Sterisheet Sterilization Wraps are single use non-woven sterilization wraps intended to enclose medical devices that are to be sterilized at a healthcare facility. They are used in 3-hour and 6hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

Device Description

Sterisheet Sterilization Wraps are single use, non-sterilyzation wraps constructed from cellulose, synthetic fibers (polypropylene), and synthetic binders, with the addition of pigmentation. They are used to enclose medical devices that are to be sterilized by a healthcare provider in 3-hour and 6-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Devices must be wrapped following manufacturer's instructions. After completion of the sterilization process. Sterisheet Sterilization Wraps maintain sterility of the enclosed medical devices for 6 month.

AN85 EO Indicators, when placed on the outside of the sterilization wraps, may be used to secure the wrapping material on the devices and to indicate ethylene oxide exposure, offering a convenient way to verify processing in the sterilization cycle. The color of the AN85 EO Indicators changes from yellow-green to blue after exposure to ethylene oxide.

AI/ML Overview

The information provided describes the acceptance criteria and a summary of non-clinical testing for the Sterisheet Sterilization Wrap (K200335), which is intended for use in a 6-hour ethylene oxide (EO) gas sterilization cycle.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Test	Purpose	Acceptance Criteria	Reported Device Performance
Compliance to ISO 11607-1
Physical and Chemical Properties	To evaluate the package integrity after EO sterilization	Various standards for various properties (e.g., ISO 536 for Substance, ISO 5636-3 for Permeability, EN 868-2 for Fluorescence and Water repellency)	There was no effect on the physical and chemical properties after EO sterilization.
Bacterial Filtration Efficiency and Germ Proofness dry and wet challenge test	To demonstrate that Sterisheet provide a microbial barrier property	Bacterial Filtration Efficiency (ASTM F2101); Germ Proofness dry and wet challenge test (DIN 58953-6)	Sterisheet passed all tests and were effective for sterility assurance pre- and post-EO sterilization.
Material Compatibility	To demonstrate Sterisheet is suitable for use in EO sterilization processes and the associated cycle parameters	The physical, chemical, and microbial barrier properties of Sterisheet are compatible for intended use in EO sterilization per ISO 10993 and USP	The ability of the wraps to act as a microbial barrier was unaffected, and the contents of the packs remained sterile after EO sterilization.
Biocompatibility	To demonstrate that Sterisheet provides reasonable assurance for safety	Biological evaluation (MEM Elution, Sensitization and Irritation Test) per ISO 10993 and USP	Not direct patient-contacting devices; Biological evaluation Showed that Sterisheet met all accepted performance criteria for non-toxicity. No pigment leaches out of Sterisheet during 6-hour EO exposures. With an additional 6-hour aeration, the residual EO detected in Sterisheet met ISO 10993-7 requirements.
Shelf Life	To evaluate the physical, chemical, and microbial barrier of the processed Sterisheet at the end of the claimed shelf life	Stability demonstrates reasonable assurance for effectiveness	The physical, chemical, and microbial barrier properties of the wraps were verified at the end of 5 years and met specifications.
Performance in the 6-hour Gas exposure in the EOGas 4 Ethylene Oxide Gas Sterilizer
Sterilant Penetration	To demonstrate Sterisheet allow sterilization of the wrapped devices in half dose, full dose, simulated-use and in-use testing	Inactivation of 6-Log biological indicators at the worst-case location in the endoscope load wrapped in the Sterisheet for all the testing performed	Data demonstrate that Sterisheet Sterilization Wraps allow penetration of EO and sterilization of the enclosed devices.
Maintenance of Package Sterility	To demonstrate Sterisheet maintain sterility of the enclosed medical device	The sterilized devices wrapped in Sterisheet remain sterile	Sterility was maintained for 6 months after processing in Sterisheet wrapped endoscopes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists "Performance Testing" and "Summary of bench tests" but does not provide details on specific sample sizes for these tests. It indicates that the tests conform to ISO 11607-1, ASTM F2101, DIN 58953-6, ISO 10993, and USP standards. These are bench-level tests (non-clinical) and do not involve human subjects or geographical data provenance in the typical sense. The testing was conducted to prove the performance of the wrap itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the study described is a non-clinical performance evaluation of a sterilization wrap, not a diagnostic device relying on expert interpretation for ground truth. The "ground truth" here is the outcome of standardized physical, chemical, and biological tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the tests are objective laboratory tests rather than subjective assessments requiring adjudication.

