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.

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.

Device Description

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.

AI/ML Overview

We are looking at sterilamp.

1. Acceptance Criteria and Device Performance:

The acceptance criteria for each test and the corresponding device performance are detailed in the "Summary of Non Clinical Tests" section of the 510(k) summary, specifically on pages 9 and 10 of the provided document.

Test	Acceptance Criteria	Reported Device Performance
Risk Management (TR13-707)	Risks associated with device use constitute acceptable risks when weighed against benefits, compatible with high protection of health and safety, and overall residual risk is acceptable.	"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."
Steam Sterilization Qualification (VP1003, TR12-343)	Sufficient lethality to produce an SAL of 10^-6 at twice the half-cycle exposure duration (full cycle) when sterilized in accordance with specified parameters. All acceptance criteria defined in ConMed Lab Study LS13S-007 Protocol were met.	"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."
Steam Sterilization Qualification (VP1005, TR12-345)	Sufficient lethality to produce an SAL of 10^-6 at twice the half-cycle exposure duration (full cycle) when sterilized in accordance with specified parameters. All acceptance criteria defined in ConMed Lab Study LS13S-010 Protocol were met.	"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."
Steam Sterilization Qualification (VP1006, TR12-346)	Sufficient lethality to produce an SAL of 10^-6 at twice the half-cycle exposure duration (full cycle) when sterilized in accordance with specified parameters. All acceptance criteria defined in ConMed Lab Study LS13S-008 Protocol were met.	"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."
Steam Sterilization Qualification (VP1007, TR12-347)	Sufficient lethality to produce an SAL of 10^-6 at twice the half-cycle exposure duration (full cycle) when sterilized in accordance with specified parameters. All acceptance criteria defined in ConMed Lab Study LS13S-009 Protocol were met.	"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-009 Protocol were met."
Cleaning Validation (TR13-121)	Devices meet specifications for acceptance; manual cleaning method using soft bristled brush and mild neutral pH detergent to clean all surfaces is validated.	"Devices tested meet specifications for acceptance. The manual cleaning using a soft bristled brush and mild neutral pH detergent to clean all surfaces described in the cleaning method. This cleaning method is validated for VP1003, VP1005, VP1006, VP1007 Video Trays."
Transportation Qualification (TR13-050)	Non-sterile product and packaging maintain physical properties and characteristics for intended use after transportation conditioning.	"The results of this study support the Transportation and Distribution Storage Qualification of the trays. The results of the qualification demonstrate that the non sterile product and packaging maintained physical properties and characteristics for intend use after transportation conditioning."
Verification Report Handle Weight Requirement (TR13-390)	Handle load requirements of ANSI/AAMI ST77:2006, Section 4.3.6.4 (b) are met, with test trays withstanding a 32-pound force without breaking free, permanent cracking, or deforming.	"The handle load requirements of ANSI/AAMI ST77:2006. Section 4.3.6.4 (b) are met. The test trays met the requirement of withstanding a 32 pound force without breaking free from the tray or permanently cracking or deforming."
Cool Down Time Validation (TR14-027)	Successful validation of the 118-minute cool down time for all listed video trays.	"This report documents the successful validation of the 118 minute cool down time for the VP1003, VP1005, VP1006, and VP1007 Video Trays."
Biological Evaluation (TR13-517)	Materials used in video trays demonstrate acceptable biocompatibility profile for intended use, do not pose a biological safety risk, and meet biological evaluation requirements of ISO 10993-1:2009 and FDA #G95-1.	"The materials used in the Video Trays have been tested and have demonstrated an acceptable biocompatibility profile for its intended use. It can be concluded that use of the Video Trays does not pose a biological safety risk as identified in the Preliminary Hazard Analysis. Based on these comprehensive tests, the benefits of the materials for the intended use outweigh the clinical risks. In conclusion, it was demonstrated that these devices meet the biological evaluation requirements of ISO 10993-1:2009 and FDA #G95-1."

