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: STERIS V-PRO® Low Temperature Sterilization Systems (STERIS V-PRO® 60, STERIS V-PRO® 1, STERIS V-PRO® 1 Plus, STERIS V-PRO® maX) and STERIZONE® VP4 Sterilization System.

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.

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.

Gemini Sterilization Wrap is available in sizes ranging from 12" x 72" across five different material weights/models listed below.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device (Gemini Sterilization Wrap) and does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-based medical device.

Instead, it details the substantial equivalence of the Gemini Sterilization Wrap to a predicate device based on physical and sterilization performance testing. The "performance studies" mentioned (Tables 4 and 5) evaluate the physical properties of the wrap (e.g., tensile strength, tear strength, hydrostatic pressure, air permeability) and its ability to maintain sterility and allow sterilant penetration. They also include biocompatibility testing.

Therefore, I cannot extract the information required for the requested table and study details (sample size, data provenance, expert ground truth, MRMC study, training set details) as they pertain to an AI/ML device, because this document describes a physical medical device.

To directly answer your prompt based on the provided document, I must state that the document does not contain the information required to populate the fields related to AI/ML device studies.

Here's why and what the document does provide:

No AI/ML information: The entire document is about a physical sterilization wrap. There is no mention of algorithms, machine learning, AI, image analysis, or any computational aspect.
Device Type: Gemini Sterilization Wrap is a non-woven fabric used for packaging medical devices for sterilization.
Acceptance Criteria & Performance: The document lists various non-clinical performance studies (Tables 4 & 5) and states they "Passed." These are the "acceptance criteria" and "reported device performance" in the context of this physical device.
- Acceptance Criteria (implicit by "Passed"): The wrap must:
  - Maintain sterility.
  - Allow sterilant penetration.
  - Meet specified tensile breaking strength and elongation (ASTM D5034).
  - Meet specified tear strength (ASTM D5587).
  - Meet specified hydrostatic pressure (AATCC 127).
  - Meet specified burst pressure (ASTM D3786 - for V-PRO 60 only).
  - Meet specified air permeability (ASTM D737).
  - Pass post-sterilization biocompatibility (Cytotoxicity – ISO 10993-5).
  - Pass post-sterilization biocompatibility (Primary Skin Irritation Testing – ISO 10993-10).
Study Proving Acceptance: The document summarizes non-clinical performance testing for both V-PRO® 60 and Sterizone VP4 sterilization systems for various Gemini Wrap models.

Therefore, the requested table and answers regarding AI/ML specifics cannot be generated from this document.

If this were an AI/ML device, the missing information would typically include details like:

Sample size for test set: Number of images/cases used to evaluate the AI.
Data provenance: Where the data came from (e.g., specific hospitals, demographics, geographical regions), and if it was collected retrospectively or prospectively.
Experts for ground truth: How many experts reviewed the data to determine the "correct" labels/diagnoses.
Qualifications of experts: Their specialties, years of experience, board certifications.
Adjudication method: How disagreements among experts were resolved (e.g., 2 out of 3, a super-expert, discussion).
MRMC study: If human performance with and without AI assistance was compared.
Effect size: The quantifiable improvement in human performance with AI.
Standalone performance: The AI's performance without human interaction.
Type of ground truth: Whether it was based on expert consensus, pathology reports, clinical outcomes, etc.
Training set size: The number of images/cases used to train the AI model.
Training set ground truth: How the labels/ground truth for the training data were established.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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	GeminiWrapWeight	STERIS V-PRO® LowTemperature SterilizationCycles
GEM11XX/GEM11XXS/GEM11XXT	Lightweight	■ STERIS V-PRO® 60 (Lumen, Non-Lumen and Flexible Cycles)
GEM21XX/GEM11XXS/GEM11XXT	Regular Weight	■ STERIS V-PRO® 1 (Lumen Cycle)(per K150698)
GEM31XX/GEM31XXS/GEM31XXT	Medium Weight	■ STERIS V-PRO® 1 Plus (Lumen andNon-Lumen Cycle) (per K150698)
GEM41XX/GEM41XXS/GEM41XXT	Heavyweight	■ STERIS V-PRO® maX (Lumen, Non-Lumen, and Flexible Cycle)(perK150698)
GEM51XX/GEM51XXS/GEM51XXT	Super Heavyweight

TABLE 2: STERIZONE® VP4 Sterilization System

Gemini Wrap Model	GeminiWrapWeight	STERIZONE® VP4Sterilization 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 WrapWeight	GeminiWrapModel	Intended Load	Maximum Recommended Wrapped PackageContent2STERIS V-PRO® 1,1Plus, maX	STERIS V-PRO 60®	STERIZONE®VP4 Sterilizer
Light Weight	GEM1	Light weightpackage (forexample: standardlinen packs)	6.5 lbs.	6 lbs.	6 lbs.
RegularWeight	GEM2	Light to moderateweight package (forexample: generaluse medicalinstruments)	9 lbs.	9 lbs.	9 lbs.
MediumWeight	GEM3	Moderate to heavyweight package (forexample: generaluse medicalinstruments)	10 lbs.	13 lbs.	13 lbs.
Heavy Weight	GEM4	Heavy weightpackage (for	10 lbs.	17 lbs.	17 lbs.

