SterilContainer S System

K142970 · Aesculap, Inc. · KCT · Jul 8, 2015 · General Hospital

Device Facts

• Record ID: K142970
• Device Name: SterilContainer S System
• Applicant: Aesculap, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Jul 8, 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. This container system has been validated with hinged, and knurled instruments. It is intended to allow sterilization of the enclosed device and also maintain sterlity of the enclosed device until used. This container system is compatible for use with STERRAD 100NX EXPRESS Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.

Device Story

SterilContainer S System is a reusable rigid container system for low-temperature sterilization of medical devices. Components include non-anodized aluminum perforated bottoms, lids with filter retention plates, and single-use polypropylene filters. Accessories include silicone mats, baskets, trays, racks, and holders. Used in healthcare facilities; operated by sterile processing staff. Device encloses instruments to be sterilized via STERRAD 100NX EXPRESS Cycle. Container maintains sterility of contents post-sterilization (360 days for full size; 30 days for 1/2 size). Healthcare providers use the system to protect instruments during sterilization and storage, ensuring sterility until the point of use.

Clinical Evidence

Bench testing only. Sterilization efficacy demonstrated 6-log reduction (SAL 10^-6). Microbial aerosol challenge confirmed barrier effectiveness. Shelf-life validated for 360 days (full size) and 30 days (1/2 size). Biocompatibility testing per ISO 10993-5 (cytotoxicity) and ASTM F756/ISO 10993-4 (hemolysis) showed no toxicity or hemolysis. No clinical data.

Technological Characteristics

Rigid container system made of non-anodized aluminum. Uses single-use polypropylene filters. Perforated design. Compatible with STERRAD 100NX EXPRESS Cycle. Biocompatibility per ISO 10993-5 and ASTM F756. No software or electronic components.

Indications for Use

Indicated for use by healthcare providers to enclose reusable metal and non-metal medical devices (including endoscopes without lumens or da Vinci Scope Platform and Si/S series scopes) for sterilization and maintenance of sterility until use. Validated for hinged and knurled instruments.

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 (K093493)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 8, 2015

Aesculap, Inc. % Denise Adams Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034

Re: K142970

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, 2015 Received: June 10, 2015

Dear Ms. Adams,

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

Device Name SterilContainer S System

Indications for Use (Describe)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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 hinged, and knurled instruments. It is intended to allow sterilization of the enclosed device and also maintain sterlity of the enclosed device until used. This container system is compatible for use with STERRAD 100NX EXPRESS Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.

Testing has been completed on the SterilContainer S Full size container to maintain the sterility of its contents for 360 days following successful sterilization.

Testing has been completed on the SterilContainer S 1/2 size container to maintain the sterility of its contents for 30 days following successful sterilization.

The validated chamber load for the SterilContainer S Full and Half sizes in the STERRAD 100NX EXPRESS Cycle consisted of one SterilContainer S placed on the bottom shelf in an otherwise empty chamber.

| Lid | Bottom | Description | Total loaded<br>container weight<br>(lbs) | Intended load |
|-------|--------|-----------------------------------------------|-------------------------------------------|------------------------------------------------------------------|
| JM489 | JM440 | Full Size 90mm (4 $1\frac{1}{4}$ ") | 25.0 | reusable metal and non-metal medical |
| | JM441 | Full Size 120mm (5 $1\frac{1}{2}$ ") | 25.0 | devices without lumens including |
| | JM442 | Full Size 135mm (6") | 25.0 | endoscopes without lumens OR the da Vinci |
| | JM444 | Full Size 187mm (8") | 25.0 | Scope Platform (MD425) and two Si or S<br>series da Vinci Scopes |
| JM389 | JM340 | $\frac{1}{2}$ Size 90mm (4 $1\frac{1}{4}$ ") | 21.2 | reusable metal and non-metal medical |
| | JM341 | $\frac{1}{2}$ Size 120mm (5 $1\frac{1}{2}$ ") | 21.5 | devices without lumens including |
| | JM342 | $\frac{1}{2}$ Size 135mm (6") | 21.7 | endoscopes without lumens |
| | JM344 | $\frac{1}{2}$ Size 187mm (8") | 22.2 | |

### SterilContainer S Compatible Containers in STERRAD 100NX EXPRESS Cycle

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| Accessories | STERRAD 100NX EXPRESS 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 |

