(280 days)
No
The device description and performance studies focus on the physical properties and sterilization efficacy of a container system, with no mention of AI or ML.
No
The device is a sterilization container system designed to enclose other medical devices for sterilization and maintain their sterility, not to treat or diagnose patients itself.
No
The device is a sterilization container system, intended to enclose other medical devices for sterilization and maintain their sterility. It does not perform any diagnostic functions.
No
The device description clearly states it is a "container system" made from "non-anodized Aluminum" and utilizes "disposable (single use) polypropylene filters," along with various physical accessories. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider." It facilitates the sterilization and maintenance of sterility of other medical devices.
- Device Description: The description reinforces its function as a container system for sterilization and storage of medical devices.
- Performance Studies: The performance studies focus on sterilization efficacy, bacterial filtration, sterility maintenance, material compatibility, and biocompatibility – all related to the sterilization and storage function of the container.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
Therefore, the SterilContainer S System is a medical device used in the sterilization process of other medical devices, not an in vitro diagnostic device.
N/A
Intended Use / 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 stainless steel and Teflon lumens, hinged, and knurled instruments. 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 TS03 Sterizone VP4 Low Temperature Sterilization System. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.
Product codes
KCT
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 TS03 Sterizone VP4 Low Temperature Sterilization System. The SterilContainer" S System rigid containers are made from non-anodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer" S System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sterilization Efficacy/Lethality Study: Testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10-6 using the biological (BI) overkill method and half-cycle validation. The SAL was achieved by placing at least 1.0 x 106 spores of Geobacillus stearothermophilus in the worst-case sterilization location through the containers and processing at one-half the expected full cycle exposure time. Following exposure, the Bi's were aseptically transferred to culture media and incubated as required. This testing was performed in triplicate on the Aesculap rigid container. The full cycle therefore results in a 12-log reduction of spores and produce a 10-6 SAL, which reflects a one-in-a-million chance of non-sterile item.
Bacterial Filtration Efficiency: The evaluation of the microbial barrier properties of the Aesculap® polypropylene filters demonstrates that the bacterial filtration efficiency is maintained by the filter after being processed in the Cycle 1 of the STERIZONE® Sterilizer.
Event Related Sterility Maintenance: Testing demonstrated the ability to provide an effective barrier for maintaining sterility of the contents after processing followed by a 180 day event related storage under conditions which simulate hospital sterile package handling and storage conditions.
Material Compatibility/Reuse Test: After 100 cycles of processing no visible or functional changes were observed.
Biocompatibility: This study is conducted to evaluate the biocompatibility properties of the Aesculap® polypropylene filters when processed in Cycle 1 of the STERIZONE® VP4 Sterilizer. The Aesculap® polypropylene filters have been proven to be biocompatible and can be safely processed in Cycle 1 of the STERIZONE® Sterilizer.
Aerosol Microbial Challenge: The contents of container were negative for growth following exposure of the containers to aerosolized microbial challenge test conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 13, 2017
Aesculap, Inc Paul Amudala Regulatory Affairs Specialist 3773 Corporate Pkwy Center Valley, Pennsylvania 18034
Re: K162815
Trade/Device Name: SterilContainer™ S System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: June 9, 2017 Received: June 12, 2017
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 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 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
1
the quality systems (OS) 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,
Tara A. Ryan -S
for
Lori Wiggins Acting 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) K162815
Device Name SterilContainer™ S System
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. This container system has been validated with stainless steel and Teflon lumens, hinged, and knurled instruments. 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 TS03 Sterizone VP4 Low Temperature Sterilization System. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.
| Load #1 (31.2 lb) | Flexible endoscopes load accommodating three single channel flexible endoscopes, one per container:
• Internal channel diameter of 1 mm and length of 850 mm. |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Load #2 (29.4 lb) | Semi-rigid and rigid channel devices load accommodating three double channel semi-rigid endoscopes, one per container, and one length of medical grade stainless steel tubing.
• Length of tubing:
➤ Internal channel diameter of 1.0 mm and length of 500 mm.
• Double channel semi-rigid endoscope
➤ Internal channel diameters of 0.7 mm and 1.1 mm, and length of 500 mm |
| Load #3 (10.2 lb) | Worst-case volume to surface perforation area ratio using a perforated container including two stacked baskets. Each basket was covered with a full length silicone mat. At least one inoculated medical device was added per level of the container. |
| Load #4 (25 lb) | Worst-case volume to surface perforation area ratio using a perforated container with maximum weight of instrument, for a total mass of 25 lb. At least three inoculated medical devices were added in the container. |
| Load #5 (75 lb) | Heavy weight load composed of three perforated containers, with a total mass of 25 lb per container. The heavy validation load was prepared based on the Aesculap SterilContainer™ S container lethality studies (PRO-169) and adapted to include a maximum weight in a single load. |
Table 1: Validated TS03 Sterilizer Flexible Cycle Load Configurations
Table 2: TS03 -Sterilizer Flexible Cycle Compatible SterilContainer S Container Systems
| Lid | Bottom | Description | Total Loaded Container
Weight (if container does not
contain a flexible endoscope
or bronchoscope)* |
| ----- | -------- | ------------- | -------------------------------------------------------------------------------------------------------------- |
|---|
3
| JM489 | JM440 | Full Size 90mm (4 ¼") | |
|---|---|---|---|
| JM441 | Full Size 120mm (5 ½") | 25 lbs for one container in the chamber | |
| JM442 | Full Size 135mm (6") | ||
| JM444 | Full Size 187mm (8") | ||
| JM789 | JM740 | ¾ Size 90mm(4 ¼") | |
| 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: TS03 Sterilizer
Cycle Compatible Accessories
| Accessories | TS03 Cycle |
|---|---|
| Stainless Steel baskets, | |
| basket lids, and dividers | Yes |
| Instrument Organization System (Silicone and Stainless Steel racks, | |
| brackets, holders, and clamps) | Yes |
| Silicone mats | Yes |
| Stainless Steel racks, trays, holders, clamps, brackets, and platforms | Yes |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) SUMMARY (as required by 21 CFR 807.92)
SterilContainer™ S System
July 7, 2017
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 291671- |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Paul Amudala
610-984-9303 (phone)
610-791-6882 (fax) |
| TRADE NAME: | SterilContainer S System |
| COMMON NAME: | Sterilization Container Wrap |
| CLASSIFICATION NAME: | Sterilization Wrap |
| REGULATION NUMBER: | 880.6850 |
| PRODUCT CODE: | KCT |
| DEVICE CLASS: | Class II per 21 CFR §880.6850 |
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the SterilContainer™ S System for use in TS03 Sterizone VP4 Low Temperature Sterilization System is substantially equivalent to Aesculap SterilContainer" S for use in V-Pro 60 Flexible Cycle via K151242.
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 TS03 Sterizone VP4 Low Temperature Sterilization System. The SterilContainer" S System rigid containers are made from non-anodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer" S System includes accessories such as mats, baskets, trays, 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 healthcare provider. This container system has been validated with stainless steel and Teflon
5
lumens, hinged, and knurled instruments. 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 TS03 Sterizone VP4 Low Temperature Sterilization System. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.
| Load #1 (31.2 lb) | Flexible endoscopes load accommodating three single channel flexible endoscopes, one per container:
• Internal channel diameter of 1 mm and length of 850 mm. |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Load #2 (29.4 lb) | Semi-rigid and rigid channel devices load accommodating three double channel semi-rigid endoscopes, one per container, and one length of medical grade stainless steel tubing.
• Length of tubing:
➤ Internal channel diameter of 1.0 mm and length of 500 mm.
