The AESCULAP Aicon™ Container is a reusable rigid sterilization container 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 during transport and until used. This container is compatible for use in the following sterilization modalities in the configurations listed below:

Ethylene Oxide (EtO)
STERIS V-PRO maX/maX 2: Lumen, Non-Lumen, Flex
STERIS V-PRO 60: Lumen, Non- Lumen, Flex
STERRAD 100NX: Standard, Express, Flex, Duo
STERRAD NX: Standard, Advanced
STERRAD 100S
STERIZONE VP4
PreVac Steam

The AESCULAP Aicon™ consists of two different container styles: a solid bottom container and enhanced drying system (EDS) container.

Device Description

The AESCULAP Aicon Container is a reusable container system intended for sterilization and storage of other medical devices. This container system is compatible for use in the following sterilization modalities:

Ethylene Oxide
STERIS VPRO maX/ maX 2: Lumen, Non- Lumen, Flex,
STERIS VPRO 60: Lumen, Non-Lumen, Flex
STERRAD 100NX: Standard, Express, Flex, Duo
STERRAD NX: Standard, Advanced
STERRAD 100S
STERIZONE VP4
PreVac Steam

The containers are perforated and made from anodized aluminum and utilize a single-use filter.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Aesculap AICON™ Container, a reusable rigid sterilization container. The following information is extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Testing	Purpose	Acceptance Criteria	Reported Device Performance
Sterilization Efficacy	To determine sterilization effectiveness of test device after processing in a sterilization cycle.	A sterility assurance level (SAL) of 10-6 will be achieved post sterilization using the BI overkill method and half cycle validation. Biological indicators must be negative for growth after incubation period.	Pass
Dry Time	To determine the proper drying time required for the Aesculap Aicon Container.	The system shall demonstrate an average pre and post sterilization weight difference of less than 0.2% within five 5 minutes of cycle completion using final validated parameters and be free of visible moisture following a cooling period.	Pass
Microbial Aerosol Challenge	To analyze the package integrity and microbial barrier properties of the test device.	The container load maintains sterility after exposure to a defined amount of aerosol microorganisms. No presence of growth after incubation period.	Pass
Simulated Use	To determine the effective sterilization of flexible scopes when used with the test device.	A minimum of 1.0 x 10^6 spores contained within organic soil representative of actual use conditions are killed during defined sterilization cycle.	Pass
Material Compatibility	To assess effects of full use cycles on device components and their intended functionality.	No impact to functionality at the completion multiple sterilization cycles.	Pass
Cytotoxicity	To determine the potential of a test device to cause cytotoxicity.	Testing completed in accordance with ISO 10993-5: 2009 to demonstrate no significant cytotoxic reaction after exposure to sterilant. Using the ISO Elution Method, the response to the article is not greater than 2 (mild reactivity).	Pass
Sterility Maintenance	To demonstrate that a processed test device can maintain a sterile barrier for a defined period of time.	Sterility of container contents is maintained after processing for 365 days under conditions which simulate hospital sterile package handling and storage conditions. Biological indicators must be negative for growth after incubation period.	Pass

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

The document does not explicitly state the sample sizes used for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "testing conducted in accordance with applicable FDA guidance and standards." For example, for "Sterilization Efficacy" and "Sterility Maintenance," it mentions using "Biological Indicators" (BI), implying an appropriate number of BIs were used to validate the SAL.

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

This information is not provided in the document. The tests described are primarily in vitro/laboratory-based performance tests for a sterilization container, rather than clinical studies requiring expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. The tests described are objective, measurable performance tests with clear pass/fail criteria, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. Such studies are typically conducted for devices that involve human interpretation of diagnostic or screening results, which is not the function of a sterilization container. The studies performed are directed at the physical and biological effectiveness of the container in sterilization and maintaining sterility.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable to a physical medical device like a sterilization container. The performance tests are inherently "standalone" in the sense that they evaluate the device itself.

7. The Type of Ground Truth Used:

The ground truth for the performance tests is established by:

Sterility Assurance Level (SAL) of 10^-6: This is a widely accepted standard for sterilization efficacy, and is verified using biological indicators (containing resistant bacterial spores).
Weight difference and visible moisture: For dry time, objective measurements and visual inspection define the ground truth for adequate drying.
Absence of microbial growth: For microbial aerosol challenge and sterility maintenance, the absence of bacterial growth from cultures of the container contents confirms sterility.
Killing of spores in organic soil: For simulated use, the elimination of a specified number of spores in a challenging environment serves as the ground truth for effective sterilization of internal lumens.
Functional integrity: For material compatibility, maintained functionality after multiple cycles serves as the ground truth.
Cytotoxicity (mild reactivity): Defined by ISO 10993-5: 2009 standards, where a response not greater than 2 (mild reactivity) indicates acceptable biocompatibility.

8. The Sample Size for the Training Set:

This information is not provided and is not applicable. The device is a physical sterilization container, not an AI/ML algorithm that requires a training set.

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

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

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

December 30, 2022

Aesculap Inc. Tim Stoudt Associate Director- Regulatory Affairs 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K214041

Trade/Device Name: Aesculap AICON™ Container Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: November 30, 2022 Received: December 2, 2022

Dear Tim Stoudt:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray III -S

Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K214041

Device Name AESCULAP Aicon™ Container

Indications for Use (Describe)

· Ethylene Oxide (EtO)
STERIS V-PRO maX/maX 2: Lumen, Non-Lumen, Flex
· STERIS V-PRO 60: Lumen, Non- Lumen, Flex
· STERRAD 100NX: Standard, Express, Flex, Duo
STERRAD NX: Standard, Advanced
· STERRAD 100S
STERIZONE VP4
PreVac Steam

The AESCULAP Aicon™ consists of two different container styles: a solid bottom container and enhanced drying system (EDS) container.

The following tables identify the load configurations.

Sterilization Cycle	Container Sizes	Compatible Lumens
Ethylene Oxide (EtO)(130°F, 60 minute exposure50-70% RH, concentration 735mg/L)	Full Size	(2) Stainless Steel Lumens (≥3.0mm ID x ≤ 400mm L)
	Three-Quarter Size	(2) Stainless Steel Lumens (≥3.0mm ID x ≤ 400mm L)
	Half Size	(2) Stainless Steel Lumens (≥3.0mm ID x ≤ 400mm L)
STERIS V-PRO maX /maX 2Lumen Cycle	Full Size	(6) Stainless Steel Lumens (≥1mm ID x ≤ 400mm L)
	Three-Quarter Size	(6) Stainless Steel Lumens (≥0.77mm ID x ≤ 250mm L)
	Half Size	(6) Stainless Steel Lumens (≥1mm ID x ≤ 400mm L)(6) Stainless Steel Lumens (≥0.77mm ID x ≤ 250mm L)
		(12) Stainless Steel Lumens (≥1mm ID x ≤ 150mm L)
STERIS V-PRO Max/ Max 2Non-Lumen Cycle	Full Size	Non lumened stainless steel instruments
	Three-Quarter Size	Non lumened stainless steel instruments
	Half Size	Non lumened stainless steel instruments
STERIS V-PRO maX / maX 2Flex Cycle	Full Size	(1) Flexible endoscope with a light cord (if not integral toendoscope) without any additional load. The flexible endoscope may be single lumenthat is ≥1mm ID x ≤1050mm L
	Three-Quarter Size	(1) Flexible endoscope with a light cord (if not integral toendoscope) without any additional load. The flexible endoscope may be single lumenthatis ≥1mm ID x ≤1050mm L
	Half Size	(2) Flexible endoscopes with a light cord (if not integral to