#### STERRAD 100NX EXPRESS Cycle Compatible SterilContainer S System Accessories

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

| | SterilContainer™ S System<br>June 29, 2015 | | | |
|----------------------|--------------------------------------------------------------------------------------------------------------------|--|--|--|
| COMPANY: | Aesculap, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 291671-4 | | | |
| CONTACT: | Denise R. Adams<br>610-984-9076 (phone)<br>610-791-6882 (fax) | | | |
| TRADE NAME: | SterilContainer S System | | | |
| COMMON NAME: | Sterilization Container | | | |
| CLASSIFICATION NAME: | Sterilization Wrap | | | |
| 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 the STERRAD 100NX EXPRESS Cycle is substantially equivalent to Aesculap SterilContainer S for use in STERRAD 200, NX (Standard and Advanced Cycles), and 100NX (Standard and Flex Cycles) cleared via K093493.

### DEVICE DESCRIPTION

The SterilContainer S System is a container system that will allow for sterilization and storage of medical devices. This container system is for use in low-temperature sterilization technology such as with the STERRAD 100NX EXPRESS Cycle. 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-evident locks.

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## 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 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 STERRAD 100NX EXPRESS Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.

Testing has been completed on the SterilContainer S Full size container to maintain the sterility of its contents for 360 days following successful sterilization.

Testing has been completed on the SterilContainer S ½ size container to maintain the sterility of its contents for 30 days following successful sterilization.

The validated chamber load for the SterilContainer S Full and Half sizes in the STERRAD 100NX EXPRESS Cycle consisted of one SterilContainer S placed on the bottom shelf in an otherwise empty chamber.

| Lid | Bottom | Description | Total loaded container weight (lbs) | Intended load |
|-------|--------|-------------------------|-------------------------------------|---------------------------------------------------------------------------------------------------------------|
| JM489 | JM440 | Full Size 90mm (4 ¼") | 25.0 | reusable metal and non-metal medical |
| | JM441 | Full Size 120mm (5 ½") | 25.0 | devices without lumens including |
| | JM442 | Full Size 135mm (6") | 25.0 | endoscopes without lumens OR the da Vinci<br>Scope Platform (MD425) and two Si or S<br>series da Vinci Scopes |
| | JM444 | Full Size 187mm (8") | 25.0 | |
| JM389 | JM340 | 1/2 Size 90mm (4 1/4") | 21.2 | reusable metal and non-metal medical |
| | JM341 | 1/2 Size 120mm (5 1/2") | 21.5 | devices without lumens including |
| | JM342 | 1/2 Size 135mm (6") | 21.7 | endoscopes without lumens |
| | JM344 | 1/2 Size 187mm (8") | 22.2 | |

#### SterilContainer S Compatible Containers in STERRAD 100NX EXPRESS Cycle

#### STERRAD 100NX EXPRESS Cycle Compatible SterilContainer S System Accessories

| Accessories | STERRAD 100NX<br>EXPRESS 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 |

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## TECHNOLIGICAL CHARACTERISTICS (compared to predicates)

The SterilContainer S System is for use in low-temperature sterilization technology such as the STERRAD 100NX EXPRESS Cycle. The SterilContainer S System is the same container system as was cleared in K093493. The materials and design have not changed.

