(131 days)
Ahlstrom Reliance® Tandem and Solo Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:
- Pre-vacuum Steam 270°F/132°C for 4 minutes
- Gravity Steam 250°F/121°C for 30 minutes
- 100% Ethylene Oxide (EO) with a concentration of 725-735 mg/L @ 131°F/55°C and 40% 80% relative humidity for 60 minutes
- Advanced Sterilization Products (ASP) STERRAD® 100S
- Advanced Sterilization Products (ASP) STERRAD® 100NX (Standard, Express and Flex cycles)
- STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems (Lumen, Non Lumen and Flexible Cycles)
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.
The Reliance® Solo and Reliance® Tandem Sterilization Wraps are square or rectangular nonwoven sheets produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The Reliance® SMS Sterilization Wraps are separated into two distinct product offerings:
Reliance® Tandem: Consists of single sheets of SMS wrap, where two sheets are used together for the sequential wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices.
Reliance® Solo: Consists of two sheets of SMS wrap, ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices.
The Reliance® Solo and Reliance® Tandem Sterilization Wraps are composed of polypropylene with the addition of blue or green pigment and an anti-static treatment. Reliance® Tandem and Reliance® Solo wraps allow a sterilized package of medical devices to be opened aseptically.
This document is a 510(k) premarket notification for the Reliance® Solo Sterilization Wrap and Reliance® Tandem Sterilization Wrap, indicating substantial equivalence to a predicate device. It is not an AI/ML device, and therefore the standard questions about acceptance criteria for AI/ML devices, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training sets are not directly applicable.
However, I can extract the closest analogous information regarding the performance criteria and studies done to demonstrate the substantial equivalence of this medical device (sterilization wrap) to its predicate.
1. A table of acceptance criteria and the reported device performance:
Since this is not an AI/ML device, the performance is not about accuracy, sensitivity, or specificity. Instead, it revolves around functional and safety characteristics meeting established standards.
| Acceptance Criterion (Category) | Reported Device Performance |
|---|---|
| Biocompatibility (Cytotoxicity) | Pass per ISO 10993 |
| Sterilant Penetration | Pass per ANSI/AAMI ST79:2010 & A1:2010 and ANSI/AAMI/ISO 14937:2009 |
| Dry Time (Pre-Vacuum Steam) | Models T100/S100, T200/S200, T300/S300: 20 minutes (validated) Models T400/S400, T500/S500, T600/S600: 30 minutes (validated) |
| Dry Time (Gravity Steam) | Models T100/S100, T200/S200, T300/S300: 20 minutes (validated) Models T400/S400: 30 minutes (validated) Models T500/S500 and T600/S600: Not validated for gravity steam sterilization. |
| Aeration Time (Ethylene Oxide) | 8 hours at 55°C (validated) |
| Physical Integrity | Pass (implicitly through comparison to predicate and adherence to standards) |
| Microbial Barrier Properties (Packaging Integrity) | Pass (through comparison to predicate) |
| Material Compatibility | Pass (through comparison to predicate) |
| Toxicological Properties (Biocompatibility) | Pass (through comparison to predicate) |
| Maintenance of Sterility (Shelf-Life) | 90 days |
| Various Sterilization Cycles (ASP STERRAD, STERIS V-PRO) | All models validated for specific cycles and load configurations as detailed in the "Indications for Use" section (e.g., specific lumen diameters, lengths, maximum weights). |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of wraps tested for dry time). It refers to "testing," implying a sufficient number of units were tested to meet the requirements of the cited standards.
- Sample Size: Not explicitly stated as numerical values for each test, but implied to be sufficient to demonstrate compliance with the referenced industry standards for sterilization wraps.
- Data Provenance: The studies were conducted by Ahlstrom Nonwovens LLC to support their 510(k) submission. The exact country of origin of the data/testing labs is not specified, but the submission is to the U.S. FDA, suggesting U.S. or internationally recognized standards-compliant testing. These would be prospective studies specific to the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not relevant for the evaluation of a sterilization wrap. "Ground truth" in this context would be derived from physical measurements during testing against established scientific and engineering standards (e.g., bacterial filtration tests, air permeability tests, strength tests, sterility tests). The "experts" would be the scientists and engineers performing and interpreting these standardized tests.