Table 1. AESCULAP Aicon™ Container Lumen Configurations

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		endoscope) without any additional load. The flexible endoscope may be single lumenthat is ≥1mm ID x ≤1050mm L or two lumens with one ≥ 1 mm ID and ≤ 990 mm Land the other ≥ 1 mm ID and ≤ 850 mm LOR(1) flexible endoscope with a light cord (if not integralto endoscope) and additional non-lumened instruments. The flexible endoscope canhave:a single lumen that is ≥ 1mm ID and ≤ 1050 L or two lumens with one ≥ 1 mm ID and< 990 L and the other ≥ 1 mm ID and ≤ 850 mm L
	Full Size	(6) Stainless Steel Lumens (≥1mm ID x ≤ 400mm L)
		(6) Stainless Steel Lumens (≥0.77mm ID x ≤ 250mm L)
STERIS VPRO 60	Three-Quarter Size	(6) Stainless Steel Lumens (≥1mm ID x ≤ 400mm L)
Lumen Cycle		(6) Stainless Steel Lumens (≥0.77mm ID x ≤ 250mm L)
	Half Size	(12) Stainless Steel Lumens (≥1mm ID x ≤ 150mm L)
STERIS VPRO 60	Full Size	Non lumened stainless steel instruments
Non-Lumen Cycle	Three-Quarter Size	Non lumened stainless steel instruments
	Half Size	Non lumened stainless steel instruments
	Full Size	(1) flexible surgical endoscope or bronchoscope with alight cord (if not integral to scope) and single lumen (≥1mm ID x ≤990mm L)

STERIS VPRO 60	Three-Quarter Size	(1) flexible surgical endoscope or bronchoscope with alight cord (if not integral to scope) and single lumen (≥1mm ID x ≤990mm L)
Flex Cycle
	Half Size	(1) flexible surgical endoscope or bronchoscope with alight cord (if not integral to scope) and single lumen or dual lumens(≥1mm ID x ≤990mm L)
	Full Size	(5) Stainless-Steel Lumens (≥1.0mm ID x ≤500mm L)
		(5) Stainless-Steel Lumens (≥0.7mm ID x ≤400mm L)
STERRAD 100NX	Three-Quarter Size	(5) Stainless-Steel Lumens (≥1.0mm ID x ≤500mm L)
Standard Cycle		(5) Stainless-Steel Lumens (≥0.7mm ID x ≤400mm L)
	Half Size	(5) Stainless-Steel Lumens (≥0.7mm ID x ≤250mm L)
		(5) Stainless-Steel Lumens (≥0.7mm ID x ≤200mm L)
	Full Size	(5) Stainless Steel Lumens (≥3.0mm I.D. x ≤ 400mm L)
STERRAD 100S	Three-Quarter Size	(5) Stainless Steel Lumens (≥3.0mm I.D. x ≤ 400mm L)
	Half Size	(5) Stainless Steel Lumens (≥2.0mm ID x ≤ 250mm L)
	Full Size	(10)Stainless-steel lumens (≥2.5mm ID x ≤ 400mm L)
STERRAD NX	Three-Quarter Size	(10)Stainless-steel lumens (≥2.5mm ID x ≤ 400mm L)
Standard Cycle
	Half Size	(10) Stainless-steel lumens (≥2mm ID x ≤ 200mm L)
	Full Size	(5) Stainless-steel lumens (≥2.5mm ID x ≤500mm L)
		(5) Flexible Lumens (≥1mm ID x ≤850mm L)
STERRAD NXAdvanced Cycle	Three-Quarter Size	(5) Stainless-steel lumens (≥2.5mm ID x ≤500mm L)
	Half Size	(5) Flexible Lumens (≥1mm ID x ≤850mm L)(10) Stainless-steel lumens (≥2mm ID x ≤ 200mm L)

STERRAD 100NX	Full Size	Non lumened stainless steel instruments
Express Cycle	Three-Quarter Size	Non lumened stainless steel instruments
	Full Size	Non lumened stainless steel instruments

STERRAD 100NX	Full Size	(1) Flexible Lumen (≥1mm ID x ≤ 850mm L)
DUO Cycle	Three-Quarter Size	(1) Flexible Lumen (≥1mm ID x ≤ 850mm L)
	Half Size	(1) Flexible Lumen (≥1.mm ID x ≤ 650mm L)
	Full Size	(1) Flexible Lumen(≥1.5mm ID x ≤ 650mm L)
STERRAD 100NX	Three-Quarter Size	(1) Flexible Lumen (≥1.5mm ID x ≤ 650mm L)
Flex Cycle
	Half Size	(1) Flexible lumen (≥1.mm ID x ≤ 650mm L)
	Full Size	(4) Stainless Steel Lumens (≥1.mm ID x ≤200mm L)
PreVac Steam with dry time
(270°F, 4 min Exposure)	Three-Quarter	(4) Stainless Steel Lumens (≥1.0mm ID x ≤200mm L)
	Half Size	(4) Stainless Steel Lumens (≥1.0mm ID x ≤200mm L)
PreVac Steam without dry time	Full Size	(4) Stainless Steel Lumens (≥1mm ID x ≤ 125 mm L)
(270°F, 4 min Exposure)	Three-Quarter Size	(4) Stainless Steel Lumens (≥1mm ID x ≤ 125 mm L)
Porous	Half Size	(4) Stainless Steel Lumens (≥1mm ID x ≤ 125 mm L)

Prevac cycles without dry times are	Prevac cycles without dry times areImmediate Use Sterilization Cycles(IUSS).

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(270°F, 3 min Exposure)	Full Size	Non-lumened instruments
Non-Porous	Three-Quarter Size	Non-lumened instruments
Prevac cycles without dry times areImmediate Use Sterilization Cycles(IUSS).	Half Size	Non-lumened instruments
STERIZONE VP4Load 8(Aicon Validated Load 1)	Full Size	(1) Dual channel flexible scope (≥1.5mm ID x ≤850mm L) and(≥1.5mm ID x ≤989mm L)(1) Single channel flexible scope (≥1.5mm ID x ≤850mm L)
	Three-Quarter Size	(1) Dual channel flexible scope (≥1.5mm ID x ≤850mm L) and(≥1.5mm ID x ≤989mm L)(1) Single channel flexible scope (≥1.5mm ID x ≤850mm L)
	Half Size	(1) Dual channel flexible scope (≥1.5mm ID x ≤850mm L) and(≥1.5mm ID x ≤989mm L)(1) Single channel flexible scope (≥1.5mm ID x ≤850mm L)
STERIZONE VP4Load 4(Aicon Validated Load 2)	Full Size	(1) Dual channel semi rigid scope (≥0.7mm ID x 500mm L; ≥1.1mm ID x ≤500mm L)(1) Dual channel semi rigid scope (≥1.1 mm ID x 500mm L; ≥1.1 mm ID x ≤500mm L)(2) Stainless Steel Lumens (≥2mm ID x ≤250mm L)(2) Stainless Steel Lumens (≥3mm ID x ≤400mm L)
	Three-Quarter Size	(1) Dual channel semi rigid scope (≥0.7mm ID x 500mm L; ≥1.1mm ID x ≤500mm L)(1) Dual channel semi rigid scope (≥1.1 mm ID x 500mm L; ≥1.1 mm ID x ≤500mm L)(2) Stainless Steel Lumens (≥2mm ID x ≤250mm L)(2) Stainless Steel Lumens (≥3mm ID x ≤400mm L)
	Half Size	(1) Stainless Steel Lumen (≥0.7 mm ID x ≤300mm L)(1) Stainless Steel Lumen (≥1.0 mm ID x ≤300mm L)(2) Stainless Steel Lumens (≥2.0 mm ID x ≤250mm L)(2) Stainless Steel Lumens (≥3.0 mm ID x ≤300mm L)
STERIZONE VP4Load 7(Aicon Validated Load 3)	Full Size	Non-Lumened Stainless Steel Instruments (including hinges, luerlocks)
	Three-Quarter Size	Non-Lumened Stainless Steel Instruments (including hinges, luerlocks)
	Half Size	Non-Lumened Stainless Steel Instruments (including hinges, luerlocks)

