Gemini Bonded 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 such content for 180 days following sterilization. Gemini Bonded Sterilization Wrap is validated for use in steam or STERRAD® sterilization processes in the following sterilization modes and cycles.

Pre-vacuum steam cycles
- Minimum 4 Minutes Exposure at 270°F/132°C with minimum 20 minutes dry time
Gravity steam cycles
- Maximum 30 Minutes Exposure at 250°F/121°C with minimum 20 minutes dry time
STERRAD® Sterilization
- STERRAD® 100NX, Flex cycle
- STERRAD® 100NX, Standard cycle
- STERRAD® 100NX, Express cycle
- STERRAD® 100S. Standard cycle
- STERRAD® NX, Advanced cycle
- STERRAD® NX, Standard cycle

Device Description

Gemini Bonded Sterilization Wrap is comprised of two ply sheets ultrasonically bonded together 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 Gemini Bonded Sterilization Wrap provides the protection of double-wrapping in an efficient manner; reducing wrapping/unwrapping time significantly compared to traditional double-wrapping methods. Gemini Bonded Sterilization Wrap items are square or rectangular sheets of fabric produced using a five-layer SSMMS (spunbondspunbond-meltblown-meltblown-spunbond) process. The standard blue wrap fabric is made of polypropylene with the addition of blue and white pigmentation. The wrap allows for aseptic opening of the sterilized package. The two-tone blue/pink wrap fabric is made of polypropylene with the addition of blue, white and red pigmentation. The wrap allows for aseptic opening of the sterilized package. Gemini sterilization wrap is available in sizes ranging from 12"x12" to 54"x72" across five different material weights/models.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the Gemini Bonded Sterilization Wrap meets these criteria.

Here's the breakdown:

1. Table of acceptance criteria and the reported device performance

Test Objective	Acceptance Criteria (based on standards)	Reported Device Performance
Primary Skin Irritation Testing	Meets ISO 10993-10 Requirements	Meets ISO Requirements
Microbial Barrier Properties	Meets ISO 11607-1 and ASTM F1980 Requirements	Meets ISO and ASTM Requirements
Sterilization Efficacy (General)	Allow sterilization and maintain sterility for 180 days	Validated for use in steam or STERRAD® sterilization processes and maintains sterility for 180 days.
Specific Sterilization Cycles:	Minimum exposure/dry times, and specific loads	The device was validated for the following:
Pre-vacuum steam cycles	Minimum 4 Minutes Exposure at 270°F/132°C with minimum 20 minutes dry time	Validated for the specified cycle with various loads (Lightweight 6 lbs, Regular Weight 9 lbs, Medium Weight 13 lbs, Heavyweight 17 lbs, Super Heavyweight 25 lbs).
Gravity steam cycles	Maximum 30 Minutes Exposure at 250°F/121°C with minimum 20 minutes dry time	Validated for the specified cycle with various loads (Lightweight 6 lbs, Regular Weight 9 lbs, Medium Weight 13 lbs, Heavyweight 17 lbs, Super Heavyweight 25 lbs).
STERRAD® 100NX, Flex cycle	Specific lumen dimensions and max load (10.7 lbs)	Validated for the specified cycle with a max load of 10.7 lbs and specific flexible endoscope configurations.
STERRAD® 100NX, Standard cycle	Specific lumen dimensions and max load (10.7 lbs)	Validated for the specified cycle with a max load of 10.7 lbs and specific lumen configurations.
STERRAD® 100NX, Express cycle	Specific device types (non-lumened) and max load (10.7 lbs)	Validated for the specified cycle with a max load of 10.7 lbs for non-lumened devices.
STERRAD® 100S, Standard cycle	Specific lumen dimensions and max load (Light Weight 6 lbs to Super Heavyweight 10.7 lbs)	Validated for the specified cycle with various loads (Light Weight 6 lbs to Super Heavyweight 10.7 lbs) and specific lumen configurations.
STERRAD® NX, Advanced cycle	Specific lumen dimensions/flexible endoscope configurations and max load (10.7 lbs)	Validated for the specified cycle with a max load of 10.7 lbs and specific lumen/flexible endoscope configurations.
STERRAD® NX, Standard cycle	Specific lumen dimensions and max load (10.7 lbs)	Validated for the specified cycle with a max load of 10.7 lbs and specific lumen configurations.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the numerical sample size for the test set for each specific sterilization or biocompatibility test. It lists the types of loads used for sterilization validation studies, which could be considered the "test samples" in these evaluations.

