(144 days)
The SterilContainer S System is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single use polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container system has been validated with flexible endoscopes and accessories, cables, and camera heads. 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 with the STERRAD 100NX DUO Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, filters, indicator cards, locks, and instrument holders.
Validation testing for event related sterility maintenance has been conducted for up to 365 days.
The SterilContainer™S System is a container system that will allow for sterilization and storage of medical devices. This container system can be used in the STERRAD 100NX DUO Sterilization System. The SterilContainer" S System rigid containers are made from nonanodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer" S System includes accessories such as mats, baskets, trays, instrument holders, organizers, filters, indicator cards and tamper proof locks.
The provided document is a 510(k) summary for the SterilContainer S System for use in the STERRAD 100NX DUO Cycle. It describes non-clinical performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Testing | Acceptance Criteria (Implied / Demonstrated) | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy / Lethality | A 12 log reduction and a sterility assurance level (SAL) of 10⁻⁶ | Achieved a 12 log reduction and a sterility assurance level (SAL) of 10⁻⁶ using the biological (BI) overkill method and half-cycle validation. |
| Maintenance of Sterility | Effective barrier for maintaining sterility of contents after sterilization for 365 days event-related storage under simulated hospital sterile package handling and storage conditions. | Continues to provide an effective barrier for maintaining sterility of the contents after sterilization for 365 days event related storage under conditions which simulate hospital sterile package handling and storage conditions. |
| Simulated Use | A 6-log reduction of G. stearothermophilus suspended in artificial soil medium for the containers when processed through a full cycle in the STERRAD 100NX DUO Cycle. | Demonstrated a 6-log reduction of G. stearothermophilus suspended in artificial soil medium for the Aesculap, Inc. SterilContainer S Containers when processed through a full cycle in the STERRAD 100NX DUO Cycle in healthcare facilities. |
| Inactivation Kinetics | No growth. | No growth was observed from three different injection doses for load configurations 1, 2, and 3 respectively. |
| Aerosol Challenge | (Implied: similar performance to predicate device, effective barrier) | The Aerosol challenge remains unchanged from the predicates as the container as well as the gaskets of the container remain the same as cleared in predicates. Predicate device data is still relevant for the proposed device. |
| Material Compatibility | (Implied: similar to predicate device) | Material Compatibility test data has not changed and remains the same as cleared in predicate. |
| Biocompatibility | (Implied: similar to predicate device) | The biocompatibility of the container remains unchanged from the predicates as the materials of the container remains the same as cleared in the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for each test in the non-clinical performance data section. However, it indicates that:
- "Testing demonstrated a 12 log reduction..." for Sterilization Efficacy.
- "No growth was observed from three different injection doses for load configuration 1, 2 and 3 respectively" for Inactivation Kinetics. This suggests at least three instances were tested.
- "Validation testing for event related sterility maintenance has been conducted for up to 365 days."
The data provenance is presented as "Non-Clinical Performance Data" and states that "These validations were conducted by a qualified testing laboratory." The document does not specify the country of origin of the data or whether it was retrospective or prospective, but clinical trials are not mentioned, which typically implies laboratory-based, prospective testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes non-clinical performance testing of a medical device (sterilization container system) rather than an AI/ML-driven diagnostic or therapeutic. The "ground truth" here is based on quantitative microbiological and physical performance metrics, not expert human interpretation.
4. Adjudication Method for the Test Set
This is not applicable for the reasons stated above.
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
This is not applicable as the device is not an AI/ML-driven system nor is it related to image interpretation or human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device described is a physical sterilization container system, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical tests is based on objective, quantitative measurements and established scientific principles for sterilization and sterility maintenance, including:
- Microbiological assays: Such as measuring log reduction of G. stearothermophilus (biological indicator) to establish a Sterility Assurance Level (SAL).
- Physical integrity testing: To assess the container's ability to maintain a sterile barrier over time.
