(85 days)
Not Found
No
The 510(k) summary describes a rigid sterilization container system and its accessories, focusing on its compatibility with various sterilization modalities and material performance. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities. The performance studies are focused on sterilization efficacy, simulated use, material compatibility, and cytotoxicity, which are standard tests for this type of device and do not involve AI/ML.
No
The device is a sterilization container system, intended to sterilize other medical devices and maintain their sterility, not to treat or diagnose patients itself.
No
This device is a sterilization container system, intended to enclose and maintain the sterility of other medical devices. It does not perform any diagnostic function.
No
The device description clearly states it is a reusable rigid container system made from anodized aluminum and includes various physical accessories like mats, baskets, trays, etc. This indicates it is a hardware device, not software-only.
Based on the provided information, 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 rigid sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider." It's for sterilizing and maintaining the sterility of other medical devices.
- Device Description: The description reinforces this, stating it's for "sterilization and storage of other medical devices."
- Lack of Diagnostic Function: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such tests or analyze biological samples.
- Focus on Sterilization: The performance studies and description are entirely focused on the device's ability to facilitate sterilization and maintain sterility.
Therefore, the Aesculap SterilContainer™ S2 System is a device used in the process of preparing other medical devices for use, not a diagnostic device itself.
N/A
Intended Use / 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:
- Ethylene Oxide
- STERRAD 100NX DUO cycle
- STERIZONE VP4
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.
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 intended for sterilization and storage of other medical devices. This container system is compatible for use in the following sterilization modalities:
- Ethylene Oxide ●
- STERRAD 100NX DUO cycle
- STERIZONE VP4 ●
The containers are perforated and made from anodized aluminum and utilize a single-use 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)
| 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 |
| 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.
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/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 17, 2020
Aesculap, Inc. Sierra Mertz Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K193582
Trade/Device Name: SterilContainer S2 System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: December 19, 2019 Received: December 23, 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 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
1
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 mediation-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
Indications for Use
510(k) Number (if known)
K193582
Device Name
Aesculap SterilContainer S2"™ System
Indications for Use (Describe)
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:
- Ethylene Oxide
- STERRAD 100NX DUO cycle
- . STERIZONE VP4
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 |
|---|---|---|
| EtO | ||
| (130°F, 60 minute exposure, |
50% RH 725mg/L gas pressure) | Full | (1) lumen ( $\geq$ 3mm ID x $\leq$ 400mm L) |
| | Three-Quarter | AND
(1) lumen ( $\geq$ 3.8mm ID x $\leq$ 370 mm L) |
| | Half | |
| STERRAD 100NX DUO
(bottom shelf only) | Full | Flexible scope ( $\geq$ 1mm ID x $\leq$ 850mm L) |
| | Three-Quarter | |
| | Half | |
| STERIZONE VP4
Validated Loads 1 & 2
(Based on Sterizone Load #7) | Full | Non Lumened Instruments |
| | Three-Quarter | |
| | Half | |
| STERIZONE VP4
Validated Load 3
(Based on Sterizone Load #8) | JS440 (base) +
JS489 (lid) | (1) Single Channel Flexible Scope ( $\geq$ 1mm ID x $\leq$ 850mm L)
OR
(1) Dual Channel Flexible Scope ( $\geq$ 1mm ID x $\leq$ 850 mm L and $\geq$ 1 mm ID x $\leq$ 989mm L) |
| STERIZONE
Validated Load 4
(Based on Sterizone Load #4) | JS440 (base) +
JS489 (lid) | (1) Semi-rigid dual channel scope ( $\geq$ 0.7mm ID x $\leq$ 500mm L and $\geq$ 1.1mm ID x $\leq$ 500mm L)
