Flexible Intubation Video Endoscope – Sterile (FIVE-S)

K212656 · Karl Storz Endoscopy America · EOQ · Dec 29, 2021 · Ear, Nose, Throat

Device Facts

• Record ID: K212656
• Device Name: Flexible Intubation Video Endoscope – Sterile (FIVE-S)
• Applicant: Karl Storz Endoscopy America
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Dec 29, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4680
• Device Class: Class 2

Intended Use

The Flexible Intubation Video Endoscope - Sterile (FIVE-S) are intended for use by physicians for endotracheal intubation and diagnostic and therapeutic procedures in nasal, sinus and nasopharyngeal endoscopy, tracheoscopy and esophagoscopy and laryngoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor. E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.

Device Story

Sterile, single-use flexible video endoscope; distal tip contains CMOS imaging sensor and LED light source. Captures raw image data; transfers to E-Box adaptor; PCB converts data to NTSC video signal. Compatible with C-MAC or C-HUB II CCUs for processing and display on monitor. Used by physicians in clinical settings for endotracheal intubation and endoscopic procedures. Provides real-time visualization of airways and body orifices; assists in tube placement and diagnostic/therapeutic interventions. Benefits include reduced cross-contamination risk due to single-use design and improved visualization for airway management.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing, including electrical safety (IEC 60601-1-2, IEC 60601-2-18), photobiological safety (IEC 62471), biocompatibility (ISO 10993), and performance testing (ISO 8600). Bench metrics included color contrast, image intensity uniformity, depth of field, spatial resolution, distortion, SNR, and sensitivity.

Technological Characteristics

Flexible video endoscope; 5.3 mm outer diameter; 650 mm length; 2.4 mm working channel. CMOS imaging sensor at distal tip; LED illumination. NTSC video output via 8-pin E-Box adaptor. Powered by C-MAC/C-HUB II CCUs. Sterile, single-use; EO gas sterilization (8.5% ETO in 91.5% CO2). Complies with IEC 60601-1-2, IEC 60601-2-18, IEC 62471, ISO 10993, and ISO 8600.

Indications for Use

Indicated for physicians performing endotracheal intubation, diagnostic, and therapeutic procedures in nasal, sinus, nasopharyngeal, bronchial, tracheal, esophageal, and laryngeal areas. No specific patient population age or gender restrictions provided.

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Predicate Devices

• KARL STORZ Flexible Video ENT Endoscope System (K071530)

Reference Devices

• KARL STORZ CMOS Video Rhino-Laryngoscope SSU (K192090)
• KARL STORZ Flexible HD Cysto-Urethroscope System (K182723)

Submission Summary (Full Text)

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December 29, 2021

KARL STORZ Endoscopy-America, Inc. Mario Trujillo Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, California 90245

Re: K212656

Trade/Device Name: Flexible Intubation Video Endoscope - Sterile (FIVE-S) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: November 23, 2021 Received: November 30, 2021

Dear Mario Trujillo:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Shu-Chen Peng Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K212656

Device Name

Flexible Intubation Video Endoscope - Sterile (FIVE-S)

Indications for Use (Describe)

The Flexible Intubation Video Endoscope - Sterile (FIVE-S) are intended for use by physicians for endotracheal intubation and diagnostic and therapeutic procedures in nasal, sinus and nasopharyngeal endoscopy, tracheoscopy and esophagoscopy and laryngoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor.

E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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 second 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 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<br>Dr.-Karl-Storz-Straße 34<br>78532 Tuttlingen, Germany |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mario Trujillo<br>Associate Regulatory Affairs Specialist<br>Tel.: [phone]<br>Email: [e-mail] |
| Date of Preparation: | August 20, 2021 |
| Type of 510(k)<br>Submission: | Special |
| Device Identification: | Trade Name: Flexible Intubation Video Endoscope – Sterile (FIVE-S) |
| | Classification Name: Bronchoscope (flexible or rigid) and accessories |
| | (21 CFR Part 876.4680); |
| Regulatory Class: | 2 |
| Product Code: | EOQ |
| Guidance Document: | Not Applicable |
| Predicate Device: | Predicate device: KARL STORZ Flexible Video ENT Endoscope System<br>(K071530). Reference devices: KARL STORZ CMOS Video Rhino-Laryngoscope SSU (K192090). KARL STORZ Flexible HD Cysto-Urethroscope System (K182723) |
| Device Description: | The Flexible Intubation Video Endoscope - Sterile (FIVE-S) is a sterile<br>single-use, flexible video-endoscopes. The distal tip houses the CMOS<br>(Complementary Metal Oxide Semiconductor) imaging sensor and the LED<br>light source. The raw data captured at the distal tip CMOS imaging sensor<br>is transferred to the E-Box adaptor, where it is converted to a standard<br>NTSC (National Television System Committee) video signal by the PCB<br>(Printed Circuit Board), which is then driven into one of the CCUs (C-MAC,<br>C-HUB II) for further processing and video formatting for output to a<br>display monitor. The videoscopes and E-Box are powered by the CCUs<br>through the connecting cords. |
| Intended Use: | Intubation endoscopes are used for oral or nasal endotracheal intubation.<br>Intubation endoscopes are designed for transient use in invasive<br>procedures through a body orifice. Intubation endoscopes are used to<br>inspect the upper and lower airways, to check the tube position with<br>double lumen tubes and for monitoring during PCT. |