- Chemical compatibility: Ensuring materials do not degrade or interfere with the sterilization process.
This is distinct from expert consensus, pathology, or outcomes data which are relevant for diagnostic or therapeutic devices.
8. The Sample Size for the Training Set
This is not applicable as the device is not an AI/ML system requiring a training set. The "testing" in this context refers to validation studies for the physical device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device.
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December 21, 2018
Aesculap, Inc. Paul Amudala Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K182032
Trade/Device Name: SterilContainer S System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: November 20, 2018 Received: November 23, 2018
Dear Paul Amudala:
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 mav, 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 avare 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
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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Elizabeth F. Claverie -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182032
Device Name SterilContainer™ S System
Indications for Use:
The SterilContainer S System is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single use polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container system has been validated with flexible endoscopes and accessories, cables, and camera heads. 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 with the STERRAD 100NX DUO Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, filters, indicator cards, locks, and instrument holders.
Validation testing for event related sterility maintenance has been conducted for up to 365 days.
| Load Configuration | Container # 1 | Container # 2 |
|---|---|---|
| 1 | • 135mm Full Size Container Bottom• Full Size Container Lid• Full Size Basket• Full Size Mat• Flexible Endoscope (1.2 mm x 785 mm)• Guide Cable (1x) | • 135mm Full Size Container Bottom• Full Size Container Lid• Full Size Basket• Full Size Mat• Flexible Endoscope (1.2 mm x 785 mm)• Guide Cable (2x) |
| 2 | • 187mm Full Size Container Bottom• Full Size Container Lid• Full Size Basket• Full Size Mat• Flexible Endoscope (1.2 mm x 785 mm)• Guide Cable (2x) | • N/A – Top shelf is removed to allow the container to fit in the chamber |
| 3 | • 90mm Full Size Container Bottom• Full Size Container Lid• Full Size Basket• Full Size Mat• Flexible Endoscope (1.2 mm x 785 mm)• Guide Cable (2x) | • 135mm Half Size Container Bottom• Half Size Container Lid• Half Size Basket• Half Size Mat• Camera Head for Endoscope |
Table 1: Validated STERRAD 100NX DUO Cycle Load Configurations
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| Lid | Bottom | Description | Container Load Weight * |
|---|---|---|---|
| JM489 | JM440 | Full Size 90mm (4 ¼") | |
| JM441 | Full Size 120mm (5 ½") | ||
| JM442 | Full Size 135mm (6") | ||
| JM444 | Full Size 187mm (8") | ||
| JM789 | JM740 | ¾ Size 90mm(4 ¼") | 13.2 lbs total weight. (1 or 2shelves based on container) |
| JM741 | ¾ Size 120mm (5 ½") | ||
| JM389 | JM340 | ½ Size 90mm (4 ¼") | |
| JM341 | ½ Size 120mm (5 ½") | ||
| JM342 | ½ Size 135mm (6") | ||
| JM344 | ½ Size 187mm (8") |
Table 2: STERRAD 100NX DUO Compatible SterilContainer S Container Systems
*Loads containing a flexible endoscope or bronchoscope should follow Table 1 recommendations
Table 3: STERRAD 100NX DUO Cycle Compatible Accessories
| Accessories | STERRAD 100NX DUOCycle |
|---|---|
| Stainless Steel baskets, basket lids, and dividers | Yes |
| Instrument Organization System (Silicone and Stainless Steel racks,brackets, instrument holders, and clamps) | Yes |
| Silicone mats | Yes |
| Stainless Steel racks, trays, instrument holders, clamps, brackets,tamper-proof locks, indicator cards and platforms | Yes |
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)
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510(k) SUMMARY (as required by 21 CFR 807.92)
SterilContainer" S System for use in the STERRAD 100NX DUO Cycle
Dec 13, 2018
| COMPANY: | Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714 |
|---|---|
| CONTACT: | Paul AmudalaRegulatory Affairs Specialist610-984-9303 (phone)610-791-6882 (fax) |
| TRADE NAME: | SterilContainer S System |
| COMMON NAME: | Sterilization Container Wrap |
| CLASSIFICATION NAME: | Sterilization Wrap |
| REGULATION NUMBER: | 21 CFR 880.6850 |
| PRODUCT CODE: | KCT |
| DEVICE CLASS: | Class II |
PREDICATE DEVICE
K093493 - SterilContainer™ S System for use in STERRAD 200, STERRAD NX (STANDARD (Std.) & ADVANCED (Adv.) and STERRAD 100NX (Std. & FLEX)
REFERENCE DEVICE
K142970- SterilContainer™ S for use in STERRAD 100NX EXPRESS Cycle via K142970.
