Who is the manufacturer of SterilContainer S2 System?

Aesculap, Inc. filed the 510(k) submission for SterilContainer S2 System (K193582).

What is the FDA product code for SterilContainer S2 System?

KCT. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for SterilContainer S2 System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SterilContainer S2 System?

Aesculap SterilContainer S2 System (K182414); SterilContainer S System (K162815); SterilContainer System (K112671).

Who can help prepare an FDA 510(k) submission like SterilContainer S2 System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SterilContainer S2 System

K193582 · Aesculap, Inc. · KCT · Mar 17, 2020 · General Hospital

Device Facts

Record ID	K193582
Device Name	SterilContainer S2 System
Applicant	Aesculap, Inc.
Product Code	KCT · General Hospital
Decision Date	Mar 17, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Intended Use

The Aesculap SterilContainer™ S2 System is a reusable rigid sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use in the following sterilization modalities: - Ethylene Oxide - STERRAD 100NX DUO cycle - STERIZONE VP4 The Aesculap SterilContainer S2 System includes accessories such as silicone mats and organizers, stainless steel baskets, trays, holders, sterilization indicator cards and tamper proof locks.

Device Story

Reusable rigid sterilization container system; constructed from anodized aluminum with silicone gaskets; utilizes single-use paper or polypropylene filters. Designed to enclose medical instruments during sterilization processes; compatible with Ethylene Oxide, STERRAD 100NX DUO, and STERIZONE VP4 cycles. Includes accessories: stainless steel baskets, trays, instrument organization systems (racks, holders), silicone mats, tamper-evident locks, and indicator cards. Used in clinical settings by healthcare providers to ensure sterility of instruments until point of use. Protects enclosed devices from contamination post-sterilization; facilitates organized instrument handling; supports various load configurations including flexible and semi-rigid scopes and stainless steel lumens.

Clinical Evidence

Bench testing only. Validated using SAL 10-6 overkill method and half-cycle validation for sterilization efficacy. Simulated use testing confirmed effective sterilization of flexible scopes. Material compatibility and cytotoxicity (ISO 10993-5:2009) testing passed.

Technological Characteristics

Reusable rigid container; anodized aluminum construction; silicone gaskets; single-use paper or polypropylene filters. Perforated lid/bottom design. Vent-to-volume ratio 1.02-3.4. Sizes: Full, Three-Quarter, Half. Accessories: stainless steel baskets, silicone mats, instrument organization systems. Sterilization: EtO, STERRAD 100NX DUO, STERIZONE VP4.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices during sterilization and to maintain sterility until use. Compatible with Ethylene Oxide, STERRAD 100NX DUO, and STERIZONE VP4 sterilization modalities.

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 SterilContainer S2 System (K182414)
SterilContainer S System (K162815)
SterilContainer System (K112671)

