(38 days)
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No
The summary describes a manually operated, reusable surgical endoscope with magnifying powers. There is no mention of any computational processing, image analysis, or AI/ML terms.
No
The device is described as a diagnostic and surgical tool for visualization, not for treating or curing a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "To provide visualization of the nasal cavities, including the nasal mucosa, during a variety of ENT diagnostic and surgical procedures". The mention of "diagnostic procedures" indicates its use as a diagnostic device.
No
The device description explicitly states it is a "manually operated, reusable surgical device" made of "surgical grade stainless steel," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The KSEA Contact Nasal Micro-Endoscope is a surgical device used for visualization within the nasal cavities during procedures. It directly interacts with the patient's body for observation, not for analyzing samples taken from the body.
The description clearly indicates it's a tool for direct visualization during ENT procedures, which falls under the category of surgical or diagnostic instruments used in vivo (within the living body), not in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The KSEA Contact Nasal Micro-Endoscopes are intended to provide visualization of the nasal cavities, during a variety of ENT diagnostic and surgical procedures, utilizing both panoramic and tissue contact vision at high magnification.
To provide visualization of the nasal cavities, including the nasal mucosa, during a variety of ENT diagnostic and surgical procedures, utilizing both panoramic and tissue contact vision at high magnification.
Product codes
77 EOB
Device Description
The KSEA Contact Nasal Micro-Endoscope is a manually operated, reusable surgical device with an assortment of magnifying powers. The KSEA Contact Nasal Micro-Endoscope is long enough to gain access to the surgical site. The body contact materials are surgical 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
nasal cavities
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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§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows a black and white speckled pattern. The black speckles are scattered across a white background, creating a textured effect. The density of the speckles varies, with some areas having a higher concentration of black spots than others. The overall impression is that of a grainy or noisy surface.
Karl Storz Endoscopy-America
00 Cornorate Pointe Culver City, California 90230-7 Phone 310 558 1500
Toll Free 800 : ax 310 1105
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 are accurate and complete to the best of KSEA's knowledge.
Applicant:
Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230 (310) 558-1500
Contact:
Regulatory Affairs Specialist
Kevin Kennan
Device Identification:
Common Name Rhinoscope Trade Name Karl Storz Contact Nasal Micro-Endoscopes
Indication: The KSEA Contact Nasal Micro-Endoscopes are intended to provide visualization of the nasal cavities, during a variety of ENT diagnostic and surgical procedures, utilizing both panoramic and tissue contact vision at high magnification ..
Device Description: The KSEA Contact Nasal Micro-Endoscope is a manually operated, reusable surgical device with an assortment of magnifying powers. The KSEA Contact Nasal Micro-Endoscope is long enough to gain access to the surgical site. The body contact materials are surgical grade stainless steel.
Substantial Equivalence: The KSEA Contact Nasal Micro-Endoscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences in design and dimensions between the KSEA Contact Nasal Micro-Endoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
Signed: Maika Anderson
Marika Anderson Senior Regulatory Affairs Specialist
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Image /page/1/Picture/0 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 figures, one behind the other, with their heads tilted upwards.
Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 1997
Marika Anderson Senior Regulatory Affairs Specialist Karl Storz Endoscopy America Inc. 600 Corporate Pointe Culver City, CA 90230-7600
K972855 Karl Storz Contact Nasal Micro-Endoscope Dated: July 30, 1997 Received: August 1, 1997 Regulatory class: II 21 CFR 874.4760/Procode: 77 EOB
Dear Ms. Anderson:
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, 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 QS 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 Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketd 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) 594-4613. 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,
h. William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Karl Storz Contact Nasal Micro-Endoscope
Indications For Use:
To provide visualization of the nasal cavities, including the nasal mucosa, during a variety of ENT diagnostic and surgical procedures, utilizing both panoramic and tissue contact vision at high magnification..
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 Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K972855 |
| Prescription Use (Per 21 CFR 801.109) | X |
| OR Over -the-Counter Use |
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