4. Adjudication method for the test set:
Not applicable. Adjudication methods are typically for subjective assessments, which are not relevant for the objective physical and biological performance tests of a sterilization wrap.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
The "ground truth" for this device's performance relies on:
- Physical and Chemical Standards: Adherence to established ASTM, AAMI, ANSI, and ISO standards for properties like air permeability, tensile strength, tear resistance, material compatibility, sterilant penetration, and residual chemicals.
- Biological Standards: Performance in microbiological tests to demonstrate bacterial filtration efficiency and maintenance of sterility.
- Validated Sterilization Cycle Parameters: The ability of the wrap to perform as intended within defined and validated parameters of various sterilization cycles (e.g., steam, EO, low-temperature plasma).
8. The sample size for the training set:
Not applicable. This is not an AI/ML device, so there is no training set in the AI/ML sense. The "training" in manufacturing would refer to process validation and quality control, which are continuously monitored rather than a one-time dataset.
9. How the ground truth for the training set was established:
Not applicable. As noted above, there is no AI/ML training set. The "ground truth" for ensuring consistent product quality in manufacturing is established through adherence to Good Manufacturing Practices (GMP) and ongoing quality assurance processes, with specifications derived from the performance testing mentioned in point 7.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 27, 2016
Ahlstrom Nonwovens LLC % Lauren Chrapowitzky Consultant AJW Technology Consultants, Inc. 445 Apollo Beach Blvd Apollo Beach, Florida 33572
Re: K160755
Trade/Device Name: Reliance® Solo Sterilization Wrap, Reliance® Tandem Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: June 22, 2016 Received: June 24, 2016
Dear Lauren Chrapowitzky:
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 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
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the quality systems (OS) 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
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160755
Device Name
Reliance® Solo Sterilization Wrap, Reliance® Tandem Sterilization Wrap
Indications for Use (Describe)
Ahlstrom Reliance® Tandem and Solo Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:
- Pre-vacuum Steam 270°F/132°C for 4 minutes ●
- Gravity Steam 250°F/121°C for 30 minutes ●
- 100% Ethylene Oxide (EO) with a concentration of 725-735 mg/L @ 131°F/55°C and 40% 80% relative ● humidity for 60 minutes
- . Advanced Sterilization Products (ASP) STERRAD® 100S
- Advanced Sterilization Products (ASP) STERRAD® 100NX (Standard, Express and Flex cycles) ●
- STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low ● Temperature Sterilization Systems (Lumen, Non Lumen and Flexible Cycles)
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.
Pre-Vacuum Steam Sterilization:
- Validated for dry time of 20 minutes for Models T100/S100, T200/S200, T300/S300. o
- Validated for dry time of 30 minutes for Models T400/S400, T500/S500, T600/S600. ●
- All models of Reliance® Tandem and Solo validated for pre-vacuum steam sterilization with stainless steel . lumens (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model.
Gravity Steam Sterilization:
- Validated for dry times of 20 minutes for Models T100/S100, T200/S200, T300/S300. ●
- Validated for dry times of 30 minutes for Models T400/S400. .
- Models T100/S100, T200/S200, T400/S400 of Reliance® Tandem and Solo validated for gravity ● steam sterilization with stainless steel lumens (3 mm in diameteror larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model.
- Models T500/S500 and T600/S600 are not validated for use for gravity steam sterilization. ●
Ethylene Oxide Sterilization:
- Validated for aeration time of 8 hours at 55°C ●
- . All models of Reliance® Tandem and Solo validated for ethylene oxide sterilization with stainless steel lumens (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 251bs dependent on the model.
Advanced Sterilization Products (ASP) STERRAD® 100S Sterilization
- All models of Reliance® Tandem and Solo validated with ASP STERRAD® 100S sterilization with stainless ● steel lumens (2 mm inside diameter or larger and a length of 250mm or less) as part of the load with a maximum weight of 10.7lbs dependent on the model.
Advanced Sterilization Products (ASP) STERRAD® 100NX Sterilization
- All models of Reliance® Tandem and Solo validated with ASP STERRAD® 100NX sterilization cycles detailed ● in Table 1.
