(239 days)
Not Found
No
The device is a rigid sterilization container system and its accessories. The description focuses on its physical properties, sterilization compatibility, and performance testing related to maintaining sterility. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
This device is a sterilization container system, designed to sterilize and maintain the sterility of other medical devices. It does not directly treat or diagnose a medical condition in a patient, which is the primary function of a therapeutic device.
No
Explanation: The device is a rigid sterilization container system designed to sterilize and maintain the sterility of other medical devices, not to diagnose a condition.
No
The device description clearly states it is a "reusable rigid sterilization container system" made from "anodized aluminum" and includes physical accessories like "baskets, trays, silicone mats," etc. The performance studies also focus on physical properties like sterilization efficacy, dry time, microbial challenge, and material compatibility. There is no mention of software as a component or the primary function of the device.
Based on the provided text, the Aesculap JJ Series Container System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to enclose another medical device for sterilization and to maintain its sterility. It does not mention any use in examining specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces its function as a container for sterilization and storage of other medical devices.
- Performance Studies: The performance studies focus on the sterilization efficacy, drying time, microbial barrier properties, sterility maintenance, material compatibility, cytotoxicity, and cleaning validation of the container system itself. These are all related to the physical and functional properties of a sterilization container, not to the analysis of biological samples.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information about a person's health. The Aesculap JJ Series Container System does not perform this function.
N/A
Intended Use / 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 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.
Product codes
KCT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Study Type: Sterilization Efficacy
Purpose: To determine sterilization effectiveness of test device after processing in a sterilization cycle.
Acceptance Criteria: 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.
Results: Pass
Study Type: Dry Time
Purpose: To determine the proper drying time required for the JJ Series Container System.
Acceptance Criteria: 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.
Results: Pass
Study Type: Microbial Aerosol Challenge
Purpose: To analyze the package integrity and microbial barrier properties of the test device.
Acceptance Criteria: 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.
Results: Pass
Study Type: Sterility Maintenance
Purpose: To demonstrate that a processed test device can maintain a sterile barrier for a defined period of time.
Acceptance Criteria: 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.
Results: Pass
Study Type: Material Compatibility
Purpose: To assess effects of full use cycles on device components and their intended functionality.
Acceptance Criteria: No degradation or impact to functionality at the completion multiple sterilization cycles according to section 5.0 of TIR17.
Results: Pass
Study Type: Cytotoxicity
Purpose: To determine the potential of a test device to cause cytotoxicity.
Acceptance Criteria: 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).
Results: Pass
Study Type: Cleaning Validation
Purpose: To verify the effectiveness of the device cleaning procedure.
Acceptance Criteria: 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.
Results: Pass
Key Results: Results of the testing demonstrate that the proposed device met the acceptance criteria for each performance test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Aesculap SterilContainer (K112671)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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) | 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) |
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
"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 1mm ID x ≤400mm L |
| Half Size | 4 stainless steel lumens with > 1mm ID x |