(41 days)
Not Found
No
The summary mentions "image/video processing" but does not include any terms like AI, ML, deep learning, or neural networks, nor does it describe any features or performance metrics typically associated with AI/ML algorithms for image analysis.
No
The device is used for illumination and visualization during arthroscopic procedures, which aids in diagnosis and surgical guidance rather than directly treating a disease or condition.
No
The device is described as a "Visualization System" used to "provide illumination and visualization in arthroscopic procedures." Its primary function is to allow a physician to see inside the body during a surgical procedure, not to diagnose a condition.
No
The device description explicitly lists hardware components beyond software, including a tablet, external power supply, reusable handpiece with LED light source, and a disposable sterile kit with a scope and instruments.
Based on the provided information, the C Scope Visualization System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide illumination and visualization in arthroscopic procedures of an interior cavity of the body through a surgical opening. This describes a device used in vivo (within a living organism) for direct visualization during surgery.
- Device Description: The components listed (tablet, handpiece with LED, scope, cannula, trocar, syringe, tubing) are all consistent with a surgical visualization system used during a procedure.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The C Scope does not perform this function. It is used to visualize the inside of the body directly.
Therefore, the C Scope Visualization System is a surgical visualization device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
The C Scope Visualization system is intended to visualize an interior cavity of the body.
Product codes (comma separated list FDA assigned to the subject device)
HRX
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.
Mentions image processing
Tablet with custom software for image/video processing and display, capture and USB data management
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interior cavity of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician / Hospital / Doctor's Office
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
NeedleCam HD Visualization System [K143705]
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
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 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
2
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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3
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, LLC
26202 Detroit Rd. Ste. 340
Westlake, Ohio 44145 | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Megan Lecavalier
Chief Operating Officer
Phone: 440-772-1421
Fax: 440-772-1422
Email: 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 Use
The C Scope Visualization System is
intended to visualize an interior
cavity of the body. | Intended Use
The Needle Cam HD™ Visualization System is
intended to visualize an
interior cavity of the body. |
| | 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. | Indications for Use
Needle Cam HD™ Visualization
System is indicated to be used
by a trained physician to
provide illumination and
visualization of an interior
cavity of the body through a
natural or surgical opening in
diagnostic and operative
arthroscopic and endoscopic
procedures. Examples of
surgical use include but are not
limited to procedures on the
knee, 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 System
Includes the following components:
Tablet with custom software for
image/video processing and
display, capture and USB data | NeedleCam HD Visualization
System includes the following
components:
An Image Capture Box with
custom software for
image/video processing
display, capture, and USB |
| Feature | Subject Device
C Scope Visualization System | Predicate Device
NeedleCam 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 –
4
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
7
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 (