VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC

Q: Who is the manufacturer of VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC?

Conmed Corporation filed the 510(k) submission for VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC (K133116).

Q: What is the FDA product code for VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC?

KCT. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

Q: What is the regulatory pathway for VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K133116 · Conmed Corporation · KCT · Mar 28, 2014 · General Hospital

Device Facts

Record ID	K133116
Device Name	VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC
Applicant	Conmed Corporation
Product Code	KCT · General Hospital
Decision Date	Mar 28, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Intended Use

The Video Trays listed above are used for loading surgical instruments in or to conveniently organize, sterilize, transport and store the instruments between uses. The Video Trays listed above are not intended to maintain sterility: they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments. The Video Trays listed above are intended to be used to enclose ConMed medical devices including hand instruments, trocars, camera heads, adapters, endoscopes, light guides, and bridge systems to steam sterilize the enclosed medical devices by a health care provider.

Device Story

Perforated sterilization trays constructed of RADEL (base R-5100, lid R-5000) with silicone brackets and stainless steel hardware; designed to hold specific ConMed surgical instruments (scopes, trocars, light guides, etc.) during steam sterilization. Used in clinical settings by healthcare providers; trays facilitate steam penetration, evacuation, and drying. Must be used with FDA-cleared sterilization wrap to maintain sterility post-process. Trays are reusable, non-serviced, and non-repaired. Benefits include organized, efficient sterilization and transport of delicate surgical instrumentation.

Clinical Evidence

Bench testing only. Validated via steam sterilization qualification (pre-vacuum cycle, 270°F/132°C, 4-minute exposure), cleaning validation, transportation qualification, and handle weight verification. Biocompatibility testing performed per ISO 10993-1 and FDA #G95-1. No clinical data required.

Technological Characteristics

Materials: RADEL R-5100 (base), RADEL R-5000 (lid), silicone (brackets), stainless steel (hardware). Design: Perforated tray/lid for steam penetration. Sterilization: Steam (wrapped), pre-vacuum cycle, 270°F (132°C), 4-minute exposure. Dimensions/load capacity vary by model. No software or electronics.

Indications for Use

Indicated for use by healthcare providers to organize, sterilize, transport, and store ConMed surgical instruments (hand instruments, trocars, camera heads, adapters, endoscopes, light guides, bridge systems) via steam sterilization. Requires use of FDA-cleared sterilization wrap to maintain sterility.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

Olympus MAJ-172 Instrument Tray for LTF Videoscope (K122818)

