(267 days)
Not Found
No
The device description and intended use focus on a physical sterilization container system and its accessories, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are related to sterilization efficacy and sterility maintenance, not AI/ML performance metrics.
No
The device is a sterilization container system designed to enclose other medical devices for sterilization and maintain their sterility, not to treat or directly therapeutic itself.
No
This device is a sterilization container system, not a diagnostic device. Its purpose is to sterilize and maintain the sterility of other medical devices, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states it is a "container system" made from "non-anodized Aluminum" and includes physical accessories like "mats, baskets, trays, holders, organizers, filters, indicator cards and tamper-evident locks." This indicates it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider." This describes a device used in the sterilization and storage of other medical devices, not a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description focuses on the physical characteristics of the container system (materials, accessories) and its function in sterilization and storage. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies described relate to sterilization efficacy, sterility maintenance, material compatibility, and biocompatibility – all relevant to a sterilization container, but not to an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information about a patient's health
- Using reagents or assays
In summary, the SterilContainer S System is a medical device used for the sterilization and storage of other medical devices, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The SterilContainer S System is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single-use polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container system has been validated with hinged, and knurled instruments. It is intended to allow sterilization of the enclosed device and also maintain sterlity of the enclosed device until used. This container system is compatible for use with STERRAD 100NX EXPRESS Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.
Testing has been completed on the SterilContainer S Full size container to maintain the sterility of its contents for 360 days following successful sterilization.
Testing has been completed on the SterilContainer S 1/2 size container to maintain the sterility of its contents for 30 days following successful sterilization.
The validated chamber load for the SterilContainer S Full and Half sizes in the STERRAD 100NX EXPRESS Cycle consisted of one SterilContainer S placed on the bottom shelf in an otherwise empty chamber.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The SterilContainer S System is a container system that will allow for sterilization and storage of medical devices. This container system is for use in low-temperature sterilization technology such as with the STERRAD 100NX EXPRESS Cycle. The SterilContainer S System rigid containers are made from non-anodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer S System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper-evident 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)
Validation studies have been performed with the SterileContainer S System in the STERRAD 100NX EXPRESS Cycle. These validations were conducted by a qualified testing laboratory.
- Sterilization Efficacy: Testing demonstrated a 6 log reduction to no growth in a half cycle validation. This testing supports a sterility assurance level (SAL) of 10-6 in a full cycle validation.
- Whole Package Microbial Aerosol Challenge: After exposure to a defined amount of aerosol microorganisms contents maintained sterility.
- Event Related Sterility Maintenance: Testing demonstrated the ability to provide an effective barrier for maintaining sterility of the contents after processing followed by a 30 or 360 day event related storage under conditions which simulate hospital sterile package handling and storage conditions.
- Material Compatibility: After 100 cycles of processing no visible or functional changes were observed.
- Biocompatibility: Cytotoxicity testing was conducted per ISO 10993-5 and showed no evidence of causing cell lysis or toxicity. A Hemolysis study was conducted per ASTM F756 and ISO 10993-4 and results were non-hemolytic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sterilization Efficacy: 6 log reduction to no growth, sterility assurance level (SAL) of 10-6.
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.
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.
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them that resemble hair or wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2015
Aesculap, Inc. % Denise Adams Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034
Re: K142970
Trade/Device Name: SterilContainer S System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: June 9, 2015 Received: June 10, 2015
Dear Ms. Adams,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Device Name SterilContainer S System
Indications for Use (Describe)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
The SterilContainer S System is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single-use polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container system has been validated with hinged, and knurled instruments. It is intended to allow sterilization of the enclosed device and also maintain sterlity of the enclosed device until used. This container system is compatible for use with STERRAD 100NX EXPRESS Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.
Testing has been completed on the SterilContainer S Full size container to maintain the sterility of its contents for 360 days following successful sterilization.
Testing has been completed on the SterilContainer S 1/2 size container to maintain the sterility of its contents for 30 days following successful sterilization.