Sterilization Validation Studies:
- Pre-vacuum steam and gravity steam: Various loads were used, described by components (e.g., "2 huck towels (17 in. x 29 in.), 3 fluid-resistant drapes", "16 huck towels... 5 lbs of metal mass"). The exact number of times each load/wrap combination was tested is not provided.
- Advanced Sterilization Products (ASP) STERRAD 100S: Various loads using "15 in. x 10 in. x 1.2 in. tray containing metal instruments" for different weight categories.
- Advanced Sterilization Products (ASP) STERRAD NX and STERRAD 100NX: Various loads using "23 in. x 11 in. x 4 in tray containing metal instruments" for different weight categories.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that it's a premarket notification for the FDA, it is highly likely that the testing was performed prospectively as part of product development and validation for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The studies listed are laboratory-based performance tests (material barrier, irritation, sterilization efficacy), not studies requiring expert interpretation of clinical data or images.

4. Adjudication method for the test set

This information is not applicable as the studies are laboratory-based performance tests, not studies requiring human interpretation or adjudication of results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a sterilization wrap, not an AI-assisted diagnostic or interpretive tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is a physical sterilization wrap, not an algorithm.

7. The type of ground truth used

The ground truth for the performance validation is based on:

Established standards and specifications: ISO 10993-10 for biocompatibility, ISO 11607-1 and ASTM F1980 for microbial barrier properties.
Sterility Assurance Level (SAL): While not explicitly stated as a numerical SAL, sterilization efficacy studies inherently use biological indicators or other methods to demonstrate a certain level of sterility (e.g., 10^-6), which serves as the "ground truth" for successful sterilization. The text states the wrap "maintains sterility of such content for 180 days following sterilization," implying successful sterility testing.
Physical and chemical measurements/observations: Tests for skin irritation involve biological response observation against established criteria. Microbial barrier properties involve challenging the material with microbes and demonstrating its effectiveness. Sterilization cycle validations involve verifying the eradication of microbes under specific conditions.

8. The sample size for the training set

This information is not applicable. The device is a physical product and does not involve machine learning or AI, so there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, each head facing a different direction. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.

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

May 7, 2015

Medline Industries, Inc. Mr. Matt Clausen Senior Regulatory Affairs Specialist One Medline Place Mundelein, IL 60060

Re: K143147

Trade/Device Name: Gemini Bonded Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: April 15, 2015 Received: April 17, 2015

Dear Mr. Clausen:

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.

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Page 2 - Mr. Clausen

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 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

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) K143147

Device Name Gemini Bonded Sterilization Wrap

Indications for Use (Describe)

Pre-vacuum steam cycles
- - Minimum 4 Minutes Exposure at 270°F/132°C with minimum 20 minutes dry time

· Gravity steam cycles

- Maximum 30 Minutes Exposure at 250°F/121°C with minimum 20 minutes dry time

· STERRAD® Sterilization

- STERRAD® 100NX, Flex cycle
- STERRAD® 100NX, Standard cycle
- STERRAD® 100NX, Express cycle
- STERRAD® 100S. Standard cycle
- STERRAD® NX, Advanced cycle
- STERRAD® NX, Standard cycle

The Gemini Bonded Sterilization Wrap intended loads with pre-vacuum steam sterilization, gravity steam sterilization, and the Advanced Sterilization Products (ASP) STERRAD® 100S, and STERRAD® 100S, and STERRAD® NX cycles are provided in Table 1.