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a stylized, abstract shape on the left, resembling a curved blade or wing. To the right of this shape is the word "CONMED" in bold, sans-serif font. Below "CONMED" is the word "CORPORATION" in a smaller, sans-serif font, with a horizontal line separating it from the word above. 化133116 # 510(k) Summary as required by section 21 CFR 807.92(c) | 21 CFR 807.92(a)(1) Submitter Name: | ConMed Corporation Viking Systems | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Address: | 525 French Road Utica, NY 13502 | | Contact Person: | Nancy J Gertlar. Quality Assurance and Regulatory Affairs | | Telephone Number: | 509-496-2248 | | Fax Number: | 508-948-8070 | | Date of Preparation: | March 18, 2014 | | 21 CFR 807.92(a)(2) Device Trade Name: | VP1003 Video Extended Length Tray (RADEL) VP1005 Video Tray Single Level (RADEL) VP1006 Video Arthroscope Tray (RADEL) VP1007 Video Laparoscope Tray (RADEL) | | Common Name: | Sterilization Container | | Classification Name: | Sterilization Wrap Containers, Trays, Cassettes and Other Accessories | | Classification Class: | Class II | | Regulation: | 21 CFR 880.6850 | | Product Code: | KCT | | 21 CFR 807.92(a)(3) Predicate Device: | Olympus MAJ-172 Instrument Tray for LTF Videoscope | | Company Name: | KeyMed (Medical and Industrial Ltd) | | 510(k) Number: | K122818 | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a stylized, curved shape to the left of the word "CONMED" in a bold, sans-serif font. Below "CONMED" is the word "CORPORATION" in a smaller, sans-serif font. 807.92(a)(4) Device Description: VP1003 Video Extended Length Tray (RADEL) VP1005 Video Tray Single Level (RADEL) VP1006 Video Arthroscope Tray (RADEL) VP1007 Video Laparoscope Tray (RADEL) VP1003 Video Extended Length Tray (RADEL), VP1005 Video Tray Single Level (RADEL), VP1006 Video Arthroscope Tray (RADEL) and VP1007 Video Laparoscope Tray (RADEL) - are constructed of RADEL with perforations to facilitate steam sterilant penetration, evacuation and drying. These trays are designed to fit any standard autoclave and are manufactured from durable, biocompatible materials that are corrosion resistant and compatible with the environment of repeated steam sterilization. Since the trays are perforated, an FDA cleared sterilization wrap K082177 must be used to maintain sterility of the contents. Interior structures of the trays have the ability to separately hold individual instruments during the entire duration they are in contact with the tray. Although these trays are reusable they will not be serviced or repaired. VP1003 Video Extended Length Tray (RADEL). VP1005 Video Tray Single Level (Tray), VP1006 Video Arthroscope Tray (RADEL) and VP1007 Video Laparoscope Tray (RADEL) - were designed in accordance with 21 CFR 820.30 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a stylized, abstract shape on the left, resembling a crescent or a curved blade. To the right of the shape, the word "CONMED" is written in bold, sans-serif font, with the word "CORPORATION" appearing in smaller letters below it. The overall design is simple and professional, conveying a sense of innovation and reliability. Statement of Indication for Use 510(k) Number: K133116 Subject Device Names VP1003 Video Extended Length Tray (RADEL) VP1005 Video Tray Single Level (RADEL) VP1006 Video Arthroscope Tray (RADEL) VP1007 Video Laparoscope Tray (RADEL) The Video Trays listed above are used for loading surgical instruments in or to conveniently organize, sterilize, transport and store the instruments between uses. The Video Trays listed above are not intended to maintain sterility: they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments. The Video Trays listed above are intended to be used to enclose ConMed medical devices including hand instruments, trocars, camera heads, adapters, endoscopes, light guides, and bridge systems to steam sterilize the enclosed medical devices by a health care provider. The instrument trays were validated as per below sterilization parameters: Steam (wrapped) sterilization