(85 days)
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 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.
The provided document is a 510(k) summary for a medical device (sterilization container system), not for an AI/ML powered device. As such, the concept of a "test set," "training set," "experts to establish ground truth," "adjudication method," or "MRMC comparative effectiveness study" does not apply to this type of device submission. The performance testing outlined is for sterilization efficacy, simulated use, material compatibility, and cytotoxicity, which are standard for sterilization container systems and do not involve AI/ML components.
Therefore, I cannot extract the information required by your prompt regarding AI/ML device acceptance criteria and study details from this document. The document describes the acceptance criteria and study that proves the device meets those criteria, but these are for a physical sterilization device, not an AI/ML algorithm.
If you are interested in the acceptance criteria and study for the sterilization container itself, I can provide that information based on the document.
However, assuming you are looking for the outlined AI/ML specific information, I must state that the document does not contain it.
{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 VP4Validated Loads 1 & 2(Based on Sterizone Load #7) | Full | Non Lumened Instruments |
| Three-Quarter | ||
| Half | ||
| STERIZONE VP4Validated 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) |
| STERIZONEValidated 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
| SterilizationMethod | Container Size | ContainerBottom Part # | ContainerLid 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 | |||
| STERIZONEValidated 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 | |||
| STERIZONEValidated Load 3 | Full Size - 4 ¼" | JS440 | JS489 | See load configurationin table 1 above |
| (Based on Sterizone Load #8) | ||||
| STERIZONEValidated Load 4 | Full Size - 4 ¼" | JS440 | JS489 | See load configurationin table 1 above |
*JS744 is for use in Ethylene Oxide only.
{4}------------------------------------------------
Table 3. Sterilization Cycle Compatible Accessories
| Accessories | Compatible withEthylene Oxide | Compatible withSTERRAD DUO | Compatible withSTERIZONE 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 indicatorcards | Yes | Yes | Yes |
Type of Use (Select one or both, as applicable)
__ Prescription Use (Part 21 CFR 801 Subpart D)
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 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."
{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 ParkwayCenter Valley, PA 18034Establishment Registration Number: 291671- |
|---|---|
| CONTACT: | Sierra M. Mertz610-984-9076 (phone)Sierra.mertz@aesculapimplants.com610-791-6882 (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 | ContainerSize | Validated Load Configuration |
|---|---|---|
| EtO(130°F, 60 minute exposure,≥50% RH 725mg/L gaspressure) | FullThree-QuarterHalf | (1) lumen (≥ 3mm ID x ≤ 400mm L)AND(1) lumen (≥ 3.8mm ID x ≤ 370 mm L) |
| STERRAD 100NX DUO(bottom shelf only) | FullThree-QuarterHalf | Flexible scope (≥ 1mm ID x ≤ 850mm L) |
| STERIZONE VP4Validated Loads 1 & 2(Based on Sterizone Load #7) | FullThree-QuarterHalf | Non Lumened Instruments |
| STERIZONE VP4Validated 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 IDx ≤ 989mm L) |
| STERIZONEValidated Load 4(Based on Sterizone Load #4) | JS440 (base)+ JS489 (lid) | (1) Semi-rigid dual channel scope (≥0.7mm ID x ≤500mm L and ≥1.1mmID 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}------------------------------------------------
| SterilizationMethod | Container Size | ContainerBottom Part# | ContainerLid Part # | Total LoadedContainer (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 | |||
| STERIZONEValidated 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 | |||
| STERIZONEValidated Load 3(Based on Sterizone Load#8) | Full Size - 4 ¼" | JS440 | JS489 | See loadconfiguration in table1 above |
| STERIZONEValidated 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 withEthylene Oxide | Compatible withSTERRAD DUO | Compatible withSTERIZONE 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 indicatorcards | 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 -AesculapSterilContainer S2(K193582) | Primary Predicate -AesculapSterilContainer S2(K182414) | Predicate -AesculapSterilContainer(K112671) | Predicate -AesculapSterilContainer S(K162815) | Discussion | |
