Gemini Titan Sterilization Wrap

K192641 · Medline Industries, Inc. · FRG · Jan 24, 2020 · General Hospital

Device Facts

• Record ID: K192641
• Device Name: Gemini Titan Sterilization Wrap
• Applicant: Medline Industries, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Jan 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

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.

Device Story

Gemini Titan Sterilization Wrap consists of two-ply bonded polypropylene sheets, ultrasonically seamed on two sides. Used by healthcare providers in clinical settings to wrap medical devices or instrument trays prior to sterilization. The wrap allows steam penetration during pre-vacuum steam sterilization cycles (270°F/132°C) and acts as a microbial barrier to maintain sterility post-processing. The wrap is disposable and intended for single use. Healthcare staff manually wrap trays using sequential or simultaneous double-wrapping techniques. The device ensures the sterility of surgical instruments, facilitating safe clinical use and reducing the risk of contamination for patients.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by non-clinical bench testing, including sterilization efficacy (10-6 SAL achieved), microbial aerosol challenge, biocompatibility (ISO 10993-5 cytotoxicity, ISO 10993-10 irritation/sensitization), and physical property testing (hydrostatic pressure, basis weight, bursting strength, tensile strength, tear force, and air permeability).

Technological Characteristics

Two-ply bonded polypropylene sheets with color pigmentation (blue/pink). Ultrasonically seamed. Dimensions: 36"x36" to 54"x54". Basis weight: 120 gsm. Sterilization: Pre-vacuum steam. Standards: ASTM D3776/D3776M (mass per unit area), ASTM D3786/D3786M-18 (bursting strength), ASTM D5034-09 (breaking strength), ASTM D5587-15 (tearing strength), ASTM D737 (air permeability), AATCC 127-18 (hydrostatic pressure).

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization and maintenance of sterility until use. Validated for pre-vacuum steam sterilization at 270°F/132°C for 4 minutes with a 30-minute dry time. Suitable for trays weighing up to 25 lbs.

Regulatory Classification

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.

Predicate Devices

• Gemini Bonded Sterilization Wrap (K152458)

Submission Summary (Full Text)

