(77 days)
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No
The summary describes a manually operated, rigid rod lens endoscope made of stainless steel. There is no mention of image processing, AI, ML, or any related concepts. The description focuses on the physical characteristics and intended use of a traditional endoscope.
No
The device is used for examination and magnification during dental procedures, not for treating a disease or condition.
No
The device is described as an endoscope for examination, magnification, and access during procedures, not for identifying or diagnosing a disease or condition.
No
The device description explicitly states it is a "manually operated surgical device" and a "rigid rod lens endoscope" composed of "medical grade stainless steel," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The KSEA Endoscopes for Dental Procedures are described as manually operated surgical devices used for examination of the operative site during dental procedures. They are used for magnification and access during these procedures. This involves direct visualization within the body, not testing samples taken from the body.
The device's function is to aid in visualization during surgical procedures, which falls under the category of surgical instruments or endoscopes, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
EIA
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.
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
OCT 1 5 1998
Image /page/0/Picture/1 description: The image shows a series of handwritten numbers and a symbol. The numbers appear to be '4982658'. Below the numbers is a circular symbol that resembles a filled-in donut shape. The numbers are written in a cursive style, and the image is in black and white.
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 Drive
Culver City, CA 90230
(310) 410-2769 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan
Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Endoscope
Trade 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
1
Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other.
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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)