Gemini Sterilization Wrap

K162993 · Medline Industries, Inc. · FRG · Jun 23, 2017 · General Hospital

Device Facts

• Record ID: K162993
• Device Name: Gemini Sterilization Wrap
• Applicant: Medline Industries, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Jun 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Gemini 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 until used.

Device Story

Gemini Sterilization Wrap is a non-woven, five-layer SSMMS (spunbond-spunbond-meltblown-meltblown-spunbond) polypropylene fabric used to wrap medical devices prior to sterilization. It is used in healthcare facilities by sterile processing staff. The wrap acts as a barrier to maintain sterility of the enclosed instruments post-sterilization. It is available in various weights and sizes, with some versions ultrasonically seamed for two-ply use. The device is used by wrapping instruments in a sequential or simultaneous double-wrap technique. The wrap is compatible with specific low-temperature sterilization systems (STERIS V-PRO and STERIZONE VP4). By maintaining the sterility of surgical instruments until the point of use, the device helps prevent surgical site infections and ensures patient safety during procedures.

Clinical Evidence

No clinical data. Bench testing only. Performance studies included maintenance of sterility, sterilant penetration, tensile breaking strength (ASTM D5034), tear strength (ASTM D5587), hydrostatic pressure (AATCC 127), burst pressure (ASTM D3786), air permeability (ASTM D737), and post-sterilization biocompatibility (ISO 10993-5 cytotoxicity and ISO 10993-10 primary skin irritation).

Technological Characteristics

Five-layer SSMMS polypropylene non-woven fabric. Contains phthalocyanine blue, titanium dioxide, and disazocondensation red pigments. Dimensions range from 12"x12" to 54"x90". Ultrasonically seamed in dotted line pattern. Single-use, disposable. Tested per ASTM D5034, D5587, D3786, D737, and AATCC 127.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization and to maintain sterility of the contents until use. Validated for specific sterilization cycles including STERIS V-PRO (1, 1 Plus, maX, 60) and STERIZONE VP4 systems.

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 Sterilization Wrap (K150698)

Reference Devices

• Gemini Sterilization Wrap (K152564)
• Gemini Bonded Sterilization Wrap (K152458)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three overlapping human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 23, 2017

Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist One Medline Place Mundelein, Illinois 60060

Re: K162993

Trade/Device Name: Gemini Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: May 16, 2017 Received: June 25, 2017

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Lori A. Wiggins -S6

Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Expiration Date: January 31, 2017 See PRA Statement below.

Form Approved: OMB No. 0910-0120

510(k) Number (if known) K162993

Device Name Gemini Sterilization Wrap

#### Indications for Use (Describe)

Gemini 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 until used. Gemini Sterilization Wrap is validated for use in the following sterilization processes modes and cycles:

| 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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TABLE 1: STERIS V-PRO® Low Temperature Sterilization Systems. The wrap was validated to be effectively aerated during the pre-programmed cycles

| Gemini Wrap Model | Gemini<br>Wrap<br>Weight | STERIS V-PRO® Low<br>Temperature Sterilization<br>Cycles |
|---------------------------|--------------------------|--------------------------------------------------------------------------------|
| GEM11XX/GEM11XXS/GEM11XXT | Lightweight | ■ STERIS V-PRO® 60 (Lumen, Non-<br>Lumen and Flexible Cycles) |
| GEM21XX/GEM11XXS/GEM11XXT | Regular Weight | ■ STERIS V-PRO® 1 (Lumen Cycle)<br>(per K150698) |
| GEM31XX/GEM31XXS/GEM31XXT | Medium Weight | ■ STERIS V-PRO® 1 Plus (Lumen and<br>Non-Lumen Cycle) (per K150698) |
| GEM41XX/GEM41XXS/GEM41XXT | Heavyweight | ■ STERIS V-PRO® maX (Lumen, Non-<br>Lumen, and Flexible Cycle)(per<br>K150698) |
| GEM51XX/GEM51XXS/GEM51XXT | Super Heavyweight | |

### TABLE 2: STERIZONE® VP4 Sterilization System

| Gemini Wrap Model | Gemini<br>Wrap<br>Weight | STERIZONE® VP4<br>Sterilization System |
|---------------------------|--------------------------|----------------------------------------|
| GEM11XX/GEM11XXS/GEM11XXT | Lightweight | • STERIZONE® VP4 Sterilizer single |
| GEM21XX/GEM21XXS/GEM21XXT | Regular Weight | preset sterilization cycle |
| GEM31XX/GEM31XXS/GEM31XXT | Medium Weight | |
| GEM41XX/GEM41XXS/GEM41XXT | Heavyweight | |
| GEM51XX/GEM51XXS/GEM51XXT | Super Heavyweight | |

