(221 days)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard video imaging components.
No
The device is indicated for visualization during diagnostic procedures, not for treatment.
Yes
The "Intended Use / Indications for Use" states that the system is indicated for visualization "during diagnostic procedures."
No
The device description explicitly states it includes two main hardware components: the CMOS Video-Rhino-Laryngoscope and the CCU.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "provide visualization of the nasal lumens and airway anatomy... during diagnostic procedures." This describes a device used for direct visualization of internal body structures, which is a characteristic of an endoscope or similar imaging device, not an IVD.
- Device Description: The description details a "Video-Rhino-Laryngoscope System" with a scope and a control unit. This aligns with the components of an endoscopic system used for visualization.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. The provided information does not mention any analysis of specimens or in vitro testing.
Therefore, the CMOS Video-Rhino-Laryngoscope System is a medical device used for direct visualization in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The CMOS Video-Rhino-Laryngoscope System is indicated to provide visualization of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic procedures.
Product codes
EOB
Device Description
The CMOS Video-Rhino-Laryngoscope System includes two main components: (1) the CMOS Video-Rhino-Laryngoscope (11102CM) and (2) the CCU. The CMOS Video-Rhino-Laryngoscope is compatible with two KARL STORZ CCUs: C-HUB and C-MAC.
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 nasopharyngeal and trachea)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
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.
Key Metrics
Not Found
Predicate Device(s)
KARL STORZ Endoscopy-America's CMOS Video Rhino-Laryngoscope System Model 11101CM (K103467)
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.
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March 22, 2019
KARL STORZ Endoscopy-America, Inc. Nozomi Yagi Sr. Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, California 90245
Re: K182186
Trade/Device Name: CMOS Video-Rhino-Laryngoscope System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB Dated: August 9, 2018 Received: August 13, 2018
Dear Nozomi Yagi:
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 mav, 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 avare 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Srinivas Nandkumar -S
for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182186
Device Name
CMOS Video-Rhino-Laryngoscope System
Indications for Use (Describe)
The CMOS Video-Rhino-Laryngoscope System is indicated to provide visualization of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic procedures.
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 word "STORZ" is in large, bold, blue letters on the top line. The words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters on the bottom line.
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. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Submitter: | KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Avenue
EI Segundo, CA 90245 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nozomi Yagi
Sr. Regulatory Affairs Specialist
Phone: (424) 218-8351
Fax: (424) 218-8519 |
| Date of
Preparation: | March 22, 2019 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: CMOS Video-Rhino-Laryngoscope System
Classification Name: Endoscope, Neurological (21 CFR Part 882.1480) |
| Regulatory
Class: | II |
| Product Code: | EOB |
| Guidance
Document: | Not Applicable for EOB product code |
| Recognized
Consensus
Standards: | Not Applicable for EOB product code |
| Predicate Device: | Primary Predicate Device: KARL STORZ Endoscopy-America's
CMOS Video Rhino-Laryngoscope System Model 11101CM
(K103467) |
| Device
Description: | The CMOS Video-Rhino-Laryngoscope System includes two main
components: (1) the CMOS Video-Rhino-Laryngoscope (11102CM)
and (2) the CCU. The CMOS Video-Rhino-Laryngoscope is compatible
with two KARL STORZ CCUs: C-HUB and C-MAC. |
| Intended Use: | The CMOS Video-Rhino-Laryngoscope System is intended for
visualization purposes during ENT procedures. |
| Indications For
Use: | The CMOS Video-Rhino-Laryngoscope System is indicated to provide
visualization of the nasal lumens and airway anatomy (including |
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Image /page/4/Picture/0 description: The image shows the logo for STORZ, a company that specializes in endoscopes. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.
| nasopharyngeal and trachea) during diagnostic procedures. | |||
|---|---|---|---|
| Technological | |||
| Characteristics: | Comparison Table: Subject vs. Primary Predicate Devices | ||
| Subject Device | Primary Predicate, | ||
| K103467 | |||
| CMOS V-R-L 11101CM | |||
| Physical Characteristics | |||
| Type of Scope | Flexible | Same as the subject device | |
| Insertion Shaft Diameter | 2.9 mm | 3.7 mm | |
| Insertion Shaft Length | 300 mm | Same as the subject device | |
| Deflection | 140° Up, 140° Down | Same as the subject device | |
| Optical and System Characteristics | |||
| Type of Imager | CMOS | Same as the subject device | |
| Direction of View | 0° | Same as the subject device | |
| Light Source | Internal LED | Same as the subject device | |
| Field of View | 100 | 85 | |
| Depth of Field | 5-50mm | 8-50mm | |
| On-axis Resolution (minimal) | 16 Lp/mm at 5mm | ||
| 1.8Lp/mm at 50mm | 8.0 Lp/mm at 8mm | ||
| 1.4 Lp/mm at 50 mm | |||
| Reprocessing Methods | |||
| Cleaning | Manual | Same as the subject device | |
| Sterilization | Yes | Same as the subject device | |
| HLD | Yes | Same as the subject device | |
| Non-Clinical | |||
| Performance | |||
| Data: | Electrical Safety and Electromagnetic Compatibility Summary | ||
| The electrical safety and EMC data included in the submission is 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 | |||
| neuroscope was performed according to ISO 10993-1 and FDA Guidance. The | |||
| following tests were conducted based contact type and duration: | |||
| ISO 10993-5:2009/(R) 2014 ISO 10993-10:2010 ISO 10993-11:2006/(R) 2010 | |||
| Reprocessing Validation Summary | |||
| The CMOS Video-Rhino-Laryngoscope (Part Number: 11102CM) is provided non- | |||
| sterile and is reusable. The users are required to reprocess it for initial and after each | |||
| use. The subject device contacts intact mucosal membranes so it is a semi-critical | |||
| device per Spaulding Classification, requiring thorough cleaning followed by | |||
| sterilization or high level disinfection (HLD) after each use. For this reason, we | |||
| performed validation activities for cleaning, sterilization, and HLD according to the |
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Image /page/5/Picture/0 description: The image shows the 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 text "KARL STORZ - ENDOSKOPE" in a smaller font.
| | FDA Guidance. The reprocessing data submitted is in compliance with the following
standards:
• AAMI TIR 12:2010
• ISO 15883-5:2005
• AAMI TIR 30:2011
• AAMI/ANSI/ISO 11737-1:2006/ (R)2011
• ASTM E1837-96:2014 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Substantial
Equivalence | As proven by the comparisons, the minor difference between the subject
and predicate devices shown in Technological Characteristics section
of this summary do not raise new or different questions of safety and
effectiveness because the intended use, operating principles,
technological characteristics, and features are similar, if not identical.
Both systems also comply with identical standards and safety testing,
where applicable.
Substantial equivalence on the effectiveness of the subject device is
supported by the comparison of performance data between the subject
and predicate devices. |
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that the
subject device, the CMOS Video-Rhino-Laryngoscope System is
substantially equivalent to the legally marketed predicate device. |