Ahlstrom Reliance® Tandem and Solo Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:

Pre-vacuum Steam 270°F/132°C for 4 minutes
Gravity Steam 250°F/121°C for 30 minutes
100% Ethylene Oxide (EO) with a concentration of 725-735 mg/L @ 131°F/55°C and 40% - 80% relative humidity for 60 minutes
Advanced Sterilization Products (ASP) STERRAD® 100S
Advanced Sterilization Products (ASP) STERRAD® 100NX (Standard, Express and Flex cycles)
STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems (Lumen, Non Lumen and Flexible Cycles)
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.

Device Description

The Reliance® Solo and Reliance® Tandem Sterilization Wraps are square or rectangular nonwoven sheets produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The Reliance® SMS Sterilization Wraps are separated into two distinct product offerings:
Reliance® Tandem: Consists of single sheets of SMS wrap, where two sheets are used together for the sequential wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices.
Reliance® Solo: Consists of two sheets of SMS wrap, ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices.
The Reliance® Solo and Reliance® Tandem Sterilization Wraps are composed of polypropylene with the addition of blue or green pigment and an anti-static treatment. Reliance® Tandem and Reliance® Solo wraps allow a sterilized package of medical devices to be opened aseptically.

AI/ML Overview

The provided text describes a medical device, Reliance® Solo and Reliance® Tandem Sterilization Wraps, and its performance data to demonstrate substantial equivalence to a predicate device. However, it does not contain information about an AI/ML powered device, nor does it detail acceptance criteria and a study in the context of AI/ML performance metrics.

The document is a 510(k) premarket notification for a sterilization wrap, which is a physical product, not a software or AI/ML device. Therefore, the requested information regarding sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, ground truth types, and training set details are not applicable to this submission.

The document does include some "performance data" in a general sense, but this refers to the physical properties and functionality of the sterilization wrap (e.g., maintaining sterility, dry times, material compatibility, microbial barrier properties, toxicological properties) and its compatibility with various sterilization methods.

Therefore, I cannot populate the table or provide the requested details because the input document does not pertain to an AI/ML device.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three faces in profile, stacked on top of each other, with a stylized representation of a human form below them.

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

June 29, 2017

Ahlstrom Nonwovens LLC % Lauren Chrapowitzky Consultant AJW Technology Consultants. Inc 445 Apollo Beach Blvd Apollo Beach, Florida 33572

Re: K171533

Trade/Device Name: Reliance® Solo Sterilization Wrap, Reliance® Tandem Sterilization Wran Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: May 5, 2017 Received: May 30, 2017

Dear Lauren Chrapowitzky:

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

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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.

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,

James P.
Bertram -S

for

Lori 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

510(k) Number (if known) K171533

Device Name

Reliance® Tandem and Reliance® Solo Sterilization Wrap

Indications for Use (Describe)

Ahlstrom Reliance® Tandem and Solo Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:

Pre-vacuum Steam 270°F/132°C for 4 minutes
Gravity Steam 250°F/121°C for 30 minutes
100% Ethylene Oxide (EO) with a concentration of 725-735 mg/L @ 131°F/55°C and 40% - 80% relative humidity for 60 minutes
Advanced Sterilization Products (ASP) STERRAD® 100S
Advanced Sterilization Products (ASP) STERRAD® 100NX (Standard, Express and Flex cycles) ●
STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low ● Temperature Sterilization Systems (Lumen, Non Lumen and Flexible Cycles)

The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.

Pre-Vacuum Steam Sterilization:

Validated for dry time of 20 minutes for Models T100/S100, T200/S200, T300/S300.
Validated for dry time of 30 minutes for Models T400/S400, T500/S500, T600/S600. .
All models of Reliance® Tandem and Solo validated for pre-vacuum steam sterilization with stainless steel ● lumens as part of the load with a maximum weight of 251bs dependent on the model.

Gravity Steam Sterilization:

Validated for dry times of 20 minutes for Models T100/S100, T200/S200, T300/S300. ●
Validated for dry times of 30 minutes for Models T400/S400. .
Models T100/S100, T200/S200, T400/S400 of Reliance® Tandem and Solo validated for gravity steam sterilization with stainless steel lumens as part of the load with a maximum weight of 251bs dependent on the model.
o Models T500/S500 and T600/S600 are not validated for use for gravity steam sterilization.

Ethylene Oxide Sterilization:

Validated for aeration time of 8 hours at 55°C ●
All models of Reliance® Tandem and Solo validated for ethylene oxide sterilization with stainless steel lumens . as part of the load with a maximum weight of 25lbs dependent on the model.