#### TABLE 3: Wrap Model Recommendations1

| Gemini Wrap<br>Weight | Gemini<br>Wrap<br>Model | Intended Load | Maximum Recommended Wrapped Package<br>Content2<br>STERIS V-<br>PRO® 1,<br>1Plus, maX | STERIS V-<br>PRO 60® | STERIZONE®<br>VP4 Sterilizer |
|-----------------------|-------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|----------------------|------------------------------|
| Light Weight | GEM1 | Light weight<br>package (for<br>example: standard<br>linen packs) | 6.5 lbs. | 6 lbs. | 6 lbs. |
| Regular<br>Weight | GEM2 | Light to moderate<br>weight package (for<br>example: general<br>use medical<br>instruments) | 9 lbs. | 9 lbs. | 9 lbs. |
| Medium<br>Weight | GEM3 | Moderate to heavy<br>weight package (for<br>example: general<br>use medical<br>instruments) | 10 lbs. | 13 lbs. | 13 lbs. |
| Heavy Weight | GEM4 | Heavy weight<br>package (for | 10 lbs. | 17 lbs. | 17 lbs. |

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| | | example: general<br>use medical<br>instruments) | | | |
|-----------------------|------|--------------------------------------------------------------------------------------|---------|---------|---------|
| Super Heavy<br>Weight | GEM5 | Very heavy weight<br>package (for<br>example: general<br>use medical<br>instruments) | 10 lbs. | 25 lbs. | 25 lbs. |

The following loads were used in STERIS V-PRO® 1, 1Plus, maX Sterility Maintenance Validation Studies:

- GEM1: 2.5 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (17 in. x 10 in. x 3.5 in.) at 4 los. ●
- GEM2: 5 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (17 in. x 10 in. x 3.5 in.) at 4 lbs. ●
- GEM3: 6 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (17 in. x 10 in. x 3.5 in.) at 4 lbs. ●
- GEM4: 5 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (21 in. x 10 in. x 3.5 in.) at 5 lbs. ●
- GEM5: 5 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (21 in. x 10 in. x 3.5 in.) at 5 lbs. ●

The following loads were used in STERIS V-PRO® 60 Sterility Maintenance Validation Studies:

- GEM1 GEM5: V-PRO® Tray (10 in. x 21 in. x 3.5 in.), metal mass to make final total weight tested ● above, and 6 forceps.
The follow loads were used in STERIZONE® VP4 Sterility Maintenance Validation Studies:

- GEM1-GEM2: Symmetry Medical MicroPack® Plastic Tray (15 in. x 1.5 in.), metal and non-● metal instruments to make final total weight recommended above.
- GEM3-GEM5: SteriPack Metal Tray (23 in. x 11 in. x 5 in.), metal and non-metal instruments to make . final total weight tested recommended above.

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 aded stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.

2 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 Sterilization Wrap (i.e.: the weight of the metal mass)

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Image /page/5/Picture/0 description: The image features the Medline logo set against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized starburst symbol. The starburst is white and appears to be composed of several elongated triangles converging at a central point, creating a dynamic and modern design.

# SECTION 5 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]

### Submitter / 510(k) Sponsor

Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060

Registration Number: 1417592

# Contact Person

Jennifer Mason Senior Regulatory Affairs Specialist Phone: [phone] Email: [e-mail]

Summary Preparation Date June 21, 2017

Type of 510(k) Submission Traditional

# Device Name / Classification

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

### Predicate Device

Gemini Sterilization Wrap K150698

# Reference Devices

Gemini Sterilization Wrap K152564

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Image /page/6/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in white, block letters on the left side of the square. To the right of the word is a white, stylized star shape. A small gray rectangle is in the upper right corner of the image.

Gemini Bonded Sterilization Wrap K152458

# Device Description

Gemini Sterilization Wraps are offered to the market place as bulk packages of single and two ply bonded sheets of wrap for use by customers in accordance with standard hospital practices which require that two sheets are used each time a medical device or collections of medical devices are wrapped. The bonded wrap is comprised of two sheets of Gemini Sterilization Wrap ultrasonically seamed on two parallel sides. This allows for convenient wrapping with two sheets simultaneously.

Gemini Sterilization Wrap items are square or rectangular sheets of non-woven fabric produced using a five-layer SSMMS (spunbond-spunbond-meltblown-meltblown-spunbond) process.