DEVICE DESCRIPTION
The SterilContainer™S System is a container system that will allow for sterilization and storage of medical devices. This container system can be used in the STERRAD 100NX DUO Sterilization System. The SterilContainer" S System rigid containers are made from nonanodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer" S System includes accessories such as mats, baskets, trays, instrument holders, organizers, filters, indicator cards and tamper proof locks.
Indications for Use:
The SterilContainer S System is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single use polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a
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healthcare provider. This container system has been validated with flexible endoscopes and accessories, cables, and camera heads. 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 with the STERRAD 100NX DUO Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, filters, indicator cards, locks, and instrument holders.
Validation testing for event related sterility maintenance has been conducted for up to 365 days.
| LoadConfiguration | Container # 1 | Container # 2 |
|---|---|---|
| 1 | • 135mm Full Size ContainerBottom• Full Size Container Lid• Full Size Basket• Full Size Mat• Flexible Endoscope (1.2 mm x 785 mm)• Guide Cable (1x) | • 135mm Full Size ContainerBottom• Full Size Container Lid• Full Size Basket• Full Size Mat• Flexible Endoscope (1.2 mm x 785 mm)• Guide Cable (2x) |
| 2 | • 187mm Full Size ContainerBottom• Full Size Container Lid• Full Size Basket• Full Size Mat• Flexible Endoscope (1.2 mm x 785 mm)• Guide Cable (2x) | • N/A – Top shelf is removed toallow the container to fit in thechamber |
| 3 | • 90mm Full Size ContainerBottom• Full Size Container Lid• Full Size Basket• Full Size Mat• Flexible Endoscope (1.2 mm x 785 mm)• Guide Cable (2x) | • 135mm Half Size ContainerBottom• Half Size Container Lid• Half Size Basket• Half Size Mat• Camera Head for Endoscope |
Table 1: Validated STERRAD 100NX DUO Cycle Load Configurations
Table 2: STERRAD 100NX DUO Compatible SterilContainer S Container Systems
| Lid | Bottom | Description | Container Load Weight * |
|---|---|---|---|
| JM489 | JM440 | Full Size 90mm (4 ¼") | 13.2 lbs total weight. (1 or 2shelves based on container) |
| JM441 | Full Size 120mm (5 ½") | ||
| JM442 | Full Size 135mm (6") | ||
| JM444 | Full Size 187mm (8") | ||
| JM789 | JM740 | ¾ Size 90mm(4 ¼") | |
| JM741 | ¾ Size 120mm (5 ½") | ||
| JM389 | JM340 | ½ Size 90mm (4 ¼") | |
| JM341 | ½ Size 120mm (5 ½") | ||
| JM342 | ½ Size 135mm (6") | ||
| JM344 | ½ Size 187mm (8") |
*Loads containing a flexible endoscope or bronchoscope should follow Table 1 recommendations
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| Accessories | STERRAD 100NX DUOCycle |
|---|---|
| Stainless Steel baskets, basket lids, and dividers | Yes |
| Instrument Organization System (Silicone and Stainless Steel racks,brackets, instrument holders, and clamps) | Yes |
| Silicone mats | Yes |
| Stainless Steel racks, trays, instrument holders, clamps, brackets,tamper-proof locks, indicator cards and platforms | Yes |
Table 3: STERRAD 100NX DUO Compatible Accessories
TECHNOLIGICAL CHARACTERISTICS COMPARISON TABLE
The SterilContainer S System for proposed use in the STERRAD 100NX DUO is the same container system that was cleared in K093493 & K142970. The materials and design have not changed.
