Who is the manufacturer of Aesculap® SterilContainer(TM) S2 System?

Aesculap, Inc. filed the 510(k) submission for Aesculap® SterilContainer(TM) S2 System (K182414).

What is the FDA product code for Aesculap® SterilContainer(TM) 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 Aesculap® SterilContainer(TM) S2 System?

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

Who can help prepare an FDA 510(k) submission like Aesculap® SterilContainer(TM) 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.

Aesculap® SterilContainer(TM) S2 System

Q: What are the predicate devices for Aesculap® SterilContainer(TM) S2 System?

Aesculap SterilContainer System (K792558).

K182414 · Aesculap, Inc. · KCT · Jul 5, 2019 · General Hospital

Device Facts

Record ID	K182414
Device Name	Aesculap® SterilContainer(TM) S2 System
Applicant	Aesculap, Inc.
Product Code	KCT · General Hospital
Decision Date	Jul 5, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Indications for Use

The Aesculap(R) 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: - Dynamic-air removal steam (PreVac) (Exposure: 270°F for 4 minutes with 15 minute dry time) - Gravity Steam (Exposure: 250°F for 30-60 minutes with 15 minute dry time) - STERRAD 100S, STERRAD NX Standard, STERRAD NX Advanced, STERRAD 100NX Standard, STERRAD 100NX Flex Cycles - STERIS V-PRO 60 Lumen, V-PRO 60 Non-Lumen, V-PRO 60 Flex, V-PRO maX Lumen, V-PRO maX Non-Lumen, and V-PRO maX Flex Cycles.

Device Story

Reusable rigid sterilization container system; constructed of anodized aluminum with silicone gaskets; utilizes single-use (paper/polypropylene) or reusable (PTFE) filters. Used by healthcare providers in clinical settings to enclose medical devices during sterilization cycles (steam, STERRAD, or STERIS V-PRO). Container protects instruments during sterilization and maintains sterility for up to 360 days post-processing. Includes accessories: silicone mats, stainless steel baskets, trays, holders, organizers, indicator cards, and tamper-proof locks. System ensures sterility maintenance of enclosed instruments until point of use.

Clinical Evidence

Bench testing only. Testing included sterilization efficacy (BI overkill method), simulated use for flexible scopes, microbial aerosol challenge, maintenance of sterility (360 days), reusable filter validation (2200 cycles), material compatibility, and cytotoxicity (ISO 10993-5). All tests passed.

Technological Characteristics

Materials: Anodized aluminum container/lid, silicone gasket. Filter: Single-use (paper/polypropylene) or reusable (PTFE). Design: Perforated bottom and lid. Sterilization: Steam, STERRAD, STERIS V-PRO. Accessories: Silicone mats, stainless steel baskets/trays/racks. Sterility maintenance: 360 days.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization and to maintain sterility of the enclosed devices until use. Compatible with steam (PreVac and Gravity), STERRAD, and STERIS V-PRO 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 System (K792558)