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 information is not applicable as MRMC studies are relevant for diagnostic tools, particularly those involving human interpretation of medical images or data, often with AI assistance. The Sterisheet Sterilization Wrap is a medical device for sterilization, not a diagnostic or AI-powered interpretative tool.

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

This information is not applicable for the same reasons as above. The device is not an algorithm. The "standalone" performance here refers to the wrap's inherent ability to function as a microbial barrier and allow sterilant penetration.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the non-clinical tests is established through objective laboratory measurements and validated biological indicators. For example:

Physical and Chemical Properties: Measured values against established standards (e.g., ISO for substance, permeability).
Bacterial Filtration Efficiency and Germ Proofness: Efficacy in preventing microbial passage according to ASTM and DIN standards.
Material Compatibility: Physical, chemical, and microbial barrier properties remaining acceptable after EO exposure.
Biocompatibility: Absence of toxicity per ISO 10993 and USP (MEM Elution, Sensitization, Irritation).
Sterilant Penetration: Inactivation of 6-Log biological indicators.
Maintenance of Package Sterility: Absence of microorganism growth after storage.

8. The sample size for the training set

This information is not applicable. The Sterisheet Sterilization Wrap is not an AI/ML device that requires a "training set." The tests are empirical demonstrations of its physical, chemical, and biological performance.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 12, 2020

Andersen Sterilizers, Inc. William Andersen President 3154 Caroline Drive Haw River, North Carolina 27258

Re: K200335

Trade/Device Name: Sterisheet Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: October 8, 2020 Received: October 13, 2020

Dear William Andersen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

CAPT Elizabeth Claverie, MS Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200335

Device Name Sterisheet Sterilization Wrap

Indications for Use (Describe)

Sterisheet Sterilization Wraps are single use non-woven sterilization wraps intended to enclose medical devices that are to be sterilized at a healthcare facility. They are used in 3-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

Critical process parameters for the cycle are summarized in Table 1.

Table 1. Critical sterilization cycle parameters in the EOGas 4 Ethylene Oxide Gas Sterilizer

Ethylene Oxide	Temperature	Relative Humidity	EO Exposure Time	Total Cycle Time
17.6 g ± 5%	50°C ± 3°C	35-70%	3 hours	3.5 hours
			6 hours	7 hours

The EOGas 4 Ethylene Oxide Gas Sterilizer 3-hour gas exposure is used for surface sterilization of medical devices, including instruments with diffusion-restricted spaces (hinges or mated surfaces), as well as for the sterilization of endoscopes working length shorter than 1100 mm as specified in the sterilizer labeling.

The EOGas 4 Ethylene Oxide Gas Sterilizer 6-hour gas exposure is used for sterilization of duodenoscopes and colonoscopes with working length longer than 1100 mm as specified in the sterilizer labeling.

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Table 2. Load and material types validated in the EOGas 4 Ethylene Oxide Gas Sterilizer
Device Type	Maximum Load	Device Examples	Required Aeration
	3-Hour EO Exposure, EOGas 4 SteriTest PCD (Blue Purge Probe)
Metal	24 lbs (11 kg)	Surgical instruments,delicate sharps,including those withhinges and matedsurfaces	No additional aerationrequired;Follow pouch or wrapmanufacturer'sinstructions (Example: Tyvepouches require ≥ 6 hoursat 50°C)
Plastic	7.0 lbs (3.2 kg)	Reusable power cords,trocars, and similardevices	24 hours at 50°C;Follow manufacturer'sinstructions
Fabric	6.1 lbs (2.8 kg)	Reusable cloth gowns,towels, and similar devices
≤ 1100 mmWorkingLumenLengthEndoscopes	One (1)≥ 2.0 mm ID biopsy channel≤ 1100 mm working length	Gastrovideoscopes,gastrointestinal videoscopes,and similar devices	8 hours at 50°C;Follow manufacturer'sinstructions
LengthEndoscopes	Four (4)≥ 1.2 mm ID biopsy channel≤ 700 mm working length	Bronchoscopes,bronchovideoscopes, cystoscopes,ureteroscopes, choledocoscopes,and similar devices

