Types of medical devices to be sterilized in the gravity cycle;
· General purpose non-lumened reusable metal and nonmetal devices with stainless steel diffusionrestricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.

Types of medical devices to be sterilized in the pre-vacuum cycle are;
· General purpose reusable metal and nonmetal devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
· Up to 2 single channel stainless steel lumened devices of the following dimensions; An inside diameter of 3 mm or larger and a length of 400 mm or shorter;

Color of wrap: Blue Size of wrap: 48 in x 48 in

The maximum validated weight of load for JAMBRO Single Core A is 25 lbs.

The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.

Device Description

JAMBRO Single Core A is a 63gsm, latex-free, 3-layer (SMS) non-woven sterile wrap, manufactured with spun-bonded / meltblown polypropylenem. JAMBRO Single Core A provides a strong barrier which protects against cuts, tears with particularly heavy orthopedic sets. JAMBRO Single Core A is designed to be implemented as an outer sterilization wrap which can be used in combination with Clinipak choice.

The Maximum Recommended Wrapped Package Content Weights for the JAMBRO Single Core A (63g/m²) is 25 lbs.

The Intended Load for the JAMBRO Single Core A (63g/m²) is moderate to heavy weight package (e.g., general use medical instruments) and the JAMBRO Single Core A can maintain sterility of sterilized devices for 90 days.

AI/ML Overview

The provided document does not describe the performance of an AI/ML powered medical device. Instead, it describes a sterilization wrap (JAMBRO Single Core A Sterilization wrap) and the performance testing conducted to demonstrate its safety and effectiveness.

Therefore, many of the requested categories related to AI/ML device performance (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth for training) are not applicable to this type of medical device.

I can, however, extract the acceptance criteria and reported device performance for the sterilization wrap based on the provided text.

Acceptance Criteria and Device Performance for JAMBRO Single Core A Sterilization Wrap

This document describes the validation and performance testing for a medical device called "JAMBRO Single Core A Sterilization wrap," which is used to enclose other medical devices for sterilization and maintain their sterility. The studies conducted are non-clinical (laboratory/testing based) and focus on the physical and barrier properties of the sterilization wrap under various sterilization conditions.

Given the nature of the device (a sterilization wrap), the requested information pertaining to AI/ML device performance (such as sample sizes for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI models) is not applicable.

The "acceptance criteria" for this device are implicitly tied to the "Description/Criteria" column in the table, with "Pass" in the "Results" column indicating that the criteria were met.