Reference Devices

Aesculap SterilContainer S (K093649)
Aesculap SterilContainer S (K093493)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue and white. July 5, 2019 Aesculap, Inc. Sierra Mertz Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034 Re: K182414 Trade/Device Name: Aesculap® SterilContainer™ S2 System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: June 6, 2019 Received: June 7, 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 {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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, For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K182414 Device Name Aesculap(R) SterilContainer™ S2 System Indications for Use (Describe) The Aesculap(R) 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: - · Dynamic-air removal steam (PreVac) (Exposure: 270°F for 4 minutes with 15 minute dry time) - · Gravity Steam (Exposure: 250°F for 30-60 minutes with 15 minute dry time) - · STERRAD 100S, STERRAD NX Standard, STERRAD NX Advanced, STERRAD 100NX Standard, STERRAD 100NX Flex Cycles - · STERIS V-PRO 60 Lumen, V-PRO 60 Non-Lumen, V-PRO 60 Flex, V-PRO maX Lumen, V-PRO maX Non-Lumen, and V-PRO maX Flex Cycles. The Aesculap SterilContainer S2 System includes accessories such as sillcone 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 | |---------------------------------------|----------------|------------------------------------------------------------------------------| | Dynamic Air Removal Steam (PreVac) | Full | 1 lumen with ≥ 3mm ID x ≤400mm L and a second lumen ≥ 3.8mm ID x ≤370mm L | | | Three-Quarter | | | | Half | | | Gravity Steam | Full | Non lumen stainless steel instruments | | | Three-Quarter | | | | Half | | | STERRAD 100S | Full | 5 Stainless steel lumens ≥ 3.0mm ID and ≤400mm L | | | Three-Quarter | | | | Half | | | STERRAD NX Standard | Full | 5 Stainless steel lumens ≥ 2mm ID and ≤400mm L | | | Three-Quarter | | | | Half | | | STERRAD NX Advanced | Full | 1 Flexible lumen (≥ 1mm ID and ≤850mm L) | | | Three-Quarter | | | | Half | | | STERRAD 100NX Standard | Full | 5 Stainless steel lumens ≥ 0.7mm ID and ≤ 500mm L | | | Three-Quarter | | | | Half | | | STERRAD 100NX Flex | Full | 1 Flexible lumen 1mm ID and ≤850mm L | | | Three-Quarter | | | | Half | | Table 1. SterilContainer S2 System Validated Load Configurations {3}------------------------------------------------ | STERIS V-PRO 60 Lumen | Full | Stainless steel lumens 1 lumen ≥ 0.77mm ID and ≤410mm L | |--------------------------------|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Three-Quarter | 1 lumen ≥ 1.2mm ID and ≤275mm L | | | Half | 1 lumen ≥ 1.8mm ID and ≤310mm L 1 lumen ≥ 2.8mm ID and ≤317mm L | | STERIS V-PRO 60 Non-Lumen | Full | Non lumen stainless steel instruments | | | Three-Quarter | | | | Half | | | STERIS V-PRO 60 Flex | Full | | | | Three-Quarter | 1 flexible surgical endoscope or bronchoscope with a light | | | Half | cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a single or dual lumens that are >1mm ID and <990 mm L | | STERIS V-PRO maX Lumen | Full | Stainless steel lumens | | | Three-Quarter | 1 lumen ≥ 0.77mm ID and ≤527mm L | | | Half | 1 lumen ≥ 1.2mm ID and ≤275mm L 1 lumen ≥ 1.8mm ID and ≤310mm L 1 lumen ≥ 2.8mm ID and ≤317mm L 1 lumen ≥ 3.0mm ID and ≤400mm L | | STERIS V-PRO maX Non- Lumen | Full | Non lumen stainless steel instruments | | | Three-Quarter | | | | Half | | | STERIS V-PRO maX Flex | Full | 2 flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The scopes can have: a single lumen that is ≥ 1 mm ID and ≤ 1050 mm 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 mat and additional non-lumened instruments. The scope can have: a single lumen that is ≥ 1 mm ID and ≤ 1050 mm L or two lumens with one ≥ 1 mm ID and ≤ 990 mm L and the other ≥ 1 mm ID and ≤ 850 mm L | | | Three-Quarter | | | | Half | | ## Table 2. SterilContainer S2 System Configurations – Prevac Steam and Gravity Steam | Sterilization Method | Container Size | Container Bottom Part # | Container Lid Part # | Total Loaded Container Weight* | |-------------------------------------------------------------|----------------------------|-------------------------------|-------------------------|-----------------------------------| | Dynamic-air