Who is the manufacturer of JJ Series Container System?

Aesculap, Inc. filed the 510(k) submission for JJ Series Container System (K192056).

What is the FDA product code for JJ Series Container System?

KCT. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for JJ Series Container System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for JJ Series Container System?

Aesculap SterilContainer (K112671).

Who can help prepare an FDA 510(k) submission like JJ Series Container System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

JJ Series Container System

K192056 · Aesculap, Inc. · KCT · Mar 27, 2020 · General Hospital

Device Facts

Record ID	K192056
Device Name	JJ Series Container System
Applicant	Aesculap, Inc.
Product Code	KCT · General Hospital
Decision Date	Mar 27, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

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 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.

Device Story

The Aesculap JJ Series Container System is a reusable rigid sterilization container designed for healthcare facilities. It consists of anodized aluminum containers (solid bottom or enhanced drying system styles) and a lid, used to house medical instruments during steam sterilization. The system utilizes single-use paper filters to maintain a sterile barrier. It is operated by healthcare personnel in a sterile processing environment. The device is loaded with instruments, placed in a steam sterilizer, and then stored until needed. The container protects the enclosed instruments from contamination during transport and storage, ensuring they remain sterile for up to 365 days when processed with specific dry-time cycles. This system facilitates the safe handling and storage of surgical instruments, reducing the risk of contamination before use in clinical procedures.

Clinical Evidence

No clinical data. Bench testing only. Performance validated per AAMI ST-77, ISO 11167-1, and ISO 10993-5. Testing included sterilization efficacy (SAL 10^-6), dry time (weight difference <0.2%), microbial aerosol challenge, sterility maintenance (365 days), material compatibility, cytotoxicity, and cleaning validation.

Technological Characteristics

Materials: Anodized aluminum container/lid, silicone gasket. Design: Rigid container with single-use paper filter. Sterilization: Prevac steam. Accessories: Baskets, trays, silicone mats, instrument organization systems. Connectivity: None. Software: None.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for steam sterilization and to maintain sterility during transport and storage. Compatible with Prevac steam cycles (with/without dry time) for porous and non-porous loads. Includes various container sizes and accessories (baskets, trays, silicone mats, etc.).

