Gemini Titan Sterilization Wrap is 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.

-Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for a dry time of 30 minutes. Gemini® Titan™ Sterilization Wrap is available in square sheets ranging from 36" x 36" and can be used with trays weighing up to 25 lbs.

Device Description

Gemini® Titan™ Sterilization Wrap is offered to the market place as bulk, non-sterile packages of two ply bonded sheets of wrap. The bonded wrap is comprised of Gemini® Titan™ Sterilization Wrap ultrasonically seamed on two parallel sides. This allows for convenient wrapping with two sheets simultaneously. Gemini® Titan™ is used to wrap a medical device or a collection of medical devices for sterilization.

The two tone wrap is comprised of a blue sheet bonded to a pink sheet. The fabric is made of polypropylene with the addition of less than 1% blue to pink color pigmentation.

Gemini® Titan™ Sterilization Wrap is available in square sheets ranging from 36" x 36" and can be used with trays weighing up to 25 lbs.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from Medline Industries, Inc. for their Gemini Titan Sterilization Wrap. It details the device description, indications for use, comparison with a predicate device, and a summary of non-clinical testing conducted to demonstrate its safety and effectiveness.

Acceptance Criteria and Device Performance Study

The study described in this document is a series of non-clinical tests designed to demonstrate that the Gemini Titan Sterilization Wrap meets specific performance criteria. Since this is a sterilization wrap, the "device" in question is the wrap itself, and its performance is evaluated based on its ability to maintain sterility, facilitate sterilization, and exhibit appropriate physical properties and biocompatibility.

Here's a breakdown of the requested information based on the provided text:

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

Test Title	Purpose	Acceptance Criteria	Reported Device Performance
Sterilization Efficacy	To validate the sterilization efficacy of the Gemini Titan Sterilization Wrap when processed in a steam pre-vacuum cycle of 132°C (270°F) for four minutes.	All biological indicator test samples shall be negative for growth following the minimum incubation period.	All biological indicator test samples were negative for growth. Results from the testing conclude that the Gemini Titan can achieve a 10-6 SAL after processing in a steam pre-vacuum sterilization cycle at 132°C (270°F) for 4 minutes.
Maintenance of Sterility (Microbial Aerosol Challenge)	To determine the microbial barrier properties of the Gemini Titan Sterilization wrap in maintaining sterility package integrity following an aerosol challenge test.	Each wrapped tray will meet the sterility maintenance requirement if there is no growth in any of the culture tubes containing the stainless-steel test coupons at the end of the incubation period.	Each wrapped tray met the sterility maintenance requirement since there was no growth in any of the culture tubes containing the stainless-steel test coupons.
Biocompatibility (Cytotoxicity)	To determine the potential biological reactivity of a mammalian cell culture (L929) in response to the test article extract.	Acceptance criteria as specified in ISO 10993-5 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity.	There was no biological reactivity (Grade 0) of the cells exposed to the test article extract. Based on the criteria of the protocol and the ISO 10993-5 guidelines, the test article meets the requirements of the test and is not considered to have a cytotoxic effect.
Biocompatibility (Irritation)	To determine the potential irritation effects of the test article extract as a result of an intracutaneous injection in New Zealand White Rabbits.	Acceptance criteria as specified in ISO 10993-10 Biological Evaluation of Medical Devices - Part 10 Tests for Irritation and Skin Sensitization.	The test article sites did not show a significantly greater biological reaction than the sites injected with the control article. Based on the criteria of the protocol, the test article meets the requirements of the ISO 10993-10 guidelines.
Biocompatibility (Sensitization)	To determine the potential allergenic or sensitizing capacity of the test article.	Acceptance criteria as specified in ISO 10993-10 Biological Evaluation of Medical Devices - Part 10 Tests for Irritation and Skin Sensitization.	The USP 0.9% sodium chloride for injection and cotton seed oil extracts of the test article elicited no reaction at the challenge, following an induction phase. Therefore, as defined by the grading scale of the USP, the test article is classified as a non-sensitizer.
Physical Properties (Hydrostatic Pressure)	To evaluate the resistance of the material to the penetration of water under hydrostatic pressure.	Acceptance criteria as defined by AATCC 127-18 Water Resistance: Hydrostatic Pressure Test.	The processed and unprocessed Gemini Titan Sterilization Wrap met the average hydrostatic pressure acceptance criteria when tested per AATCC 127.
Physical Properties (Basis Weight)	To evaluate the basis weight of Gemini Titan Sterilization Wrap.	Acceptance criteria as defined by ASTM D3776/D3776M Standard Test Methods for Mass Per Unit Area (Weight) of Fabric.	The average basis weight of the processed and unprocessed Gemini Titan Sterilization Wrap met the acceptance criteria when tested per ASTM D3776/D3776M.
Physical Properties (Bursting Strength)	The bursting strength of Gemini Titan was evaluated using a pneumatic burst tester.	Acceptance criteria as defined by ASTM D3786/D3786M-18 Standard Test Method for Bursting Strength of Textile Fabrics Diaphragm Bursting Strength Tester Method.	The average bursting pressure of the processed and unprocessed Gemini Titan Sterilization Wrap met the acceptance criteria when tested per ASTM D3786/D3786M.
Physical Properties (Tensile Strength)	Testing was performed per the "Grab" tensile method with specimens evaluated for their Load at Break and % Elongation at Break.	Acceptance criteria as defined by ASTM D5034-09 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test).	When tested for machine direction and cross-machine direction, the processed and unprocessed Gemini Titan Sterilization Wrap met the average load at break when tested per ASTM D5034.
Physical Properties (Tear Strength)	Testing was performed to evaluate the Peak and Average Tear Forces using the trapezoid procedure.	Acceptance criteria as defined by ASTM D5587-15 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure.	When tested for machine direction and cross-machine direction, the processed and unprocessed Gemini Titan Sterilization Wrap met the average peak tear force acceptance criteria when tested per ASTM D5587.
Physical Properties (Air Permeability)	Testing to evaluate the air permeability of the Gemini Titan Sterilization Wrap.	Acceptance criteria as defined by ASTM D737 Standard Test Method for Air Permeability of Textile Fabrics.	Both the processed and unprocessed Gemini Titan Sterilization Wrap met the acceptance criteria for air permeability when tested per ASTM D737.

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

The document does not explicitly state the specific sample sizes for each test in the "Summary of Non-Clinical Testing" section. It refers to "samples" or "specimens" being tested in accordance with the specified ASTM or ISO standards.

Data Provenance: The tests are described as non-clinical tests. They are performed in a laboratory setting to evaluate the material properties and performance of the sterilization wrap. The document does not specify the country of origin of the data directly, but Medline Industries, Inc. is based in Northfield, IL, USA. Given the context of a US FDA 510(k) submission, it's highly probable that the testing was conducted either in the US or in a facility compliant with US regulatory requirements and good laboratory practices (GLP). These are prospective tests, as they are performed specifically to demonstrate the performance of the new device for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable to this type of device and study. The "ground truth" for the performance of a sterilization wrap is established through adherence to recognized international standards (ISO, ASTM, AATCC) and validated laboratory testing protocols, not through expert consensus on qualitative data like images. The results are quantitative and objective (e.g., presence/absence of growth, pressure readings, weight measurements).

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

Not applicable. As noted above, the "ground truth" is based on objective, quantitative measurements derived from standardized test methods, not subjective interpretation 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

Not applicable. This device is a sterilization wrap, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Not applicable. This is not an algorithm or AI device. The "standalone" performance refers to the physical and biological characteristics of the wrap itself under defined conditions.

