SterilContainer S

K151242 · Aesculap, Inc. · KCT · Oct 9, 2015 · General Hospital

Device Facts

• Record ID: K151242
• Device Name: SterilContainer S
• Applicant: Aesculap, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Oct 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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. 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.

Device Story

SterilContainer S is a reusable rigid container system made of non-anodized aluminum with disposable polypropylene filters. It functions as a protective enclosure for medical instruments during sterilization in the V-PRO maX Low Temperature Sterilization System. The system includes accessories like baskets, silicone mats, and racks to organize instruments. It is used by healthcare providers in clinical settings to facilitate sterilization and maintain sterility of instruments until needed. The device allows sterilization of flexible endoscopes, bronchoscopes, and non-lumened metal/non-metal instruments. By providing a validated barrier, it ensures the sterility of the enclosed devices, supporting safe surgical and diagnostic procedures.

Clinical Evidence

Bench testing only. Validation studies for the V-PRO maX Flexible Cycle demonstrated a 6-log reduction and SAL of 10^-6 using biological indicators. Additional testing included whole package microbial aerosol challenge, 180-day event-related sterility maintenance, material compatibility after 100 cycles, and simulated use testing with worst-case dual-channel flexible endoscopes.

Technological Characteristics

Rigid container system; materials: non-anodized aluminum, polypropylene filters; components: perforated bottoms, lids with filter retention plates; accessories: stainless steel baskets, silicone mats, racks; sterilization compatibility: V-PRO maX Low Temperature Sterilization System (Flexible Cycle).

Indications for Use

Indicated for use by healthcare providers to enclose medical devices during sterilization and to maintain sterility of the enclosed devices until use. Compatible with the V-PRO maX Low Temperature Sterilization System Flexible Cycle for specific load configurations including flexible endoscopes and bronchoscopes.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• Aesculap SterilContainer S (K093649)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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 | | |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Load<br>Configuration 1 | Two SterilContainer S System containers each with a basket, mat,<br>accessories and a flexible surgical endoscope or bronchoscope with a light<br>cord (if not integral to endoscope) and no additional load.<br>The flexible endoscopes may contain either:<br>• a single lumen with an inside diameter of 1 mm or larger and a<br>length of 1050 mm or shorter<br>• or two lumens: one lumen with an inside diameter of 1mm or<br>larger and length of 990mm or shorter; the second lumen with<br>an inside diameter of 1mm or larger and length of 850mm or<br>shorter | |
| | Load<br>Configuration 2 | Two SterilContainer S System containers, each with a basket, mat and<br>accessories.**<br>The first SterilContainer S System container holds a flexible surgical<br>endoscope or bronchoscope with a light cord (if not integral to endoscope)<br>and no additional load.<br>The flexible endoscopes may contain either:<br>• a single lumen with an inside diameter of 1 mm or larger and a<br>length of 1050 mm or shorter<br>• or two lumens: one lumen with an inside diameter of 1mm or<br>larger and length of 990mm or shorter; the second lumen with<br>an inside diameter of 1mm or larger and length of 850mm or<br>shorter<br>The second SterilContainer S System container holds reusable metal and<br>non-metal non-lumened instruments including instruments with diffusion-<br>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.

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### Table 2: V-PRO maX Sterilizer Flexible Cycle Compatible SterilContainer S Container Systems

| Lid | Bottom | Description | Total Loaded Container<br>Weight (if container does not<br>contain a flexible endoscope<br>or bronchoscope)* |
|-------|--------|------------------------|--------------------------------------------------------------------------------------------------------------|
| JM489 | JM440 | Full Size 90mm (4 ¼”) | 24 lbs for one container in the<br>chamber |
| | JM441 | Full Size 120mm (5 ½”) | |
| | JM442 | Full Size 135mm (6”) | |
| JM789 | JM740 | ¾ Size 90mm(4 ¼”) | OR<br>24 lbs split between two<br>containers 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 maX<br>Flexible Cycle |
|-------------------------------------------------------------------------------------------------------------|-----------------------------|
| Stainless Steel baskets,<br>basket lids, and dividers | Yes |
| Instrument Organization<br>System (Silicone and<br>Stainless Steel racks,<br>brackets, holders, and clamps) | Yes |
| Silicone mats | Yes |
| Stainless Steel racks, trays,<br>holders, clamps, brackets, and<br>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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FORM FDA 3881 (8/14)

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# K151242

# 510(k) SUMMARY (as required by 21 CFR 807.92)

# SterilContainer™ S

| COMPANY: | Tuesday, October 06, 2015<br>Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 291671- |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Peter Stoll<br>610-984-9076 (phone)<br>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