removal steam (PreVac) & Gravity Steam | Full Size - 4 ¼" | JS440 | JS489 | 25 pounds | | | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 ¼ " | JS740 | JS789 | 25 pounds | | | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Half Size - 4 ¼ " | JS340 | JS389 | 25 pounds | | | Half Size - 5 ½ | JS341 | | | | | Half Size - 6" | JS342 | | | *Maximum load weight is 25 pounds or the maximum indicated weight for the sterilizer, whichever is less. {4}------------------------------------------------ ## Table 3. Sterilization Cycle Compatible Accessories - Prevac Steam and Gravity Steam | Accessories | Compatible with Prevac Steam | Compatible with Gravity Steam | |----------------------------------------------------------------------------------------------------------|---------------------------------|----------------------------------| | Stainless Steel baskets, basket lids, and dividers | Yes | Yes | | Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps) | Yes | Yes | | Silicone mats | Yes | Yes | ## Table 4. SterilContainer S2 System Configurations – STERRAD Sterilization Systems | Sterilization Method | Container Size | Container Bottom Part # | Container Lid Part # | Total Loaded Container Weight | |-------------------------|---------------------------|-------------------------------|-------------------------|----------------------------------| | STERRAD 100 S | Full Size - 4 ½" | JS440 | JS489 | 13.95 pounds | | | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 ½" | JS740 | JS789 | 13.90 pounds | | | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Half Size - 4 ½" | JS340 | JS389 | 13.90 pounds | | | Half Size - 5 ½ | JS341 | | | | | Half Size - 6" | JS342 | | | | STERRAD NX Standard | Full Size - 4 ½" | JS440 | JS489 | 10.70 pounds | | | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 ½" | JS740 | JS789 | 10.70 pounds | | | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Half Size - 4 ½" | JS340 | JS389 | 10.70 pounds | | | Half Size - 5 ½ | JS341 | | | | | Half Size - 6" | JS342 | | | | STERRAD NX Advanced | Full Size - 4 ½" | JS440 | JS489 | 10.70 pounds | | | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 ½" | JS740 | JS789 | 10.70 pounds | | | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Half Size - 4 ½" | JS340 | JS389 | 10.70 pounds | | | Half Size - 5 ½ | JS341 | | | | | Half Size - 6" | JS342 | | | | STERRAD 100NX Standard | Full Size - 4 ½" | JS440 | JS489 | 21.45 pounds | | | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 ½" | JS740 | JS789 | 13.85 pounds | | | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | {5}------------------------------------------------ | | Half Size - 4 ¼" | JS340 | JS389 | 13.85 pounds | |--------------------|---------------------------|-------|-------|--------------| | | Half Size - 5 ½ | JS341 | | | | | Half Size - 6" | JS342 | | | | STERRAD 100NX Flex | Full Size - 4 ¼" | JS440 | JS489 | 10.95 pounds | | | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 ¼" | JS740 | JS789 | | | | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Half Size - 4 ¼" | JS340 | JS389 | | | | Half Size - 5 ½ | JS341 | | | | | Half Size - 6" | JS342 | | | ## Table 5. Sterilization Cycle Compatible Accessories – STERRAD Sterilization Systems | Accessories | Compatible with 1005 | Compatible with NX Standard | Compatible with NX Advanced | Compatible with 100NX Standard | Compatible with 100NX Flex | |----------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------------------|--------------------------------|--------------------------------------|-------------------------------| | Stainless Steel baskets, basket lids, and dividers | Yes | Yes | Yes | Yes | Yes | | Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps) | Yes | Yes | Yes | Yes | Yes | | Silicone mats | Yes | No | Yes | No | No | # Table 6. SterilContainer S2 System Configurations – STERIS Sterilization Systems | Sterilization Method | Container Size | Container Bottom Part # | Container Lid Part # | Total Loaded Container Weight | |--------------------------------|---------------------------|-------------------------------|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | STERIS V-PRO 60 Lumen | Full Size - 4 ¼" | JS440 | JS489 | 11.1 pounds | | | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 ¼" | JS740 | JS789 | 9.6 pounds | | | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Half Size - 4 ¼" | JS340 | JS389 | 9.6 pounds | | | Half Size - 5 ½ | JS341 | | | | Half Size - 6" | JS342 | | | | | STERIS V-PRO 60 Non-Lumen | Full Size - 4 ¼" | JS440 | JS489 | 12.0 pounds | | | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | | | | | | | Three-Quarter Size - 4 ½" | JS740 | JS789 | 12.0 pounds | | | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Half Size - 4 ½" | JS340 | JS389 | 12.0 pounds | | | Half Size - 5 ½ | JS341 | | | | | Half Size - 6" | JS342 | | | | STERIS V-PRO 60 Flex | Full Size - 4 ½" | JS440 | JS489 | 1 flexible surgical endoscope or bronchoscope with a light cord (if not integra to endoscope) and mat without any additional load. The flexible endoscope may be a single or dual lumens that are >1mm ID and <990 mm L | | | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 ½" | JS740 | JS789 | 1 flexible surgical endoscope or bronchoscope with a light cord (if not integra to endoscope) and mat without any additional load. The flexible endoscope may be a single or dual lumens that are >1mm ID and <990 mm L | | | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Half Size - 4 ½" | JS340 | JS389 | | | | Half Size - 5 ½ | JS341 | | 1 flexible surgical endoscope or bronchoscope with a light cord (if not integra to endoscope) and mat without any additional load. The flexible endoscope may be a single or dual lumens that are >1mm ID and <990 mm L | | | Half Size - 6" | JS342 | | | | | Full Size - 4 ½" | JS440 | JS489 | 11.1 pounds | | | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | STERIS V-PRO maX Lumen | Three-Quarter Size - 4 ½" | JS740 | JS789 | 9.6 pounds | | | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Half Size - 4 ½" | JS340 | JS389 | 9.6 pounds | | | Half Size - 5 ½ | JS341 | | | | | Half Size - 6" | JS342 | | | | STERIS V-PRO maX Non- Lumen | Full Size - 4 ½" | JS440 | JS489 | 18.6 pounds | | | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 ½" | JS740 | JS789 | 18.6 pounds | | | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | | | | | | | | | | | | Half Size - 4 ¼" | JS340 | JS389 | 18.6 pounds | | | Half Size - 5 ½ | JS341 | | | | | Half Size - 6" | JS342 | | | | | Full Size - 4 ¼" | JS440 | JS489 | 10.3 pounds | | STERIS V-PRO maX Flex | Full Size - 5 ½" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 ¼" | JS740 | JS789 | | | | Three-Quarter Size - 5 ½" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Half Size - 4 ¼" | JS340 | JS389 | | | | Half Size - 5 ½ | JS341 | | | | | Half Size - 6" | JS342 | | | {6}------------------------------------------------ {7}------------------------------------------------ Table 7. Sterilization Cycle Compatible Accessories - STERIS Sterilization Systems | Accessories | Compatible with V-PRO 60 Lumen | Compatible with V-PRO 60 Non-Lumen | Compatible with V-PRO 60 Flex | Compatible with V-PRO maX Lumen | Compatible with V-PRO maX Non- Lumen | Compatible with V-PRO maX Flex | |----------------------------------------------------------------------------------------------------------------|--------------------------------------|------------------------------------------|----------------------------------------|---------------------------------------|-----------------------------------------------|-----------------------------------| | Stainless Steel baskets, basket lids, and dividers | Yes | Yes | Yes | Yes | Yes | Yes | | Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps) | Yes | Yes | Yes | Yes | Yes | Yes | | Silicone mats | No | No | No | No | No | No | 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. X 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 complete 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 aqency 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." EF {8}------------------------------------------------ ### 510(k) SUMMARY (as required by 21 CFR 