Advanced Sterilization Products (ASP) STERRAD® 100S Sterilization

All models of Reliance® Tandem and Solo validated with ASP STERRAD® 100S sterilization with stainless ● steel lumens as part of the load with a maximum weight of 10.7lbs dependent on the model.

Advanced Sterilization Products (ASP) STERRAD® 100NX Sterilization

All models of Reliance® Tandem and Solo validated with ASP STERRAD® 100NX sterilization cycles detailed ● in Table 1.

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Table 1: Validated Advanced Sterilization Products (ASP) STERRAD® 100NX Cycles
Advanced Sterilization Products (ASP)STERRAD® System and Cycle	Intended Load
100NX Standard Cycle	Reusable metal and non-metal medical devices,including up to 10 lumens of the followingdimensions per chamber load:• An inside diameter of 0.7mm or larger anda length of 500mm or shorter of single-channel stainless steel lumens.
100NX Flex Cycle	One or two single-channel flexible endoscopes withor without a silicone mat. Flexible endoscope maycontain:• A single channel Teflon/PE/PTFE lumenwith an inside diameter of 1 mm or largerand a length of 850mm or shorter. (Amaximum of two flexible endoscopes, oneper tray per sterilization cycle)
100NX Express Cycle	Non-lumened reusable metal and non-metalmedical devices requiring surface sterilization, orsterilization of mated stainless steel and titaniumsurfaces, and rigid or semi-rigid endoscopeswithout lumens.

Table 1: Validated Advanced Sterilization Products (ASP) STERRAD® 100NX Cycles

STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems

All models of Reliance® Tandem and Solo Sterilization Wraps have been validated for use with STERIS V-● PRO® cycles detailed in Table 2.
Reliance® Tandem and Solo Sterilization Wraps were validated to be effectively aerated during the preprogrammed STERIS Amsco V-PRO® Sterilization Cycles.

STERIS Amsco® V-PRO Cycle	Intended Load
Lumen Cycle	Reusable metal and non-metal medical devices,including up to 20 stainless steel lumens withdimensions of 3.0mm diameter or larger and alength of 400mm or shorter.
Non Lumen Cycle	Non lumened reusable metal and non-metalmedical devices.
Flexible Cycle	Single lumen surgical flexible endoscopes andbronchoscopes in the following load configuration:1.) One tray containing a flexible endoscope with alight cord (if not integral to endoscope) and mat.The flexible endoscope having an inside diameterof 1 mm or larger and a length of 850 mm orshorter.2.) An additional tray containing non-lumenedmedical devices.

Table 2: Validated STERIS Amsco® V-PRO Cycles

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510(k) SUMMARY (as required by 807.92) K171533

I. SUBMITTER

Ahlstrom Nonwovens LLC 2 Elm Street Windsor Locks, CT 06096

Contact Person: Gary Jackson Date Prepared: 31 January 2017

REGULATORY CORRESPONDENT

AJW Technology Consultants, Inc 445 Apollo Beach, Blvd Apollo Beach, FL 33572

Phone: 813-645-2855 Fax: 813-645-2856

Contact Person: Lauren Chrapowitzky Email: laurenc@ajwtech.com

II. DEVICE

Name of Device: Reliance® Tandem and Reliance® Solo Sterilization Wrap Common or Usual Name: Sterilization Wrap Classification Name: Sterilization Wrap Device Panel: General Hospital Regulatory Class: Il Product Code: FRG Regulation Number: 880.6850

III. PREDICATE DEVICE

The Ahlstrom Nonwovens LLC Reliance® Tandem and Reliance® Solo Sterilization Wrap, cleared under K160755, is the predicate device for this submission.

IV. DEVICE DESCRIPTION

Reliance® Tandem: Consists of single sheets of SMS wrap, where two sheets are used together for the sequential wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices.

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Reliance® Solo: Consists of two sheets of SMS wrap, ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices.

The Reliance® Solo and Reliance® Tandem Sterilization Wraps are composed of polypropylene with the addition of blue or green pigment and an anti-static treatment. Reliance® Tandem and Reliance® Solo wraps allow a sterilized package of medical devices to be opened aseptically.

Table 1: Dimensional Specifications of Reliance® Tandem and Reliance® Solo Wrap Models
----------------------------------------------------------------------------------------	--	--	--

Dimensions	T100/S100	T200/S200	T300/S300	T400/S400	T500/S500	T600/S600
9 in. x 9 in.	×
12 in. x 12 in.	×	×
15 in. x 15 in.	×	×
18 in. x 18 in.	×	×	×	×	×
20 in. x 20 in.	×
24 in. x 24 in.	×	×	×	×	×
30 in. x 30 in.	×	×	×	×	×
36 in. x 36 in.	×	×	×	×	×	×
40 in. x 40 in.	×	×	×	×	×	×
45 in. x 45 in.	×		×	×	×	×
48 in. x 48 in.	×	×	×	×	×	×
54 in. x 54 in.	×	×	×	×	×	×
60 in. x 60 in.					×
54 in. x 72 in.	×	×	×	×	×	×
54 in. x 90 in.					×

Wrap Model Recommendations

Table 2 provides the recommended wrapped package content weights by model and sterilization modality for the Reliance® Tandem and Solo products.