Pre-vacuum cycle at 270 F ( 132 °C) for 4 minutes Cool down to 48°C for 118 minutes VP1003 Video Extended Length Tray (RADEL) dry cycle is 35 minutes. ConMed Corporation instruments which can be sterilized in this tray are scopes with an outer diameter not less than 5.5mm or greater than 10mm with lengths no greater than 530mm. and light guides with a length no greater than 10ft. VP1005 Video Tray Single Level (RADEL) dry cycle is 40 minutes. ConMed Corporation instruments which can be sterilized in this tray are Scopes. Sheaths, Cannulas and Bridge System with internal diameters not less than 2.3mm. outer diameter not less than 2.9mm or greater than 10mm, and with lengths no greater than 404mm. Non-Cannulated. Non-Porous instruments with outer diameters not less than 2.9mm or greater than 3.2mm and with lengths no greater than 404mm may also be sterilized in this tray. VP1006 Video Arthroscope Tray (RADEL) dry cycle is 20 minutes. ConMed Corporation instruments which can be sterilized in this tray are scopes with diameters not less than 2.9mm or greater than 4mm. with lengths no greater than 233mm. لدم {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of a stylized, abstract shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font. The logo is black and white. VP1007 Video Laparoscope Tray (RADEL) dry cycle is 25 minutes. ConMed Corporation instruments which can be sterilized in this tray are scopes with diameters not less than 5.5mm or greater than 10mm. with lengths no greater than 404mm. For additional instrument trays specifications refer to the table below. | Model Name | VP1003 | VP1005 | VP1006 | VP1007 | |----------------------------|--------------------------------------------------|--------------------------------------------------|--------------------------------------------------|--------------------------------------------------| | | Video Extended Length Tray (RADELL) | Video Tray Single Level (RADEL) | Video Arthroscope Tray (RADEL) | Vidco Laparoscope Tray (RADEL) | | Method | Steam (Wrapped) | Steam (Wrapped) | Steam (Wrapped) | Steam (Wrapped) | | Cycle | Pre-vacuum | Pre-vacuum | Pre-vacuum | Pre-vacuum | | Temperature | 270F (132°C) | 270F (132°C) | 270F (132°C) | 270F (132°C) | | Exposure | 4 minutes | 4 minutes | 4 minutes | 4 minutes | | Dry Cycle | 35 minutes | 40 minutes | 20 minutes | 25 minutes | | Cool Down to 48°C | 118 minutes | 118 minutes | 118 minutes | 118 minutes | | Maximum Load | 3.9lbs (1.8kg) | 8.0lbs (3.6kg) | 1.1 lbs (0.5kg) | 1.7 Ibs (0.8kg) | | Maximum Density | 0.069lb/in3 (1.91gm/cm3) | 0.094lb/in3 (2.60gm/cm3) | 0.064 lb/in3 (1.77 gm/cm3) | 0.077 lb/in3 (2.13gm/cm3) | | Base | 22.441 Length x 6.923 Width x 1.695 Height | 20.901 Length x 9.715 Width x 2.045 Height | 12.110 Length x 3.150 Width x 1.615 Height | 17.253 Length x 3.158 Width x 1.615 Height | | Lid | 22.486 Length x 7.000 Width x .910 Height | 20.921 Length x 9.760 Width x 1.52 Height | 12.615 Length x 3.225 Width x .75 Height | 17.295 Length x 3.220 Width x .750 Height | | Assembled Unit | 23 Length x 7.4 Width x 2.2 Height | 21.5 Length x 10.2 Width x 3.2 Height | 12.7 Length x 3.6 Width x 2.0 Height | 17.8 Length x 3.6 Width x 2.0 Height | | Stainless Steel Handles | 2 | 2 | N/A | N/A | | Base Material | RADEL R-5100, Color Blue (PMS 300) | RADEL R-5100, Color Blue (PMS 300) | RADEL R-5100, Color Blue (PMS 300) | RADEL R-5100, Color Blue (PMS 300) | | Hardware | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel | | Brackets | Silicone | Silicone | Silicone | Silicone | | Graphics | Laser Etched | Laser Etched | Laser Etched | Laser Etched | | Lid Material | RADEL R-5000, Color Smoke | RADEL R-5000, Color Smoke | RADEL R-5000, Color Smoke | RADEL R-5000, Color Smoke | | Graphics | Silk Screen, White | Silk Screen, White | Silk Screen, White | Silk Screen, White | 4 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a stylized swoosh shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below "CONMED" is the word "CORPORATION" in a smaller font size. The logo is black and white. ## 21 CFR 