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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<br>Weight | Gemini Wrap Model | Sterilization<br>Cycle | Intended Load | Maximum<br>Recommended<br>Wrapped Package<br>Content |
| Titan<br>Weight | GEMTITANXXT | Pre-vacuum<br>steam at<br>270°F/132°C for<br>4 minutes with 30<br>minute dry time | Very heavy weight<br>packages (for example:<br>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<br>Analysis |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Gemini® TitanTM Sterilization<br>Wrap | Gemini® Bonded Sterilization<br>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<br>by spunbond-meltblown<br>process | Square or rectangular sheets<br>manufactured by spunbond-<br>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<br>gsm, and 75 gsm | Different |
| Materials | Polypropylene with pigment<br>red, titanium dioxide,<br>phthalein cyanine, permanent<br>violet, carbon black colorants | Polypropylene with<br>phthalocyanine blue, titanium<br>dioxide and<br>disazocondensation red | Different |
| Wrapping Technique | Sequential/simultaneous<br>double wrapping | Sequential/simultaneous<br>double wrapping | Same |
| Bonding Material | Ultrasonically seamed in a<br>dotted line pattern | Ultrasonically seamed in a<br>dotted line pattern | Same |
| Sterilization | Pre-vacuum steam | Pre-vacuum steam<br>Gravity steam<br>STERRAD 50, 200S and 100<br>NX DUO Cycles | Same |
| Disposable vs. Non-<br>Disposable | Disposable | Disposable | Same |
| Single Use vs. Reusable | Single Use Only | Single Use Only | Same |
| Maintenance of Sterility | Steam - 2 years | Steam - 2 years<br>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<br>Efficacy | To validate the sterilization efficacy of<br>the Gemini Titan Sterilization Wrap<br>when processed in a steam pre-<br>vacuum cycle of 132°C (270°F) for<br>four minutes. | All biological indicator test<br>samples shall be negative for<br>growth following the<br>minimum incubation period. | All biological indicator test<br>samples were negative for<br>growth. Results from the<br>testing conclude that the<br>Gemini Titan can achieve a<br>10-6 SAL after processing in<br>a steam pre-vacuum<br>sterilization cycle at 132°C<br>(270°F) for 4 minutes. | |
| Maintenance of<br>Sterility<br>(Microbial<br>Aerosol<br>Challenge) | To determine the microbial barrier<br>properties of the Gemini Titan<br>Sterilization wrap in maintaining<br>sterility package integrity following an<br>aerosol challenge test. | Each wrapped tray will meet<br>the sterility maintenance<br>requirement if there is no<br>growth in any of the culture<br>tubes containing the<br>stainless-steel test coupons at | Each wrapped tray met the<br>sterility maintenance<br>requirement since there was<br>no growth in any of the<br>culture tubes containing the<br>stainless-steel test coupons. | |
| | | the end of the incubation<br>period. | | |
| Biocompatibility | To determine the potential biological<br>reactivity of a mammalian cell culture<br>(L929) in response to the test article<br>extract. | Acceptance criteria as<br>specified in ISO 10993-5<br>Biological Evaluation of<br>Medical Devices - Part 5:<br>Tests for In Vitro<br>Cytotoxicity. | There was no biological<br>reactivity (Grade 0) of the<br>cells exposed to the test<br>article extract. Based on the<br>criteria of the protocol and<br>the ISO 10993-5 guidelines,<br>the test article meets the<br>requirements of the test and<br>is not considered to have a<br>cytotoxic effect. | |
| | To determine the potential irritation<br>effects of the test article extract as a<br>result of an intracutaneous injection in<br>New Zealand White Rabbits. | Acceptance criteria as<br>specified in ISO 10993-10<br>Biological Evaluation of<br>Medical Devices -Part 10<br>Tests for Irritation and Skin<br>Sensitization. | The test article sites did not<br>show a significantly greater<br>biological reaction than the<br>sites injected with the control<br>article. Based on the criteria<br>of the protocol, the test<br>article meets the<br>requirements of the ISO<br>10993-10 guidelines. | |
| | To determine the potential allergenic<br>or sensitizing capacity of the test<br>article. | Acceptance criteria as<br>specified in ISO 10993-10<br>Biological Evaluation of<br>Medical Devices -Part 10<br>Tests for Irritation and Skin<br>Sensitization. | The USP 0.9% sodium<br>chloride for injection and<br>cotton seed oil extracts of the<br>test article elicited no<br>reaction at the challenge,<br>following an induction phase.<br>Therefore, as defined by the<br>grading scale of the USP, the<br>test article is classified as a<br>non-sensitizer. | |
| Physical<br>Properties | To evaluate the resistance of the<br>material to the penetration of water<br>under hydrostatic pressure. | Acceptance criteria as<br>defined by AATCC 127-18<br>Water Resistance:<br>Hydrostatic Pressure Test. | The processed and<br>unprocessed Gemini Titan<br>Sterilization Wrap met the<br>average hydrostatic pressure<br>acceptance criteria when<br>tested per AATCC 127. | |
| | To evaluate the basis weight of<br>Gemini Titan Sterilization Wrap. | Acceptance criteria as<br>defined by ASTM<br>D3776/D3776M Standard<br>Test Methods for Mass Per<br>Unit Area (Weight) of Fabric. | The average basis weight of<br>the processed and<br>unprocessed Gemini Titan<br>Sterilization Wrap met the<br>acceptance criteria when<br>tested per ASTM<br>D3776/D3776M. | |
| | The bursting strength of Gemini Titan<br>was evaluated using a pneumatic burst<br>tester. | Acceptance criteria as<br>defined by ASTM<br>D3786/D3786M-18 Standard<br>Test Method for Bursting<br>Strength of Textile Fabrics | The average bursting<br>pressure of the processed and<br>unprocessed Gemini Titan<br>Sterilization Wrap met the<br>acceptance criteria when<br>tested per ASTM<br>D3786/D3786M. | |
| | | | Diaphragm Bursting Strength<br>Tester Method. | tested per ASTM<br>D3786/D3786M. |
| | Testing was performed per the "Grab"<br>tensile method with specimens<br>evaluated for their Load at Break and<br>% Elongation at Break. | Acceptance criteria as<br>defined by ASTM D5034-09<br>Standard Test Method for<br>Breaking Strength and<br>Elongation of Textile Fabrics<br>(Grab Test). | When tested for machine<br>direction and cross-machine<br>direction, the processed and<br>unprocessed Gemini Titan<br>Sterilization Wrap met the<br>average load at break when<br>tested per ASTM D5034. | |
| | Testing was performed to evaluate the<br>Peak and Average Tear Forces using<br>the trapezoid procedure. | Acceptance criteria as<br>defined by ASTM D5587-15<br>Standard Test Method for<br>Tearing Strength of Fabrics<br>by Trapezoid Procedure. | When tested for machine<br>direction and cross-machine<br>direction, the processed and<br>unprocessed Gemini Titan<br>Sterilization Wrap met the<br>average peak tear force<br>acceptance criteria when<br>tested per ASTM D5587. | |
| | | Testing to evaluate the air<br>permeability of the Gemini Titan<br>Sterilization Wrap. | Acceptance criteria as<br>defined by ASTM D737<br>Standard Test Method for Air<br>Permeability of Textile<br>Fabrics. | Both the processed and<br>unprocessed Gemini Titan<br>Sterilization Wrap met the<br>acceptance criteria for air<br>permeability when tested per<br>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

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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.