(151 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. 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 V-PRO maX Low Temperature Sterilization System Flexible Cycle.
The SterilContainer" S is a container system that will allow for sterilization and storage of medical devices. This container system can be used in the Amsco® V-PRO" maX Flexible Cycle. The SterilContainer" S rigid containers are made from non-anodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer" S includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks.
Here's an analysis of the acceptance criteria and study information provided for the SterilContainer™ S device, as described in the FDA 510(k) submission K151242:
This document primarily focuses on the performance data used to support substantial equivalence for a medical device (sterilization container system), not on an AI/ML powered device, which is indicated by the type of testing performed (e.g., sterilization efficacy, microbial challenge, material compatibility). Thus, many of the requested fields related to AI/ML studies (like expert consensus, adjudication methods, MRMC studies, or training set details) are not applicable or cannot be answered from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with numerical targets in the same way an AI/ML study would (e.g., "sensitivity must be >90%"). Instead, it presents performance properties that were evaluated, and the results demonstrate the device met the necessary standards for sterilization and sterility maintenance.
| Performance Property | Reported Device Performance |
|---|---|
| Sterilization Efficacy | Achieved a 6 log reduction and a sterility assurance level (SAL) of 10⁻⁶ using the biological (BI) overkill method and half-cycle validation. |
| Whole Package Microbial Aerosol Challenge | Contents maintained sterility after exposure to a defined amount of aerosol microorganisms. |
| Event Related Sterility Maintenance | Demonstrated an effective barrier for maintaining sterility of contents after processing, followed by 180 days of event-related storage under simulated hospital sterile package handling and storage conditions. |
| Material Compatibility | No visible or functional changes were observed after 100 cycles of processing. |
| Simulated Use | A worst-case dual-channel flexible endoscope was reproducibly sterilized under worst-case simulated use testing conditions in the Flexible Cycle. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical "sample size" in terms of number of containers or tests for each performance property. It refers to "testing," "validations," and "studies" being conducted. For example, "100 cycles of processing" for material compatibility suggests a sample size of at least one container subjected to 100 cycles.
- Data Provenance: The studies were "conducted by a qualified testing laboratory." The country of origin is not specified, but the submission is to the U.S. FDA, suggesting the testing was performed to U.S. standards or by a lab recognized by the FDA. The studies are prospective in nature, as they involve actively performing tests (sterilization cycles, microbial challenges, material cycling).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is Not Applicable (N/A). This device is a sterilization container, not an AI/ML diagnostic system that requires expert interpretation for establishing ground truth. The "ground truth" for this device revolves around objective measurements of sterility, material integrity, and functionality based on standardized testing protocols.
4. Adjudication Method for the Test Set
This section is Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in human expert interpretations, which is not relevant for testing a physical sterilization device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This section is Not Applicable (N/A). MRMC studies are specific to evaluating the impact of AI on human reader performance for diagnostic tasks. This device is a sterilization container, not an imaging or diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is Not Applicable (N/A). This is not an algorithm or AI device. The device itself (the SterilContainer S and its components) is being evaluated for its standalone performance in sterilization and sterility maintenance. The performance data is standalone performance of the device.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective scientific and microbiological standards.
- Sterilization Efficacy: Measured by biological indicators (BI) overkill method and the achievement of a Sterility Assurance Level (SAL) of 10⁻⁶. This is a quantitative, laboratory-based measurement.
- Microbial Aerosol Challenge: Measured by the absence of microorganisms in the contents after exposure to a defined aerosol challenge.
- Sterility Maintenance: Measured by maintaining sterility over a 180-day period under simulated conditions.
- Material Compatibility: Measured by visual and functional assessment after repeated cycles.
- Simulated Use: Measured by the reproducible sterilization of a worst-case endoscope under defined conditions.
8. The Sample Size for the Training Set
This section is Not Applicable (N/A). This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is Not Applicable (N/A). As there is no training set for an AI/ML algorithm, this question is not relevant to the provided device information.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 9, 2015
Aesculap®, Inc. Peter Stoll Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034
Re: K151242
Trade/Device Name: SterilContainer S Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: September 8, 2015 Received: September 9, 2015
Dear Mr. Stoll:
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. 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
{1}------------------------------------------------
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K151242
Device Name SterilContainer S
Indications for Use (Describe)
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. 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 V-PRO maX Low Temperature Sterilization System Flexible Cycle.
