The SterilContainer S System is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single-use polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container system has been validated with hinged, and knurled instruments. It is intended to allow sterilization of the enclosed device and also maintain sterlity of the enclosed device until used. This container system is compatible for use with STERRAD 100NX EXPRESS Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.

Testing has been completed on the SterilContainer S Full size container to maintain the sterility of its contents for 360 days following successful sterilization.

Testing has been completed on the SterilContainer S 1/2 size container to maintain the sterility of its contents for 30 days following successful sterilization.

The validated chamber load for the SterilContainer S Full and Half sizes in the STERRAD 100NX EXPRESS Cycle consisted of one SterilContainer S placed on the bottom shelf in an otherwise empty chamber.

Device Description

The SterilContainer S System is a container system that will allow for sterilization and storage of medical devices. This container system is for use in low-temperature sterilization technology such as with the STERRAD 100NX EXPRESS Cycle. The SterilContainer S System rigid containers are made from non-anodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer S System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper-evident locks.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, the "SterilContainer S System", and focuses on demonstrating its substantial equivalence to a predicate device. This is a regulatory filing, not a clinical study, and therefore the acceptance criteria and study data provided are for performance validation rather than clinical efficacy.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Performance Property)	Reported Device Performance (Results)
Sterilization Efficacy	Achieved a 6 log reduction to no growth in a half-cycle validation, supporting a sterility assurance level (SAL) of 10-6 in a full cycle validation.
Whole Package Microbial Aerosol Challenge	After exposure to a defined amount of aerosol microorganisms, the contents maintained sterility.
Event Related Sterility Maintenance	For the full-size container: Maintained sterility for 360 days following successful sterilization. For the ½ size container: Maintained sterility for 30 days following successful sterilization. This was achieved after processing and subsequent storage under simulated hospital sterile package handling and storage conditions. After 100 cycles of processing, no visible or functional changes were observed.
Material Compatibility	After 100 cycles of processing, no visible or functional changes were observed (this is included under Event Related Sterility Maintenance in the document, but is a distinct material compatibility aspect).
Biocompatibility	Cytotoxicity: No evidence of causing cell lysis or toxicity (per ISO 10993-5). Hemolysis: Results were non-hemolytic (per ASTM F756 and ISO 10993-4).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific numerical sample sizes for each test. For example, it doesn't say "X number of containers were tested for sterilization efficacy." However, it describes the type of testing performed:

Sterilization Efficacy: "a half cycle validation."
Whole Package Microbial Aerosol Challenge: "exposure to a defined amount of aerosol microorganisms."
Event Related Sterility Maintenance: Mentions "30 or 360 day event related storage" and "100 cycles of processing."
Biocompatibility: Mentions "Cytotoxicity testing" and "A Hemolysis study."

The data provenance is not specified regarding country of origin. The studies are prospective in nature, as they involve performing tests on the device to validate its performance according to defined protocols.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a technical performance validation of a sterilization container, not a diagnostic device requiring expert interpretation of images or clinical outcomes. Therefore, the concept of "experts used to establish ground truth" in the clinical sense (e.g., radiologists) is not applicable here. The "ground truth" for these tests would be established by the adherence to recognized industry standards (e.g., ISO, ASTM) and microbiology principles for sterility and biological safety, as performed by a "qualified testing laboratory."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, this is a technical device validation following standardized protocols, not a clinical study involving human interpretation that would require an adjudication method for ground truth.

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

Not applicable. This device is a sterilization container, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

Not applicable. This device does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device validation is based on accepted scientific and industry standards for sterility, microbial barrier performance, material durability, and biocompatibility.

Sterilization Efficacy: No microbial growth after sterilization and challenge, achieving a specified sterility assurance level (SAL).
Whole Package Microbial Aerosol Challenge: No microbial ingress or contamination of contents.
Event Related Sterility Maintenance: Maintenance of sterility for specified durations (30 or 360 days) and no degradation after repeated use (100 cycles).
Biocompatibility: Meeting the criteria for non-cytotoxicity (per ISO 10993-5) and non-hemolysis (per ASTM F756 and ISO 10993-4).

These are objectively verifiable measurements and observations against established benchmarks, not subjective expert consensus or pathology.

8. The sample size for the training set

Not applicable. This device does not utilize machine learning or AI algorithms, and therefore does not have a "training set."

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

Not applicable, as there is no training set for this device.