Table 2. AESCULAP Aicon™ Container Configurations

SterilizationMethod	Container Size	StandardContainer	EDSContainer	ContainerLid Part #	Total LoadedContainer (lbs)
EtO(130°F, 60 minute exposure50-70% RH, concentration 735mg/L)	Full Size 4"	JJ110	JJ111
	Full Size 6"	JJ120	JJ121
	Full Size 8"	JJ130	JJ131	JJ410	25
	Full Size 10"	JJ140	JJ141
	Three-Quarter Size 4"	JJ310	JJ311
	Three-Quarter Size 6"	JJ320	JJ321
	Three-Quarter Size 8"	JJ330	JJ331	JJ430	25
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221
	Half Size 8"	JJ230	JJ231	JJ420	25
	Half Size 10"	JJ240	JJ241
STERIS VPROmaX/ maX 2 Lumen	Full Size 4"	JJ110	JJ111
	Full Size 6"	JJ120	JJ121
	Full Size 8"	JJ130	JJ131	JJ410	19.65
	Full Size 10"	JJ140	JJ141
	Three-Quarter Size 4"	JJ310	JJ311
	Three-Quarter Size 6"	JJ320	JJ321
	Three-Quarter Size 8"	JJ330	JJ331	JJ430	19.65
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221	JJ420	13.8
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241
	Full Size 4"	JJ110	JJ111		25
STERIS VPROmaX / maX 2 Non-Lumen	Full Size 6"	JJ120	JJ121	JJ410
	Full Size 8"	JJ130	JJ131
	Full Size 10"	JJ140	JJ141
	Three-Quarter Size 4"	JJ310	JJ311		25
	Three-Quarter Size 6"	JJ320	JJ321	JJ430
	Three-Quarter Size 8"	JJ330	JJ331
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221		JJ420
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241
	Full Size 4"	JJ110	JJ111		(1) Flexible endoscope witha light cord (if not integral toendoscope) without anyadditional load. The flexibleendoscope may be singlelumen that is ≥1mm ID x<1050mm L
	Full Size 6"	JJ120	JJ121	JJ410
	Full Size 8"	JJ130	JJ131
	Three-Quarter Size 4"	JJ310	JJ311
	Three-Quarter Size 6"	JJ320	JJ321
	Three-Quarter Size 8"	JJ330	JJ331	JJ430
	Three-Quarter Size 10"	JJ340	JJ341
STERIS VPROmaX / maX 2 Flex	Half Size 4"	JJ210	JJ211	JJ420	(2) Flexible endoscopeswith a light cord (if notintegral toendoscope) without anyadditional load. Theflexible endoscope may besingle lumen that is ≥1mmID x ≤1050mm L or twolumens with one ≥ 1 mmID and ≤ 990 mm L andthe other ≥ 1 mm ID and< 850 mm LOR(1) flexible endoscopewith a light cord (if notintegral to endoscope) andadditional non-lumenedinstruments (24lbs). Theflexible endoscope canhave: a single lumen that is≥ 1mm ID and ≤ 1050 L ortwo lumens with one≥ 1 mm ID and ≤ 990 Land the other ≥ 1 mm IDand ≤ 850 mm L
	Half Size 6"	JJ220	JJ221
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241
STERIS VPRO 60 Lumen	Full Size 4"	JJ110	JJ111	JJ410	11

	Full Size 6"	JJ120	JJ121
	Full Size 8"	JJ130	JJ131
	Three-Quarter Size 4"	JJ310	JJ311
	Three-Quarter Size 6"	JJ320	JJ321
	Three-Quarter Size 8"	JJ330	JJ331	JJ430	11
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211		11
	Half Size 6"	JJ220	JJ221
	Half Size 8"	JJ230	JJ231	JJ420
	Half Size 10"	JJ240	JJ241
STERIS VPRO 60 Non-Lumen	Full Size 4"	JJ110	JJ111
	Full Size 6"	JJ120	JJ121	JJ410	12
	Full Size 8"	JJ130	JJ131
	Three-Quarter Size 4"	JJ310	JJ311
	Three-Quarter Size 6"	JJ320	JJ321
	Three-Quarter Size 8"	JJ330	JJ331	JJ430	12
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221		12
	Half Size 8"	JJ230	JJ231	JJ420
	Half Size 10"	JJ240	JJ241
STERIS VPRO 60 Flex	Full Size 4"	JJ110	JJ111		(1) flexible surgicalendoscope or bronchoscopewith a light cord (if notintegral to scope) and singlelumen (≥1mm ID x<990mm L )
	Full Size 6"	JJ120	JJ121	JJ410
	Full Size 8"	JJ130	JJ131
	Three-Quarter Size 4"	JJ310	JJ311
	Three-Quarter Size 6"	JJ320	JJ321	JJ430	(1) flexible surgicalendoscope or bronchoscopewith a light cord (if notintegral to scope) and singlelumen (≥1mm ID x<990mm L )
	Three-Quarter Size 8"	JJ330	JJ331
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211	JJ420	(1) flexible surgicalendoscope or bronchoscopewith a light cord (if notintegral to scope) and single
	Half Size 6"	JJ220	JJ221		lumen (≥1mm ID x≤990mm L )
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241
STERRAD 100NX Standard	Full Size 4"	JJ110	JJ111		21.4
	Full Size 6"	JJ120	JJ121	JJ410
	Full Size 8"	JJ130	JJ131
	Full Size 10"	JJ140	JJ141
	Three-Quarter Size 4"	JJ310	JJ311		21.4
	Three-Quarter Size 6"	JJ320	JJ321	JJ430
	Three-Quarter Size 8"	JJ330	JJ331
	Three-Quarter Size 10"	JJ340	JJ341
STERRAD 100S	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221	JJ420	13.8
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241
	Full Size 4"	JJ110	JJ111		13.9
	Full Size 6"	JJ120	JJ121	JJ410
	Full Size 8"	JJ130	JJ131
	Full Size 10"	JJ140	JJ141
	Three-Quarter Size 4"	JJ310	JJ311		13.9
	Three-Quarter Size 6"	JJ320	JJ321	JJ430
	Three-Quarter Size 8"	JJ330	JJ331
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221	JJ420	13.9
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241
STERRAD NX Standard	Full Size 4"	JJ110	JJ111		10.7
	Full Size 6"	JJ120	JJ121	JJ410
	Full Size 8"	JJ130	JJ131
	Full Size 10"	JJ140	JJ141
	Three-Quarter Size 4"	JJ310	JJ311		10.7
	Three-Quarter Size 6"	JJ320	JJ321	JJ430
	Three-Quarter Size 8"	JJ330	JJ331
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221	JJ420	10.7
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241
STERRAD NX Advanced	Full Size 4"	JJ110	JJ111	JJ410	10.7
	Full Size 6"	JJ120	JJ121
	Three-Quarter Size 4"	JJ310	JJ311	JJ430	10.7