The validated chamber load for the SterilContainer S Full and Half sizes in the STERRAD 100NX EXPRESS Cycle consisted of one SterilContainer S placed on the bottom shelf in an otherwise empty chamber.
| Lid | Bottom | Description | Total loaded
container weight
(lbs) | Intended load |
|-------|--------|-----------------------------------------------|-------------------------------------------|------------------------------------------------------------------|
| JM489 | JM440 | Full Size 90mm (4 $1\frac{1}{4}$ ") | 25.0 | reusable metal and non-metal medical |
| | JM441 | Full Size 120mm (5 $1\frac{1}{2}$ ") | 25.0 | devices without lumens including |
| | JM442 | Full Size 135mm (6") | 25.0 | endoscopes without lumens OR the da Vinci |
| | JM444 | Full Size 187mm (8") | 25.0 | Scope Platform (MD425) and two Si or S
series da Vinci Scopes |
| JM389 | JM340 | $\frac{1}{2}$ Size 90mm (4 $1\frac{1}{4}$ ") | 21.2 | reusable metal and non-metal medical |
| | JM341 | $\frac{1}{2}$ Size 120mm (5 $1\frac{1}{2}$ ") | 21.5 | devices without lumens including |
| | JM342 | $\frac{1}{2}$ Size 135mm (6") | 21.7 | endoscopes without lumens |
| | JM344 | $\frac{1}{2}$ Size 187mm (8") | 22.2 | |
SterilContainer S Compatible Containers in STERRAD 100NX EXPRESS Cycle
3
| Accessories | STERRAD 100NX EXPRESS Cycle |
|---|---|
| Stainless Steel baskets, basket lids, and dividers | Yes |
| Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps) | Yes |
| Silicone mats | Yes |
| Stainless Steel racks, trays, holders, clamps, brackets, and platforms | Yes |
STERRAD 100NX EXPRESS Cycle Compatible SterilContainer S System Accessories
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)
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."
4
510(k) SUMMARY (as required by 21 CFR 807.92)
| | SterilContainer™ S System
June 29, 2015 | | | |
|----------------------|--------------------------------------------------------------------------------------------------------------------|--|--|--|
| COMPANY: | Aesculap, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 291671-4 | | | |
| CONTACT: | Denise R. Adams
610-984-9076 (phone)
610-791-6882 (fax) | | | |
| TRADE NAME: | SterilContainer S System | | | |
| COMMON NAME: | Sterilization Container | | | |
| CLASSIFICATION NAME: | Sterilization Wrap | | | |
| PRODUCT CODE: | KCT | | | |
| DEVICE CLASS: | Class II per 21 CFR §880.6850 | | | |
SUBSTANTIAL EQUIVALENCE
Aesculap, Inc. believes that the SterilContainer S System for use in the STERRAD 100NX EXPRESS Cycle is substantially equivalent to Aesculap SterilContainer S for use in STERRAD 200, NX (Standard and Advanced Cycles), and 100NX (Standard and Flex Cycles) cleared via K093493.
DEVICE DESCRIPTION
The SterilContainer S System is a container system that will allow for sterilization and storage of medical devices. This container system is for use in low-temperature sterilization technology such as with the STERRAD 100NX EXPRESS Cycle. The SterilContainer S System rigid containers are made from non-anodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer S System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper-evident locks.
5
INDICATIONS FOR USE
The SterilContainer S System is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single-use polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container system has been validated with hinged, and knurled instruments. 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 with STERRAD 100NX EXPRESS Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.
Testing has been completed on the SterilContainer S Full size container to maintain the sterility of its contents for 360 days following successful sterilization.
Testing has been completed on the SterilContainer S ½ size container to maintain the sterility of its contents for 30 days following successful sterilization.
