(165 days)
The TIPCAM®1 Rubina Video Endoscope System is intended to be used together with the camera control unit during diagnostic and/or surgical procedures when endoscopic video assistance is required. For use in all endoscopy and endoscopic surgery within the peritoneal and thoracic cavity, including gynecological and urological anatomy.
The TIPCAM®1 Rubina video endoscope is an integrated unit that includes a camera and an endoscope. The endoscope receives the illumination light from the light source by the light guide connector connected to the light source device. The illumination light is transferred to the distal end through the optical fiber bundle inside of the endoscope and illuminates the inside of the patient body through the illumination lens at the distal end. The endoscope receives the reflected light from the inner lumen of a patient by the objective lens at the distal end. The built-in dual CMOS sensors convert the light to an electrical signal, and the signal is sent to the camera control unit (Image1 S Connect II + 4U-Link) via the attached cable for processing and display.
The provided text, a 510(k) summary for the TIPCAM®1 Rubina Video Endoscope System, does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled device.
The document describes a traditional 510(k) submission for an endoscope system, where the substantial equivalence to a predicate device (SPIES 3D System) is established through non-clinical performance data (bench testing) of the hardware components. The "Technological Characteristics" section mentions "two image viewing features: A 2D auto-leveling (autorotation) mode... and a 2D Auto-switch mode...", which are described as features of the subject device itself, not an external AI/ML system assisting it.
The non-clinical performance data section lists various tests like "Color Reproduction and Color Contrast Enhancement," "Distortion," "Depth of Field," "Spatial Resolution," etc., which are standard tests for video endoscope systems' optical and image quality. These are not acceptance criteria related to the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device and the study proving it meets those criteria based on this document. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications." This indicates that the device's clearance was based on hardware performance and established equivalence, not on the performance of an AI/ML component assessed via a clinical or reader study.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 20, 2020
Karl Storz Endoscopy-America, Inc. Mario Trujillo Associate Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245
K201526 Re:
Trade/Device Name: TIPCAM®1 Rubina Video Endoscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: GCJ, FGB, HET Dated: October 21, 2020 Received: October 23, 2020
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.
{1}------------------------------------------------
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 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-regulatoryinformation/postmarketing-safety-reporting-combination-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 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,
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology 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) K201526
Device Name TIPCAM®1 Rubina Video Endoscope System
Indications for Use (Describe)
The TIPCAM®1 Rubina Video Endoscope System is intended to be used together with the camera control unit during diagnostic and/or surgical procedures when endoscopic video assistance is required. For use in all endoscopy and endoscopic surgery within the peritoneal and thoracic cavity, including gynecological anatomy.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image is a logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, blue 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. All data included in this document is accurate and complete to the best of KARL STORZ Endoscopy-America's knowledge.
