(239 days)
The Aesculap JJ Series Container System is a reusable rigid 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 during transport and until used. This container system is compatible for use in steam sterilization according to the configurations listed in the tables below.
The JJ Series Container System container styles: a solid bottom container and enhanced drying system (EDS) container.
The Aesculap JJ Series Container System includes accessories such as baskets, trays, silicone mats, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags.
The attached tables identifies the load configurations.
The Aesculap JJ Series Container System is a reusable rigid 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 in Prevac steam with and without dry time.
The JJ Series Container System consists of two different container styles: a solid bottom container and enhanced drying system (EDS) container.
The containers are made from anodized aluminum and utilize a single-use filter. The JJ Series Container System includes accessories such as baskets, trays, silicone mats, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags.
The provided text is a 510(k) Summary for the Aesculap JJ Series Container System. This document focuses on demonstrating substantial equivalence to a predicate device based on nonclinical performance data, rather than on a comparative effectiveness study with human readers (MRMC) or a standalone AI algorithm. Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this document as they are specific to studies involving AI or human interpretation of data, which is not the nature of this device (a sterilization container system).
However, I can provide the acceptance criteria and reported device performance from the nonclinical testing, as well as general information about the device and its testing.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and the Reported Device Performance
| Performance Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | A sterility assurance level (SAL) of 10-6 will be achieved post sterilization using the BI overkill method and half cycle validation indicated in section 5.6 of AAMI ST-77. Biological indicators must be negative for growth after incubation period. | Pass |
| Dry Time | Per AAMI ST-77 section 4.4.2, (in association with EN868-8 section G.3/G.4 and EN 285 section G20.3), the system shall demonstrate an average pre and post sterilization weight difference of less than 0.2% within five 5 minutes of cycle completion using final validated parameters and be free of visible moisture following a cooling period. | Pass |
| Microbial Aerosol Challenge | The container load maintains sterility after exposure to a defined amount of aerosol microorganisms per ST-77 sections 5.9.1.1 & 5.9.1.2. No presence of growth after incubation period. | Pass |
| Sterility Maintenance | Sterility of container contents is maintained under conditions which simulate hospital sterile package handling and storage conditions and were tested per ISO 11167-1 section 6.4. Test articles stored for their post processing shelf life. Biological indicators must be negative for growth after incubation period. | Pass |
| Material Compatibility | No degradation or impact to functionality at the completion of multiple sterilization cycles according to section 5.0 of TIR17. | Pass |
| Cytotoxicity | Testing completed in accordance with ISO 10993-5:2009. Using the ISO Elution Method, the response to the article must not be greater than 2 (mild reactivity). | Pass |
| Cleaning Validation | In accordance with Annex A and section 7.5 of TIR30, test samples shall show no visible soil after cleaning and shall have protein or hemoglobin levels less than the predetermined amounts. | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes the acceptance criteria for various performance tests, but does not specify the sample sizes used for these tests or the data provenance. It states "Testing was conducted in accordance with applicable FDA guidance and standards," which implies a prospective testing approach conducted by the manufacturer to meet regulatory requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The device is a sterilization container. The "ground truth" for the performance tests listed (e.g., sterility, dry time, material compatibility) is established through standardized laboratory testing protocols and objective measurements, not by expert consensus or interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in studies where human judgment is involved in establishing ground truth (e.g., reading medical images) and disagreements need to be resolved. This is not relevant for the type of objective performance testing described for a sterilization container.
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
This information is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools with human readers. The Aesculap JJ Series Container System is a physical medical device (sterilization container), not an AI diagnostic tool, so such a study was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This question pertains to the performance of an AI algorithm in isolation. The Aesculap JJ Series Container System is a physical product and does not involve an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed on the Aesculap JJ Series Container System is established through objective, standardized laboratory measurements and scientific principles as defined by recognized standards (e.g., AAMI ST-77, EN868-8, EN 285, ISO 11167-1, TIR17, ISO 10993-5:2009, TIR30). For example:
- Sterilization Efficacy: Achieved Sterility Assurance Level (SAL) of 10-6, confirmed by negative biological indicators.
- Dry Time: Measured weight difference and absence of visible moisture.
- Microbial Aerosol Challenge: Absence of microbial growth after exposure.