The validated chamber load for the SterilContainer S Full and Half sizes in the STERRAD 100NX EXPRESS Cycle consisted of one SterilContainer S placed on the bottom shelf in an otherwise empty chamber.
| Lid | Bottom | Description | Total loaded container weight (lbs) | Intended load |
|---|---|---|---|---|
| JM489 | JM440 | Full Size 90mm (4 ¼") | 25.0 | reusable metal and non-metal medical |
| JM441 | Full Size 120mm (5 ½") | 25.0 | devices without lumens including | |
| JM442 | Full Size 135mm (6") | 25.0 | endoscopes without lumens OR the da Vinci | |
| Scope Platform (MD425) and two Si or S | ||||
| series da Vinci Scopes | ||||
| JM444 | Full Size 187mm (8") | 25.0 | ||
| JM389 | JM340 | 1/2 Size 90mm (4 1/4") | 21.2 | reusable metal and non-metal medical |
| JM341 | 1/2 Size 120mm (5 1/2") | 21.5 | devices without lumens including | |
| JM342 | 1/2 Size 135mm (6") | 21.7 | endoscopes without lumens | |
| JM344 | 1/2 Size 187mm (8") | 22.2 |
SterilContainer S Compatible Containers in STERRAD 100NX EXPRESS Cycle
STERRAD 100NX EXPRESS Cycle Compatible SterilContainer S System Accessories
| Accessories | STERRAD 100NX
EXPRESS Cycle |
|-------------------------------------------------------------------------------------------------------------|--------------------------------|
| Stainless Steel baskets,
basket lids, and dividers | Yes |
| Instrument Organization
System (Silicone and
Stainless Steel racks,
brackets, holders, and clamps) | Yes |
| Silicone mats | Yes |
| Stainless Steel racks, trays,
holders, clamps, brackets, and
platforms | Yes |
6
TECHNOLIGICAL CHARACTERISTICS (compared to predicates)
The SterilContainer S System is for use in low-temperature sterilization technology such as the STERRAD 100NX EXPRESS Cycle. The SterilContainer S System is the same container system as was cleared in K093493. The materials and design have not changed.
| System | SterilContainer S
(K142970) | | | | | SterilContainer S
(K093493) | | | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-----------------------------------------------------|-------|
| Indica-
tions for
Use | The SterilContainer S System is a reusable sterilization container
system (consisting of perforated bottoms and perforated lids with
filter retention plates, and single-use polypropylene filters)
intended to be used to enclose another medical device that is to be
sterilized by a healthcare provider. This container system has been
validated with hinged, and knurled instruments. 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 with STERRAD 100NX EXPRESS Cycle. The
SterilContainer S System includes accessories such as silicone
mats, baskets, trays, racks, eyepiece holders and sleeve holders.
Testing has been completed on the SterilContainer S Full size
container to maintain the sterility of its contents for 360 days
following successful sterilization.
Testing has been completed on the SterilContainer S ½ size container
maintain the sterility of its contents for 30 days following successful
sterilization.
The validated chamber load for the SterilContainer S Full and Half
sizes in the STERRAD 100NX EXPRESS Cycle consisted of one
SterilContainer S placed on the bottom shelf in an otherwise empty
chamber. | | | | | The Aesculap Sterilcontainer S is a reusable sterilization container system
(consisting of perforated bottoms and perforated lids with filter retention plates, and