Summary

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

July 8, 2015

Aesculap, Inc. % Denise Adams Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034

Re: K142970

Trade/Device Name: SterilContainer S System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: June 9, 2015 Received: June 10, 2015

Dear Ms. Adams,

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 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

Device Name SterilContainer S System

Indications for Use (Describe)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

Testing has been completed on the SterilContainer S Full size container to maintain the sterility of its contents for 360 days following successful sterilization.

Testing has been completed on the SterilContainer S 1/2 size container to maintain the sterility of its contents for 30 days following successful sterilization.

Lid	Bottom	Description	Total loadedcontainer weight(lbs)	Intended load
JM489	JM440	Full Size 90mm (4 $1\frac{1}{4}$ ")	25.0	reusable metal and non-metal medical
	JM441	Full Size 120mm (5 $1\frac{1}{2}$ ")	25.0	devices without lumens including
	JM442	Full Size 135mm (6")	25.0	endoscopes without lumens OR the da Vinci
	JM444	Full Size 187mm (8")	25.0	Scope Platform (MD425) and two Si or Sseries da Vinci Scopes
JM389	JM340	$\frac{1}{2}$ Size 90mm (4 $1\frac{1}{4}$ ")	21.2	reusable metal and non-metal medical
	JM341	$\frac{1}{2}$ Size 120mm (5 $1\frac{1}{2}$ ")	21.5	devices without lumens including
	JM342	$\frac{1}{2}$ Size 135mm (6")	21.7	endoscopes without lumens
	JM344	$\frac{1}{2}$ Size 187mm (8")	22.2

SterilContainer S Compatible Containers in STERRAD 100NX EXPRESS Cycle

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Accessories	STERRAD 100NX EXPRESS Cycle
Stainless Steel baskets, basket lids, and dividers	Yes
Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps)	Yes
Silicone mats	Yes
Stainless Steel racks, trays, holders, clamps, brackets, and platforms	Yes

STERRAD 100NX EXPRESS Cycle Compatible SterilContainer S System Accessories

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

Prescription Use (Part 21 CFR 801 Subpart D)

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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510(k) SUMMARY (as required by 21 CFR 807.92)

	SterilContainer™ S SystemJune 29, 2015
COMPANY:	Aesculap, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 291671-4
CONTACT:	Denise R. Adams610-984-9076 (phone)610-791-6882 (fax)
TRADE NAME:	SterilContainer S System
COMMON NAME:	Sterilization Container
CLASSIFICATION NAME:	Sterilization Wrap
PRODUCT CODE:	KCT
DEVICE CLASS:	Class II per 21 CFR §880.6850

SUBSTANTIAL EQUIVALENCE

Aesculap, Inc. believes that the SterilContainer S System for use in the STERRAD 100NX EXPRESS Cycle is substantially equivalent to Aesculap SterilContainer S for use in STERRAD 200, NX (Standard and Advanced Cycles), and 100NX (Standard and Flex Cycles) cleared via K093493.

DEVICE DESCRIPTION

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INDICATIONS FOR USE

The SterilContainer S System is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single-use polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container system has been validated with hinged, and knurled instruments. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with STERRAD 100NX EXPRESS Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.

Testing has been completed on the SterilContainer S Full size container to maintain the sterility of its contents for 360 days following successful sterilization.

Testing has been completed on the SterilContainer S ½ size container to maintain the sterility of its contents for 30 days following successful sterilization.

Lid	Bottom	Description	Total loaded container weight (lbs)	Intended load
JM489	JM440	Full Size 90mm (4 ¼")	25.0	reusable metal and non-metal medical
	JM441	Full Size 120mm (5 ½")	25.0	devices without lumens including
	JM442	Full Size 135mm (6")	25.0	endoscopes without lumens OR the da VinciScope Platform (MD425) and two Si or Sseries da Vinci Scopes
	JM444	Full Size 187mm (8")	25.0
JM389	JM340	1/2 Size 90mm (4 1/4")	21.2	reusable metal and non-metal medical
	JM341	1/2 Size 120mm (5 1/2")	21.5	devices without lumens including
	JM342	1/2 Size 135mm (6")	21.7	endoscopes without lumens
	JM344	1/2 Size 187mm (8")	22.2

SterilContainer S Compatible Containers in STERRAD 100NX EXPRESS Cycle

STERRAD 100NX EXPRESS Cycle Compatible SterilContainer S System Accessories

Accessories	STERRAD 100NXEXPRESS Cycle
Stainless Steel baskets,basket lids, and dividers	Yes
Instrument OrganizationSystem (Silicone andStainless Steel racks,brackets, holders, and clamps)	Yes
Silicone mats	Yes
Stainless Steel racks, trays,holders, clamps, brackets, andplatforms	Yes

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TECHNOLIGICAL CHARACTERISTICS (compared to predicates)

The SterilContainer S System is for use in low-temperature sterilization technology such as the STERRAD 100NX EXPRESS Cycle. The SterilContainer S System is the same container system as was cleared in K093493. The materials and design have not changed.

