STERILCONTAINER SYSTEM

K112671 · Aesculap, Ltd. · KCT · May 4, 2012 · General Hospital

Device Facts

• Record ID: K112671
• Device Name: STERILCONTAINER SYSTEM
• Applicant: Aesculap, Ltd.
• Product Code: KCT · General Hospital
• Decision Date: May 4, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Aesculap SterilContainer System 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 for 360 days. The SterilContainer System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks. The container system consists of a three-quarter size, 8" tall perforated (JN744) or solid (JK744) container bottom and an aluminum or PrimeLine lid. The lids are available in different colors to aide in set recognition. There are three types of filter materials. A single use paper filter (US751, US994), a single use polypropylene filter (MD344), and a reusable PTFE filter (JK090). The reusable PTFE is validated for 2200 uses. There are a variety of accessories for use with the container system. Please refer to the chart on the next page for sterilization compatibility of the container system.

Device Story

Reusable sterilization container system; consists of anodized aluminum bottom, aluminum or Radel R (PrimeLine) lids, and various internal accessories (mats, baskets, trays, holders, organizers). Used by healthcare providers in clinical settings to house medical instruments during sterilization. Input: medical devices placed inside container. Process: container allows penetration of sterilant (pre-vacuum steam, immediate use steam, or EtO) through filter system while maintaining sterile barrier post-process. Output: sterilized medical devices ready for storage or use. Benefit: provides protective, reusable environment for instrument sterilization and maintenance of sterility for 360 days. Healthcare providers use visual inspection of tamper-proof locks and indicator cards to verify sterility status before use.

Clinical Evidence

Bench testing only. Validation conducted in accordance with AAMI standards for pre-vacuum steam, immediate use steam, and EtO sterilization. Testing confirmed 360-day event-related shelf life and sterilization efficacy for the worst-case vent-to-volume ratio configuration.

Technological Characteristics

Materials: Anodized aluminum, Radel R (polyphenylsulfone). Components: Perforated/solid bottoms, aluminum/Radel R lids, various internal organizers. Sterilization: Pre-vacuum steam, immediate use steam, EtO. Filters: Single-use paper, single-use polypropylene, reusable PTFE (validated for 2200 uses). Connectivity: None. Form factor: Three-quarter size, 8" height.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices during sterilization processes (pre-vacuum steam, immediate use steam, and EtO) and to maintain sterility of the enclosed devices for up to 360 days.

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 PrimeLine Container (K073168)
• Aesculap SterilContainer System (Flash Indication) (K053389)
• Aesculap PriMed Rigid Container System (K944864)
• Aesculap Container System (K792558)

Submission Summary (Full Text)

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K112671

Page 1 of 4

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

# MAY - 4 2012

## Aesculap SterilContainer for PreVac Steam, Immediate Use Steam, and EtO Sterilization September 12, 2011

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Denise R. Adams<br>610-984-9076 (phone)<br>[e-mail]<br>610-791-6882 (fax) |
| TRADE NAME: | Aesculap SterilContainer |
| COMMON NAME: | Sterilization Container Wrap |
| CLASSIFICATION NAME: | Wrap, Sterilization |
| REGULATION NUMBER: | 880.6850 |
| PRODUCT CODE: | KCT |

## SUBSTANTIAL EQUIVALENCE

Aesculap, Inc. believes that the SterilContainer is substantially equivalent to:

- Aesculap PrimeLine Container (K073168) .
- Aesculap SterilContainer System (Flash Indication) (K053389) �
- Aesculap PriMed Rigid Container System (K944864) .
- Aesculap Container System (K792558) .

## DEVICE DESCRIPTION

The Aesculap SterilContainer is designed as a container system that will allow for sterilization The Aesculap StelliContainer is designed as a sommittee of full, three-quarter, half, quarter, and storage of other medical devices. "This cystem bolights. There are a variety of accessories extra long and wide body container system. They include mats, baskets, trays, holders, organizers, also available for this container byetem. This container is designed to be compatible for filiers, findcator Cards and tamper proof for the se steam and Ethylene Oxide (EO)
use in pre-vacuum steam, pre-vacuum immediate use steam and beso sta use in pre-vacuum steam, pre-vaoually in modiate as a sub-dized aluminum and has stainless steel handles on each end.