disposable polypropylene filters) intended to be used to enclose another medical
device that is to be sterilized by a healthcare provider. This container has been
validated with stainless steel lumens, hinged, and knurled instruments. 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 with the
STERRAD 200, STERRAD NX (Standard cycle and Advanced cycle), and
STERRAD 100NX (Standard cycle and Flex cycle). The Sterilcontainer S System
includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders
and sleeve holders. | | | |
| | | The Sterilcontainer S is recommended for surface and lumens:
STERRAD 200, stainless steel lumens ≥ 3mm I.D. x ≤ 400mm L
STERRAD NX standard cycle, stainless steel lumens
≥ 2mm I.D. x ≤ 400mm L
STERRAD NX advanced cycle, stainless steel lumens
1mm I.D. x ≤ 500mm L
STERRAD 100NX standard cycle, stainless steel lumens
≥ 0.7mm I.D. x ≤ 500mm L | | | | | | | |
| | | STERRAD 100NX flex cycle, porous lumens (flexible endoscope)
1mm I.D. x ≤ 850mm L
30 days of shelf life testing has been conducted for the Sterilicontainer S. | | | | | | | |
| | SterilContainer S Compatible Containers in STERRAD 100NX
EXPRESS Cycle | | | | TABLE 1: SterilContainer S Compatible Containers in STERRAD 200 | | | | |
| | Lid | Bottom | Description | Total
loaded
container
weight
(lbs) | Intended load | Item # | Description | Total loaded container
weight (lbs) | |
| | J
M
48
9 | JM4
40 | Full Size
90mm (4 ¼") | 25.0 | reusable metal
and non-metal
medical devices
without lumens | JM440 | Full Size Perforated Bottom 90mm (4 ¼") | 21.46 | |
| | | JM4
41 | Full Size
120mm (5 ½") | 25.0 | including
endoscopes
without lumens | JM441 | Full Size Perforated Bottom 120mm (5 ½") | 21.46 | |
| | | JM4
42 | Full Size
135mm
(6") | 25.0 | OR the da
Vinci Scope
Platform
(MD425) and
two Si or S
series da Vinci
Scopes | JM442 | Full Size Perforated Bottom 135mm (6") | 21.46 | |
| | | JM4
44 | Full Size
187mm
(8") | 25.0 | | JM444 | Full Size Perforated Bottom 187mm (8") | 21.46 | |
| | J
M
38
9 | JM3
40 | ½ Size
90mm (4 ¼") | 21.2 | reusable metal
and non-metal
medical devices
without lumens | JM740 | ¾ Size Perforated Bottom 90mm(4 ¼") | 14.42 | |
| | | JM3
41 | ½ Size
120mm (5 ½") | 21.5 | including
endoscopes
without lumens | JM741 | ¾ Size Perforated Bottom 120mm (5 ½") | 14.42 | |
| | | JM3
42 | ½ Size
135mm
(6") | 21.7 | | JM742 | ¾ Size Perforated Bottom 135mm (6") | 14.42 | |
| | | JM3
44 | ½ Size
187mm
(8") | 22.2 | | JM340 | ½ Size Perforated Bottom 90mm (4 ¼") | 14.42 | |
| | | | | | | | JM341 | ½ Size Perforated Bottom 120mm (5 ½") | 14.42 |
| | | | | | | | JM342 | ½ Size Perforated Bottom 135mm (6") | 14.42 |
| | | | | | | | JM344 | ½ Size Perforated Bottom 187mm (8") | 14.42 |
| | | | | | | | JM094 | ¼ Size Perforated Bottom with Lid
65mm (2 ½") | 14.42 |
| | | | | | | | JM096 | ¼ Size Perforated Bottom with Lid
130mm (5 1/8") | 14.42 |
| | | | | | | | JM021 | Extra Long Mini Bottom 73mm (3") | 7.64 |
| | | | | | | | JM489 | Full Size Lid | |
| | | | | | | | JM789 | ¾ Size Lid | |
| | | | | | | | JM389 | ½ Size Lid | |
| | | | | | | | See
JM094 &
JM096 | ¼ Size Lid | |
| | | | | | | | JM020 | Extra Long Mini Lid | |
| | STERRAD 100NX EXPRESS Cycle Compatible | | | | | | | | |
7
| Accessories | SterilContainer S System Accessories
STERRAD 100NX
EXPRESS Cycle | Note: Full, 3/4, 1/2, and 1/4 size container
lumens per container system.