	Three-Quarter Size 6"	JJ320	JJ321
	Three-Quarter Size 8"	JJ330	JJ331
	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221	JJ420	10.7
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241
	Full Size 4"	JJ110	JJ111
	Full Size 6"	JJ120	JJ121	JJ410	10.7
	Full Size 8"	JJ130	JJ131
STERRAD 100NX Express	Three-Quarter Size 4"	JJ310	JJ311
	Three-Quarter Size 6"	JJ320	JJ321	JJ430	10.7
	Three-Quarter Size 8"	JJ330	JJ331
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221
	Half Size 8"	JJ230	JJ231	JJ420	10.7
	Half Size 10"	JJ240	JJ241
	Full Size 4"	JJ110	JJ111
	Full Size 6"	JJ120	JJ121
STERRAD 100NX DUO	Full Size 8"	JJ130	JJ131	JJ410	13.2
	Full Size 10"	JJ140	JJ141
	Three-Quarter Size 4"	JJ310	JJ311
	Three-Quarter Size 6"	JJ320	JJ321	JJ430	13.2
	Three-Quarter Size 8"	JJ330	JJ331
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221
	Half Size 8"	JJ230	JJ231	JJ420	6.0
	Half Size 10"	JJ240	JJ241
	Full Size 4"	JJ110	JJ111
	Full Size 6"	JJ120	JJ121	JJ410	14.7
	Full Size 8"	JJ130	JJ131
	Full Size 10"	JJ140	JJ141
STERRAD 100NX Flex	Three-Quarter Size 4"	JJ310	JJ311
	Three-Quarter Size 6"	JJ320	JJ321	JJ430	14.7
	Three-Quarter Size 8"	JJ330	JJ331
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221	JJ420	10.7
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241
Prevac Steam270°F, 4 min exposure	Full Size 4"	JJ110	JJ111		25
	Full Size 6"	JJ120	JJ121	JJ410	24
With silicone mat and lid cover*30 minute dry time	Full Size 8"	JJ130	JJ131		23
	Full Size 10"	JJ140	JJ141		22
Without silicone mat and lid	Three-Quarter Size 4"	JJ310	JJ311	JJ430	23
Three-Quarter Size 6"cover*

20 minute dry time	Three-Quarter Size 8"	JJ330	JJ331		20
	Three-Quarter Size 10"	JJ340	JJ341		18
	Half Size 4"	JJ210	JJ211		18
	Half Size 6"	JJ220	JJ221		18
	Half Size 8"	JJ230	JJ231	JJ420	15
	Half Size 10"	JJ240	JJ241		13
	Full Size 4"	JJ110	JJ111
	Full Size 6"	JJ120	JJ121
	Full Size 8"	JJ130	JJ131	JJ410	25
PreVac Steam without dry time270°F	Full Size 10"	JJ140	JJ141
3 min Exposure(Non-porous)	Three-Quarter Size 4"	JJ310	JJ311
	Three-Quarter Size 6"	JJ320	JJ321
	Three-Quarter Size 8"	JJ330	JJ331	JJ430	25
AND	Three-Quarter Size 10"	JJ340	JJ341
Prevac Steam without dry time270°F	Half Size 4"	JJ210	JJ211
4 min Exposure(Porous)	Half Size 6"	JJ220	JJ221
	Half Size 8"	JJ230	JJ231	JJ420	25
	Half Size 10"	JJ240	JJ241
Prevac cycles without dry timesare Immediate Use SterilizationCycles (IUSS).
	Full Size 4"	JJ110	JJ111	JJ410	Based on Load Configuration
	Full Size 6"	JJ120	JJ121		in Table 1
	Full Size 8"	JJ130	JJ131		13.8lbs
STERIZONE VP4Based on Sterizone ValidatedLoad 8	Three-Quarter Size 4"	JJ310	JJ311	JJ430
(Aicon Validated Load 1)	Three-Quarter Size 6"	JJ320	JJ321		Based on Load Configuration
	Three-Quarter Size 8"	JJ330	JJ331		in Table 1
	Three-Quarter Size 10"	JJ340	JJ341		13.8lbs
	Half Size 4"	JJ210	JJ211	JJ420
	Half Size 6"	JJ220	JJ221		Based on Load Configuration
	Half Size 8"	JJ230	JJ231		in Table 1
	Half Size 10"	JJ240	JJ241		5.8lbs
	Full Size 4"	JJ110	JJ111
					Based on Load Configuration
	Full Size 6"Full Size 8"	JJ120	JJ121	JJ410	in Table 1
		JJ130	JJ131		11.7lbs
	Three-Quarter Size 4"	JJ310	JJ311
STERIZONE VP4Based on Sterizone ValidatedLoad 4	Three-Quarter Size 6"	JJ320	JJ321		Based on Load Configuration
(Aicon Validated Load 2)	Three-Quarter Size 8"	JJ330	JJ331	JJ430	in Table 1
	Three-Quarter Size 10"	JJ340	JJ341		11.7lbs
	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221		Based on Load Configuration
				JJ420	in Table 1
	Half Size 8"	JJ230	JJ231		5.8lbs
	Half Size 10"	JJ240	JJ241
	Full Size 4"Full Size 6"	JJ110	JJ111
	Full Size 8"	JJ130	JJ131	JJ410	25
STERIZONE VP4Based on Sterizone ValidatedLoad 7	Three-Quarter Size 4"	JJ310	JJ311
(Aicon Validated Load 3)	Three-Quarter Size 6"	JJ320	JJ321
	Three-Quarter Size 8"	JJ330	JJ331	JJ430	25
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211	JJ420	25
	Half Size 6"	JJ220	JJ221
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241

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Aesculap AICON Containers may be used with commercially available Aesculap accessories according to the table below:

Accessories	EtO	Steris V-PROSystems	STERRADSystems	STERIZONEVP4	PREVACSTEAM
Baskets, trays, indicator cards,tamper evident locks, faceplateholders, and tags.	Yes	Yes	Yes	Yes	Yes
Instrument Organization System(Silicone and Stainless Steel racks,brackets, holders, and clamps)	Yes	No Silicone Pieces	No Silicone Pieces	No Silicone Pieces	Yes
Silicone mats	No	No	No	No	Yes*
Lid Covers	No	No	No	No	Yes*

Use of silicone mats and/or lid covers may require a longer drying time.

Silicone mats and lid covers are compatible with PreVac steam only. Silicone pieces should not be used with Ethylene Oxide, Steris V-Pro Systems, STERRAD Systems, or STERIZONE VP4 Systems.

Healthcare Facilities should follow steam sterilization cycle guidelines as stated in AAM ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

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)

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510(k) SUMMARY K214041

Aesculap Aicon™ Container

November 30, 2022

COMPANY:	Aesculap, Inc.3773 Corporate Parkway Center Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Tim Stoudt tim.stoudt@bbraunusa.com(484) 523-4581610-791-6882 (fax)
TRADE NAME:	Aesculap Aicon™ Container
COMMON NAME:	Sterilization Container Wrap
CLASSIFICATION NAME:	Wrap, Sterilization
REGULATION NUMBER:	880.6850
PRODUCT CODE:	KCT
DEVICE CLASS:	Class II per 21 CFR 880.6850
PREDICATE DEVICE
TRADE NAME:	Aesculap JJ Series Container System
510(k) NUMBER:	K192056
COMMON NAME:	Sterilization Container Wrap
CLASSIFICATION NAME:	Wrap, Sterilization
REGULATION NUMBER:	880.6850
PRODUCT CODE:	KCT
DEVICE CLASS:	Class II per 21 CFR 880.6850

DEVICE DESCRIPTION

Ethylene Oxide
· STERIS VPRO maX/ maX 2: Lumen, Non- Lumen, Flex,
STERIS VPRO 60: Lumen, Non-Lumen, Flex
STERRAD 100NX: Standard, Express, Flex, Duo

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STERRAD NX: Standard, Advanced
· STERRAD 100S
· STERIZONE VP4
· PreVac Steam

The containers are perforated and made from anodized aluminum and utilize a single-use filter.