807.92(a)(5) ### Summary of Testing: All model numbers included in K133116 were tested in accordance with Risk Management, Steam Sterilization Qualification, Cleaning Validation, Transportation Qualification. Verification of Report Handle Weight, and the Application of ISO 10883 and FDA #G95-1 in the Biological Evaluation of Video Trays. The protocols of all the listed tests were successfully completed. ### Comparison to the Predicate Devices: All model numbers included in K133116 were compared to the predicate device by review of the intended use and technological characteristics - product design, device characteristics and materials. Please refer to the Comparison Table for Substantial Equivalence on the following pages. ### Substantial Equivalence Discussion: All model numbers included in K133116 were found to be substantially equivalent based on the same intended use and side by side comparison of technological characteristics. The predicate is cleared for steam and ETO. The model numbers in K133116 are claiming steam sterilization only. This does not create any new risks or hazards. ## Verifications regarding this 510(k) Summary: The summary includes only information that is also covered in the body of the 510(k). The summary does not contain any raw data. i.e., contains only summary data. The summary does not contain trade secret or confidential commercial information. The summary does not contain any patient identification information. ## 21 CFR 807.92 (b)(c) Substantial Equivalence Conclusion: It is concluded that the models numbers listed above, are substantially equivalent, based on the non clinical testing (discussed above) that demonstrates that the device is as safe and effective as the predicate device. {5}------------------------------------------------ ## 21 CFR 807.92 (a)(6) # Comparison Table for Substantial Equivalence Table 1 | 510(k) Number | K133116 | K122818 | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | Proprietary Name | VP1003 Video Extended Length Tray (RADEL), VP1005 Video Tray Single Level (RADEL), VP1006 Video Arthroscope Tray (RADEL). VP1007 Video Laparoscope Tray (RADEL) | Olympus MAJ-172 Instrument Tray for LTF Videoscope | | Original Applicant Name | ConMed Corporation Viking Systems Utica. NY | Olympus KeyMed. San Diego, CA | | Submitter | ConMed Corporation Viking Systems Utica, NY | KeyMed Essex UK | | Regulation Number | 21 CFR 880.6850 | 21 CFR 880.6850 | | Class | II | II | | Product Code | KCT | KCT | | Decision Date | Pending | January 4, 2013 | | Common/Usual Name Classification Name | Sterilization Container Sterilization wrap, containers, trays, cassettes and other accessories | Sterilization Container Sterilization wrap, containers, trays, cassettes and other accessories | | Predicate Device | K122818 | K033222 | | Target Populations | Health Care Provider | Health Care Provider | | Design | Perforated tray and lid | Perforated tray and lid | | Sterilization Wrap | K082177 | Not stated in the summary | 6 : {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of a stylized, abstract shape on the left, resembling a crescent or a curved blade. To the right of the shape is the word "CONMED" in bold, sans-serif font. Below "CONMED" is the word "CORPORATION" in a smaller, sans-serif font. # 21 CFR 807.92 (a) (6) # Comparison Table for Substantial Equivalence Table 2 | K133116 Model Numbers | K122818 | Differences | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | VP1003 Video Extended Length Tray (RADEL) VP1005 Video Tray Single Level (RADEL) VP1006 Video Arthroscope Tray (RADEL) VP1007 Video Laparoscope Tray (RADEL) | KeyMed Olympus MAJ-172 Instrument Tray for LTF Videoscope | | | The model numbers listed above are intended to be used to enclose ConMed medical devices including hand instruments, trocars, camera heads, adapters, endoscopes. light guides, and bridge systems to steam sterilize the enclosed medical devices by a health care provider. | The Olympus MAJ-172 Instrument Tray for LTF Videoscopes is intended to be used to enclose Olympus medical devices including hand