(128 days)
No
The description focuses on standard video processing and signal conversion, with no mention of AI or ML algorithms for image analysis, diagnosis, or other functions.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is intended for "diagnostic and therapeutic procedures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic and therapeutic procedures".
No
The device description clearly outlines hardware components including a flexible endoscope with a CMOS imaging sensor and LED light source, and an E-Box adaptor with a PCB. The device relies on these physical components for image acquisition and signal conversion.
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 for endotracheal intubation and diagnostic and therapeutic procedures in various anatomical sites (nasal, sinus, nasopharyngeal, tracheoscopy, esophagoscopy, laryngoscopy). These are all procedures performed directly on the patient for visualization and intervention.
- Device Description: The description details a video endoscope system used for capturing images inside the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside the body, such as blood, urine, tissue samples, etc., which is the defining characteristic of an in vitro diagnostic device.
IVD devices are used to examine specimens in vitro (in glass, or outside the body) to provide information for diagnosis, monitoring, or screening. This device is used in vivo (in the living body).
N/A
Intended Use / Indications for 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.
Product codes
EOQ
Device Description
The Flexible Intubation Video Endoscope - Sterile (FIVE-S) is a sterile single-use, flexible video-endoscopes. The distal tip houses the CMOS (Complementary Metal Oxide Semiconductor) imaging sensor and the LED light source. The raw data captured at the distal tip CMOS imaging sensor is transferred to the E-Box adaptor, where it is converted to a standard NTSC (National Television System Committee) video signal by the PCB (Printed Circuit Board), which is then driven into one of the CCUs (C-MAC, C-HUB II) for further processing and video formatting for output to a display monitor. The videoscopes and E-Box are powered by the CCUs through the connecting cords.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal, sinus, nasopharyngeal, tracheoscopy, esophagoscopy, laryngoscopy, upper and lower airways
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Non-Clinical Performance Data: There are no performance standards or special controls developed under Section 514 of the FD&C Act for endoscopes. However, the subject device follows the FDA recognized consensus standards and is tested according to the following standards and FDA Guidance: Electrical Safety and EMC 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
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.(b)
Classification. Class II.
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| ☑ 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 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
Dr.-Karl-Storz-Straße 34
78532 Tuttlingen, Germany |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mario Trujillo
Associate Regulatory Affairs Specialist
Tel.: (424) 218-8481
Email: Mario.Trujillo@karlstorz.com |
| Date of Preparation: | August 20, 2021 |
| Type of 510(k)
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
(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
single-use, flexible video-endoscopes. The distal tip houses the CMOS
(Complementary Metal Oxide Semiconductor) imaging sensor and the LED
light source. The raw data captured at the distal tip CMOS imaging sensor
is transferred to the E-Box adaptor, where it is converted to a standard
NTSC (National Television System Committee) video signal by the PCB
(Printed Circuit Board), which is then driven into one of the CCUs (C-MAC,
C-HUB II) for further processing and video formatting for output to a
display monitor. The videoscopes and E-Box are powered by the CCUs
through the connecting cords. |
| Intended Use: | Intubation endoscopes are used for oral or nasal endotracheal intubation.
Intubation endoscopes are designed for transient use in invasive
procedures through a body orifice. Intubation endoscopes are used to
inspect the upper and lower airways, to check the tube position with
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
for use by physicians for endotracheal intubation and diagnostic and
therapeutic procedures in nasal, sinus and nasopharyngeal endoscopy,
bronchoscopy, 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. | | | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------|
| Technological Characteristics: | Comparison Table: Subject vs. Predicate and Reference Devices | | | |
| | | Subject Device
Flexible Intubation Video Endoscope –
Sterile (FIVE-S) | Predicate Device, K071530
Flex. Intubation Video Endoscope | Reference Device:
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
4.5 Lp/mm at 15 mm
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
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
bar absolute, 8.5 % ETO
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
Section 514 of the FD&C Act for endoscopes. However, the subject device
follows the FDA recognized consensus standards and is tested according
to the following standards and FDA Guidance:
● 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. |