The standard blue wrap fabric is made of polypropylene with the addition of less than 2% of phthalocyanine blue pigmentation and less than 0.35% titanium dioxide white pigmentation. The wraps are offered in 3 different shades of blue that vary in the amount of phthalocyanine blue pigmentation depending on the weight of the wrap. Also, some wraps contain titanium dioxide and others do not. A detailed description of material composition can be found in the Device Description section.

The two-tone blue/pink wrap fabric is made of polypropylene with the addition of less than 2% phthalocyanine blue pigmentation, less than 0.5% of titanium dioxide white pigmentation and less than 2% of disazocondensation red pigmentation. The two-tone blue/pink wraps are offered in 3 different shades of blue and pink that vary in the amount of phthalocyanine, disazocondensation red and titanium dioxide depending on the weight of the wrap. A detailed description of material composition can be found in the Device Description section.

Gemini Sterilization Wrap is available in sizes ranging from 12" x 72" across five different material weights/models listed below. Photos showing the different material weights are listed in Figure 2 below. Additional product and size information is provided in Table 1 below. The material composition of the Gemini Sterilization Wrap is listed in Table 2. Details on the product variations and composition are also provided with Appendix B.

# Indications for Use

Gemini 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 until used. Gemini Sterilization Wrap is validated for use in the following sterilization processes modes and cycles:

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Image /page/7/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, bold, sans-serif font, stacked on top of a white stylized cross. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a symbol that suggests healthcare.

# TABLE 1: STERIS V-PRO® Low Temperature Sterilization Systems. The wrap was validated to be effectively aerated during the pre-programmed cycles

| Gemini Wrap Model | Gemini<br>Wrap<br>Weight | STERIS V-PRO® Low<br>Temperature Sterilization<br>Cycles |
|---------------------------|--------------------------|--------------------------------------------------------------------------------|
| GEM11XX/GEM11XXS/GEM11XXT | Lightweight | ■ STERIS V-PRO® 60 (Lumen, Non-<br>Lumen and Flexible Cycles) |
| GEM21XX/GEM11XXS/GEM11XXT | Regular Weight | |
| GEM31XX/GEM31XXS/GEM31XXT | Medium Weight | ■ STERIS V-PRO® 1 (Lumen Cycle)<br>(per K150698) |
| GEM41XX/GEM41XXS/GEM41XXT | Heavyweight | |
| GEM51XX/GEM51XXS/GEM51XXT | Super Heavyweight | ■ STERIS V-PRO® 1 Plus (Lumen and<br>Non-Lumen Cycle) (per K150698) |
| | | ■ STERIS V-PRO® maX (Lumen, Non-<br>Lumen, and Flexible Cycle)(per<br>K150698) |

### TABLE 2: STERIZONE® VP4 Sterilization System

| Gemini Wrap Model | Gemini<br>Wrap<br>Weight | STERIZONE® VP4<br>Sterilization System |
|---------------------------|--------------------------|------------------------------------------------------------------|
| GEM11XX/GEM11XXS/GEM11XXT | Lightweight | • STERIZONE® VP4 Sterilizer single<br>preset sterilization cycle |
| GEM21XX/GEM11XXS/GEM11XXT | Regular Weight | |
| GEM31XX/GEM31XXS/GEM31XXT | Medium Weight | |
| GEM41XX/GEM41XXS/GEM41XXT | Heavyweight | |
| GEM51XX/GEM51XXS/GEM51XXT | Super Heavyweight | |

#### TABLE 3: Wrap Model Recommendations1

| Gemini<br>Wrap<br>Weight | Gemini<br>Wrap<br>Model | Intended Load | Maximum Recommended Wrapped Package Content2 | | |
|--------------------------|-------------------------|------------------------------------------------------------------------------------------|----------------------------------------------|----------------------|------------------------------|
| | | | STERIS V-<br>PRO® 1,<br>1Plus, maX | STERIS V-<br>PRO 60® | STERIZONE® VP4<br>Sterilizer |
| Light<br>Weight | GEM1 | Light weight<br>package (for<br>example: standard<br>linen packs) | 6.5 lbs. | 6 lbs. | 6 lbs. |
| Regular<br>Weight | GEM2 | Light to moderate<br>weight package (for<br>example: general use<br>medical instruments) | 9 lbs. | 9 lbs. | 9 lbs. |
| Medium<br>Weight | GEM3 | Moderate to heavy<br>weight package (for | 10 lbs. | 13 lbs. | 13 lbs. |