System	SterilContainer S(K142970)					SterilContainer S(K093493)
Indica-tions forUse	The SterilContainer S System is a reusable sterilization containersystem (consisting of perforated bottoms and perforated lids withfilter retention plates, and single-use polypropylene filters)intended to be used to enclose another medical device that is to besterilized by a healthcare provider. This container system has beenvalidated with hinged, and knurled instruments. It is intended toallow sterilization of the enclosed device and also maintain sterilityof the enclosed device until used. This container system iscompatible for use with STERRAD 100NX EXPRESS Cycle. TheSterilContainer S System includes accessories such as siliconemats, baskets, trays, racks, eyepiece holders and sleeve holders.Testing has been completed on the SterilContainer S Full sizecontainer to maintain the sterility of its contents for 360 daysfollowing successful sterilization.Testing has been completed on the SterilContainer S ½ size containermaintain the sterility of its contents for 30 days following successfulsterilization.The validated chamber load for the SterilContainer S Full and Halfsizes in the STERRAD 100NX EXPRESS Cycle consisted of oneSterilContainer S placed on the bottom shelf in an otherwise emptychamber.					The Aesculap Sterilcontainer S is a reusable sterilization container system(consisting of perforated bottoms and perforated lids with filter retention plates, anddisposable polypropylene filters) intended to be used to enclose another medicaldevice that is to be sterilized by a healthcare provider. This container has beenvalidated with stainless steel lumens, hinged, and knurled instruments. It is intendedto allow sterilization of the enclosed device and also maintain sterility of theenclosed device until used. This container system is compatible for use with theSTERRAD 200, STERRAD NX (Standard cycle and Advanced cycle), andSTERRAD 100NX (Standard cycle and Flex cycle). The Sterilcontainer S Systemincludes accessories such as silicone mats, baskets, trays, racks, eyepiece holdersand sleeve holders.
		The Sterilcontainer S is recommended for surface and lumens:STERRAD 200, stainless steel lumens ≥ 3mm I.D. x ≤ 400mm LSTERRAD NX standard cycle, stainless steel lumens≥ 2mm I.D. x ≤ 400mm LSTERRAD NX advanced cycle, stainless steel lumens> 1mm I.D. x ≤ 500mm LSTERRAD 100NX standard cycle, stainless steel lumens≥ 0.7mm I.D. x ≤ 500mm L
		STERRAD 100NX flex cycle, porous lumens (flexible endoscope)> 1mm I.D. x ≤ 850mm L30 days of shelf life testing has been conducted for the Sterilicontainer S.
	SterilContainer S Compatible Containers in STERRAD 100NXEXPRESS Cycle				TABLE 1: SterilContainer S Compatible Containers in STERRAD 200
	Lid	Bottom	Description	Totalloadedcontainerweight(lbs)	Intended load	Item #	Description	Total loaded containerweight (lbs)
	JM489	JM440	Full Size90mm (4 ¼")	25.0	reusable metaland non-metalmedical deviceswithout lumens	JM440	Full Size Perforated Bottom 90mm (4 ¼")	21.46
		JM441	Full Size120mm (5 ½")	25.0	includingendoscopeswithout lumens	JM441	Full Size Perforated Bottom 120mm (5 ½")	21.46
		JM442	Full Size135mm(6")	25.0	OR the daVinci ScopePlatform(MD425) andtwo Si or Sseries da VinciScopes	JM442	Full Size Perforated Bottom 135mm (6")	21.46
		JM444	Full Size187mm(8")	25.0		JM444	Full Size Perforated Bottom 187mm (8")	21.46
	JM389	JM340	½ Size90mm (4 ¼")	21.2	reusable metaland non-metalmedical deviceswithout lumens	JM740	¾ Size Perforated Bottom 90mm(4 ¼")	14.42
		JM341	½ Size120mm (5 ½")	21.5	includingendoscopeswithout lumens	JM741	¾ Size Perforated Bottom 120mm (5 ½")	14.42
		JM342	½ Size135mm(6")	21.7		JM742	¾ Size Perforated Bottom 135mm (6")	14.42
		JM344	½ Size187mm(8")	22.2		JM340	½ Size Perforated Bottom 90mm (4 ¼")	14.42
							JM341	½ Size Perforated Bottom 120mm (5 ½")	14.42
							JM342	½ Size Perforated Bottom 135mm (6")	14.42
							JM344	½ Size Perforated Bottom 187mm (8")	14.42
							JM094	¼ Size Perforated Bottom with Lid65mm (2 ½")	14.42
							JM096	¼ Size Perforated Bottom with Lid130mm (5 1/8")	14.42
							JM021	Extra Long Mini Bottom 73mm (3")	7.64
							JM489	Full Size Lid
							JM789	¾ Size Lid
							JM389	½ Size Lid
							SeeJM094 &JM096	¼ Size Lid
							JM020	Extra Long Mini Lid
	STERRAD 100NX EXPRESS Cycle Compatible

