The Gemini Single Ply and Bonded Sterilization Wraps are intended to allow sterilization of the enclosed medical devices(s) and also maintain sterility of the enclosed medical device(s) within the period of time for which performance data demonstrating maintenance of sterility has been provided.

The Gemini Single Ply and Bonded Sterilization Wraps have been validated for use with Lumen, Non Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus, and Amsco® V-PRO™ maX Low Temperature Sterilization Systems.

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 the Gemini Sterilization Wrap ultrasonically seamed on two parallel sides. This allows for convenient wrapping with two sheets simultaneously. The wrap allows for aseptic opening of the sterilized package.

Gemini Sterilization Wrap items are square or rectangular sheets of 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 5 different shades of blue that vary in the amount of phthalocyanine blue pigmentation depending on the weight of the wrap. The lightest weight wrap has the least amount of blue pigment and the super heavy weight has the highest amount. Also, some wraps contain titanium dioxide and others do not.

Gemini Sterilization Wrap is available in sizes ranging from 12"x12" to 54"x72" across five different material weights/models.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Medline Gemini Sterilization Wrap. However, the provided text does not contain information about a study that assesses a device's performance against detailed acceptance criteria for an AI/CADe device, nor does it involve human readers improving with AI assistance, ground truth establishment by experts, or training/test sets as would be typical for such a device.

The document is for a medical device (sterilization wrap) which is evaluated based on its ability to maintain sterility and its physical properties. The testing described is primarily bench testing and biocompatibility testing, not clinical performance or AI algorithm validation.

Therefore, I cannot fulfill your request using the provided input, as the information required for an AI/CADe device's acceptance criteria and study proving its performance against those criteria is simply not present in this regulatory submission for a sterilization wrap.

To provide a descriptive answer, the input must be a regulatory document for an AI/CADe device, or a device that involves image analysis, diagnosis, or has a human-in-the-loop component with AI assistance.

Summary

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Public Health Service

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

November 20, 2015

Medline Industries. Inc. Ms. Jennifer Mason Senior Regulatory Affairs Specialist 1 Medline Place Mundelein, IL 60060

Re: K150698

Trade/Device Name: Gemini Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: October 16, 2015 Received: October 19, 2015

Dear Ms. 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

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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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Erin | Keith -S

Erin I. Keith, M.S. 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

510(k) Number (if known)

Device Name Gemini Sterilization Wrap

Indications for Use (Describe)

The Gemini Single Ply and Bonded Sterilization Wraps have been validated for use with Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO™ 1. Amsco® V-PRO™ 1 Plus, and Amsco® V-PRO™ maX Low Temperature Sterilization Systems.

Table 1 provides a listing of validated sterilization cycles

Table 2 provides recommended weights for each wrap model

Table 3 provides maintenance of package sterility recommendations

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 - Validated STERIS Amsco® V-PRO™ Cycles
Amsco® V-PRO™ Cycle	Maximum Recommended Chamber Load	Intended Load
Lumen Cycle	19.65 lbs.	Reusable metal and non-metal medical devices, including up to 20 lumens of the following dimensions per chamber load:• An inside diameter of 1 mm or larger and a length of 125 mm or shorter• An inside diameter of 2 mm or larger and a length of 250 mm or shorter• An inside diameter of 3 mm or larger and a length of 400 mm or shorter
Non Lumen Cycle	19.65 lbs.	Non-lumened reusable metal and non-metal medical devices
Flexible Cycle	24 lbs.	Single or dual lumen surgical flexible endoscopes and bronchoscopes in either of two load configurations:1. Two trays, each containing a flexible endoscope with a light cord (if not integral to endoscope) and mat with no additional load2. One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat and an additional tray containing non-lumened medical devicesThe flexible endoscopes(s) may contain either:• A single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter• Two lumens, with one lumen having an inside diameter of 1 mm or larger and length of 998 mm or shorter and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter

Table 1 – Validated STERIS Amsco® V-PRO™ Cycles

Gemini Single Ply and Bonded Sterilization Wraps Recommendations for Use with the STERIS Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus, and Amsco® V-PRO™ maX Low Temperature Sterilization Systems are provided in Table 3.

