(30 days)
No
The description focuses on automated control of fluid flow and pressure using peristaltic pumps and a control valve, with no mention of AI or ML technologies.
No
This device is an irrigation system used during surgical procedures to provide fluid distention, irrigation, and suction, which are supporting functions rather than therapeutic interventions that directly treat a disease or condition.
No
Explanation: The device is an irrigation system intended to provide fluid distention, irrigation, and suction during arthroscopic procedures. While it mentions "diagnostic and operative" procedures, its function is assistive during these procedures, not to diagnose conditions itself by acquiring or processing diagnostic information.
No
The device description clearly outlines a physical system including a console with pumps, a control valve, and a remote control, indicating it is a hardware device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide fluid distention, irrigation, and suction during surgical procedures (arthroscopy). This is a direct intervention on the patient's body during surgery.
- Device Description: The device is a pump system designed to manage fluid flow within the surgical site. It does not analyze biological samples or provide diagnostic information based on in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, tissue, etc.) or providing diagnostic results. The device's function is purely mechanical and related to fluid management during surgery.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The CONMED CrystalView™ Pro Irrigation System is a dual-head pump system intended to provide fluid distention, irrigation, and suction during diagnostic and operative knee, shoulder, hip, and small bone arthroscopic procedures.
Product codes
HRX
Device Description
The CONMED CrystalView™ Pro Irrigation System is designed to automatically provide and control distention and irrigation of the operative site during arthroscopic procedures. The system consists of a console with two peristaltic pumps and a control valve. It can be used as an inflow only pump or as an inflow and outflow / suction pump, utilizing currently marketed CONMED disposable tubing sets.. The set pressure and measured pressure are displayed on the equipment. A USB port allows for easy import and export of Surgeon Presets and System settings to or from the console.
The CONMED CrystalView™ Pro Irrigation console is sold non-sterile and must be located in a non-sterile area of the operating suite. The console gets connected to an autoclavable remote control which is a hand-held device, used in the sterile field with the cord connected to the console, that provides the same control functions as the console with the exception of Stand-by and Presets. The remote control gives the user the added advantage of controlling these functions from within the sterile field.
Additionally, the system communicates with different existing, marketed accessories like power supply, tubing sets, cables, shaver sensor etc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, hip, and small bone
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 was completed to confirm that the CONMED CrystalView™ Pro Irrigation System provides equivalent results in fluid distention, irrigation, and suction in comparison to the predicate device, ConMed Linvatec 24k Irrigation System (K063326). All system specifications were verified as having been met through extensive bench testing. Performance testing included confirming all functional and performance attributes of the system met their respective specifications and requirements. All clinical input requirements were validated.
Performance testing included, but was not limited, to confirming compliance with each of the applicable portions of the FDA/industry recognized standards.
This testing included the following:
| Performance Test | Results |
|---|---|
| Reliability (console & remote) | Pass |
| Flow & Pressure Performance | Pass |
| Design Verification | Pass |
| Environmental | Pass |
| Electrical Safety (IEC 60601-1-2) | Pass |
| Electromagnetic compatibility (IEC 60601-2-2) | Pass |
| Software development | Pass |
| Packaging | Pass |
| Transportation | Pass |
| User Validation | Pass |
| Packaging & Labeling | Pass |
| Sterilization (remote) | Pass |
| Cleaning & Disinfection | Pass |
Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of the CONMED CrystalView™ Pro Irrigation System are mitigated to an acceptable level.
The design verification and validation testing of the CONMED CrystalView™ Pro Irrigation System included Electrical Safety, EMC, software, system integration, labeling, and packaging/transportation qualifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 and 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.
November 14, 2018
CONMED Corporation Ms. Orjada Dervishleri Regulatory Affairs Specialist 525 French Road Utica, New York 13502
Re: K182882
Trade/Device Name: CONMED CrystalView™ Pro Irrigation System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: October 12, 2018 Received: October 15, 2018
Dear Ms. Dervishleri:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Long H. Chen -S Long H. 0 Date: 2018.11.14 12:41:16 -05'00
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K182882
Device Name
CONMED Crystal View™ Pro Irrigation System
Indications for Use (Describe)
The CONMED CrystalView™ Pro Irrigation System is a dual-head pump system intended to provide fluid distention, irrigation, and suction during diagnostic and operative knee, shoulder, hip, and small bone arthroscopic procedures.
| 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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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:
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3
Image /page/3/Picture/2 description: The image shows the logo for Conmed Corporation. The logo consists of a blue square with a white curved shape inside, followed by the word "CONMED" in black, with the word "CORPORATION" in smaller font below it. There is a blue line above the word "CORPORATION".
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, CONMED Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number:
SUBMITTER I.