| Applicant: | KARL STORZ Endoscopy-America, Inc.2151 E. Grand AvenueEl Segundo, CA 90245 |
|---|---|
| Contact: | Mario TrujilloAssociate Regulatory Affairs SpecialistTel.: (424) 218-8481Email: Mario.Trujillo@karlstorz.com |
| Date ofPreparation: | November 19, 2020 |
| Type of 510(k)Submission: | Traditional |
| DeviceIdentification: | Trade Name: TIPCAM®1 Rubina Video Endoscope SystemRegulation Name: Endoscope and Accessories |
| Regulatory Class: | 2 |
| Product Code: | GCJ, FGB, HET |
| RegulationNumber: | 21 CFR 876.1500 |
| PredicateDevice(s): | SPIES 3D System (K150525)This predicate device has not been subject to a design-related recall. |
| DeviceDescription: | This predicate device has not been subject to a design-related recall.The TIPCAM®1 Rubina video endoscope is an integrated unit thatincludes a camera and an endoscope. The endoscope receives theillumination light from the light source by the light guide connectorconnected to the light source device. The illumination light istransferred to the distal end through the optical fiber bundle inside ofthe endoscope and illuminates the inside of the patient body throughthe illumination lens at the distal end. The endoscope receives thereflected light from the inner lumen of a patient by the objective lens atthe distal end. The built-in dual CMOS sensors convert the light to anelectrical signal, and the signal is sent to the camera control unit(Image1 S Connect II + 4U-Link) via the attached cable for processingand display. |
| Intended Use: | TIPCAM®1 Rubina videoscopes and corresponding accessories(camera control unit, light sources, monitor) are used for endoscopicimaging of the surgical field during diagnostic and/or surgicalprocedures in the abdominal and thoracic cavity.TIPCAM®1 Rubina videoscopes are designed for short-term use insurgically invasive procedures |
| Indications ForUse: | The TIPCAM®1 Rubina Video Endoscope System is intended to beused together with the camera control unit during diagnostic and/orsurgical procedures when endoscopic video assistance is required.For use in all endoscopy and endoscopic surgery within the peritonealand thoracic cavity, including gynecological and urological anatomy. |
| TechnologicalCharacteristics: | The predicate and subject devices are both camera systems that areused for observation purposes in general endoscopic surgery withinthe thoracic and peritoneal cavity, including gynecological andurological anatomy. There are some minor differences in thetechnological characteristics. These differences are:The subject device has two image viewing features: A 2Dauto-leveling (autorotation) mode which allows the user tomaintain fixed horizon while rotating the endoscope and a 2DAuto-switch mode that automatically switches the image from3D mode to 2D Auto-leveling mode when the scope is rotatedoutside the 3D viewing range to prevent the user from losingthe perspective of the image. The subject device is also available in a 30° direction of viewmodel in addition to the 0° model. The total length of the subject endoscope is 5mm longerthan the predicate These differences do not raise different questions of safety andeffectiveness and can be evaluated through performance testing. |
| Non-ClinicalPerformance Data: | The TIPCAM®1 Rubina System was tested forelectrical/mechanical/thermal safety and EMC according to thefollowing standards:IEC 60601-1 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1(2012) IEC 60601-1-2:2014 (4th Edition) IEC 60601-2-18:2009 IEC 62471:2009 The following additional bench testing for performance verificationand validation purposes was performed: Photobiological Safety per IEC 62471:2006 Color Reproduction and Color Contrast Enhancement Distortion Depth of Field Detection Linearity Illumination Detection Uniformity Signal-to-Noise Ratio (SNR) & Sensitivity Latency Spatial Resolution Dynamic Range Direction of View per ISO 8600-3:2019 |
| • Field of View per ISO 8600-3:2019• System Horizontal ParallaxThe subject device software was validated per the FDA guidance"Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices" as a moderate level of concern. | |
| The subject device materials and manufacturing are identical to that ofthe predicate, therefore, biocompatibility testing was leveraged fromK150525 to support the biocompatibility of the subject device. | |
| Cleaning and sterilization validation of the subject device wasleveraged from the predicate device K150525, as the subject device issubstantially similar in specifications to that of the predicate, and thesterilization process remains identical to the predicate. | |
| The bench testing noted above confirmed that the TIPCAM®1 Rubinasystem has met all its design specification and is as safe and effectiveas the predicate device, SPIES 3D System. | |
| ClinicalPerformance Data: | Clinical testing was not required to demonstrate the substantialequivalence to the predicate device. Non-clinical bench testing wassufficient to assess safety and effectiveness and to establish thesubstantial equivalence of the modifications. |
| Conclusion: | The subject device has the same intended use as the predicate. Thetechnological differences between the subject and predicate do notraise different questions of safety and effectiveness. The conclusionsdrawn from the non-clinical performance data demonstrated that thesubject device is as safe as and as effective as the predicate device.Therefore, the subject device is substantially equivalent to thepredicate. |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in a smaller font.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for KARL STORZ. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.
§ 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.