(304 days)
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.
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
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.
The document provided is a 510(k) premarket notification for a medical device, the Aesculap® SterilContainer™ S2 System. It details the device's intended use, compatibility with various sterilization modalities, and comparisons to predicate devices. Crucially, it includes a "Summary of Non-Clinical Testing" which outlines performance tests, acceptance criteria, and results.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Performance Testing | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization Efficacy | To determine sterilization effectiveness of test device after processing in a sterilization cycle. | A sterility assurance level (SAL) of 10⁻⁶ will be achieved post sterilization using the BI overkill method and half cycle validation. Biological indicators must be negative for growth after incubation period. | Pass |
| 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 |
| Microbial Aerosol Challenge | To analyze the package integrity and microbial barrier properties of the test device. | Post sterilization, the container load maintains sterility after exposure to a defined amount of aerosol microorganisms. No presence of growth after incubation period. | Pass |
| Maintenance of Sterility | To demonstrate that a processed test device can maintain a sterile barrier for a defined period of time | Sterility of container contents is maintained after processing for 360 days under conditions which simulate hospital sterile package handling and storage conditions. Biological indicators must be negative for growth after incubation period. | Pass |
| Reusable Filter | To demonstrate sterilization effectiveness after determined number of sterilization and wash cycles. | Sterility Assurance Level (SAL) of 10⁻⁶ will be achieved after 2200 sterilization and washing cycles using half cycle testing with biological indicators to demonstrate a 6 log reduction. | 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 |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes (e.g., number of container units, number of test cycles) for each non-clinical test. It indicates that "Non-clinical testing was conducted to verify the performance of the subject device," implying that these tests were performed experimentally. The data provenance is implied to be from laboratory testing as part of the device's premarket submission, likely conducted by the manufacturer (Aesculap, Inc.) or a contracted testing facility. The nature of these tests suggests they are prospective, designed specifically to validate the device's performance. There is no information regarding the country of origin of the data beyond the manufacturer's location in Pennsylvania, USA.
For tests like "Sterilization Efficacy," "Simulated Use," and "Reusable Filter," the acceptance criteria mention specific biological indicator (BI) outcomes (e.g., "Biological indicators must be negative for growth") and log reductions, which imply a certain number of biological indicators and test cycles would have been used to statistically ensure the SAL. However, the concrete numbers are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This document describes technical performance testing of a sterilization container, not a diagnostic or AI-driven device that requires human expert interpretation of images or other data. Therefore, the concept of "experts establishing ground truth" as it would apply to, for example, a medical imaging AI, is not relevant here. The ground truth for these tests (e.g., "sterility," "no degradation," "no cytotoxicity") is established through objective, quantifiable laboratory methods and established standards (like SAL of 10⁻⁶, ISO 10993-5: 2009).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
As this is not a study involving human reader interpretation or subjective assessments, there is no mention of an adjudication method. The test results are based on objective, measured outcomes and pass/fail criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC study was not done. This device is a physical medical device (sterilization container), not an AI-driven diagnostic tool or imaging software that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable to the device described. The device is a sterilization container, not an algorithm. The tests performed are "standalone" in the sense that they assess the device's inherent physical and functional properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for these performance tests is based on:
- Microbiological Standards: Demonstrated sterility (e.g., SAL of 10⁻⁶) measured by the absence of biological indicator growth.
- Physical/Functional Integrity: Observation of no degradation, impact on functionality, or maintenance of barrier properties after challenging conditions.
- Biocompatibility Standards: Adherence to ISO standards for cytotoxicity, measured by the reactivity level.
These are objective, empirical measures defined by scientific and regulatory standards for medical device sterilization and material safety.
8. The sample size for the training set:
This question is not applicable. The device is a physical product and does not involve AI or machine learning models that require training sets. All tests described are performance validation tests.
9. How the ground truth for the training set was established:
This question is not applicable, as there is no training set for this type of device.