instruments. trocars. camera heads. adapters, and endoscopes to be sterilized by a health care provider. | The only difference is ConMed product vs Olympus product. | | | It is intended to allow steam or ethylene oxide sterilization of the enclosed medical device. | K133116 is steam only | | The model numbers listed above are used for loading surgical instruments in or to conveniently organize, sterilize, and transport and store the instruments between uses. | The Olympus MAJ-172 Instrument Tray for LTF Videoscope is designed to secure and store a single videoscope and its accessories for sterilization at a healthcare facility. | K122818 is only for one videoscope and accessories. K133116 is for multiple ConMed products and accessories. | | VP1003 Video Extended Length Tray (RADEL). Method: Steam (Wrapped); Cycle: Pre-vacuum: Temperature: 270degF (132degC); Exposure: 4 minutes; Dry Cycle: 35 | Steam Sterilization: Vacuum: 0.016 MPa minimum Pressure: 0.101 MPa minimum Temperature: 135 deg C Exposure Time: 3 minutes | K133116 Temp 132degC Exposure 4 min Dry 35 min K122818 Temp 135degC Exposure 3 min | . . {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a stylized graphic to the left of the company name. The word "CONMED" is printed in a bold, sans-serif font, with the word "CORPORATION" printed in a smaller font directly below it. | minutes: Maximum Load: 3.9lbs (1.8kg); Maximum Density: 0.069lb/in3 (1.91gm/cm3) | Drying Time: 20 minutes | Dry 20 min | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | VP1005 Video Tray Single Level (RADEL), Method: Steam (Wrapped); Cycle: Pre- vacuum; Temperature: 270degF (132degC); Exposure: 4 minutes; Dry Cycle: 40 minutes; Maximum Load: 8.0lbs (3.6kg); Maximum Density: 0.094lb/in3 (2.60gm/cm3) | Steam Sterilization: Vacuum: 0.016 MPa minimum Pressure: 0.101 MPa minimum Temperature: 135 deg C Exposure Time: 3 minutes Drying Time: 20 minutes | K133116 Temp 132degC Exposure 4 min Dry 40 min K122818 Temp 135degC Exposure 3 min Dry 20 min | | VP1006 Video Arthroscope Tray (RADEL), Method: Steam (Wrapped); Cycle: Pre- vacuum: Temperature: 270degF (132degC); Exposure: 4 minutes; Dry Cycle: 15 minutes; Maximum Load: 1.1lbs (0.5kg): Maximum Density: 0.064lb/in3 (1.77gm/cm3) | Steam Sterilization: Vacuum: 0.016 MPa minimum Pressure: 0.101 MPa minimum Temperature: 135 deg C Exposure Time: 3 minutes Drying Time: 20 minutes | K133116 Temp 132degC Exposure 4 min Dry 15 min K122818 Temp 135degC Exposure 3 min Dry 20 min | | VP1007 Video Laparoscope Tray (RADEL), Method: Steam (Wrapped); Cycle: Pre- vacuum: Temperature: 270degF (132degC): Exp: 4 minutes: Dry Cycle: 25 minutes; Maximum Load: 1.7lbs (0.8kg); Max Density: 0.077lb/in3 (2.13gm/cm). | Steam Sterilization: Vacuum: 0.016 MPa minimum Pressure: 0.101 MPa minimum Temperature: 135 deg C Exposure Time: 3 minutes Drying Time: 20 minutes | K133116 Temp 132degC Exposure 4 min Dry 25 min K122818 Temp 135degC Exposure 3 min Dry 20 min | . 8 : {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a stylized letter "C" on the left, followed by the word "CONMED" in bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font. # 21 CFR 807.92 (b) (1) # Comparison Table for Substantial Equivalence Table 3 | | K133116 | K122818 | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Standards Met | ST77 Containment devices for reusable medical device sterilization | Not stated in the summary | | | ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" | Not stated in the summary | | | FDA #G95-1 "Use of International Standards Series 10993- 1:2009/Cor1:2010" | Not stated in the summary | | Materials | RADEL | RADEL | | Biocompatibility | ISO 10993- 1:2009/Cor1:2010 | Not stated in the summary | | Sterility | The device is sold non sterile | The device is sold non sterile | | Cleaning Studies | ConMed Report CL227 Cleaning Validation | Not stated in the summary | | Environmental Studies | ConMed Report TR13-390 Verification Report Handle Weight Requirement ANSI/AAMI ST77:2006 | Not stated in the summary | | Transportation Studies | ConMed Report TR13-050 Transportation