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

The "ground truth" for this device is based on objective, quantitative measurements obtained through validated laboratory testing protocols and adherence to recognized international standards (ISO, ASTM, AATCC). For example:

Sterilization Efficacy: Absence of biological indicator growth (objective, quantitative).
Maintenance of Sterility (Microbial Barrier): Absence of microbial growth on coupons (objective, quantitative).
Biocompatibility: Quantified biological reactivity (e.g., Grade 0 for cytotoxicity, defined reaction levels for irritation/sensitization) according to ISO standards.
Physical Properties: Measured values (e.g., pressure, weight, load at break, tear force, air permeability) falling within specified acceptance criteria defined by ASTM/AATCC standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for this device's development would involve material science development and engineering, not data-driven model training.

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

Not applicable, as there is no training set for this type of medical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 24, 2020

Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093

Re: K192641

Trade/Device Name: Gemini Titan Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: December 23, 2019 Received: December 26, 2019

Dear Jennifer Mason:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 (OS) 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,

For Sreekanth Gutala, Ph.D. Acting 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) K192641

Device Name Gemini Titan Sterilization Wrap

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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			Wrap Model Recommendations 1
WrapWeight	Gemini Wrap Model	SterilizationCycle	Intended Load	MaximumRecommendedWrapped PackageContent
TitanWeight	GEMTITANXXT	Pre-vacuumsteam at270°F/132°C for4 minutes with 30minute dry time	Very heavy weightpackages (for example:large orthopedic sets)	25 lbs.

The following loads were used in the pre-vacuum steam sterility Maintenance Validation Study:

Titan Weight: 5 lb Sterilization Tray (22.8 in. x 11.1. in. x 3.8 in.) was loaded with evenly dispersed instruments and additional medical devices throughout to achieve a total combined weight, with load and wrap, of twenty-five (25) pounds.

1 Individual results may differ due to factors such as variations in handling practices, wrapping techniques and folding methods. Results may also differ due to the use of irregularly shaped contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.

It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthermore it is recommended to not exceed the number, weight and sizes of individual content types that were validated for the Gemini Titan Sterilization Wrap.

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Image /page/4/Picture/0 description: The image features the Medline logo, which is a well-known brand in the healthcare industry. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with a stylized star-like symbol positioned to the right of the text. The logo is set against a blue background, which provides a strong contrast and makes the logo easily recognizable.

edline Industries, Inc. hree Lakes Drive Northfield, II 60093

K192641 510(k) SUMMARY [AS REQUIRED BY 21CFR 807.92]

Submitter / 510(k) Sponsor

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093

Registration Number: 1417592

Contact Person

Jennifer Mason Senior Regulatory Affairs Specialist Phone: 847-643-3652 Email: jamason@medline.com

Summary Preparation Date January 24, 2020

Type of 510(k) Submission Traditional

Device Name / Classification

Name of Device: Gemini® Titan Sterilization™ Wrap Proprietary Name: Gemini® Titan Sterilization™ Wrap Common Name: Sterilization Wrap Classification Name: Wrap, Sterilization Product Code: FRG Classification Panel: General Hospital Regulatory Class: Class II Regulation #: 21 CFR 880.6850

Predicate Device Gemini® Bonded Sterilization Wrap K152458

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Image /page/5/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo is set against a blue square background. The word "MEDLINE" is written in a sans-serif font, with a stylized white cross symbol positioned vertically, intersecting the letters. The cross is designed to look like two intersecting lines, adding a modern and clean aesthetic to the logo.

Medline Industries, Inc.
Three Lakes Drive
Northfield, IL 60093

Device Description

The two tone wrap is comprised of a blue sheet bonded to a pink sheet. The fabric is made of polypropylene with the addition of less than 1% blue to pink color pigmentation.

Gemini® Titan™ Sterilization Wrap is available in square sheets ranging from 36" x 36" and can be used with trays weighing up to 25 lbs.

Indications for Use

Gemini® Titan™ Wrap is 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 such content until used.

-Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for a dry time of 30 minutes.