6-Hour EO Exposure, EOGas 4 Endo-SteriTest PCD (Gold Purge Probe)

>1100 mm	Two (2) Duodenoscopes*	Olympus TJF-Q180V,	6 hours at 50°C for
Working	≥ 2.0 mm ID biopsy channel	Olympus TJF-Q160VF,	Olympus and Pentax
Lumen	≤ 1250 mm working length	Olympus TJF-Q190V,	endoscopes in Sterisheet
Length	≥ 1.2 mm ID, ≤ 3530 mmmaximum length of anychannel	Olympus PJF-160,Fujifilm ED-530XT,Pentax ED34-i10T2,Pentax ED-3490TK	8 hours at 50°C forFujifilm endoscopesin Sterisheet
Endoscopes	Two (2) Colonoscopes*	Olympus CF-Q180AL,	Follow manufacturer's
	≥ 3.7 mm ID biopsy channel	Fujifilm EC-600HL,	instructions
	≤ 1700 mm working length	Pentax EC-3490Li
	≥ 1.2 mm ID, ≤ 3530 mmmaximum length of any channel

One (1) duodenoscope may also be paired with one (1) colonoscope

After completion of the EOGas 4 sterilization process, sterility is months in Sterisheet sterilization wraps.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	区 Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary K200335

Applicant's Name and Address

Andersen Sterilizers, Inc. Establishment Registration Number 3004634710 3154 Caroline Drive Haw River, NC 27258

Contact Person

William K. Andersen, BE, MD, FAAOS President Phone: 336-376-8622, Fax: 336-376-5428

Date of Preparation

October 8, 2020

Device

Proprietary Name Common Name Classification Product Code

Sterisheet Sterilization Wrap Sterilization Wrap Class II (21 CFR 880.6850) FRG

Predicate Device

Device Name	Sterisheet Sterilization Wrap
510(k) number	K152291
Manufacturer	Arjowiggins Medical Inc.

The predicate Sterilization Wrap (K152291) was cleared for use in 3-hour gas exposures in the EOGas 4 Ethylene Oxide Gas Sterilization system manufactured by Andersen Sterilizers, Inc.

The 510(k) submission modifies the indications for use of the predicate device in order to include it as an accessory for 6-hour gas exposures in the EOGas 4 Ethylene Oxide Gas Sterilization system manufactured by Andersen Sterilizers, Inc. No modifications were made to the manufacturing method, technology, or intended use.

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Device Description

Indications for Use

Ethylene Oxide	Temperature	RelativeHumidity	Ethylene OxideExposure Time	Total Cycle Time
17.6 g ± 5%	50°C ± 3°C	35-90%	3 hours	3.5 hours
			6 hours	7 hours

Table 5-1. Critical sterilization cycle parameters in the EOGas 4 Ethylene Oxide Gas Sterilizer

