(41 days)
The C Scope Visualization System is indicated to be used by a trained physician to provide illumination and visualization in arthroscopic procedures of an interior cavity of the body through a surgical opening.
The C Scope Visualization System Includes the following components: Tablet with custom software for image/video processing and display, capture and USB data management, and external power supply Reusable handpiece with LED light source. Disposable single-use sterile kit including a semi-rigid scope with integral drape, and supplemental instruments including a cannula, trocar/obturator, and syringe and tubing for flushing.
This document (K203526/S001) is a 510(k) premarket notification for the C Scope Visualization System, which is an arthroscope. The document primarily focuses on demonstrating substantial equivalence to a predicate device, not on presenting a standalone study proving the device meets specific performance criteria in a clinical setting with human readers or a detailed statistical analysis of AI performance.
Therefore, the requested information elements related to AI performance, ground truth establishment for a training set, human reader performance, sample sizes for test/training sets in the context of AI, and adjudication methods are not addressed in this document. This submission relies on non-clinical performance test data to demonstrate substantial equivalence to a predicate device, rather than a novel AI algorithm with specific acceptance criteria that needs to be "proven" through a clinical study.
Here's the information that can be extracted or inferred from the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a specific table of "acceptance criteria" for a novel AI device with corresponding performance metrics (e.g., sensitivity, specificity, AUC). Instead, it lists various non-clinical tests conducted to demonstrate that the C Scope Visualization System meets regulatory requirements and performs similarly to its predicate device. The "reported device performance" is essentially that the device passed these tests.
| Test Category | Acceptance Criteria (Implied: Conformance to relevant standards) | Reported Device Performance |
|---|---|---|
| Environmental and Packaging | ASTM D4169-16 DC-13, ASTM D4332-14, ISO 11607-2 2019 (E) | Met all standards; seal formation validated. |
| Mechanical and Durability | IEC/EN 60529:2013, ISO 80369-7:2016 | Met all product requirements. |
| Human Factors | Guidance for Industry and FDA Staff "Applying Human Factors..." | Two formative studies and one summative validation study conducted. |
| Electrical Safety & EMC | IEC 60601-1:2012, IEC 60601-2-18:2009, IEC 60601-1-2:2014, AIM 7351731 | Complies with all standards. |
| Software Validation & Verification | FDA Guidance for Industry and Staff "Guidance for the Content...", AAMI/IEC 62304:2006/A1:2016, FDA Guidance "General Principles of Software Validation." | Validation and verification testing conducted. |
| Biocompatibility Testing | ISO 10993-1:2018 (parts 5, 10, 11, 17, 18) | Testing conducted as per ISO 10993-1:2018. |
| Sterilization and Shelf Life | ISO 11135-1:2014, ISO 10993-7:2008 Amd 1:2019 (E), ASTM F1980:2016 | Validated to SAL of 10-6; residuals below limits; shelf-life demonstrated. |
| Reprocessing (Handpiece) | AAMI TIR12:2010, AAMI TIR30:2011 (R2016), FDA Guidance "Reprocessing Medical Devices..." | Validation studies conducted. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided for AI performance. This document describes non-clinical testing of a physical medical device. There is no information about a "test set" in the context of an AI algorithm evaluated for diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided for AI performance. Ground truth establishment for a test set of medical images/data is not relevant to this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided for AI performance. Adjudication methods are not relevant to the non-clinical performance testing described.
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
- No, an MRMC comparative effectiveness study was not done. This submission does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The device is a "Visualization System" (arthroscope) for human physicians, not a standalone AI algorithm. While it has custom software for image/video processing, the submission does not present it as an AI-driven diagnostic tool with standalone performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided for AI performance. The "ground truth" in this context would be the specifications and requirements defined by the various engineering and biocompatibility standards to which the device was tested. For example, for sterilization, the ground truth is a SAL of 10^-6 validated according to ISO 11135-1:2014.