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 (K112671)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ 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 | Sterilization Cycle | Size | Lumens | |-----------------------------------------------------------------------------|---------------------------|------------------------------------------------------| | PreVac Steam with dry time (270°F 4 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 Steam without dry time (270°F 3 min Exposure) Non-Porous | Full Size | Non lumened instruments | | | Three- Quarter Size | Non lumened instruments | | | Half Size | Non lumened instruments | | Prevac Steam without dry time (270°F 4 min Exposure) Porous | Full Size | 4 stainless steel lumens with ≥ 1mm ID x ≤500mm L | | | Three- Quarter Size | 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. {3}------------------------------------------------ Table 2. JJ Series Container System Configurations, Without Silicone Mat and Lid cover* | Container Type | Sterilization Method | Container Bottom Part # | Container Lid Part # | Maximum Load Weight (lbs)* | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-------------------------|-------------------------------| | Solid Bottom Container | Prevac Steam 270°F 4 min exposure 15 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 Steam 270°F 4 min exposure 8 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 Bottom Container | Prevac Steam Without dry time 270°F 3 min Exposure (Non-porous) AND Prevac Steam Without dry time 270°F 4 min Exposure (Porous) | JJ140 | JJ410 | 25 | | | | JJ130 | | | | | | JJ120 | | | | | | JJ110 | | | | | | JJ340 | JJ430 | 25 | | | | JJ330 | | | | | | JJ320 | | | | | | JJ310 | | | | | | JJ240 | JJ420 | 25 | | | | JJ230 JJ220 JJ210 | | | | EDS Container | Prevac Steam Without dry time 270°F 3 min Exposure (Non-porous) AND Prevac Steam Without dry time 270°F 4 min Exposure (Porous) | JJ141 | JJ410 | 25 | | | | JJ131 | | | | | | JJ121 | | | | | | JJ111 | | | | | | JJ341 | JJ430 | 25 | | | | JJ331 | | | | | | JJ321 | | | | | | JJ311 | | | | | | JJ241 | JJ420 | 25 | | | | JJ231 JJ221 | | | | Container Type | Sterilization Method | Container Bottom Part # | Container Lid Part # | Maximum Load Weight (lbs)* | | Solid Bottom Container | Prevac Steam 270°F 4 min exposure 30 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 Steam 270°F 4 min exposure 30 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 Bottom Container | Prevac Steam Without dry time 270°F 3 min Exposure (Non-porous) AND | JJ140 | JJ410 | 25 | | | | JJ130 | | | | | | JJ120 | | | | | | JJ110 | | | | | | JJ340 | JJ430 | 25 | | | | JJ330 | | | | | Prevac Steam Without dry time 270°F 4 min Exposure (Porous) | JJ320 | | | | | | JJ310 | | | | | | JJ240 | JJ420 | 25 | | | | JJ230 | | | | | | JJ220 | | | | | | JJ210 | | | | EDS Container | Prevac Steam Without dry time 270°F 3 min Exposure (Non-porous) AND | JJ141 | JJ410 | 25 | | | | JJ131 | | | | | | JJ121 | | | | | | JJ111 | | | | | | JJ341 | JJ430 | 25 | | | | JJ331 | | | | | Prevac Steam Without dry time 270°F 4 min Exposure (Porous) | JJ321 | | | | | | JJ311 | | | | | | JJ241 | JJ420 | 25 | | | | JJ231 | | | | | | JJ221 | | | | | | JJ211 | | | {4}------------------------------------------------ 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. {5}------------------------------------------------ | | Table 4: Sterilization Cycle Compatible Accessories - Prevac Steam | | | | | | |--|--------------------------------------------------------------------|--|--|--|--|--| |--|--------------------------------------------------------------------|--|--|--|--|--| | Accessories | Prevac Steam with dry time | Prevac Steam Without dry time | |----------------------------------------------------------------------------------------------------------|-------------------------------|----------------------------------| | Baskets, trays, indicator cards, tamper evident locks, faceplate holders, and tags. | Yes | Yes | | Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps) | 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) | <table style="display:inline-table;"><tr><td><input type="checkbox"/></td><td>Prescription Use (Part 21 CFR 801 Subpart D)</td></tr></table> <table style="display:inline-table;"><tr><td><input checked="" type="checkbox"/></td><td>Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <input type="checkbox"/> | Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> | Over-The-Counter Use (21 CFR 801 Subpart C) | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|----------------------------------------------|-------------------------------------|---------------------------------------------| | <input type="checkbox"/> | Prescription Use (Part 21 CFR 801 Subpart D) | | | | | | <input checked="" type="checkbox"/> | Over-The-Counter Use (21 CFR 801 Subpart C) | | | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff *PRAStaff@fda.hhs.gov* "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443- | |----------------------|-------------|------------------------------------| | 6740 | EF | | {6}------------------------------------------------ #### 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 Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714 | |----------------------|-------------------------------------------------------------------------------------------------------------------| | CONTACT: | Sierra M. Mertz 610-984-9076 (phone) Sierra.mertz@aesculapimplants.com 610-791-6882 (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. | Sterilization Cycle | Size | Lumens | |-----------------------------------------------------------------------------|-----------------------|---------------------------------------------------| | PreVac Steam with dry time (270°F 4 min Exposure) | Full Size | 4 stainless steel lumens with > 1mm ID x ≤500mm L | | | Three-Quarter Size | 4 stainless steel lumens with > 1mm ID x ≤400mm L | | | Half Size | 4 stainless steel lumens with > 1mm ID x ≤200mm L | | Prevac Steam without dry time (270°F 3 min Exposure) Non-Porous | Full Size | Non lumened instruments | | | Three-Quarter Size | Non