Aesculap AICON Container

K214041 · Aesculap, Inc. · KCT · Dec 30, 2022 · General Hospital

Device Facts

• Record ID: K214041
• Device Name: Aesculap AICON Container
• Applicant: Aesculap, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Dec 30, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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

Device Story

Reusable rigid sterilization container system; constructed from anodized aluminum with single-use polypropylene filters. Encloses medical devices for sterilization; maintains sterility during transport and storage. Used in healthcare facilities by sterile processing staff. Compatible with multiple sterilization modalities: EtO, STERIS V-PRO (maX/maX 2, 60), STERRAD (100NX, NX, 100S), STERIZONE VP4, and PreVac Steam. Available in solid bottom or enhanced drying system (EDS) configurations. Healthcare providers load instruments into the container; process through validated sterilization cycles; store until use. Benefits include protection of sterile instruments and maintenance of sterility barrier for up to 365 days.

Clinical Evidence

No clinical data. Bench testing only: sterilization efficacy (SAL 10^-6), dry time, microbial aerosol challenge, simulated use for flexible scopes, material compatibility, cytotoxicity (ISO 10993-5), and sterility maintenance (365 days). All tests passed.

Technological Characteristics

Reusable rigid container; anodized aluminum construction; silicone gaskets; single-use polypropylene filters. Dimensions: Full, Three-Quarter, and Half sizes. Vent-to-volume ratios: 0.04mm^-1 * 10^-3 to 0.26mm^-1 * 10^-3. Sterilization modalities: EtO, V-PRO, STERRAD, STERIZONE, PreVac Steam. No software or electronic components.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization and to maintain sterility during transport and storage. Compatible with various sterilization modalities including EtO, specific STERIS V-PRO cycles, STERRAD cycles, STERIZONE VP4, and PreVac Steam. Patient population is not specified; intended for use in clinical settings.

Regulatory Classification

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.

Predicate Devices

• Aesculap JJ Series Container System (K192056)

Reference Devices

• Aesculap SterilContainer S2 System (K193582)
• Aesculap SterilContainer S2 System (K182414)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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)<br>(130°F, 60 minute exposure<br>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<br>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)<br>(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<br>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<br>Flex Cycle | Full Size | (1) Flexible endoscope with a light cord (if not integral to<br>endoscope) without any additional load. The flexible endoscope may be single lumen<br>that is ≥1mm ID x ≤1050mm L |
| | Three-Quarter Size | (1) Flexible endoscope with a light cord (if not integral to<br>endoscope) without any additional load. The flexible endoscope may be single lumen<br>that<br>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<br>that is ≥1mm ID x ≤1050mm L or two lumens with one ≥ 1 mm ID and ≤ 990 mm L<br>and the other ≥ 1 mm ID and ≤ 850 mm L<br>OR<br>(1) flexible endoscope with a light cord (if not integral<br>to endoscope) and additional non-lumened instruments. The flexible endoscope can<br>have:<br>a single lumen that is ≥ 1mm ID and ≤ 1050 L or two lumens with one ≥ 1 mm ID and<br>< 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 a<br>light 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 a<br>light 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 a<br>light cord (if not integral to scope) and single lumen or dual lumens<br>(≥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 NX<br>Advanced Cycle | Three-Quarter Size | (5) Stainless-steel lumens (≥2.5mm ID x ≤500mm L) | | | |
| | Half Size | (5) Flexible Lumens (≥1mm ID x ≤850mm L)<br>(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 are<br>Immediate Use Sterilization Cycles<br>(IUSS). | | | | |

{4}------------------------------------------------

| (270°F, 3 min Exposure) | Full Size | Non-lumened instruments |
|--------------------------------------------------------------------------------------|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Porous | Three-Quarter Size | Non-lumened instruments |
| Prevac cycles without dry times are<br>Immediate Use Sterilization Cycles<br>(IUSS). | Half Size | Non-lumened instruments |
| STERIZONE VP4<br>Load 8<br>(Aicon Validated Load 1) | Full Size | (1) Dual channel flexible scope (≥1.5mm ID x ≤850mm L) and<br>(≥1.5mm ID x ≤989mm L)<br>(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<br>(≥1.5mm ID x ≤989mm L)<br>(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<br>(≥1.5mm ID x ≤989mm L)<br>(1) Single channel flexible scope (≥1.5mm ID x ≤850mm L) |
| STERIZONE VP4<br>Load 4<br>(Aicon Validated Load 2) | Full Size | (1) Dual channel semi rigid scope (≥0.7mm ID x 500mm L; ≥1.1mm ID x ≤500mm L)<br>(1) Dual channel semi rigid scope (≥1.1 mm ID x 500mm L; ≥1.1 mm ID x ≤500mm L)<br>(2) Stainless Steel Lumens (≥2mm ID x ≤250mm L)<br>(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)<br>(1) Dual channel semi rigid scope (≥1.1 mm ID x 500mm L; ≥1.1 mm ID x ≤500mm L)<br>(2) Stainless Steel Lumens (≥2mm ID x ≤250mm L)<br>(2) Stainless Steel Lumens (≥3mm ID x ≤400mm L) |
| | Half Size | (1) Stainless Steel Lumen (≥0.7 mm ID x ≤300mm L)<br>(1) Stainless Steel Lumen (≥1.0 mm ID x ≤300mm L)<br>(2) Stainless Steel Lumens (≥2.0 mm ID x ≤250mm L)<br>(2) Stainless Steel Lumens (≥3.0 mm ID x ≤300mm L) |
| STERIZONE VP4<br>Load 7<br>(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

| Sterilization<br>Method | Container Size | Standard<br>Container | EDS<br>Container | Container<br>Lid Part # | Total Loaded<br>Container (lbs) |
|--------------------------------------------------------------------------------------|------------------------------|-----------------------|------------------|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EtO<br>(130°F, 60 minute exposure<br>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 | | |
| | 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 VPRO<br>maX/ 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 VPRO<br>maX / 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 | |…