AND one of the following:
(4) Stainless steel lumens
( $\geq$ 5.5mm ID x $\leq$ 166mm L; $\geq$ 7mm ID x $\leq$ 105mm L; $\geq$ 7.0mm ID x $\leq$ 227mm L;
$\geq$ 7.8mm ID x $\leq$ 198mm L)
OR
(2) Stainless steel lumens
( $\geq$ 4mm ID x $\leq$ 370mm L; $\geq$ 2mm ID x $\leq$ 152mm L)
OR
(3) Stainless steel lumens
( $\geq$ 2.2mm ID x $\leq$ 173mm L; $\geq$ 4.7mm ID x $\leq$ 270mmL ; $\geq$ 4mm ID x $\leq$ 445mm L) |
Table 1. SterilContainer S2 System Validated Load Configurations
3
Table 2. SterilContainer S2 System Load Weights
| Sterilization
Method | Container Size | Container
Bottom Part # | Container
Lid Part # | Total Loaded Container
(lb) |
|------------------------------------|---------------------------|----------------------------|-------------------------|--------------------------------------------|
| | Full Size - 4 ¼" | JS440 | JS489 | 25 |
| | Full Size - 5 ½" | JS441 | | |
| | Full Size - 6" | JS442 | | |
| | Full Size - 8" | JS444 | | |
| | Three-Quarter Size - 4 ¼" | JS740 | JS789 | 25 |
| EtO | Three-Quarter Size - 5 ½" | JS741 | | |
| | Three-Quarter Size - 6" | JS742 | | |
| | Three-Quarter Size - 8" | JS744* | | |
| | Half Size - 4 ½" | JS340 | JS389 | 25 |
| | Half Size - 5 ½" | JS341 | | |
| | Half Size - 6" | JS342 | | |
| | Full Size - 4 ¼" | JS440 | JS489 | 10.97 |
| | Full Size - 5 ½" | JS441 | | |
| | Full Size - 6" | JS442 | | |
| | Full Size - 8" | JS444 | | |
| | Three-Quarter Size - 4 ¼" | JS740 | JS789 | 10.04 |
| STERRAD 100NX DUO | Three-Quarter Size - 5 ½" | JS741 | | |
| | Three-Quarter Size - 6" | JS742 | | |
| | Half Size - 4 ½" | JS340 | JS389 | 11.7 |
| | Half Size - 5 ½" | JS341 | | |
| | Half Size - 6" | JS342 | | |
| | Full Size - 4 ¼" | JS440 | JS489 | 25 |
| | Full Size - 5 ½" | JS441 | | |
| | Full Size - 6" | JS442 | | |
| | Full Size - 8" | JS444 | | |
| STERIZONE
Validated Loads 1 & 2 | Three-Quarter Size - 4 ¼" | JS740 | JS789 | 25 |
| | Three-Quarter Size - 5 ½" | JS741 | | |
| | Three-Quarter Size - 6" | JS742 | | |
| (Based on Sterizone Load #7) | Half Size - 4 ½" | JS340 | JS389 | 25 |
| | Half Size - 5 ½" | JS341 | | |
| | Half Size - 6" | JS342 | | |
| | Half Size - 5 ½" | JS341 | | |
| | Half Size - 6" | JS342 | | |
| STERIZONE
Validated Load 3 | Full Size - 4 ¼" | JS440 | JS489 | See load configuration
in table 1 above |
| (Based on Sterizone Load #8) | | | | |
| STERIZONE
Validated Load 4 | Full Size - 4 ¼" | JS440 | JS489 | See load configuration
in table 1 above |
*JS744 is for use in Ethylene Oxide only.
4
Table 3. Sterilization Cycle Compatible Accessories
| Accessories | Compatible with
Ethylene Oxide | Compatible with
STERRAD DUO | Compatible with
STERIZONE VP4 |
|----------------------------------------------------------------------------------------------------------|-----------------------------------|--------------------------------|----------------------------------|
| Stainless Steel baskets,
basket lids, and dividers | Yes | Yes | Yes |
| Instrument Organization System
(Silicone and Stainless Steel racks,
brackets, holders, and clamps) | Yes | Yes | Yes |
| Silicone mats | Yes | No | Yes |
| Tamper Evident locks and indicator
cards | Yes | Yes | Yes |
Type of Use (Select one or both, as applicable)
__ Prescription Use (Part 21 CFR 801 Subpart D)
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5
510(k) SUMMARY (as required by 21 CFR 807.92)
Aesculap SterilContainer S2 System for Ethylene Oxide, STERIZONE VP4, STERRAD 100NX DUO March 11, 2020
| COMPANY: | Aesculap, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 291671- |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| 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 per 21 CFR 880.6850 |
PREDICATE DEVICES
Aesculap SterilContainer S2 System - K182414 (Primary), SterilContainer S System - K162815 SterilContainer System - K112671
DEVICE DESCRIPTION
The Aesculap SterilContainer S2 System is a reusable rigid container system intended for sterilization and storage of other medical devices. This container system is compatible for use in the following sterilization modalities:
- Ethylene Oxide ●
- STERRAD 100NX DUO cycle
- STERIZONE VP4 ●
The containers are perforated and made from anodized aluminum and utilize a single-use filter. The SterilContainer S2 System includes accessories such as mats, baskets, trays, instrument holders, organizers, filters, indicator cards and tamper proof locks.