2 stainless steel lumens per container system | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Stainless Steel baskets, basket lids, and dividers | Yes | TABLE 2: SterilContainer S
and Advanced Cycle
Item # Description JM440 Full Size Perforated (1/4") JM441 Full Size Perforated (1/2") JM740 3/4 Size Perforated JM741 3/4 Size Perforated (1/2") JM742 3/4 Size Perforated JM340 1/2 Size Perforated JM341 1/2 Size Perforated (1/2") JM094 1/4 Size Perforated 65mm (2 1/2") JM096 1/4 Size Perforated 130mm (5 1/8") JM021 Extra Long Mini JM489 Full Size Lid JM789 3/4 Size Lid JM389 1/2 Size Lid See JM094 & JM096 1/4 Size Lid | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps) | Yes | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Silicone mats | Yes | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Stainless Steel racks, trays, holders, clamps, brackets, and platforms | Yes | | JM020 Extra Long Mini Note: Full, 3/4, 1/2, and 1/4 size container
lumens per container system.
2 stainless steel lumens per container TABLE 3: SterilContainer S
Standard Cycle Item # Description JM440 Full Size Perforated (1/4") JM441 Full Size Perforated (1/2") JM442 Full Size Perforated (6") JM444 Full Size Perforated (8") JM740 3/4 Size Perforated JM741 3/4 Size Perforated (1/2") JM742 3/4 Size Perforated JM340 1/2 Size Perforated JM341 1/2 Size Perforated (1/2") JM342 1/2 Size Perforated JM344 1/2 Size Perforated JM094 1/4 Size Perforated 65mm (2 1/2") JM096 1/4 Size Perforated 130mm (5 1/8") JM021 Extra Long Mini JM489 Full Size Lid JM789 3/4 Size Lid JM389 1/2 Size Lid | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
ntainers have been validated with 5 stainless steel The Extra Long Mini container has been validated with tainer system.
Compatible Containers in STERRAD NX Standard
| Item # | Description | Total loaded container
weight (lbs) |
|-------------------------|-------------------------------------------------------|----------------------------------------|
| JM440 | Full Size Perforated Bottom 90mm (4 1/4") | 21.46 |
| JM441 | Full Size Perforated Bottom 120mm (5 1/2") | 21.46 |
| JM740 | 3/4 Size Perforated Bottom 90mm (4 1/4") | 13.85 |
| JM741 | 3/4 Size Perforated Bottom 120mm (5 1/2") | 13.85 |
| JM742 | 3/4 Size Perforated Bottom 135mm (6") | 13.85 |
| JM340 | 1/2 Size Perforated Bottom 90mm (4 1/4") | 13.85 |
| JM341 | 1/2 Size Perforated Bottom 120mm (5 1/2") | 13.85 |
| JM094 | 1/4 Size Perforated Bottom with Lid
65mm (2 1/2") | 13.85 |
| JM096 | 1/4 Size Perforated Bottom with Lid
130mm (5 1/8") | 13.85 |
| JM021 | Extra Long Mini Bottom 73mm (3") | 7.64 |
| JM489 | Full Size Lid | |
| JM789 | 3/4 Size Lid | |
| JM389 | 1/2 Size Lid | |
| See
JM094 &
JM096 | 1/4 Size Lid | |
id
ontainers have been validated with 5 stainless steel The Extra Long Mini container has been validated with
ntainer system.