There are two types of lids for the container bottom. There are anodized aluminum lids that There are two types of hids for the ochtainer becess steel latch on each end nave removable relemion plates to noid the mere as o Prime Line lids available for use of the lid lock the lid only the container bottom. There are that in the sommonly known

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as Radel R. The PrimeLine lids have a reusable filter system. The reusable filter is ao Hadol Ri Pre-vac steam and Immediate Use steam sterilization only.

### INDICATIONS FOR USE

The Aesculap SterilContainer System 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 for 360 days. The InterilContainer System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks.

niters, indicator cards and tamper proch looks.
The container system consists of a three-quarter size, 8" tall perforated (JN744) or solid (JK744) r ho ooncalner oyoten of three-quarter size aluminum or PrimeLine lid. The lids are available in different colors to aide in set recognition. There are three types of filter materials. A single use differ (US751, US994), a single use polypropylene filter (MD344), and a reusable PTFE filter paper liker (UST) , USB 17) a cligidated for 2200 uses. There are a variety of accessories for use (ortood). The rousebile in Please refer to the chart on the next page for sterilization compatibility of the container system.

## Validated Sterilization Cycle Parameters

AAMI and AORN guidances recommend maximum load weights of 25 pounds or less in the healthcare setting. testing has been conducted

| 360 days of event related shelf life testing has been conducted. | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|----------------------------------------|----------------------------------|----------------|------------------------------------------------------------------------------------------|
| Sterilization<br>Cycle<br>Parameters | PrimeLine Lid<br>w/ JP050 filter | Aluminum Lid | Filter | Bottom | Max No. of Lumens/<br>Lumen Configuration |
| Immediate Use<br>(Non porous)<br>270°F Temp,<br>3 min. Exposure<br>Stacking not<br>recommended | JP011, JP012,<br>JP013, JP014,<br>JP015, JP016,<br>JP017 | JK785, JK786,<br>JK787,<br>JK788,JK789 | US751<br>US994<br>MD344<br>JK090 | JK744 | |
| Immediate Use<br>(Porous)<br>270°F Temp,<br>4 min. Exposure<br>Stacking not<br>recommended | JP011, JP012,<br>JP013, JP014,<br>JP015, JP016,<br>JP017 | JK785, JK786,<br>JK787,<br>JK788,JK789 | US751<br>US994<br>MD344<br>JK090 | JK744 | 1 lumen with ≥ 3mm I.D.<br>x ≤ 400mm L and a<br>second lumen ≥ 3.8mm<br>I.D. x ≤ 370mm L |
| Pre-vacuum<br>270°F Temp,<br>4min.Exposure,<br>30 min. Dry time<br>Stacking should<br>not exceed 18" in<br>height | JP011, JP012,<br>JP013, JP014,<br>JP015, JP016,<br>JP017 | JK785, JK786,<br>JK787,<br>JK788,JK789 | US751<br>US994<br>MD344<br>JK090 | JK744<br>JN744 | 1 lumen with ≥ 3mm I.D.<br>x ≤ 400mm L and a<br>second lumen ≥ 3.8mm<br>I.D. x ≤ 370mm L |
| Ethylene Oxide<br>130° F temp,<br>60 min exposure<br>≥ 50% Relative<br>Humidity<br>725 mg/L gas<br>pressure<br>Stacking not<br>recommended | | JK785, JK786,<br>JK787,<br>JK788,JK789 | US751<br>US994 | JK744<br>JN744 | 1 lumen with ≥ 3mm I.D.<br>x ≤ 400mm L and a<br>second lumen ≥ 3.8mm<br>I.D. x ≤ 370mm L |

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| Accessories | Pre-vac<br>Steam | Immediate Use Steam | EtO |
|----------------------------------------------------------------------------------------------------------|------------------|---------------------|-----|
| Stainless Steel baskets, basket lids and<br>dividers | X | X | X |
| Instrument Organization System (Silicone<br>and Stainless Steel racks, brackets, holders,<br>and clamps) | X | X | X |
| Silicone mats | X | X | X |
| Stainless Steel racks, trays, holders, clamps,<br>brackets and platforms | X | X | X |