• Double channel semi-rigid endoscope
➤ Internal channel diameters of 0.7 mm and 1.1 mm, and length of 500 mm |
| Load #3 (10.2 lb) | Worst-case volume to surface perforation area ratio using a perforated container including two stacked baskets. Each basket was covered with a full length silicone mat. At least one inoculated medical device was added per level of the container. |
| Load #4 (25 lb) | Worst-case volume to surface perforation area ratio using a perforated container with maximum weight of instrument, for a total mass of 25 lb. At least three inoculated medical devices were added in the container. |
| Load #5 (75 lb) | Heavy weight load composed of three perforated containers, with a total mass of 25 lb per container. The heavy validation load was prepared based on the Aesculap® SterilContainer™ S container lethality studies (PRO-169) and adapted to include a maximum weight in a single load. |
Table 1: Validated TS03 Sterizone VP4 Cycle Load Configurations
| Table 2: TS03 Sterilizer Cycle Compatible SterilContainer S Container Systems | |||
|---|---|---|---|
| -- | -- | ------------------------------------------------------------------------------- | -- |
| Lid | Bottom | Description | Total Loaded Container
Weight (if container does not
contain a flexible endoscope
or bronchoscope)* |
|-------|--------|--------------------------|--------------------------------------------------------------------------------------------------------------|
| JM489 | JM440 | Full Size 90mm (4 1/4") | |
| | JM441 | Full Size 120mm (5 1/2") | 25 lbs for one container in the |
| | JM442 | Full Size 135mm (6") | chamber |
| | JM444 | Full Size 187mm (8") | |
| JM789 | JM740 | 3/4 Size 90mm(4 1/4") | |
| | JM741 | 3/4 Size 120mm (5 1/2") | |
| | JM742 | 3/4 Size 135mm (6") | |
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
| Accessories | TS03 Cycle |
|---|---|
| Stainless Steel baskets, | |
| basket lids, and dividers | Yes |
| Instrument Organization | |
| System (Silicone and | |
| Stainless Steel racks, | |
| brackets, holders, and clamps) | Yes |
| Silicone mats | Yes |
| Stainless Steel racks, trays, | |
| holders, clamps, brackets, and | |
| platforms | Yes |
Table 3: TS03 Sterilizer Cycle Compatible Accessories
TECHNOLIGICAL CHARACTERISTICS (compared to predicate)
The SterilContainer S System that can be used in the TS03 Sterizone VP4 Low Sterilization cycle is the same container system that was cleared in K151242. The materials and design have not changed.
| System | SterilContainer S System
(not assigned) | SterilContainer S System
(K151242) |
|--------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Sterilization
process | TS03 Sterizone VP4 Low
Temperature Sterilization
System 46 min cycle,
Ozone (O3), H2O2 | V-PRO 60 38 min Low Temperature
Flexible Cycle, H2O2 |
| Material | Non-anodized aluminum | Non-anodized aluminum |
| Container type | Perforated | Perforated |
| Filter type | Polypropylene | Polypropylene |
PERFORMANCE DATA
The Aesculap SterilContainer S System has been validated for the TS03 Sterizone VP4 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.
7
| Performance Properties | Results |
|---|---|
| Sterilization Efficacy/ | |
| Lethality Study | Testing demonstrated a 12 log reduction and a sterility |
| assurance level (SAL) of 10-6 using the biological (BI) | |
| overkill method and half-cycle validation. The SAL was | |
| achieved by placing at least 1.0 x 106 spores of Geobacillus | |
| stearothermophilus in the worst-case sterilization location | |
| through the containers and processing at one-half the | |
| expected full cycle exposure time. Following exposure, the | |
| Bi's were aseptically transferred to culture media and | |
| incubated as required. This testing was performed in | |
| triplicate on the Aesculap rigid container. The full cycle | |
| therefore results in a 12-log reduction of spores and | |
| produce a 10-6 SAL, which reflects a one-in-a-million | |
| chance of non-sterile item. | |
| Bacterial Filtration | |
| Efficiency | The evaluation of the microbial barrier properties of the |
| Aesculap® polypropylene filters demonstrates that the | |
| bacterial filtration efficiency is maintained by the filter after | |
| being processed in the Cycle 1 of the STERIZONE® | |
| Sterilizer. | |
| Event Related Sterility | |
| Maintenance | Testing demonstrated the ability to provide an effective |
| barrier for maintaining sterility of the contents after | |
| processing followed by a 180 day event related storage | |
| under conditions which simulate hospital sterile package | |
| handling and storage conditions. | |
| Material | |
| Compatibility/Reuse Test | After 100 cycles of processing no visible or functional |
| changes were observed | |
| Biocompatibility | This study is conducted to evaluate the biocompatibility |
| properties of the Aesculap® polypropylene filters when | |
| processed in Cycle 1 of the STERIZONE® VP4 Sterilizer. | |
| The Aesculap® polypropylene filters have been proven to | |
| be biocompatible and can be safely processed in Cycle 1 | |
| of the STERIZONE® Sterilizer. | |
| Aerosol Microbial Challenge | The contents of container were negative for growth |
| following exposure of the containers to aerosolized | |
| microbial challenge test conditions |
Conclusion:
The Aesculap SterilContainer S System is substantially equivalent to the predicate device.