(147 days)
Ambu® aScope™ 4 Cysto is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The Ambu® aScope™ 4 Cysto is intended to provide visualization via Ambu® displaying unit and can be used with endoscopic accessories.
Ambu® aScope™ 4 Cysto is intended for use in a hospital environment or medical office environment. Ambu® aScope™ 4 Cysto is designed for use in adults.
Ambu® aScope™ 4 Cysto is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. Visualization will be achieved by Ambu® displaying unit. The Ambu® aScope™ 4 Cysto is intended to be used with a reusable Ambu® displaying unit to visualize the urethra and the bladder. The Ambu® aScope™ 4 Cysto can be operated by either the left or right hand. The optical module in the distal tip consists of a camera housing containing camera and LED light sources.
Ambu® aScope™ 4 Cysto has the following physical and performance characteristics:
Maneuverable tip controlled by the user
Flexible insertion cord
Working channel that can be used for graspers or other instrumentation
Camera and LED light source at the distal tip
Luer lock connector for irrigation and aspiration
Sterilized by Ethylene Oxide sterilization
For single use
The provided text describes the 510(k) summary for the Ambu® aScope™ 4 Cysto, a medical device. It focuses on demonstrating substantial equivalence to predicate devices through various performance tests and compliance with recognized standards.
However, the document specifically states "Performance Data - Clinical: Not applicable." This indicates that a clinical study with human subjects, which would typically involve assessing how human readers (like radiologists) improve with or without AI assistance, or the performance of an AI algorithm in a clinical setting, was not performed or required for this 510(k) submission.
Therefore, many of the requested elements for describing the acceptance criteria and study that proves the device meets the acceptance criteria (specifically in the context of AI performance or human reader improvement) cannot be directly extracted from this document, as the device is a physical endoscope, not an AI/software device.
I will provide the information that can be extracted or reasonably inferred from the provided text regarding the device's performance, focusing on the physical and functional aspects tested.
Acceptance Criteria and Device Performance for Ambu® aScope™ 4 Cysto
The acceptance criteria for the Ambu® aScope™ 4 Cysto are based on compliance with recognized consensus standards and meeting specified physical and performance characteristics, demonstrating substantial equivalence to predicate devices. The study proving these criteria were met involved a series of bench tests and a declaration of conformity to relevant standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standard Applied | Reported Device Performance (Result) |
|---|---|---|
| Declaration of Conformity | ISO 8600-1 (Optics & Optical Inst. - Medical Endoscopes) | All tests were passed. |
| ISO 8600-3 (Optics & Optical Inst. - Medical Endoscopes) | All tests were passed. | |
| ISO 8600-4 (Optics & Optical Inst. - Medical Endoscopes) | All tests were passed. | |
| IEC 60601-2-18 ED 3.0:2009 (Medical Electrical Equipment - Endoscopic Equipment) | All tests were passed. | |
| Physical/Performance Characteristics | Insertion cord working length | Tested and passed. (Noted as 390 mm, predicate 380 mm) |
| Insertion cord outer diameter | Tested and passed. (Noted as 5.4 mm, predicate 4.8 mm) | |
| Maximum diameter of the insertion portion | Tested and passed. | |
| Distal end outer diameter | Tested and passed. (Noted as 5.4 mm, predicate 4.8 mm) | |
| Minimum diameter of the working channel | Tested and passed. | |
| Irrigation possible | Tested and passed. | |
| Luer Lock Connector to working channel | Tested and passed. | |
| Angulations range (Distal bending section) | Tested and passed. (Noted as larger than predicate due to no integrated grasper) | |
| Field of view | Tested and passed. | |
| Depth of field | Tested and passed. (Noted as 3-100 mm, predicate 3-50 mm) | |
| Direction of View | Tested and passed. | |
| Sterilization | ISO 11135:2014 (Ethylene Oxide Sterilization) | Sterility Assurance Level (SAL) of 10-6 achieved using half-cycle overkill approach. |
| Shelf Life | Performance and Sterile Packaging Integrity after aging | Tested and passed. |
| Biocompatibility | ISO 10993-1 (Biological evaluation of medical devices) | All tests were passed. |
| ISO 10993-5 (Cytotoxicity) | All tests were passed. | |
| ISO 10993-10 (Sensitization) | All tests were passed. | |
| ISO 10993-10 (Intracutaneous reactivity test) | All tests were passed. | |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | All tests were passed. |
| Electrical Safety | IEC 60601-1 and IEC 60601-2-18 | All tests were passed. |
Regarding the AI-specific questions (2-7), the supplied document explicitly states "Performance Data - Clinical: Not applicable." This means no clinical study involving human readers, AI assistance, or standalone AI performance was conducted or submitted for this specific 510(k) clearance, as the device is a physical endoscope and not an AI/software product.