Related Devices

K182414 — Aesculap® SterilContainer(TM) S2 System · Aesculap, Inc. · Jul 5, 2019
K093493 — AESCULAP STERILCONTAINER S · Aesculap, Inc. · Jul 27, 2010
K080558 — STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS · Case Medical, Inc. · Dec 5, 2008
K221492 — SteriTite Container System with MediTray Parts · Case Medical, Inc. · Oct 7, 2022
K214041 — Aesculap AICON Container · Aesculap, Inc. · Dec 30, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 17, 2020 Aesculap, Inc. Sierra Mertz Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034 ## Re: K193582 Trade/Device Name: SterilContainer S2 System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: December 19, 2019 Received: December 23, 2019 ## Dear Sierra Mertz: 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 mediation-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, For CAPT Elizabeth Claverie, M.S. 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) #### K193582 Device Name Aesculap SterilContainer S2"™ System #### Indications for Use (Describe) The Aesculap SterilContainer™ S2 System is a reusable rigid sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use in the following sterilization modalities: - Ethylene Oxide - STERRAD 100NX DUO cycle - . STERIZONE VP4 The Aesculap SterilContainer S2 System includes accessories such as silicone mats and organizers, stainless steel baskets, trays, holders, sterilization indicator cards and tamper proof locks. The attached table identifies the validated load configurations for each of the modalities. | Sterilization Cycle | Container Size | Validated Load Configuration | |------------------------------------------------------------------------|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | EtO (130°F, 60 minute exposure, >50% RH 725mg/L gas pressure) | Full | (1) lumen ( $\geq$ 3mm ID x $\leq$ 400mm L) | | | Three-Quarter | AND (1) lumen ( $\geq$ 3.8mm ID x $\leq$ 370 mm L) | | | Half | | | STERRAD 100NX DUO (bottom shelf only) | Full | Flexible scope ( $\geq$ 1mm ID x $\leq$ 850mm L) | | | Three-Quarter | | | | Half | | | STERIZONE VP4 Validated Loads 1 & 2 (Based on Sterizone Load #7) | Full | Non Lumened Instruments | | | Three-Quarter | | | | Half | | | STERIZONE VP4 Validated Load 3 (Based on Sterizone Load #8) | JS440 (base) + JS489 (lid) | (1) Single Channel Flexible Scope ( $\geq$ 1mm ID x $\leq$ 850mm L) OR (1) Dual Channel Flexible Scope ( $\geq$ 1mm ID x $\leq$ 850 mm L and $\geq$ 1 mm ID x $\leq$ 989mm L) | | STERIZONE Validated Load 4 (Based on Sterizone Load #4) | JS440 (base) + JS489 (lid) | (1) Semi-rigid dual channel scope ( $\geq$ 0.7mm ID x $\leq$ 500mm L and $\geq$ 1.1mm ID x $\leq$ 500mm L) AND one of the following: (4) Stainless steel lumens ( $\geq$ 5.5mm ID x $\leq$ 166mm L; $\geq$ 7mm ID x $\leq$ 105mm L; $\geq$ 7.0mm ID x $\leq$ 227mm L; $\geq$ 7.8mm ID x $\leq$ 198mm L) OR (2) Stainless steel lumens ( $\geq$ 4mm ID x $\leq$ 370mm L; $\geq$ 2mm ID x $\leq$ 152mm L) OR (3) Stainless steel lumens ( $\geq$ 2.2mm ID x $\leq$ 173mm L; $\geq$ 4.7mm ID x $\leq$ 270mmL ; $\geq$ 4mm ID x $\leq$ 445mm L) | #### Table 1. SterilContainer S2 System Validated Load Configurations {3}------------------------------------------------ ## Table 2. SterilContainer S2 System Load Weights | Sterilization Method | Container Size | Container Bottom Part # | Container Lid Part # | Total Loaded Container (lb) | |------------------------------------|---------------------------|----------------------------|-------------------------|--------------------------------------------| | | Full Size - 4 ¼" | JS440 | JS489 | 25 | | | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 ¼" | JS740 | JS789 | 25 | | EtO | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Three-Quarter Size - 8" | JS744* | | | | | Half Size - 4 ½" | JS340 | JS389 | 25 | | | Half Size - 5 ½" | JS341 | | | | | Half Size - 6" | JS342 | | | | | Full Size - 4 ¼" | JS440 | JS489 | 10.97 | | | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 ¼" | JS740 | JS789 | 10.04 | | STERRAD 100NX DUO | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Half Size - 4 ½" | JS340 | JS389 | 11.7 | | | Half Size - 5 ½" | JS341 | | | | | Half Size - 6" | JS342 | | | | | Full Size - 4 ¼" | JS440 | JS489 | 25 | | | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | STERIZONE Validated Loads 1 & 2 | Three-Quarter Size - 4 ¼" | JS740 | JS789 | 25 | | | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | (Based on Sterizone Load #7) | Half Size - 4 ½" | JS340 | JS389 | 25 | | | Half Size - 5 ½" | JS341 | | | | | Half Size - 6" | JS342 | | | | | Half Size - 5 ½" | JS341 | | | | | Half Size - 6" | JS342 | | | | STERIZONE Validated Load 3 | Full Size - 4 ¼" | JS440 | JS489 | See load configuration in table 1 above | | (Based on Sterizone Load #8) | | | | | | STERIZONE Validated Load 4 | Full Size - 4 ¼" | JS440 | JS489 | See load configuration in table 1 above | *JS744 is for use in Ethylene Oxide only. {4}------------------------------------------------ #### Table 3. Sterilization Cycle Compatible Accessories | Accessories | Compatible with Ethylene Oxide | Compatible with STERRAD DUO | Compatible with STERIZONE VP4 | |----------------------------------------------------------------------------------------------------------|-----------------------------------|--------------------------------|----------------------------------| | Stainless Steel baskets, basket lids, and dividers | Yes | Yes | Yes | | Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps) | Yes | Yes | Yes | | Silicone mats | Yes | No | Yes | | Tamper Evident locks and indicator cards | Yes | Yes | Yes | Type of Use (Select one or both, as applicable) __ Prescription Use (Part 21 CFR 801 Subpart D) ______________________________________________________________________________________________________________________________________________________________________________ ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > 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 OMB number." {5}------------------------------------------------ ## 510(k) SUMMARY (as required by 21 CFR 807.92) ### Aesculap SterilContainer S2 System for Ethylene Oxide, STERIZONE VP4, STERRAD 100NX DUO March 11, 2020 | COMPANY: | Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 291671- | |----------------------|-------------------------------------------------------------------------------------------------------------------| | CONTACT: | Sierra M. Mertz 610-984-9076 (phone) Sierra.mertz@aesculapimplants.com 610-791-6882 (fax) | | TRADE NAME: | Aesculap® SterilContainer™ S2 System | | 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 DEVICES Aesculap SterilContainer S2 System - K182414 (Primary), SterilContainer S System - K162815 SterilContainer System - K112671 ### DEVICE DESCRIPTION The Aesculap SterilContainer S2 System is a reusable rigid 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 ● - STERRAD 100NX DUO cycle - STERIZONE VP4 ● The containers are perforated and made from anodized aluminum and utilize a single-use filter. The SterilContainer S2 System includes accessories such as mats, baskets, trays, instrument holders, organizers, filters, indicator cards and tamper proof locks. {6}------------------------------------------------ ## INDICATIONS FOR USE The Aesculap SterilContainer™ S2 System is a reusable rigid sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use in the following sterilization modalities: - Ethylene Oxide - STERRAD 100NX DUO cycle - STERIZONE VP4 The Aesculap SterilContainer S2 System includes accessories such as silicone mats and organizers, stainless steel baskets, trays, holders, sterilization indicator cards and tamper proof locks. The attached table identifies the validated load configurations for each of the modalities. Table 1. SterilContainer S2 System Validated Load Configurations | Sterilization Cycle | Container Size | Validated Load Configuration | |------------------------------------------------------------------------|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | EtO (130°F, 60 minute exposure, ≥50% RH 725mg/L gas pressure) | Full Three-Quarter Half | (1) lumen (≥ 3mm ID x ≤ 400mm L) AND (1) lumen (≥ 3.8mm ID x ≤ 370 mm L) | | STERRAD 100NX DUO (bottom shelf only) | Full Three-Quarter Half | Flexible scope (≥ 1mm ID x ≤ 850mm L) | | STERIZONE VP4 Validated Loads 1 & 2 (Based on Sterizone Load #7) | Full Three-Quarter Half | Non Lumened Instruments | | STERIZONE VP4 Validated Load 3 (Based on Sterizone Load #8) | JS440 (base) + JS489 (lid) | (1) Single Channel Flexible Scope (≥1mm ID x ≤ 850mm L) OR (1) Dual Channel Flexible Scope (≥1mm ID x ≤850 mm L and ≥1 mm ID x ≤ 989mm L) | | STERIZONE Validated Load 4 (Based on Sterizone Load #4) | JS440 (base) + JS489 (lid) | (1) Semi-rigid dual channel scope (≥0.7mm ID x ≤500mm L and ≥1.1mm ID x ≤500mm L) AND one of the following: (4) Stainless steel lumens (≥ 5.5mm ID x ≤ 166mm L; ≥ 7mm ID x ≤ 105mm L; ≥ 7.0mm ID x ≤ 227mm L: ≥ 7.8mm ID x ≤ 198mm L) OR (2) Stainless steel lumens (≥ 4mm ID x ≤ 370mm L; ≥ 2mm ID x ≤ 152mm L) OR (3) Stainless steel lumens (≥ 2.2mm ID x ≤ 173mm L; ≥ 4.7mm ID x ≤ 270mmL ; ≥ 4mm ID x ≤ 445mm L) | {7}------------------------------------------------ | Sterilization Method | Container Size | Container Bottom Part # | Container Lid Part # | Total Loaded Container (lb) | |-----------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------|-------------------------|-----------------------------------------------| | EtO | Full Size - 4 ¼" | JS440 | JS489 | 25 | | | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 ¼" | JS740 | JS789 | 25 | | | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Three-Quarter Size - 8" | JS744* | | | | | Half Size - 4 ½" | JS340 | JS389 | 25 | | | Half Size - 5 ½ | JS341 | | | | STERRAD 100NX DUO | Full Size - 4 ¼" | JS440 | JS489 | 10.97 | | | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 ¼" | JS740 | JS789 | 10.04 | | | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Half Size - 4 ¼" | JS340 | JS389 | 11.7 | | | Half Size - 5 ½ | JS341 | | | | | Half Size - 6" | JS342 | | | | STERIZONE Validated Loads 1 & 2 (Based on Sterizone Load #7) | Full Size - 4 ¼" | JS440 | JS489 | 25 | | | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 ¼" | JS740 | JS789 | 25 | | | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Half Size - 4 ¼" | JS340 | JS389 | 25 | | | Half Size - 5 ½ | JS341 | | | | | Half Size - 6" | JS342 | | | | STERIZONE