Table 2: Wrap Model Recommendations 1

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		Maximum Recommended Wrapped Package Content Weights2
SterilizationWrapModels	Intended Load	Pre-Vacuumand Gravity*Steam andEO	AdvancedSterilizationProducts (ASP)Sterrad®100S	AdvancedSterilizationProducts(ASP)Sterrad®100NX	SterisAmsco®V-PROLumen andNon LumenCycle	SterisAmsco®V-PROFlexCycle
T100andS100	Very Light WeightPackage (for example:gauze or towel packs orbatteries)	3 lbs*	10.7 lbs	10.7 lbs	10.7 lbs	3 lbs
T200andS200	Light Weight Package(for example: standardlinen packs ortelescope with lightcord)	6 lbs*	10.7 lbs	10.7 lbs	10.7 lbs	6.5 lbs
T300andS300	Light to ModerateWeightPackage (for example:general use medicalinstruments)	9 lbs*	10.7 lbs	10.7 lbs	10.7 lbs	9 lbs
T400andS400	Moderate to HeavyWeight Package (forexample: general usemedical instruments)	13 lbs*	10.7 lbs	10.7 lbs	10.7 lbs	9 lbs
T500andS500	Heavy Weight Package(for example: generaluse medical	17 lbs	10.7 lbs	10.7 lbs	10.7 lbs	9 lbs
S500	instruments)
T600andS600	Very Heavy WeightPackage (for example:general use medicalinstruments)	25 lbs	10.7 lbs	10.7 lbs	10.7 lbs	9 lbs

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*Gravity Steam Sterilization is validated for models T100/S200, T300/S300, T400/S400 only. T500/S500 and T600/S600 models are not validated for gravity steam.

¹ Individual results may differ due to factors such as variations in wrapping techniques, handling practices and folding methods. Results may also differ due to the use of irregularly shaped contents that may result in 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. In addition, it is recommended to not exceed the number, weight and size of individual content types that were validated Ahlstrom Nonwovens Sterilization Wraps (i.e. wrapped contents).

V. INDICATIONS FOR USE

Ahlstrom Reliance® Tandem and Solo Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:

Pre-vacuum Steam 270°F/132°C for 4 minutes
Gravity Steam 250°F/121°C for 30 minutes ●
100% Ethylene Oxide (EO) with a concentration of 725-735 mg/L @ 131°F/55°C and ● 40% - 80% relative humidity for 60 minutes
Advanced Sterilization Products (ASP) STERRAD® 100S
Advanced Sterilization Products (ASP) STERRAD® 100NX (Standard, Express and Flex cycles)
. STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems (Lumen, Non Lumen and Flexible Cycles)

The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.

Pre-Vacuum Steam Sterilization:

Validated for dry time of 20 minutes for Models T100/S100, T200/S200, T300/S300.
Validated for dry time of 30 minutes for Models T400/S400, T500/S500, T600/S600. .
All models of Reliance® Tandem and Solo validated for pre-vacuum steam ● sterilization with stainless steel lumens as part of the load with a maximum weight of 25lbs dependent on the model.

Gravity Steam Sterilization:

Validated for dry times of 20 minutes for Models T100/S100, T200/S200, T300/S300. ●
Validated for dry times of 30 minutes for Models T400/S400. .
Models T100/S100, T200/S200, T300/S300, T400/S400 of Reliance® Tandem and . Solo validated for gravity steam sterilization with stainless steel lumens as part of the load with a maximum weight of 25lbs dependent on the model.

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Models T500/S500 and T600/S600 are not validated for use for gravity steam sterilization.

Ethylene Oxide Sterilization:

Validated for aeration time of 8 hours at 55°C
All models of Reliance® Tandem and Solo validated for ethylene oxide sterilization . with stainless steel lumens as part of the load with a maximum weight of 25lbs dependent on the model.

Advanced Sterilization Products (ASP) STERRAD® 100S Sterilization

All models of Reliance® Tandem and Solo validated with ASP STERRAD® 100S . sterilization with stainless steel lumens as part of the load with a maximum weight of 10.7lbs dependent on the model.

Advanced Sterilization Products (ASP) STERRAD® 100NX Sterilization

All models of Reliance® Tandem and Solo validated with ASP STERRAD® 100NX . sterilization cycles detailed in Table 1.