8. The sample size for the training set
- Not Applicable / Not Provided for AI performance. There is no mention of a training set for an AI algorithm.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided for AI performance. There is no mention of a training set for an AI algorithm.
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January 12, 2021
Image /page/0/Picture/1 description: The image contains 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
CIT Ortho, LLC % Prithul Bom Most Responsible Person Regulatory Technology Services 1000 Westgate Drive, Suite #510k Saint Paul. Minnesota 55114
Re: K203526/S001
Trade/Device Name: C Scope™ Visualization System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: November 11, 2020 Received: January 8, 2021
Dear Prithul Bom:
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 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,
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic 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) K203526
Device Name C Scope Visualization System
Indications for Use (Describe)
The C Scope Visualization System is indicated to be used by a trained physician to provide illumination and visualization in arthroscopic procedures of an interior cavity of the body through a surgical opening.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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/1 description: The image is a logo for CIT Ortho. The logo features a stylized image of a knee joint inside of a circle on the left. To the right of the image is the text "CIT Ortho", with "CIT" in black and "Ortho" in blue.
510(k) SUMMARY
| Applicant: | CIT Ortho, LLC26202 Detroit Rd. Ste. 340Westlake, Ohio 44145 | |
|---|---|---|
| Company Contact: | Megan LecavalierChief Operating OfficerPhone: 440-772-1421Fax: 440-772-1422Email: mlecavalier@clearimg.com | |
| Date Summary Prepared: | December 28, 2020 | |
| Trade Name: | C Scope™ Visualization System | |
| Common Name: | Arthroscope | |
| Classification Name: | Arthroscope, Class II | |
| Product Code: | HRX | |
| Regulatory Class: | Class II | |
| Regulation Number: | 21 CFR §888.1100 | |
| Predicate Device: | NeedleCam HD Visualization System [K143705]BioVision Technologies. Golden, CO | |
| Subject Device | Predicate Device | |
| Feature | C Scope Visualization System | NeedleCam HD Visualization System |
| FDA Classification | Class II | Class II |
| Product Code(s) | HRX | HRX/GCJ |
| Regulation Number | 21 CFR §888.1100 | 21 CFR §888.1100/ 876.1500 |
| Regulation Name | Arthroscope | Arthroscope/ Laparoscope, General & Plastic Surgery |
| Indications for Use / Intended Use | Intended UseThe C Scope Visualization System isintended to visualize an interiorcavity of the body. | Intended UseThe Needle Cam HD™ Visualization System isintended to visualize aninterior cavity of the body. |
| Indications for useThe C Scope Visualization System isindicated to be used by a trainedphysician to provide illuminationand visualization in arthroscopicprocedures of an interior cavity ofthe body through a surgicalopening. | Indications for UseNeedle Cam HD™ VisualizationSystem is indicated to be usedby a trained physician toprovide illumination andvisualization of an interiorcavity of the body through anatural or surgical opening indiagnostic and operativearthroscopic and endoscopicprocedures. Examples ofsurgical use include but are notlimited to procedures on theknee, shoulder, ankle, elbow,wrist, shoulder,temporomandibular joint(TMJ), spinal, ophthalmic, ENT,and cervix. | |
| Where Used | Hospital / Doctor's Office | Hospital / Doctor's office |
| Device Description | The C Scope Visualization SystemIncludes the following components:Tablet with custom software forimage/video processing anddisplay, capture and USB data | NeedleCam HD VisualizationSystem includes the followingcomponents:An Image Capture Box withcustom software forimage/video processingdisplay, capture, and USB |
| Feature | Subject DeviceC Scope Visualization System | Predicate DeviceNeedleCam HD Visualization System |
| management, and external power supply Reusable handpiece with LED light source. Disposable single-use sterile kit including a semi-rigid scope with integral drape, and supplemental instruments including a cannula, trocar/obturator, and syringe and tubing for flushing. | data management, and external power supply.Video Outputs for external monitor Reusable Camera-handpiece with an LED light source A disposable single-use sterile kit including a semi-rigid fiberoptic scope with integral drape, and supplemental instruments including a cannula, trocar, obturator, and cannula plug. | |