1. Table of Acceptance Criteria and Reported Device Performance

Study	Standards Used	Acceptance Criteria (Description/Criteria)	Reported Device Performance (Results)
Sterilization Validation - Steam GRAVITY	ANSI/AAMI ST8:2013, ST77:2013, ST79:2017, ISO 14937:2009/(R)2013	A method of steam sterilization was validated to a sterility assurance level (SAL) of 10^-6.	Pass
Sterilant Penetration - Steam GRAVITY	ANSI/AAMI ST8:2013, ST77:2013, ST79:2017	The testing details the methods used in determining the internal temperature profile for wrapped sterilization packs when processed in a steam sterilization gravity cycle at 121°C (250°F) for thirty (30) minutes. (Implied: adequate penetration should be demonstrated).	Demonstrated adequate sterilant penetration.
Validation - Dry Time Study GRAVITY	ANSI/AAMI ST8:2013, ST77:2013, ST79:2017, BS EN 868-8:2009, BS EN 285:2006+A2:2009	Determining the proper drying time required. (Implied: samples should meet or exceed minimum criteria).	Test samples meet or exceed the minimum criteria for dry time.
90 Day Real Time Maintenance of Sterility Validation - Steam GRAVITY	ANSI/AAMI ST79:2017, United States Pharmacopeia <71>	The study details the methods used in verifying the test samples can maintain the integrity of its contents for an extended period of time following exposure to a steam gravity sterilization process. (Implied: No microbial growth.)	No growth.
Sterilization Validation - Steam PREVACUUM	ANSI/AAMI ST8:2013, ST77:2013, ST79:2017, ISO 14937:2009/(R)2013	A method of steam sterilization was validated to a sterility assurance level (SAL) of 10^-6.	Pass
Sterilant Penetration - Steam PREVACUUM	ANSI/AAMI ST8:2013, ST77:2013, ST79:2017, ISO 14937:2009/(R)2013	The testing details the methods used in determining the internal temperature profile for wrapped sterilization packs when processed in a steam sterilization pre-vacuum cycle at 132°C (270°F) for four (4) minutes exposure. (Implied: adequate penetration should be demonstrated).	Demonstrated adequate sterilant penetration.
Validation - Dry Time Study PREVACUUM	ANSI/AAMI ST8:2013, ST77:2013, ST79:2017, BS EN 868-8:2009, BS EN 285:2006+A2:2009	Determining the proper drying time required. (Implied: samples should meet or exceed minimum criteria).	Test samples meet or exceed the minimum criteria for dry time.
90 Day Real Time Maintenance of Sterility Validation - Steam PREVACUUM	ANSI/AAMI ST79:2017, United States Pharmacopeia <71>	The study details the methods used in verifying the test samples can maintain the integrity of its contents for an extended period of time following exposure to a steam sterilization process. (Implied: No microbial growth.)	No growth.
Aerosol Challenge Whole Package Integrity Test - Steam (Gravity & Prevaccum)	ANSI/AAMI ST8:2013, ST77:2013, ST79:2017	The testing details the methods used to challenge the effectiveness of the test sample in maintaining package integrity following a microbial aerosol challenge test. (Implied: the wrap should be an effective barrier).	Found to be effective barriers when subjected to a rigorous microbial aerosol challenge.
Bacterial Filtration Efficiency (BFE) of Non-Woven Sterilization Wrap	ASTM F2101-14, EN 14683: 2014, AS4381: 2015	BFE testing is a type of test used to determine the efficiency of filter materials to provide protection against microbial organisms. (Implied: successful filtration performance).	Pass
Physical Integrity	ISO 11607	The purpose of the physical properties testing was to demonstrate passing results for the physical properties for the wrap. (Implied: meet acceptance criteria for physical properties).	Met the acceptance criteria and demonstrated passing results.
Shelf Life Testing	ANSI/AAMI ST8:2013, ST77:2013, ST79:2017	Whole package integrity test of real time shelf life samples. (Implied: capable of maintaining sterility and package integrity after specified shelf life).	Capable of maintaining sterility and package integrity after ~18 months of real-time shelf life.
Biocompatibility Assessment (Cytotoxicity)	ANSI/AAMI/ISO 10993-5	Determine whether use of the device can have any potentially harmful physiological effects, specifically for cytotoxicity of leachable materials. (Implied: device should not be cytotoxic). Materials were exposed to one full sterilization cycle prior to testing.	Found not to be cytotoxic.

Since this is not an AI/ML device, the following points are not applicable (N/A):

Sample sizes used for the test set and the data provenance: N/A (Not an AI/ML device; testing involves physical and biological challenges to the wrap).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth derived from laboratory test results against established physical/biological standards, not human expert consensus for AI model evaluation).
Adjudication method: N/A (No human interpretation or adjudication as typically done for AI/ML diagnostic outputs).
If a multi reader multi case (MRMC) comparative effectiveness study was done: N/A (Not an AI/ML device; no human-in-the-loop performance is being evaluated).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI/ML device).
The type of ground truth used: For this device, the "ground truth" is established by adherence to internationally recognized consensus standards (e.g., AAMI, ISO, ASTM, Pharmacopeia) for sterilization, barrier integrity, and biocompatibility. This involves laboratory measurements, microbial challenge tests, and physical property assessments rather than clinical outcomes or expert consensus on image interpretation.
The sample size for the training set: N/A (Not an AI/ML device).
How the ground truth for the training set was established: N/A (Not an AI/ML device).

Summary

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Image /page/0/Picture/0 description: The image shows 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.

June 11, 2019

Jiangsu Zhande Medical Supplies Co., Ltd % Jigar Shah Consultant mdi Consultants, Inc. 55 Northern Blvd Great Neck, New York 11021

Re: K182656

Trade/Device Name: JAMBRO Single Core A Sterilization wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: March 12, 2019 Received: March 14, 2019

Dear Jigar Shah:

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

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Elizabeth F. Claverie-Williams. MS Assistant Director, THT4B2: Disinfection Reprocessing and Personal Protection Acting Assistant Director, THT4B1: Sterility Devices DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182656

Device Name

JAMBRO Single Core A Sterilization wrap

Indications for Use (Describe)

JAMBRO Single Core A is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:

· Gravity steam at 250°F/121°C for 30 minutes
· Pre-vacuum steam at 270°F/132°C for 4 minutes

Gravity steam and Pre-vacuum steam sterilization: Validated for dry times of 30 minutes for JAMBRO Single Core A

Types of medical devices to be sterilized in the gravity cycle;

· General purpose non-lumened reusable metal and nonmetal devices with stainless steel diffusionrestricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.

Types of medical devices to be sterilized in the pre-vacuum cycle are;

· General purpose reusable metal and nonmetal devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.