- Sterility Maintenance: Absence of microbial growth in stored test articles.
- Material Compatibility: Absence of degradation or impact on functionality.
- Cytotoxicity: Response to article not greater than 2 (mild reactivity) via ISO Elution Method.
- Cleaning Validation: Absence of visible soil and protein/hemoglobin levels below predetermined amounts.
8. The sample size for the training set
This information is not applicable/provided. A "training set" refers to data used to train machine learning models. This device is a physical product, not an AI algorithm, so there is no training set in this context.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
March 27, 2020
Aesculap, Inc. Sierra Mertz Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K192056
Trade/Device Name: Aesculap JJ Series Container System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: February 25, 2020 Received: February 27, 2020
Dear Sierra Mertz:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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 of medical device-related adverse events) (21 CFR 803) for
{1}------------------------------------------------
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K192056
Device Name
Aesculap JJ Series Container System
Indications for Use (Describe)
The Aesculap JJ Series Container System is a reusable rigid sterilization container system intended to be used to enclose another medical device that is to be sterlized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device during transport and until used. This container system is compatible for use in steam sterilization according to the configurations listed in the tables below.
The JJ Series Container System container styles: a solid bottom container and enhanced drying system (EDS) container.
The Aesculap JJ Series Container System includes accessories such as baskets, trays, silicone mats, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags.
The attached tables identifies the load configurations.
Table 1. JJ Series Container System Lumen Configurations
| SterilizationCycle | Size | Lumens |
|---|---|---|
| PreVac Steamwith dry time(270°F4 min Exposure) | Full Size | 4 stainless steel lumens with ≥ 1mm ID x≤500mm L |
| Three-Quarter | 4 stainless steel lumens with ≥ 1mm ID x≤400mm L | |
| Half Size | 4 stainless steel lumens with ≥ 1mm ID x≤200mm L | |
| Prevac Steamwithout dry time(270°F3 min Exposure)Non-Porous | Full Size | Non lumened instruments |
| Three-QuarterSize | Non lumened instruments | |
| Half Size | Non lumened instruments | |
| Prevac Steamwithout dry time(270°F4 min Exposure)Porous | Full Size | 4 stainless steel lumens with ≥ 1mm ID x≤500mm L |
| Three-QuarterSize | 4 stainless steel lumens with ≥ 1mm ID x≤400mm L | |
| Half Size | 4 stainless steel lumens with ≥ 1mm ID x≤125mm L |
Validation testing was performed using the JJ612 single use paper filter.
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Table 2. JJ Series Container System Configurations, Without Silicone Mat and Lid cover*
| ContainerType | SterilizationMethod | ContainerBottom Part # | ContainerLid Part # | Maximum Load Weight (lbs)* |
|---|---|---|---|---|
| Solid BottomContainer | Prevac Steam270°F4 min exposure15 minute*dry time | JJ140 | JJ410 | 25 |
| JJ130 | 24 | |||
| JJ120 | 23 | |||
| JJ110 | 22 | |||
| JJ340 | JJ430 | 23 | ||
| JJ330 | 22 | |||
| JJ320 | 20 | |||
| JJ310 | 18 | |||
| JJ240 | JJ420 | 18 | ||
| JJ230 | 18 | |||
| JJ220 | 15 | |||
| JJ210 | 13 | |||
| EDS Container | Prevac Steam270°F4 min exposure8 minute*dry time | JJ141 | JJ410 | 25 |
| JJ131 | 24 | |||
| JJ121 | 23 | |||
| JJ111 | 22 | |||
| JJ341 | JJ430 | 23 | ||
| JJ331 | 22 | |||
| JJ321 | 20 | |||
| JJ311 | 18 | |||
| JJ241 | JJ420 | 18 | ||
| JJ231 | 18 | |||
| JJ221 | 15 | |||
| JJ211 | 13 | |||
| Solid BottomContainer | Prevac SteamWithout dry time270°F3 min Exposure(Non-porous)ANDPrevac SteamWithout dry time270°F4 min Exposure(Porous) | JJ140 | JJ410 | 25 |
