SterilContainer S

• K Number: K151242
• Device Name: SterilContainer S
• Manufacturer: Aesculap, Inc.
• Date Cleared: 2015-10-09 ( 151 days)
• Product Code: KCT
• Regulation Number: 880.6850

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 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.

Predicate Devices

K093649

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a reusable sterilization container system and its performance in sterilization and sterility maintenance. There is no mention of AI or ML technology in the intended use, device description, or performance studies.

Therapeutic

No

The device is a container system used for sterilizing and maintaining the sterility of other medical devices, rather than directly treating or diagnosing a medical condition.

Diagnostic

No

The device is a sterilization container system designed to sterilize and maintain the sterility of other medical devices, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states the device is a container system made from non-anodized Aluminum and includes physical accessories like mats, baskets, and filters. It is a hardware device for sterilization and storage.

IVD (In Vitro Diagnostic)

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's designed for sterilization and maintaining sterility of other medical devices.
• Device Description: The description reinforces this by detailing its components and function in the sterilization process.
• 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 falls under the category of a medical device used for sterilization and storage, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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. 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.

Product codes (comma separated list FDA assigned to the subject device)

KCT

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.

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)

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: Sterilization Efficacy
Results: Testing demonstrated a 6 log reduction and a sterility assurance level (SAL) of 10-6 using the biological (BI) overkill method and half-cycle validation.

Performance Properties: Whole Package Microbial Aerosol Challenge
Results: After exposure to a defined amount of aerosol microorganisms contents maintained sterility

Performance Properties: Event Related Sterility Maintenance
Results: 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.

Performance Properties: Material Compatibility
Results: After 100 cycles of processing no visible or functional changes were observed

Performance Properties: Simulated Use
Results: A worst case dual channel flexible endoscope was reproducibly sterilized under worst case simulated use testing conditions in the Flexible Cycle.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sterilization Efficacy: 6 log reduction and a sterility assurance level (SAL) of 10-6

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K093649

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

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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
Configuration 1	Two SterilContainer S System containers each with a basket, mat,
accessories and a flexible surgical endoscope 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 a
length of 1050 mm or shorter
• or two lumens: one lumen with an inside diameter of 1mm or
larger and length of 990mm or shorter; the second lumen with
an inside diameter of 1mm or larger and length of 850mm or
shorter
	Load
Configuration 2	Two SterilContainer S System containers, each with a basket, mat and
accessories.**
The first SterilContainer S System container holds a flexible surgical
endoscope 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 a
length of 1050 mm or shorter
• or two lumens: one lumen with an inside diameter of 1mm or
larger and length of 990mm or shorter; the second lumen with
an inside diameter of 1mm or larger and length of 850mm or
shorter
The second SterilContainer S System 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 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
Weight (if container does not
contain a flexible endoscope
or bronchoscope)* |
|-------|--------|------------------------|--------------------------------------------------------------------------------------------------------------|
| JM489 | JM440 | Full Size 90mm (4 ¼”) | 24 lbs for one container in the
chamber |
| | JM441 | Full Size 120mm (5 ½”) | |
| | JM442 | Full Size 135mm (6”) | |
| JM789 | JM740 | ¾ Size 90mm(4 ¼”) | OR
24 lbs split between two
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
Flexible 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)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (8/14)

5

K151242

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

SterilContainer™ S

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

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| Load
Configuration 1 | Two SterilContainer S containers each with a basket, mat, accessories and
a flexible surgical endoscope 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 a
length of 1050 mm or shorter.
• or two lumens: one lumen with an inside diameter of 1mm or
larger and length of 990mm or shorter; the second lumen with
an inside diameter of 1mm or larger and length of 850mm or
shorter. |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Load
Configuration 2 | Two SterilContainer S containers, each with a basket, mat and
accessories.
**
The first SterilContainer S container holds a flexible surgical endoscope
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 a
length of 1050 mm or shorter.
• or two lumens: one lumen with an inside diameter of 1mm or
larger and length of 990mm or shorter; the second lumen with
an inside diameter of 1mm or larger and length of 850mm or
shorter.
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

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| 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") | 24 lbs for one container in the
chamber |
| | JM441 | Full Size 120mm (5 1/2") | |
| | JM442 | Full Size 135mm (6") | |
| JM789 | JM740 | 3/4 Size 90mm(4 1/4") | OR
24 lbs split between two
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
Flexible 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 |

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) |
|--------------------------|--------------------------------|----------------------------------------------------------------|
| Sterilization
process | 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 |

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| 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. | The Aesculap Sterilcontainer 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
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 1
and V-PRO 1 Plus Systems. The
Sterilcontainer S System includes
accessories such as
silicon mats, baskets, trays, and
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
level (SAL) of 10-6 using the biological (BI) overkill method and
half-cycle validation.
Whole Package Microbial
Aerosol Challenge	After exposure to a defined amount of aerosol microorganisms
contents maintained sterility
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	After 100 cycles of processing no visible or functional changes
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.