Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and sterilization capabilities of a rigid container, with no mention of AI or ML.

Therapeutic

No
The device is a sterilization container used to enclose other medical devices for sterilization and storage, not for treating patients.

Diagnostic

No

The device is a reusable sterilization container intended to enclose another medical device for sterilization and maintain its sterility. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "reusable rigid sterilization container" made from "anodized aluminum" and utilizes a "single-use filter," indicating it is a physical hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the AESCULAP Aicon™ Container is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states that the container is used to enclose another medical device for sterilization and maintain sterility. It does not mention any use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
Device Description: The description focuses on the physical characteristics and function of the container for sterilization and storage.
Performance Studies: The performance studies evaluate the container's ability to achieve and maintain sterility, dry time, microbial barrier properties, and material compatibility. These are all related to the sterilization and storage function, not diagnostic testing.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with IVD devices.

Therefore, the AESCULAP Aicon™ Container is a medical device used for sterilization and storage, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

KCT

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare provider / healthcare facilities

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Testing:
Sterilization Efficacy: To determine sterilization effectiveness of test device after processing in a sterilization cycle. Acceptance Criteria: 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. Results: Pass.
Dry Time: To determine the proper drying time required for the Aesculap Aicon Container. Acceptance Criteria: 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. Results: Pass.
Microbial Aerosol Challenge: To analyze the package integrity and microbial barrier properties of the test device. Acceptance Criteria: The container load maintains sterility after exposure to a defined amount of aerosol microorganisms. No presence of growth after incubation period. Results: Pass.
Simulated Use: To determine the effective sterilization of flexible scopes when used with the test device. Acceptance Criteria: A minimum of 1.0 x 10^6 spores contained within organic soil representative of actual use conditions are killed during defined sterilization cycle. Results: Pass.
Material Compatibility: To assess effects of full use cycles on device components and their intended functionality. Acceptance Criteria: No impact to functionality at the completion multiple sterilization cycles. Results: Pass.
Cytotoxicity: To determine the potential of a test device to cause cytotoxicity. Acceptance Criteria: 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). Results: Pass.
Sterility Maintenance: To demonstrate that a processed test device can maintain a sterile barrier for a defined period of time. Acceptance Criteria: 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. Results: Pass.
Results of the testing demonstrates that the proposed device met the acceptance criteria for each performance test.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K192056

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K193582, K182414

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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

1

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

2

Indications for Use

510(k) Number (if known) K214041

Device Name AESCULAP Aicon™ Container

Indications for Use (Describe)

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.

The following tables identify the load configurations.

Sterilization Cycle	Container Sizes	Compatible Lumens
Ethylene Oxide (EtO)
(130°F, 60 minute exposure
50-70% 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 2
Lumen 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 2
Non-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 2
Flex Cycle	Full Size	(1) Flexible endoscope with a light cord (if not integral to
endoscope) without any additional load. The flexible endoscope may be single lumen
that is ≥1mm ID x ≤1050mm L
	Three-Quarter Size	(1) Flexible endoscope with a light cord (if not integral to
endoscope) without any additional load. The flexible endoscope may be single lumen
that
is ≥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

3

| | | endoscope) 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 L
OR
(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
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid 0MB number."

11

510(k) SUMMARY K214041

Aesculap Aicon™ Container

November 30, 2022

| COMPANY: | Aesculap, Inc.
3773 Corporate Parkway Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|----------------------|----------------------------------------------------------------------------------------------------------------|
| CONTACT: | Tim Stoudt tim.stoudt@bbraunusa.com
(484) 523-4581
610-791-6882 (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

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

12

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

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.