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Accessories	SterilContainer S System AccessoriesSTERRAD 100NXEXPRESS Cycle	Note: Full, 3/4, 1/2, and 1/4 size containerlumens per container system.2 stainless steel lumens per container system
Stainless Steel baskets, basket lids, and dividers	Yes	TABLE 2: SterilContainer Sand Advanced CycleItem # Description JM440 Full Size Perforated (1/4") JM441 Full Size Perforated (1/2") JM740 3/4 Size Perforated JM741 3/4 Size Perforated (1/2") JM742 3/4 Size Perforated JM340 1/2 Size Perforated JM341 1/2 Size Perforated (1/2") JM094 1/4 Size Perforated 65mm (2 1/2") JM096 1/4 Size Perforated 130mm (5 1/8") JM021 Extra Long Mini JM489 Full Size Lid JM789 3/4 Size Lid JM389 1/2 Size Lid See JM094 & JM096 1/4 Size Lid
Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps)	Yes
Silicone mats	Yes
Stainless Steel racks, trays, holders, clamps, brackets, and platforms	Yes		JM020 Extra Long Mini Note: Full, 3/4, 1/2, and 1/4 size containerlumens per container system.2 stainless steel lumens per container TABLE 3: SterilContainer SStandard Cycle Item # Description JM440 Full Size Perforated (1/4") JM441 Full Size Perforated (1/2") JM442 Full Size Perforated (6") JM444 Full Size Perforated (8") JM740 3/4 Size Perforated JM741 3/4 Size Perforated (1/2") JM742 3/4 Size Perforated JM340 1/2 Size Perforated JM341 1/2 Size Perforated (1/2") JM342 1/2 Size Perforated JM344 1/2 Size Perforated JM094 1/4 Size Perforated 65mm (2 1/2") JM096 1/4 Size Perforated 130mm (5 1/8") JM021 Extra Long Mini JM489 Full Size Lid JM789 3/4 Size Lid JM389 1/2 Size Lid

ntainers have been validated with 5 stainless steel The Extra Long Mini container has been validated with tainer system.

Compatible Containers in STERRAD NX Standard

Item #	Description	Total loaded containerweight (lbs)
JM440	Full Size Perforated Bottom 90mm (4 1/4")	21.46
JM441	Full Size Perforated Bottom 120mm (5 1/2")	21.46
JM740	3/4 Size Perforated Bottom 90mm (4 1/4")	13.85
JM741	3/4 Size Perforated Bottom 120mm (5 1/2")	13.85
JM742	3/4 Size Perforated Bottom 135mm (6")	13.85
JM340	1/2 Size Perforated Bottom 90mm (4 1/4")	13.85
JM341	1/2 Size Perforated Bottom 120mm (5 1/2")	13.85
JM094	1/4 Size Perforated Bottom with Lid65mm (2 1/2")	13.85
JM096	1/4 Size Perforated Bottom with Lid130mm (5 1/8")	13.85
JM021	Extra Long Mini Bottom 73mm (3")	7.64
JM489	Full Size Lid
JM789	3/4 Size Lid
JM389	1/2 Size Lid
SeeJM094 &JM096	1/4 Size Lid

ontainers have been validated with 5 stainless steel The Extra Long Mini container has been validated with
ntainer system.

	TABLE 3: SterilContainer S Compatible Containers in STERRAD 100NX
Standard Cycle

Item #	Description	Total loaded containerweight (lbs)
JM440	Full Size Perforated Bottom 90mm (4 1/4")	21.46
JM441	Full Size Perforated Bottom 120mm (5 1/2")	21.46
JM442	Full Size Perforated Bottom 135mm (6")	21.46
JM444	Full Size Perforated Bottom 187mm (8")	21.46
JM740	3/4 Size Perforated Bottom 90mm(4 1/4")	13.85
JM741	3/4 Size Perforated Bottom 120mm (5 1/2")	13.85
JM742	3/4 Size Perforated Bottom 135mm (6")	13.85
JM340	1/2 Size Perforated Bottom 90mm (4 1/4")	13.85
JM341	1/2 Size Perforated Bottom 120mm (5 1/2")	13.85
JM342	1/2 Size Perforated Bottom 135mm (6")	13.85
JM344	1/2 Size Perforated Bottom 187mm (8")	13.85
JM094	1/4 Size Perforated Bottom with Lid 65mm (2 1/2")	13.85
JM096	1/4 Size Perforated Bottom with Lid 130mm (5 1/8")	13.85
JM021	Extra Long Mini Bottom 73mm (3")	7.64
JM489	Full Size Lid
JM789	3/4 Size Lid
JM389	1/2 Size Lid
SeeJM094 &JM096	1/4 Size Lid

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JM020 Extra Long Mini Lid
Note: Full, ¾, ½, and ¼ size containers have been validated with 5 stainless steel lumens per container system. The Extra Long Mini container has been validated with 2 stainless steel lumens per container system.
TABLE 4: SterilContainer S Compatible Containers in STERRAD 100NX Flex Cycle
Item #	Description	Total loaded container weight (lbs)
JM440	Full Size Perforated Bottom 90mm (4 ¼")	9.67
JM441	Full Size Perforated Bottom 120mm (5 ½")	9.67
JM442	Full Size Perforated Bottom 135mm (6")	9.67
JM444	Full Size Perforated Bottom 187mm (8")	9.67
JM740	¾ Size Perforated Bottom 90mm(4 ¼")	9.67
JM741	¾ Size Perforated Bottom 120mm (5 ½")	9.67
JM742	¾ Size Perforated Bottom 135mm (6")	9.67
JM340	½ Size Perforated Bottom 90mm (4 ¼")	9.67
JM341	½ Size Perforated Bottom 120mm (5 ½")	9.67
JM342	½ Size Perforated Bottom 135mm (6")	9.67
JM344	½ Size Perforated Bottom 187mm (8")	9.67
JM489	Full Size Lid
JM789	¾ Size Lid
JM389	½ Size Lid
Note: Full, ¾, and ½ size containers have been validated with 1 PTFE/PE lumen per container system.
Sterilization process	STERRAD 100NX EXPRESS Cycle	STERRAD 200, NX (Standard and Advanced Cycles), 100NX (Standard and Flex Cycles)
Material	Non-anodized aluminum	Non-anodized aluminum
Container type	Perforated	Perforated
Filter type	Polypropylene	Polypropylene

PERFORMANCE DATA

Validation studies have been performed with the SterileContainer S System in the STERRAD 100NX EXPRESS Cycle. These validations were conducted by a qualified testing laboratory.

Performance Properties	Results
Sterilization Efficacy	Testing demonstrated a 6 log reduction to no growth in a half cycle validation. This testing supports a sterility assurance level (SAL) of 10-6 in a full cycle validation.
Whole Package MicrobialAerosol Challenge	After exposure to a defined amount of aerosol microorganisms contents maintained sterility
Event Related SterilityMaintenance	Testing demonstrated the ability to provide an effective barrier for maintaining sterility of the contents after processing followed by a 30 or 360 day event related storage under conditions which simulate hospital sterile

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Material Compatibility	package handling and storage conditions.After 100 cycles of processing no visible or functionalchanges were observed
Biocompatibility	Cytotoxicity testing was conducted per ISO 10993-5 andshowed no evidence of causing cell lysis or toxicity.A Hemolysis study was conducted per ASTM F756 andISO 10993-4 and results were non-hemolytic

CONCLUSION

Performance testing demonstrates that the subject device is substantially equivalent to the predicate device.

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).