Used to enclose another medical device that is to be sterilized. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the device until used. ArjoRad Sterilization Wraps will maintain sterility for a maximum period of thirty (30) days. Intended for use with STERRAD 100S, NX, and 100NX Systems.

Device Description

ArjoRad Sterilization Wrap is a sterilization packaging system consisting of one SMS sheet to be double wrapped during use. ArjoRad Sterilization Wrap will be sold in a non-sterile condition in packaged form of various sizes depending on the needs of the end user.

AI/ML Overview

The ArjoRad Sterilization Wrap is a sterilization packaging system. The performance testing detailed in the provided 510(k) summary demonstrates its substantial equivalence to the predicate device (K092167 - Kimguard one step sterilization wrap - Kimberly - Clark Corporation) and its ability to meet acceptance criteria for maintaining sterility and allowing sterilant penetration.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Device Performance (ArjoRad Sterilization Wrap)	Predicate Device (K092167)	Test Standard/Method	Outcome/Proof
Physical Protection/Strength Properties			EN 868-2:2009, ASTM D737
Substance Weight	Meets minimum requirements; specific values not provided.	Not detailed	Not detailed	ArjoRad meets criteria for non-woven sterilization wrap.
Strip Tensile Strength	Higher than predicate sterilization wrap.	Lower than ArjoRad	Not detailed	ArjoRad performs better or equally.
Mullen Burst	Higher than predicate sterilization wrap.	Lower than ArjoRad	Not detailed	ArjoRad performs better or equally.
Elmendorf Tear	Higher than predicate sterilization wrap.	Lower than ArjoRad	Not detailed	ArjoRad performs better or equally.
Air Permeability	Meets acceptance criteria after sterilization.	Not detailed	ASTM D737	ArjoRad meets minimum requirement level.
Sterile Barrier Integrity
Germ Resistance (after H2O2 sterilization)	Demonstrated germ resistance.	Demonstrated germ resistance	Microbial Aerosol Challenge Test	ArjoRad shows similar germ resistance to predicate.
Maintenance of Sterility	Maintains sterility for 30 days.	Maintains sterility for 30 days	Shelf Life Study	ArjoRad is a sterile barrier system capable of 30-day sterility (if barrier not compromised).
Sterilant Penetration/Efficacy
Sterilization Efficacy (STERRAD cycles)	Assures a Sterility Assurance Level (SAL) of 10^-6 after each half cycle tested.	Performed similarly	Sterilization Efficacy Studies	Demonstrated successful penetration and sterilization across various STERRAD systems.

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

The document does not explicitly state the specific "sample size" in terms of number of wraps tested for each physical property or sterility test. However, it implicitly refers to "performance testing" and "studies" being carried out.

Data Provenance: The studies were conducted by Arjo Wiggins Medical to demonstrate substantial equivalence to a legally marketed predicate device (Kimguard one step sterilization wrap). The testing would typically be performed in a controlled laboratory setting. No country of origin for data is specified, but it originates from the manufacturer for submission to the US FDA. The studies are prospective in nature, designed specifically to evaluate the performance of the ArjoRad Sterilization Wrap against established standards and a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the summary. For a physical device like sterilization wrap, "ground truth" is typically established through adherence to recognized international standards (e.g., EN, ASTM) and validated test methodologies rather than expert consensus on a test set in the way a diagnostic algorithm might require. The "experts" would be the scientists and engineers conducting the tests in accordance with these standards.

4. Adjudication Method for the Test Set

This concept is not applicable in the context of testing a physical device like sterilization wrap. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers when establishing ground truth for diagnostic studies, particularly in medical imaging. For device performance testing, results are determined by objective measurements against predefined acceptance criteria from standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the device is a sterilization wrap, not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical sterilization wrap, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance of the ArjoRad Sterilization Wrap is based on:

Objective Measurements against Industry Standards: Physical properties (tensile strength, burst, tear, air permeability) are measured against criteria defined in standards like EN 868-2:2009 and ASTM D737.
Validated Test Methodologies: Microbial aerosol challenge tests and sterilization efficacy studies follow validated protocols to demonstrate germ resistance and sterility assurance levels (SAL).
Comparability to Predicate Device: The performance data is explicitly compared to a legally marketed predicate device (K092167) to establish substantial equivalence.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical product and does not involve a "training set" in the context of machine learning or AI algorithms.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reason as above (not an AI/ML device). The "ground truth" for the development and validation of the sterilization wrap would involve materials science, engineering principles, and adherence to regulatory and industry standards for medical device manufacturing and sterilization.

Summary

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510(k) SUMMARY (as required by 807.92(c))

AUG 2 4 2012

ਨ

Regulatory and Marketing Services, Inc. Regulatory Correspondent: 962 Allegro Lane Apollo Beach, FL 33572 Jonathan Ward wardip@ajwtech.com 813-645-2855 813-677-4787

Submitter of 510(k):

Arjo Wiggins Medical 1301 Charleston Regional Parkway, Suite 500 Charleston, SC 29492 Patrick Ritchie PRitchie@arjomedical.com

August 17, 2012 Date of Summary:

Trade/Proprietary Name:

Classification Name:

Product Code:

Device Description:

Sterilization Wrap

FRG

ArjoRad Sterilization Wrap

Intended Use: -

Cycle	RecommendedInstrumentConfiguration	Inside Diameter	Length	RecommendedIndividualTray Load Weight	Number of Lumens perValidation Load	Cycle Length
STERRAD 100S	Stainless Steel Lumens	3 mm	400 mm	9.1 lbs	2 trays, 5 lumens each	55 minutes
STERRAD NXStandard	Single Channel PTFELumens	1 mm	150 mm	10.7 lbs	10 lumens	28 minutes
STERRAD NXAdvanced	Single ChannelFlexible Endoscope	1.2 mm	845 mm	10.7 lbs	1 endoscope	38 minutes
	Stainless SteelLumens	1 mm	500 mm		10 lumens
STERRAD100NXStandard	Stainless SteelLumens	0.7 mm	500 mm	10.7 lbs	2 trays, 5 lumens each	47 minutes
STERRAD 100NX Flex	Single ChannelFlexible Endoscope(s)	1.2 mm1.2 mm	830 mm840 mm	6.4 lbs	2 trays, 1 endoscope pertray	42 minutes
STERRAD 100NX Express	Stainless SteelSurfaces(2mm x 8mm)	N/A	N/A	10.7 lbs	N/A	24 minutes

510(k) Summary

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Predicate Device:

K092167 - Kimguard one step sterilization wrap - Kimberly - Clark Corporation

Substantial Equivalence:

The subject wraps have the same fundamental technological characteristics as the predicate device(s). Performance testing between the predicate device and the subject device have verified substantial equivalence in design, materials and intended use, and confirmed there are no significant differences between the proposed and predicate devices that raise new questions of safety or efficacy.

Performance Testing:

The intended use is to contain medical devices and to maintain sterility. Physical protection is consequently needed during the handling of non-sterile product. It is controlled with following performance testing: substance weight, strip tensile strength, Mullen burst and Elmendorf tear. Arjorad developed higher tensile strength and burst and tearing strength than predicate sterilization wrap. In addition ArjoRad meets the acceptance criteria with regard to the minimum requirement for strength properties dedicated to non-woven sterilization wrap. When applied to the minimum performance level, the properties of ArjoRad still meet the criteria of acceptation after sterilization which equals the minimum requirement level for sterilization wrap defined according to EN 868-2:2009 and ASTM D737: Standard Test Method for Air Permeability of Textile Fabrics.

During microbial aerosol challenge test, similarly to predicate, ArjoRad demonstrated germ resistance after hydrogen peroxide sterilization cycle. The microbial aerosol challenge test and the shelf life study demonstrate that, the subject wrap is considered as a sterile barrier system that is capable to maintaining sterility for 30 days after sterilization, as long as the sterile barrier is not compromised in any way.

The ability to let the sterilant penetrate has been validated as well. This was demonstrated by sterilization efficacy studies after different cycles of STERRAD hydrogen peroxide gas plasma sterilization. Studies carried out demonstrated that Arjorad can assure an SAL of 10 after each half cycle tested.

Conclusion: The minor differences between the proposed and predicate devices do not introduce new issues of safety and efficacy. The ArjoRad Sterilization Wrap is substantially equivalent to the predicates in that it meets all of the requirements for use in a STERRAD 100S, NX and 100NX Systems. All testing performed indicates that the ArjoRad Sterilization Wrap will provide a sterile barrier for use in the STERRAD device. There are a series of detailed Comparison Tables for testing results included in Section 18 Performance Testing, which was completed by comparing the ArjoRad Sterilization Wrap against the primary predicate device. The KC300 sterilization wrap chosen as a test predicate has been cleared for low temperature V-Pro sterilization, the comparative performance data demonstrates that the proposed device performs equally or better than the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings, rendered in black. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the bird.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002

Arjo Wiggins Medical, Incorporated C/O Mr. Jonathan Ward President Regulatory and Marketing Services, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572

Re: K110954

Trade/Device Name: ArjoRad Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: August 17, 2012 Received: August 22, 2012

Dear Mr. Ward:

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.

AUG 2 4 2012

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Page 2- Mr. Ward

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

For

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K110954

Device Name: ArjoRad Sterilization Wrap

Used to enclose another medical device that is to be sterilized. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the device until used. ArjoRad Of the choose will maintain sterility for a maximum period of thirty (30) days. Intended for use with STERRAD 100S, NX, and 100NX Systems

Cycle	RecommendedInstrumentConfiguration	InsideDiameter	Length	RecommendedIndividualTray Load Weight	Number of LumensperValidation Load	Cycle Length
STERRAD 100S	Stainless Steel Lumens	3 mm	400 mm	9.1 lbs	2 trays, 5 lumens each	55 minutes
STERRADNXStandard	Single ChannelPTFE Lumens	1 mm	150 mm	10.7 lbs	10 lumens	28 minutes
STERRADNX Advanced	Single ChannelFlexible Endoscope	1.2 mm	845 mm	10.7 lbs	1 endoscope	38 minutes
	Stainless SteelLumens	1 mm	500 mm		10 lumens
STERRAD100NXStandard	Stainless SteelLumens	0.7 mm	500 mm	10.7 lbs	2 trays, 5 lumens each	47 minutes
STERRAD100 NX Flex	Single ChannelFlexibleEndoscope(s)	1.2 mm1.2 mm	830 mm840 mm	6.4 lbs	2 trays, 1 endoscopeper tray	42 minutes
STERRAD100 NXExpress	Stainless SteelSurfaces(2mm x 8mm)	N/A	N/A	10.7 lbs	N/A	24 minutes

Sterilization Loads

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X AND/OR (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mau' Smith (Attorney)

(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices

510(k) Number: K110454

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).