| System | SterilContainer S<br>(K142970) | | | | | SterilContainer S<br>(K093493) | | | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-----------------------------------------------------|-------|
| Indica-<br>tions for<br>Use | The SterilContainer S System is a reusable sterilization container<br>system (consisting of perforated bottoms and perforated lids with<br>filter retention plates, and single-use polypropylene filters)<br>intended to be used to enclose another medical device that is to be<br>sterilized by a healthcare provider. This container system has been<br>validated with hinged, and knurled instruments. It is intended to<br>allow sterilization of the enclosed device and also maintain sterility<br>of the enclosed device until used. This container system is<br>compatible for use with STERRAD 100NX EXPRESS Cycle. The<br>SterilContainer S System includes accessories such as silicone<br>mats, baskets, trays, racks, eyepiece holders and sleeve holders.<br><br>Testing has been completed on the SterilContainer S Full size<br>container to maintain the sterility of its contents for 360 days<br>following successful sterilization.<br><br>Testing has been completed on the SterilContainer S ½ size container<br>maintain the sterility of its contents for 30 days following successful<br>sterilization.<br><br>The validated chamber load for the SterilContainer S Full and Half<br>sizes in the STERRAD 100NX EXPRESS Cycle consisted of one<br>SterilContainer S placed on the bottom shelf in an otherwise empty<br>chamber. | | | | | The Aesculap Sterilcontainer S is a reusable sterilization container system<br>(consisting of perforated bottoms and perforated lids with filter retention plates, and<br>disposable polypropylene filters) intended to be used to enclose another medical<br>device that is to be sterilized by a healthcare provider. This container has been<br>validated with stainless steel lumens, hinged, and knurled instruments. It is intended<br>to allow sterilization of the enclosed device and also maintain sterility of the<br>enclosed device until used. This container system is compatible for use with the<br>STERRAD 200, STERRAD NX (Standard cycle and Advanced cycle), and<br>STERRAD 100NX (Standard cycle and Flex cycle). The Sterilcontainer S System<br>includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders<br>and sleeve holders. | | | |
| | | The Sterilcontainer S is recommended for surface and lumens:<br>STERRAD 200, stainless steel lumens ≥ 3mm I.D. x ≤ 400mm L<br>STERRAD NX standard cycle, stainless steel lumens<br>≥ 2mm I.D. x ≤ 400mm L<br>STERRAD NX advanced cycle, stainless steel lumens<br>> 1mm I.D. x ≤ 500mm L<br>STERRAD 100NX standard cycle, stainless steel lumens<br>≥ 0.7mm I.D. x ≤ 500mm L | | | | | | | |
| | | STERRAD 100NX flex cycle, porous lumens (flexible endoscope)<br>> 1mm I.D. x ≤ 850mm L<br><br>30 days of shelf life testing has been conducted for the Sterilicontainer S. | | | | | | | |
| | SterilContainer S Compatible Containers in STERRAD 100NX<br>EXPRESS Cycle | | | | TABLE 1: SterilContainer S Compatible Containers in STERRAD 200 | | | | |
| | Lid | Bottom | Description | Total<br>loaded<br>container<br>weight<br>(lbs) | Intended load | Item # | Description | Total loaded container<br>weight (lbs) | |
| | J<br>M<br>48<br>9 | JM4<br>40 | Full Size<br>90mm (4 ¼") | 25.0 | reusable metal<br>and non-metal<br>medical devices<br>without lumens | JM440 | Full Size Perforated Bottom 90mm (4 ¼") | 21.46 | |
| | | JM4<br>41 | Full Size<br>120mm (5 ½") | 25.0 | including<br>endoscopes<br>without lumens | JM441 | Full Size Perforated Bottom 120mm (5 ½") | 21.46 | |
| | | JM4<br>42 | Full Size<br>135mm<br>(6") | 25.0 | OR the da<br>Vinci Scope<br>Platform<br>(MD425) and<br>two Si or S<br>series da Vinci<br>Scopes | JM442 | Full Size Perforated Bottom 135mm (6") | 21.46 | |
| | | JM4<br>44 | Full Size<br>187mm<br>(8") | 25.0 | | JM444 | Full Size Perforated Bottom 187mm (8") | 21.46 | |
| | J<br>M<br>38<br>9 | JM3<br>40 | ½ Size<br>90mm (4 ¼") | 21.2 | reusable metal<br>and non-metal<br>medical devices<br>without lumens | JM740 | ¾ Size Perforated Bottom 90mm(4 ¼") | 14.42 | |
| | | JM3<br>41 | ½ Size<br>120mm (5 ½") | 21.5 | including<br>endoscopes<br>without lumens | JM741 | ¾ Size Perforated Bottom 120mm (5 ½") | 14.42 | |
| | | JM3<br>42 | ½ Size<br>135mm<br>(6") | 21.7 | | JM742 | ¾ Size Perforated Bottom 135mm (6") | 14.42 | |
| | | JM3<br>44 | ½ Size<br>187mm<br>(8") | 22.2 | | JM340 | ½ Size Perforated Bottom 90mm (4 ¼") | 14.42 | |
| | | | | | | | JM341 | ½ Size Perforated Bottom 120mm (5 ½") | 14.42 |
| | | | | | | | JM342 | ½ Size Perforated Bottom 135mm (6") | 14.42 |
| | | | | | | | JM344 | ½ Size Perforated Bottom 187mm (8") | 14.42 |
| | | | | | | | JM094 | ¼ Size Perforated Bottom with Lid<br>65mm (2 ½") | 14.42 |
| | | | | | | | JM096 | ¼ Size Perforated Bottom with Lid<br>130mm (5 1/8") | 14.42 |
| | | | | | | | JM021 | Extra Long Mini Bottom 73mm (3") | 7.64 |
| | | | | | | | JM489 | Full Size Lid | |
| |…