CONMED Corporation 11311 Concept Blvd Largo, Florida 33773
Contact Person: Ms. Orjada Dervishleri Regulatory Affairs Specialist
Phone: 727-399-5491 727-399-5264 Fax: E-mail: orjadadervishleri@conmed.com
Date Prepared: October 12, 2018
II. DEVICE NAME
Device Name: CONMED CrystalView™ Pro Irrigation System Common Name: Irrigation System Classification Name: Arthroscope Class II, per 21 Regulatory Class: Regulation: CFR Part 888.1100 Product Codes: HRX
III. PREDICATE/ LEGALLY MARKET DEVICE
| Device Name: | ConMed Linvatec 24k Irrigation System |
|---|---|
| Company Name: | ConMed |
| 510(k) #: | K063326 |
IV. DEVICE DESCRIPTION
The CONMED CrystalView™ Pro Irrigation System is designed to automatically provide and control distention and irrigation of the operative site during arthroscopic procedures. The system consists of a console with two peristaltic pumps and a control valve. It can be used as an inflow only pump or as an inflow and outflow / suction pump, utilizing currently marketed CONMED disposable tubing sets.. The set pressure and measured
4
Image /page/4/Picture/2 description: The image shows the Conmed Corporation logo. The logo features a blue square with a white "C" shape inside on the left. To the right of the square is the word "Conmed" in a bold, black font. Below the word "Conmed" is the word "Corporation" in a smaller, black font.
pressure are displayed on the equipment. A USB port allows for easy import and export of Surgeon Presets and System settings to or from the console.
The CONMED CrystalView™ Pro Irrigation console is sold non-sterile and must be located in a non-sterile area of the operating suite. The console gets connected to an autoclavable remote control which is a hand-held device, used in the sterile field with the cord connected to the console, that provides the same control functions as the console with the exception of Stand-by and Presets. The remote control gives the user the added advantage of controlling these functions from within the sterile field.
Additionally, the system communicates with different existing, marketed accessories like power supply, tubing sets, cables, shaver sensor etc.
V. INTENDED USE/ INDICATIONS FOR USE
The CONMED CrystalView™ Pro Irrigation System is a dual-head pump system intended to provide fluid distention, irrigation, and suction during diagnostic and operative knee, shoulder, hip, and small bone arthroscopic procedures.
VI. SUMMARY OF PERFORMANCE TESTING
Performance Testing was completed to confirm that the CONMED CrystalView™ Pro Irrigation System provides equivalent results in fluid distention, irrigation, and suction in comparison to the predicate device, ConMed Linvatec 24k Irrigation System (K063326). All system specifications were verified as having been met through extensive bench testing. Performance testing included confirming all functional and performance attributes of the system met their respective specifications and requirements. All clinical input requirements were validated.
Performance testing included, but was not limited, to confirming compliance with each of the applicable portions of the FDA/industry recognized standards.
This testing included the following:
| Performance Test | Results |
|---|---|
| Reliability (console & remote) | Pass |
| Flow & Pressure Performance | Pass |
| Design Verification | Pass |
| Environmental | Pass |
| Electrical Safety (IEC 60601-1-2) | Pass |
| Electromagnetic compatibility (IEC 60601-2-2) | Pass |
| Software development | Pass |
| Packaging | Pass |
| Transportation | Pass |
| User Validation | Pass |
| Packaging & Labeling | Pass |
| Sterilization (remote) | Pass |
| Cleaning & Disinfection | Pass |
5
Image /page/5/Picture/2 description: The image shows the logo for Conmed Corporation. The logo consists of a blue square with a white "C" shape inside, followed by the word "CONMED" in black, sans-serif font. Below the word "CONMED" is a thin blue line, and below that is the word "CORPORATION" in a smaller, sans-serif font.
Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of the CONMED CrystalView™ Pro Irrigation System are mitigated to an acceptable level.
The design verification and validation testing of the CONMED CrystalView™ Pro Irrigation System included Electrical Safety, EMC, software, system integration, labeling, and packaging/transportation qualifications.
VII. COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Both, the proposed irrigation system and the predicate irrigation system have the identical intended use, with similar design and technological characteristics.
The CONMED CrystalView™ Pro Irrigation System technological characteristics are: dual head pump for fluid distention, irrigation, and suction, touch-screen display and a remote control. The ConMed Linvatec 24k Irrigation System technological characteristics are dual head pump for fluid distention, irrigation, and suction, touchscreen display and a remote control.
The following table represents a summary of the differences in the technological characteristics between the proposed CONMED CrystalView™ Pro Irrigation System and the predicate device ConMed Linvatec 24k Irrigation System.
| | PROPOSED DEVICE
CONMED CrystalView™ Pro Irrigation System | PREDICATE DEVICE
Conmed Linvatec 24k® Irrigation System |
|-------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Brief
Description | Console with two peristaltic pumps and a control
valve | Console with two peristaltic pumps and
a control valve |
| Functionality | Functions as powered irrigation console for
providing fluid distention, irrigation, and suction. | Functions as powered irrigation console
for providing fluid distention, irrigation,
and suction. |
| Operation
modes | Inflow and outflow / suction pump | Inflow and outflow / suction pump |
| Number of
pump heads | Two | Two |
| Pumping
mechanism | Peristaltic pump | Peristaltic pump |
| Display | LCD with touchscreen
USB ports | Push buttons front panel |
| Weight | 18.5lb | 10.3lb |
| Remote
Control | Corded
8 Button remote | Corded
6 Button remote |
6
Image /page/6/Picture/2 description: The image shows the logo for Conmed Corporation. The logo consists of a blue square with a white curved shape inside, followed by the word "CONMED" in black, sans-serif font. Below "CONMED" is the word "CORPORATION" in a smaller, sans-serif font.
VIII. CONCLUSION
The differences between the predicate and modified device do not raise any new risks of safety or efficacy. Testing and supporting information per this premarket submission confirms that the modified CONMED CrystalView™ Pro Irrigation System is safe and effective for its intended use and is substantially equivalent in design, intended use, conditions of use, principal of operation, utilizing the same fundamental scientific technology as the predicate device - ConMed Linvatec 24k Irrigation System cleared by K063326.