(60 days)
Not Found
No
The device description and intended use focus on illumination, insufflation, and irrigation functions, with no mention of AI or ML capabilities. The performance studies are limited to bench testing verifying design specifications.
No
The device provides illumination, insufflation, and irrigation for endoscopic procedures, which are supportive functions and not direct therapeutic interventions.
No
The Intended Use / Indications for Use section states the device is "intended to provide illumination" and "insufflate CO2 or air as a distention media... or water irrigation for lens cleaning". These are functions that support a procedure but do not inherently diagnose a condition.
No
The device description explicitly states it is a "portable and compact all-in-one LED Light source and insufflation unit" that includes hardware components like a touchscreen control display, an insufflation pump, an internal LED light source, and a water bottle.
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 providing illumination and insufflation/irrigation during GI endoscopic procedures. It is used in conjunction with flexible endoscopes to visualize and distend the gastrointestinal tract and clean the lens.
- Device Description: The description reinforces its function as a light source and insufflation unit for use with endoscopes.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. Its function is entirely focused on supporting a procedure performed in vivo (within the body).
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases or conditions. This device's purpose is to facilitate a visual examination and procedure within the body.
N/A
Intended Use / Indications 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 the gastronitestional tract or water irrigation for lens cleaning when used in conjunction with flexible endoscopes for GI endoscopic procedures.
Product codes
FCX, FEQ, NTN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestional tract
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: There are no performance standards or special controls developed under Section 514 of the FD&C Act for endoscopes. However, the CO2mbiLED follows the FDA recognized consensus standards and is tested 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 Submissions For Software Contained in Medical Device Level of concern: Moderate Additional bench testing was performed to ensure the device met its design specifications. The bench testing performed verified and validated that the CO2mbiLED has met all its design specification and is substantially equivalent to its predicate devices.
Clinical Performance Data: Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence.
Conclusion: The CO2mbiLED is substantially equivalent to its predicate device. The non-clinical bench and comparative testing demonstrate that the device is as safe and effective as the legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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
2
Indications for Use
510(k) Number (if known)
Device Name CO2mbi LED SCB
Indications for Use (Describe)
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.
| 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".
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, Inc
2151 E. Grand Avenue
EI Segundo, CA 90245 | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact: | Winkie Wong
Regulatory Affairs Manager
424-218-8379 (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) – Primary
Xenon 100 SCB (K082925) – Secondary
The 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, 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. | |
| Intended Use and
Indications 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 the
gastrointestional tract or water irrigation for lens cleaning when used
in conjunction with flexible endoscopes for GI endoscopic
procedures. | |
| Substantial
Equivalence: | The intended use, operating principles, technological
characteristics and features are similar, if not identical, between
that subject device and predicates, primary – CO2MPACT
(K111648) and secondary – Xenon 100 SCB (K082925). The
minor differences between the subject and predicate devices that
do not raise new or different questions or safety and effectiveness are:
The subject device offers additional options (CO2, air or
combination of both) for distension media when compared
to either of the predicates (CO2 or air only). The subject device and predicate devices have slightly
different flow rates and flow rate settings. The subject device has slightly different operating
pressures and pressure to activate pressure relief valve
(CO2) As proven by the comparisons and rationale in this section, the
above 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). | |
| 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
CO2mbiLED follows the FDA recognized consensus standards and is
tested 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 Submissions
for Software Contained in Medical Device Level of concern: Moderate Additional bench testing was performed to ensure the device met its
design specifications. The bench testing performed verified and
validated that the CO2mbiLED has met all its design specification
and is substantially equivalent to its predicate devices. | |
| Clinical Performance
Data: | Clinical performance is not required to demonstrate substantial
equivalence to the predicate devices. Non-clinical bench testing was
sufficient to establish substantial equivalence. | |
| Conclusion: | The CO2mbiLED is substantially equivalent to its predicate device.
The non-clinical bench and comparative testing demonstrate that the
device is as safe and effective as the legally marketed devices. | |
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