INDICATIONS FOR USE

Ethylene Oxide (EtO)
STERIS V-PRO maX/maX 2: Lumen, Non-Lumen, Flex
STERIS V-PRO 60: Lumen, Non- Lumen, Flex
· STERRAD 100NX: Standard, Express, Flex, Duo
· STERRAD NX: Standard, Advanced
STERRAD 100S
STERIZONE VP4
PreVac Steam

The AESCULAP Aicon™ consists of two different container styles: a solid bottom container and enhanced drying system (EDS) container.

The following tables identify the load configurations.

Table 1. AESCULAP Aicon™ Container Lumen Configurations
Sterilization Cycle	Container Sizes	Compatible Lumens
Ethylene Oxide (EtO)(130°F, 60 minute exposure50-70% RH, concentration735mg/L)	Full Size	(2) Stainless Steel Lumens (≥3.0mm ID x ≤ 400mm L)
	Three-QuarterSize	(2) Stainless Steel Lumens (≥3.0mm ID x ≤ 400mm L)
	Half Size	(2) Stainless Steel Lumens (≥3.0mm ID x ≤ 400mm L)
STERIS V-PRO maX /maX 2Lumen Cycle	Full Size	(6) Stainless Steel Lumens (≥1mm ID x ≤ 400mm L)(6) Stainless Steel Lumens (≥0.77mm ID x ≤ 250mm L)
	Three-QuarterSize	(6) Stainless Steel Lumens (≥1mm ID x ≤ 400mm L)(6) Stainless Steel Lumens (≥0.77mm ID x ≤ 250mm L)
	Half Size	(12) Stainless Steel Lumens (≥1mm ID x ≤ 150mm L)
STERIS V-PRO Max/ Max 2Non-Lumen Cycle	Full Size	Non lumened stainless steel instruments
	Three-QuarterSize	Non lumened stainless steel instruments
	Half Size	Non lumened stainless steel instruments
STERIS V-PRO maX / maX 2Flex Cycle	Full Size	(1) Flexible endoscope with a light cord (if not integral toendoscope) without any additional load. The flexible endoscope may be single lumen that is≥1mm ID x ≤1050mm L
	Three-QuarterSize	(1) Flexible endoscope with a light cord (if not integral toendoscope) without any additional load. The flexible endoscope may be single lumen thatis ≥1mm ID x ≤1050mm L
	Half Size	(2) Flexible endoscopes with a light cord (if not integral toendoscope) without any additional load. The flexible endoscope may be single lumen that is≥1mm ID x ≤1050mm L or two lumens with one ≥ 1 mm ID and ≤ 990 mm L and the other ≥1 mm ID and ≤ 850 mm LOR(1) flexible endoscope with a light cord (if not integral
		to endoscope) and additional non-lumened instruments. The flexible endoscope can have:a single lumen that is ≥ 1mm ID and ≤ 1050 L or two lumens with one ≥ 1 mm ID and
		≤ 990 L and the other ≥ 1 mm ID and ≤ 850 mm L
STERIS VPRO 60Lumen Cycle	Full Size	(6) Stainless Steel Lumens (≥1mm ID x ≤ 400mm L)
STERIS VPRO 60Lumen Cycle	Three-QuarterSize	(6) Stainless Steel Lumens (≥0.77mm ID x ≤ 250mm L)
	Half Size	(12) Stainless Steel Lumens (≥1mm ID x ≤ 150mm L)
STERIS VPRO 60Non-Lumen Cycle	Full Size	Non lumened stainless steel instruments
STERIS VPRO 60Non-Lumen Cycle	Three-QuarterSize	Non lumened stainless steel instruments
STERIS VPRO 60Non-Lumen Cycle	Half Size	Non lumened stainless steel instruments
STERIS VPRO 60Flex Cycle	Full Size	(1) flexible surgical endoscope or bronchoscope with alight cord (if not integral to scope) and single lumen (≥1mm ID x ≤990mm L)
STERIS VPRO 60Flex Cycle	Three-QuarterSize	(1) flexible surgical endoscope or bronchoscope with alight cord (if not integral to scope) and single lumen (≥1mm ID x ≤990mm L)
STERIS VPRO 60Flex Cycle	Half Size	(1) flexible surgical endoscope or bronchoscope with alight cord (if not integral to scope) and single lumen or dual lumens(≥1mm ID x ≤990mm L)
STERRAD 100NXStandard Cycle	Full Size	(5) Stainless-Steel Lumens (≥1.0mm ID x ≤500mm L)
STERRAD 100NXStandard Cycle	Three-QuarterSize	(5) Stainless-Steel Lumens (≥0.7mm ID x ≤400mm L)
STERRAD 100NXStandard Cycle	Half Size	(5) Stainless-Steel Lumens (≥0.7mm ID x ≤250mm L)
STERRAD 100S	Full Size	(5) Stainless Steel Lumens (≥3.0mm I.D. x ≤ 400mm L)
STERRAD 100S	Three-QuarterSize	(5) Stainless Steel Lumens (≥3.0mm I.D. x ≤ 400mm L)
STERRAD 100S	Half Size	(5) Stainless Steel Lumens (≥2.0mm ID x ≤ 250mm L)
STERRAD NXStandard Cycle	Full Size	(10)Stainless-steel lumens (≥2.5mm ID x ≤ 400mm L)
STERRAD NXStandard Cycle	Three-QuarterSize	(10)Stainless-steel lumens (≥2.5mm ID x ≤ 400mm L)
STERRAD NXStandard Cycle	Half Size	(10) Stainless-steel lumens (≥2mm ID x ≤ 200mm L)
STERRAD NXAdvanced Cycle	Full Size	(5) Stainless-steel lumens (≥2.5mm ID x ≤500mm L)(5) Flexible Lumens (≥1mm ID x ≤850mm L)
STERRAD NXAdvanced Cycle	Three-QuarterSize	(5) Stainless-steel lumen (≥2.5mm ID x ≤500mm L)(5) Flexible Lumens (≥1mm ID x ≤850mm L)
STERRAD NXAdvanced Cycle	Half Size	(10) Stainless-steel lumens (≥2mm ID x ≤ 200mm L)
STERRAD 100NXExpress Cycle	Full Size	Non lumened stainless steel instruments
STERRAD 100NXExpress Cycle	Three-QuarterSize	Non lumened stainless steel instruments
STERRAD 100NXExpress Cycle	Full Size	Non lumened stainless steel instruments
STERRAD 100NXDUO Cycle	Full Size	(1) Flexible Lumen (≥1mm ID x ≤ 850mm L)
STERRAD 100NXDUO Cycle	Three-QuarterSize	(1) Flexible Lumen (≥1mm ID x ≤ 850mm L)
STERRAD 100NXDUO Cycle	Half Size	(1) Flexible Lumen (≥1.mm ID x ≤ 650mm L)
STERRAD 100NXFlex Cycle	Full Size	(1) Flexible Lumen(≥1.5mm ID x ≤ 650mm L)
STERRAD 100NXFlex Cycle	Three-QuarterSize	(1) Flexible Lumen (≥1.5mm ID x ≤ 650mm L)
STERRAD 100NXFlex Cycle	Half Size	(1) Flexible lumen (≥1.mm ID x ≤ 650mm L)
PreVac Steam withdry time (270°F, 4min Exposure)	Full Size	(4) Stainless Steel Lumens (≥1.mm ID x ≤200mm L)
PreVac Steam withdry time (270°F, 4min Exposure)	Three-Quarter	(4) Stainless Steel Lumens (≥1.0mm ID x ≤200mm L)
PreVac Steam withdry time (270°F, 4min Exposure)	Half Size	(4) Stainless Steel Lumens (≥1.0mm ID x ≤200mm L)
		Size
PreVac Steamwithout dry time(270°F, 4 minExposure) Porous	Full Size		(4) Stainless Steel Lumens (≥1mm ID x ≤ 125 mm L)
	Three-Quarter Size		(4) Stainless Steel Lumens (≥1mm ID x ≤ 125 mm L)
	Half Size		(4) Stainless Steel Lumens (≥1mm ID x ≤ 125 mm L)
	Prevac cycles without dry timeare Immediate Use SterilizationCycles (IUSS).
Prevac Steamwithout dry time(270°F, 3 minExposure)Non-Porous	Full Size		Non-lumened instruments
	Three-Quarter Size		Non-lumened instruments
	Half Size		Non-lumened instruments
	Prevac cycles without dry timeare Immediate Use SterilizationCycles (IUSS).
STERIZONE VP4Load 8(Aicon Validated Load 1)	Full Size		(1) Dual channel flexible scope (≥1.5mm ID x ≤850mm L) and (≥1.5mmID x ≤989mm L)(1) Single channel flexible scope (≥1.5mm ID x ≤850mm L)
	Three-Quarter Size		(1) Dual channel flexible scope (≥1.5mm ID x ≤850mm L) and (≥1.5mmID x ≤989mm L)(1) Single channel flexible scope (≥1.5mm ID x ≤850mm L)
	Half Size		(1) Dual channel flexible scope (≥1.5mm ID x ≤850mm L) and (≥1.5mmID x ≤989mm L)(1) Single channel flexible scope (≥1.5mm ID x ≤850mm L)