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| Table 1: Validated Advanced Sterilization Products (ASP) STERRAD® 100NX Cycles | |
|---|---|
| Advanced Sterilization Products (ASP) STERRAD® System and Cycle | Intended Load |
| 100NX Standard Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:• An inside diameter of 0.7mm or larger and a length of 500mm or shorter of single-channel stainless steel lumens. |
| 100NX Flex Cycle | One or two single-channel flexible endoscopes with or without a silicone mat. Flexible endoscope may contain:• A single channel Teflon/PE/PTFE lumen with an inside diameter of 1 mm or larger and a length of 850mm or shorter. (A maximum of two flexible endoscopes, one per tray per sterilization cycle) |
| 100NX Express Cycle | Non-lumened reusable metal and non-metal medical devices requiring surface sterilization, or sterilization of mated stainless steel and titanium surfaces, and rigid or semi-rigid endoscopes without lumens. |
T-1 1000 1000 1000V
STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems
- All models of Reliance® Tandem and Solo Sterilization Wraps have been validated for use with STERIS V-● PRO® cycles detailed in Table 2.
- Reliance® Tandem and Solo Sterilization Wraps were validated to be effectively aerated during the pre-● programmed STERIS Amsco V-PRO® Sterilization Cycles.
| STERIS Amsco® V-PRO Cycle | Intended Load |
|---|---|
| Lumen Cycle | Reusable metal and non-metal medical devices, including up to 20 stainless steel lumens with dimensions of 3.0mm diameter or larger and a length of 400mm or shorter. |
| Non Lumen Cycle | Non lumened reusable metal and non-metal medical devices. |
| Flexible Cycle | Single lumen surgical flexible endoscopes and bronchoscopes in the following load configuration:1.) One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat. The flexible endoscope having an inside diameter of 1 mm or larger and a length of 850 mm or shorter.2.) An additional tray containing non-lumened medical devices. |
Table 2: Validated STERIS Amsco® V-PRO Cycles
Type of Use (Select one or both, as applicable)
__ Prescription Use (Part 21 CFR 801 Subpart D)
[x] Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY (as required by 807.92)
I. SUBMITTER
Ahlstrom Nonwovens LLC 2 Elm Street Windsor Locks, CT 06096
Contact Person: Gary Jackson Date Prepared: 25 July 2016
REGULATORY CORRESPONDENT
AJW Technology Consultants, Inc 445 Apollo Beach, Blvd Apollo Beach, FL 33572
Phone: 813-645-2855 x100 Fax: 813-645-2856
Contact Person: Lauren Chrapowitzky Email: laurenc@ajwtech.com
II. DEVICE
Name of Device: Reliance® Solo Sterilization Wrap, Reliance® Tandem Sterilization Wrap Common or Usual Name: Sterilization Wrap Classification Name: Sterilization Wrap Device Panel: General Hospital Regulatory Class: II Product Code: FRG Regulation Number: 880.6850
III. PREDICATE DEVICE
The Kimberly Clark Kimguard® and Kimguard® ONE-STEP® sterilization wraps, cleared under K082177 is the primary predicate device utilized in this submission.
The following 510(k) numbers, also referencing the Kimberly Clark Kimguard® and Kimguard® ONE-STEP® sterilization wraps, are utilized as secondary predicate devices for this submission:
- . K082554, K091685, K141071, K092167, K112805, K113806, K141612
These predicate devices have not been subject to a design-related recall. No reference devices were used in this submission.
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IV. DEVICE DESCRIPTION
The Reliance® Solo and Reliance® Tandem Sterilization Wraps are square or rectangular nonwoven sheets produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The Reliance® SMS Sterilization Wraps are separated into two distinct product offerings:
Reliance® Tandem: Consists of single sheets of SMS wrap, where two sheets are used together for the sequential wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices.
Reliance® Solo: Consists of two sheets of SMS wrap, ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices.
The Reliance® Solo and Reliance® Tandem Sterilization Wraps are composed of polypropylene with the addition of blue or green pigment and an anti-static treatment. Reliance® Tandem and Reliance® Solo wraps allow a sterilized package of medical devices to be opened aseptically.