Table 1: Validated V-PRO maX Sterilizer Flexible Cycle Load Configurations
| Table 1: Validated V-PRO maX Sterilizer Flexible Cycle Load Configurations | ||
|---|---|---|
| LoadConfiguration 1 | Two SterilContainer S System containers each with a basket, mat,accessories and a flexible surgical endoscope or bronchoscope with a lightcord (if not integral to endoscope) and no additional load.The flexible endoscopes may contain either:• a single lumen with an inside diameter of 1 mm or larger and alength of 1050 mm or shorter• or two lumens: one lumen with an inside diameter of 1mm orlarger and length of 990mm or shorter; the second lumen withan inside diameter of 1mm or larger and length of 850mm orshorter | |
| LoadConfiguration 2 | Two SterilContainer S System containers, each with a basket, mat andaccessories.**The first SterilContainer S System container holds a flexible surgicalendoscope or bronchoscope with a light cord (if not integral to endoscope)and no additional load.The flexible endoscopes may contain either:• a single lumen with an inside diameter of 1 mm or larger and alength of 1050 mm or shorter• or two lumens: one lumen with an inside diameter of 1mm orlarger and length of 990mm or shorter; the second lumen withan inside diameter of 1mm or larger and length of 850mm orshorterThe second SterilContainer S System container holds reusable metal andnon-metal non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. | |
| The total load weight validated was 24 lbs. |
** The validation studies were conducted with a flexible endoscope in a SterilContainer S System container with basket, silicone mat, accessories and light cord (if not integral to endoscope). Also included in the load was an additional SterilContainer S System container with instruments for a total load weight of 24.0 lbs.
{3}------------------------------------------------
Table 2: V-PRO maX Sterilizer Flexible Cycle Compatible SterilContainer S Container Systems
| Lid | Bottom | Description | Total Loaded ContainerWeight (if container does notcontain a flexible endoscopeor bronchoscope)* |
|---|---|---|---|
| JM489 | JM440 | Full Size 90mm (4 ¼”) | 24 lbs for one container in thechamber |
| JM441 | Full Size 120mm (5 ½”) | ||
| JM442 | Full Size 135mm (6”) | ||
| JM789 | JM740 | ¾ Size 90mm(4 ¼”) | OR24 lbs split between twocontainers in the chamber |
| JM741 | ¾ Size 120mm (5 ½”) | ||
| JM742 | ¾ Size 135mm (6”) | ||
| JM389 | JM340 | ½ Size 90mm (4 ¼”) | |
| JM341 | ½ Size 120mm (5 ½”) | ||
| JM342 | ½ Size 135mm (6”) |
*Loads containing a flexible endoscope or bronchoscope should follow Table 1 recommendations
Table 3: V-PRO maX Sterilizer Flexible Cycle Compatible Accessories
| Accessories | V-PRO maXFlexible Cycle |
|---|---|
| Stainless Steel baskets,basket lids, and dividers | Yes |
| Instrument OrganizationSystem (Silicone andStainless Steel racks,brackets, holders, and clamps) | Yes |
| Silicone mats | Yes |
| Stainless Steel racks, trays,holders, clamps, brackets, andplatforms | 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and 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 agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
FORM FDA 3881 (8/14)
{5}------------------------------------------------
K151242
510(k) SUMMARY (as required by 21 CFR 807.92)
SterilContainer™ S
| COMPANY: | Tuesday, October 06, 2015Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 291671- |
|---|---|
| CONTACT: | Peter Stoll610-984-9076 (phone)610-791-6882 (fax) |
| TRADE NAME: | SterilContainer S |
| COMMON NAME: | Sterilization Container |
| CLASSIFICATION NAME: | Sterilization Wrap |
| REGULATION NUMBER: | 880.6850 |
| PRODUCT CODE: | KCT |
| DEVICE CLASS: | Class II per 21 CFR §880.6850 |
DEVICE DESCRIPTION
The SterilContainer" S is a container system that will allow for sterilization and storage of medical devices. This container system can be used in the Amsco® V-PRO" maX Flexible Cycle. The SterilContainer" S rigid containers are made from non-anodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer" S includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks.
INDICATIONS FOR USE
The SterilContainer S 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. 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 V-PRO maX Low Temperature Sterilization System Flexible Cycle.
Table 1: Validated V-PRO maX Sterilizer Flexible Cycle Load Configurations
{6}------------------------------------------------
| LoadConfiguration 1 | Two SterilContainer S containers each with a basket, mat, accessories anda flexible surgical endoscope or bronchoscope with a light cord (if notintegral to endoscope) and no additional load.The flexible endoscopes may contain either:• a single lumen with an inside diameter of 1 mm or larger and alength of 1050 mm or shorter.• or two lumens: one lumen with an inside diameter of 1mm orlarger and length of 990mm or shorter; the second lumen withan inside diameter of 1mm or larger and length of 850mm orshorter. |
|---|---|
| LoadConfiguration 2 | Two SterilContainer S containers, each with a basket, mat andaccessories.**The first SterilContainer S container holds a flexible surgical endoscopeor bronchoscope with a light cord (if not integral to endoscope) and noadditional load.The flexible endoscopes may contain either:• a single lumen with an inside diameter of 1 mm or larger and alength of 1050 mm or shorter.• or two lumens: one lumen with an inside diameter of 1mm orlarger and length of 990mm or shorter; the second lumen withan inside diameter of 1mm or larger and length of 850mm orshorter.The second SterilContainer S container holds reusable metal and non-metal non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors.The total load weight validated was 24 lbs. |
** The validation studies were conducted with a flexible endoscope in a SterilContainer S container with basket, silicone mat, accessories and light cord (if not integral to endoscope). Also included in the load was an additional SterilContainer S container with instruments for a total load weight of 24.0 lbs.