| JJ130 | ||||
| JJ120 | ||||
| JJ110 | ||||
| JJ340 | JJ430 | 25 | ||
| JJ330 | ||||
| JJ320 | ||||
| JJ310 | ||||
| JJ240 | JJ420 | 25 | ||
| JJ230JJ220JJ210 | ||||
| EDS Container | Prevac SteamWithout dry time270°F3 min Exposure(Non-porous)ANDPrevac SteamWithout dry time270°F4 min Exposure(Porous) | JJ141 | JJ410 | 25 |
| JJ131 | ||||
| JJ121 | ||||
| JJ111 | ||||
| JJ341 | JJ430 | 25 | ||
| JJ331 | ||||
| JJ321 | ||||
| JJ311 | ||||
| JJ241 | JJ420 | 25 | ||
| JJ231JJ221 | ||||
| ContainerType | SterilizationMethod | ContainerBottom Part # | ContainerLid Part # | Maximum LoadWeight (lbs)* |
| Solid BottomContainer | Prevac Steam270°F4 min exposure30 minute*dry time | JJ140 | JJ410 | 25 |
| JJ130 | 24 | |||
| JJ120 | 23 | |||
| JJ110 | 22 | |||
| JJ340 | JJ430 | 23 | ||
| JJ330 | 22 | |||
| JJ320 | 20 | |||
| JJ310 | 18 | |||
| JJ240 | JJ420 | 18 | ||
| JJ230 | 18 | |||
| JJ220 | 15 | |||
| JJ210 | 13 | |||
| EDS Container | Prevac Steam270°F4 min exposure30 minute*dry time | JJ141 | JJ410 | 25 |
| JJ131 | 24 | |||
| JJ121 | 23 | |||
| JJ111 | 22 | |||
| JJ341 | JJ430 | 23 | ||
| JJ331 | 22 | |||
| JJ321 | 20 | |||
| JJ311 | 18 | |||
| JJ241 | JJ420 | 18 | ||
| JJ231 | 18 | |||
| JJ221 | 15 | |||
| JJ211 | 13 | |||
| Solid BottomContainer | Prevac SteamWithout dry time270°F3 min Exposure(Non-porous)AND | JJ140 | JJ410 | 25 |
| JJ130 | ||||
| JJ120 | ||||
| JJ110 | ||||
| JJ340 | JJ430 | 25 | ||
| JJ330 | ||||
| Prevac SteamWithout dry time270°F4 min Exposure(Porous) | JJ320 | |||
| JJ310 | ||||
| JJ240 | JJ420 | 25 | ||
| JJ230 | ||||
| JJ220 | ||||
| JJ210 | ||||
| EDS Container | Prevac SteamWithout dry time270°F3 min Exposure(Non-porous)AND | JJ141 | JJ410 | 25 |
| JJ131 | ||||
| JJ121 | ||||
| JJ111 | ||||
| JJ341 | JJ430 | 25 | ||
| JJ331 | ||||
| Prevac SteamWithout dry time270°F4 min Exposure(Porous) | JJ321 | |||
| JJ311 | ||||
| JJ241 | JJ420 | 25 | ||
| JJ231 | ||||
| JJ221 | ||||
| JJ211 |
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Table 3. JJ Series Container System Configurations, with Silicone Mat and Lid Cover*
*Dry times and load weights are based on container with silicone mats and/or lid cover.
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| Table 4: Sterilization Cycle Compatible Accessories - Prevac Steam | ||||||
|---|---|---|---|---|---|---|
| -- | -------------------------------------------------------------------- | -- | -- | -- | -- | -- |
| Accessories | Prevac Steamwith dry time | Prevac SteamWithout dry time |
|---|---|---|
| Baskets, trays, indicator cards, tamper evidentlocks, faceplate holders, and tags. | Yes | Yes |
| Instrument Organization System (Silicone andStainless Steel racks, brackets, holders, andclamps) | Yes | Yes |
| Silicone mats | Yes¹ | Yes |
| Lid Covers | Yes¹ | Yes |
1 Using silicone mats and/or lid covers may require a longer drying time.
When used with PreVac Steam with dry time (270°F, 4 minute exposure), the maintenance of sterility of the Aesculap JJ Series Container System is 365 days.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ||
|---|---|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |||||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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ട. 510(k) SUMMARY (as required by 21 CFR 807.92)
Aesculap JJ Series Container System for Steam
March 27, 2020
| COMPANY: | Aesculap, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714 |
|---|---|
| CONTACT: | Sierra M. Mertz610-984-9076 (phone)Sierra.mertz@aesculapimplants.com610-791-6882 (fax) |
| TRADE NAME: | Aesculap® JJ Series Container System |
| COMMON NAME: | Sterilization Container Wrap |
| CLASSIFICATION NAME: | Wrap, Sterilization |
| REGULATION NUMBER: | 880.6850 |
| PRODUCT CODE: | KCT |
| DEVICE CLASS: | Class II per 21 CFR 880.6850 |
DEVICE DESCRIPTION
The Aesculap JJ Series Container System is a reusable rigid 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 in Prevac steam with and without dry time.