## TECHNOLIGICAL CHARACTERISTICS(compared to predicate(s))

The Aesculap SterilContainer is compatible for use in pre-vacuum steam, pre-vacuum immediate use steam and EtO. These SterilContainers are a similar shape and size as the immodiate devices. The material used is the same as that used to manufacture the predicate devices. The new three-quarter size eight inch (187mm) container is exactly the same as the dontainers that received clearance in K944864, K053389, and K073168 with the exception of its size. This container represents the worst case vent to volume ratio for the SterilContainer System.

| Device/<br>System | Aesculap<br>SterilContainer<br>w/ Aluminum<br>Lid and<br>*PrimeLine Lid | Aesculap<br>PrimeLine<br>Container | Aesculap<br>SterilContainer<br>(Flash) | Aesculap<br>PriMed<br>Rigid<br>Container<br>System | Aesculap<br>Container<br>System |
|------------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------|----------------------------------------|----------------------------------------------------|---------------------------------------------------|
| 510(k) | K112671 | K073168 | K053389 | K944864 | K792558 |
| Sterilization<br>Processes | Pre-vac steam,<br>Immediate<br>Use Pre-vac<br>steam &<br>EtO | Pre-vac steam,<br>Immediate Use<br>Pre-vac steam | Immediate Use<br>steam | Gravity<br>steam,<br>High-<br>vacuum<br>steam, EtO | Pre-vac<br>steam, EtO |
| Material | Anodized<br>Aluminum/Radel<br>R | Anodized<br>Aluminum/Radel<br>R | Anodized<br>Aluminum | Anodized<br>Aluminum/<br>JADEX | Anodized<br>Aluminum |
| Worst case<br>Vent to<br>Volume<br>Ratio | .41 | .49 | .68 | .59 | Not<br>available |
| Filter | Single use<br>paper filter,<br>*single use<br>polypropylene<br>filter, *reusable<br>filter | Reusable filter | Single use<br>paper filter | Single use<br>paper filter | Single use<br>paper filter,<br>reusable<br>filter |
| Shelf-life/<br>Barrier | 360 days (event<br>related) | 360 days (event<br>related) | N/A | Not<br>defined | Not defined |
| Reuse<br>testing | 100 cycles<br>minimum | 100 cycles<br>minimum<br>(bottom)/ 2,200<br>cycles (lid) | 100 cycles<br>minimum | 100 cycles<br>minimum | 100 cycles<br>minimum |
| Max total<br>weight | 25 pounds | 35 pounds | 35 pounds | 25 pounds | 35 pounds |

*The PrimeLine lid, polypropylene fiter, and the reusable filter are not for use in EtO sterliization

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## PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications 510(k)'s" for Aesculap SterilContainer was completed on this new three-quarter size 8" (187mm) for Acounty of the worst case vent to volume ratio of the SterilContainer System making this container the most challenging container to achieve sterilization. The Aesculap SterilContainer was fully validated for pre-vacuum steam, pre-vacuum immediate use steam, and EtO sterilization processes. These validations were conducted in accordance with FDA and Eto othillable AAMI standards by a qualified testing laboratory. This performance testing demonstrates substantial equivalence to the predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Denise Adams Regulatory Affairs Specialist Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

MAY - 4 2012

Re: K112671

. '

Trade/Device Name: Aesculap SterilContainer System Regulation Number: 21 CFR 880.6850 . Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: April 23, 2012 Received: April 25, 2012

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.

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## Page 2 - Ms. Adams

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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ph From

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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#### INDICATIONS FOR USE STATEMENT A.

## 510(k) Number:_ K112671

## Device Name: Aesculap SterilContainer System

### Indications for Use:

The Aesculap SterilContainer System is a reusable sterilization container system intended to be I he resource 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 for 360 days. The Interiable to allett stories accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks.

The container system consists of a three-quarter size, 8" tall perforated (JN744) or solid (JK744) r he ountainer cyclem ocheles overter size aluminum or PrimeLine lid. The lids are available in different colors to aide in set recognition. There are three types of filter materials. A single use unner filter (US751, US994), a single use polypropylene filter (MD344), and a reusable PTFE filter (JK090). The reusable PTFE is validated for 2200 uses. There are a variety of accessories for use with the container system. Please refer to the chart on the next page for sterilization compatibility of the container system.

and/or Over-the-Counter Use __ × Prescription Use_ (per 21 CFR 801 Subpart C) (per 21 CFR 801 Subpart D)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Elishatt F. Clavine- Will
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: