(304 days)
No
The device description and performance studies focus on the physical properties and sterilization efficacy of a rigid container system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a sterilization container system, not a device used for treating a disease or condition.
No
This device is a sterilization container system, designed to sterilize and maintain the sterility of other medical devices. It does not perform any diagnostic functions.
No
The device is a reusable rigid sterilization container system made of anodized aluminum and includes various physical accessories like mats, baskets, and filters. It is clearly a hardware device.
Based on the provided text, the Aesculap(R) SterilContainer™ S2 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device 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." Its purpose is to facilitate sterilization and maintain the sterility of other medical devices.
- Device Description: The description reinforces this, stating it's a "reusable rigid container system that will allow for sterilization and storage of other medical devices."
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information for diagnosis, monitoring, or treatment decisions based on those analyses.
- Reagents, calibrators, or controls used in laboratory testing.
The Aesculap SterilContainer S2 System is a device used in the sterilization process of other medical devices, which is a crucial step in healthcare but distinct from in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Aesculap(R) SterilContainer™ S2 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 the following sterilization modalities:
- ·Dynamic-air removal steam (PreVac) (Exposure: 270°F for 4 minutes with 15 minute dry time)
- ·Gravity Steam (Exposure: 250°F for 30-60 minutes with 15 minute dry time)
- ·STERRAD 100S, STERRAD NX Standard, STERRAD NX Advanced, STERRAD 100NX Standard, STERRAD 100NX Flex Cycles
- ·STERIS V-PRO 60 Lumen, V-PRO 60 Non-Lumen, V-PRO 60 Flex, V-PRO maX Lumen, V-PRO maX Non-Lumen, and V-PRO maX Flex Cycles.
The Aesculap SterilContainer S2 System includes accessories such as sillcone mats and organizers, stainless steel baskets, trays, holders, sterilization indicator cards and tamper proof locks.
The attached table identifies the validated load configurations for each of the modalities.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The Aesculap SterilContainer S2 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:
- Dynamic-air removal steam (PreVac) (270°F for 4 minutes with 15 minute dry time)
- Gravity Steam (250°F for 30-60 minutes with 15 minute dry time)
- STERRAD 100S, STERRAD NX Standard, STERRAD NX Advanced, STERRAD ● 100NX Standard, STERRAD 100NX Flex Cycles
- STERIS V-PRO 60 Lumen, V-PRO 60 Non-Lumen, V-PRO 60 Flex, V-PRO maX . Lumen, V-PRO maX Non-Lumen, V-PRO maX Flex cycles
The containers are perforated and made from anodized aluminum and utilize a single-use or reusable filter. The SterilContainer S2 System includes accessories such as mats, baskets, trays, instrument holders, organizers, filters, indicator cards and tamper proof locks.
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)
Non-clinical testing was conducted to verify the performance of the subject device. The testing provided below demonstrates that the subject device met the acceptance criteria of each test below.
| 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. Biological indicators must be negative for growth after incubation period. | Pass |
| Simulated Use | To determine the effective sterilization of flexible scopes when used with the test device. | A minimum of 1.0 x 106 spores contained within organic soil representative of actual use conditions are killed during defined sterilization cycle. Biological indicators must be negative for growth after incubation period. | Pass |
| Microbial Aerosol Challenge | To analyze the package integrity and microbial barrier properties of the test device. | Post sterilization, the container load maintains sterility after exposure to a defined amount of aerosol microorganisms. No presence of growth after incubation period. | Pass |
| Maintenance of Sterility | To demonstrate that a processed test device can maintain a sterile barrier for a defined period of time | Sterility of container contents is maintained after processing for 360 days under conditions which simulate hospital sterile package handling and storage conditions. Biological indicators must be negative for growth after incubation period. | Pass |
| Reusable Filter | To demonstrate sterilization effectiveness after determined number of sterilization and wash cycles. | Sterility Assurance Level (SAL) of 10-6 will be achieved after 2200 sterilization and washing cycles using half cycle testing with biological indicators to demonstrate a 6 log reduction. | 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. | Pass |
| Cytotoxicity | To determine the potential of a test device to cause cytotoxicity. | Testing completed in accordance with ISO 10993-5: 2009 to demonstrate no significant cytotoxic reaction after exposure to sterilant. Using the ISO Elution Method, the response to the article is not greater than 2 (mild reactivity). | Pass |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Aesculap SterilContainer System (K792558)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Aesculap SterilContainer S (K093649), Aesculap SterilContainer S (K093493)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue and white.