lumened instruments | | | Half Size | Non lumened instruments | | Prevac Steam without dry time (270°F 4 min Exposure) Porous | Full Size | 4 stainless steel lumens with > 1mm ID x <500mm L | | | Three-Quarter Size | 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. {8}------------------------------------------------ | Container Type | Sterilization Method | Container Bottom Part # | Container Lid Part # | Maximum LoadWeight (lbs) | |----------------------------|-----------------------------------------------------------------------------|----------------------------------|-------------------------|--------------------------| | Solid Bottom Container | Prevac Steam 270°F 4 min exposure 15 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 JJ210 | | 15 13 | | EDS Container | Prevac Steam 270°F 4 min exposure 8 minute* dry time | JJ141 JJ131 JJ121 JJ111 | JJ410 | 25 24 23 22 | | | | JJ341 | JJ430 | 23 | | | | JJ331 JJ321 JJ311 | | 22 20 18 | | | | JJ241 JJ231 | JJ420 | 18 18 | | | | JJ221 JJ211 | | 15 13 | | Solid Bottom Container | Prevac Steam Without dry time 270°F 3 min Exposure (Non-porous) | JJ140 JJ130 JJ120 JJ110 | JJ410 | 25 | | | AND | JJ340 JJ330 | JJ430 | 25 | | | Prevac Steam Without dry time | JJ320 JJ310 | | | | | 270°F 4 min Exposure (Porous) | JJ240 JJ230 JJ220 JJ210 | JJ420 | 25 | | EDS Container | Prevac Steam Without dry time 270°F 3 min Exposure (Non-porous) | JJ141 JJ131 JJ121 JJ111 | JJ430 | 25 | | | AND | JJ341 JJ331 | JJ310 | 25 | | | Prevac Steam Without 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* {9}------------------------------------------------ | Table 3. JJ Series Container System Configurations, with Silicone Mat and Lid Cover* | | | |--------------------------------------------------------------------------------------|--|--| |--------------------------------------------------------------------------------------|--|--| | Container Type | Sterilization Method | Container Bottom Part # | Container Lid Part # | Maximum Load Weight (lbs)* | |---------------------------|--------------------------------------------------------------------------------|----------------------------|-------------------------|-------------------------------| | Solid Bottom Container | Prevac Steam 270°F 4 min exposure 30 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 Steam 270°F 4 min exposure 30 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 Bottom Container | Prevac Steam Without dry time 270°F 3 min Exposure (Non-porous) | JJ140 | JJ410 | 25 | | | | JJ130 | | | | | | JJ120 | | | | | | JJ110 | | | | | AND Prevac Steam Without dry time 270°F 4 min Exposure (Porous) | JJ340 | JJ430 | 25 | | | | JJ330 | | | | | | JJ320 | | | | | | JJ310 | | | | | | JJ240 | JJ420 | 25 | | | 270°F 4 min Exposure (Porous) | JJ230 | | | | | | JJ220 | | | | | | JJ210 | | | | | | | | | {10}------------------------------------------------ | EDS Container | Prevac Steam Without dry time 270°F 3 min Exposure (Non-porous) AND Prevac Steam Without dry time 270°F 4 min Exposure (Porous) | | | | |---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|----|--| | | JJ141 JJ131 JJ121 JJ111 | JJ410 | 25 | | | | JJ341 JJ331 JJ321 JJ311 | JJ430 | 25 | | | | JJ241 JJ231 JJ221 JJ211 | 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 with dry time | Prevac Steam Without dry time | |----------------------------------------------------------------------------------------------------------|-------------------------------|----------------------------------| | Baskets, trays, indicator cards, tamper evident locks, faceplate holders, and tags. | Yes | Yes | | Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps) | 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 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. | 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. | Same | | Sterilization Modalities | PreVac Steam with dry time PreVac Steam without dry time | PreVac Steam IUSS Ethylene Oxide | Similar | | Material | Container: Anodized aluminum Lid: Anodized aluminum Gasket: Silicone | Container: Anodized aluminum Lid: Anodized aluminum Gasket: Silicone | Same | | Filter Type | Single use (Paper) | Single use (Paper) and reusable (PTFE) | Similar | | Container Design | Solid bottom or Solid bottom with enhanced drying system Perforated Lid | Solid or perforated bottom Perforated Lid | Similar | | Sizes | Full size Three-Quarter Size Half Size | Three-Quarter Size | Similar | | Accessories | Baskets, trays, silicone mats, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags. | Silicone mats, instrument organization system, lid covers, baskets, trays, and racks, indicator cards, locks | Similar | | Maintenance of Sterility | Prevac Steam with dry time - 365 days | Prevac Steam & Ethylene Oxide- 360 days IUSS - 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. | Performance Testing | Purpose | Acceptance Criteria | Results | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Sterilization Efficacy | To determine sterilization effectiveness of test device after processing in a sterilization cycle. | 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 | To determine the proper drying time required for the JJ Series Container System. | 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 | To analyze the package integrity and microbial barrier properties of the test device. | 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 | To demonstrate that a processed test device can maintain a sterile barrier for a defined period of time. | 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 | To assess effects of full use cycles on device components and their intended functionality. | No degradation or impact to functionality at the completion multiple sterilization cycles according to section 5.0 of TIR17. | Pass | | Cytotoxicity | To determine the potential of a test device to cause 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 | To verify the effectiveness of the device cleaning procedure. | 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 | 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.

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