(233 days)
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 Aesculap SterilContainer is designed as a container system that will allow for sterilization and storage of other medical devices. This system consists of full, three-quarter, half, quarter, and extra long and wide body container system. There are a variety of accessories also available for this container system. This container is designed to be compatible for use in pre-vacuum steam, pre-vacuum immediate use steam and EtO sterilization. The container bottom is manufactured in anodized 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 have removable retention plates to hold the filter and a stainless steel latch on each end to lock the lid only to the container bottom. There are also Prime Line lids available for use that are manufactured in the material commonly known as Radel R. The PrimeLine lids have a reusable filter system. The reusable filter is for Pre-vac steam and Immediate Use steam sterilization only.
The provided text describes the Aesculap SterilContainer System for sterilization. Here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" with pass/fail thresholds in a formal table separate from the performance results. Instead, it presents the validated sterilization cycle parameters and states that the device was "fully validated" according to FDA and AAMI standards. The reported device performance is that it meets these validated parameters and achieves a 360-day event-related shelf life.
| Acceptance Criteria Category | Specific Criteria / Performance Target (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Must achieve sterilization under the stated parameters for: - Pre-vacuum steam (270°F, 4 min. exposure, 30 min. dry) - Pre-vacuum immediate use steam (270°F, 3 min. (non-porous) / 4 min. (porous) exposure) - Ethylene Oxide (130°F, 60 min exposure, ≥ 50% RH, 725 mg/L gas pressure) | Achieved: "fully validated for pre-vacuum steam, pre-vacuum immediate use steam, and EtO sterilization processes." |
| Shelf Life | Maintain sterility for 360 days. | Achieved: "360 days of event related shelf life testing has been conducted." |
| Compatibility | Compatible with specified lids, filters, and accessories for each sterilization method. | Achieved: Detailed tables provided for compatibility across various configurations and accessories. |
| Max Load Weight | Accommodate maximum load weights of 25 pounds or less (AAMI/AORN recommendation). | Achieved: "Max total weight 25 pounds." |
| Vent to Volume Ratio | Meet predetermined standards for the "worst case vent to volume ratio" to ensure sterilization. | Achieved: "This container represents the worst case vent to volume ratio for the SterilContainer System," and validation was successful. |
| Reuse Testing | Maintain performance after repeat sterilization cycles. | Achieved: "100 cycles minimum" for container, "2,200 cycles (lid)" for reusable filter. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample size used for the test set in terms of number of containers or cycles. However, it does state:
- "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) container of the worst case vent to volume ratio..."
- The testing was conducted by "a qualified testing laboratory."
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given that it's a 510(k) submission for a new device, the testing would inherently be prospective in nature, specifically designed to validate the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for sterilization efficacy is established through standardized biological and physical indicator tests, not expert consensus on medical images or patient outcomes. The testing was performed in a laboratory setting per established standards (FDA and AAMI).
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 refer to a process where multiple human reviewers independently assess data (e.g., medical images) and disagreements are resolved by an expert panel. Sterilization and shelf-life testing relies on objective, measurable scientific and engineering principles (e.g., microbial kill, barrier integrity), not subjective human interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device for sterilization, not an AI-powered diagnostic or assistive tool for human readers/clinicians, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of a device on its own, without human intervention in its function during testing. In this context, the device (the SterilContainer) was tested in a standalone manner as its primary function is to achieve and maintain sterility independently when subjected to specified sterilization cycles. The performance data presented (sterilization cycle parameters met, 360-day shelf-life) reflects the container's inherent capabilities.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for sterilization efficacy is typically established through:
- Biological Indicators (BIs): Contain a known number of highly resistant microorganisms (e.g., bacterial spores). A successful sterilization cycle renders the BI sterile, demonstrating microbial kill.
- Chemical Indicators (CIs): React to one or more sterilization parameters with a visible change in color or state.
- Physical Monitoring: Readings from sterilizer gauges, thermometers, pressure recorders, and timers confirm that the physical parameters (temperature, pressure, time) of the cycle were met.
- Barrier Integrity Testing: For shelf-life, tests ensure the container maintains a sterile barrier over time, often involving microbial ingress challenges or visual inspection for damage.
