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 stainless steel and Teflon lumens, 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 the TS03 Sterizone VP4 Low Temperature Sterilization System. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.

Device Description

The SterilContainer™ S System is a container system that will allow for sterilization and storage of medical devices. This container system can be used in the TS03 Sterizone VP4 Low Temperature Sterilization System. 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 proof locks.

AI/ML Overview

This documentation describes the regulatory clearance of the SterilContainer™ S System by Aesculap, Inc. as a reusable sterilization container system. The validation studies demonstrate its effectiveness and safety.

Here's an analysis of the provided text in the context of acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate table. However, the "Performance Properties" table (page 7) implicitly outlines the performance requirements that the device needed to meet for clearance.

Acceptance Criterion (Inferred from "Performance Properties")	Reported Device Performance
Sterilization Efficacy/Lethality Study: Achieve a certain sterility assurance level (SAL).	Testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10-6 using the biological (BI) overkill method and half-cycle validation. This was achieved by placing at least 1.0 x 10^6 spores of Geobacillus stearothermophilus in the worst-case sterilization location through the containers. The full cycle results in a 12-log reduction of spores and produces a 10-6 SAL, reflecting a one-in-a-million chance of a non-sterile item.
Bacterial Filtration Efficiency: Maintain microbial barrier properties after processing.	The evaluation of the microbial barrier properties of the Aesculap® polypropylene filters demonstrates that the bacterial filtration efficiency is maintained by the filter after being processed in Cycle 1 of the STERIZONE® Sterilizer.
Event Related Sterility Maintenance: Maintain sterility of contents for a specified period after processing.	Testing demonstrated the ability to provide an effective barrier for maintaining sterility of the contents after processing followed by a 180 day event related storage under conditions which simulate hospital sterile package handling and storage conditions.
Material Compatibility/Reuse Test: Withstand repeated processing cycles without visible or functional changes.	After 100 cycles of processing, no visible or functional changes were observed for the device materials.
Biocompatibility: Polypropylene filters must be biocompatible.	The Aesculap® polypropylene filters have been proven to be biocompatible when processed in Cycle 1 of the STERIZONE® VP4 Sterilizer.
Aerosol Microbial Challenge: Prevent microbial ingress in challenging conditions.	The contents of the container were negative for growth following exposure of the containers to aerosolized microbial challenge test conditions.

2. Sample Size Used for the Test Set and Data Provenance:

Sterilization Efficacy/Lethality Study: Performed in triplicate on the Aesculap rigid container. The specific number of containers per replicate is not stated. The data provenance is not explicitly mentioned as country of origin but is implied to be from a "qualified testing laboratory" (page 7) in support of US FDA clearance. It is a prospective study as tests were conducted specifically for this clearance.
Bacterial Filtration Efficiency: The "evaluation" suggests a test set, but the sample size for filters or test runs is not specified.
Event Related Sterility Maintenance: Not specified for individual containers, but the study simulated "hospital sterile package handling and storage conditions" over 180 days.
Material Compatibility/Reuse Test: The device was subjected to 100 cycles of processing.
Biocompatibility: The "study" evaluated the polypropylene filters, but the sample size of filters tested is not specified.
Aerosol Microbial Challenge: Not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This document describes the mechanical and biological performance of a medical device (sterilization container), not a diagnostic or AI-based device that relies on human interpretation for "ground truth". Therefore, the concept of "experts used to establish ground truth" based on interpretation is not applicable in this context. The "ground truth" for these tests is based on objective, standardized laboratory measurements and methods (e.g., microbial growth, visual inspection, filtration efficiency).

4. Adjudication Method for the Test Set:

Not applicable, as "adjudication method" often refers to resolving discrepancies among human readers or interpreters. The tests here are objective performance measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and AI assistance can be evaluated for its impact on their performance. This document is about a sterilization container system, which does not involve human interpretation in the same way.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

Not applicable. This device is a physical container and doesn't involve any algorithm or AI for "standalone performance."

7. Type of Ground Truth Used:

The ground truth for the performance tests relies on:

Microbial Challenge Testing: Demonstrating a log reduction of Geobacillus stearothermophilus spores and achieving a specific Sterility Assurance Level (SAL).
Physical and Functional Testing: Visual inspection for material integrity, flow rate/filtration measurements for barrier function, and functional checks after repeated cycles.
Chemical Testing: Biocompatibility assessment of materials.
Time-based Stability: Maintaining sterility over a defined storage period.

These are all objective, laboratory-based measurements defined by established standards for medical device sterilization.

8. Sample Size for the Training Set:

Not applicable. This document describes the validation of a physical medical device. There is no AI or machine learning component that would require a "training set." The listed studies are for device validation, not model training.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an AI/ML model 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 13, 2017

Aesculap, Inc Paul Amudala Regulatory Affairs Specialist 3773 Corporate Pkwy Center Valley, Pennsylvania 18034

Re: K162815

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, 2017 Received: June 12, 2017

Dear Paul Amudala:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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,

Tara A. Ryan -S

for

Lori Wiggins 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) K162815

K102813

Device Name SterilContainer™ S System

Indications for Use (Describe)

Load #1 (31.2 lb)	Flexible endoscopes load accommodating three single channel flexible endoscopes, one per container:• Internal channel diameter of 1 mm and length of 850 mm.
Load #2 (29.4 lb)	Semi-rigid and rigid channel devices load accommodating three double channel semi-rigid endoscopes, one per container, and one length of medical grade stainless steel tubing.• Length of tubing:➤ Internal channel diameter of 1.0 mm and length of 500 mm.• Double channel semi-rigid endoscope➤ Internal channel diameters of 0.7 mm and 1.1 mm, and length of 500 mm
Load #3 (10.2 lb)	Worst-case volume to surface perforation area ratio using a perforated container including two stacked baskets. Each basket was covered with a full length silicone mat. At least one inoculated medical device was added per level of the container.
Load #4 (25 lb)	Worst-case volume to surface perforation area ratio using a perforated container with maximum weight of instrument, for a total mass of 25 lb. At least three inoculated medical devices were added in the container.
Load #5 (75 lb)	Heavy weight load composed of three perforated containers, with a total mass of 25 lb per container. The heavy validation load was prepared based on the Aesculap SterilContainer™ S container lethality studies (PRO-169) and adapted to include a maximum weight in a single load.

Table 1: Validated TS03 Sterilizer Flexible Cycle Load Configurations

Table 2: TS03 -Sterilizer Flexible Cycle Compatible SterilContainer S Container Systems

Lid	Bottom	Description	Total Loaded ContainerWeight (if container does notcontain a flexible endoscopeor bronchoscope)*
-----	--------	-------------	--------------------------------------------------------------------------------------------------------------

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JM489	JM440	Full Size 90mm (4 ¼")
	JM441	Full Size 120mm (5 ½")	25 lbs for one container in the chamber
	JM442	Full Size 135mm (6")
	JM444	Full Size 187mm (8")
JM789	JM740	¾ Size 90mm(4 ¼")
	JM741	¾ Size 120mm (5 ½")
	JM742	¾ Size 135mm (6")
JM389	JM340	½ Size 90mm (4 ¼")
	JM341	½ Size 120mm (5 ½")
	JM342	½ Size 135mm (6")

*Loads containing a flexible endoscope or bronchoscope should follow Table 1 recommendations

Table 3: TS03 Sterilizer

Cycle Compatible Accessories

Accessories	TS03 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

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

SterilContainer™ S System

July 7, 2017

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 291671-
CONTACT:	Paul Amudala610-984-9303 (phone)610-791-6882 (fax)
TRADE NAME:	SterilContainer S System
COMMON NAME:	Sterilization Container Wrap
CLASSIFICATION NAME:	Sterilization Wrap
REGULATION NUMBER:	880.6850
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 TS03 Sterizone VP4 Low Temperature Sterilization System is substantially equivalent to Aesculap SterilContainer" S for use in V-Pro 60 Flexible Cycle via K151242.

DEVICE DESCRIPTION

Indications for Use:

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lumens, 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 the TS03 Sterizone VP4 Low Temperature Sterilization System. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.

Load #1 (31.2 lb)	Flexible endoscopes load accommodating three single channel flexible endoscopes, one per container:• Internal channel diameter of 1 mm and length of 850 mm.
Load #2 (29.4 lb)	Semi-rigid and rigid channel devices load accommodating three double channel semi-rigid endoscopes, one per container, and one length of medical grade stainless steel tubing.• Length of tubing:➤ Internal channel diameter of 1.0 mm and length of 500 mm.• Double channel semi-rigid endoscope➤ Internal channel diameters of 0.7 mm and 1.1 mm, and length of 500 mm
Load #3 (10.2 lb)	Worst-case volume to surface perforation area ratio using a perforated container including two stacked baskets. Each basket was covered with a full length silicone mat. At least one inoculated medical device was added per level of the container.
Load #4 (25 lb)	Worst-case volume to surface perforation area ratio using a perforated container with maximum weight of instrument, for a total mass of 25 lb. At least three inoculated medical devices were added in the container.
Load #5 (75 lb)	Heavy weight load composed of three perforated containers, with a total mass of 25 lb per container. The heavy validation load was prepared based on the Aesculap® SterilContainer™ S container lethality studies (PRO-169) and adapted to include a maximum weight in a single load.

Table 1: Validated TS03 Sterizone VP4 Cycle Load Configurations

		Table 2: TS03 Sterilizer Cycle Compatible SterilContainer S Container Systems
--	--	-------------------------------------------------------------------------------	--

Lid	Bottom	Description	Total Loaded ContainerWeight (if container does notcontain a flexible endoscopeor bronchoscope)*
JM489	JM440	Full Size 90mm (4 1/4")
	JM441	Full Size 120mm (5 1/2")	25 lbs for one container in the
	JM442	Full Size 135mm (6")	chamber
	JM444	Full Size 187mm (8")
JM789	JM740	3/4 Size 90mm(4 1/4")
	JM741	3/4 Size 120mm (5 1/2")
	JM742	3/4 Size 135mm (6")

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JM389	JM340	½ Size 90mm (4 ¼")
	JM341	½ Size 120mm (5 ½")
	JM342	½ Size 135mm (6")

*Loads containing a flexible endoscope or bronchoscope should follow Table 1 recommendations

Accessories	TS03 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

Table 3: TS03 Sterilizer Cycle Compatible Accessories

TECHNOLIGICAL CHARACTERISTICS (compared to predicate)

The SterilContainer S System that can be used in the TS03 Sterizone VP4 Low Sterilization cycle is the same container system that was cleared in K151242. The materials and design have not changed.

System	SterilContainer S System(not assigned)	SterilContainer S System(K151242)
Sterilizationprocess	TS03 Sterizone VP4 LowTemperature SterilizationSystem 46 min cycle,Ozone (O3), H2O2	V-PRO 60 38 min Low TemperatureFlexible Cycle, H2O2
Material	Non-anodized aluminum	Non-anodized aluminum
Container type	Perforated	Perforated
Filter type	Polypropylene	Polypropylene

PERFORMANCE DATA

The Aesculap SterilContainer S System has been validated for the TS03 Sterizone VP4 Low Temperature Sterilization System. These validations were conducted by a qualified testing laboratory. The performance testing demonstrates substantial equivalence to the predicate devices. The following performance testing has been completed to ensure substantial equivalence.

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Performance Properties	Results
Sterilization Efficacy/Lethality Study	Testing demonstrated a 12 log reduction and a sterilityassurance level (SAL) of 10-6 using the biological (BI)overkill method and half-cycle validation. The SAL wasachieved by placing at least 1.0 x 106 spores of Geobacillusstearothermophilus in the worst-case sterilization locationthrough the containers and processing at one-half theexpected full cycle exposure time. Following exposure, theBi's were aseptically transferred to culture media andincubated as required. This testing was performed intriplicate on the Aesculap rigid container. The full cycletherefore results in a 12-log reduction of spores andproduce a 10-6 SAL, which reflects a one-in-a-millionchance of non-sterile item.
Bacterial FiltrationEfficiency	The evaluation of the microbial barrier properties of theAesculap® polypropylene filters demonstrates that thebacterial filtration efficiency is maintained by the filter afterbeing processed in the Cycle 1 of the STERIZONE®Sterilizer.
Event Related SterilityMaintenance	Testing demonstrated the ability to provide an effectivebarrier for maintaining sterility of the contents afterprocessing followed by a 180 day event related storageunder conditions which simulate hospital sterile packagehandling and storage conditions.
MaterialCompatibility/Reuse Test	After 100 cycles of processing no visible or functionalchanges were observed
Biocompatibility	This study is conducted to evaluate the biocompatibilityproperties of the Aesculap® polypropylene filters whenprocessed in Cycle 1 of the STERIZONE® VP4 Sterilizer.The Aesculap® polypropylene filters have been proven tobe biocompatible and can be safely processed in Cycle 1of the STERIZONE® Sterilizer.
Aerosol Microbial Challenge	The contents of container were negative for growthfollowing exposure of the containers to aerosolizedmicrobial challenge test conditions

Conclusion:

The Aesculap SterilContainer S System 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).