The CO2mbi LED SCB is a combination of an LED light source, intended to provide illumination, and an insufflation/ irrigation pump, intended to insufflate CO2 or air as a distention media in the gastronitestional tract or water irrigation for lens cleaning when used in conjunction with flexible endoscopes for GI endoscopic procedures.

Device Description

CO2mbi LED SCB is a portable and compact all-in-one LED Light source and insufflation unit that includes a touchscreen control display, an insufflation pump and internal LED light source, intended to be connected to a compatible GI Videoendoscope and CCU for illumination and insufflation purposes. It is also equipped with a water bottle and lid with tube to provide irrigation for lens cleaning.

AI/ML Overview

The provided text describes a medical device, the CO2mbiLED SCB, but it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of clinical performance. The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical data.

Therefore, many of the requested details cannot be extracted from this document, as the document explicitly states: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence."

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria for clinical performance because it did not conduct a clinical study. Instead, it refers to:

Compliance with FDA recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, IEC 62471).
Software Verification and Validation Testing guided by "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device" with a "Level of concern: Moderate."
Additional bench testing "to ensure the device met its design specifications."

The reported device performance, in terms of its functions, is stated as having:

Different flow rates and flow rate settings compared to predicates.
Slightly different operating pressures and pressure to activate the pressure relief valve (CO2) compared to predicates.

The summary then concludes that these differences "do not raise different questions of safety and effectiveness because the intended use, operating principles, technological characteristics, and features are significantly 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 the flow rate, flow rate settings operating pressure and pressure to activate pressure relief valve (Table F) and bench testing to show that the subject device function as intended (Section 21 – Performance Testing)."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available because no clinical test set was used for a substantial equivalence determination in this document. The evaluation was based on non-clinical bench testing and comparison to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not available because no clinical test set requiring expert-established ground truth was part of this submission for substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available because no clinical test set requiring adjudication was part of this submission.

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

An MRMC comparative effectiveness study was not done. The device is an endoscope accessory (light source and insufflation/irrigation pump), not an AI-powered diagnostic tool for human reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is not an algorithm, but a hardware device (light source and pump).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance, the "ground truth" was established by design specifications for the device, and compliance with recognized consensus standards.

8. The sample size for the training set

This information is not available as the device is not an AI/machine learning algorithm that requires a training set. The evaluation was based on non-clinical bench testing.

9. How the ground truth for the training set was established

This information is not available as the device is not an AI/machine learning algorithm requiring a training set with established ground truth.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 23, 2020

Karl Storz Endoscopy America, Inc. Winkie Wong Manager, Regulatory Affairs 2151 E. Grand Ave El Segundo, CA 90245

Re: K201096 Trade/Device Name: CO2mbiLED Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FCX, FEQ, NTN Dated: April 20, 2020 Received: April 24, 2020

Dear Winkie Wong:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-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,

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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)

K201096

Device Name CO2mbi LED SCB

Indications for Use (Describe)

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 STORZ. The word "STORZ" is in large, bold, blue letters. Below that, in smaller blue letters, is the phrase "KARL STORZ - ENDOSKOPE".

K201096

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information 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.

Applicant:	KARL STORZ Endoscopy-America, Inc2151 E. Grand AvenueEI Segundo, CA 90245
Contact:	Winkie WongRegulatory Affairs Manager424-218-8379 (phone)
Date of Preparation:	June 22nd, 2020
Type of 510(k) Submission:	Traditional
Device Identification:	Trade Name: CO2mbiLED
	Classification Name:	Insufflator, Automatic Carbon-Dioxide for Endoscope (FCX)Pump, air, Non-Manual, For Endoscope (FEQ)LED Light Source
Product Code:	FCX, FEQ, NTN
Regulation:	21 CFR 876.1500 (Endoscope and Accessories)
Device Class:	II
Classification Panel:	Gastroenterology/ Urology
Predicate Device(s):	CO2MPACT (K111648) – PrimaryXenon 100 SCB (K082925) – SecondaryThe above predicate and reference device have not been subject to any recall
Device Description:	CO2mbi LED SCB is a portable and compact all-in-one LED Light source and insufflation unit that includes a touchscreen control
	display, an insufflation pump and internal LED light source, intendedto be connected to a compatible GI Videoendoscope and CCU forillumination and insufflation purposes. It is also equipped with awater bottle and lid with tube to provide irrigation for lens cleaning.
Intended Use andIndications for use:	The CO2mbi LED SCB is a combination of an LED light source,intended to provide illumination, and an insufflation/irrigation pump,intended to insufflate CO2 or air as a distention media in thegastrointestional tract or water irrigation for lens cleaning when usedin conjunction with flexible endoscopes for GI endoscopicprocedures.
SubstantialEquivalence:	The intended use, operating principles, technologicalcharacteristics and features are similar, if not identical, betweenthat subject device and predicates, primary – CO2MPACT(K111648) and secondary – Xenon 100 SCB (K082925). Theminor differences between the subject and predicate devices thatdo not raise new or different questions or safety and effectiveness are:The subject device offers additional options (CO2, air orcombination of both) for distension media when comparedto either of the predicates (CO2 or air only). The subject device and predicate devices have slightlydifferent flow rates and flow rate settings. The subject device has slightly different operatingpressures and pressure to activate pressure relief valve(CO2) As proven by the comparisons and rationale in this section, theabove differences do not raise different questions of safety andeffectiveness because the intended use, operating principles,technological characteristics, and features are significantlysimilar, if not identical. Both systems also comply with identicalstandards and safety testing, where applicable.Substantial equivalence on the effectiveness of the subject deviceis supported by the comparison of the flow rate, flow rate settingsoperating pressure and pressure to activate pressure relief valve(Table F) and bench testing to show that the subject devicefunction as intended (Section 21 – Performance Testing).
Non-ClinicalPerformance Data:	There are no performance standards or special controls developedunder Section 514 of the FD&C Act for endoscopes. However, theCO2mbiLED follows the FDA recognized consensus standards and istested according to the following standards and FDA Guidance:
	Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-2-2 IEC 60601-2-18 IEC 62471 Software Verification and Validation Testing Guidance for the Content of Premarket Submissionsfor Software Contained in Medical Device Level of concern: Moderate Additional bench testing was performed to ensure the device met itsdesign specifications. The bench testing performed verified andvalidated that the CO2mbiLED has met all its design specificationand is substantially equivalent to its predicate devices.
Clinical PerformanceData:	Clinical performance is not required to demonstrate substantialequivalence to the predicate devices. Non-clinical bench testing wassufficient to establish substantial equivalence.
Conclusion:	The CO2mbiLED is substantially equivalent to its predicate device.The non-clinical bench and comparative testing demonstrate that thedevice is as safe and effective as the legally marketed devices.

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Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.