Summary of Technological Characteristics

Device Characteristic	Proposed Device	Predicate Device	ComparisonAnalysis
Product Name	Gemini® TitanTM SterilizationWrap	Gemini® Bonded SterilizationWrap	Same
510(k) Reference	K192641	K152458	N/A
Product Owner	Medline Industries, Inc.	Medline Industries, Inc.	Same
Product Code	FRG	FRG	Same
Intended Use	Gemini Titan Wrap is 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 such content until used.	Gemini Bonded Sterilization Wraps are 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 such content under used.	Same
Regulation Number	21 CFR 880.6850	21 CFR 880.6850	Same

TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES

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Image /page/6/Picture/0 description: The image features the Medline logo, which is set against a blue square background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a white, stylized cross-like symbol. The cross is oriented vertically, with its arms extending upwards and downwards from the center of the word "MEDLINE."

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093

Design Features	Square sheets manufacturedby spunbond-meltblownprocess	Square or rectangular sheetsmanufactured by spunbond-meltblown process	Similar
Design Configurations	36 in. x 36 in. to 54 in. x 54 in.	12 in. x 12 in. to 54 in. x 90 in.	Similar
Device Weight	120 gsm	47 gsm, 54 gsm, 61 gsm, 71gsm, and 75 gsm	Different
Materials	Polypropylene with pigmentred, titanium dioxide,phthalein cyanine, permanentviolet, carbon black colorants	Polypropylene withphthalocyanine blue, titaniumdioxide anddisazocondensation red	Different
Wrapping Technique	Sequential/simultaneousdouble wrapping	Sequential/simultaneousdouble wrapping	Same
Bonding Material	Ultrasonically seamed in adotted line pattern	Ultrasonically seamed in adotted line pattern	Same
Sterilization	Pre-vacuum steam	Pre-vacuum steamGravity steamSTERRAD 50, 200S and 100NX DUO Cycles	Same
Disposable vs. Non-Disposable	Disposable	Disposable	Same
Single Use vs. Reusable	Single Use Only	Single Use Only	Same
Maintenance of Sterility	Steam - 2 years	Steam - 2 yearsSTERRAD – 180 days	Different

Summary of Non-Clinical Testing

Sterilization efficacy, maintenance of sterility, physical properties and biocompatibility testing was conducted on the Gemini® Titan™ Sterilization Wrap to demonstrate that the product meets its intended use.