2. Sample Size for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for each specific test (e.g., number of trays tested for sterilization, cleaning, etc.). It refers to "three half cycles" for sterilization qualification, which likely indicates a specific number of sterilization runs. The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective, beyond indicating that the studies were conducted by ConMed Corporation (the submitter).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This device (sterilization containers) is not a diagnostic or prognostic device that relies on expert interpretation of images or other subjective data to establish ground truth. The ground truth for this type of medical device is established through objective performance metrics and standardized test methods (e.g., sterilization efficacy, material compatibility, mechanical strength). Therefore, information regarding "number of experts" or their "qualifications" for establishing ground truth in the context of diagnostic interpretation is not applicable and not provided in the document.

4. Adjudication Method for the Test Set:

Adjudication methods like "2+1" or "3+1" are typically used in studies where there is subjective interpretation of data (e.g., reviewing medical images). For a device like a sterilization container, the tests involve objective measurements and established scientific protocols (e.g., sterility testing, material strength testing). Therefore, an explicit "adjudication method" in the sense of expert consensus on subjective findings is not applicable and not mentioned in the document. The studies were concluded based on whether the results met the predefined acceptance criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this device is a sterilization container, not a diagnostic or AI-assisted interpretation tool. The concept of "human readers improving with AI vs without AI assistance" is not relevant to this type of medical device.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study (algorithm only without human-in-the-loop performance) was not done. This device is a physical medical device (sterilization container), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not applicable.

7. Type of Ground Truth Used:

The ground truth used for these tests is based on objective performance metrics and established scientific and regulatory standards. This includes:

Sterility Assurance Level (SAL) of 10^-6: This is a widely accepted standard for demonstrating effective sterilization.
Material compatibility: Assessed against standards like ISO 10993 for biocompatibility.
Mechanical integrity: Measured against standards like ANSI/AAMI ST77 for handle load requirements.
Cleaning efficacy: Evaluated through validation studies to ensure effective removal of contaminants.
Physical property maintenance: Ensuring the product and packaging withstand transportation conditions.

These are not based on expert consensus on subjective findings, pathology, or outcomes data in the way a diagnostic device would be.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable to this device. This is a physical medical device, not a machine learning model or algorithm that requires training data. The studies conducted are verification and validation tests of the device's physical and functional properties.

9. How the Ground Truth for the Training Set Was Established:

Since there is no "training set" for this physical device, the question of how its ground truth was established is not applicable. The device's performance is evaluated against predetermined, objective criteria as detailed in section 7.

Summary

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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 RoadUtica, 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 OtherAccessories
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

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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 (Tray), VP1006 Video Arthroscope Tray (RADEL) and VP1007 Video Laparoscope Tray (RADEL) - were designed in accordance with 21 CFR 820.30

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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 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

لدم

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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.

For additional instrument trays specifications refer to the table below.

Model Name	VP1003	VP1005	VP1006	VP1007
	Video ExtendedLength Tray(RADELL)	Video Tray SingleLevel (RADEL)	Video ArthroscopeTray (RADEL)	VidcoLaparoscope 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 to48°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 x6.923 Width x1.695 Height	20.901 Length x9.715 Width x2.045 Height	12.110 Lengthx 3.150 Width x1.615 Height	17.253 Length x3.158 Width x1.615 Height
Lid	22.486 Length x7.000 Width x .910Height	20.921 Length x9.760 Width x 1.52Height	12.615 Length x3.225 Width x .75Height	17.295 Length x3.220 Width x .750Height
Assembled Unit	23 Lengthx 7.4 Widthx 2.2 Height	21.5 Lengthx 10.2 Widthx 3.2 Height	12.7 Lengthx 3.6 Widthx 2.0 Height	17.8 Length x 3.6Width x 2.0 Height
Stainless SteelHandles	2	2	N/A	N/A
Base Material	RADEL R-5100,Color Blue (PMS300)	RADEL R-5100,Color Blue (PMS300)	RADEL R-5100,Color Blue (PMS300)	RADEL R-5100,Color Blue (PMS300)
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

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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.

