(175 days)
No reference devices were used in this submission.
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on visualization hardware.
No
The device is intended for visualization during diagnostic procedures, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic procedures."
No
The device description explicitly lists three main hardware components: the Rhino-Laryngoscope SSU, the E-Box adaptor, and the CCU. While software is mentioned and validated, it is part of a system that includes significant hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide visualization of nasal lumens and airway anatomy... during diagnostic procedures." This describes a device used for direct visualization within the body, not for testing samples taken from the body.
- Device Description: The device is a "CMOS Video Rhino-Laryngoscope SSU System" which includes a videoscope, adaptor, and CCU. This is consistent with an endoscopic device used for internal examination.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a physiological state, health, or disease. This device is used for direct visual inspection within the body.
N/A
Intended Use / Indications for Use
The CMOS Video Rhino-Laryngoscope SSU is intended to provide visualization of nasal lumens and airway anatomy (including nasopharynx and trachea) during diagnostic procedures.
The E-Box serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.
Product codes
EOB
Device Description
The CMOS Video Rhino-Laryngoscope SSU System includes three main components: (1) the CMOS Video Rhino-Laryngoscope SSU (091330-01), (2) E-Box adaptor (TP010) and (3) the CCU. CMOS Video Rhino-Laryngoscope SSU is compatible with two KARL STORZ CCUs: C-HUB and C-MAC. CMOS Video Rhino-Laryngoscope SSU is provided sterile (EtO), for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal lumens and airway anatomy (including nasopharynx and trachea)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical Performance Data:
The electrical safety and EMC data for the subject device and compatible CCUs was provided to FDA in the primary predicate device's 510(k)# K182186 and was in compliance with the following FDA recognized standards: ANSI/AAMI ES:60601-1:2005, IEC 60601-1-2:2007.
Bench Testing Summary
The performance data submitted in the submission is in compliance with the following FDA recognized standards: ISO 8600-1:2015, ISO 8600-3:1997, ISO 8600-4:2014, ISO 8600-5:2005, IEC 62471:2006, IEC 60601-2-18:2009.
Biocompatibility Summary
The biocompatibility evaluation for the patient contacting components of the CMOS Video Rhino-Laryngoscope SSU was performed according to ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"". Tests in accordance with following standards were conducted based on contact type and duration: ISO 10993-1:2009/(R)2013, ISO 10993-5:2009/(R)2014, ISO 10993-10:2010/(R)2014, ISO 10993-11:2006/(R) 2010, ISO 10993-12:2012.
Sterilization Validation Summary
The CMOS Video Rhino-Laryngoscope SSU is provided sterile and do not require user reprocessing. The subject device is validated to be sterilized with EO in accordance with validated sterilization cycle "6.Storz". Sterilization validation is in compliance with the following standard.
Software Verification and Validation Summary
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued on May 11, 2005. The software for this device was considered as a "minor" level of concern, since a failure or latent flaw in the software is unlikely to cause any injury to the patient or operator.
Animal Study
Animal study was not required to demonstrate the substantial equivalence to the predicate devices.
Clinical Performance Data:
Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications.
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the subject device, the CMOS Video Rhino-Laryngoscope SSU is substantially equivalent to the predicate devices, that are currently marketed for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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
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January 27, 2020
Karl Storz SE & Co. KG Alexey Davidov Manager Regulatory Affairs, US Submissions Dr.-Karl-Storz-Straße 34 78532 Tuttlingen, Germany
Re: K192090
Trade/Device Name: CMOS Video Rhino-Laryngoscope SSU Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB Dated: December 24, 2019 Received: December 27, 2019
Dear Alexey Davidov:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192090
Device Name CMOS Video Rhino-Laryngoscope SSU
Indications for Use (Describe)
The CMOS Video Rhino-Laryngoscope SSU is intended to provide visualization of nasal lumens and airway anatomy (including nasopharynx and trachea) during diagnostic procedures.
The E-Box serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92 and the FDA guidance document titled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued on July 28, 2014. All data included in this document is accurate and complete to the best of KARL STORZ SE & Co. KG knowledge.
| Submitter: | KARL STORZ SE & Co. KG
Dr.-Karl-Storz-Straße 34
78532 Tuttlingen, Germany |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Alexey Davidov
Manager Regulatory Affairs, US Submissions
Phone: +49 (0)7461 708-7909
Fax: +49 (0)7461 708-75095
Email: Alexey.Davidov@karlstorz.com |
| Date of Preparation: | September 2, 2019 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name:
CMOS Video Rhino-Laryngoscope SSU
Classification Name:
Nasopharyngoscope, Flexible or Rigid (21 CFR Part 874.4760) |
| Regulatory Class: | II |
| Product Code: | EOB |
| Guidance
Document: | Not Applicable for EOB product codes |
| Recognized
Consensus
Standards: | Not Applicable for EOB product codes |
| Predicate Device: | Primary predicate device: KARL STORZ Endoscopy-America's CMOS
Video Rhino-Laryngoscope Model 11102CM (K182186). Secondary
predicate device: KARL STORZ CMOS Video Rhino-Laryngoscope
Model 11101CM (K103467).