Title	Purpose	Acceptance Criteria	Results
SterilizationEfficacy	To validate the sterilization efficacy ofthe Gemini Titan Sterilization Wrapwhen processed in a steam pre-vacuum cycle of 132°C (270°F) forfour minutes.	All biological indicator testsamples shall be negative forgrowth following theminimum incubation period.	All biological indicator testsamples were negative forgrowth. Results from thetesting conclude that theGemini Titan can achieve a10-6 SAL after processing ina steam pre-vacuumsterilization cycle at 132°C(270°F) for 4 minutes.
Maintenance ofSterility(MicrobialAerosolChallenge)	To determine the microbial barrierproperties of the Gemini TitanSterilization wrap in maintainingsterility package integrity following anaerosol challenge test.	Each wrapped tray will meetthe sterility maintenancerequirement if there is nogrowth in any of the culturetubes containing thestainless-steel test coupons at	Each wrapped tray met thesterility maintenancerequirement since there wasno growth in any of theculture tubes containing thestainless-steel test coupons.
		the end of the incubationperiod.
Biocompatibility	To determine the potential biologicalreactivity of a mammalian cell culture(L929) in response to the test articleextract.	Acceptance criteria asspecified in ISO 10993-5Biological Evaluation ofMedical Devices - Part 5:Tests for In VitroCytotoxicity.	There was no biologicalreactivity (Grade 0) of thecells exposed to the testarticle extract. Based on thecriteria of the protocol andthe ISO 10993-5 guidelines,the test article meets therequirements of the test andis not considered to have acytotoxic effect.
	To determine the potential irritationeffects of the test article extract as aresult of an intracutaneous injection inNew Zealand White Rabbits.	Acceptance criteria asspecified in ISO 10993-10Biological Evaluation ofMedical Devices -Part 10Tests for Irritation and SkinSensitization.	The test article sites did notshow a significantly greaterbiological reaction than thesites injected with the controlarticle. Based on the criteriaof the protocol, the testarticle meets therequirements of the ISO10993-10 guidelines.
	To determine the potential allergenicor sensitizing capacity of the testarticle.	Acceptance criteria asspecified in ISO 10993-10Biological Evaluation ofMedical Devices -Part 10Tests for Irritation and SkinSensitization.	The USP 0.9% sodiumchloride for injection andcotton seed oil extracts of thetest article elicited noreaction at the challenge,following an induction phase.Therefore, as defined by thegrading scale of the USP, thetest article is classified as anon-sensitizer.
PhysicalProperties	To evaluate the resistance of thematerial to the penetration of waterunder hydrostatic pressure.	Acceptance criteria asdefined by AATCC 127-18Water Resistance:Hydrostatic Pressure Test.	The processed andunprocessed Gemini TitanSterilization Wrap met theaverage hydrostatic pressureacceptance criteria whentested per AATCC 127.
	To evaluate the basis weight ofGemini Titan Sterilization Wrap.	Acceptance criteria asdefined by ASTMD3776/D3776M StandardTest Methods for Mass PerUnit Area (Weight) of Fabric.	The average basis weight ofthe processed andunprocessed Gemini TitanSterilization Wrap met theacceptance criteria whentested per ASTMD3776/D3776M.
	The bursting strength of Gemini Titanwas evaluated using a pneumatic bursttester.	Acceptance criteria asdefined by ASTMD3786/D3786M-18 StandardTest Method for BurstingStrength of Textile Fabrics	The average burstingpressure of the processed andunprocessed Gemini TitanSterilization Wrap met theacceptance criteria whentested per ASTMD3786/D3786M.
			Diaphragm Bursting StrengthTester Method.	tested per ASTMD3786/D3786M.
	Testing was performed per the "Grab"tensile method with specimensevaluated for their Load at Break and% Elongation at Break.	Acceptance criteria asdefined by ASTM D5034-09Standard Test Method forBreaking Strength andElongation of Textile Fabrics(Grab Test).	When tested for machinedirection and cross-machinedirection, the processed andunprocessed Gemini TitanSterilization Wrap met theaverage load at break whentested per ASTM D5034.
	Testing was performed to evaluate thePeak and Average Tear Forces usingthe trapezoid procedure.	Acceptance criteria asdefined by ASTM D5587-15Standard Test Method forTearing Strength of Fabricsby Trapezoid Procedure.	When tested for machinedirection and cross-machinedirection, the processed andunprocessed Gemini TitanSterilization Wrap met theaverage peak tear forceacceptance criteria whentested per ASTM D5587.
		Testing to evaluate the airpermeability of the Gemini TitanSterilization Wrap.	Acceptance criteria asdefined by ASTM D737Standard Test Method for AirPermeability of TextileFabrics.	Both the processed andunprocessed Gemini TitanSterilization Wrap met theacceptance criteria for airpermeability when tested perASTM D737.

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Image /page/7/Picture/0 description: The image features the Medline logo, which consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized white cross-like symbol. The logo is set against a solid blue background, providing a strong contrast that makes the logo easily visible. The overall design is clean and professional, reflecting the company's presence in the medical or healthcare industry.

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093

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Image /page/8/Picture/0 description: The image features the Medline logo, which consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized star or compass symbol. The logo is set against a solid blue square background. The star symbol has four points, with the top and bottom points being longer than the side points.

Aedline Industries, Inc. Three Lakes Drive Northfield. IL 60093

Summary of Clinical Testing

This section does not apply. No clinical testing was performed.

Conclusion

The conclusions drawn from the nonclinical (and clinical) tests demonstrate that the Gemini® Titan™ Sterilization Wrap is as safe, as effective, and performs as well as or better than the legally marketed device.

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).