July 5, 2019
Aesculap, Inc. Sierra Mertz Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K182414
Trade/Device Name: Aesculap® SterilContainer™ S2 System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: June 6, 2019 Received: June 7, 2019
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
1
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 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 (QS) 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 Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K182414
Device Name
Aesculap(R) SterilContainer™ S2 System
Indications for Use (Describe)
The Aesculap(R) SterilContainer™ S2 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 the following sterilization modalities:
- · Dynamic-air removal steam (PreVac) (Exposure: 270°F for 4 minutes with 15 minute dry time)
- · Gravity Steam (Exposure: 250°F for 30-60 minutes with 15 minute dry time)
- · STERRAD 100S, STERRAD NX Standard, STERRAD NX Advanced, STERRAD 100NX Standard, STERRAD 100NX Flex Cycles
- · STERIS V-PRO 60 Lumen, V-PRO 60 Non-Lumen, V-PRO 60 Flex, V-PRO maX Lumen, V-PRO maX Non-Lumen, and V-PRO maX Flex Cycles.
The Aesculap SterilContainer S2 System includes accessories such as sillcone mats and organizers, stainless steel baskets, trays, holders, sterilization indicator cards and tamper proof locks.
The attached table identifies the validated load configurations for each of the modalities.
| Sterilization Cycle | Container Size | Validated Load Configuration |
|---|---|---|
| Dynamic Air Removal Steam | ||
| (PreVac) | Full | 1 lumen with ≥ 3mm ID x ≤400mm L |
| and a second lumen ≥ 3.8mm ID x ≤370mm L | ||
| Three-Quarter | ||
| Half | ||
| Gravity Steam | Full | Non lumen stainless steel instruments |
| Three-Quarter | ||
| Half | ||
| STERRAD 100S | Full | 5 Stainless steel lumens ≥ 3.0mm ID and ≤400mm L |
| Three-Quarter | ||
| Half | ||
| STERRAD NX Standard | Full | 5 Stainless steel lumens ≥ 2mm ID and ≤400mm L |
| Three-Quarter | ||
| Half | ||
| STERRAD NX Advanced | Full | 1 Flexible lumen (≥ 1mm ID and ≤850mm L) |
| Three-Quarter | ||
| Half | ||
| STERRAD 100NX Standard | Full | 5 Stainless steel lumens ≥ 0.7mm ID and ≤ 500mm L |
| Three-Quarter | ||
| Half | ||
| STERRAD 100NX Flex | Full | 1 Flexible lumen 1mm ID and ≤850mm L |
| Three-Quarter | ||
| Half |
Table 1. SterilContainer S2 System Validated Load Configurations
3
| STERIS V-PRO 60 Lumen | Full | Stainless steel lumens
1 lumen ≥ 0.77mm ID and ≤410mm L |
|--------------------------------|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Three-Quarter | 1 lumen ≥ 1.2mm ID and ≤275mm L |
| | Half | 1 lumen ≥ 1.8mm ID and ≤310mm L
1 lumen ≥ 2.8mm ID and ≤317mm L |
| STERIS V-PRO 60 Non-Lumen | Full | Non lumen stainless steel instruments |
| | Three-Quarter | |
| | Half | |
| STERIS V-PRO 60 Flex | Full | |
| | Three-Quarter | 1 flexible surgical endoscope or bronchoscope with a light
|
| | Half | cord (if not integral to endoscope) and mat without any
additional load. The flexible endoscope may be a single or
dual lumens that are >1mm ID and
1mm ID and
1mm ID and
1mm ID and
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 aqency 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."