The Gemini Bonded Sterilization Wrap Recommendations for Use with Pre-vacuum steam cycles. and the Advanced Sterilization Products STERRAD® Sterilization Systems are provide in Table 2.

(tables 1 and 2 are on a separate attachment. SEE ATTACHMENT)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

V | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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510(k) Number: K143147

Device Name: Gemini Bonded Sterilization Wrap

Table 1 – Validated Advanced Sterilization Products STERRAD® 100S, and STERRAD® NX Cycles

Cycle	Maximum recommendedChamber Load	Intended Load
Pre-Vacuum Steam& Gravity SteamCycles	Lightweight 6 lbs.	2 huck towels (17 in. x 29 in.), 3 fluid-resistant drapes (108 in. x 72 in.)
	RegularWeight 9 lbs.	16 huck towels (17 in. x 29 in.), 1 fluid resistant table cover (90 in. x 60 in.). 5 lbs. of metal mass.
	MediumWeight 13 lbs.	4 tray liners (20 in. x 25 in.) stacked 23 in. x 11 in. x 3.5 in. tray containing 11 lbs. of metal mass.
	Heavyweight 17 lbs.	4 tray liners (20 in. x 25 in.) stacked 23 in. x 11 in. x 3.5 in. tray containing 15 lbs. of metal mass.
	SuperHeavyweight 25 lbs.	4 tray liners (20 in. x 25 in.) stacked 23in. x 11in. x 3.5 in. tray containing 20 lbs. of metal mass.
STERRAD® 100NX,Flex Cycle	10.7 lbs.	One or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain:• A single-channel- Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter. (A maximum of two flexible endoscope, one per tray per sterilization cycle.)
STERRAD® 100NX,Standard Cycle	10.7 lbs.	Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:• An inside diameter of 0.7 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens. (A maximum of two flexible endoscopes, one per tray per sterilization cycle.)
STERRAD® 100NX,EXPRESS Cycle	10.7 lbs.	Non-lumened reusable metal and non-metal devices requiring surface sterilization, and sterilization of diffusion-restricted spaces such as the hinged portions of forceps and scissors, and rigid or semi-rigid endoscopes without lumens.

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STERRAD® 100S,Standard Cycle	Light Weight	6lbs.	Reusable metal and non-metal medical devices, includingup to 10 lumens of the following dimensions per chamber
	Regular Weight		load:
	Medium Weight		• An inside diameter of 1mm or larger and a length of
	Heavyweight		125 mm or shorter of single-channel stainless steel
	Super Heavyweight		lumens.
		10.7lbs.	• An inside diameter OF 2 mm or larger and length of
			250 mm or shorter of single-channel stainless steellumens.
			• An inside diameter of 3 mm or larger and a length of
			400 mm or shorter of single-channel stainless lumens.
			• An inside diameter of 6 mm or larger and a length of
			310 mm or shorter of single-channelTeflon/Polyethylene lumens.

STERRAD® NX,Advanced Cycle	10.7 lbs.	Reusable metal and non-metal medical devices, including up to 10lumens of the following dimensions per chamber load:• An inside diameter of 1 mm of larger and a length of 500 mm
		or shorter of single-channel stainless steel lumens
		Or
		One single-channel Flexible Endoscope with or without a silicone
		mat and no additional load. The flexible endoscope may contain:
		• A single-channel Teflon®/Polyethylene lumen with an inside
		diameter of 1 mm or larger and a length of 850 mm or
		shorter.
STERRAD® NX,Standard Cycle	10.7 lbs.	Reusable metal and non-metal medical devices, including up to 10
		lumens of the following dimensions per chamber load:
		• An inside diameter of 1 mm of larger and a length of 150 mm
		or shorter of single-channel stainless steel lumens.
		• An inside diameter of 2 mm or larger and a length of 400 mm
		or shorter of single-channel stainless steel lumens.

