(26 days)
510(k) Exempt
No
The summary describes a standard endoscopic visualization system with a 4K camera and monitor. There is no mention of AI, ML, or any advanced image processing beyond basic visualization. The performance studies focus on system functionality, electrical safety, and standard compliance, not on algorithmic performance metrics typically associated with AI/ML.
No.
The device provides visualization during surgical procedures but does not directly treat or diagnose a disease or condition.
No
Explanation: The device description states it provides "image visualization to the user during minimally invasive surgical procedures." Its intended use is for various endoscopic surgical procedures as a visualization tool, not to diagnose conditions.
No
The device description explicitly states it is a "combined system" comprised of a 4K monitor, camera control electronics, and a Camera Head, which are all hardware components. While software is mentioned in the performance studies (IEC 62304), the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "image visualization to the user during minimally invasive surgical procedures." This involves visualizing internal structures of the body during surgery, which is a clinical procedure performed on a living patient.
- Device Description: The description details a camera system and monitor used with endoscopes. This is consistent with a device used for direct visualization during surgery, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to perform tests on these types of samples to diagnose conditions or monitor health.
Therefore, the ConMed Looking Glass System is a surgical visualization system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ConMed Looking Glass System is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, laparoscopic, sinuscopic, plastic and as an accessory for microscopic surgery.
Product codes
GCJ
Device Description
The Looking Glass™ 4K Integrated Visualization System (Looking Glass System, LG4K) is a combined system that provides image visualization to the user during minimally invasive surgical procedures. The system is comprised of a 4K monitor with a built-in camera control electronics and the Camera Head. The Camera Head is connected to the Looking Glass via Cable Connector Interface (CCI).
The Camera Head is a hand-held, sterilizable portion of the system which gets connected to the CCI via electrical cable. The Looking Glass System is designed to be used with Standard Eye-Cup Endoscopes. Additionally, the system can be used in conjunction with other light sources, e.g. Xenon or LED. The Camera Head is offered in non-sterile configuration and requires sterilization prior to use via Autoclave Method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Performance Testing on the subject device was conducted to demonstrate that the device performs per its intended use and meets the specifications of the modifications as listed in the Substantial Equivalence Table. The tests results demonstrated the safety and effectiveness of the device is in accordance with design specifications and applicable standards.
- System Testing
- Verification
- Validation
- Standard Compliance
- Electromagnetic compatibility, IEC 60601-1-2
- Electrical Safety, IEC 60601-1
- Safety and essential performance of endoscopic equipment, IEC 60601-2-18
- Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification test and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
- The software verification and validation activities were performed in accordance with the IEC 62304.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
510(k) Exempt
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 8, 2020
ConMed Corporation Kavita Amin Sr. Specialist, Regulatory Affairs 525 French Road Utica, New York 13502
Re: K201593
Trade/Device Name: Looking Glass 4K Integrated Visualization System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: June 11, 2020 Received: June 12, 2020
Dear Kavita Amin:
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.
1
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 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.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K201593
Device Name
Looking Glass 4K Integrated Visualization System
Indications for Use (Describe)
The ConMed Looking Glass System is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, laparoscopic, sinuscopic, plastic and as an accessory for microscopic surgery.
| 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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510(k) SUMMARY
Looking Glass™ 4K Integrated Visualization System
Submitter Name and Address:
ConMed Corporation 525 French Road Utica, NY -13502 USA
Contact Person Name and Telephone:
Kavita Amin Sr Specialist, Regulatory Affairs Telephone: 508-948-2084
Date of Summary Prepared: June 11, 2020
Name of the device:
| Trade Name: | Looking Glass™ 4K Integrated Visualization System |
|---|---|
| Common Name: | Looking Glass |
| Classification Name: Class II | |
| Product Code: | GCJ |
Predicate Device:
The Looking Glass™ 4K Integrated Visualization System represents a change to the ConMed, True HD 3MOS Camera System (IM8000). The information presented in this submission demonstrates the Looking Glass 4K Integrated Visualization System is substantially equivalent in function and intended use as its predicate device, True HD 3MOS Camera System, and reference device, 4K UHD Monitor. The list of predicate and reference devices are provided in Table 1.
| | 510(k)
Number | Product
Code | Trade Name | Manufacturer |
|---------------------|------------------|-----------------|------------------------------|--------------------------------------|
| Predicate
Device | K161017 | GCJ | True HD 3MOS Camera System | ConMed Corporation |
| Reference
Device | 510(k) Exempt | KQM | 4K UHD Monitor, 32 in, 81 cm | Foreseeson Customs
Displays, Inc. |
Table 1: Predicate Device
4
Device Description:
The Looking Glass™ 4K Integrated Visualization System (Looking Glass System, LG4K) is a combined system that provides image visualization to the user during minimally invasive surgical procedures. The system is comprised of a 4K monitor with a built-in camera control electronics and the Camera Head. The Camera Head is connected to the Looking Glass via Cable Connector Interface (CCI).
The Camera Head is a hand-held, sterilizable portion of the system which gets connected to the CCI via electrical cable. The Looking Glass System is designed to be used with Standard Eye-Cup Endoscopes. Additionally, the system can be used in conjunction with other light sources, e.g. Xenon or LED. The Camera Head is offered in non-sterile configuration and requires sterilization prior to use via Autoclave Method.
Indications for Use:
The Looking Glass™ 4K Integrated Visualization System is intended for use in a variety of endoscopic surgical procedures, including but not limited to, orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery.
Summary of Technological Characteristics:
The modified device, Looking Glass System, uses the same technological characteristics as the predicate, True HD 3MOS Camera System, devices except for the following:
- The predicate device comprises of Camera Controller Unit (CCU) contained in a separate enclosure. The video output of the CCU is connected to a surgical monitor which displays a live video of the surgical field.
- Unlike the predicate device, the proposed device has camera control circuitry built-into ● surgical monitor
- The proposed camera head has 5 control buttons versus 2-button for predicate device. This ● modification is for the ease of surgeon to navigate the menu during procedure.
Therefore, based on this assessment, there are no significant technological differences between the two devices as described in the Substantial Equivalence section of this submission.
Performance Testing:
Performance Testing on the subject device was conducted to demonstrate that the device performs per its intended use and meets the specifications of the modifications as listed in the Substantial Equivalence Table. The tests results demonstrated the safety and effectiveness of the device is in accordance with design specifications and applicable standards.
5
- 0 System Testing
- Verification o
- Validation ●
- Standard Compliance ●
- Electromagnetic compatibility, IEC 60601-1-2 O
- Electrical Safety, IEC 60601-1 o
- Safety and essential performance of endoscopic equipment, IEC 60601-2-18 O
- Risk analysis was carried out in accordance with established in-house acceptance criteria ● based on ISO 14971:2007. The design verification test and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
- The software verification and validation activities were performed in accordance with the ● IEC 62304.
Substantial Equivalence:
The subject device, Looking Glass 4K Integrated Visualization System, utilizes similar features and technological characteristics as the predicate device, True HD 3MOS Camera System. The only difference is the reconfiguration of the hardware and the use of the latest sensor technology. The modifications made to the camera head provides the surgeon options for navigation during a procedure.
Conclusion:
The modified device, Looking Glass™ 4K Integrated Visualization System, is substantially equivalent to the commercially available marketed device, True HD 3MOS Camera System. The modifications expressed in this 510(k) Premarket Notification are assessed using the performance data that are from well-established method and do not raise any new issues of safety and effectiveness.