Predicates have not been subjects to a design-related recalls.
No reference devices were used in this submission. |
4
Image /page/4/Picture/0 description: The image is a logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
| Device Description: | The CMOS Video Rhino-Laryngoscope SSU System includes three main components: (1) the CMOS Video Rhino-Laryngoscope SSU (091330-01), (2) E-Box adaptor (TP010) and (3) the CCU. CMOS Video Rhino-Laryngoscope SSU is compatible with two KARL STORZ CCUs: C-HUB and C-MAC. CMOS Video Rhino-Laryngoscope SSU is provided sterile (EtO), for single use only. | |||
|---|---|---|---|---|
| Intended Use: | CMOS Video Rhino-Laryngoscope SSU is intended for visualization purposes during ENT procedures. | |||
| Indications for Use: | The CMOS Video Rhino-Laryngoscope SSU is intended to provide visualization of nasal lumens and airway anatomy (including nasopharynx and trachea) during diagnostic procedures. | |||
| The E-Box serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU. | ||||
| Technological Characteristics: | Comparison Table: Subject vs. Predicate Devices | |||
| Subject Device | Primary Predicate device | |||
| K182186 | ||||
| CMOS Video Rhino-Laryngoscope | ||||
| 11102CM | Secondary Predicate device | |||
| K103467 | ||||
| CMOS Video Rhino-Laryngoscope | ||||
| 11101CM | ||||
| CMOS Video Rhino-Laryngoscope SSU | ||||
| 091330-01 | ||||
| Physical Characteristics | ||||
| Type of Scope | Flexible video endoscope | Same as the subject device | Same as the subject device | |
| Insertion Shaft Diameter | 3.5 mm | 2.9 mm | 3.7 mm | |
| Insertion Shaft Length | 300 mm | Same as the subject device | Same as the subject device | |
| Deflection | 140° Up, 140° Down | Same as the subject device | Same as the subject device | |
| Optical and System Characteristics | ||||
| Type of Imager | CMOS | Same as the subject device | Same as the subject device | |
| Direction of View | 0° | Same as the subject device | Same as the subject device | |
| Field of view | 110° | 100° | 85° | |
| Light Source | Internal LED | Same as the subject device | Same as the subject device | |
| Reprocessing Methods | ||||
| How device is provided | Sterile single-use | Unsterile, reusable | Unsterile, reusable | |
| EO Sterilization Cycle | 6.Storz / 1.75 bar / | |||
| 50° C / 80 min / | ||||
| 17.5h" | N/A | N/A | ||
| Sterilizing agent | Mixture of EO in CO2; resulting | |||
| concentration: 8,5 ± 0,5 % EO; CO2 added | ||||
| up to 100 % | N/A | N/A |
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Image /page/5/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters. The logo is simple and professional.
Electrical Safety and Electromagnetic Compatibility Summary Non-Clinical The electrical safety and EMC data for the subject device and compatible Performance Data: CCUs was provided to FDA in the primary predicate device's 510(k)# K182186 and was in compliance with the following FDA recognized standards: ✓ ANSI/AAMI ES:60601-1:2005 √ IEC 60601-1-2:2007 Bench Testing Summary The performance data submitted in the submission is in compliance with the following FDA recognized standards: ISO 8600-1:2015 > > ISO 8600-3:1997 V ISO 8600-4:2014 ISO 8600-5:2005 > > IEC 62471:2006 IEC 60601-2-18:2009 Biocompatibility Summary The biocompatibility evaluation for the patient contacting components of the CMOS Video Rhino-Laryngoscope SSU was performed according to ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"". Tests in accordance with following standards were conducted based on contact type and duration: ISO 10993-1:2009/(R)2013 > ISO 10993-5:2009/(R)2014 > > ISO 10993-10:2010/(R)2014 > ISO 10993-11:2006/(R) 2010 ISO 10993-12:2012 Sterilization Validation Summary The CMOS Video Rhino-Laryngoscope SSU is provided sterile and do not require user reprocessing. The subject device is validated to be sterilized with EO in accordance with validated sterilization cycle "6.Storz". Sterilization validation is in compliance with the following standard: √ Software Verification and Validation Summary Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued on May 11, 2005. The software for this device was considered as a "minor" level of concern, since a failure or latent flaw in the software is unlikely to cause any injury to the patient or operator. Animal Study Animal study was not required to demonstrate the substantial equivalence to the predicate devices.
6
Image /page/6/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is written in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters. The logo is simple and professional.
| Clinical
Performance Data: | Clinical testing was not required to demonstrate the substantial
equivalence to the predicate devices. Non-clinical bench testing was
sufficient to establish the substantial equivalence of the modifications. |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that the
subject device, the CMOS Video Rhino-Laryngoscope SSU is substantially
equivalent to the predicate devices, that are currently marketed for the
same intended use. |