{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 Land 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 lumens1 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 L1 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 anyadditional load. The flexible endoscope may be a single ordual 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 L1 lumen ≥ 1.8mm ID and ≤310mm L1 lumen ≥ 2.8mm ID and ≤317mm L1 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 toendoscope) and mat with no additional load. The scopescan have: a single lumen that is ≥ 1 mm ID and ≤ 1050 mm Lor two lumens with one ≥ 1 mm ID and ≤ 990 mm L and theother ≥ 1 mm ID and ≤ 850 mm LOR1 flexible endoscope with a light cord (if not integral toendoscope) and mat and additional non-lumenedinstruments. The scope can have: a single lumen that is ≥ 1mm ID and ≤ 1050 mm L or two lumens with one ≥ 1 mm IDand ≤ 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
| SterilizationMethod | Container Size | ContainerBottom Part# | ContainerLid Part # | Total Loaded ContainerWeight* |
|---|---|---|---|---|
| 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 withPrevac Steam | Compatible withGravity 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
| SterilizationMethod | Container Size | ContainerBottom Part# | ContainerLid Part # | Total Loaded ContainerWeight |
|---|---|---|---|---|
| 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 | Compatiblewith1005 | CompatiblewithNX Standard | Compatible withNX Advanced | Compatiblewith100NX Standard | Compatible with100NX Flex |
|---|---|---|---|---|---|
| Stainless Steel baskets,basket lids, and dividers | Yes | Yes | Yes | Yes | Yes |
| Instrument OrganizationSystem(Silicone and StainlessSteel 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
| SterilizationMethod | Container Size | ContainerBottom Part# | ContainerLid Part # | Total Loaded ContainerWeight |
|---|---|---|---|---|
| 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 surgicalendoscope orbronchoscope with alight cord (if not integrato endoscope) and matwithout any additionalload. The flexibleendoscope may be asingle or dual lumensthat 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 surgicalendoscope orbronchoscope with alight cord (if not integrato endoscope) and matwithout any additionalload. The flexibleendoscope may be asingle or dual lumensthat 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 surgicalendoscope orbronchoscope with alight cord (if not integrato endoscope) and matwithout any additionalload. The flexibleendoscope may be asingle or dual lumensthat 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 | Compatiblewith V-PRO60 Lumen | Compatiblewith V-PRO 60Non-Lumen | CompatiblewithV-PRO 60Flex | Compatiblewith V-PROmaX Lumen | Compatiblewith V-PROmaX Non-Lumen | Compatible withV-PRO maX Flex |
|---|---|---|---|---|---|---|
| Stainless Steel baskets,basket lids, and dividers | Yes | Yes | Yes | Yes | Yes | Yes |
| Instrument OrganizationSystem (Silicone andStainless Steel racks,brackets, holders, andclamps) | 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 ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714 |
|---|---|
| CONTACT: | Sierra M. Mertz610-984-9076 (phone)Sierra.Mertz@aesculapimplants.com610-791-6882 (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 RemovalSteam (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 100NXStandard | 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 | FullThree-QuarterHalf | 1 Flexible Lumen 1mm ID and $<$ 850mm L |
|---|---|---|
| STERIS V-PRO 60 Lumen | FullThree-QuarterHalf | Stainless steel lumens1 lumen $≥$ 0.77mm ID and $≤$ 410mm L1 lumen $≥$ 1.2mm ID and $≤$ 275mm L1 lumen $≥$ 1.8mm ID and $≤$ 310mm L1 lumen $≥$ 2.8mm ID and $≤$ 317mm L |
| STERIS V-PRO 60 Non-Lumen | FullThree-QuarterHalf | Non lumen stainless steel instruments |
| STERIS V-PRO 60 Flex | FullThree-QuarterHalf | 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 | FullThree-QuarterHalf | Stainless steel lumens1 lumen $≥$ 0.77mm ID and $≤$ 527mm L1 lumen $≥$ 1.2mm ID and $≤$ 275mm L1 lumen $≥$ 1.8mm ID and $≤$ 310mm L1 lumen $≥$ 2.8mm ID and $≤$ 317mm L1 lumen $≥$ 3.0mm ID and $≤$ 400mm L |