| System | SterilContainer SSystem (K182032) | SterilContainer S System(K093493) PrimaryPredicate | SterilContainer SSystem (K142970)Reference Device | Comparison |
|---|---|---|---|---|
| Sterilizationprocess | STERRAD 100NXDUO | STERRAD 200 ,STERRAD NX &Adv. , STERRAD100 NX Std. &FLEX Cycle | STERRAD 100NXEXPRESS | Different |
| Material | Non-anodizedaluminum | Non-anodized aluminum | Non-anodizedaluminum | Same |
| Containertype | Perforated | Perforated | Perforated | Same |
| Filter type | Polypropylene | Polypropylene | Polypropylene | Same |
| Gasket | Silicone | Silicone | Silicone | Same |
| Sizes | Full, 1/2, 3/4 | Full, ½, ¾, ¼, XL Mini | Full,1/2 | Similar |
| Accessories | Stainless Steelbaskets, basket lids,dividers, racks, trays,holders clamps;instrumentorganization systems;silicone mats; tamperproof locks; indicatorcards | Stainless Steel baskets,basket lids, dividers,racks, trays, holdersclamps; instrumentorganization systems;silicone mats; tamperproof locks; indicatorcards | Stainless Steelbaskets, basket lids,dividers, racks,trays, holdersclamps; instrumentorganizationsystems; siliconemats; tamper prooflocks; indicatorcards | Same |
| Reuse | Reusable | Reusable | Reusable | Same |
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NON-CLINICAL PERFORMANCE DATA
The Aesculap SterilContainer S System has been validated for the STERRAD 100NX DUO Cycle. These validations were conducted by a qualified testing laboratory. The performance testing demonstrates that the device meets the acceptance criteria for each test.
| Performance Testing | Results |
|---|---|
| Sterilization Efficacy/Lethality Study | Testing demonstrated a 12 log reduction and a sterility assurancelevel (SAL) of $10^{-6}$ using the biological (BI) overkill method andhalf-cycle validation. |
| Maintenance ofSterility | Maintenance Sterility for the proposed devices remainsunchanged and continues to provide an effective barrier formaintaining sterility of the contents after sterilization for 365days event related storage under conditions which simulatehospital sterile package handling and storage conditions stillapplies for the DUO cycle. |
| Simulated Use | Testing demonstrated that a 6-log reduction of G.stearothermophilus suspended in artificial soil medium isachieved for the Aesculap, Inc. SterilContainer S Containerswhen processed through a full cycle in the STERRAD 100NXDUO Cycle in healthcare facilities. |
| Inactivation Kinetics | No growth was observed from three different injectiondoses for load configuration 1, 2 and 3 respectively. |
| Aerosol Challenge | The Aerosol challenge remains unchanged from the predicates asthe container as well as the gaskets of the container remain thesame as cleared in predicates.Predicate device data is still relevant for the proposed device. |
| Material Compatibility | Material Compatibility test data has not changed and remainsthe same as cleared in predicate. |
| Biocompatibility | The biocompatibility of the container remains unchanged fromthe predicates as the materials of the container remains thesame as cleared in the predicate. |
CONCLUSION
The non-clinical testing demonstrates that the SterilContainer S System for use in the STERRAD 100NX DUO Cycle is as safe, as effective and performs as well as or better than the legally marketed predicate device, the Aesculap SterilContainer S System for use in the STERRAD 200, STERRAD NX (Std. & Adv.) and STERRAD 100NX (Std. and Flex) Cycles (K093493) .
§ 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).