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Gemini WrapWeight	Item NumberSeries	Intended Load	MaximumRecommendedWrapped PackageContent	Description of Loads Used inSterility Maintenance ValidationStudy²
Light Weight	GEM1XXXGEM11XXS	Light WeightPackage (forexample:telescope withlight cord)	6.5 lbs.	2.5 lbs. metal mass6 forcepsV-PRO tray (17" x 10" x 3 ½") at4 lbs.
Regular Weight	GEM2XXXGEM21XXS	Light to ModerateWeight Package(for example:general usemedicalinstruments)	9 lbs.	5 lbs. metal mass6 forcepsV-PRO tray (17" x 10" x 3 ½") at4 lbs.
Medium Weight	GEM3XXXGEM31XXS	Moderate toHeavy WeightPackage (forexample: generaluse medicalinstruments)	10 lbs.	6 lbs. metal mass6 forcepsV-PRO tray (17" x 10" x 3 ½") at4 lbs.
Heavyweight	GEM4XXXGEM41XXS	HeavyweightPackage (forexample: generaluse medicalinstruments)	10 lbs.	5 lbs. metal mass6 forcepsV-PRO tray (17" x 10" x 3 ½") at5 lbs.
SuperHeavyweight	GEM5XXXGEM51XXS	VeryHeavyweightPackage (forexample: generaluse medicalinstruments)	10 lbs.	5 lbs. metal mass6 forcepsV-PRO tray (17" x 10" x 3 ½") at5 lbs.

Table 2 – Wrap Model Recommendations for STERIS Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus, and
Amsco® V-PRO" maX Low Temperature Sterilization'

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.

if 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 size of individual content types that were validated for the Gemini Single Ply and Bonded Sterilization Wraps (i.e.: the weight of the metal mass).

		Table 3 - Maintenance of Package Sterility Recommendations

Models	V-PRO Cycles
Gemini Sterilization Wrap Single Play and Bonded	30 days

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Image /page/5/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in white, bold sans-serif font, positioned to the left of a stylized white starburst or cross-like symbol. The starburst is oriented vertically, with its points extending upwards and downwards from the center. A small portion of a gray rectangle is visible on the right edge of the image.

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 November 19, 2015

Type of 510(k) Submission Traditional

Device Name / Classification

Name of Device: Gemini Sterilization Wrap Proprietary Name: Gemini Sterilization Wrap Common Name: Sterilization Wrap Classification Name: Sterilization Wrap Product Code: FRG Classification Panel: General Hospital

Predicate Device KIMGUARD ONE-STEP Sterilization Wrap PREDICATE DEVICE K112805

Device Description

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Image /page/6/Picture/0 description: The image is a logo for Medline. The logo consists of the word "MEDLINE" in a sans-serif font, with a white cross-like symbol behind the text. The background is a solid dark blue color. The logo is simple and clean, with a professional look.

ne Medline Place

parallel sides. This allows for convenient wrapping with two sheets simultaneously. The wrap allows for aseptic opening of the sterilized package.

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

Gemini Sterilization Wrap is available in sizes ranging from 12"x12" to 54"x72" across five different material weights/models.

Indications for Use

The Gemini Single Ply and Bonded Sterilization Wraps have been validated for use with Lumen. Non Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus, and Amsco® V-PRO™ maX Low Temperature Sterilization Systems.

Table 1 provides a listing of validated sterilization cycles

Table 2 provides recommended weights for each wrap model

Table 3 provides maintenance of package sterility recommendations

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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, stacked vertically, and placed to the left of a white starburst-like symbol. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a recognizable symbol.

