Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly define the device as a physical tray for organizing and sterilizing surgical instruments. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies focus on physical properties, sterilization efficacy, and biocompatibility.

Therapeutic

No

The device is an instrument tray used to organize, sterilize, transport, and store medical instruments, not to treat or diagnose a disease or condition.

Diagnostic

No

Explanation: The device, "Video Trays," is intended for organizing, sterilizing, transporting, and storing surgical instruments. It does not perform any diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description clearly states that the device is constructed of RADEL, a physical material, and describes its physical properties and testing related to those properties (e.g., steam sterilization, cleaning, transportation, handle weight). This indicates it is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the trays are used for "loading surgical instruments in or to conveniently organize, sterilize, transport and store the instruments between uses." This describes a device used in the process of preparing and handling surgical instruments, not a device used to perform tests on specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
Device Description: The description focuses on the physical construction and materials of the trays, their compatibility with sterilization processes, and their ability to hold instruments. This aligns with a device used for instrument management, not for in vitro diagnostic testing.
Lack of IVD characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing diagnostic information
- Reagents or calibrators

The device's function is entirely focused on the physical handling and sterilization of surgical instruments.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

KCT

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.

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Health Care Provider

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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 VP1007 Video Laparoscope 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-009 Protocol were met.

TR13-121 Cleaning Validation: Conclusion: 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 Video Extended Length Tray, VP1005 Video Tray Single Level, VP1006 Video Arthroscope Tray, VP1007 Video Laparoscope Tray.

TR13-050 Transportation Qualification: Conclusion: 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.

TR13-390 Verification Report Handle Weight Requirement: Conclusion: 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.

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 Application of ISO 10993 and FDA #G95-1 in the Biological Evaluation of Video Trays: Conclusion: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K122818

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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

```
    | RADEL R-5100,
```

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

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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

.

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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

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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

.

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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

| TR13-707
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

```
    | RADEL R-5100.
```

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'