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Device Type	Maximum Load	Device Examples	Required Aeration
3-Hour EO Exposure, EOGas 4 SteriTest PCD (Blue Purge Probe)
Metal	24 lbs(11 kg)	Surgical instruments,delicate sharps,including those withhinges and matedsurfaces	No additional aerationrequired;Follow pouch or wrapmanufacturer'sinstructions (Example:Tyvek pouches require≥ 6 hours at 50°C)
Plastic	7.0 lbs(3.2 kg)	Reusable power cords,trocars, and similardevices	24 hours at 50°C;
Fabric	6.1 lbs(2.8 kg)	Reusable cloth gowns,towels, and similardevices	Follow manufacturer'sinstructions
≤ 1100 mmWorkingLumenLengthEndoscopes	One (1)≥ 2.0 mm ID biopsy channel≤ 1100 mm working length	Gastrovideoscopes,gastrointestinalvideoscopes, and similardevices	8 hours at 50°C if inSterisheet;
	Four (4)≥ 1.2 mm ID biopsy channel≤ 700 mm working length	Bronchoscopes,bronchovideoscopes,cystoscopes,ureteroscopes,choledocoscopes, andsimilar devices	Follow manufacturer'sinstructions
6-Hour EO Exposure, EOGas 4 Endo-SteriTest PCD (Gold Purge Probe)
>1100 mmWorkingLumenLengthEndoscopes	Two (2) Duodenoscopes ≥ 2.0 mm ID biopsy channel≤ 1250 mm working length≥ 1.2 mm ID, ≤ 3530 mmmaximum length of any channelTwo (2) Colonoscopes ≥ 3.7 mm ID biopsy channel≤ 1700 mm working length≥ 1.2 mm ID, ≤ 3530 mmmaximum length of any channel	Olympus TJF-Q180V,Olympus TJF-Q160VF,Olympus TJF-Q190V,Olympus PJF-160,Fujifilm ED-530XT,Pentax ED34-i10T2Pentax ED-3490TKOlympus CF-Q180AL,Fujifilm EC-600HL,Pentax EC-3490Li	6 hours at 50°C forOlympus and Pentaxendoscopes inSterisheet;8 hours at 50°C forFujifilm endoscopes inSterisheet;Follow manufacturer'sinstructions
	* One (1) duodenoscope may also be paired with one (1)colonoscope

Table 5- 2. Load and material types validated in the EOGas 4 Ethylene Oxide Gas Sterilizer

After completion of the EOGas 4 sterilization process, sterility is maintained for 6 months in Sterisheet sterilization wraps.

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Technological Characteristics Comparison

The technological characteristics of the subject Sterilization Wraps are identical to the predicate device (K152291) - both are intended for the same use, use the same technology, and are designed in the same way.

The only difference between the subject Sterilization Wrap and the predicate device is the sterilization cycle for which the subject Sterisheet Sterilization Wrap is indicated.. A comparison between the devices is listed in Table 5-3.

Elements	Predicate Sterisheet SterilizationWraps (K152291)	Subject Sterisheet SterilizationWraps (K200335)	Remarks
Manufacturer	Arjowiggins Healthcare	Arjowiggins Healthcare	Same
Intended Use	To enclose medical devices, allowsterilization of the encloseddevices, and maintain sterility ofthe enclosed devices	Identical	Identical
Indications forUse	Sterisheet Sterilization Wraps aresingle use non-woven sterilizationwraps intended to enclose medicaldevices that are to be sterilized at ahealthcare facility. They are usedin 3-hour gas exposures at 50°C inthe EOGas 4 Ethylene Oxide GasSterilizer.	Sterisheet Sterilization Wrapsare single use non-wovensterilization wraps intended toenclose medical devices that areto be sterilized at a healthcarefacility. They are used in 3-hourand 6-hour gas exposures at50°C in the EOGas 4 EthyleneOxide Gas Sterilizer.	Similar
SterilizationCycle Time	3-hour gas exposure	3-hour and 6-hour gas exposure	Different
Materials	Cellulose, synthetic fibers(polypropylene), and syntheticbinders	Identical	Identical
Design	Cellulose allows EO to passthrough the wrap but preventsmicroorganisms from crossingthrough the wrap, providing amicrobial barrier for the wrappeddevices after sterilization;Synthetic fibers increasemechanical resistance;Synthetic binders enhancedrapeability, strength, softness, andfluid repellency	Identical	Identical
Wrap Shape	Square or rectangular	Identical	Identical
Configuration inLoad	Double sequential envelope wrap isrecommended	Identical	Identical
Shelf Life	5 years from date of manufacture	Identical	Identical
Aeration Time	$\ge$ 6 hours	$\ge$ 6 hours	Similar
SterilityMaintenance	3 months after cycle	6 months after cycle	Similar