STERIZONE VP4Load 4(Aicon Validated Load 2)	Full Size		(1) Dual channel semi rigid scope (≥0.7mm ID x 500mm L; ≥1.1mm ID x ≤500mm L)(1) Dual channel semi rigid scope (≥1.1 mm ID x 500mm L; ≥1.1 mm ID x ≤500mm L)(2) Stainless Steel Lumens (≥2mm ID x ≤250mm L)(2) Stainless Steel Lumens (≥3mm ID x ≤400mm L)
	Three-Quarter Size		(1) Dual channel semi rigid scope (≥0.7mm ID x 500mm L; ≥1.1mm ID x ≤500mm L)(1) Dual channel semi rigid scope (≥1.1 mm ID x 500mm L; ≥1.1 mm ID x ≤500mm L)(2) Stainless Steel Lumens (≥2mm ID x ≤250mm L)(2) Stainless Steel Lumens (≥3mm ID x ≤400mm L)
	Half Size		(1) Stainless Steel Lumen (≥0.7 mm ID x ≤300mm L)(1) Stainless Steel Lumen (≥1.0 mm ID x ≤300mm L)(2) Stainless Steel Lumens (≥2.0 mm ID x ≤250mm L)(2) Stainless Steel Lumens (≥3.0 mm ID x ≤300mm L)

STERIZONE VP4Load 7(Aicon Validated Load 3)	Full Size		Non-Lumened Stainless Steel Instruments (including hinges, luerlocks)
	Three-Quarter Size		Non-Lumened Stainless Steel Instruments (including hinges, luerlocks)
	Half Size		Non-Lumened Stainless Steel Instruments (including hinges, luerlocks)

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Table 2. AESCULAP Aicon™ Container Configurations

SterilizationMethod	Container Size	StandardContainer	EDSContainer	ContainerLid Part #	Total LoadedContainer (lbs)
EtO(130°F, 60 minute exposure50-70% RH, concentration 735mg/L)	Full Size 4"	JJ110	JJ111
	Full Size 6"	JJ120	JJ121
	Full Size 8"	JJ130	JJ131	JJ410	25
	Full Size 10"	JJ140	JJ141
EtO(130°F, 60 minute exposure50-70% RH, concentration 735mg/L)	Three-Quarter Size 4"	JJ310	JJ311
	Three-Quarter Size 6"	JJ320	JJ321
	Three-Quarter Size 8"	JJ330	JJ331	JJ430	25
	Three-Quarter Size 10"	JJ340	JJ341
EtO(130°F, 60 minute exposure50-70% RH, concentration 735mg/L)	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221
	Half Size 8"	JJ230	JJ231	JJ420	25
	Half Size 10"	JJ240	JJ241
EtO(130°F, 60 minute exposure50-70% RH, concentration 735mg/L)	Full Size 4"	JJ110	JJ111

