(133 days)
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.
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.
The provided document describes the Karl Storz SE & Co. KG CMOS Video Esophagoscope SSU, a flexible video endoscope intended for visualization during diagnostic procedures of nasal sinuses, larynx, esophagus, and gastroesophageal junction. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving device performance against specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding clinical study design, performance metrics (like sensitivity, specificity, AUC), expert adjudication, and effect sizes of AI assistance is not available in this filing.
Here's a breakdown of the available information and an explanation of the missing components:
1. A table of acceptance criteria and the reported device performance
The submission does not define specific clinical acceptance criteria (e.g., sensitivity, specificity, AUC) for the CMOS Video Esophagoscope SSU's diagnostic performance, as no clinical study was conducted for this purpose to demonstrate substantial equivalence. Instead, the acceptance criteria are related to technical performance and safety, assessed through non-clinical testing against recognized standards, and direct comparison of technological characteristics to the predicate device.
| Acceptance Criteria Category | Details and Reported Performance |
|---|---|
| Electrical Safety & EMC | Criteria: Compliance with recognized standards. Performance: Complied with ANSI/AAMI ES:60601-1:2005 and IEC 60601-1-2:2007. |
| Bench Testing Performance | Criteria: Compliance with recognized standards for endoscopes. Performance: Complied with ISO 8600-1:2015, ISO 8600-3:1997, ISO 8600-4:2014, ISO 8600-5:2005, IEC 62471:2006, and IEC 60601-2-18:2009. |
| Biocompatibility | Criteria: Evaluation according to ISO 10993-1 and FDA Guidance for patient-contacting components. Performance: Tests conducted in accordance with ISO 10993-1:2009/(R)2013, ISO 10993-5:2009/(R)2014, ISO 10993-10:2010/(R)2014, ISO 10993-11:2006/(R)2010, and ISO 10993-12:2012. |
| Sterilization Validation | Criteria: Validation of the sterilization cycle for a sterile, single-use device. Performance: Sterilization with EO validated in accordance with ANSI AAMI ISO 11135:2014 for cycle "6.Storz" (1.75 bar / 50° C / 80 min / 17.5h", 8.5 ± 0.5 % EO in CO2). |
| Software Verification & Validation | Criteria: Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Performance: Software verification and validation testing conducted, categorized as "minor" level of concern. |
| Technological Characteristics Comparison | Criteria: Demonstrate substantial equivalence to the predicate device (KARL STORZ Endoscopy-America's Trans-Nasal Esophagoscope Model 11302BD1 (K051972)) based on physical and optical characteristics. Performance: The subject device (CMOS Video Esophagoscope SSU) has similar characteristics to the predicate, with minor differences in insertion shaft diameter (3.5mm vs 3.7mm), length (750mm vs 650mm), deflection (210° Up, 140° Down vs 140° Up, 140° Down), field of view (110° vs 87°), and light source (Internal LED vs External). The primary technological difference is the use of CMOS imager in the subject device vs. "None" specified for the predicate, and subject device being single-use and sterile while predicate is reusable and unsterile. This was deemed acceptable as the overall intended use and fundamental scientific technology for visualization remains the same. |
2. Sample size used for the test set and the data provenance
Not Applicable. The document explicitly states: "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." Therefore, there is no clinical test set, sample size, or data provenance from clinical trials to report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. As no clinical study was conducted for performance evaluation using a test set requiring ground truth, this information is not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. No clinical test set means no adjudication method was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. This device is an endoscope for "visualization" during diagnostic procedures. It is not an AI-powered diagnostic algorithm or an AI-assisted device. Therefore, no MRMC study, AI assistance, or related effect sizes are relevant or present in the submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is directly operated by a human. It is not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable. No clinical study was performed to establish diagnostic performance, therefore no ground truth was established through external means like expert consensus, pathology, or outcomes data. Ground truth in this context typically refers to a definitive diagnosis or finding against which a device's diagnostic output is compared.
8. The sample size for the training set
Not Applicable. This device is a medical instrument (hardware with internal software), not a machine learning model that requires a "training set" in the context of AI/ML development. The software for the device underwent standard software verification and validation, but not in the framework of a training set for an AI algorithm.