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Image /page/8/Picture/0 description: The image features the Medline logo set against a blue background. The logo consists of the word "MEDLINE" in bold, sans-serif font, positioned to the left of a stylized, white starburst symbol. The starburst has four points, with the top and bottom points being more elongated than the side points. A gray bar is visible on the right edge of the image, partially obscuring the blue background.

| | | example: general use<br>medical instruments) | | | |
|--------------------------|------|-----------------------------------------------------------------------------------|---------|---------|---------|
| Heavy<br>Weight | GEM4 | Heavy weight<br>package (for<br>example: general use<br>medical instruments) | 10 lbs. | 17 lbs. | 17 lbs. |
| Super<br>Heavy<br>Weight | GEM5 | Very heavy weight<br>package (for<br>example: general use<br>medical instruments) | 10 lbs. | 25 lbs. | 25 lbs. |

The following loads were used in STERIS V-PRO® 1, 1Plus, maX Sterility Maintenance Validation Studies:

- GEM1: 2.5 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (17 in. x 10 in. x 3.5 in.) at 4 lbs. ●
- . GEM2: 5 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (17 in. x 10 in. x 3.5 in.) at 4 lbs.
- GEM3: 6 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (17 in. x 10 in. x 3.5 in.) at 4 lbs. ●
- GEM4: 5 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (21 in. x 10 in. x 3.5 in.) at 5 lbs. ●
- GEM5: 5 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (21 in. x 10 in. x 3.5 in.) at 5 lbs. ●

The following loads were used in STERIS V-PRO® 60 Sterility Maintenance Validation Studies:

- GEM1 GEM5: V-PRO® Tray (10 in. x 21 in. x 3.5 in.), metal mass to make final total weight tested ● above, and 6 forceps.
The follow loads were used in STERIZONE® VP4 Sterility Maintenance Validation Studies:

- GEM1-GEM2: Symmetry Medical MicroPack® Plastic Tray (15 in. x 10 in. x 1.5 in.), metal and non-● metal instruments to make final total weight recommended above.
- . GEM3-GEM5: SteriPack Metal Tray (23 in. x 11 in. x 5 in.), metal and non-metal instruments to make final total weight tested recommended above.

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.

2 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 Sterilization Wrap (i.e .: the weight of the metal mass)

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Image /page/9/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked on top of a white starburst-like shape. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a visual element that suggests energy or innovation.