Table 5-3. Device Comparison

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Summary of Non-Clinical Testing

Performance Testing

Sterisheet Sterilization Wraps conform to all applicable requirements for packaging for terminally sterilized medical devices for EO sterilization, based on ISO 11607-1. Performance testing was conducted to show that Sterisheet Sterilization Wraps perform as intended to allow sterilization and maintain sterility of the enclosed medical device. Sterilization efficacy testing demonstrated a sterility assurance level of 106 using the half dose validation method under worst-case conditions. Shelf life studies demonstrated after completion of the EOGas 4 sterilization process, sterility is maintained for 6 months. The performance of Sterisheet Sterilization Wraps is summarized in Table 5-4.

Table 5-4. Summary of bench tests performed to demonstrate safety and effectiveness of Sterisheet Sterilization Wraps

Test	Purpose	Acceptance Criteria	Results
Compliance to ISO 11607-1
Physical andChemicalProperties	To evaluate thepackage integrityafter EO sterilization	Various standards forvarious properties. Forexample, ISO 536 forSubstance, ISO 5636-3for Permeability, EN868-2 for Fluorescenceand Water repellency	There was no effect on thephysical and chemical propertiesafter EO sterilization.
Bacterial FiltrationEfficiency andGerm Proofnessdry and wetchallenge test	To demonstrate thatSterisheet provide amicrobial barrierproperty	Bacterial FiltrationEfficiency (ASTMF2101)Germ Proofness dry andwet challenge test (DIN58953-6)	Sterisheet passed all tests andwere effective for sterilityassurance pre- and post-EOsterilization.
MaterialCompatibility	To demonstrateSterisheet is suitablefor use in EOsterilizationprocesses and theassociated cycleparameters	The physical, chemical,and microbial barrierproperties of Sterisheetare compatible forintended use in EOsterilization per ISO10993 and USP	The ability of the wraps to act as amicrobial barrier was unaffected,and the contents of the packsremained sterile after EOsterilization

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Test	Purpose	Acceptance Criteria	Results
Biocompatibility	To demonstrate thatSterisheet providesreasonable assurancefor safety	Biological evaluation(MEM Elution,Sensitization andIrritation Test) per ISO10993 and USP	Not direct patient-contactingdevices;Biological evaluation Showed thatSterisheet met all acceptedperformance criteria for non-toxicity.No pigment leaches out ofSterisheet during 6-hour EOexposures.With an additional 6-houraeration, the residual EO detectedin Sterisheet met ISO 10993-7requirements.
Shelf Life	To evaluate thephysical, chemical,and microbial barrierof the processedSterisheet at the endof the claimed shelflife	Stability demonstratesreasonable assurance foreffectiveness	The physical, chemical, andmicrobial barrier properties of thewraps were verified at the end of5 years and met specifications.
Performance in the 6-hour Gas exposure in the EOGas 4 Ethylene Oxide Gas Sterilizer
SterilantPenetration	To demonstrateSterisheet allowsterilization of thewrapped devices inhalf dose, full dose,simulated-use and in-use testing	Inactivation of 6-Logbiological indicators atthe worst-case locationin the endoscope loadwrapped in theSterisheet for all thetesting performed	Data demonstrate that SterisheetSterilization Wraps allowpenetration of EO andsterilization of the encloseddevices.
Maintenance ofPackage Sterility	To demonstrateSterisheet maintainsterility of theenclosed medicaldevice	The sterilized deviceswrapped in Sterisheetremain sterile	Sterility was maintained for 6months after processing inSterisheet wrapped endoscopes.

Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K200335, the Sterisheet Sterilization Wrap is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K152291.

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).