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Image /page/4/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 phrase "KARL STORZ - ENDOSKOPE" in smaller letters.

| Indications For Use: | The Flexible Intubation Video Endoscope - Sterile (FIVE-S) are intended<br>for use by physicians for endotracheal intubation and diagnostic and<br>therapeutic procedures in nasal, sinus and nasopharyngeal endoscopy,<br>bronchoscopy, tracheoscopy and esophagoscopy and laryngoscopy. The<br>Karl Storz Video Bronchoscope is intended to provide visualization via a<br>video monitor.<br><br>E-Box: the product serves as an adaptor for operating the flexible single-<br>use videoscope on the compatible CCU. | | | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------|
| Technological Characteristics: | Comparison Table: Subject vs. Predicate and Reference Devices | | | |
| | | Subject Device<br>Flexible Intubation Video Endoscope –<br>Sterile (FIVE-S) | Predicate Device, K071530<br>Flex. Intubation Video Endoscope | Reference Device:<br>CMOS Video Rhino-Laryngoscope SSU (K192090) |
| | Maximal Outer diameter Insertion Portion | 5.3 mm | 5.5mm | 3.5 mm |
| | Outer diameter Insertion Tube | 5.3 mm | 5.5mm | 3.5 mm |
| | Outer diameter Distal End | 5.3 mm | 5.5mm | 3.5 mm |
| | Insertion portion length | 650 mm | Same as subject device | 300 mm |
| | Working channel | Present | Same as subject device | Not Present |
| | Inner diameter Working Channel | 2.4 mm | 2.2mm | No Channel |
| | Tip deflection up/down | 180°/180° | 180°/100° | 140°/140° |
| | Field of view | 110° | 120° | Same as subject device |
| | Direction of View | 0° | Same as subject device | Same as subject device |
| | Depth of Field | 5 - 50 mm | Same as subject device | Same as subject device |
| | On-axis Resolution | 12.5 Lp/mm at 5 mm<br>4.5 Lp/mm at 15 mm<br>1.25 Lp/mm at 50 mm | No data available | Same as subject device |
| | Chip type | CMOS | Same as subject device | Same as subject device |
| | Chip location | Distal | Same as subject device | Same as subject device |
| | Illumination source | LED | Same as subject device | Same as subject device |
| | E-Box type | 8-pin | N/A | 6-pin |
| | Compatible CCU | C-MAC<br>C-HUB II | Same as subject device | Same as subject device |
| | How device is provided | Sterile single-use | Unsterile, reusable | Same as subject device |
| | EO Sterilization cycle | EO, Overpressure 2.7<br>bar absolute, 8.5 % ETO<br>in 91.5 % CO2 | N/A | Same as subject device |
| | Sterilizing Agent | Ethylene Oxide (EO) | N/A | Same as subject device |
| Non-Clinical Performance Data: | There are no performance standards or special controls developed under<br>Section 514 of the FD&C Act for endoscopes. However, the subject device<br>follows the FDA recognized consensus standards and is tested according<br>to the following standards and FDA Guidance:<br>● Electrical Safety and EMC | | | |

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Image /page/5/Picture/0 description: The image shows the logo for STORZ. The logo is blue and consists of the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font. The logo is simple and professional.

| | IEC 60601-1-2 IEC 60601-2-18 IEC 62471 ISO 10993 ISO 8600 Performance Testing Color Contrast Enhancement Image intensity uniformity Depth of field & Spatial Resolution Distortion Signal-to-Noise Ratio (SNR) & Sensitivity Additional bench testing was performed to ensure the device met its design specifications. The bench testing performed verified and validated that the Flexible Intubation Video Endoscope – Sterile (FIVE-S) has met all its design specification and is substantially equivalent to its 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 devices, the Flexible Intubation Video Endoscope – Sterile (FIVE-S) performs as well as the predicate device. |