Therefore, I cannot provide information for the following points based on the provided text, as they are not relevant to this device's 510(k) submission:
- Sample sized used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
Conclusion stated in the document:
Based on the indication for use, technological characteristics, performance data, and comparison to predicate devices, it was concluded that the functionality and intended use of Ambu® aScope™ 4 Cysto is equivalent to the predicate and reference devices. The device is concluded to be as safe and effective and performs as well as the chosen legally marketed predicate device.
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April 2, 2020
Ambu Inc. Sanjay Parikh Director, QA/RA 6230 Old Dobbin Lane, Suite 250 Columbia, MD 21045
Re: K193095
Trade/Device Name: Ambu aScope 4 Cysto Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ Dated: March 2, 2020 Received: March 4, 2020
Dear Sanjay Parikh:
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,
Martha W. Betz, Ph.D. Acting 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
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Indications for Use
510(k) Number (if known) K193095
Device Name Ambu® aScone™ 4 Cysto
Indications for Use (Describe)
Ambu® aScope™ 4 Cysto is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The Ambu® aScope™ 4 Cysto is intended to provide visualization via Ambu® displaying unit and can be used with endoscopic accessories.
Ambu® aScope™ 4 Cysto is intended for use in a hospital environment or medical office environment. Ambu® aScope™ 4 Cysto is designed for use in adults.
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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Section 5 510(k) Summary
This 510(k) summary has been prepared in accordance with 21 CFR 807.87(h) and the content and format of the 510(k) summery has been prepared in accordance with 21 CFR 807.92.
| Submitter | Ambu A/SBaltorpbakken 13DK-2750 BallerupDenmarkTel.: +45 7225 2000Fax: +45 7225 2050 |
|---|---|
| Contact Person | Name: Anita FjaestadJob Title: Senior Regulatory Affairs ProfessionalAddress: Ambu A/S, Baltorpbakken 13, DK-2750 BallerupTelephone number: +45 7225 2544Fax number: +45 7225 2050 |
| Date SummaryPrepared | April 1, 2020 |
| Device TradeName | Ambu® aScope™TM 4 Cysto |
| Device CommonName | Flexible Cystoscope |
| DeviceClassification | Cystoscope and Accessories, Flexible/RigidProduct Codes: FAJ21 CFR 876.1500Class II |
| LegallyMarketeddevices to whichthe device issubstantiallyequivalent | Predicate Device:Ambu® USR, Ambu® M, (K160766), Ambu A/SReference Device:VISERA Cystovideoscope CYF-V2/VA2 (K133538), Olympus MedicalSystems Corporation |
| Description ofthe Device | Ambu® aScope™ 4 Cysto is a sterile, single-use, flexible cystoscopeintended to be used for endoscopic access to and examination of thelower urinary tract. Visualization will be achieved by Ambu® displayingunit. The Ambu® aScope™ 4 Cysto is intended to be used with areusable Ambu® displaying unit to visualize the urethra and the bladder.The Ambu® aScope™ 4 Cysto can be operated by either the left or righthand. The optical module in the distal tip consists of a camera housingcontaining camera and LED light sources |
| Ambu® aScope™ 4 Cysto has the following physical and performancecharacteristics: | |
| Maneuverable tip controlled by the user Flexible insertion cord Working channel that can be used for graspers or otherinstrumentation Camera and LED light source at the distal tip Luer lock connector for irrigation and aspiration Sterilized by Ethylene Oxide sterilization For single use | |
| Indications forUse | Ambu® aScope™ 4 Cysto is a sterile, single-use, flexible cystoscopeintended to be used for endoscopic access to and examination of thelower urinary tract. The Ambu® aScope™ 4 Cysto is intended to providevisualization via Ambu® displaying unit and can be used with endoscopicaccessories. |
| Ambu® aScope™ 4 Cysto is intended for use in a hospital environment ormedical office environment. | |