Table 1 – Validated STERIS Amsco® V-PRO™ Cycles

Amsco® V-PROTMCycle	MaximumRecommendedChamber Load	Intended Load
Lumen Cycle	19.65 lbs.	Reusable metal and non-metal medical devices, including up to 20 lumens of the following dimensions per chamber load:• An inside diameter of 1 mm or larger and a length of 125 mm or shorter• An inside diameter of 2 mm or larger and a length of 250 mm or shorter• An inside diameter of 3 mm or larger and a length of 400 mm or shorter
Non Lumen Cycle	19.65 lbs.	Non-lumened reusable metal and non-metal medical devices
Flexible Cycle	24 lbs.	Single or dual lumen surgical flexible endoscopes and bronchoscopes in either of two load configurations:1. Two trays, each containing a flexible endoscope with a light cord (if not integral to endoscope) and mat with no additional load2. One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat and an additional tray containing non-lumened medical devicesThe flexible endoscopes(s) may contain either:• A single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter• Two lumens, with one lumen having an inside diameter of 1 mm or larger and length of 998 mm or shorter and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter

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Image /page/8/Picture/0 description: The image shows the Medline logo, which features the word "MEDLINE" in white, bold, sans-serif font. The word is positioned diagonally across a white, stylized starburst symbol. The background is a solid dark blue color, and there is a small gray rectangle in the upper right corner of the image.

Gemini Single Ply and Bonded Sterilization Wraps Recommendations for Use with the STERIS Amsco® V-PRO™1, Amsco® V-PRO™ 1 Plus, and Amsco® V-PRO™ maX Low Temperature Sterilization systems are provided in Table 3.

Table 2 - Wrap Model Recommendations for STERIS Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus, and Amsco® V-PRO™ maX Low Temperature Sterilization1

GeminiWrapWeight	ItemNumberSeries	IntendedLoad	MaximumRecommendedWrappedPackageContent	Description of Loads Used inSterility Maintenance ValidationStudy2
Light Weight	GEM11XXGEM11XXS	Light WeightPackage (forexample:telescope withlight cord)	6.5 lbs.	2.5 lbs. metal mass6 forcepsV-PRO tray (17" x 10" x 3 ½") at 4 lbs.
RegularWeight	GEM21XXGEM21XXS	Light toModerateWeight Package(for example:general usemedicalinstruments)	9 lbs.	5 lbs. metal mass6 forcepsV-PRO tray (17" x 10" x 3 ½") at 4 lbs.
MediumWeight	GEM31XXGEM31XXS	Moderate toHeavy WeightPackage (forexample: generaluse medicalinstruments)	10 lbs.	6 lbs. metal mass6 forcepsV-PRO tray (17" x 10" x 3 ½") at 4 lbs.
Heavyweight	GEM41XXGEM41XXS	HeavyweightPackage (forexample: generaluse medicalinstruments)	10 lbs.	5 lbs. metal mass6 forcepsV-PRO tray (17" x 10" x 3 ½") at 5 lbs.
SuperHeavyweight	GEM51XXGEM51XXS	VeryHeavyweightPackage (forexample: generaluse medicalinstruments	10 lbs.	5 lbs. metal mass6 forcepsV-PRO tray (17" x 10" x 3 ½") at 5 lbs.

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Image /page/9/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with the letters stacked vertically. To the right of the word is a white starburst symbol. The background of the logo is a dark blue square.