· Up to 2 single channel stainless steel lumened devices of the following dimensions; An inside diameter of 3 mm or larger and a length of 400 mm or shorter;

Color of wrap: Blue Size of wrap: 48 in x 48 in

The maximum validated weight of load for JAMBRO Single Core A is 25 lbs.

The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

The assigned 510(k) number is K182656

l. SUBMITTER

Jiangsu Zhande Medical Supplies Co., Ltd Nanjing Binjiang Economic Development Park

#719 Shengan Avenue, 1/F Building H1

Jiangsu, Nanjing, China 211178

Date Summary Prepared: June 3, 2019

Contact Person: Ms. Chaniuan Xu

ll. DEVICE

Name of Device: JAMBRO® Single Core A Sterilization wrap Common or Usual Name: Sterilization Wrap Classification Name: Sterilization Wrap Regulatory Class: 21 CFR Part 880.6850 Class II Product Code: FRG

lll. PREDICATE DEVICE

Ahlstrom Nonwovens LLC's Reliance® Solo Sterilization Wrap, Reliance® Tandem Sterilization Wrap, K160755

IV. DEVICE DESCRIPTION

The Maximum Recommended Wrapped Package Content Weights for the JAMBRO Single Core A (63g/m²) is 25 lbs.

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V. INDICATIONS FOR USE

JAMBRO Single Core A is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:

. Gravity steam at 250°F/121°C for 30 minutes
Pre-vacuum steam at 270°F/132°C for 4 minutes ●

Gravity steam and Pre-vacuum steam sterilization: Validated for dry times of 30 minutes for JAMBRO Single Core A

Types of medical devices to be sterilized in the gravity cycle;

General purpose non-lumened reusable metal and nonmetal devices . including devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
Types of medical devices to be sterilized in the pre-vacuum cycle are;
General purpose reusable metal and nonmetal devices including devices ● with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
Up to 2 single channel stainless steel lumened devices of the following . dimensions; An inside diameter of 3 mm or larger and a length of 400 mm or shorter:

Color of wrap: Blue Size of wrap: 48 in x 48 in

The maximum validated weight of load for JAMBRO Single Core A is 25 lbs.

The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The JAMBRO Single Core A sterilization wrap is similar to the RELIANCE Solo sterilization wrap, K160755. The following Comparison Chart is outlined:

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Comparison Chart

DeviceCharacteristic	Proposed Device	Predicate Device	Comparison
Product Name	JAMBRO® Single Core ASterilization wrap	Reliance® Solo SterilizationWrap, Reliance® TandemSterilization Wrap
510(k) Reference	K182656	K160755
Product Owner	Jiangsu Zhande MedicalSupplies Co., Ltd	Ahlstrom Nonwovens LLC
Product Code	FRG	FRG	Similar
Indications for Use	JAMBRO Single Core A is intended to beused to enclose another medical devicethat is to be sterilized by a health careprovider using:Gravity steam at 250°F/121°C for 30minutesPre-vacuum steam at 270°F/132°C for 4minutesTypes of medical devices to be sterilizedin the gravity cycle;General purpose non-lumened reusablemetal and nonmetal devices includingdevices with stainless steel diffusion-restricted spaces such as the hingedportion of forceps and scissors, as wellas other general medical instrumentshaving mated surfaces, knurled areasetc.Types of medical devices to be sterilizedin the pre-vacuum cycle are;General purpose reusable metal andnonmetal devices including devices withstainless steel diffusion-restricted spacessuch as the hinged portion of forcepsand scissors, as well as other eneralmedical instruments having matedsurfaces, knurled areas etc.Up to 2 single channel stainless steellumened devices of the followingdimensions; An inside diameter of 3 mmor larger and a length of 400 mm orshorter;Color of wrap: BlueSize of wrap: 48 in x 48 inThe maximum validated weight of loadfor JAMBRO Single Core A is 25 Ibs.The wrap is intended to allow sterilizationof the enclosed medical device(s) andalso to maintain sterility of the encloseddevice(s) until used.	Ahlstrom Reliance® Tandemand Solo Sterilization Wrapsare intended to be used toenclose another medicaldevice that is to be sterilizedby a healthcare provider viathe following:• Pre-vacuum Steam270°F/132°C for 4 minutes• Gravity Steam250°F/121°C for 30minutes• 100% Ethylene Oxide (EO)with a concentration of 725-735 mg/L @ 131°F/55°Cand 40%-80% relativehumidity for 60 minutes• Advanced SterilizationProducts (ASP)STERRAD® 100S• Advanced SterilizationProducts (ASP)STERRAD® 100NX(Standard, Express andFlex cycles)• STERIS Amsco® V-PRO 1,STERIS Amsco® V-PRO 1Plus, STERIS Amsco® V-PRO maX LowTemperature SterilizationSystems (Lumen, NonLumen and FlexibleCycles)The wrap is intended to allow	Similar
		sterilization of the enclosedmedical device(s) andmaintain sterility of theenclosed device(s) until used.
Regulation Number	21 CFR 880.6850	21 CFR 880.6850	Similar
Design Features	The JAMBRO® Single CoreA Sterilization wrap aresquare nonwoven sheetsproduces using a three-layerSMS (spunbond-meltblown-spunbond) process.• JAMBRO® Single Core AConsists of single sheets ofSMS wrap, where two sheetsare used together for thesequential wrapping of one ora collection of medicaldevices that will be sterilizedfollowing standard healthcarepractices.	The Reliance® Tandem andSolo Sterilization Wraps aresquare or rectangularnonwoven sheets producedusing a three-layer SMS(spunbond-meltblown-spunbond) process.The Reliance® SMSSterilization Wraps areseparated into two distinctproduct offerings:• Reliance® Tandem:Consists of single sheets ofSMS wrap, where twosheets are used together forthe sequential wrapping ofone or a collection ofmedical devices that will besterilized following standardhealthcare practices.• Reliance® Solo: Consists oftwo sheets of SMS wrap,ultrasonically bondedtogether along two edges forconvenient simultaneouswrapping of one or acollection of medical devicesthat will be sterilizedfollowing standardhealthcare practices.	Similar
Size and color	48"X 48"Blue	9"x9" to 54"x90"Blue or Green	similar
Materials	The JAMBRO® Single CoreA Sterilization wrap arecomposed of polypropylenewith blue pigments and ananti-static treatment. TheJAMBRO® Single Core ASterilization wrap allows asterilized package of medicaldevices to be openedaseptically.	The Reliance® Tandem andSolo Sterilization Wraps arecomposed of polypropylenewith the addition of blue orgreen pigment and an anti-static treatment. Reliance®Tandem and SoloSterilization Wraps allow asterilized package of medicaldevices to be openedaseptically.	Similar
Prescription vs. OTC	OTC	OTC	Similar
Sterilization	pre-vacuum steam at270°F/132°C for 4 minutes Gravity Steam at250°F/121°C for 30 minutes Drying time: 30 minutes	pre-vacuum steam at270°F/132°C for 4 minutes Drying time: Reliance®Tandem and Solo ModelsT100/S100, T200/S200,T300/S300: 20 minutesReliance® Tandem andSolo Models T400/S400,T500/S500, T600/S600:30 minutes 100% ethylene oxide (EO)with a concentration of725 -735 mg/L at131°F/55°C and 40% -80% relative humidity for60 minutes Gravity Steam at250°F/121°C for 30minutes Advanced Sterilization	Similar
Wrapping Technique	Sequential	Sequential/simultaneousdoublewrapping	Similar
Disposable vs. Non-Disposable	Disposable	Disposable	Similar

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Single Use vs.Reusable	Single Use	Single Use	Similar
Biocompatibility	Cytotoxicity ISO 10993-5	Cytotoxicity ISO 10993-5	Similar
Maintenance ofPackageSterility	90 days	90 days	Similar
Shelf Life	18 months	NA	Similar

VII. PERFORMANCE DATA

For the sterilization wrap performance testing, the following standards were utilized to demonstrate that the device met the acceptance criteria in the following standards below:

ANSI/ AAMI ST77:2013, Containment devices for reusable medical device sterilization

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ANSI/ AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities

ANSI/ AAMI/ ISO 14937:2009/(R) 2013, Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)]

STUDY	STANDARDS	DESCRIPTION/CRITERIA	RESULTS
SterilizationValidation - SteamGRAVITY	ANSI/AAMI ST8:2013ANSI/AAMI ST77:2013ANSI/AAMI ST79:2017ANSI/AAMI/ISO14937:2009/(R)2013	A method of steamSterilization wasvalidated to asterility assurancelevel (SAL) of 10-6	Pass
Sterilant Penetration -Steam GRAVITY	ANSI/AAMI ST8:2013ANSI/AAMI ST77:2013ANSI/AAMI ST79:2017	The testing detailsthe methods usedin determining theinternaltemperature profilefor wrappedsterilization packswhen processed ina steamsterilization gravitycycle at 121° C(250°F) for thirty(30) minutes.	Testing hasdemonstratedadequate sterilantpenetration
Validation - Dry TimeStudy GRAVITY	ANSI/AAMI ST8:2013ANSI/AAMI ST77:2013ANSI/AAMI ST79:2017BS EN 868-8:2009BS EN285:2006+A2:2009	Determining theproper drying timerequired	Test samplesmeet or exceedthe minimumcriteria for drytime.
90 Day Real TimeMaintenance ofSterility Validation -Steam GRAVITY	ANSI/AAMI ST79:2017United StatesPharmacopeia < 71 >	The study detailsthe methods usedin verifying the testsamples canmaintain theintegrity of itscontents for anextended period of	No growth

