(27 days)
Not Found
Not Found
No
The description focuses on manual operation and fiber-optic technology, with no mention of AI, ML, or image processing that would typically indicate AI/ML involvement.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device can "perform various diagnostic and therapeutic procedures" using additional accessories.
Yes
The intended use explicitly states the device is designed for "examination" of various anatomical sites and to perform "various diagnostic and therapeutic procedures." Examination and diagnostic procedures are core functions of diagnostic devices.
No
The device description explicitly states it is a "manually operated surgical device" and a "flexible fiberoptic telescope," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. They perform tests outside of the body.
- Device Function: The description clearly states that these are flexible fiberoptic telescopes used for the direct examination of internal anatomical sites (nasal sinuses, larynx, pharynx, bronchi) within the patient's body. They are used for visualization and potentially performing procedures in vivo.
The device's function is to visualize internal structures directly, not to analyze samples taken from the body. Therefore, it falls under the category of a medical device used for examination and procedures, not an IVD.
N/A
Intended Use / Indications for Use
The KSEA Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope are designed to be used by qualified surgeons and physicians for examination of the nasal sinuses, larynx, pharynx and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The Rhino-Laryngo-Broncho-Fiberscope is indicated for examination of the nasal sinuses, larynx and bronchi and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The Pediatric Broncho-Fiberscope is indicated for examination of the larynx and bronchi in pediatric patients and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The Broncho-Fiberscope is indicated for examination of the larynx and bronchi in adult patients and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Product codes
77 EOB, 77 EOQ
Device Description
The KSEA Rhino-Laryngo-Broncho-Device Description: Fiberscope, and Broncho-Fiberscope are manually operated surgical devices. The KSEA Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope are flexible fiberoptic telescopes which utilize fiber-optic technology. The body contact portions of the KSEA Intubation Laryngoscope are composed of medical grade polyurethane.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal sinuses, larynx, pharynx, bronchi
Indicated Patient Age Range
pediatric patients, adult patients
Intended User / Care Setting
qualified surgeons and physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for STORZ Karl Storz Endoscopy. The logo is in white text on a black background. The word "STORZ" is in large, bold letters, with the "O" represented by three concentric circles with a dot in the center. Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font.
1981458
MAY 20 1998 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: Flexible ENT Scopes
Trade Name: (optional) Karl Storz Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope, 11001 RK, 11002 BC and 11004 B
Indication: The KSEA Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope are designed to be used by qualified surgeons and physicians for examination of the nasal sinuses, larynx, pharynx and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The KSEA Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Device Description: Fiberscope, and Broncho-Fiberscope are manually operated surgical devices. The KSEA Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope are flexible fiberoptic telescopes which utilize fiber-optic technology. The body contact portions of the KSEA Intubation Laryngoscope are composed of medical grade polyurethane.
Substantial Equivalence: The KSEA Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope 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:
Kurm'sinnany
Kevin Kennan
Senior Regulatory Affairs Specialist
1
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1998
Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy 600 Corporate Pointe Culver City, California 90230-7600 Re: K981458 Rhino-Laryngo-Broncho-Fiberscope Dated: April 20, 1998 Received: April 23, 1998 Regulatory Class: II 21 CFR 874.4760/Procode: 77 EOB 21 CFR 874.4680/Procode: 77 EOQ
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 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 requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (2) 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4613. Additionally, for question 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/odrh/dsmaldsmamain.html".
Sincerely yours,
William Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is white text on a black background. The word "STORZ" is in large, bold letters, with the "O" in "STORZ" having a white circle in the middle. Below "STORZ" is the text "Karl Storz Endoscopy" in a smaller font.
1981458
510(k) Number (if known): Not yet assigned
Device Name: Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope
Indications for Use:
The Rhino-Laryngo-Broncho-Fiberscope is indicated for examination of the nasal sinuses, larynx and bronchi and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The Pediatric Broncho-Fiberscope is indicated for examination of the larynx and bronchi in pediatric patients and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The Broncho-Fiberscope is indicated for examination of the larynx and bronchi in adult patients and, using additional accessories, to perform various diagnostic and therapeutic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seymour
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K981458
| Prescription Use: | ✓ |
|---|---|
| (Per 21 CFR 801.109) | |
| OR Over-The-Counter Use: |
(Optional Format 1-2-96)
000003