Table 2 – Wrap Model Recommendations for Use with Pre-vacuum steam cycles, Gravity steam cycles, and the Advanced Sterilization Products STERRAD® Sterilization Systems

			Maximum Wrapped PackageContent Weights Based on Validated SterilityCycle
Gemini WrapWeight	Item NumberSeries	Intended Load	Pre-VacuumSteam &GravitySteam	AdvancedSterilizationProducts(ASP)STERRAD®100S	AdvancedSterilizationProducts(ASP)STERRAD®NX and100NX
Light Weight	GEM11XXGEM11XXS	Light weight package (forexample: standard linen	6 lbs	6 lbs	10.7 lbs

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	GEM11XXT	packs)
Regular Weight	GEM21XXGEM21XXSGEM21XXT	Light to moderate weightpackage (for example:general use medicalinstruments)	9 lbs	9.7 lbs	10.7 lbs
Medium Weight	GEM31XXGEM31XXSGEM31XXT	Moderate to heavyweight package (forexample: general usemedical instruments)	13 lbs	9.7 lbs	10.7 lbs
Heavyweight	GEM41XXGEM41XXSGEM41XXT	Heavyweight package (forexample: general usemedical instruments)	17 lbs	9.7 lbs	10.7 lbs
SuperHeavyweight	GEM51XXGEM51XXSGEM51XXT	Very heavyweightpackage (for example:general use medicalinstruments)	25 lbs	9.7 lbs	10.7 lbs

The following loads were used in the pre-vacuum steam and gravity steam Sterility Validation Studies:

Light Weight: 2 huck towels (17 in. x 29 in.), 3 fluid-resistant drapes (108 in. x 72 in.)
. Regular Weight: 16 huck towels (17 in. x 29 in.), 1 fluid resistant table cover (90 in. x 60 in.). 5 lbs of metal mass.
Medium Weight: 4 tray liners (20 in. x 25 in.) stacked 23 in. x 11 in. x 3.5 in. tray containing 11 Ibs of metal mass.
o Heavyweight: 4 tray liners (20 in. x 25 in.) stacked 23 in. x 11 in. x 3.5 in. tray containing 15 lbs of metal mass.
. Super Heavyweight: 4 tray liners (20 in. x 25 in.) stacked 23in. x 11in. x 3.5 in. tray containing 20 lbs of metal mass.

The following loads were used in the Advanced Sterilization Products (ASP) STERRAD 100S Sterility Validation Studies:

Light Weight: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.
Regular Weight: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.
. Medium Weight: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.
Heavyweight: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.
Super Heavyweight: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.

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The following loads were used in the Advanced Sterilization Products (ASP) STERRAD NX and STERRAD 100NX Sterility Validation Studies:

Light Weight: 23 in. x 11 in. x 4 in tray containing metal instruments. ●
Regular Weight: 23 in. x 11 in. x 4 in tray containing metal instruments.
Medium Weight: 23 in. x 11 in. x 4 in tray containing metal instruments.
Heavyweight: 23 in. x 11 in. x 4 in tray containing metal instruments. .
. Super Heavyweight: 23 in. x 11 in. x 4 in tray containing metal instruments.

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Image /page/8/Picture/0 description: The image shows the logo for Medline. The word "MEDLINE" is written in blue, stylized, sans-serif font. Below the text is a blue, four-pointed star-like shape, with the bottom point extending further down than the other three. The logo is simple and clean, using only the color blue.

510(k) Summary (as required per 21 CFR 807.92)

Summary Preparation Date

May 7, 2015

Submitter / 510(k) Sponsor

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

Contact Person

Matt Clausen Sr. Regulatory Affairs Specialist Phone: 847-643-4785 Fax: 847-643-4482

Device Name / Classification

Device Name: Gemini Bonded Sterilization Wrap Proprietary Name: Medline's Gemini Bonded Sterilization Wrap Common Name: Sterilization Wrap Classification Name: Sterilization Wrap (21 CRF 880.6850, product code - FRG)

Predicate Device

Gemini Sterilization Wrap - K113353

Device Description

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Image /page/9/Picture/0 description: The image shows the logo for Medline. The logo is blue and consists of the word "MEDLINE" in a sans-serif font, with a stylized starburst symbol below it. The starburst has four points and a curved line connecting the bottom two points.