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21 CFR 807.92 (a)(6)

Comparison Table for Substantial Equivalence Table 1

510(k) Number	K133116	K122818
Proprietary Name	VP1003 Video ExtendedLength Tray (RADEL), VP1005Video Tray Single Level(RADEL), VP1006 VideoArthroscope Tray (RADEL).VP1007 Video LaparoscopeTray (RADEL)	Olympus MAJ-172 Instrument Trayfor LTF Videoscope
Original ApplicantName	ConMed CorporationViking SystemsUtica. NY	OlympusKeyMed.San Diego, CA
Submitter	ConMed CorporationViking SystemsUtica, NY	KeyMedEssex 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 NameClassification Name	Sterilization ContainerSterilization wrap, containers,trays, cassettes and otheraccessories	Sterilization ContainerSterilization 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

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21 CFR 807.92 (a) (6)

Comparison Table for Substantial Equivalence Table 2

K133116 Model Numbers	K122818	Differences
VP1003 Video ExtendedLength Tray (RADEL)VP1005 Video Tray SingleLevel (RADEL)VP1006 Video ArthroscopeTray (RADEL)VP1007 Video LaparoscopeTray (RADEL)	KeyMedOlympus MAJ-172Instrument Tray for LTFVideoscope
The model numbers listedabove are intended to be usedto enclose ConMed medicaldevices including handinstruments, trocars, cameraheads, adapters, endoscopes.light guides, and bridgesystems to steam sterilize theenclosed medical devices by ahealth care provider.	The Olympus MAJ-172Instrument Tray for LTFVideoscopes is intended tobe used to enclose Olympusmedical devices includinghand instruments. trocars.camera heads. adapters, andendoscopes to be sterilizedby a health care provider.	The only difference isConMed product vsOlympus product.
	It is intended to allow steamor ethylene oxidesterilization of the enclosedmedical device.	K133116 is steam only
The model numbers listedabove are used for loadingsurgical instruments in or toconveniently organize,sterilize, and transport andstore the instruments betweenuses.	The Olympus MAJ-172Instrument Tray for LTFVideoscope is designed tosecure and store a singlevideoscope and itsaccessories for sterilizationat a healthcare facility.	K122818 is only for onevideoscope andaccessories.K133116 is for multipleConMed products andaccessories.
VP1003 Video ExtendedLength Tray (RADEL).Method: Steam (Wrapped);Cycle: Pre-vacuum:Temperature: 270degF(132degC); Exposure: 4minutes; Dry Cycle: 35	Steam Sterilization:Vacuum: 0.016 MPaminimumPressure: 0.101 MPaminimumTemperature: 135 deg CExposure Time: 3 minutes	K133116Temp 132degCExposure 4 minDry 35 minK122818Temp 135degCExposure 3 min

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minutes: Maximum Load:3.9lbs (1.8kg); MaximumDensity: 0.069lb/in3(1.91gm/cm3)	Drying Time: 20 minutes	Dry 20 min
VP1005 Video Tray SingleLevel (RADEL), Method:Steam (Wrapped); Cycle: Pre-vacuum; Temperature:270degF (132degC);Exposure: 4 minutes; DryCycle: 40 minutes; MaximumLoad: 8.0lbs (3.6kg);Maximum Density:0.094lb/in3 (2.60gm/cm3)	Steam Sterilization:Vacuum: 0.016 MPaminimumPressure: 0.101 MPaminimumTemperature: 135 deg CExposure Time: 3 minutesDrying Time: 20 minutes	K133116Temp 132degCExposure 4 minDry 40 minK122818Temp 135degCExposure 3 minDry 20 min
VP1006 Video ArthroscopeTray (RADEL), Method:Steam (Wrapped); Cycle: Pre-vacuum: Temperature:270degF (132degC);Exposure: 4 minutes; DryCycle: 15 minutes; MaximumLoad: 1.1lbs (0.5kg):Maximum Density:0.064lb/in3 (1.77gm/cm3)	Steam Sterilization:Vacuum: 0.016 MPaminimumPressure: 0.101 MPaminimumTemperature: 135 deg CExposure Time: 3 minutesDrying Time: 20 minutes	K133116Temp 132degCExposure 4 minDry 15 minK122818Temp 135degCExposure 3 minDry 20 min
VP1007 Video LaparoscopeTray (RADEL), Method:Steam (Wrapped); Cycle: Pre-vacuum: Temperature:270degF (132degC): Exp: 4minutes: Dry Cycle: 25minutes; Maximum Load:1.7lbs (0.8kg); Max Density:0.077lb/in3 (2.13gm/cm).	Steam Sterilization:Vacuum: 0.016 MPaminimumPressure: 0.101 MPaminimumTemperature: 135 deg CExposure Time: 3 minutesDrying Time: 20 minutes	K133116Temp 132degCExposure 4 minDry 25 minK122818Temp 135degCExposure 3 minDry 20 min