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		example: generaluse medicalinstruments)
Super HeavyWeight	GEM5	Very heavy weightpackage (forexample: generaluse medicalinstruments)	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: 847-643-3652 Email: jamason@medline.com

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

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

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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	GeminiWrapWeight	STERIS V-PRO® LowTemperature SterilizationCycles
GEM11XX/GEM11XXS/GEM11XXT	Lightweight	■ STERIS V-PRO® 60 (Lumen, Non-Lumen and Flexible Cycles)
GEM21XX/GEM11XXS/GEM11XXT	Regular Weight
GEM31XX/GEM31XXS/GEM31XXT	Medium Weight	■ STERIS V-PRO® 1 (Lumen Cycle)(per K150698)
GEM41XX/GEM41XXS/GEM41XXT	Heavyweight
GEM51XX/GEM51XXS/GEM51XXT	Super Heavyweight	■ STERIS V-PRO® 1 Plus (Lumen andNon-Lumen Cycle) (per K150698)
		■ STERIS V-PRO® maX (Lumen, Non-Lumen, and Flexible Cycle)(perK150698)

TABLE 2: STERIZONE® VP4 Sterilization System

Gemini Wrap Model	GeminiWrapWeight	STERIZONE® VP4Sterilization System
GEM11XX/GEM11XXS/GEM11XXT	Lightweight	• STERIZONE® VP4 Sterilizer singlepreset 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

GeminiWrapWeight	GeminiWrapModel	Intended Load	Maximum Recommended Wrapped Package Content2
			STERIS V-PRO® 1,1Plus, maX	STERIS V-PRO 60®	STERIZONE® VP4Sterilizer
LightWeight	GEM1	Light weightpackage (forexample: standardlinen packs)	6.5 lbs.	6 lbs.	6 lbs.
RegularWeight	GEM2	Light to moderateweight package (forexample: general usemedical instruments)	9 lbs.	9 lbs.	9 lbs.
MediumWeight	GEM3	Moderate to heavyweight 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 usemedical instruments)
HeavyWeight	GEM4	Heavy weightpackage (forexample: general usemedical instruments)	10 lbs.	17 lbs.	17 lbs.
SuperHeavyWeight	GEM5	Very heavy weightpackage (forexample: general usemedical 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.

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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

DeviceCharacteristic	Proposed Device	Predicate Device	Reference Devices	ComparisonAnalysis
Product Name	Gemini SterilizationWrap	Gemini SterilizationWrap	Gemini and GeminiBonded SterilizationWrap	Same
510(k) Reference		K150698	K152564 K152458	N/A
Product Owner	Medline Industries, Inc.	Medline Industries, Inc.	Medline Industries, Inc.	Identical
Product Code	FRG	FRG	FRG	Identical
Intended Use	Gemini SterilizationWraps are intended to beused to enclose anothermedical device that is tobe sterilized by a healthcare provider. It isintended to allowsterilization of theenclosed medical deviceand also to maintainsterility of such contentuntil used.	The Gemini Single Plyand Bonded Wraps areintended to allowsterilization of theenclosed medicaldevice(s) and also tomaintain sterility of theenclosed medicaldevice(s) within theperiod of time for whichperformance datademonstratingmaintenance of sterilityhas been provided.	Gemini and GeminiBonded SterilizationWraps are intended tobe used to encloseanother medical devicethat is to be sterilizedby a health careprovider. It is intendedto allow sterilization ofthe enclosed medicaldevice and also tomaintain sterility ofsuch content until used.	Identical toK152564 andK152458.Similar toK150698.
Regulation Number	21 CFR 880.6850	21 CFR 880.6850	21 CFR 880.6850	Identical
Design Features	Square or rectangularsheets manufactured byspunbond-meltblownprocess	Square or rectangularsheets manufactured byspunbond-meltblownprocess	Square or rectangularsheets manufactured byspunbond-meltblownprocess	Identical
DesignConfigurations	12 in. x 12 in. to 54 in. x90 in.	12 in. x 12 in. to 54 in. x90 in.	12 in. x 12 in. to 54 in.x 90 in.	Identical
Materials	Polypropylene withphthalocyanine blue,titanium dioxide anddisazocondensation red	Polypropylene withphthalocyanine blue,titanium dioxide	Polypropylene withphthalocyanine blue,titanium dioxide anddisazocondensation red	Similar toK150698.Identical toK152564 andK152458.
WrappingTechnique	Sequential/simultaneousdouble wrapping	Sequential/simultaneousdouble wrapping	Sequential/simultaneousdouble wrapping	Identical
Bonding Material	Ultrasonically seamed ina dotted line pattern	Ultrasonically seamed ina dotted line pattern	Ultrasonically seamedin a dotted line pattern	Identical
Prescription vs.OTC	OTC	OTC	OTC	Identical
Sterilization	Sterizone VP4V-PRO® 60 (Lumen,Non-Lumen, Flexible)V-PRO® 1 (Lumencycle)V-PRO® 1 Plus (Lumen,Non-Lumen)V-PRO® maX (Lumen,Non-Lumen, Flexible)	V-PRO® 1 (Lumencycle)V-PRO® 1 Plus (Lumen,Non-Lumen)V-PRO® maX (Lumen,Non-Lumen, Flexible)	Pre-vacuum steamGravity steamSTERRAD 50, 200Sand 100NX DUOCycles	Different
Disposable vs. Non-Disposable	Disposable	Disposable	Disposable	Identical
Single Use vs.Reusable	Single Use Only	Single Use Only	Single Use Only	Identical
Maintenance ofSterility	V-PRO® 1 – 1 yearV-PRO® 1 Plus – 1yearV-PRO® maX – 1 year*V-PRO® 60 - 1 yearSterizone VP4 - 1 year	30 days	Steam – 2 yearsSTERRAD – 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 IrritationTesting- 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 SkinIrritation 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).

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).