| STERIS V-PRO maX Non-Lumen | FullThree-QuarterHalf | Non lumen stainless steel instruments |
| STERIS V-PRO maX Flex | FullThree-QuarterHalf | 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
| SterilizationMethod | Container Size | ContainerBottom Part# | ContainerLid Part # | Total LoadedContainer 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 withPrevac Steam | Compatible withGravity Steam |
|---|---|---|
| Stainless Steel baskets,basket lids, and dividers | Yes | Yes |
| Instrument Organization System(Silicone and Stainless Steelracks, brackets, holders, andclamps) | Yes | Yes |
| Silicone mats | Yes | Yes |
Table 4. SterilContainer S2 System Configurations – STERRAD Sterilization Systems
| SterilizationMethod | Container Size | ContainerBottomPart # | ContainerLid Part # | Total LoadedContainer 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 100NXStandard | 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 | |||
| Full Size - 6" | JS442 | |||
| Full Size - 8" | JS444 | |||
| Three-Quarter Size - 4 1/4" | JS740 | JS789 | 10.35 pounds | |
| Three-Quarter Size - 5 1/2" | JS741 | |||
| Three-Quarter Size - 6" | JS742 | |||
| Half Size - 4 ¼" | JS340 | JS389 | 10.35 pounds | |
| Half Size - 5 ½ | JS341 | |||
| Half Size - 6" | JS342 |
Table 5. Sterilization Cycle Compatible Accessories – STERRAD Sterilization Systems
| Accessories | Compatiblewith100S | CompatiblewithNX Standard | Compatible withNX Advanced | Compatiblewith100NX Standard | Compatiblewith100NX Flex |
|---|---|---|---|---|---|
| Stainless Steel baskets,basket lids, and dividers | Yes | Yes | Yes | Yes | Yes |
| Instrument OrganizationSystem(Silicone and StainlessSteel racks, brackets,holders, and clamps) | Yes | Yes | Yes | Yes | Yes |
| Silicone mats | Yes | No | Yes | No | No |
{13}------------------------------------------------
| SterilizationMethod | Container Size | ContainerBottomPart # | ContainerLid Part # | Total LoadedContainer Weight | |
|---|---|---|---|---|---|
| STERIS V-PRO 60 Lumen | Full Size - 4 1/4" | JS440 | JS489 | 11.1 pounds | |
| Full Size - 5 1/2" | JS441 | ||||
| Full Size - 6" | JS442 | ||||
| Full Size - 8" | JS444 | ||||
| STERIS V-PRO 60 Lumen | Three-Quarter Size - 4 1/4" | JS740 | JS789 | 9.6 pounds | |
| Three-Quarter Size - 5 ½" | JS741 | ||||
| Three-Quarter Size - 6" | JS742 | ||||
| STERIS V-PRO 60 Lumen | Half Size - 4 1/4" | JS340 | JS389 | 9.6 pounds | |
| Half Size - 5 ½" | JS341 | ||||
| Half Size - 6" | JS342 | ||||
| STERIS V-PRO 60 Non-Lumen | Full Size - 4 1/4" | JS440 | JS489 | 12.0 pounds | |
| Full Size - 5 1/2" | JS441 | ||||
| Full Size - 6" | JS442 | ||||
| Full Size - 8" | JS444 | ||||
| STERIS V-PRO 60 Non-Lumen | Three-Quarter Size - 4 1/4" | JS740 | JS789 | 12.0 pounds | |
| Three-Quarter Size - 5 1/2" | JS741 | ||||
| Three-Quarter Size - 6" | JS742 | ||||
| STERIS V-PRO 60 Non-Lumen | Half Size - 4 1/4" | JS340 | JS389 | 12.0 pounds | |
| Half Size - 5 1/2" | JS341 | ||||
| Half Size - 6" | JS342 | ||||
| STERIS V-PRO 60 Flex | Full Size - 4 1/4" | JS440 | JS489 | 1 flexible surgicalendoscope orbronchoscope with alight cord (if notintegral to endoscopeand mat without anyadditional load. Theflexible endoscopemay be a single ordual lumens that are>1mm ID and<990 mm L | |
| Full Size - 5 1/2" | JS441 | ||||
| Full Size - 6" | JS442 | ||||
| Full Size - 8" | JS444 | ||||
| STERIS V-PRO 60 Flex | Three-Quarter Size - 4 1/4" | JS740 | JS789 | 1 flexible surgicalendoscope orbronchoscope with alight cord (if notintegral to endoscopeand mat without anyadditional load. Theflexible endoscopemay be a single ordual lumens that are>1mm ID and<990 mm L | |
| Three-Quarter Size - 5 1/2" | JS741 | ||||
| Three-Quarter Size - 6" | JS742 | ||||
| Half Size - 4 ¼" | JS340 | JS389 | 1 flexible surgicalendoscope orbronchoscope with alight cord (if notintegral to endoscopeand mat without anyadditional load. Theflexible endoscopemay be a single ordual lumens that are>1mm ID and<990 mm L | ||
| Half Size - 5 ½" | JS341 | ||||
| Half Size - 6" | JS342 | ||||