Table 2: V-PRO maX Sterilizer Flexible Cycle Compatible SterilContainer S Container
{7}------------------------------------------------
| Lid | Bottom | Description | Total Loaded ContainerWeight (if container does notcontain a flexible endoscopeor bronchoscope)* |
|---|---|---|---|
| JM489 | JM440 | Full Size 90mm (4 1/4") | 24 lbs for one container in thechamber |
| JM441 | Full Size 120mm (5 1/2") | ||
| JM442 | Full Size 135mm (6") | ||
| JM789 | JM740 | 3/4 Size 90mm(4 1/4") | OR24 lbs split between twocontainers in the chamber |
| JM741 | 3/4 Size 120mm (5 1/2") | ||
| JM742 | 3/4 Size 135mm (6") | ||
| JM389 | JM340 | 1/2 Size 90mm (4 1/4") | |
| JM341 | 1/2 Size 120mm (5 1/2") | ||
| JM342 | 1/2 Size 135mm (6") |
*Loads containing a flexible endoscope or bronchoscope should follow Table 1 recommendations
Table 3: V-PRO maX Sterilizer Flexible Cycle Compatible Accessories
| Accessories | V-PRO maXFlexible Cycle |
|---|---|
| Stainless Steel baskets,basket lids, and dividers | Yes |
| Instrument OrganizationSystem (Silicone andStainless Steel racks,brackets, holders, and clamps) | Yes |
| Silicone mats | Yes |
| Stainless Steel racks, trays,holders, clamps, brackets, andplatforms | Yes |
COMPARISON TO PREDICATE
The SterilContainer S that can be used in the Amsco® V-PRO™ maX Flexible Cycle is the same container system as was cleared in K093649. The materials and design have not changed.
| System | SterilContainer S(K151242) | Aesculap SterilContainer S(K093649) |
|---|---|---|
| Sterilizationprocess | Amsco V-PRO maX Flexible Cycle | Amsco V-PRO 1 and V-PRO 1 Plus(Lumen and Non Lumen Cycles) |
| Material | Non-anodized aluminum | Non-anodized aluminum |
| Container type | Perforated | Perforated |
| Filter type | Polypropylene | Polypropylene |
{8}------------------------------------------------
| Indications forUse | The SterilContainer S is a reusablesterilization container system(consisting of perforated bottoms andperforated lids with filter retentionplates, and single use polypropylenefilters) intended to be used to encloseanother medical device that is to besterilized by a healthcare provider. Itis intended to allow sterilization ofthe enclosed device and alsomaintain sterility of the encloseddevice until used. This containersystem is compatible for use with theV-PRO maX Low TemperatureSterilization System Flexible Cycle. | The Aesculap Sterilcontainer is areusable sterilization containersystem intended to beused to enclose another medicaldevice that is to be sterilized by ahealthcare provider. Itis intended to allow sterilization ofthe enclosed device and alsomaintain sterility of theenclosed device until used. Thiscontainer system is compatible foruse with the V-PRO 1and V-PRO 1 Plus Systems. TheSterilcontainer S System includesaccessories such assilicon mats, baskets, trays, andracks. |
|---|---|---|
| ------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
PERFORMANCE DATA
The Aesculap SterilContainer S has been validated for the Amsco® V-PRO™ maX Flexible Cycle Low Temperature Sterilization System. These validations were conducted by a qualified testing laboratory. The performance testing demonstrates substantial equivalence to the predicate devices. The following performance testing has been completed to ensure substantial equivalence.
| Performance Properties | Results |
|---|---|
| Sterilization Efficacy | Testing demonstrated a 6 log reduction and a sterility assurancelevel (SAL) of 10-6 using the biological (BI) overkill method andhalf-cycle validation. |
| Whole Package MicrobialAerosol Challenge | After exposure to a defined amount of aerosol microorganismscontents maintained sterility |
| Event Related SterilityMaintenance | Testing demonstrated the ability to provide an effective barrierfor maintaining sterility of the contents after processing followedby a 180 day event related storage under conditions whichsimulate hospital sterile package handling and storageconditions. |
| Material Compatibility | After 100 cycles of processing no visible or functional changeswere observed |
{9}------------------------------------------------
| Simulated Use | A worst case dual channel flexible endoscope was reproducibly sterilized under worst case simulated use testing conditions in the Flexible Cycle. |
|---|---|
| --------------- | --------------------------------------------------------------------------------------------------------------------------------------------------- |
Conclusion
The SterilContainer" S is substantially equivalent to the predicate device cleared under K093649.
§ 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).