Indications for Use

Gemini Bonded 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 opened. Gemini Bonded Sterilization Wrap is validated for use in steam or STERRAD® sterilization processes in the following sterilization modes and cycles.

Pre-vacuum steam cycles
- Minimum 4 Minutes Exposure at 270°F/132°C with minimum 20 minutes dry time o
Gravity steam cycles
- Maximum 30 Minutes Exposure at 250°F/121°C with minimum 20 minutes dry time o
STERRAD® Sterilization ●
- STERRAD® 100NX, Flex cycle o
- STERRAD® 100NX, Standard cycle o
- STERRAD® 100NX, Express cycle o
- STERRAD® 100S, Standard cycle O
- STERRAD® NX, Advanced cycle o
- STERRAD®NX, Standard cycle O

The Gemini Bonded Sterilization Wrap intended loads with pre-vacuum steam sterilization, gravity steam sterilization, and the Advanced Sterilization Products (ASP) STERRAD® 100NX, STERRAD® 100S, and STERRAD® NX cycles are provided in Table 1.

The Gemini Bonded Sterilization Wrap Recommendations for Use with Pre-vacuum steam cycles, Gravity steam cycles, and the Advanced Sterilization Products STERRAD® Sterilization Systems are provided in Table 2.

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Image /page/10/Picture/0 description: The image shows the word "MEDLINE" in blue, with a stylized star symbol to the right of the word. The word is in a bold, italicized font, and the star symbol has four points. The star symbol is also in blue and appears to be connected to the word "MEDLINE".

Table 1 – Validated Advanced Sterilization Products STERRAD® 100NX, STERRAD® 100S, and STERRAD® NX Cycles

Cycle	Maximum recommended Chamber Load	Intended Load
Pre-Vacuum Steam & Gravity Steam Cycles	Lightweight 6 lbs.	2 huck towels (17 in. x 29 in.), 3 fluid-resistant drapes (108 in. x 72 in.)
	Regular Weight 9 lbs.	16 huck towels (17 in. x 29 in.), 1 fluid resistant table cover (90 in. x 60 in.). 5 lbs. of metal mass.
	Medium Weight 13 lbs.	4 tray liners (20 in. x 25 in.) stacked 23 in. x 11 in. x 3.5 in. tray containing 11 lbs. of metal mass.
	Heavyweight 17 lbs.	4 tray liners (20 in. x 25 in.) stacked 23 in. x 11 in. x 3.5 in. tray containing 15 lbs. of metal mass.
	Super Heavyweight 25 lbs.	4 tray liners (20 in. x 25 in.) stacked 23in. x 11in. x 3.5 in. tray containing 20 lbs. of metal mass.
STERRAD® 100NX, Flex Cycle	10.7 lbs.	One or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain:• A single-channel- Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter. (A maximum of two flexible endoscope, one per tray per sterilization cycle.)
STERRAD® 100NX, Standard Cycle	10.7 lbs.	Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:• An inside diameter of 0.7 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens. (A maximum of two flexible endoscopes, one per tray per sterilization cycle.)
STERRAD® 100NX, EXPRESS Cycle	10.7 lbs.	Non-lumened reusable metal and non-metal devices requiring surface sterilization, and sterilization of diffusion-restricted spaces such as the hinged portions of forceps and scissors, and rigid or semi-rigid endoscopes without lumens.
STERRAD® 100S, Standard Cycle	Light Weight 6 lbs.	Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:
	Regular Weight	10.7
	Medium WeightHeavyweightSuper Heavyweight	lbs.
		An inside diameter of 1mm or larger and a length of 125 mm or shorter of single-channel stainless steel lumens. An inside diameter OF 2 mm or larger and length of 250 mm or shorter of single-channel stainless steel lumens. An inside diameter of 3 mm or larger and a length of 400 mm or shorter of single-channel stainless lumens. An inside diameter of 6 mm or larger and a length of 310 mm or shorter of single-channel Teflon/Polyethylene lumens.
STERRAD®NX, AdvancedCycle	10.7 lbs.	Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: An inside diameter of 1 mm of larger and a length of 500 mm or shorter of single-channel stainless steel lumens OrOne single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain: A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter.
STERRAD®NX, StandardCycle	10.7 lbs.	Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: An inside diameter of 1 mm of larger and a length of 150 mm or shorter of single-channel stainless steel lumens. An inside diameter of 2 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens.

