Predicate Devices

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a video esophagoscope system for visualization and diagnostic procedures. There is no mention of AI, ML, image processing beyond basic visualization, or any performance metrics typically associated with AI/ML algorithms. The performance studies focus on non-clinical aspects like safety, compatibility, and software validation, not algorithmic performance.

Therapeutic

No
The device is described as providing visualization for diagnostic procedures, not for treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to provide visualization... during diagnostic procedures."

SaMD (Software as a Medical Device)

No

The device description explicitly lists three main hardware components: the CMOS Video Esophagoscope SSU, the E-Box adaptor, and the CCU. The performance studies also include hardware-related testing like electrical safety, biocompatibility, and sterilization validation.

IVD (In Vitro Diagnostic)

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 sinuses, larynx, esophagus and gastroesophageal junction during diagnostic procedures." This describes a device used for direct visualization of internal body structures, which is a characteristic of an endoscope, not an IVD.
Device Description: The description details a "CMOS Video Esophagoscope SSU System" with components like a videoscope, adaptor, and CCU. 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 diagnose diseases or conditions. The provided information does not mention any analysis of specimens or in vitro testing.

Therefore, the CMOS Video Esophagoscope SSU System is a medical device used for direct visualization within the body, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The CMOS Video Esophagoscope SSU is intended to provide visualization of nasal sinuses, larynx, esophagus and gastroesophageal junction during diagnostic procedures.

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

Product codes

EOX

Device Description

The CMOS Video Esophagoscope SSU System includes three main components: (1) the CMOS Video Esophagoscope SSU (091370-01), (2) E-Box adaptor (TP010) and (3) the CCU. CMOS Video Esophagoscope SSU is compatible with two KARL STORZ CCUs: C-HUB and C-MAC. CMOS Video Esophagoscope SSU is provided sterile single-use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

nasal sinuses, larynx, esophagus and gastroesophageal junction

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:
Electrical Safety and Electromagnetic Compatibility Summary The electrical safety and EMC data for the subject device and compatible CCUs was provided to FDA 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

Animal Study: Animal study was not required to demonstrate the substantial equivalence to the predicate devices.

Biocompatibility Summary: The biocompatibility evaluation for the patient contacting components of the CMOS Video Esophagoscope 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 Esophagoscope SSU is provided sterile and does 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:

ANSI AAMI ISO 11135:2014

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.

Clinical Performance Data: Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing and labeling were sufficient to establish the substantial equivalence of the modifications.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K051972

Reference Device(s)

No reference devices were used in this submission.

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 874.4710 Esophagoscope (flexible or rigid) and accessories.

(a)
Identification. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. 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 flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.

Summary

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January 24, 2020

Karl Storz SE & Co. KG Alexey Davidov Manager Regulatory Affairs, US Submissions Dr.-Karl-Storz-Straße 34 78532 Tuttlingen, Germany

Re: K192523

Trade/Device Name: CMOS Video Esophagoscope SSU Regulation Number: 21 CFR 874.4710 Regulation Name: Esophagoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOX 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

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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 (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

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Indications for Use

510(k) Number (if known) K192523

Device Name CMOS Video Esophagoscope SSU

Indications for Use (Describe)

The CMOS Video Esophagoscope SSU is intended to provide visualization of nasal sinuses, larynx, esophagus and gastroesophageal junction 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 in 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 9, 2019 |
| Type of 510(k) Submission: | Traditional |
| Device Identification: | Trade Name:
CMOS Video Esophagoscope SSU
Classification Name:
Esophagoscope (Flexible Or Rigid) (21 CFR Part 874.4710) |
| Regulatory Class: | II |
| Product Code: | EOX |
| Guidance Document: | Not Applicable for EOX product codes |
| Recognized Consensus Standards: | Not Applicable for EOX product codes |
| Predicate Device: | Predicate device: KARL STORZ Endoscopy-America's Trans-Nasal
Esophagoscope Model 11302BD1 (K051972).
The predicate device has not been subjects to a design-related recalls.
No reference devices were used in this submission. |
| Device Description: | The CMOS Video Esophagoscope SSU System includes three main
components: (1) the CMOS Video Esophagoscope SSU (091370-01),
(2) E-Box adaptor (TP010) and (3) the CCU. CMOS Video
Esophagoscope SSU is compatible with two KARL STORZ CCUs: C-HUB and C-MAC. CMOS Video Esophagoscope SSU is provided |

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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.

CMOS Video Esophagoscope SSU

| Intended Use: | CMOS Video Esophagoscope SSU is intended for visualization
purposes during ENT procedures. | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------|
| Indications for Use: | The CMOS Video Esophagoscope SSU is intended to provide
visualization of nasal sinuses, larynx, esophagus and gastro-
esophageal junction during diagnostic procedures.

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

Animal Study
Animal study was not required to demonstrate the substantial
equivalence to the predicate devices. | | |

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Image /page/5/Picture/0 description: The image contains 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.

| Biocompatibility Summary
The biocompatibility evaluation for the patient contacting
components of the CMOS Video Esophagoscope 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 Esophagoscope SSU is provided sterile and does
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:
✓ ANSI AAMI ISO 11135:2014
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.
Clinical Performance Data:	Clinical testing was not required to demonstrate the substantial
equivalence to the predicate device. Non-clinical bench testing and
labeling were 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 Esophagoscope SSU is
substantially equivalent to the predicate device, that is currently
marketed for the same intended use.