Qualification | Simulated tests included use tests, drop testing resistance to chemical, cleaning, steam sterilization | | Electrical Safety | N/A | N/A | | Mechanical Safety | N/A | N/A | | Chemical Safety | N/A | N/A | | Thermal Safety | N/A | N/A | | Radiation Safety | N/A | N/A | . - : {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a stylized, abstract shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font, with a horizontal line separating the two words. ## 21 CFR 807.92 (b)(3) ## Summary of Non Clinical Tests | TR13-707 Risk Management Report | Conclusion: Throughout the design process, various mitigations and control methods have been identified and applied to the device(s), including safety mechanisms that address concerns identified in relevant post-market surveillance. These have been verified or validated to demonstrate that the risks have been reduced as far as reasonably practicable and the device(s) perform as intended by the established design requirements. This report confirms that the Risk Management Plan has been appropriately implemented and that methods are in place to obtain relevant production and post-production information. The risks associated with the use of these devices constitute acceptable risks when weighed against the benefits to the patient and are compatible with high level of protection of health and safety. It has been determined that the overall residual risk is acceptable. | |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | TR12-343 Steam Sterilization Qualification VP1003 Video Extended Length Tray | Conclusion: Results of the three half cycles demonstrate the tested cycle imparts sufficient lethality to produce an SAL of 10-6 at twice the half cycle exposure duration (full cycle) when the full tray is sterilized in accordance with the cycle type, temperature, exposure time, configuration and placement within the chamber tested in this study. All acceptance criteria defined in the ConMed Lab Study LS13S-007 Protocol were met. | | TR12-345 Steam Sterilization Qualification VP1005 Video Tray Single Level | Conclusion: Results of the three half cycles demonstrate the tested cycle imparts sufficient lethality to produce an SAL of 10-6 at twice the half cycle exposure duration (full cycle) when the full tray is sterilized in accordance with the cycle type, temperature, exposure time, configuration and placement within the chamber tested in this study. All acceptance criteria defined in the ConMed Lab Study LS13S-010 Protocol were met. | | TR12-346 Steam Sterilization Qualification VP1006 Video Arthroscope Tray | Conclusion: Results of the three half cycles demonstrate the tested cycle imparts sufficient lethality to produce an SAL of 10-6 at twice the half cycle exposure duration (full cycle) when the full tray is sterilized in accordance with the cycle type, temperature, exposure time, configuration and placement within the chamber tested in this study. All acceptance criteria defined in the ConMed Lab Study LS13S-008 Protocol were met. | | TR12-347 Steam Sterilization Qualification | Conclusion: Results of the three half cycles demonstrate the tested cycle imparts sufficient lethality to produce an SAL of 10-6 at twice the half cycle exposure duration (full cycle) when the full tray is sterilized in accordance with the cycle type, temperature, exposure time, configuration and placement within the chamber tested in this study | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a stylized "C" shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below the word "CONMED" is a horizontal line, and below that is the word "CORPORATION" in a smaller, sans-serif font. The logo is black and white. | VP1007 Video | All acceptance criteria defined in the ConMed Lab Study LS13S-009 | | | | | |----------------|-------------------------------------------------------------------------|--|--|--|--| | Laparoscope | Protocol were met. | | | | | | Tray | | | | | | | TR13-121 | Conclusion: Devices tested meet specifications for acceptance. The | | | | | | Cleaning | manual cleaning