EF
8
510(k) SUMMARY (as required by 21 CFR 807.92)
Aesculap®)SterilContainer™ S2 System For Steam & Low Temperature Sterilization Cycles July 5, 2019
| 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® SterilContainer™ S2 System |
| COMMON NAME: | Sterilization Container Wrap |
| CLASSIFICATION NAME: | Wrap, Sterilization |
| REGULATION NUMBER: | 880.6850 |
| PRODUCT CODE: | KCT |
| DEVICE CLASS: | Class II |
Predicate Device
Aesculap SterilContainer System (K792558)
Reference Device
Aesculap SterilContainer S (K093649) Aesculap SterilContainer S (K093493)
DEVICE DESCRIPTION
The Aesculap SterilContainer S2 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:
- Dynamic-air removal steam (PreVac) (270°F for 4 minutes with 15 minute dry time)
- Gravity Steam (250°F for 30-60 minutes with 15 minute dry time)
- STERRAD 100S, STERRAD NX Standard, STERRAD NX Advanced, STERRAD ● 100NX Standard, STERRAD 100NX Flex Cycles
- STERIS V-PRO 60 Lumen, V-PRO 60 Non-Lumen, V-PRO 60 Flex, V-PRO maX . Lumen, V-PRO maX Non-Lumen, V-PRO maX Flex cycles
9
The containers are perforated and made from anodized aluminum and utilize a single-use or reusable filter. The SterilContainer S2 System includes accessories such as mats, baskets, trays, instrument holders, organizers, filters, indicator cards and tamper proof locks.
Maintenance of Sterility
The maintenance of sterility for the load in this device is 360 days.
INDICATIONS FOR USE
The Aesculap SterilContainer S2 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 the following sterilization modalities:
- Dynamic-air removal steam (PreVac) (Exposure: 270°F for 4 minutes with 15 minute dry . time)
- Gravity Steam (Exposure: 250°F for 30-60 minutes with 15 minute dry time)
- STERRAD 100S, STERRAD NX Standard, STERRAD NX Advanced, STERRAD 100NX Standard, STERRAD 100NX Flex Cycles
- STERIS V-PRO 60 Lumen, V-PRO 60 Non-Lumen, V-PRO 60 Flex, V-PRO maX . Lumen, V-PRO maX Non-Lumen, and V-PRO maX Flex Cycles.
The Aesculap SterilContainer S2 System includes accessories such as silicone mats and organizers, stainless steel baskets, trays, holders, sterilization indicator cards and tamper proof locks.
The attached table identifies the validated load configurations for each of the modalities.
| Sterilization Cycle | Container Size | Validated Load Configuration |
|---|---|---|
| Dynamic Air Removal | ||
| Steam (PreVac) | Full | 1 lumen with ≥ 3mm ID x ≤400mm L |
| Three-Quarter | and a second lumen ≥ 3.8mm ID x ≤370mm L | |
| Half | ||
| Gravity Steam | Full | Non lumen stainless steel instruments |
| Three-Quarter | ||
| Half | ||
| STERRAD 100S | Full | 5 Stainless steel lumens ≥ 3.0mm ID and ≤400mm L |
| Three-Quarter | ||
| Half | ||
| STERRAD NX Standard | Full | 5 Stainless steel lumens ≥ 2mm ID and ≤400mm L |
| Three-Quarter | ||
| Half | ||
| STERRAD NX Advanced | Full | 1 Flexible lumen (≥ 1mm ID and ≤850mm L) |
| Three-Quarter | ||
| Half | ||
| STERRAD 100NX | ||
| Standard | Full | 5 Stainless steel lumens ≥ 0.7mm ID and ≤ 500mm L |
| Three-Quarter | ||
| Half |
Table 1. SterilContainer S2 System Validated Load Configurations
10
| STERRAD 100NX Flex | Full
Three-Quarter
Half | 1 Flexible Lumen 1mm ID and $1mm ID and $1mm ID and
1mm ID and
1mm ID and