| Single Use/Reusable | Tablet and Handpiece: Reusable.Scope and instruments: Sterile, Single Use. | Image capture box and camera handpiece: Reusable.Scopes & instruments: Sterile, Single Use |
| Sterilization | Scope kit - Ethylene Oxide (EO) sterilization | Scope kit - Ethylene Oxide (EO) sterilization |
| Sterility, How Supplied | Scope Kit - sterile in PETG tray w/ sealed LLDPE header pouch | Scope Kit – sterile in PETG tray w/ sealed Tyvek lid. |
| Tablet, Handpiece - non-sterile in cardboard packaging with protective padding | Camera Handpiece and Image Capture Box- non-sterile in cardboard packaging with protective padding | |
| Image Acquisition | Image acquisition is achieved through the camera, which is a CMOS sensor located in the scope. | Image acquisition is achieved through the camera, which is a CCD sensor located in the handpiece. |
| Connectivity | The scope w/ camera connects to the handpiece with a quick release connector. The handpiece (with illumination source) and cable connects to the Tablet through USB connection. | The scope connects to the camera handpiece with a quick release connection. The handpiece (with illumination source) cable connects to the Image Capture Box through a custom electrical connection. |
| Image Display(s) | All-in-one Tablet | External display connection |
| Data Storage | Images and video automatically stored to Tablet.Images and video can be exported to USB device. | Image and video storage to USB device. |
| Type of Light Source | LED | LED |
| Feature | Subject Device | Predicate Device |
| C Scope Visualization System | NeedleCam HD Visualization System | |
| Endoscope coupler | Built-in | Built-in |
| Materials | Commonly used medical-grade plastics and stainless steel | Commonly used medical-grade plastics and stainless steel |
Device Description:
The C Scope Visualization System is an arthroscope that allows users to illuminate and visualize patient anatomy during minimally-invasive arthroscopic procedures. The system consists of a single-use rigid Scope, a reusable Handpiece and a Tablet for viewing the images. The Scope contains a CMOS camera chip to visualize and an optical fiber to illuminate anatomical structures. The Scope includes an integral drape which covers the Handpiece to provide a sterile gripping surface for the user. The Scope is packaged in a sterile C Scope Disposable Scope Kit containing single use items syringe, tubing, cannula, and trocar to aid in the procedure. The Handpiece provides control of the direction and depth of the Scope and allows the user to capture images and videos. The reusable tablet Viewing Tablet is loaded with custom ImageClear software which provides image and video display and data management.
Indications for Use:
The C Scope Visualization System is indicated to be used by a trained physician to provide illumination and visualization in arthroscopic procedures of an interior cavity of the body through a surgical opening.
Intended Use:
The C Scope Visualization system is intended to visualize an interior cavity of the body.
Technology Characteristics:
The technological characteristics of the C Scope Visualization System are similar to its predicate device –
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NeedleCam HD Visualization System (K143705). The indications and contraindications listed in this submission are in congruence between these devices. The C Scope Visualization system utilizes a disposable arthroscope, included in a sterile kit with supplemental instruments. The disposable scope connects to a reusable handpiece to display a live image on a viewing tablet with custom software for image processing and capture.
Comparison to Predicate Device:
The fundamental scientific technology of the C Scope Visualization System and the previously cleared predicate device, NeedleCam HD Visualization System [K143705], are the same. The table below shows relevant similarities and differences.
Table 1- Predicate Comparison
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Based on the evaluation of the performance characteristics, construction, and indications of use, CIT Ortho has concluded that the C Scope Visualization System is substantially equivalent to the predicate device listed in this submission.