using a soft bristled brush and mild neutral pH | | | | | | Validation | detergent to clean all surfaces described in the cleaning method. This | | | | | | | cleaning method is validated for | | | | | | | VP1003 Video Extended Length Tray | | | | | | | VP1005 Video Tray Single Level | | | | | | | VP1006 Video Arthroscope Tray | | | | | | | VP1007 Video Laparoscope Tray | | | | | | TR13-050 | Conclusion: The results of this study support the Transportation and | | | | | | Transportation | Distribution Storage Qualification of the trays. The results of the | | | | | | Qualification | qualification demonstrate that the non sterile product and packaging | | | | | | | maintained physical properties and characteristics for intend use after | | | | | | | transportation conditioning. | | | | | | TR13-390 | Conclusion: The handle load requirements of ANSI/AAMI | | | | | | Verification | ST77:2006. Section 4.3.6.4 (b) are met. The test trays met the | | | | | | Report Handle | requirement of withstanding a 32 pound force without breaking free | | | | | | Weight | from the tray or permanently cracking or deforming. | | | | | | Requirement | | | | | | | TR14-027 | This report documents the successful validation of the 118 minute cool | | | | | | | down time for the VP1003 Video Extended Length Tray (RADEL), | | | | | | | VP1005 Video Tray Single Level (RADEI.). VP1006 Video | | | | | | | Arthroscope Tray (RADEL) and VP1007 Video Laparoscope Tray | | | | | | | (RADEL). | | | | | | TR13-517 | Conclusion: The materials used in the Video Trays have been tested | | | | | | Application of | and have demonstrated an acceptable biocompatibility profile for its | | | | | | ISO 10993 and | intended use. It can be concluded that use of the Video Trays does not | | | | | | FDA #G95-1 | pose a biological safety risk as identified in the Preliminary Hazard | | | | | | in the | Analysis. Based on these comprehensive tests. the benefits of the | | | | | | Biological | materials for the intended use outweigh the clinical risks. In | | | | | | Evaluation of | conclusion. it was demonstrated that these devices meet the biological | | | | | | Video Trays | evaluation requirements of ISO 10993-1:2009 and FDA #G95-1. | | | | | . {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 28, 2014 ConMed Corporation Viking Systems Ms. Nancy J. Gertlar Quality Assurance and Regulatory Affairs 525 French Road Utica, NY 13502 Re: K133116 Trade/Device Name: VP1003 Video Extended Length Tray (RADEL) VP1005 Video Tray Single Level (RADEL) VPI 006 Video Arthroscope Tray (RADEL) VP1007 Video Laparoscope Tray (RADEL) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Containers, Trays Cassettes and Other Accessories Regulatory Class: II Product Code: KCT Dated: March 18, 2014 Received: March 20, 2014 Dear Ms. Gertlar: 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. 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. {12}------------------------------------------------ Page 2 - Ms. Gertlar 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. Tejashri Puro Clinical Depu DAGRID Teiashri Purohit-Sheth, M.D. Clinical Deputy Director FOR Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {13}------------------------------------------------ ### Indications for Use Statement ### 510(k) Number: K133116 Subject Device Names VP1003 Video Extended Length Tray (RADEL) VP1005 Video Tray Single Level (RADEL) VP1006 Video Arthroscope Tray (RADEL) VP1007 Video Laparoscope Tray (RADEI.) The Video Trays listed above are used for loading surgical instruments in or to conveniently organize, sterilize, transport and store the instruments between uses. The Video Trays listed above are not intended to maintain sterility: they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments. The Video Trays listed above are intended to be used to enclose ConMed medical devices including hand instruments. trocars. camera heads. adapters. endoscopes, light guides, and bridge systems to steam sterilize the enclosed medical devices by a health care provider. The instrument trays were validated as