# Summary of Technological Characteristics

# TABLE 3: Comparison of Proposed and Predicate Devices

| Device<br>Characteristic | Proposed Device | Predicate Device | Reference Devices | Comparison<br>Analysis |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Product Name | Gemini Sterilization<br>Wrap | Gemini Sterilization<br>Wrap | Gemini and Gemini<br>Bonded Sterilization<br>Wrap | Same |
| 510(k) Reference | | K150698 | K152564<br>K152458 | N/A |
| Product Owner | Medline Industries, Inc. | Medline Industries, Inc. | Medline Industries, Inc. | Identical |
| Product Code | FRG | FRG | FRG | Identical |
| Intended Use | Gemini Sterilization<br>Wraps are intended to be<br>used to enclose another<br>medical device that is to<br>be sterilized by a health<br>care provider. It is<br>intended to allow<br>sterilization of the<br>enclosed medical device<br>and also to maintain<br>sterility of such content<br>until used. | The Gemini Single Ply<br>and Bonded Wraps are<br>intended to allow<br>sterilization of the<br>enclosed medical<br>device(s) and also to<br>maintain sterility of the<br>enclosed medical<br>device(s) within the<br>period of time for which<br>performance data<br>demonstrating<br>maintenance of sterility<br>has been provided. | Gemini and Gemini<br>Bonded Sterilization<br>Wraps are intended to<br>be used to enclose<br>another medical device<br>that is to be sterilized<br>by a health care<br>provider. It is intended<br>to allow sterilization of<br>the enclosed medical<br>device and also to<br>maintain sterility of<br>such content until used. | Identical to<br>K152564 and<br>K152458.<br>Similar to<br>K150698. |
| Regulation Number | 21 CFR 880.6850 | 21 CFR 880.6850 | 21 CFR 880.6850 | Identical |
| Design Features | Square or rectangular<br>sheets manufactured by<br>spunbond-meltblown<br>process | Square or rectangular<br>sheets manufactured by<br>spunbond-meltblown<br>process | Square or rectangular<br>sheets manufactured by<br>spunbond-meltblown<br>process | Identical |
| Design<br>Configurations | 12 in. x 12 in. to 54 in. x<br>90 in. | 12 in. x 12 in. to 54 in. x<br>90 in. | 12 in. x 12 in. to 54 in.<br>x 90 in. | Identical |
| Materials | Polypropylene with<br>phthalocyanine blue,<br>titanium dioxide and<br>disazocondensation red | Polypropylene with<br>phthalocyanine blue,<br>titanium dioxide | Polypropylene with<br>phthalocyanine blue,<br>titanium dioxide and<br>disazocondensation red | Similar to<br>K150698.<br>Identical to<br>K152564 and<br>K152458. |
| Wrapping<br>Technique | Sequential/simultaneous<br>double wrapping | Sequential/simultaneous<br>double wrapping | Sequential/simultaneous<br>double wrapping | Identical |
| Bonding Material | Ultrasonically seamed in<br>a dotted line pattern | Ultrasonically seamed in<br>a dotted line pattern | Ultrasonically seamed<br>in a dotted line pattern | Identical |
| Prescription vs.<br>OTC | OTC | OTC | OTC | Identical |
| Sterilization | Sterizone VP4<br>V-PRO® 60 (Lumen,<br>Non-Lumen, Flexible)<br>V-PRO® 1 (Lumen<br>cycle)<br>V-PRO® 1 Plus (Lumen,<br>Non-Lumen)<br>V-PRO® maX (Lumen,<br>Non-Lumen, Flexible) | V-PRO® 1 (Lumen<br>cycle)<br>V-PRO® 1 Plus (Lumen,<br>Non-Lumen)<br>V-PRO® maX (Lumen,<br>Non-Lumen, Flexible) | Pre-vacuum steam<br>Gravity steam<br>STERRAD 50, 200S<br>and 100NX DUO<br>Cycles | Different |
| Disposable vs. Non-<br>Disposable | Disposable | Disposable | Disposable | Identical |
| Single Use vs.<br>Reusable | Single Use Only | Single Use Only | Single Use Only | Identical |
| Maintenance of<br>Sterility | V-PRO® 1 – 1 year*<br>V-PRO® 1 Plus – 1<br>year*<br>V-PRO® maX – 1 year*<br>V-PRO® 60 - 1 year<br>Sterizone VP4 - 1 year | 30 days | Steam – 2 years<br>STERRAD – 180 days | Different |

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Image /page/10/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, sans-serif font, stacked vertically. A white, stylized starburst symbol is positioned behind the text, with its points extending above and below the word "MEDLINE".

*Sterilization cycles cleared in previous 510(k)'s are included here due to the additional indication for use of maintenance of sterility now being 1 year.

# Summary of Non-Clinical Testing

# TABLE4: Summary of Performance Testing V-PRO® 60

| Performance Study | Performance Results |
|----------------------------------------------------------------------------------------|---------------------|
| Maintenance of Sterility | Passed |
| Sterilant Penetration | Passed |
| Tensile breaking strength and elongation (ASTM D5034) | Passed |
| Tear Strength (ASTM D5587) | Passed |
| Hydrostatic Pressure (AATCC 127) | Passed |
| Burst Pressure (ASTM D3786) | Passed |
| Air Permeability (ASTM D737) | Passed |
| Post Sterilization Biocompatibility (Cytotoxicity – ISO 10993-5 | Passed |
| Post Sterilization Biocompatibility (Primary Skin Irritation<br>Testing- ISO 10993-10) | Passed |

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Image /page/11/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, set against a blue square background. Above the word, there is a white star-like symbol with four points. To the right of the blue square, there is a gray vertical bar.

#### TABLE 5: Summary of Performance Testing Sterizone VP4

| Performance Study | Performance Results |
|----------------------------------------------------------------------------------------|---------------------|
| Maintenance of Sterility | Passed |
| Sterilant Penetration | Passed |
| Tensile breaking strength and elongation (ASTM D5034) | Passed |
| Tear Strength (ASTM D5587) | Passed |
| Hydrostatic pressure (AATCC 127) | Passed |
| Air Permeability (ASTM D737) | Passed |
| Post Sterilization Biocompatibility (Cytotoxicity – ISO 10993-5 | Passed |
| Post Sterilization Biocompatibility (Primary Skin<br>Irritation Testing- ISO 10993-10) | Passed |

# Summary of Clinical Testing

Not applicable.

### Conclusion

In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Gemini Sterilization Wrap is as safe and as effective for their intended use as the predicate device Gemini Sterilization Wrap (K150698).