| Full Size - 4 ¼" | JS440 | JS489 | 11.1 pounds | ||
| Full Size - 5 ½" | JS441 | ||||
| Full Size - 6" | JS442 | ||||
| Full Size - 8" | JS444 | ||||
| STERIS V-PRO maXLumen | 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 | ||||
| Full Size - 4 ¼" | JS440 | JS489 | 18.6 pounds | ||
| Full Size - 5 ½" | JS441 | ||||
| STERIS V-PRO maX Non-Lumen | Full Size - 6" | JS442 | |||
| Full Size - 8" | JS444 | ||||
| Three-Quarter Size - 4 ¼" | JS740 | JS789 | 18.6 pounds | ||
| Three-Quarter Size - 5 ½" | JS741 | ||||
| Three-Quarter Size - 6" | JS742 | ||||
| Half Size - 4 ¼" | JS340 | JS389 | 18.6 pounds | ||
| Half Size - 5 ½" | JS341 | ||||
| Half Size - 6" | JS342 | ||||
| STERIS V-PRO maX Flex | Full Size - 4 ¼" | JS440 | JS489 | 10.3 pounds | |
| Full Size - 5 ½" | JS441 | ||||
| Full Size - 6" | JS442 | ||||
| Full Size - 8" | JS444 | ||||
| Three-Quarter Size - 4 ¼" | JS740 | JS789 | 10.0 pounds | ||
| Three-Quarter Size - 5 ½" | JS741 | ||||
| Three-Quarter Size - 6" | JS742 | ||||
| Half Size - 4 ¼" | JS340 | JS389 | 10.0 pounds | ||
| Half Size - 5 ½" | JS341 | ||||
| Half Size - 6" | JS342 |
Table 6. SterilContainer S2 System Configurations – STERIS Sterilization Systems
{14}------------------------------------------------
{15}------------------------------------------------
| Table 7. Sterilization Cycle Compatible Accessories - STERIS Sterilization Systems | |||||||
|---|---|---|---|---|---|---|---|
| ------------------------------------------------------------------------------------ | -- | -- | -- | -- | -- | -- | -- |
| Accessories | Compatiblewith V-PRO60 Lumen | Compatiblewith V-PRO 60Non-Lumen | Compatiblewith V-PRO 60Flex | Compatiblewith V-PROmaX Lumen | Compatiblewith V-PROmaX Non-Lumen | Compatiblewith V-PROmaX Flex |
|---|---|---|---|---|---|---|
| Stainless Steel baskets,basket lids, and dividers | Yes | Yes | Yes | Yes | Yes | Yes |
| Instrument OrganizationSystem (Silicone andStainless Steel racks,brackets, holders, andclamps) | Yes | Yes | Yes | Yes | Yes | Yes |
| Silicone mats | No | No | No | No | No | No |
{16}------------------------------------------------
TECHNOLIGICAL CHARACTERISTICS (compared to predicate device)
Shown below is the Aesculap SterilContainer™ S2 System comparison with the predicate device.
| Subject Device -AesculapSterilContainer™ S2System(K182414) | Primary Predicate –AesculapSterilContainer™(K792558) | Reference Device –AesculapSterilContainer™ S(K093649) | Reference Device –AesculapSterilContainer™ S(K093493) | ||
|---|---|---|---|---|---|
| Intended Use | A device intended to beused to enclose anothermedical device that is to besterilized by a health careprovider. It is intended toallow sterilizationof the enclosed medicaldevice and also to maintainsterility of the encloseddevice until used. | A device intended to beused to enclose anothermedical device that is to besterilized by a health careprovider. It is intended toallow sterilizationof the enclosed medicaldevice and also to maintainsterility of the encloseddevice until used. | A device intended to beused to enclose anothermedical device that is to besterilized by a health careprovider. It is intended toallow sterilizationof the enclosed medicaldevice and also to maintainsterility of the encloseddevice until used. | A device intended to beused to enclose anothermedical device that is to besterilized by a health careprovider. It is intended toallow sterilizationof the enclosed medicaldevice and also to maintainsterility of the encloseddevice until used. | Same |
| SterilizationModalities | Prevac Steam (Exposure:270°F for 4 minutes with 15minute dry time)Gravity Steam (Exposure:250°F for 30-60 minuteswith 15 minute dry time)STERRAD 100SSTERRAD NX StandardSTERRAD NX AdvancedSTERRAD 100NX StandardSTERRAD 100NX FlexSTERIS V-PRO 60 LumenSTERIS V-PRO 60 Non-LumenSTERIS V-PRO 60 FlexSTERIS V-PRO maXLumenSTERIS V-PRO maX Non-LumenSTERIS V-PRO maX Flex | PreVac Steam (270°F for 4minutes with 15 minute drytime)Gravity Steam (250°F for 30-60 minutes with 15 minutedry time) | V-PRO 1V-PRO Plus | STERRAD 200STERRAD NXSTERRAD 100NX | Similar |