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| Load<br>Configuration 1 | Two SterilContainer S containers each with a basket, mat, accessories and<br>a flexible surgical endoscope or bronchoscope with a light cord (if not<br>integral to endoscope) and no additional load.<br>The flexible endoscopes may contain either:<br>• a single lumen with an inside diameter of 1 mm or larger and a<br>length of 1050 mm or shorter.<br>• or two lumens: one lumen with an inside diameter of 1mm or<br>larger and length of 990mm or shorter; the second lumen with<br>an inside diameter of 1mm or larger and length of 850mm or<br>shorter. |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Load<br>Configuration 2 | Two SterilContainer S containers, each with a basket, mat and<br>accessories.<br>**<br>The first SterilContainer S container holds a flexible surgical endoscope<br>or bronchoscope with a light cord (if not integral to endoscope) and no<br>additional load.<br>The flexible endoscopes may contain either:<br>• a single lumen with an inside diameter of 1 mm or larger and a<br>length of 1050 mm or shorter.<br>• or two lumens: one lumen with an inside diameter of 1mm or<br>larger and length of 990mm or shorter; the second lumen with<br>an inside diameter of 1mm or larger and length of 850mm or<br>shorter.<br>The second SterilContainer S container holds reusable metal and non-<br>metal non-lumened instruments including instruments with diffusion-<br>restricted areas such as the hinged portion of forceps or scissors.<br>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

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| Lid | Bottom | Description | Total Loaded Container<br>Weight (if container does not<br>contain a flexible endoscope<br>or bronchoscope)* |
|-------|--------|--------------------------|--------------------------------------------------------------------------------------------------------------|
| JM489 | JM440 | Full Size 90mm (4 1/4") | 24 lbs for one container in the<br>chamber |
| | JM441 | Full Size 120mm (5 1/2") | |
| | JM442 | Full Size 135mm (6") | |
| JM789 | JM740 | 3/4 Size 90mm(4 1/4") | OR<br>24 lbs split between two<br>containers 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 maX<br>Flexible Cycle |
|-------------------------------------------------------------------------------------------------------------|-----------------------------|
| Stainless Steel baskets,<br>basket lids, and dividers | Yes |
| Instrument Organization<br>System (Silicone and<br>Stainless Steel racks,<br>brackets, holders, and clamps) | Yes |
| Silicone mats | Yes |
| Stainless Steel racks, trays,<br>holders, clamps, brackets, and<br>platforms | 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<br>(K151242) | Aesculap SterilContainer S<br>(K093649) |
|--------------------------|--------------------------------|----------------------------------------------------------------|
| Sterilization<br>process | Amsco V-PRO maX Flexible Cycle | Amsco V-PRO 1 and V-PRO 1 Plus<br>(Lumen and Non Lumen Cycles) |
| Material | Non-anodized aluminum | Non-anodized aluminum |
| Container type | Perforated | Perforated |
| Filter type | Polypropylene | Polypropylene |

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| Indications for<br>Use | The SterilContainer S is a reusable<br>sterilization container system<br>(consisting of perforated bottoms and<br>perforated lids with filter retention<br>plates, and single use polypropylene<br>filters) intended to be used to enclose<br>another medical device that is to be<br>sterilized by a healthcare provider. It<br>is intended to allow sterilization of<br>the enclosed device and also<br>maintain sterility of the enclosed<br>device until used. This container<br>system is compatible for use with the<br>V-PRO maX Low Temperature<br>Sterilization System Flexible Cycle. | The Aesculap Sterilcontainer is a<br>reusable sterilization container<br>system intended to be<br>used to enclose another medical<br>device that is to be sterilized by a<br>healthcare provider. It<br>is intended to allow sterilization of<br>the enclosed device and also<br>maintain sterility of the<br>enclosed device until used. This<br>container system is compatible for<br>use with the V-PRO 1<br>and V-PRO 1 Plus Systems. The<br>Sterilcontainer S System includes<br>accessories such as<br>silicon mats, baskets, trays, and<br>racks. |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

# 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 assurance<br>level (SAL) of 10-6 using the biological (BI) overkill method and<br>half-cycle validation. |
| Whole Package Microbial<br>Aerosol Challenge | After exposure to a defined amount of aerosol microorganisms<br>contents maintained sterility |
| Event Related Sterility<br>Maintenance | Testing demonstrated the ability to provide an effective barrier<br>for maintaining sterility of the contents after processing followed<br>by a 180 day event related storage under conditions which<br>simulate hospital sterile package handling and storage<br>conditions. |
| Material Compatibility | After 100 cycles of processing no visible or functional changes<br>were observed |

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| 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.