807.92) ### Aesculap®)SterilContainer™ S2 System For Steam & Low Temperature Sterilization Cycles July 5, 2019 | COMPANY: | Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714 | |----------------------|-------------------------------------------------------------------------------------------------------------------| | 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 | #### Predicate Device Aesculap SterilContainer System (K792558) #### Reference Device Aesculap SterilContainer S (K093649) Aesculap SterilContainer S (K093493) ### DEVICE DESCRIPTION The Aesculap SterilContainer S2 System is a reusable rigid container system that will allow for sterilization and storage of other medical devices. This container system is compatible for use in the following sterilization modalities: - Dynamic-air removal steam (PreVac) (270°F for 4 minutes with 15 minute dry time) - Gravity Steam (250°F for 30-60 minutes with 15 minute dry time) - STERRAD 100S, STERRAD NX Standard, STERRAD NX Advanced, STERRAD ● 100NX Standard, STERRAD 100NX Flex Cycles - 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 cycles {9}------------------------------------------------ The containers are perforated and made from anodized aluminum and utilize a single-use or reusable filter. The SterilContainer S2 System includes accessories such as mats, baskets, trays, instrument holders, organizers, filters, indicator cards and tamper proof locks. ### Maintenance of Sterility The maintenance of sterility for the load in this device is 360 days. # 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: - Dynamic-air removal steam (PreVac) (Exposure: 270°F for 4 minutes with 15 minute dry . time) - Gravity Steam (Exposure: 250°F for 30-60 minutes with 15 minute dry time) - STERRAD 100S, STERRAD NX Standard, STERRAD NX Advanced, STERRAD 100NX Standard, STERRAD 100NX Flex Cycles - STERIS V-PRO 60 Lumen, V-PRO 60 Non-Lumen, V-PRO 60 Flex, V-PRO maX . Lumen, V-PRO maX Non-Lumen, and V-PRO maX Flex Cycles. 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 | |---------------------------------------|----------------|---------------------------------------------------| | Dynamic Air Removal Steam (PreVac) | Full | 1 lumen with ≥ 3mm ID x ≤400mm L | | | Three-Quarter | and a second lumen ≥ 3.8mm ID x ≤370mm L | | | Half | | | Gravity Steam | Full | Non lumen stainless steel instruments | | | Three-Quarter | | | | Half | | | STERRAD 100S | Full | 5 Stainless steel lumens ≥ 3.0mm ID and ≤400mm L | | | Three-Quarter | | | | Half | | | STERRAD NX Standard | Full | 5 Stainless steel lumens ≥ 2mm ID and ≤400mm L | | | Three-Quarter | | | | Half | | | STERRAD NX Advanced | Full | 1 Flexible lumen (≥ 1mm ID and ≤850mm L) | | | Three-Quarter | | | | Half | | | STERRAD 100NX Standard | Full | 5 Stainless steel lumens ≥ 0.7mm ID and ≤ 500mm L | | | Three-Quarter | | | | Half | | Table 1. SterilContainer S2 System Validated Load Configurations {10}------------------------------------------------ | STERRAD 100NX Flex | Full Three-Quarter Half | 1 Flexible Lumen 1mm ID and $<$ 850mm L | |----------------------------|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | STERIS V-PRO 60 Lumen | Full Three-Quarter Half | Stainless steel lumens 1 lumen $≥$ 0.77mm ID and $≤$ 410mm L 1 lumen $≥$ 1.2mm ID and $≤$ 275mm L 1 lumen $≥$ 1.8mm ID and $≤$ 310mm L 1 lumen $≥$ 2.8mm ID and $≤$ 317mm L | | STERIS V-PRO 60 Non-Lumen | Full Three-Quarter Half | Non lumen stainless steel instruments | | STERIS V-PRO 60 Flex | Full Three-Quarter Half | 1 flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a single or dual lumens that are >1mm ID and $<$ 990 mm L | | STERIS V-PRO maX Lumen | Full Three-Quarter Half | Stainless steel lumens 1 lumen $≥$ 0.77mm ID and $≤$ 527mm L 1 lumen $≥$ 1.2mm ID and $≤$ 275mm L 1 lumen $≥$ 1.8mm ID and $≤$ 310mm L 1 lumen $≥$ 2.8mm ID and $≤$ 317mm L 1 lumen $≥$ 3.0mm ID and $≤$ 400mm L | | STERIS V-PRO maX Non-Lumen | Full Three-Quarter Half | Non lumen stainless steel instruments | | STERIS V-PRO maX Flex | Full Three-Quarter Half | 2 flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The scopes can have: a single lumen that is $≥$ 1 mm ID and $≤$ 