		time followingexposure to asteam gravitysterilizationprocess.
SterilizationValidation - SteamPREVACUUM	ANSI/AAMI ST8:2013ANSI/AAMI ST77:2013ANSI/AAMI ST79:2017ANSI/AAMI/ISO14937:2009/(R)2013	A method of steamsterilization wasvalidated to asterility assurancelevel (SAL) of 10-6	Pass
Sterilant Penetration -Steam PREVACUUM	ANSI/AAMI ST8:2013ANSI/AAMI ST77:2013ANSI/AAMI ST79:2017ANSI/AAMI/ISO14937:2009/(R)2013	The testing detailsthe methods usedin determining theinternaltemperature profilefor wrappedsterilization packswhen processed ina steamsterilization pre-vacuum cycle at132°C (270°F) forfour (4) minutesexposure.	Testing hasdemonstratedadequate sterilantpenetration
Validation - Dry TimeStudy PREVACUUM	ANSI/AAMI ST8:2013ANSI/AAMI ST77:2013ANSI/AAMI ST79:2017BS EN 868-8:2009BS EN285:2006+A2:2009	Determining theproper drying timerequired	Test samplesmeet or exceedthe minimumcriteria for drytime.
90 Day Real TimeMaintenance ofSterility Validation -Steam PREVACUUM	ANSI/AAMI ST79:2017United StatesPharmacopeia < 71 >	The study detailsthe methods usedin verifying the testsamples canmaintain theintegrity of itscontents for anextended period oftime followingexposure to asteam sterilizationprocess.	No growth
Aerosol ChallengeWhole PackageIntegrity Test - Steam	ANSI/AAMI ST8:2013ANSI/AAMI ST77:2013	The testing detailsthe methods usedto challenge the	The subject wrap,were found to beeffective barriers
Aerosol ChallengeWhole PackageIntegrity Test - SteamPREVACUUM	ANSI/AAMI ST8:2013ANSI/AAMI ST77:2013ANSI/AAMI ST79:2017	maintainingpackage integrityfollowing amicrobial aerosolchallenge test.The testing detailsthe methods usedto challenge theeffectiveness ofthe test sample inmaintainingpackage integrityfollowing amicrobial aerosolchallenge test.	cycle andsubjected to arigorous microbialaerosol challenge.The subject wrap,were found to beeffective barrierswhen processed ina Steam Pre-Vacuum cycle andsubjected to arigorous microbialaerosol challenge.
Bacterial FiltrationEfficiency (BFE) ofNon-WovenSterilization WrapWhen Processed In aSteam SterilizationCycle	ASTM F2101-14EN 14683: 2014AS4381: 2015	BFE testing is atype of test usedto determine theefficiency of filtermaterials toprovide protectionagainstmicrobialorganisms. It	Pass
Physical Integrity	ISO 11607	The purpose of thephysical propertiestesting was todemonstratepassing results forthe physicalproperties for thewrap.	The physicalproperties testingmet theacceptance criteriaand demonstratedpassing results
Shelf Life Testing	ANSI/AAMI ST8:2013ANSI/AAMI ST77:2013ANSI/AAMI ST79:2017	Whole packageintegrity test ofreal time shelf lifesamples	Sterilization Wrapwas capable ofmaintainingsterility andpackage integrity(whenused as a steamsterilizationwrapper) followingan approximate 18month period ofreal time shelf lifeprior to beingsterilized in thesteam sterilizationcycles

Following testing have been performed:

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Biocompatibility Assessment

Cytotoxicity testing is a type of biocompatibility test used to determine whether use of a medical device can have any potentially harmful physiological effects. This involves extracting leachable materials from the device or components and analyzing the leachable extracts for potentially harmful chemicals or cytotoxicity. The materials were exposed to one (1) full sterilization cycle.

. ANSI/AAMI/ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for in vitro Cytotoxicity
Based on the conditions of the study the device was found not to be cytotoxic.

VIII. CONCLUSIONS

The conclusion drawn from the non-clinical tests demonstrate that the subject device (K182565) is as safe, as effective and performs as well as or better than the legally marketed predicated device (K160755).

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).