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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 devicesfor reusable medical devicesterilization	Not stated in the summary
	ISO 10993-1 "BiologicalEvaluation of MedicalDevices - Part 1:Evaluation and Testingwithin a Risk ManagementProcess"	Not stated in the summary
	FDA #G95-1 "Use ofInternational StandardsSeries 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 nonsterile	The device is sold nonsterile
Cleaning Studies	ConMed Report CL227Cleaning Validation	Not stated in the summary
Environmental Studies	ConMed Report TR13-390Verification Report HandleWeight RequirementANSI/AAMI ST77:2006	Not stated in the summary
Transportation Studies	ConMed Report TR13-050TransportationQualification	Simulated tests included usetests, drop testing resistanceto chemical, cleaning, steamsterilization
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

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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

TR13-707RiskManagementReport	Conclusion: Throughout the design process, various mitigations andcontrol methods have been identified and applied to the device(s),including safety mechanisms that address concerns identified inrelevant post-market surveillance. These have been verified orvalidated to demonstrate that the risks have been reduced as far asreasonably practicable and the device(s) perform as intended by theestablished design requirements. This report confirms that the RiskManagement Plan has been appropriately implemented and thatmethods are in place to obtain relevant production and post-productioninformation. The risks associated with the use of these devicesconstitute acceptable risks when weighed against the benefits to thepatient and are compatible with high level of protection of health andsafety. It has been determined that the overall residual risk isacceptable.
TR12-343SteamSterilizationQualificationVP1003 VideoExtendedLength Tray	Conclusion: Results of the three half cycles demonstrate the testedcycle imparts sufficient lethality to produce an SAL of 10-6 at twice thehalf cycle exposure duration (full cycle) when the full tray is sterilizedin 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-007Protocol were met.
TR12-345SteamSterilizationQualificationVP1005 VideoTray SingleLevel	Conclusion: Results of the three half cycles demonstrate the testedcycle imparts sufficient lethality to produce an SAL of 10-6 at twice thehalf cycle exposure duration (full cycle) when the full tray is sterilizedin 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-010Protocol were met.
TR12-346SteamSterilizationQualificationVP1006 VideoArthroscopeTray	Conclusion: Results of the three half cycles demonstrate the testedcycle imparts sufficient lethality to produce an SAL of 10-6 at twice thehalf cycle exposure duration (full cycle) when the full tray is sterilizedin 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-008Protocol were met.
TR12-347SteamSterilizationQualification	Conclusion: Results of the three half cycles demonstrate the testedcycle imparts sufficient lethality to produce an SAL of 10-6 at twice thehalf cycle exposure duration (full cycle) when the full tray is sterilizedin accordance with the cycle type, temperature, exposure time,configuration and placement within the chamber tested in this study

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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.

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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.

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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

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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 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

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.

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Indications for Use Statement

Model Name	VP1003	VP1005	VP1006	VP1007
	Video ExtendedLength Tray(RADEL)	Video Tray SingleLevel (RADEL)	Video ArthroscopeTray (RADEL)	VideoLaparoscope 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 to48°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 x6.923 Width x1.695 Height	20.901 Length x9.715 Width x2.045 Height	12.110 Lengthx 3.150 Width x1.615 Height	17.253 Length x3.158 Width x1.615 Height
Lid	22.486 Length x7.000 Width x .910Height	20.921 Length x9.760 Width x 1.52Height	12.615 Length x3.225 Width x .75Height	17.295 Length x3.220 Width x .750Height
Assembled Unit	23 Lengthx 7.4 Widthx 2.2 Height	21.5 Lengthx 10.2 Widthx 3.2 Height	12.7 Lengthx 3.6 Widthx 2.0 Height	17.8 Length x 3.6Width x 2.0 Height
Stainless SteelHandles	2	2	N/A	N/A
Base Material	RADEL R-5100.Color Blue (PMS300)	RADEL R-5100.Color Blue (PMS300)	RADEL. R-5100.Color Blue (PMS300)	RADEL R-5100.Color Blue (PMS300)
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'

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
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.(b)
Classification. Class II (performance standards).