| Ambu® aScope™ 4 Cysto is designed for use in adults. | |
| Summary of thetechnologicalcharacteristicsin comparison tothe predicatedevice | Ambu® aScope™ 4 Cysto is similar to the predicate device in thefollowing areas:It is a flexible endoscope with a manoeuvrable tip It has a handle with a control button giving the operator ability tomanoeuvre the tip of the endoscope up and down It is a video endoscope with a camera located in the distal tip toprovide an image on a separate monitor |
| It's provide illumination from the distal tip It is connected to a monitor by a cable It allows for irrigation It is single use and delivered sterile | |
| Ambu® aScope™ 4 Cysto is different to the predicate devices in thefollowing area: | |
| Ambu® aScope™ 4 Cysto has a working channel that can be usedfor graspers or other instrumentation. The predicate device hasa working channel with an integrated grasper for stent removal The bending angle is larger in aScope 4 cysto than in thepredicate, which is because the predicate has an integratedgrasper | |
| Insertion cord working length is 390 mm for Ambu® aScope™ 4 Cysto while predicate device insertion cord working length is 380 mm. Distal end outer diameter is 5.4 mm for Ambu® aScope™ 4 Cysto while predicate device distal end outer diameter is 4.8 mm. Depth of field for Ambu® aScope™ 4 Cysto is 3-100 mm while for predicate device it is 3-50 mm. | |
| PerformanceData -Bench | The following data has been submitted in the premarket notification:Declaration of conformity to the following recognized consensus standards applicable for Ambu® aScope™ 4 Cysto: ISO 8600-1, ISO 8600-3 and ISO 8600-4 Optics and optical instruments - Medical endoscopes and certain accessories. IEC 60601-2-18 ED 3.0:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment Result: All tests were passed.Performance test reports to document the following properties of the Ambu® aScope™ 4 Cysto: Insertion cord working length Insertion cord outer diameter Maximum diameter of the insertion portion Distal end outer diameter Maximum Diameter of the insertion portion Minimum diameter of the working channel Irrigation possible Luer Lock Connector to working channel Angulations range (Distal bending section) Field of view Depth of field Direction of View Result: All tests were passed.SterilizationThe sterilization method used is Ethylene Oxide (EO) with devices in a fixed chamber, in accordance with ISO 11135:2014.Sterilization is conducted in a facility certified to EN ISO 13485:2016 with respect to sterilization in accordance with ISO 11135:2014.Result: The Ambu® aScope™ 4 Cysto is sterile with a determination of lethal rate of the sterilization process to demonstrate achievement of the required SAL of 10-6 is in accordance to half cycle overkill approach as described in Annex B of ISO 11135:2014.Shelf lifePerformance test report to document shelf life. Tests were performed on finished, sterilized and aged products: Performance test Sterile Packaging Integrity |
| Biocompatibility tests reports to document that Ambu® aScope™ 4 Cysto complies with the requirements of ISO 10993-1. | |
| Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Intracutaneous reactivity test (ISO 10993-10) Result: All tests were passed. | |
| Test reports that verify the Electromagnetic Compatibility and Electrical Safety . | |
| Electromagnetic Compatibility in compliance with IEC 60601-1-2. Electrical Safety in compliance with IEC 60601-1 and IEC 60601-2-18. Result: All tests were passed. | |
| Performance Data - Clinical | Not applicable. |
| Conclusion | Based on the indication for use, technological characteristics, performance data, and comparison to predicate device it has been concluded that the functionality and intended use of Ambu® aScope™ 4 Cysto is equivalent to the predicate and reference devices.It is concluded that Ambu® aScope™ 4 Cysto is as safe and effective and performs as well as the chosen legally marketed predicate device. |
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§ 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.