Performance Data Summary:
Determination of substantial equivalence is based on an assessment of non-clinical performance test data. The C Scope Visualization System has successfully completed the following relevant performance testing to demonstrate substantial equivalence. Testing was performed to evaluate physical integrity, functionality, and performance of the system.
The results of these tests provide reasonable assurance that the C Scope Visualization System has been designed and tested to assure conformance to the requirements for its intended use and indications for use. No new safety or performance issues were raised during the testing; therefore, this device is considered to be substantially equivalent to the predicate device.
Environmental and Packaging
The sterile packaging for the Disposable Scope Kit of the C Scope Visualization system was verified for transportation and environmental conditions according to ASTM D4169-16 DC-13 and ASTM D4332-14. Seal formation for the sterile LLDPE header pouch was validated per ISO 11607-2 2019 (E).
Mechanical and Durability
Testing was performed to verify the mechanical integrity and durability of the C Scope Visualization system. Testing also included ingress protection testing per IEC/EN 60529:2013 and luer testing per ISO 80369-7:2016. These tests demonstrated that the system met all product requirements.
Human Factors
Human factors validations were performed per Guidance for Industry and FDA Staff "Applying Human Factors and Usability Engineering to Medical Devices." Two formative studies and one summative validation study were conducted utilizing the complete C Scope Visualization System in a productionequivalent state.
Electrical Safety and Electromagnetic Compatibility
Electrical safety and Electromagnetic Compatibility (EMC) testing were conducted on the C Scope Visualization System consisting of the Tablet, Handpiece, and Disposable Scope. The system complies with the IEC 60601-1:2012 and IEC 60601-2-18:2009 standards for safety with the Disposable Scope being a type BF applied part. The system complies with the IEC 60601-1-2:2014 standard for EMC. Immunity of the system to RFID readers was verified using AIM 7351731.
Software Validation and Verification Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care
CIT Ortho C Scope Visualization System Page 5- 4
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provider. Software validation was conducted according to AAMI/IEC 62304:2006/A1:2016 and FDA's Guidance for Industry and FDA Staff "General Principles of Software Validation."
Biocompatibility Testing
The patient-contacting components of the device are categorized as Externally Communicating Device, Tissue and Bone, Limited Contact (< 24 hours). Per ISO 10993-1:2018, the following testing was conducted:
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity .
- ISO 10993-10:2013 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- . ISO 10993-11:2018 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- ISO 10993-17:2009 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-18:2020 Biological evaluation of medical devices Part 18: Chemical characterization of ● medical device materials within a risk management process
Documentation for the biocompatibility testing was provided as recommended by Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.'"
Sterilization and Shelf Life
The C Scope Visualization System Disposable Scope Kit sterilization process, using 100% Ethylene Oxide (EO), has been validated in accordance with ISO 11135-1:2014 to achieve a SAL of 10 °. EO and ECH residuals were below the limits specified in ISO 10993-7:2008 Amd 1:2019 (E). Both baseline and accelerated shelf-life testing were conducted demonstrating the device will perform as intended to support the proposed shelf-life. Accelerated aging testing was carried out according to ASTM F1980:2016.
Reprocessing of the reusable C Scope Handpiece was validated through a Manual Cleaning Validation, including Simulated Use, and an Intermediate Level Disinfection Validation. These studies were conducted in accordance with AAMI TIR12:2010, AAMI TIR30:2011 (R2016), and "Guidance for Industry and FDA Staff – Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Animal Testing
No animal studies were required to demonstrate substantial equivalence.
Clinical Testing
No clinical studies were required to demonstrate substantial equivalence.
Conclusion
CIT Ortho concludes through a review of the benchtop assessments, the comparison of the device classification, intended use, operating principle, technological characteristics, sterility, and biocompatibility that the C Scope Visualization System is substantially equivalent to the predicate device and is as safe, as effective, and performs as well as or better than the predicate device.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.