	STERIS VPROmaX/ maX 2 Lumen	Full Size 6"	JJ120	JJ121	JJ410	19.65
		Full Size 8"	JJ130	JJ131
		Full Size 10"	JJ140	JJ141
		Three-Quarter Size 4"	JJ310	JJ311
		Three-Quarter Size 6"	JJ320	JJ321	JJ430	19.65
		Three-Quarter Size 8"	JJ330	JJ331
		Three-Quarter Size 10"	JJ340	JJ341
		Half Size 4"	JJ210	JJ211	JJ420	13.8
		Half Size 6"	JJ220	JJ221
		Half Size 8"	JJ230	JJ231
		Half Size 10"	JJ240	JJ241
	STERIS VPROmaX/maX 2 Non-Lumen	Full Size 4"	JJ110	JJ111	JJ410	25
		Full Size 6"	JJ120	JJ121
		Full Size 8"	JJ130	JJ131
		Full Size 10"	JJ140	JJ141
		Three-Quarter Size 4"	JJ310	JJ311	JJ430	25
		Three-Quarter Size 6"	JJ320	JJ321
		Three-Quarter Size 8"	JJ330	JJ331
		Three-Quarter Size 10"	JJ340	JJ341
		Half Size 4"	JJ210	JJ211	JJ420	18.7
		Half Size 6"	JJ220	JJ221
		Half Size 8"	JJ230	JJ231
		Half Size 10"	JJ240	JJ241
	STERIS VPROmaX/maX 2 Flex	Full Size 4"	JJ110	JJ111	JJ410	(1) Flexible endoscope witha light cord (if not integral toendoscope) without anyadditional load. The flexibleendoscope may be singlelumen that is ≥1mm ID x<1050mm L
		Full Size 6"	JJ120	JJ121
		Full Size 8"	JJ130	JJ131
		Three-Quarter Size 4"	JJ310	JJ311	JJ430	(1) Flexible endoscope witha light cord (if not integral toendoscope) without anyadditional load. The flexibleendoscope may be singlelumen that is ≥1mm ID x<1050mm L
		Three-Quarter Size 6"	JJ320	JJ321
		Three-Quarter Size 8"	JJ330	JJ331
		Three-Quarter Size 10"	JJ340	JJ341
		Half Size 4"	JJ210	JJ211	JJ420	(2) Flexible endoscopeswith a light cord (if notintegral toendoscope) without anyadditional load. The
	Half Size 6"	JJ220	JJ221		flexible endoscope may besingle lumen that is ≥1mmID x ≤1050mm L or twolumens with one ≥ 1 mmID and ≤ 990 mm L andthe other ≥ 1 mm ID and≤ 850 mm LOR(1) flexible endoscopewith a light cord (if notintegral to endoscope) andadditional non-lumenedinstruments (24lbs). Theflexible endoscope canhave: a single lumen that is
	Half Size 8"	JJ230	JJ231		≥ 1mm ID and ≤ 1050 L ortwo lumens with one≥ 1 mm ID and ≤ 990 Land the other ≥ 1 mm IDand ≤ 850 mm L
	Half Size 10"	JJ240	JJ241
STERIS VPRO 60 Lumen	Full Size 4"	JJ110	JJ111	JJ410	11
	Full Size 6"	JJ120	JJ121
	Full Size 8"	JJ130	JJ131
	Three-Quarter Size 4"	JJ310	JJ311
	Three-Quarter Size 6"	JJ320	JJ321
	Three-Quarter Size 8"	JJ330	JJ331	JJ430	11
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221	JJ420	11
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241
STERIS VPRO 60 Non-Lumen	Full Size 4"	JJ110	JJ111
	Full Size 6"	JJ120	JJ121	JJ410	12
	Full Size 8"	JJ130	JJ131
	Three-Quarter Size 4"	JJ310	JJ311
	Three-Quarter Size 6"	JJ320	JJ321	JJ430	12
	Three-Quarter Size 8"	JJ330	JJ331
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221		12
	Half Size 8"	JJ230	JJ231	JJ420
	Half Size 10"	JJ240	JJ241
	Full Size 4"	JJ110	JJ111
	Full Size 6"	JJ120	JJ121	JJ410	(1) flexible surgicalendoscope or bronchoscopewith a light cord (if notintegral to scope) and singlelumen (≥1mm ID x<990mm L )
	Full Size 8"	JJ130	JJ131
	Three-Quarter Size 4"	JJ310	JJ311
STERIS VPRO 60 Flex	Three-Quarter Size 6"	JJ320	JJ321	JJ430
	Three-Quarter Size 8"	JJ330	JJ331
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211	JJ420	(1) flexible surgicalendoscope or bronchoscopewith a light cord (if notintegral to scope) and singlelumen (≥1mm ID x<990mm L )
	Half Size 6"	JJ220	JJ221
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241
	Full Size 4"	JJ110	JJ111
	Full Size 6"	JJ120	JJ121	JJ410	21.4
STERRAD 100NX Standard	Full Size 8"	JJ130	JJ131
	Full Size 10"	JJ140	JJ141
	Three-Quarter Size 4"	JJ310	JJ311
	Three-Quarter Size 6"	JJ320	JJ321
	Three-Quarter Size 8"	JJ330	JJ331	JJ430	21.4
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221
	Half Size 8"	JJ230	JJ231	JJ420	13.8
	Half Size 10"	JJ240	JJ241
	Full Size 4"	JJ110	JJ111
STERRAD 100S	Full Size 6"	JJ120	JJ121	JJ410	13.9
	Full Size 8"	JJ130	JJ131
	Full Size 10"	JJ140	JJ141
	Three-Quarter Size 4"	JJ310	JJ311	JJ430	13.9
	Three-Quarter Size 6"	JJ320	JJ321
	Three-Quarter Size 8"	JJ330	JJ331
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211	JJ420	13.9
	Half Size 6"	JJ220	JJ221
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241
STERRAD NX Standard	Full Size 4"	JJ110	JJ111	JJ410	10.7
	Full Size 6"	JJ120	JJ121
	Full Size 8"	JJ130	JJ131
	Full Size 10"	JJ140	JJ141
	Three-Quarter Size 4"	JJ310	JJ311	JJ430	10.7
	Three-Quarter Size 6"	JJ320	JJ321
	Three-Quarter Size 8"	JJ330	JJ331
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211	JJ420	10.7
	Half Size 6"	JJ220	JJ221
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241
STERRAD NX Advanced	Full Size 4"	JJ110	JJ111	JJ410	10.7
	Full Size 6"	JJ120	JJ121
	Three-Quarter Size 4"	JJ310	JJ311	JJ430
	Three-Quarter Size 6"	JJ320	JJ321
	Three-Quarter Size 8"	JJ330	JJ331
	Half Size 4"	JJ210	JJ211	JJ420	10.7
	Half Size 6"	JJ220	JJ221
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241
STERRAD 100NX Express	Full Size 4"	JJ110	JJ111	JJ410	10.7
	Full Size 6"	JJ120	JJ121
	Full Size 8"	JJ130	JJ131	JJ430
	Three-Quarter Size 4"	JJ310	JJ311
	Three-Quarter Size 6"	JJ320	JJ321
	Three-Quarter Size 8"	JJ330	JJ331
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221
	Half Size 8"	JJ230	JJ231	JJ420	10.7
	Half Size 10"	JJ240	JJ241
	Full Size 4"	JJ110	JJ111
	Full Size 6"	JJ120	JJ121	JJ410	13.2
STERRAD 100NX DUO	Full Size 8"	JJ130	JJ131
	Full Size 10"	JJ140	JJ141
	Three-Quarter Size 4"	JJ310	JJ311
	Three-Quarter Size 6"	JJ320	JJ321	JJ430	13.2
	Three-Quarter Size 8"	JJ330	JJ331
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221	JJ420	6.0
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241
	Full Size 4"	JJ110	JJ111
	Full Size 6"	JJ120	JJ121	JJ410	14.7
	Full Size 8"	JJ130	JJ131
	Full Size 10"	JJ140	JJ141
	Three-Quarter Size 4"	JJ310	JJ311
STERRAD 100NX Flex	Three-Quarter Size 6"	JJ320	JJ321
	Three-Quarter Size 8"	JJ330	JJ331	JJ430	14.7
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211
	Half Size 6"	JJ220	JJ221	JJ420	10.7
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241
Prevac Steam270°F, 4 min exposure	Full Size 4"	JJ110	JJ111		25
	Full Size 6"	JJ120	JJ121	JJ410	24
With silicone mat and lid cover*30 minute dry time	Full Size 8"	JJ130	JJ131		23
	Full Size 10"	JJ140	JJ141		22
Without silicone mat and lidcover*20 minute dry time	Three-Quarter Size 4"	JJ310	JJ311		23
	Three-Quarter Size 6"	JJ320	JJ321	JJ430	22
	Three-Quarter Size 8"	JJ330	JJ331		20
	Three-Quarter Size 10"	JJ340	JJ341		18
	Half Size 4"	JJ210	JJ211		18
	Half Size 6"	JJ220	JJ221		18
	Half Size 8"	JJ230	JJ231	JJ420	15
	Half Size 10"	JJ240	JJ241		13
	Full Size 4"	JJ110	JJ111
	Full Size 6"	JJ120	JJ121	JJ410	25
	Full Size 8"	JJ130	JJ131
PreVac Steam without dry time270°F3 min Exposure(Non-porous)AND	Full Size 10"	JJ140	JJ141
	Three-Quarter Size 4"	JJ310	JJ311
	Three-Quarter Size 6"	JJ320	JJ321	JJ430	25
	Three-Quarter Size 8"	JJ330	JJ331
	Three-Quarter Size 10"	JJ340	JJ341
Prevac Steam without dry time270°F4 min Exposure(Porous)	Half Size 6"	JJ220	JJ221	JJ420	25
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241
Prevac cycles without dry times areImmediate Use Sterilization Cycles(IUSS).
STERIZONE VP4Based on Sterizone ValidatedLoad 8(Aicon Validated Load 1)	Full Size 4"	JJ110	JJ111	JJ410	Based on Load Configurationin Table 1
	Full Size 6"	JJ120	JJ121
	Full Size 8"	JJ130	JJ131		13.8lbs
	Three-Quarter Size 4"	JJ310	JJ311	JJ430
	Three-Quarter Size 6"	JJ320	JJ321		Based on Load Configurationin Table 1
	Three-Quarter Size 8"	JJ330	JJ331
	Three-Quarter Size 10"	JJ340	JJ341		13.8lbs
	Half Size 4"	JJ210	JJ211	JJ420
	Half Size 6"	JJ220	JJ221		Based on Load Configurationin Table 1
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241		5.8lbs
	Full Size 4"	JJ110	JJ111	JJ410	Based on Load Configurationin Table 1
	Full Size 6"	JJ120	JJ121
	Full Size 8"	JJ130	JJ131		11.7lbs
	Three-Quarter Size 4"	JJ310	JJ311	JJ430
STERIZONE VP4Based on Sterizone ValidatedLoad 4(Aicon Validated Load 2)	Three-Quarter Size 6"	JJ320	JJ321		Based on Load Configurationin Table 1
	Three-Quarter Size 8"	JJ330	JJ331
	Three-Quarter Size 10"	JJ340	JJ341		11.7lbs
	Half Size 4"	JJ210	JJ211	JJ420
	Half Size 6"	JJ220	JJ221		Based on Load Configurationin Table 1
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241		5.8lbs
	Full Size 4"	JJ110	JJ111	JJ410	25
	Full Size 6"	JJ120	JJ121
	Full Size 8"	JJ130	JJ131
STERIZONE VP4Based on Sterizone ValidatedLoad 7(Aicon Validated Load 3)	Three-Quarter Size 4"	JJ310	JJ311	JJ430
	Three-Quarter Size 6"	JJ320	JJ321
	Three-Quarter Size 8"	JJ330	JJ331		25
	Three-Quarter Size 10"	JJ340	JJ341
	Half Size 4"	JJ210	JJ211	JJ420	25
	Half Size 6"	JJ220	JJ221
	Half Size 8"	JJ230	JJ231
	Half Size 10"	JJ240	JJ241