| Material ofConstruction | Container: AnodizedaluminumLid: Anodized aluminumGasket: Silicone | Container: AnodizedaluminumLid: Anodized aluminumGasket: Silicone | Container: Non-AnodizedAluminumLid: Non-AnodizedAluminumGasket: Silicone | Container: Non-AnodizedAluminumLid: Non-AnodizedAluminumGasket: Silicone | Same |
| Filter Type | Single use and reusable | Single use and reusable | Single use | Single use | Same |
| Filtermaterial | Single use: Paper(cellulose) or polypropyleneReusable: PTFE | Single use: Paper (cellulose)or polypropyleneReusable: PTFE | Single use: Polypropylene | Single use: Polypropylene | Same |
| ContainerDesign | Perforated bottom withperforated lid | Solid or perforated bottomwith perforated lid | Perforated bottom withperforated lid | Perforated bottom withperforated lid | Same |
| Vent toVolume ratio | 1.4 - 3.4 | 0.69 - 3.42 | 1.4 - 3.4 | 1.4 - 3.4 | Similar |
| Sizes | Full sizeThree-Quarter SizeHalf Size | Full sizeThree-Quarter SizeHalf SizeMini/XL Mini | Full sizeThree-Quarter SizeHalf SizeMini/XL Mini | Full sizeThree-Quarter SizeHalf SizeMini/XL Mini | Same |
| Accessories | Silicone mats, baskets,trays, and racks. | Silicone mats, baskets,trays, and racks. | Silicone mats, baskets,trays, and racks. | Silicone mats, baskets,trays, and racks. | Same |
| Maintenanceof Sterility | 360 days | 360 days | 360 days | 360 days | Same |
{17}------------------------------------------------
Summary of Non-Clinical Testing
Non-clinical testing was conducted to verify the performance of the subject device. The testing provided below demonstrates that the subject device met the acceptance criteria of each test below.
| Performance Testing | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Sterilization Efficacy | To determine sterilizationeffectiveness of testdevice after processing ina sterilization cycle. | A sterility assurance level (SAL) of10-6 will be achieved post sterilization using theBI overkill method and half cycle validation.Biological indicators must be negative for growthafter incubation period. | Pass |
| Simulated Use | To determine the effectivesterilization of flexiblescopes when used withthe test device. | A minimum of 1.0 x 106 spores contained withinorganic soil representative of actual useconditions are killed during defined sterilizationcycle. Biological indicators must be negative forgrowth after incubation period. | Pass |
| Microbial AerosolChallenge | To analyze the packageintegrity and microbialbarrier properties of thetest device. | Post sterilization, the container load maintainssterility after exposure to a defined amount ofaerosol microorganisms. No presence of growthafter incubation period. | Pass |
| Maintenance of Sterility | To demonstrate that aprocessed test device canmaintain a sterile barrierfor a defined period of time | Sterility of container contents is maintained afterprocessing for 360 days under conditions whichsimulate hospital sterile package handling andstorage conditions. Biological indicators must benegative for growth after incubation period. | Pass |
| Reusable Filter | To demonstratesterilization effectivenessafter determined numberof sterilization and washcycles. | Sterility Assurance Level (SAL) of 10-6 will beachieved after 2200 sterilization and washingcycles using half cycle testing with biologicalindicators to demonstrate a 6 log reduction. | Pass |
| Material Compatibility | To assess effects of fulluse cycles on devicecomponents and theirintended functionality. | No degradation or impact to functionality at thecompletion multiple sterilization cycles. | Pass |
| Cytotoxicity | To determine the potentialof a test device to causecytotoxicity. | Testing completed in accordance with ISO10993-5: 2009 to demonstrate no significantcytotoxic reaction after exposure to sterilant.Using the ISO Elution Method, the response tothe article is not greater than 2 (mild reactivity). | Pass |
CONCLUSION
The conclusions drawn from the nonclinical tests that demonstrate that the Aesculap®
SterilContainer™ S2 System is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Aesculap SterilContainer System (K792558).
§ 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).