6
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:
- Ethylene Oxide
- STERRAD 100NX DUO cycle
- STERIZONE VP4
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.
Table 1. SterilContainer S2 System Validated Load Configurations
| Sterilization Cycle | Container
Size | Validated Load Configuration |
|------------------------------------------------------------------------|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EtO
(130°F, 60 minute exposure,
≥50% RH 725mg/L gas
pressure) | Full
Three-Quarter
Half | (1) lumen (≥ 3mm ID x ≤ 400mm L)
AND
(1) lumen (≥ 3.8mm ID x ≤ 370 mm L) |
| STERRAD 100NX DUO
(bottom shelf only) | Full
Three-Quarter
Half | Flexible scope (≥ 1mm ID x ≤ 850mm L) |
| STERIZONE VP4
Validated Loads 1 & 2
(Based on Sterizone Load #7) | Full
Three-Quarter
Half | Non Lumened Instruments |
| STERIZONE VP4
Validated Load 3
(Based on Sterizone Load #8) | JS440 (base)
- JS489 (lid) | (1) Single Channel Flexible Scope (≥1mm ID x ≤ 850mm L)
OR
(1) Dual Channel Flexible Scope (≥1mm ID x ≤850 mm L and ≥1 mm ID
x ≤ 989mm L) |
| STERIZONE
Validated Load 4
(Based on Sterizone Load #4) | JS440 (base) - JS489 (lid) | (1) Semi-rigid dual channel scope (≥0.7mm ID x ≤500mm L and ≥1.1mm
ID x ≤500mm L)
AND one of the following:
(4) Stainless steel lumens
(≥ 5.5mm ID x ≤ 166mm L; ≥ 7mm ID x ≤ 105mm L; ≥ 7.0mm ID x ≤
227mm L:
≥ 7.8mm ID x ≤ 198mm L)
OR
(2) Stainless steel lumens
(≥ 4mm ID x ≤ 370mm L; ≥ 2mm ID x ≤ 152mm L)
OR
(3) Stainless steel lumens
(≥ 2.2mm ID x ≤ 173mm L; ≥ 4.7mm ID x ≤ 270mmL ; ≥ 4mm ID x ≤
445mm L) |
7
| Sterilization
Method | Container Size | Container
Bottom Part
| Container
Lid Part # | Total Loaded
Container (lb) |
|-----------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------|-------------------------|-----------------------------------------------|
| EtO | Full Size - 4 ¼" | JS440 | JS489 | 25 |
| | Full Size - 5 ½" | JS441 | | |
| | Full Size - 6" | JS442 | | |
| | Full Size - 8" | JS444 | | |
| | Three-Quarter Size - 4 ¼" | JS740 | JS789 | 25 |
| | Three-Quarter Size - 5 ½" | JS741 | | |
| | Three-Quarter Size - 6" | JS742 | | |
| | Three-Quarter Size - 8" | JS744* | | |
| | Half Size - 4 ½" | JS340 | JS389 | 25 |
| | Half Size - 5 ½ | JS341 | | |
| STERRAD 100NX DUO | Full Size - 4 ¼" | JS440 | JS489 | 10.97 |
| | Full Size - 5 ½" | JS441 | | |
| | Full Size - 6" | JS442 | | |
| | Full Size - 8" | JS444 | | |
| | Three-Quarter Size - 4 ¼" | JS740 | JS789 | 10.04 |
| | Three-Quarter Size - 5 ½" | JS741 | | |
| | Three-Quarter Size - 6" | JS742 | | |
| | Half Size - 4 ¼" | JS340 | JS389 | 11.7 |
| | Half Size - 5 ½ | JS341 | | |
| | Half Size - 6" | JS342 | | |
| STERIZONE
Validated Loads 1 & 2
(Based on Sterizone Load
#7) | Full Size - 4 ¼" | JS440 | JS489 | 25 |
| | Full Size - 5 ½" | JS441 | | |
| | Full Size - 6" | JS442 | | |
| | Full Size - 8" | JS444 | | |
| | Three-Quarter Size - 4 ¼" | JS740 | JS789 | 25 |
| | Three-Quarter Size - 5 ½" | JS741 | | |
| | Three-Quarter Size - 6" | JS742 | | |
| | Half Size - 4 ¼" | JS340 | JS389 | 25 |
| | Half Size - 5 ½ | JS341 | | |
| | Half Size - 6" | JS342 | | |
| STERIZONE
Validated Load 3
(Based on Sterizone Load
#8) | Full Size - 4 ¼" | JS440 | JS489 | See load
configuration in table
1 above |
| | STERIZONE
Validated Load 4
(Based on Sterizone Load
#4) | Full Size - 4 ¼" | JS440 | JS489 |
*JS744 is for use in Ethylene Oxide only.