The document implicitly refers to these methods by stating: "These validations were conducted in accordance with FDA and AAMI standards by a qualified testing laboratory." These standards prescribe the use of BIs, CIs, and physical monitoring for sterilization efficacy, and specific tests for packaging integrity and shelf-life.
8. The Sample Size for the Training Set
Not applicable. Training sets are relevant for machine learning or AI models. This device is a physical container, and its performance is evaluated through conventional engineering and microbiological testing, not by training an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reason as point 8.
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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.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714 |
|---|---|
| CONTACT: | Denise R. Adams610-984-9076 (phone)denise.adams@aesculap.com610-791-6882 (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. | |||||
|---|---|---|---|---|---|
| SterilizationCycleParameters | PrimeLine Lidw/ JP050 filter | Aluminum Lid | Filter | Bottom | Max No. of Lumens/Lumen Configuration |
| Immediate Use(Non porous)270°F Temp,3 min. ExposureStacking notrecommended | JP011, JP012,JP013, JP014,JP015, JP016,JP017 | JK785, JK786,JK787,JK788,JK789 | US751US994MD344JK090 | JK744 | |
| Immediate Use(Porous)270°F Temp,4 min. ExposureStacking notrecommended | JP011, JP012,JP013, JP014,JP015, JP016,JP017 | JK785, JK786,JK787,JK788,JK789 | US751US994MD344JK090 | JK744 | 1 lumen with ≥ 3mm I.D.x ≤ 400mm L and asecond lumen ≥ 3.8mmI.D. x ≤ 370mm L |
| Pre-vacuum270°F Temp,4min.Exposure,30 min. Dry timeStacking shouldnot exceed 18" inheight | JP011, JP012,JP013, JP014,JP015, JP016,JP017 | JK785, JK786,JK787,JK788,JK789 | US751US994MD344JK090 | JK744JN744 | 1 lumen with ≥ 3mm I.D.x ≤ 400mm L and asecond lumen ≥ 3.8mmI.D. x ≤ 370mm L |
| Ethylene Oxide130° F temp,60 min exposure≥ 50% RelativeHumidity725 mg/L gaspressureStacking notrecommended | JK785, JK786,JK787,JK788,JK789 | US751US994 | JK744JN744 | 1 lumen with ≥ 3mm I.D.x ≤ 400mm L and asecond lumen ≥ 3.8mmI.D. x ≤ 370mm L |
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| Accessories | Pre-vacSteam | Immediate Use Steam | EtO |
|---|---|---|---|
| Stainless Steel baskets, basket lids anddividers | X | X | X |
| Instrument Organization System (Siliconeand Stainless Steel racks, brackets, holders,and clamps) | X | X | X |
| Silicone mats | X | X | X |
| Stainless Steel racks, trays, holders, clamps,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/System | AesculapSterilContainerw/ AluminumLid and*PrimeLine Lid | AesculapPrimeLineContainer | AesculapSterilContainer(Flash) | AesculapPriMedRigidContainerSystem | AesculapContainerSystem |
|---|---|---|---|---|---|
| 510(k) | K112671 | K073168 | K053389 | K944864 | K792558 |
| SterilizationProcesses | Pre-vac steam,ImmediateUse Pre-vacsteam &EtO | Pre-vac steam,Immediate UsePre-vac steam | Immediate Usesteam | Gravitysteam,High-vacuumsteam, EtO | Pre-vacsteam, EtO |
| Material | AnodizedAluminum/RadelR | AnodizedAluminum/RadelR | AnodizedAluminum | AnodizedAluminum/JADEX | AnodizedAluminum |
| Worst caseVent toVolumeRatio | .41 | .49 | .68 | .59 | Notavailable |
| Filter | Single usepaper filter,*single usepolypropylenefilter, *reusablefilter | Reusable filter | Single usepaper filter | Single usepaper filter | Single usepaper filter,reusablefilter |
| Shelf-life/Barrier | 360 days (eventrelated) | 360 days (eventrelated) | N/A | Notdefined | Not defined |
| Reusetesting | 100 cyclesminimum | 100 cyclesminimum(bottom)/ 2,200cycles (lid) | 100 cyclesminimum | 100 cyclesminimum | 100 cyclesminimum |
| Max totalweight | 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 (800) 638-2041 or (301) 796-7100 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:
§ 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).