The Aesculap Sterilcontainer System is a reusable sterilization container system (consisting of solid & perforated bottoms, a perforated lid w/ filter retention plates, and reusable polytetrafluoroethylene (PTFE) filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. 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 in pre-vacuum steam and IUSS (Immediate Use Steam Sterilization modalities. The SterilContainer System for includes accessories such as silicone mats, baskets, trays, and racks.

Device Description

The SterilContainer with PrimeLine Pro Lid is used in conjunction with Aesculap's Sterilcontainer Systems (K792558/K944864/K053389/K112671). The SterilContainer with PrimeLine Pro Lid is designed to be compatible for use with pre-vacuum steam and IUSS sterilization. The lid is manufactured from anodized aluminum and utilizes a reusable polytetrafluoroethylene (PTFE) filter. The SterilContainer with PrimeLine Pro Lid is offered in a various colors and range of sizes as the predicates including full, ¾, and half sizes lids.

AI/ML Overview

The Aesculap SterilContainer with PrimeLine Pro Lid is a reusable sterilization container system designed to sterilize and maintain the sterility of medical devices. The device was found to be substantially equivalent to its predicate devices based on non-clinical performance testing.

Here's a breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Sterilization Efficacy	Testing demonstrated a 6 log reduction and a sterility assurance level (SAL) of $10^{-6}$ using the biological (BI) overkill method and half-cycle validation.
Whole Package Microbial Aerosol Challenge	After exposure to a defined amount of aerosol microorganisms, the contents maintained sterility.
Event Related Sterility Maintenance	The test reports demonstrated that the SterilContainer with PrimeLine Pro Lid consistently maintained sterility of the contents after processing followed by 30, 180, and 365-day event-related storage under conditions which simulate hospital sterile package handling and storage conditions as long as the barrier is not compromised.
Mechanical Cleaning (Protein Analysis)	The study results validate that the mechanical cleaning instructions were effective in removing gross amounts of soil from the SterilContainer with PrimeLine Pro Lid to a protein level of less than $6.4 \mu g/cm^2$ per device.
Mechanical Cleaning (Hemoglobin Analysis)	The study results validate that the mechanical cleaning instructions were effective in removing gross amounts of soil from the SterilContainer with PrimeLine Pro Lid to a hemoglobin level of less than $2.2 \mu g/cm^2$ per device.
Manual Cleaning (Protein Analysis)	The study results validate that the manual cleaning instructions were effective in removing gross amounts of soil from the SterilContainer with PrimeLine Pro Lid to a protein level of less than $6.4 \mu g/cm^2$ per device.
Manual Cleaning (Hemoglobin Analysis)	The study results validate that the manual cleaning instructions were effective in removing gross amounts of soil from the SterilContainer with PrimeLine Pro Lid to a protein level of less than $2.2 \mu g/cm^2$ per device.

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 sample sizes used for each test. It mentions that "Test were performed in best/mid/worst case sized regarding vent to volume ratio and container size." The data provenance is not specified, but the testing was conducted by a "qualified testing laboratory" in accordance with FDA guidance and AAMI standards. This indicates a prospective and controlled experimental design.

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 device is not an AI/imaging device requiring expert interpretation for ground truth. The performance testing involves objective measures of sterilization efficacy, microbial challenge, sterility maintenance, and cleaning effectiveness, which do not typically rely on expert consensus for ground truth establishment in the same way an AI diagnostic tool would.

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

Not applicable. As noted above, this device does not involve human interpretation or subjective assessment that would require an adjudication method.

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 is not an AI device, so MRMC studies and the concept of human readers improving with AI assistance are not relevant.

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

Not applicable. This is not an algorithm-based device. The testing focuses on the physical and functional performance of the sterilization container system.

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

The ground truth for the performance testing is based on established scientific and regulatory standards for sterilization, microbial challenge, sterility maintenance, and cleaning efficacy.

Sterilization Efficacy: Ground truth is a 6 log reduction and SAL of $10^{-6}$ as per biological indicator results and half-cycle validations.
Microbial Aerosol Challenge: Ground truth is the absence of microbial growth in the contents after exposure to a defined amount of aerosol microorganisms.
Event Related Sterility Maintenance: Ground truth is the absence of microbial growth in the contents after storage periods, indicating sterility was maintained.
Cleaning Effectiveness: Ground truth is a protein level of less than $6.4 \mu g/cm^2$ and a hemoglobin level of less than $2.2 \mu g/cm^2$ per device, as determined by laboratory analysis.

These are objective, measurable outcomes based on established scientific principles and regulatory benchmarks.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of 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, a method for establishing its ground truth is not relevant.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 17, 2017

Aesculap, Inc. Lisa Boyle Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K172850

Trade/Device Name: SterilContainer with PrimeLine Pro Lid Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: October 24, 2017 Received: October 25, 2017

Dear Lisa Boyle:

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K172850

Device Name

SterilContainer with PrimeLine Pro Lid

Indications for Use (Describe)

A combined maximum load validated for all container configurations is 25lbs.
Sterilization Cycle Parameters	PrimeLime Pro ContainerLid with JP050 - Lid Size	Solid Base to be usedwith Lid	Max No. of LumensLumen Configuration
Immediate Use (Non porous)270°F Temp, 3 min. ExposureNo stacking recommended	1/2 size Lid(298 x281 x36)Art. No. JP121 - JP125	JK340 (4-1/4 in height)JK341 (5-1/2 in height)JK342 (6 in height)JK344 (8 in height)JK346 (10-1/2 in height)	Immediate Use - Non Porous:No lumens, a hinged device,and a knurled (irregularsurface) device.
Immediate Use (porous)270°F Temp, 4 min. ExposureNo stacking recommended	3/4 size Lid(465 x 281 x 36)Art. No. JP111 - JP115	JK740 (4-1/4 in height)JK741 (5-1/2 in height)JK742 (6 in height)JK744 (8 in height)	Immediate Use - Porous:1 SS lumen with 3mm I.D. x400mm L and a hinged device.
Prevacuum Dry Time Study270°FTemp, 4min.Exposure, 30 min.Dry TimeStacking should not exceed 16-18"height	Full size Lid(588 x 281 x 36)Art. No. JP101 - JP105	JK440 (4-1/4 in height)JK441 (5-1./2 in height)JK442 (6 in height)JK444 (8 in height)JK446 (10-1/2 in height)
Sterilization Cycle	Lid Size	Perforated Base to beused with Lid
	1/2 size Lid(298 x281 x36)Art. No. JP121 - JP125	JN340 (41/2 in height)JN341 (51/2 in height)JN342 (6 in height)JN344 (8 in height)JN346 (101/2 in height)
Prevacuum Dry Time Study270°FTemp, 4min.Exposure, 30 min.Dry TimeStacking should not exceed 16-18"height	3/4 size Lid(465 x 281 x 36)Art. No. JP111 - JP115	JN740 (4-1/4 in height)JN741 (5-1/2 in height)JN742 (6 in height)JN744 (8 in height)
	Full size Lid(588 x 281 x 36)Art. No. JP101 - JP105	JN440 (4-1/4 in height)JN441 (5-1/2 in height)JN442 (6 in height)JN444 (8 in height)JN446 (10-1/2 in height)

Table 2: Steam and IUSS Cycle Compatible Accessories

Accessories	Steam and IUSS
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

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

SterilContainer with PrimeLine Pro Lid November 10, 2017

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 291671-
CONTACT:	Lisa Boyle610-984-9274 (phone)610-791-6882 (fax)
TRADE NAME:	SterilContainer with PrimeLine Pro Lid
COMMON NAME:	Sterilization Container
CLASSIFICATION NAME:	Wrap, Sterilization
REGULATION NUMBER:	880.6850
PRODUCT CODE:	KCT

PREDICATE DEVICES

Primary Predicate : Primeline Lid (K073168) Reference Devices: Sterilcontainer System (K792558), Rigid Container System (K944864), and the SterilContainer System for Flash Indications (K053389), and SterilContainer System for Pre-Vac Steam. Immediate Use Steam, and EtO Sterilization (K112671).