|---|---|---|---|---|---|
| IntendedUse | A device intended to beused to enclose anothermedical device that is to besterilizedby a health care provider. Itis intended to allowsterilizationof the enclosed medicaldevice and also to maintainsterility of the encloseddevice until used. | A device intended to beused to enclose anothermedical device that is to besterilizedby a health care provider. Itis intended to allowsterilizationof the enclosed medicaldevice and also to maintainsterility of the encloseddevice until used. | A device intended to beused to enclose anothermedical device that is to besterilizedby a health care provider. Itis intended to allowsterilizationof the enclosed medicaldevice and also to maintainsterility of the encloseddevice until used. | A device intended to beused to enclose anothermedical device that is to besterilizedby a health care provider. Itis intended to allowsterilizationof the enclosed medicaldevice and also to maintainsterility of the encloseddevice until used. | The subject deviceand the predicateshave the sameintended use. |
| SterilizationModalities | EtOSTERIZONE VP4STERRAD 100NX DUO | Prevac SteamGravity SteamSTERRAD: 100S, NXStandard, NXAdvanced, 100NXStandard, 100NX FlexSTERIS: V-PRO 60Lumen, V-PRO 60Non-Lumen, V-PRO 60 Flex, V-PRO maX Lumen, V-PROmaX Non-Lumen, V-PROmaX Flex | EtOPreVac SteamGravity SteamIUSS | STERIZONE VP4 | The subject devicehas beenvalidated usingsterilizationmethods similar tothe predicatedevices. |
| Material | Container: AnodizedaluminumLid: Anodized aluminumGasket: Silicone | Container: AnodizedaluminumLid: Anodized aluminumGasket: Silicone | Container: AnodizedaluminumLid: Anodized aluminumGasket: Silicone | Container: Non-anodizedaluminumLid: Non-anodizedaluminumGasket: Silicone | The material of thesubject device isidentical to thepredicates. |
| Filter Type | Single use: Paper(cellulose)or polypropylene | Single use: Paper(cellulose) or polypropyleneReusable: PTFE | Single use: Paper(cellulose) or polypropyleneReusable: PTFE | Single use: polypropylene | The proposeddevice utilizes anidentical singleuse filter. |
| ContainerDesign | Perforated bottom withperforated lid | Perforated bottom withperforated lid | Perforated or solid bottomwith perforated lid | Perforated bottom withperforated lid | The design of thesubject device isidentical to that ofthe predicatedevices. |
| Vent toVolume ratio | 1.02 - 3.4 | 1.4 - 3.4 | 1.02 | 1.4 - 3.4 | The vent-to-volume ratios ofthe subject devicefall within those ofthe predicates. |
| Sizes | Full sizeThree-Quarter SizeHalf Size | Full sizeThree-Quarter SizeHalf Size | Three-Quarter Size | Full sizeThree-Quarter SizeHalf Size | The size of thesubject device andpredicate devicesare 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 andpredicate devicesutilize the sameaccessories. |
{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 sterilizationeffectiveness of testdevice after processing ina sterilization cycle. | A sterility assurance level (SAL) of10-6 will be achieved post sterilization using theBI overkill method and half cycle validation.Biological indicators must be negative for growthafter incubation period. | Pass |
| Simulated Use | To determine the effectivesterilization of flexiblescopes when used withthe test device. | A minimum of 1.0 x 106 spores contained withinorganic soil representative of actual useconditions are killed during defined sterilizationcycle. Biological indicators must be negative forgrowth after incubation period. | Pass |
| Material Compatibility | To assess effects of fulluse cycles on devicecomponents and theirintended functionality. | No degradation or impact to functionality at thecompletion multiple sterilization cycles. | Pass |
| Cytotoxicity | To determine the potentialof a test device to causecytotoxicity. | Testing completed in accordance with ISO10993-5: 2009 to demonstrate no significantcytotoxic reaction after exposure to sterilant.Using the ISO Elution Method, the response tothe 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.
§ 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).