9. How the ground truth for the training set was established
Not Applicable. As there is no training set for an AI/ML model, this question is not applicable.
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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. KGDr.-Karl-Storz-Straße 3478532 Tuttlingen, Germany |
|---|---|
| Contact: | Alexey DavidovManager Regulatory Affairs, US SubmissionsPhone: +49 (0)7461 708-7909Fax: +49 (0)7461 708-75095Email: Alexey.Davidov@karlstorz.com |
| Date of Preparation: | September 9, 2019 |
| Type of 510(k) Submission: | Traditional |
| Device Identification: | Trade Name:CMOS Video Esophagoscope SSUClassification 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-NasalEsophagoscope 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 maincomponents: (1) the CMOS Video Esophagoscope SSU (091370-01),(2) E-Box adaptor (TP010) and (3) the CCU. CMOS VideoEsophagoscope 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 visualizationpurposes during ENT procedures. | ||
|---|---|---|---|
| Indications for Use: | The CMOS Video Esophagoscope SSU is intended to providevisualization of nasal sinuses, larynx, esophagus and gastro-esophageal junction during diagnostic procedures.The E-Box serves as an adaptor for operating the flexible single-usevideoscope on the compatible CCU. | ||
| TechnologicalCharacteristics: | Comparison Table: Subject vs. Predicate Device | ||
| Subject Device | Predicate device K051972 | ||
| CMOS Video EsophagoscopeSSU | Trans-Nasal Esophagoscope11302BD1 | ||
| Physical Characteristics | |||
| Type of Scope | Flexible video endoscope | Same as the subject device | |
| Insertion Shaft Diameter | 3.5 mm | 3.7 mm | |
| Insertion Shaft Length | 750 mm | 650 mm | |
| Deflection | 210° Up, 140° Down | 140° Up, 140° Down | |
| Optical and System Characteristics | |||
| Type of Imager | CMOS | None | |
| Direction of View | 0° | Same as the subject device | |
| Field of view | 110° | 87° | |
| Light Source | Internal LED | External light source | |
| Reprocessing Methods | |||
| How device is provided | Sterile single-use | Unsterile, reusable | |
| EO Sterilization Cycle | 6.Storz / 1.75 bar / 50° C /80 min / 17.5h" | N/A | |
| Sterilizing agent | Mixture of EO in CO2;resulting concentration: 8,5± 0,5 % EO; CO2 added upto 100 % | N/A | |
| Non-ClinicalPerformance Data: | Electrical Safety and Electromagnetic Compatibility SummaryThe electrical safety and EMC data for the subject device andcompatible CCUs was provided to FDA and was in compliance withthe following FDA recognized standards:✓ ANSI/AAMI ES:60601-1:2005✓ IEC 60601-1-2:2007Bench Testing SummaryThe performance data submitted in the submission is incompliance 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 60601-2-18:2009Animal StudyAnimal study was not required to demonstrate the substantialequivalence 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 SummaryThe biocompatibility evaluation for the patient contactingcomponents of the CMOS Video Esophagoscope SSU was performedaccording to ISO 10993-1 and FDA Guidance "Use of InternationalStandard 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 conductedbased 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 SummaryThe CMOS Video Esophagoscope SSU is provided sterile and doesnot require user reprocessing. The subject device is validated to besterilized with EO in accordance with validated sterilization cycle"6.Storz". Sterilization validation is in compliance with thefollowing standard:✓ ANSI AAMI ISO 11135:2014 | |
| Software Verification and Validation SummarySoftware verification and validation testing were conducted, anddocumentation was provided as recommended by FDA's Guidancefor Industry and FDA Staff, "Guidance for the Content of PremarketSubmissions for Software Contained in Medical Devices", issued onMay 11, 2005. The software for this device was considered as a"minor" level of concern, since a failure or latent flaw in thesoftware is unlikely to cause any injury to the patient or operator. | |
| Clinical Performance Data: | Clinical testing was not required to demonstrate the substantialequivalence to the predicate device. Non-clinical bench testing andlabeling were sufficient to establish the substantial equivalence ofthe modifications. |
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate thatthe subject device, the CMOS Video Esophagoscope SSU issubstantially equivalent to the predicate device, that is currentlymarketed for the same intended use. |
§ 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.