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Image /page/11/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in blue, with a stylized blue starburst symbol below it. The starburst has four points, with the bottom point extending downwards.

Medline Industries, Inc. One Medline Place Mundelein, IL 60060-4486

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Image /page/12/Picture/0 description: The image shows the word "MEDLINE" in blue, with a star-like symbol below it. The word is written in a bold, italicized font. The star symbol has four points, with the bottom point being longer than the other three. The image is set against a white background.

Table 2 – Wrap Model Recommendations for Use with Pre-vacuum steam cycles, Gravity steam cycles, and the Advanced Sterilization Products STERRAD® Sterilization Systems

	Item NumberSeries		Maximum Wrapped PackageContent Weights Based on ValidatedSterility Cycle
Gemini WrapWeight		Intended Load	Pre-VacuumSteam &GravitySteam	AdvancedSterilization Products(ASP)STERRAD® 100S	AdvancedSterilization Products(ASP)STERRAD® NX and100NX
Light Weight	GEM11XXGEM11XXSGEM11XXT	Light weight package(for example: standardlinen packs)	6 lbs	6 lbs	10.7 lbs
RegularWeight	GEM21XXGEM21XXSGEM21XXT	Light to moderateweight package (forexample: general usemedical instruments)	9 lbs	9.7 lbs	10.7 lbs
MediumWeight	GEM31XXGEM31XXSGEM31XXT	Moderate to heavyweight package (forexample: general usemedical instruments)	13 lbs	9.7 lbs	10.7 lbs
Heavyweight	GEM41XXGEM41XXSGEM41XXT	Heavyweight package(for example: generaluse medicalinstruments)	17 lbs	9.7 lbs	10.7 lbs
SuperHeavyweight	GEM51XXGEM51XXSGEM51XXT	Very heavyweightpackage (for example:general use medicalinstruments)	25 lbs	9.7 lbs	10.7 lbs

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Image /page/13/Picture/0 description: The image shows the logo for Medline. The word "MEDLINE" is in blue, block letters. Below the word is a blue star-like shape with four points. The bottom point of the star is elongated.

Summary of Technological Characteristics

Comparison of Subject and Predicate Devices

Characteristic	Subject Device	Predicate Device	Comparison
510(k)	TBD	K113353	n/a
Product Code	FRG	FRG	Same
Regulation No.	21 CRF 880.6850	21 CRF 880.6850	Same
Class	II	II	Same
Intended Use	Gemini Bonded SterilizationWrap is intended to be used toenclose another medical devicethat is to be sterilized by a healthcare provider. It is intended toallow sterilization of the enclosedmedical device and also tomaintain sterility of such contentfor 180 days followingsterilization. Gemini BondedSterilization Wrap is validated foruse in steam or STERRAD®sterilization processes.	Gemini Sterilization Wrap isintended to be used to encloseanother medical device that is tobe sterilized by a health careprovider. It is intended to allowsterilization of the enclosedmedical device and also tomaintain sterility of such contentfor 180 days followingsterilization. Gemini SterilizationWrap is validated for use in steamor STERRAD® sterilizationprocesses.	Same
OTC / singleuse	Yes	Yes	Same
Devicematerials	Polypropylene w/ blue and pinkpigmentation	Polypropylene w/ blue and pinkpigmentation	Same
Device features	Square or rectangular sheets mfd.by spunbond-meltblown process	Square or rectangular sheets mfd.by spunbond-meltblown process	Same
Sizes	12"x12" to 54"x72"	12"x12" to 54"x72"	Same
Wrappingtechnique	Sequential/simultaneous doublewrapping	Sequential/simultaneous doublewrapping	Same
Bondingmethod	Ultrasonically seamed in a dottedline pattern along two sides	Unbonded	Different
Sterilization	Pre-Vacuum Steam Cycle: 4-Minutes Exposure at270°F/132C° with minimum20 minutes dry timeGravity Steam Cycle: 30	Pre-Vacuum Steam Cycle: 4-Minutes Exposure at270°F/132C° with minimum20 minutes dry timeGravity Steam Cycle: 30	Same
	Minutes Exposure at250°F/121°C with minimum20 minutes dry time		Minutes Exposure at250°F/121°C with minimum20 minutes dry time
-	STERRAD® 100NX (Flex,Standard, and ExpressCycles)	-	STERRAD® 100NX (Flex,Standard, and ExpressCycles)
-	STERRAD® 100S,Standard Cycle	-	STERRAD® 100S,Standard Cycle
-	STERRAD® NX (Advanceand Standard Cycles)	-	STERRAD® NX (Advanceand Standard Cycles)