The JJ Series Container System consists of two different container styles: a solid bottom container and enhanced drying system (EDS) container.
The containers are made from anodized aluminum and utilize a single-use filter. The JJ Series Container System includes accessories such as baskets, trays, silicone mats, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags.
INDICATIONS FOR USE
The Aesculap JJ Series Container System is a reusable rigid sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare
{7}------------------------------------------------
provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device during transport and until used. This container system is compatible for use in steam sterilization according to the configurations listed in the tables below.
The JJ Series Container System consists of two different container styles: a solid bottom container and enhanced drying system (EDS) container.
The Aesculap JJ Series Container System includes accessories such as baskets, trays, silicone mats, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags.
The attached tables identifies the load configurations.
| SterilizationCycle | Size | Lumens |
|---|---|---|
| PreVac Steamwith dry time(270°F4 min Exposure) | Full Size | 4 stainless steel lumens with > 1mm ID x ≤500mm L |
| Three-QuarterSize | 4 stainless steel lumens with > 1mm ID x ≤400mm L | |
| Half Size | 4 stainless steel lumens with > 1mm ID x ≤200mm L | |
| Prevac Steamwithout dry time(270°F3 min Exposure)Non-Porous | Full Size | Non lumened instruments |
| Three-QuarterSize | Non lumened instruments | |
| Half Size | Non lumened instruments | |
| Prevac Steamwithout dry time(270°F4 min Exposure)Porous | Full Size | 4 stainless steel lumens with > 1mm ID x <500mm L |
| Three-QuarterSize | 4 stainless steel lumens with > 1mm ID x ≤400mm L | |
| Half Size | 4 stainless steel lumens with > 1mm ID x <125mm L |
Validation testing was performed using the JJ612 single use paper filter.
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| ContainerType | SterilizationMethod | ContainerBottom Part # | ContainerLid Part # | Maximum LoadWeight (lbs) |
|---|---|---|---|---|
| Solid BottomContainer | Prevac Steam270°F4 min exposure15 minute*dry time | JJ140 | JJ410 | 25 |
| JJ130 | 24 | |||
| JJ120 | 23 | |||
| JJ110 | 22 | |||
| JJ340 | JJ430 | 23 | ||
| JJ330 | 22 | |||
| JJ320 | 20 | |||
| JJ310 | 18 | |||
| JJ240 | JJ420 | 18 | ||
| JJ230 | 18 | |||
| JJ220JJ210 | 1513 | |||
| EDS Container | Prevac Steam270°F4 min exposure8 minute*dry time | JJ141JJ131JJ121JJ111 | JJ410 | 25242322 |
| JJ341 | JJ430 | 23 | ||
| JJ331JJ321JJ311 | 222018 | |||
| JJ241JJ231 | JJ420 | 1818 | ||
| JJ221JJ211 | 1513 | |||
| Solid BottomContainer | Prevac SteamWithout dry time270°F3 min Exposure(Non-porous) | JJ140JJ130JJ120JJ110 | JJ410 | 25 |
| AND | JJ340JJ330 | JJ430 | 25 | |
| Prevac SteamWithout dry time | JJ320JJ310 | |||
| 270°F4 min Exposure(Porous) | JJ240JJ230JJ220JJ210 | JJ420 | 25 | |
| EDS Container | Prevac SteamWithout dry time270°F3 min Exposure(Non-porous) | JJ141JJ131JJ121JJ111 | JJ430 | 25 |
| AND | JJ341JJ331 | JJ310 | 25 | |