DEVICE DESCRIPTION

INDICATIONS FOR USE

The Aesculap Sterilcontainer System is a reusable sterilization container system (consisting of solid & perforated bottoms, a perforated lid w/ filter retention plates, and reusable polytetrafluoroethylene (PTFE) filters) intended to enclose another medical device that is to be sterilized by a healthcare provider. 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 in pre-vacuum steam and IUSS

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(Immediate Use Steam Sterilization) sterilization modalities. The SterilContainer System includes accessories such as silicone mats, baskets, trays, and racks.

A combined maximum load validated for all container configurations is 25lbs.
Sterilization Cycle Parameters	PrimeLime Pro ContainerLid with JP050 - Lid Size	Solid Base to be usedwith Lid	Max No. of LumensLumen Configuration
Immediate Use (Non porous)270°F Temp, 3 min. ExposureNo stacking recommended	½ size Lid(298 x281 x36)Art. No. JP121 - JP125	JK340 (4-1/4 in height)JK341 (5-1/2 in height)JK342 (6 in height)JK344 (8 in height)JK346 (10-1/2 in height)	Immediate Use - Non Porous:No lumens, a hinged device,and a knurled (irregularsurface) device.
Immediate Use (porous)270°F Temp, 4 min. ExposureNo stacking recommended	¾ size Lid(465 x 281 x 36)Art. No. JP111 - JP115	JK740 (4-1/4 in height)JK741 (5-1/2 in height)JK742 (6 in height)JK744 (8 in height)	Immediate Use - Porous:1 SS lumen with 3mm I.D. x400mm L and a hinged device.
Prevacuum Dry Time Study270°FTemp, 4min.Exposure, 30 min.Dry TimeStacking should not exceed 16-18"height	Full size Lid(588 x 281 x 36)Art. No. JP101 - JP105	JK440 (4-1/4 in height)JK441 (5-1./2 in height)JK442 (6 in height)JK444 (8 in height)JK446 (10-1/2 in height)
Sterilization Cycle	Lid Size	Perforated Base to beused with Lid
Prevacuum Dry Time Study270°FTemp, 4min.Exposure, 30 min.Dry TimeStacking should not exceed 16-18"height	½ size Lid(298 x281 x36)Art. No. JP121 - JP125	JN340 (41/2 in height)JN341 (51/2 in height)JN342 (6 in height)JN344 (8 in height)JN346 (101/2 in height)
	¾ size Lid(465 x 281 x 36)Art. No. JP111 - JP115	JN740 (4-1/4 in height)JN741 (5-1/2 in height)JN742 (6 in height)JN744 (8 in height)
	Full size Lid(588 x 281 x 36)Art. No. JP101 - JP105	JN440 (4-1/4 in height)JN441 (5-1/2 in height)JN442 (6 in height)JN444 (8 in height)JN446 (10-1/2 in height)

Table 1: Steam and IUSS Compatible SterilContainer with PrimeLine Pro Lid

Table 2: Steam and IUSS

Cycle Compatible Accessories

Accessories	Steam and IUSS
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

TECHNOLIGICAL CHARACTERISTICS (compared to predicates)

The SterilContainer with PrimeLine Pro Lid is made from anodized aluminum (AMg1). The only difference between the subject device and the predicate lid is material of the lid. The original Primeline Lid (K073168) is constructed of a plastic polymer, but uses the exact same integrated PTFE filter and retention plate system of the subject SterilContainer with PrimeLine Pro Lid. This new lid is manufactured from the same aluminum type material that is used for other Aesculap SterilContainer Lids (K112671/K053389/K792258).

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The SterilContainer with PrimeLine Pro Lid is compatible for use with pre-vacuum steam and IUSS sterilization which are the cycles that the Primeline Lid (K073168) was cleared for use with (steam and flash). Aesculap's Sterilization Container System was cleared for use in pre-vacuum steam and pre-vacuum IUSS among other sterilization modalities.