Table 3 - Maintenance of Package Sterility Recommendations

Models	V-PRO Cycles
Gemini Sterilization Wrap Single Play and Bonded	30 days

Summary of Technological Characteristics

Comparison of Proposed and Predicate Devices

DeviceCharacteristic	Proposed Device	Predicate Device	ComparisonAnalysis
Product Name	Gemini Sterilization Wrap	KIMGUARD ONE-STEPSterilization Wrap
510(k) Reference		K112805
Product Owner	Medline Industries, Inc	Kimberly Clark
Product Code	FRG	FRG	Same
Intended Use	The Gemini Single Plyand BondedSterilization Wraps areintended to encloseanother medical devicethat is to be sterilizedby a health careprovider using:• Lumen, NonLumen, andFlexibleCycles by theSTERISAmsco V-PRO, AmscoV-PRO 1 Plu,and amsco V-PRO maXLowTemperatureSterilizationSystems.	KIMGUARD ONE-STEP*Sterilization Wrap is intended tobe used to enclose anothermedical device that is to besterilized by a healthcareprovider in the Amsco® V-PRO™ 1 Low TemperatureSterilization System's Cycle,The Amsco® V-PRO™ 1 PlusLow Temperature SterilizationSystem's Lumen (Identical tothe V-PRO™ 1 Cycle), andNon Lumen Cycles, and The V-PRO™ Low TemperatureSterilization System's FlexibleCycle. The wrap is intended tomaintain sterility of theenclosed device(s) until openedwithin the period of time forwhich performance datademonstrating maintenance ofsterility has been provided.	Similar
sterilization of theenclosed medicaldevice(s) and alsomaintain sterility of theenclosed device(s)until used, whichcomplies with 21 CFR880.6850. "Asterilization wrap(pack, sterilizationwrapper, bag, oraccessories) is a deviceintended to be used toenclose anothermedical device that isto sterilized by ahealthcare provider. Itis intended to allowsterilization of theenclosed medicaldevice and also tomaintain sterility of theenclosed device untilused."
Regulation Number	21 CFR 880.6850	21 CFR 880.6850	Same
Design Features	Single Ply and Bonded with anultrasonic seam	Bonded with an ultrasonic seam	Similar
Sizes	12"x12" to 54"x72"	12"x12" to 54"x72"	Same
Materials	Polypropylene Spunbond-Spunbond-meltblown-meltblown-spunbond nonwovenfabric	Polypropylene Spunbond-meltblown-spunbond (SMS0Trilaminate nonwoven fabric	Similar
Prescription vs. OTC	OTC	OTC	Same
Sterilization	Lumen, Non Lumen, andFlexible Cycles by the STERISAmsco V-PRO1, AMSCO V-PRO 1 Plus, and Amsco V-PROmaX Low TemperatureSterilization Systems	Lumen, Non Lumen, andFlexible Cycle in the Amsco V-Pro 1, Amsco V-PRO 1 Plus,and Amsco V-PRO maX LowTemperature SterilizationSystems	Same
Wrapping Technique	Sequential/simultaneous doublewrapping	Simultaneous double wrapping	Similar
Disposable vs. Non-Disposable	Disposable	Disposable	Same
Single Use vs. Reusable	Single Use	Single Use	Same
BiocompatibilityTesting	Pass	Pass	Same
Event RelatedMaintenance ofPackage Sterility	Pass	Pass	Same

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Image /page/10/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo consists of the word "MEDLINE" in bold, sans-serif font, positioned to the left of a stylized, four-pointed star-like symbol. The background is a solid, dark blue color, providing a strong contrast to the white text and symbol. The overall design is clean and professional, reflecting the company's focus on healthcare solutions.

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Image /page/11/Picture/0 description: The image shows the logo for Medline. The logo features the word "MEDLINE" in white, bold, sans-serif font, stacked above a white, stylized starburst symbol. The background is a solid dark blue color. A small portion of a gray rectangle is visible on the right side of the image.

Summary of Non-Clinical Testing

Biocompatibility Testing

The biocompatibility evaluation for Gemini Sterilization Wrap was conducted in accordance with ANSI/AAMI/ISO 10993-1:2009 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. Gemini Sterilization Wrap is classified as non-patient contacting devices. Specific biocompatibility tests were selected under the guidance of ISO 10993-1:2009 Annex A.

The following tests were performed to evaluate the biocompatibility of Gemini Sterilization Wrap:

ISO 10993-10: Irritation Intracutaneous reactivity; and ●
. ISO 10993-10: Delayed-Type Hypersensitivity (Sensitization) – Guinea Pig Maximization Test

A study was performed on the Gemini Sterilization Wrap by analysis of semi-volatile and elemental leachables utilizing inductively coupled plasma-mass spectrometry (ICP-MS) and highperformance liquid chromatography (HPLC-MS).

Performance Testing (Bench)

Medline Gemini Wraps were evaluated through a series of performance tests including tensile breaking strength and elongation (ASTM D5034), tearing strength (ASTM D5587), hydrostatic pressure (AATCC 127), and air permeability (ASTM D737).

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 Wraps are as safe and as effective and substantially equivalent to the predicate KIMGUARD ONE-STEP Sterilization Wrap (K112805)] as described herein.

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).