Advanced Sterilization Products (ASP)	Intended Load
STERRAD® System and Cycle
100NX Standard Cycle	Reusable metal and non-metal medicaldevices, including up to 10 lumens of thefollowing dimensions per chamber load:An inside diameter of 0.7mm or larger●
	and a length of 500mm or shorter ofsingle-channel stainless steel lumens.
100NX Flex Cycle	One or two single-channel flexible endoscopeswith or without a silicone mat. Flexibleendoscope may contain:A single channel Teflon/PE/PTFE lumen●with an inside diameter of 1 mm orlarger and a length of 850mm orshorter. (A maximum of two flexibleendoscopes, one per tray persterilization cycle)
100NX Express Cycle	Non-lumened reusable metal and non-metalmedical devices requiring surface sterilization,or sterilization of mated stainless steel andtitanium surfaces, and rigid or semi-rigidendoscopes without lumens.

Table 1: Validated Advanced Sterilization Products (ASP) STERRAD® 100NX Cycles

STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO max Low Temperature Sterilization Systems

. All models of Reliance® Tandem and Solo Sterilization Wraps have been validated for use with STERIS V-PRO® cycles detailed in Table 2.

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Reliance® Tandem and Solo Sterilization Wraps were validated to be effectively . aerated during the pre-programmed STERIS Amsco V-PRO® Sterilization Cycles.

STERIS Amsco® V-PRO Cycle	Intended Load
Lumen Cycle	Reusable metal and non-metal medical
	devices, including up to 20 stainless steel
	lumens with dimensions of 3.0mm diameter or
	larger and a length of 400mm or shorter.
Non Lumen Cycle	Non lumened reusable metal and non-metal
	medical devices.
Flexible Cycle	Single lumen surgical flexible endoscopes and
	bronchoscopes in the following load
	configuration:
	1.) One tray containing a flexible endoscope
	with a light cord (if not integral to endoscope)
	and mat. The flexible endoscope having an
	inside diameter of 1 mm or larger and a length
	of 850 mm or shorter.
	2.) An additional tray containing non-lumened
	medical devices.

Table 2: Validated STERIS Amsco® V-PRO Cycles

VI. COMPARISON OF TECHNOLIGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Manufacturer	Ahlstrom Nonwovens, LLC	Comparison of subject devicewith the predicate device
Device Name	RELIANCE® Tandem and SoloSterilization Wrap	RELIANCE® Tandem and SoloSterilization Wrap
Intended use	Reliance® Tandem and SoloSterilization Wrap is intended tobe used to enclose anothermedical device that is to besterilized by a health careprovider	same
Material Composition	Polypropylene spunbond-meltblown-spunbond (SMS)fabric	same
Configurations/Dimensions	Various	same
Sterilant Penetration	Pass per ANSI/AAMI ST79:2010 &A1:2010 and ANSI/AAMI/ISO14937:2009	same
Validated for use inSterilization System	Pre-vacuum Steam 270°F/132°Cfor 4 minutesGravity Steam 250°F/121°C for 30	same

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	minutes
	100% Ethylene Oxide (EO) with aconcentration of 725-735 mg/L@ 131°F/55°C and 40% - 80%relative humidity for 60 minutes	same
	(ASP) STERRAD® 100S, and 100NX(STANDARD, EXPRESS and Flexcycles)	same
	STERIS Amsco® V-PRO 1 & V-PRO1 Plus (Non-Lumen and Lumencycles) and V-PRO maX cycle	same
Microbial BarrierProperties (PackagingIntegrity)	Pass	Pass
Material Compatibility	Pass	Pass
Toxicological Properties(Biocompatibility)	Pass	Pass
Maintenance of Sterility	90 days	180 days
Dry Time	Reliance® Tandem and SoloModels T100/S100, T200/S200,T300/S300: 20 minutesReliance® Tandem and SoloModels T400/S400, T500/S500,T600/S600: 30 minutes	Same

VII. PERFORMANCE DATA

Summary of Testing:

Performance data for the Reliance® Tandem and Reliance® Solo Sterilization wrap was included under K160755. This submission includes data to demonstrate continued conformance with the microbial barrier properties recommended in Premarket Notification {510(k)} Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002). Reliance® Tandem and Solo Sterilization Wraps have been tested for the ability to maintain sterility of pack contents after sterilization for up to 180 days under standard conditions. All results of testing met acceptance criteria.

Standards Utilized

AAMI / ANSI ST79: 2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities.
. ASTM F2101-14, Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus. (General Plastic Surgery/General Hospital)

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VIII. CONCLUSIONS

In conclusion, results from nonclinical testing demonstrate that Reliance® Tandem and Reliance® Solo Sterilization Wrap is as safe, as effective, and performs as well as the predicate device (K160755).

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).