| TABLE 3: SterilContainer S Compatible Containers in STERRAD 100NX | ||
|---|---|---|
| Standard Cycle |
| Item # | Description | Total loaded container
weight (lbs) |
|-------------------------|----------------------------------------------------|----------------------------------------|
| JM440 | Full Size Perforated Bottom 90mm (4 1/4") | 21.46 |
| JM441 | Full Size Perforated Bottom 120mm (5 1/2") | 21.46 |
| JM442 | Full Size Perforated Bottom 135mm (6") | 21.46 |
| JM444 | Full Size Perforated Bottom 187mm (8") | 21.46 |
| JM740 | 3/4 Size Perforated Bottom 90mm(4 1/4") | 13.85 |
| JM741 | 3/4 Size Perforated Bottom 120mm (5 1/2") | 13.85 |
| JM742 | 3/4 Size Perforated Bottom 135mm (6") | 13.85 |
| JM340 | 1/2 Size Perforated Bottom 90mm (4 1/4") | 13.85 |
| JM341 | 1/2 Size Perforated Bottom 120mm (5 1/2") | 13.85 |
| JM342 | 1/2 Size Perforated Bottom 135mm (6") | 13.85 |
| JM344 | 1/2 Size Perforated Bottom 187mm (8") | 13.85 |
| JM094 | 1/4 Size Perforated Bottom with Lid 65mm (2 1/2") | 13.85 |
| JM096 | 1/4 Size Perforated Bottom with Lid 130mm (5 1/8") | 13.85 |
| JM021 | Extra Long Mini Bottom 73mm (3") | 7.64 |
| JM489 | Full Size Lid | |
| JM789 | 3/4 Size Lid | |
| JM389 | 1/2 Size Lid | |
| See
JM094 &
JM096 | 1/4 Size Lid | |
8
| JM020 Extra Long Mini Lid | ||
|---|---|---|
| Note: Full, ¾, ½, and ¼ size containers have been validated with 5 stainless steel lumens per container system. The Extra Long Mini container has been validated with 2 stainless steel lumens per container system. | ||
| TABLE 4: SterilContainer S Compatible Containers in STERRAD 100NX Flex Cycle | ||
| Item # | Description | Total loaded container weight (lbs) |
| JM440 | Full Size Perforated Bottom 90mm (4 ¼") | 9.67 |
| JM441 | Full Size Perforated Bottom 120mm (5 ½") | 9.67 |
| JM442 | Full Size Perforated Bottom 135mm (6") | 9.67 |
| JM444 | Full Size Perforated Bottom 187mm (8") | 9.67 |
| JM740 | ¾ Size Perforated Bottom 90mm(4 ¼") | 9.67 |
| JM741 | ¾ Size Perforated Bottom 120mm (5 ½") | 9.67 |
| JM742 | ¾ Size Perforated Bottom 135mm (6") | 9.67 |
| JM340 | ½ Size Perforated Bottom 90mm (4 ¼") | 9.67 |
| JM341 | ½ Size Perforated Bottom 120mm (5 ½") | 9.67 |
| JM342 | ½ Size Perforated Bottom 135mm (6") | 9.67 |
| JM344 | ½ Size Perforated Bottom 187mm (8") | 9.67 |
| JM489 | Full Size Lid | |
| JM789 | ¾ Size Lid | |
| JM389 | ½ Size Lid | |
| Note: Full, ¾, and ½ size containers have been validated with 1 PTFE/PE lumen per container system. | ||
| Sterilization process | STERRAD 100NX EXPRESS Cycle | STERRAD 200, NX (Standard and Advanced Cycles), 100NX (Standard and Flex Cycles) |
| Material | Non-anodized aluminum | Non-anodized aluminum |
| Container type | Perforated | Perforated |
| Filter type | Polypropylene | Polypropylene |
PERFORMANCE DATA
Validation studies have been performed with the SterileContainer S System in the STERRAD 100NX EXPRESS Cycle. These validations were conducted by a qualified testing laboratory.
| Performance Properties | Results |
|---|---|
| Sterilization Efficacy | Testing demonstrated a 6 log reduction to no growth in a half cycle validation. This testing supports a sterility assurance level (SAL) of 10-6 in a full cycle validation. |
| Whole Package Microbial | |
| Aerosol Challenge | After exposure to a defined amount of aerosol microorganisms contents maintained sterility |
| Event Related Sterility | |
| Maintenance | Testing demonstrated the ability to provide an effective barrier for maintaining sterility of the contents after processing followed by a 30 or 360 day event related storage under conditions which simulate hospital sterile |
9
| Material Compatibility | package handling and storage conditions.
After 100 cycles of processing no visible or functional
changes were observed |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Cytotoxicity testing was conducted per ISO 10993-5 and
showed no evidence of causing cell lysis or toxicity.
A Hemolysis study was conducted per ASTM F756 and
ISO 10993-4 and results were non-hemolytic |
CONCLUSION
Performance testing demonstrates that the subject device is substantially equivalent to the predicate device.