acceptance criteria based on a clinical study or algorithm performance.
Therefore, the document does not contain information on acceptance criteria, a study proving device performance in the way described in the request (e.g., sample size for test set, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details common for AI/diagnostic devices).
The "study" in this context is the submission for substantial equivalence. The "performance" is implicitly deemed acceptable because it is substantially equivalent to a device already on the market.
Here's a breakdown of why this information is missing based on the provided text:
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A table of acceptance criteria and the reported device performance: Not applicable. For a device like an endoscope holder, performance is typically assessed through engineering specifications, material biocompatibility, and functional testing to ensure it holds the endoscope securely and safely. These specific criteria are not detailed in this public 510(k) summary. The document states its performance is "substantially equivalent" to a predicate device.
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Sample size used for the test set and the data provenance: Not applicable. This device is not an AI/diagnostic algorithm that would have a "test set" in the sense of patient data. Testing would involve engineering verification and validation (e.g., mechanical stress tests, sterility tests) on the device itself.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" to establish for an endoscope holder in the context of diagnostic accuracy.
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Adjudication method for the test set: Not applicable for the same reasons as above.
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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: Not applicable. This is a mechanical device, not an AI diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
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The sample size for the training set: Not applicable. There is no "training set" for a mechanical endoscope holder.
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How the ground truth for the training set was established: Not applicable.
Summary based on the provided text:
The document describes a medical device seeking 510(k) clearance based on substantial equivalence. It does not provide the kind of performance data (acceptance criteria, test/training sets, expert consensus) that would be expected for an AI or diagnostic device. The "study" is the 510(k) submission itself, demonstrating that the "Mitaka Point Setter" is substantially equivalent to a previously cleared predicate device, meaning its safety and effectiveness are considered comparable.
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K991989
AUG 27 1999
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of Mitaka's knowledge.
| Applicant: | Mitaka USA, Inc.2337 Lucky John DrivePark City, Utah 84060(435) 649-2236 |
|---|---|
| Contact: | Max SturgisPresident |
| Device Identification: | Common Name:Endoscope Holder |
Trade Name: (optional) Point Setter
Indication: The Mitaka Point Setter is intended for use by qualified surgeons for holding rigid and flexible endoscopes during diagnostic and therapeutic neurologic procedures.
Device Description: The Mitaka Point Setter is a manual/pneumatic surgical device composed of materials commonly used in medical devices for a wide range of applications.
Substantial Equivalence: The Mitaka Point Setter is substantially equivalent to the predicate device since the basic features and intended uses are the same.
Signed:
Max Sturgis
President
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Image /page/1/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 image of three human profiles facing right, with flowing lines representing hair or clothing.
Public Health Service
AUG 27 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Max Sturgis President Mitaka USA, Inc. 2337 Lucky John Drive Park City, Utah 84060
Re: K991989 Trade Name: Mitaka Point Setter Regulatory Class: II Product Code: GWG Dated: June 7, 1999 Received: June 14, 1999
Dear Mr. Sturgis:
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 - Mr. Max Sturgis
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,
Mark N. Milkman
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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K 991989 510(k) Number (if known):
Device Name: Mitaka Point Setter
Indications for Use: This instrument is intended for use by qualified surgeons for holding rigid and flexible endoscopes during diagnostic and therapeutic neurologic procedures.
Mark N Mulkerron
for
(Division Sign-Off) Division of General Restorative Devices 510(k) Number ..
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: OR Over-The-Counter Use: (Per 21 CFR 801.109)
(Optional Format 1-2-96)
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(99198
§ 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).