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 exposure
50-70% 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 2
Lumen Cycle	Full Size	(6) Stainless Steel Lumens (≥1mm ID x ≤ 400mm L)
(6) Stainless Steel Lumens (≥0.77mm ID x ≤ 250mm L)
	Three-Quarter
Size	(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 2
Non-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 2
Flex Cycle	Full Size	(1) Flexible endoscope with a light cord (if not integral to
endoscope) without any additional load. The flexible endoscope may be single lumen that is
≥1mm ID x ≤1050mm L
	Three-Quarter
Size	(1) Flexible endoscope with a light cord (if not integral to
endoscope) without any additional load. The flexible endoscope may be single lumen that
is ≥1mm ID x ≤1050mm L
	Half Size	(2) Flexible endoscopes with a light cord (if not integral to
endoscope) 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 L
OR
(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 60
Lumen Cycle	Full Size	(6) Stainless Steel Lumens (≥1mm ID x ≤ 400mm L)
STERIS VPRO 60
Lumen Cycle	Three-Quarter
Size	(6) Stainless Steel Lumens (≥0.77mm ID x ≤ 250mm L)
	Half Size	(12) Stainless Steel Lumens (≥1mm ID x ≤ 150mm L)
STERIS VPRO 60
Non-Lumen Cycle	Full Size	Non lumened stainless steel instruments
STERIS VPRO 60
Non-Lumen Cycle	Three-Quarter
Size	Non lumened stainless steel instruments
STERIS VPRO 60
Non-Lumen Cycle	Half Size	Non lumened stainless steel instruments
STERIS VPRO 60
Flex Cycle	Full Size	(1) flexible surgical endoscope or bronchoscope with a
light cord (if not integral to scope) and single lumen (≥1mm ID x ≤990mm L)
STERIS VPRO 60
Flex Cycle	Three-Quarter
Size	(1) flexible surgical endoscope or bronchoscope with a
light cord (if not integral to scope) and single lumen (≥1mm ID x ≤990mm L)
STERIS VPRO 60
Flex Cycle	Half Size	(1) flexible surgical endoscope or bronchoscope with a
light cord (if not integral to scope) and single lumen or dual lumens
(≥1mm ID x ≤990mm L)
STERRAD 100NX
Standard Cycle	Full Size	(5) Stainless-Steel Lumens (≥1.0mm ID x ≤500mm L)
STERRAD 100NX
Standard Cycle	Three-Quarter
Size	(5) Stainless-Steel Lumens (≥0.7mm ID x ≤400mm L)
STERRAD 100NX
Standard 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-Quarter
Size	(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 NX
Standard Cycle	Full Size	(10)Stainless-steel lumens (≥2.5mm ID x ≤ 400mm L)
STERRAD NX
Standard Cycle	Three-Quarter
Size	(10)Stainless-steel lumens (≥2.5mm ID x ≤ 400mm L)
STERRAD NX
Standard Cycle	Half Size	(10) Stainless-steel lumens (≥2mm ID x ≤ 200mm L)
STERRAD NX
Advanced Cycle	Full Size	(5) Stainless-steel lumens (≥2.5mm ID x ≤500mm L)
(5) Flexible Lumens (≥1mm ID x ≤850mm L)
STERRAD NX
Advanced Cycle	Three-Quarter
Size	(5) Stainless-steel lumen (≥2.5mm ID x ≤500mm L)
(5) Flexible Lumens (≥1mm ID x ≤850mm L)
STERRAD NX
Advanced Cycle	Half Size	(10) Stainless-steel lumens (≥2mm ID x ≤ 200mm L)
STERRAD 100NX
Express Cycle	Full Size	Non lumened stainless steel instruments
STERRAD 100NX
Express Cycle	Three-Quarter
Size	Non lumened stainless steel instruments
STERRAD 100NX
Express Cycle	Full Size	Non lumened stainless steel instruments
STERRAD 100NX
DUO Cycle	Full Size	(1) Flexible Lumen (≥1mm ID x ≤ 850mm L)
STERRAD 100NX
DUO Cycle	Three-Quarter
Size	(1) Flexible Lumen (≥1mm ID x ≤ 850mm L)
STERRAD 100NX
DUO Cycle	Half Size	(1) Flexible Lumen (≥1.mm ID x ≤ 650mm L)
STERRAD 100NX
Flex Cycle	Full Size	(1) Flexible Lumen(≥1.5mm ID x ≤ 650mm L)
STERRAD 100NX
Flex Cycle	Three-Quarter
Size	(1) Flexible Lumen (≥1.5mm ID x ≤ 650mm L)
STERRAD 100NX
Flex Cycle	Half Size	(1) Flexible lumen (≥1.mm ID x ≤ 650mm L)
PreVac Steam with
dry time (270°F, 4
min Exposure)	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)
PreVac Steam with
dry time (270°F, 4
min Exposure)	Half Size	(4) Stainless Steel Lumens (≥1.0mm ID x ≤200mm L)
		Size
PreVac Steam
without dry time
(270°F, 4 min
Exposure) 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 time
are Immediate Use Sterilization
Cycles (IUSS).
Prevac Steam
without dry time
(270°F, 3 min
Exposure)
Non-Porous	Full Size		Non-lumened instruments
	Three-Quarter Size		Non-lumened instruments
	Half Size		Non-lumened instruments
	Prevac cycles without dry time
are Immediate Use Sterilization
Cycles (IUSS).
STERIZONE VP4
Load 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 VP4
Load 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 VP4
Load 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)

13

14

Table 2. AESCULAP Aicon™ Container Configurations

| Sterilization
Method | Container Size | Standard
Container | EDS
Container | Container
Lid Part # | Total Loaded
Container (lbs) | |
|--------------------------------------------------------------------------------------|------------------------------------|------------------------|------------------|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EtO
(130°F, 60 minute exposure
50-70% 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 exposure
50-70% 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 exposure
50-70% 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 exposure
50-70% RH, concentration 735mg/L) | Full Size 4" | JJ110 | JJ111 | | | |
| | | | | | | |
| | STERIS VPRO
maX/ 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 VPRO
maX/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 VPRO
maX/maX 2 Flex | Full Size 4" | JJ110 | JJ111 | JJ410 | (1) Flexible endoscope with
a light cord (if not integral to
endoscope) without any
additional load. The flexible
endoscope may be single
lumen that is ≥1mm ID x