per below stcrilization parameters: Steam ( wrapped) sterilization Pre-vacuum cycle at 270 F ( 132 °C) for 4 minutes Cool down to 48°C for 118 minutes VP1003 Video Extended Length Tray (RADEL) dry cycle is 35 minutes. ConMed Corporation instruments which can be sterilized in this tray are scopes with an outer diameter not less than 5.5mm or greater than 10mm with lengths no greater than 530mm. and light guides with a length no greater than 10ff. VP1005 Vidco Tray Single 1.evel (RADEL) dry cycle is 40 minutes. ConMed Corporation instruments which can be sterilized in this tray are Scopes, Sheaths. Cannulas and Bridge System with internal diameters not less than 2.3mm. outer diameter not less than 2.9mm or greater than 10mm. and with lengths no greater than 404mm. Non-Cannulated, Non-Porous instruments with outer diameters not less than 2.9mm or greater than 3.2mm and with lengths no greater than 404mm may also be sterilized in this tray. VP1006 Video Arthroscope Tray (RADEL) dry cycle is 20 minutes. ConMed Corporation instruments which can be sterilized in this tray are scopes with diameters not less than 2.9mm or greater than 4mm. with lengths no greater than 233mm. VP1007 Video Laparoscope Tray (RADEL) dry cycle is 25 minutes. ConMed Corporation instruments which can be sterilized in this tray are scopes with diameters not less than 5.5mm or greater than 10mm, with lengths no greater than 404mm. {14}------------------------------------------------ ## Indications for Use Statement | Model Name | VP1003 | VP1005 | VP1006 | VP1007 | |----------------------------|--------------------------------------------------|--------------------------------------------------|--------------------------------------------------|--------------------------------------------------| | | Video Extended Length Tray (RADEL) | Video Tray Single Level (RADEL) | Video Arthroscope Tray (RADEL) | Video Laparoscope Tray (RADEL) | | Method | Steam (Wrapped) | Steam (Wrapped) | Steam (Wrapped) | Steam (Wrapped) | | Cycle | Pre-vacuum | Pre-vacuum | Pre-vacuum | Pre-vacuum | | Temperature | 270F (132°C) | 270F (132°C) | 270F (132°C) | 270F (132°C) | | Exposure | 4 minutes | 4 minutes | 4 minutes | 4 minutes | | Dry Cycle | 35 minutes | 40 minutes | 20 minutes | 25 minutes | | Cool Down to 48°C | 118 minutes | 118 minutes | 118 minutes | 118 minutes | | Maximum Load | 3.9lbs (1.8kg) | 8.0lbs (3.6kg) | 1.1 lbs (0.5kg) | 1.7 lbs (0.8kg) | | Maximum Density | 0.069lb/in3 (1.91gm/cm3) | 0.094lb/in3 (2.60gm/cm3) | 0.064 lb/in3 (1.77 gm/cm3) | 0.077 lb/in3 (2.13gm/cm3) | | Base | 22.441 Length x 6.923 Width x 1.695 Height | 20.901 Length x 9.715 Width x 2.045 Height | 12.110 Length x 3.150 Width x 1.615 Height | 17.253 Length x 3.158 Width x 1.615 Height | | Lid | 22.486 Length x 7.000 Width x .910 Height | 20.921 Length x 9.760 Width x 1.52 Height | 12.615 Length x 3.225 Width x .75 Height | 17.295 Length x 3.220 Width x .750 Height | | Assembled Unit | 23 Length x 7.4 Width x 2.2 Height | 21.5 Length x 10.2 Width x 3.2 Height | 12.7 Length x 3.6 Width x 2.0 Height | 17.8 Length x 3.6 Width x 2.0 Height | | Stainless Steel Handles | 2 | 2 | N/A | N/A | | Base Material | RADEL R-5100. Color Blue (PMS 300) | RADEL R-5100. Color Blue (PMS 300) | RADEL. R-5100. Color Blue (PMS 300) | RADEL R-5100. Color Blue (PMS 300) | | Hardware | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel | | Brackets | Silicone | Silicone | Silicone | Silicone | | Graphics | Laser Etched | Laser Etched | Laser Etched | Laser Etched | | Lid Material | RADEL. R-5000. Color Smoke | RADEL R-5000. Color Smoke | RADEL R-5000. Color Smoke | RADEL R-5000. Color Smoke | | Graphics | Silk Screen. White | Silk Screen. White | Silk Screen. White | Silk Screen. White | For additional instrument trays specifications refer to the table below. AND/OR Prescription Use_ (Pari 2) CFR 801 Subpart D) Over-the-Counter Use_ X (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE: ON ANOTHER PAGE II NEEDED) Concurrence of CDRH. Office of Device I:valuation (ODE) Mary S. Runner -S na 2014.03.26 13:10:08 -04'00'