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Image /page/14/Picture/0 description: The image shows the Medline logo. The logo is blue and consists of the word "MEDLINE" in a stylized font, with a star-like symbol to the right of the word. The star symbol has four points, and there is a curved shape below the star.

Medline Industries. Inc. One Medline Place Mundelein, IL 60060-4486

This table illustrates the identical nature of the subject/predicate devices across all but one of the comparative features. The singular difference of ultrasonic bonding is the reason for this Special 510(k) submission.

Discussion of similarities and differences:

The proposed Gemini Bonded Sterilization Wrap is substantially equivalent in intended use, materials, device features / specifications and function in comparison to the predicate Gemini Sterilization Wrap. As noted in the table above, these characteristic comparisons render the devices identical. The difference between subject/predicate devices is related to:

. Bonding Method: The process involves the ultrasonic bonding on two single ply sheets of Gemini Sterilization Wrap. High-frequency ultrasonic acoustic vibrations and pressure fuse bond the layers together in a three-dotted line pattern along two open sides. There is no adhesive or other materials introduced to facilitate the bonding operation - strictly ultrasonic acoustic vibration and pressure.
Once the bonding process is completed, the predicate Gemini Wrap is converted into the proposed Gemini Bonded Wrap.

The following responses to FDA's 510(k) "Substantial Equivalence" Decision-Making Process (Overview) flow chart demonstrate substantial equivalence in terms of indications for use and technological characteristics.

Does the New Device Have the Same Intended Use?

Yes, the subject and predicate (K113353) have the same intended uses.

Does the New Device Have Technological Characteristics That Raise New Types of Safety and Effectiveness Ouestions?

There are no new technology characteristics. The Gemini Bonded Sterilization Wrap incorporates the same design features and principles of operation found in currently marketed product.

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Image /page/15/Picture/0 description: The image shows the Medline logo and address. The logo is a blue star with the word "MEDLINE" in blue letters. The address is "Medline Industries, Inc., One Medline Place, Mundelein, IL 60060-4486".

This product modification involving the subject and predicate devices does not significantly alter the Gemini Wrap or raise questions regarding safety or effectiveness.

Information within this Premarket Notification demonstrates that there are no significant differences in technological characteristics between Medline's Gemini Bonded Sterilization Wrap and the cited predicate device.

Summary of Non-Clinical Testing

Table 1 - Summary of Performance Testing

Test Objective	Testing Standards	Performance Results
Primary Skin Irritation Testing	ISO 10993-10	Meets ISO Requirements
Microbial Barrier Properties	ISO 11607-1ASTM F1980	Meets ISO and ASTMRequirements

The safety and effectiveness of Medline's Gemini Bonded Sterilization Wrap is adequately supported by the substantial equivalence information, materials information, and Design Control activities referenced within this Premarket Notification.

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 Bonded Sterilization Wrap is as safe, as effective, and performs as well as the predicate device [Gemini Sterilization Wrap (K113353)].

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).