| Prevac SteamWithout dry time | JJ321 | |||
| 270°F | JJ241 | JJ420 | 25 | |
| 4 min Exposure(Porous) | JJ231 | |||
| JJ221 | ||||
| JJ211 |
Table 2. JJ Series Container System Configurations, Without Silicone Mat and Lid cover*
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| Table 3. JJ Series Container System Configurations, with Silicone Mat and Lid Cover* | ||
|---|---|---|
| -------------------------------------------------------------------------------------- | -- | -- |
| ContainerType | SterilizationMethod | ContainerBottom Part # | ContainerLid Part # | Maximum LoadWeight (lbs)* |
|---|---|---|---|---|
| Solid BottomContainer | Prevac Steam270°F4 min exposure30 minute*dry time | JJ140 | JJ410 | 25 |
| JJ130 | 24 | |||
| JJ120 | 23 | |||
| JJ110 | 22 | |||
| JJ340 | JJ430 | 23 | ||
| JJ330 | 22 | |||
| JJ320 | 20 | |||
| JJ310 | 18 | |||
| JJ240 | JJ420 | 18 | ||
| JJ230 | 18 | |||
| JJ220 | 15 | |||
| JJ210 | 13 | |||
| EDS Container | Prevac Steam270°F4 min exposure30 minute*dry time | JJ141 | JJ410 | 25 |
| JJ131 | 24 | |||
| JJ121 | 23 | |||
| JJ111 | 22 | |||
| JJ341 | JJ430 | 23 | ||
| JJ331 | 22 | |||
| JJ321 | 20 | |||
| JJ311 | 18 | |||
| JJ241 | JJ420 | 18 | ||
| JJ231 | 18 | |||
| JJ221 | 15 | |||
| JJ211 | 13 | |||
| Solid BottomContainer | Prevac SteamWithout dry time270°F3 min Exposure(Non-porous) | JJ140 | JJ410 | 25 |
| JJ130 | ||||
| JJ120 | ||||
| JJ110 | ||||
| ANDPrevac SteamWithout dry time270°F4 min Exposure(Porous) | JJ340 | JJ430 | 25 | |
| JJ330 | ||||
| JJ320 | ||||
| JJ310 | ||||
| JJ240 | JJ420 | 25 | ||
| 270°F4 min Exposure(Porous) | JJ230 | |||
| JJ220 | ||||
| JJ210 | ||||
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| EDS Container | Prevac SteamWithout dry time270°F3 min Exposure(Non-porous)ANDPrevac SteamWithout dry time270°F4 min Exposure(Porous) | |||
|---|---|---|---|---|
| JJ141JJ131JJ121JJ111 | JJ410 | 25 | ||
| JJ341JJ331JJ321JJ311 | JJ430 | 25 | ||
| JJ241JJ231JJ221JJ211 | JJ420 | 25 |
*Dry times and load weights are based on container with silicone mats and/or lid cover.
| Table 4: Sterilization Cycle Compatible Accessories - Prevac Steam |
|---|
| -------------------------------------------------------------------- |
| Accessories | Prevac Steam withdry time | Prevac SteamWithout dry time |
|---|---|---|
| Baskets, trays, indicator cards, tamper evidentlocks, faceplate holders, and tags. | Yes | Yes |
| Instrument Organization System (Silicone andStainless Steel racks, brackets, holders, andclamps) | Yes | Yes |
| Silicone mats | Yes1 | Yes |
| Lid Covers | Yes1 | Yes |
1 Using silicone mats and/or lid covers may require a longer drying time.
When used with PreVac Steam with dry time (270°F, 4 minute exposure), the maintenance of sterility of the Aesculap JJ Series Container System is 365 days.
{11}------------------------------------------------
TECHNOLIGICALLCHARACTERISTICS (compared to predicate device)
The Aesculap JJ Series Container System has the same intended use as the Aesculap predicate device. The subject device is offered in similar sizes and is comprised of similar materials of construction as the predicate device.
