(77 days)
The KSEA Endoscopes for Dental Procedures are designed to be used for examination of the operative site during endodontic procedures.
The Endoscopes for Dental procedures are indicated for use whenever magnification is desirable and/or access is restricted during dental, endodontic, and periodontic procedures.
The KSEA Endoscopes for Dental Procedures are manually operated surgical devices. The KSEA Endoscopes for Dental Procedures are rigid rod lens endoscopes. The body contact portions of the KSEA Endoscopes for Dental Procedures are composed of medical grade stainless steel.
The provided document is a 510(k) summary for Karl Storz Endoscopy - America, Inc.'s "Endoscopes for Dental Procedures," seeking clearance for a medical device. This type of document, particularly from 1998, focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies with detailed acceptance criteria and statistical analysis as would be expected for novel or higher-risk devices today.
Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is provided:
Explanation:
- Substantial Equivalence: The core of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics, intended use, and performance data (often bench testing or limited clinical data if necessary to address specific performance differences). It does not usually require the kind of detailed, prospective clinical trials with predefined acceptance criteria and statistical power analysis that would be needed for a PMA (Premarket Approval) or for a novel device where no substantial equivalence can be claimed.
- Device Type: This device is an endoscope for dental procedures, described as "manually operated surgical devices" and "rigid rod lens endoscopes." These are well-established technologies, and significant new performance claims beyond those of predicate devices would be unusual.
- Date: The document is from 1998, an era when 510(k) submissions generally had less stringent requirements for detailed clinical performance data compared to current FDA guidelines, particularly for devices like endoscopes with established safety and effectiveness profiles.
Information from the document that does relate to the request (albeit indirectly, by absence):
- Table of acceptance criteria and reported device performance: This information is not present in the document. The document states: "The KSEA Endoscopes for Dental Procedures are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Endoscopes for Dental Procedures and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices." This implies that the performance is considered equivalent to the predicate, and no new performance thresholds were established or tested.
- Sample size used for the test set and the data provenance: This information is not present. No specific test set or clinical study data is referenced. The submission relies on substantial equivalence.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present. No test set or ground truth establishment is described.
- Adjudication method for the test set: This information is not present. No test set or adjudication process is described.
- 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 present. The device is a manually operated endoscope, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present. The device is a manually operated endoscope, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not present. No specific ground truth data is mentioned for performance evaluation.
- The sample size for the training set: This information is not present. The device is not an AI/ML algorithm that requires a training set.
- How the ground truth for the training set was established: This information is not present. The device is not an AI/ML algorithm that requires a training set.
In summary, the provided 510(k) summary demonstrates substantial equivalence by comparing the device's design, materials, and intended use to a predicate device, rather than by presenting a detailed performance study against specific acceptance criteria.
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OCT 1 5 1998
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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 KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.600 Corporate Pointe DriveCulver City, CA 90230(310) 410-2769 |
|---|---|
| Contact: | Kevin KennanSenior Regulatory Affairs Specialist |
| Device Identification: | Common Name:EndoscopeTrade Name: (optional)Endoscopes for Dental Procedures |
Indication: The KSEA Endoscopes for Dental Procedures are designed to be used for examination of the operative site during endodontic procedures.
Device Description: The KSEA Endoscopes for Dental Procedures are manually operated surgical devices. The KSEA Endoscopes for Dental Procedures are rigid rod lens endoscopes. The body contact portions of the KSEA Endoscopes for Dental Procedures are composed of medical grade stainless steel.
Substantial Equivalence: The KSEA Endoscopes for Dental Procedures are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Endoscopes for Dental Procedures and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.
Signed: Kevin Kennan
Senior Regulatory Affairs Specialist
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 1998
Mr. Kevin A. Keenan Senior Regulatory Affaris Specialist Karl Storz Endoscopy-America, Incorporated 600 Corporate Pointe Culver City, California 90230-7600
K982658 Re : Ksea Endoscopes for Dental Procedures Trade Name: Requlatory Class: I Product Code: EIA Dated: July 28, 1998 Received: July 30, 1998
Dear Mr. Kennan:
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 legally marketed predicate 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 reqistration, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਮ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) 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 In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. Kennan
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. ula Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K982658
Device Name: Dental Endopscope
. ...
Indications for Use:
The Endoscopes for Dental procedures are indicated for use whenever magnification is desirable and/or access is restricted during dental, endodontic, and periodontic procedures.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | |
|---|---|
| 510(k) Number | K982658 |
| Prescription Use: | OR Over-The-Counter Use: |
|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.