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Aesculap AICON Containers may be used with commercially available Aesculap accessories according to the table below:

Accessories	EtO	Steris V-PROSystems	STERRADSystems	STERIZONEVP4	PREVACSTEAM
Baskets, trays, indicator cards,tamper evident locks, faceplateholders, and tags.	Yes	Yes	Yes	Yes	Yes
Instrument Organization System(Silicone and Stainless Steel racks,brackets, holders, and clamps)	Yes	No Silicone Pieces	No Silicone Pieces	No Silicone Pieces	Yes
Silicone mats	No	No	No	No	Yes*
Lid Covers	No	No	No	No	Yes*

Use of silicone mats and/or lid covers may require a longer drying time.

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Silicone mats and lid covers are compatible with PreVac steam only. Silicone pieces should not be used with Ethylene Oxide, Steris V-Pro Systems, STERRAD Systems, or STERIZONE VP4 Systems.

Healthcare Facilities should follow steam sterilization cycle guidelines as laid out in AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

TECHNOLOGICAL CHARACTERISTICS (compared to predicate device)

The table below provides a summary of the device technological characteristics comparing the subject device and predicate device. The subject device is offered in similar sizes and is comprised of similar materials of construction as the predicate device. The AESCULAP Aicon Container has the same intended use as the Aesculap predicate device.

Characteristic	Subject Device -Aesculap AiconContainer (JJ Series)(K214041)Product Code: KCT	Primary PredicateDevice - Aesculap JJSeries Container System(K192056)Product Code: KCT	Reference Device-Aesculap SterilContainerS2 System(K193582)Product Code: KCT	Reference Device-Aesculap SterilContainerS2 System(K182414 )Product Code: KCT	Discussion
Intended Use	A device intended to beused to enclose anothermedical device that is to besterilized by a health careprovider. It is intended toallow sterilization of theenclosed medical deviceand also to maintainsterility of the encloseddevice until used.	A device intended to beused to enclose anothermedical device that is to besterilized by a health careprovider. It is intended toallow sterilization of theenclosed medical deviceand also to maintainsterility of the encloseddevice until used.	A device intended to beused to enclose anothermedical device that is to besterilized by a health careprovider. It is intended toallow sterilization of theenclosed medical deviceand also to maintainsterility of the encloseddevice until used.	A device intended to beused to enclose anothermedical device that is to besterilized by a health careprovider. It is intended toallow sterilization of theenclosed medical deviceand also to maintainsterility of the encloseddevice until used.	Same
SterilizationModalities	• PreVac Steam with drytime• PreVac Steam withoutdry time• Ethylene Oxide• STERIS VPRO maX/maX2: Lumen, Non-Lumen,Flex,• STERIS VPRO 60:Lumen,Non- Lumen, Flex• STERRAD: 100S, NXStandard, NX Advanced,100NX Standard, 100NXFlex, 100 NX Express,100NX Duo	• PreVac Steam with drytime• Prevac Steam withoutdry time	• EtO• STERIZONE VP4• STERRAD 100NX DUO	• Prevac Steam• Gravity Steam• STERIS VPRO maX:Lumen, Non-Lumen, Flex• STERIS VPRO 60:Lumen,Non-Lumen, Flex• STERRAD: 100S, NXStandard,NXAdvanced,100NXStandard, 100NX Flex	Similar
Material	Container:AnodizedaluminumLid: Anodized aluminumGasket: Silicone	Container:AnodizedaluminumLid: Anodized aluminumGasket: Silicone	Container:AnodizedaluminumLid: Anodized aluminumGasket: Silicone	Container:AnodizedaluminumLid: Anodized aluminumGasket: Silicone	Same
Filter Type &Material	Single use (Polypropylene)	Single use (Paper)	Single use (Paper orpolypropylene)	Single use (Paperor polypropylene)Reusable (PTFE)	Similar
ContainerDesign	Solid bottom orSolid bottom with enhanceddrying system with	Solid bottom orSolid bottom with enhanceddrying system with	Perforated bottom withperforated lid	Perforated bottom withperforated lid	Similar

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	Perforated Lid	Perforated Lid
Vent tovolumeratios	$0.04mm^{-1} * 10^{-3}$to$0.26mm^{-1} * 10^{-3}$	$0.04mm^{-1} * 10^{-3}$to$0.26mm^{-1} * 10^{-3}$	$0.50mm^{-1} * 10^{-3}$to$3.43mm^{-1} * 10^{-3}$	$0.50mm^{-1} * 10^{-3}$to$3.43mm^{-1} * 10^{-3}$	Similar
Maintenanceof sterility	365 days	365 days	360 days	360 days	Similar

PERFORMANCE DATA

Testing was conducted in accordance with applicable FDA guidance and standards. The table below outlines the testing which was performed on the subject device.

PerformanceTesting	Purpose	Acceptance Criteria	Results
SterilizationEfficacy	To determine sterilization effectivenessof test device after processing in asterilization cycle.	A sterility assurance level (SAL) of 10-6 willbe achieved post sterilization using the BIoverkill method and half cycle validation.Biological indicators must be negative forgrowth after incubation period.	Pass
Dry Time	To determine the proper drying timerequired for the Aesculap AiconContainer.	The system shall demonstrate an average preand post sterilization weight difference ofless than 0.2% within five 5 minutes of cyclecompletion using final validated parametersand be free of visible moisture following acooling period.	Pass
Microbial AerosolChallenge	To analyze the package integrity andmicrobial barrier properties of the testdevice.	The container load maintains sterility afterexposure to a defined amount of aerosolmicroorganisms. No presence of growth afterincubation period.	Pass
Simulated Use	To determine the effective sterilization offlexible scopes when used with the testdevice.	A minimum of 1.0 x $10^6$ spores containedwithin organic soil representative of actualuse conditions are killed during definedsterilization cycle.	Pass
MaterialCompatibility	To assess effects of full use cycles ondevice components and their intendedfunctionality.	No impact to functionality at the completionmultiple sterilization cycles.	Pass
Cytotoxicity	To determine the potential of a test deviceto cause cytotoxicity.	Testing completed in accordance with ISO10993-5: 2009 to demonstrate no significantcytotoxic reaction after exposure to sterilant.Using the ISO Elution Method, the responseto the article is not greater than 2 (mildreactivity).	Pass
SterilityMaintenance	To demonstrate that a processed testdevice can maintain a sterile barrier for adefined period of time.	Sterility of container contents is maintainedafter processing for 365 days underconditions which simulate hospital sterilepackage handling and storage conditions.Biological indicators must be negative forgrowth after incubation period.	Pass

Results of the testing demonstrates that the proposed device met the acceptance criteria for each performance test.

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CONCLUSION

The conclusions drawn from the nonclinical tests demonstrate that Aesculap Aicon Container is as safe, as effective, and performs as well as or better than the legally marketed predicate device K192056.

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).