1050 mm 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 mat and additional non-lumened instruments. The scope can have: a single lumen that is $≥$ 1 mm ID and $≤$ 1050 mm L or two lumens with one $≥$ 1 mm ID and $≤$ 990 mm L and the other $≥$ 1 mm ID and $≤$ 850 mm L | # Table 2. SterilContainer S2 System Configurations – Prevac Steam and Gravity Steam | Sterilization Method | Container Size | Container Bottom Part # | Container Lid Part # | Total Loaded Container Weight* | |-------------------------------------------------------------|--------------------|-------------------------------|-------------------------|-----------------------------------| | Dynamic-air removal steam (PreVac) & Gravity Steam | Full Size - 4 1/4" | JS440 | JS489 | 25 pounds | | | Full Size - 5 1/2" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | {11}------------------------------------------------ | Three-Quarter Size - 4 1/4 " | JS740 | JS789 | 25 pounds | |------------------------------|-------|-------|-----------| | Three-Quarter Size - 5 1/2" | JS741 | | | | Three-Quarter Size - 6" | JS742 | | | | Half Size - 4 1/4 " | JS340 | JS389 | 25 pounds | | Half Size - 5 1/2 | JS341 | | | | Half Size - 6" | JS342 | | | *Maximum load weight is 25 pounds or the maximum indicated weight for the sterilizer, whichever is less. # Table 3. Sterilization Cycle Compatible Accessories - Prevac Steam and Gravity Steam | Accessories | Compatible with Prevac Steam | Compatible with Gravity Steam | |-------------------------------------------------------------------------------------------------------------|---------------------------------|----------------------------------| | Stainless Steel baskets, basket lids, and dividers | Yes | Yes | | Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps) | Yes | Yes | | Silicone mats | Yes | Yes | ## Table 4. SterilContainer S2 System Configurations – STERRAD Sterilization Systems | Sterilization Method | Container Size | Container Bottom Part # | Container Lid Part # | Total Loaded Container Weight | |-------------------------|-----------------------------|-------------------------------|-------------------------|----------------------------------| | | Full Size - 4 1/4" | JS440 | JS489 | 13.95 pounds | | | Full Size - 5 1/2" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 1/4" | JS740 | JS789 | 13.90 pounds | | STERRAD 100 S | Three-Quarter Size - 5 1/2" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Half Size - 4 1/2" | JS340 | JS389 | 13.90 pounds | | | Half Size - 5 ½ | JS341 | | | | | Half Size - 6" | JS342 | | | | | Full Size - 4 1/4" | JS440 | JS489 | 10.70 pounds | | | Full Size - 5 1/2" | JS441 | | | | STERRAD NX Standard | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 1/4" | JS740 | JS789 | 10.70 pounds | | | Three-Quarter Size - 5 1/2" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Half Size - 4 1/4" | JS340 | JS389 | 10.70 pounds | | | Half Size - 5 ½ | JS341 | | | | | Half Size - 6" | JS342 | | | {12}------------------------------------------------ | STERRAD NX Advanced | Full Size - 4 1/4" | JS440 | JS489 | 10.70 pounds | |---------------------|-----------------------------|--------------------|-------|--------------| | | Full Size - 5 1/2" | JS441 | | | | | Full Size - 6" | JS442 | | | | | Full Size - 8" | JS444 | | | | | Three-Quarter Size - 4 1/4" | JS740 | JS789 | 10.70 pounds | | | Three-Quarter Size - 5 1/2" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Half Size - 4 ¼" | JS340 | JS389 | 10.70 pounds | | | Half Size - 5 ½ | JS341 | | | | | Half Size - 6" | JS342 | | | | | STERRAD 100NX Standard | Full Size - 4 1/4" | JS440 | JS489 | | Full Size - 5 1/2" | | JS441 | | | | Full Size - 6" | | JS442 | | | | Full Size - 8" | | JS444 | | | | | Three-Quarter Size - 4 1/4" | JS740 | JS789 | 13.85 pounds | | | Three-Quarter Size - 5 1/2" | JS741 | | | | | Three-Quarter Size - 6" | JS742 | | | | | Half Size - 4 1/4" | JS340 | JS389 | 13.85 pounds | | | Half Size - 5 1/2 | JS341 | | | | | Half Size - 6" | JS342 | | | | | STERRAD 100NX Flex | Full Size - 4 1/4" | JS440 | JS489 | | Full Size - 5 1/2" | | JS441 | |…

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