8
| Table 3. Sterilization Cycle Compatible Accessories | ||
|---|---|---|
| Accessories | Compatible with
Ethylene Oxide | Compatible with
STERRAD DUO | Compatible with
STERIZONE VP4 |
|----------------------------------------------------------------------------------------------------------|-----------------------------------|--------------------------------|----------------------------------|
| Stainless Steel baskets,
basket lids, and dividers | Yes | Yes | Yes |
| Instrument Organization System
(Silicone and Stainless Steel racks,
brackets, holders, and clamps) | Yes | Yes | Yes |
| Silicone mats | Yes | No | Yes |
| Tamper Evident locks and indicator
cards | Yes | Yes | Yes |
9
TECHNOLIGICAL CHARACTERISTICS (compared to predicate devices)
The Aesculap SterilContainer S2 System has the same intended use and the technological characteristics as the Aesculap SterilContainer predicate devices. The subject devices are offered in the same design and same sizes and are made of the same materials as the predicate devices.
| | Subject Device -
Aesculap
SterilContainer S2
(K193582) | Primary Predicate -
Aesculap
SterilContainer S2
(K182414) | Predicate -
Aesculap
SterilContainer
(K112671) | Predicate -
Aesculap
SterilContainer S
(K162815) | Discussion |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| 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. | 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. | The subject device
and the predicates
have the same
intended use. |
| Sterilization
Modalities | EtO
STERIZONE VP4
STERRAD 100NX DUO | Prevac Steam
Gravity Steam
STERRAD: 100S, NX
Standard, NX
Advanced, 100NX
Standard, 100NX Flex
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 | EtO
PreVac Steam
Gravity Steam
IUSS | STERIZONE VP4 | The subject device
has been
validated using
sterilization
methods similar to
the predicate
devices. |
| Material | Container: Anodized
aluminum
Lid: Anodized aluminum
Gasket: Silicone | Container: Anodized
aluminum
Lid: Anodized aluminum
Gasket: Silicone | Container: Anodized
aluminum
Lid: Anodized aluminum
Gasket: Silicone | Container: Non-anodized
aluminum
Lid: Non-anodized
aluminum
Gasket: Silicone | The material of the
subject device is
identical to the
predicates. |
| Filter Type | Single use: Paper
(cellulose)
or polypropylene | Single use: Paper
(cellulose) or polypropylene
Reusable: PTFE | Single use: Paper
(cellulose) or polypropylene
Reusable: PTFE | Single use: polypropylene | The proposed
device utilizes an
identical single
use filter. |
| Container
Design | Perforated bottom with
perforated lid | Perforated bottom with
perforated lid | Perforated or solid bottom
with perforated lid | Perforated bottom with
perforated lid | The design of the
subject device is
identical to that of
the predicate
devices. |
| Vent to
Volume ratio | 1.02 - 3.4 | 1.4 - 3.4 | 1.02 | 1.4 - 3.4 | The vent-to-
volume ratios of
the subject device
fall within those of
the predicates. |
| Sizes | Full size
Three-Quarter Size
Half Size | Full size
Three-Quarter Size
Half Size | Three-Quarter Size | Full size
Three-Quarter Size
Half Size | The size of the
subject device and
predicate devices
are the same. |
| Accessories | Silicone mats, baskets,
trays, IOS, and racks. | Silicone mats, baskets,
trays, IOS, and racks. | Silicone mats, baskets,
trays, IOS, and racks. | Silicone mats, baskets,
trays, IOS and racks. | The subject and
predicate devices
utilize the same
accessories. |
10
PERFORMANCE TESTING
Non-clinical testing was conducted to verify performance of the subject device. The testing summarized below demonstrates that the subject device meets the established acceptance criteria.
| 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 | ||
| 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 |
CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the Aesculap SterilContainer S2 System is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.