Gemini Titan Sterilization Wrap

• K Number: K192641
• Device Name: Gemini Titan Sterilization Wrap
• Manufacturer: Medline Industries, Inc.
• Date Cleared: 2020-01-24 ( 122 days)
• Product Code: FRG
• Regulation Number: 880.6850

Intended Use

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.

Predicate Devices

K152458

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical sterilization wrap and the summary describes its material properties and performance in sterilization and sterility maintenance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

No.
The device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain their sterility, not to treat or diagnose a disease or condition.

Diagnostic

No

Explanation: The device is a sterilization wrap intended to enclose another medical device for sterilization and maintain its sterility. It does not diagnose any condition or disease.

SaMD (Software as a Medical Device)

No

The device is a physical sterilization wrap made of polypropylene, not software. The description details its material composition, physical properties, and performance in sterilization and sterility maintenance, all of which relate to a physical product.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is to enclose another medical device for sterilization and maintain its sterility. This is a physical process related to preparing medical devices for use, not a diagnostic test performed on biological samples.
• Device Description: The device is a sterilization wrap made of polypropylene. It does not contain reagents, instruments, or software designed to analyze biological specimens.
• Performance Studies: The performance studies focus on sterilization efficacy, maintenance of sterility, physical properties of the wrap, and biocompatibility. These are relevant to the function of a sterilization wrap, not to diagnostic performance metrics like sensitivity, specificity, or AUC.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.

Therefore, Gemini Titan Sterilization Wrap is a medical device used in the sterilization process, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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

FRG

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care provider

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

Not Found

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

Not Found

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

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.

Sterilization Efficacy

• Purpose: 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.
• Acceptance Criteria: All biological indicator test samples shall be negative for growth following the minimum incubation period.
• Results: 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)

• Purpose: To determine the microbial barrier properties of the Gemini Titan Sterilization wrap in maintaining sterility package integrity following an aerosol challenge test.
• Acceptance Criteria: 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.
• Results: 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:
  • Purpose: To determine the potential biological reactivity of a mammalian cell culture (L929) in response to the test article extract.
  • Acceptance Criteria: Acceptance criteria as specified in ISO 10993-5 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity.
  • Results: 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.
• Irritation:
  • Purpose: 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: Acceptance criteria as specified in ISO 10993-10 Biological Evaluation of Medical Devices -Part 10 Tests for Irritation and Skin Sensitization.
  • Results: 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.
• Sensitization:
  • Purpose: To determine the potential allergenic or sensitizing capacity of the test article.
  • Acceptance Criteria: Acceptance criteria as specified in ISO 10993-10 Biological Evaluation of Medical Devices -Part 10 Tests for Irritation and Skin Sensitization.
  • Results: 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

• Water Resistance (Hydrostatic Pressure Test):
  • Purpose: To evaluate the resistance of the material to the penetration of water under hydrostatic pressure.
  • Acceptance Criteria: Acceptance criteria as defined by AATCC 127-18 Water Resistance: Hydrostatic Pressure Test.
  • Results: The processed and unprocessed Gemini Titan Sterilization Wrap met the average hydrostatic pressure acceptance criteria when tested per AATCC 127.
• Basis Weight:
  • Purpose: To evaluate the basis weight of Gemini Titan Sterilization Wrap.
  • Acceptance Criteria: Acceptance criteria as defined by ASTM D3776/D3776M Standard Test Methods for Mass Per Unit Area (Weight) of Fabric.
  • Results: The average basis weight of the processed and unprocessed Gemini Titan Sterilization Wrap met the acceptance criteria when tested per ASTM D3776/D3776M.
• Bursting Strength:
  • Purpose: The bursting strength of Gemini Titan was evaluated using a pneumatic burst tester.
  • Acceptance Criteria: Acceptance criteria as defined by ASTM D3786/D3786M-18 Standard Test Method for Bursting Strength of Textile Fabrics Diaphragm Bursting Strength Tester Method.
  • Results: The average bursting pressure of the processed and unprocessed Gemini Titan Sterilization Wrap met the acceptance criteria when tested per ASTM D3786/D3786M.
• Tensile Strength (Grab Test):
  • Purpose: Testing was performed per the "Grab" tensile method with specimens evaluated for their Load at Break and % Elongation at Break.
  • Acceptance Criteria: Acceptance criteria as defined by ASTM D5034-09 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test).
  • Results: 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.
• Tearing Strength (Trapezoid Procedure):
  • Purpose: Testing was performed to evaluate the Peak and Average Tear Forces using the trapezoid procedure.
  • Acceptance Criteria: Acceptance criteria as defined by ASTM D5587-15 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure.
  • Results: 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.
• Air Permeability:
  • Purpose: Testing to evaluate the air permeability of the Gemini Titan Sterilization Wrap.
  • Acceptance Criteria: Acceptance criteria as defined by ASTM D737 Standard Test Method for Air Permeability of Textile Fabrics.
  • Results: Both the processed and unprocessed Gemini Titan Sterilization Wrap met the acceptance criteria for air permeability when tested per ASTM D737.

No clinical testing was performed.

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

Not Found

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

K152458

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

Not Found

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

Not Found

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).

Summary

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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 ([e-mail]) or phone [phone] 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)

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.

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
Wrap
Weight	Gemini Wrap Model	Sterilization
Cycle	Intended Load	Maximum
Recommended
Wrapped Package
Content
Titan
Weight	GEMTITANXXT	Pre-vacuum
steam at
270°F/132°C for
4 minutes with 30
minute dry time	Very heavy weight
packages (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: [phone] Email: [e-mail]

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

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.

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 | Comparison
Analysis |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Gemini® TitanTM Sterilization
Wrap | Gemini® Bonded Sterilization
Wrap | 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 manufactured
by spunbond-meltblown
process | Square or rectangular sheets
manufactured 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, 71
gsm, and 75 gsm | Different |
| Materials | Polypropylene with pigment
red, titanium dioxide,
phthalein cyanine, permanent
violet, carbon black colorants | Polypropylene with
phthalocyanine blue, titanium
dioxide and
disazocondensation red | Different |
| Wrapping Technique | Sequential/simultaneous
double wrapping | Sequential/simultaneous
double wrapping | Same |
| Bonding Material | Ultrasonically seamed in a
dotted line pattern | Ultrasonically seamed in a
dotted line pattern | Same |
| Sterilization | Pre-vacuum steam | Pre-vacuum steam
Gravity steam
STERRAD 50, 200S and 100
NX 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 years
STERRAD – 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
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	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.
		the end of the incubation
period.
Biocompatibility	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.
	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.
	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	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.
	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.
	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	The average bursting
pressure of the processed and
unprocessed Gemini Titan
Sterilization Wrap met the
acceptance criteria when
tested per ASTM
D3786/D3786M.
			Diaphragm Bursting Strength
Tester Method.	tested per ASTM
D3786/D3786M.
	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.
	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.
		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.

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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

8

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.