| Subject Device -Aesculap JJ Series Container System(K192056)Product Code: KCT | Predicate Device-Aesculap SterilContainer(K112671)Product Code: KCT | ||
|---|---|---|---|
| Intended Use | A device intended to be used to enclose anothermedical device that is to be sterilized by a health careprovider. It is intended to allow sterilization of theenclosed medical device and also to maintain sterilityof the enclosed device until used. | A device intended to be used to enclose anothermedical device that is to be sterilized by a health careprovider. It is intended to allow sterilization of theenclosed medical device and also to maintain sterilityof the enclosed device until used. | Same |
| SterilizationModalities | PreVac Steam with dry timePreVac Steam without dry time | PreVac SteamIUSSEthylene Oxide | Similar |
| Material | Container: Anodized aluminumLid: Anodized aluminumGasket: Silicone | Container: Anodized aluminumLid: Anodized aluminumGasket: Silicone | Same |
| Filter Type | Single use (Paper) | Single use (Paper) and reusable (PTFE) | Similar |
| ContainerDesign | Solid bottom orSolid bottom with enhanced drying systemPerforated Lid | Solid or perforated bottomPerforated Lid | Similar |
| Sizes | Full sizeThree-Quarter SizeHalf Size | Three-Quarter Size | Similar |
| Accessories | Baskets, trays, silicone mats, instrumentorganizational accessories, holders, indicator cards,tamper evident locks, lid covers, faceplate holders,and tags. | Silicone mats, instrument organization system, lidcovers, baskets, trays, and racks, indicator cards, locks | Similar |
| Maintenanceof Sterility | Prevac Steam with dry time - 365 days | Prevac Steam & Ethylene Oxide- 360 daysIUSS - N/A | Similar |
{12}------------------------------------------------
SUMMARY OF NONCLINICAL PERFORMANCE DATA
The Aesculap JJ Series Container System is a reusable rigid container system that will allow for sterilization and storage of other medical devices. This container system is compatible for use in the following sterilization modalities:
- Prevac steam with dry time (Exposure: 270°F for 4 minutes) ●
- Prevac steam without dry time (Exposure: 270°F for 4 minutes Porous) ●
- Prevac steam without dry time (Exposure: 270°F for 3 minutes - Non-Porous)
Testing was conducted in accordance with applicable FDA guidance and standards. The table below outlines the testing which was performed on the subject device.
| PerformanceTesting | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| SterilizationEfficacy | To determinesterilizationeffectiveness of testdevice after processingin a sterilization cycle. | A sterility assurance level (SAL) of10-6 will be achieved post sterilization using the BI overkillmethod and half cycle validation indicated in section 5.6 ofAAMI ST-77. Biological indicators must be negative forgrowth after incubation period. | Pass |
| Dry Time | To determine the properdrying time required forthe JJ Series ContainerSystem. | Per AAMI ST-77 section 4.4.2, (in association with EN868-8section G.3/G.4 and EN 285 section G20.3), the systemshall demonstrate an average pre and post sterilizationweight difference of less than 0.2% within five 5 minutes ofcycle completion using final validated parameters and befree of visible moisture following a cooling period. | Pass |
| MicrobialAerosolChallenge | To analyze the packageintegrity and microbialbarrier properties of thetest device. | The container load maintains sterility after exposure to adefined amount of aerosol microorganisms per ST-77sections 5.9.1.1 & 5.9.1.2. No presence of growth afterincubation period. | Pass |
| SterilityMaintenance | To demonstrate that aprocessed test devicecan maintain a sterilebarrier for a definedperiod of time. | Sterility of container contents is maintained under conditionswhich simulate hospital sterile package handling and storageconditions and were tested per ISO 11167-1 section 6.4.Test articles stored for their post processing shelf life.Biological indicators must be negative for growth afterincubation period. | Pass |
| MaterialCompatibility | To assess effects of fulluse cycles on devicecomponents and theirintended functionality. | No degradation or impact to functionality at the completionmultiple sterilization cycles according to section 5.0 ofTIR17. | Pass |
| Cytotoxicity | To determine thepotential of a test deviceto cause cytotoxicity. | Testing completed in accordance with ISO 10993-5:2009.Using the ISO Elution Method, the response to the articlemust not be greater than 2 (mild reactivity). | Pass |
| CleaningValidation | To verify theeffectiveness of thedevice cleaningprocedure. | In accordance with Annex A and section 7.5 of TIR30, testsamples shall show no visible soil after cleaning and shallhave protein or hemoglobin levels less than thepredetermined amounts. | Pass |
Results of the testing demonstrate that the proposed device met the acceptance criteria for each performance test.
CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that Aesculap JJ Series Container System the device is as safe, as effective, and performs as well as or better than the legally marketed device.
§ 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).