The SterilContainer with PrimeLine Pro Lid is offered in variety of colors and sizes (full, 3/4, and half).

Device/System	AesculapSterilContainerw/ PrimeLinePro Lid	AesculapSterilContainerw/AluminumLid andPrimeLine Lid	AesculapSterilContainerwith PrimelineLid	AesculapSterilContainer(Flash)	AesculapPriMed RigidContainerSystem	AesculapContainerSystem
510(k)	Pending	K112671	K073168	K053389	K944864	K792558
SterilizationModalities	Pre-vac steam,ImmediateUse Pre-vacsteam	Pre-vac steam,Immediate Usesteam	Pre-vac steam,Immediate UsePre-vac steam	Immediate Usesteam	Gravitysteam, High-vacuumsteam, EO	Pre-vac,Steam, EtO
Material	AnodizedAluminum	AnodizedAluminum/RadelR	AnodizedAluminum/RadelR	AnodizedAluminum	AnodizedAluminum/JADEX	AnodizedAluminum
Worst caseVent toVolume Ratio	.50	.41	.49	.68	.59	Not Available
Filter	Reusable filter	Single UsePaper Filter,Single UsePolypropyleneFilter, Reusablefilter	Reusable filter	Single UsePaper Filter	Single UsePaper filter	Single UsePaper Filter,
Shelf-life/Barrier	30,180, and365 days(event related)	360 days (eventrelated)	360 days (eventrelated)	N/A (24 hrbarrier)	Not defined	Not defined
Reuse testing	2,200 uses (lidand filter)	2,200 uses (lidand filter)	2,200 uses (lidand filter)	100 cyclesminimum	100 cyclesminimum	100 cyclesminimum
Max totalweight	25 pounds	25 pounds	35 pounds	35 pounds	25 pounds	35 pounds

PERFORMANCE DATA

The SterilContainer with PrimeLine Pro Lid was fully validated for pre-vacuum steam and IUSS sterilization cycles. The validations were conducted in accordance with FDA guidance and available AAMI standards 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. Test were performed in best/mid/worst case sized regarding vent to volume ratio and container size.

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Performance Properties	Results
Sterilization Efficacy	Testing demonstrated a 6 log reduction and a sterilityassurance level (SAL) of 10-6 using the biological (BI)overkill method and half-cycle validation.
Whole Package MicrobialAerosol Challenge	After exposure to a defined amount of aerosolmicroorganisms contents maintained sterility.
Event Related SterilityMaintenance (30, 180, and365 days).	The test reports demonstrated that the SterilContainer withPrimeLine Pro Lid consistently maintained sterility of thecontents after processing followed by a 30, 180, and 365day event related storage under conditions which simulatehospital sterile package handling and storage conditions aslong as the barrier is not compromised.
Mechanical Cleaning(Protein Analysis)	The study results validate that the mechanical cleaninginstructions were effective in removing gross amounts ofsoil from the SterilContainer with PrimeLine Pro Lid to aprotein level of less than 6.4µg/cm² per device.
Mechanical Cleaning(Hemoglobin Analysis)	The study results validate that the mechanical cleaninginstructions were effective in removing gross amounts ofsoil from the SterilContainer with PrimeLine Pro Lid to ahemoglobin level of less than 2.2 µg/cm² per device.
Manual Cleaning (ProteinAnalysis)	The study results validate that the manual cleaninginstructions were effective in removing gross amounts ofsoil from the SterilContainer with PrimeLine Pro Lid to aprotein level of less than 6.4µg/cm² per device.
Manual Cleaning(Hemoglobin Analysis)	The study results validate that the manual cleaninginstructions were effective in removing gross amounts ofsoil from the SterilContainer with PrimeLine Pro Lid to aprotein level of less than 2.2 µg/cm² per device.

CONCLUSION

The SterilContainer with PrimeLine Pro Lid is substantially equivalent to the predicate device. The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well or better than the legally marketed 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).