Validated Load 3 (Based on Sterizone Load #8) | Full Size - 4 ¼" | JS440 | JS489 | See load configuration in table 1 above | | | STERIZONE Validated Load 4 (Based on Sterizone Load #4) | Full Size - 4 ¼" | JS440 | JS489 | *JS744 is for use in Ethylene Oxide only. {8}------------------------------------------------ | Table 3. Sterilization Cycle Compatible Accessories | | | |-----------------------------------------------------|--|--| | | | | | Accessories | Compatible with Ethylene Oxide | Compatible with STERRAD DUO | Compatible with STERIZONE VP4 | |----------------------------------------------------------------------------------------------------------|-----------------------------------|--------------------------------|----------------------------------| | Stainless Steel baskets, basket lids, and dividers | Yes | Yes | Yes | | Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps) | Yes | Yes | Yes | | Silicone mats | Yes | No | Yes | | Tamper Evident locks and indicator cards | Yes | Yes | Yes | {9}------------------------------------------------ # TECHNOLIGICAL CHARACTERISTICS (compared to predicate devices) The Aesculap SterilContainer S2 System has the same intended use and the technological characteristics as the Aesculap SterilContainer predicate devices. The subject devices are offered in the same design and same sizes and are made of the same materials as the predicate devices. | | Subject Device - Aesculap SterilContainer S2 (K193582) | Primary Predicate - Aesculap SterilContainer S2 (K182414) | Predicate - Aesculap SterilContainer (K112671) | Predicate - Aesculap SterilContainer S (K162815) | Discussion | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | Intended Use | 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. | 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. | 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. | 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. | The subject device and the predicates have the same intended use. | | Sterilization Modalities | EtO STERIZONE VP4 STERRAD 100NX DUO | Prevac Steam Gravity Steam STERRAD: 100S, NX Standard, NX Advanced, 100NX Standard, 100NX Flex STERIS: V-PRO 60 Lumen, V-PRO 60 Non- Lumen, V-PRO 60 Flex, V- PRO maX Lumen, V-PRO maX Non-Lumen, V-PRO maX Flex | EtO PreVac Steam Gravity Steam IUSS | STERIZONE VP4 | The subject device has been validated using sterilization methods similar to the predicate devices. | | Material | Container: Anodized aluminum Lid: Anodized aluminum Gasket: Silicone | Container: Anodized aluminum Lid: Anodized aluminum Gasket: Silicone | Container: Anodized aluminum Lid: Anodized aluminum Gasket: Silicone | Container: Non-anodized aluminum Lid: Non-anodized aluminum Gasket: Silicone | The material of the subject device is identical to the predicates. | | Filter Type | Single use: Paper (cellulose) or polypropylene | Single use: Paper (cellulose) or polypropylene Reusable: PTFE | Single use: Paper (cellulose) or polypropylene Reusable: PTFE | Single use: polypropylene | The proposed device utilizes an identical single use filter. | | Container Design | Perforated bottom with perforated lid | Perforated bottom with perforated lid | Perforated or solid bottom with perforated lid | Perforated bottom with perforated lid | The design of the subject device is identical to that of the predicate devices. | | Vent to Volume ratio | 1.02 - 3.4 | 1.4 - 3.4 | 1.02 | 1.4 - 3.4 | The vent-to- volume ratios of the subject device fall within those of the predicates. | | Sizes | Full size Three-Quarter Size Half Size | Full size Three-Quarter Size Half Size | Three-Quarter Size | Full size Three-Quarter Size Half Size | The size of the subject device and predicate devices are the same. | | Accessories | Silicone mats, baskets, trays, IOS, and racks. | Silicone mats, baskets, trays, IOS, and racks. | Silicone mats, baskets, trays, IOS, and racks. | Silicone mats, baskets, trays, IOS and racks. | The subject and predicate devices utilize the same accessories. | {10}------------------------------------------------ ## PERFORMANCE TESTING Non-clinical testing was conducted to verify performance of the subject device. The testing summarized below demonstrates that the subject device meets the established acceptance criteria. | Performance Testing | Purpose | Acceptance Criteria | Results | |------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | 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 | | Simulated Use | To determine the effective sterilization of flexible scopes when used with the test device. | A minimum of 1.0 x 106 spores contained within organic soil representative of actual use conditions are killed during defined sterilization cycle. Biological indicators must be negative for growth after incubation period. | Pass | | Material Compatibility | To assess effects of full use cycles on device components and their intended functionality. | No degradation or 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 | ## CONCLUSION The conclusions drawn from the nonclinical tests demonstrate that the Aesculap SterilContainer S2 System is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.

SterilContainer S2 System

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