| Dimensions | T100/S100 | T200/S200 | T300/S300 | T400/S400 | T500/S500 | T600/S600 |
|---|---|---|---|---|---|---|
| 9 in. x 9 in. | x | |||||
| 12 in. x 12 in. | x | x | ||||
| 15 in. x 15 in. | x | x | ||||
| 18 in. x 18 in. | x | x | x | x | x | |
| 20 in. x 20 in. | x | |||||
| 24 in. x 24 in. | x | x | x | x | x | |
| 30 in. x 30 in. | x | x | x | x | x | |
| 36 in. x 36 in. | x | x | x | x | x | x |
| 40 in. x 40 in. | x | x | x | x | x | x |
| 45 in. X 45 in. | x | x | x | x | x | x |
| 48 in. x 48 in. | x | x | x | x | x | x |
| 54 in. x 54 in. | x | x | x | x | x | x |
| 60 in. x 60 in. | x | |||||
| 54 in. x 72 in. | x | x | x | x | x | x |
Table 1: Dimensional Specifications of Reliance® Tandem and Reliance® Solo Wrap Models
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| 54 in. x 90 in. | x | |||||
|---|---|---|---|---|---|---|
| ----------------- | -- | -- | -- | -- | --- | -- |
Wrap Model Recommendations
Table 2 provides the recommended wrapped package content weights by model and sterilization modality for the Reliance® Tandem and Solo products.
Table 2: Wrap Model Recommendations¹
| SterilizationWrapModels | Intended Load | Pre-Vacuumand Gravity*Steam andEO | Maximum Recommended Wrapped Package Content Weights2AdvancedSterilizationProducts (ASP)Sterrad®100S | AdvancedSterilizationProducts(ASP)Sterrad®100NX | SterisAmsco®V-PROLumen andNon LumenCycle | SterisAmsco®V-PROFlexCycle |
|---|---|---|---|---|---|---|
| T100andS100 | Very Light WeightPackage (for example:gauze or towel packs orbatteries) | 3 lbs* | 10.7 lbs | 10.7 lbs | 10.7 lbs | 3 lbs |
| T200andS200 | Light Weight Package(for example: standardlinen packs ortelescope with lightcord) | 6 lbs* | 10.7 lbs | 10.7 lbs | 10.7 lbs | 6.5 lbs |
| T300andS300 | Light to ModerateWeightPackage (for example:general use medicalinstruments) | 9 lbs* | 10.7 lbs | 10.7 lbs | 10.7 lbs | 9 lbs |
| T400andS400 | Moderate to HeavyWeight Package (forexample: general usemedical instruments) | 13 lbs* | 10.7 lbs | 10.7 lbs | 10.7 lbs | 9 lbs |
| T500andS500 | Heavy Weight Package(for example: generaluse medicalinstruments) | 17 lbs | 10.7 lbs | 10.7 lbs | 10.7 lbs | 9 lbs |
| T600andS600 | Very Heavy WeightPackage (for example:general use medicalinstruments) | 25 lbs | 10.7 lbs | 10.7 lbs | 10.7 lbs | 9 lbs |
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*Gravity Steam Sterilization is validated for models T100/S200, T300/S300, T400/S400 only. T500/S500 and T600/S600 models are not validated for gravity steam.
4 Individual results may differ due to factors such as variations in wrapping techniques, handling practices and folding methods. Results may also differ due to the use of irregularly shaped contents that may result in added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.
2 It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. In addition, it is recommended to not exceed the number, weight and size of individual content types that were validated Ahlstrom Nonwovens Sterilization Wraps (i.e. wrapped contents).
V. INDICATIONS FOR USE
Ahlstrom Reliance® Tandem and Solo Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:
- Pre-vacuum Steam 270°F/132°C for 4 minutes ●
- Gravity Steam 250°F/121°C for 30 minutes
- . 100% Ethylene Oxide (EO) with a concentration of 725-735 mg/L @ 131°F/55°C and 40% - 80% relative humidity for 60 minutes
- Advanced Sterilization Products (ASP) STERRAD® 100S
- Advanced Sterilization Products (ASP) STERRAD® 100NX (Standard, Express and Flex cycles)
- . STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems (Lumen, Non Lumen and Flexible Cycles)
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.
Pre-Vacuum Steam Sterilization:
- Validated for dry time of 20 minutes for Models T100/S100, T200/S200, T300/S300.
- Validated for dry time of 30 minutes for Models T400/S400, T500/S500, T600/S600.
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- All models of Reliance® Tandem and Solo validated for pre-vacuum steam sterilization with stainless steel lumens (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model.
Gravity Steam Sterilization:
- Validated for dry times of 20 minutes for Models T100/S100, T200/S200, T300/S300.
- Validated for dry times of 30 minutes for Models T400/S400.
- Models T100/S100, T200/S200, T300/S300, T400/S400 of Reliance® Tandem and Solo validated for gravity steam sterilization with stainless steel lumens (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model.
- Models T500/S500 and T600/S600 are not validated for use for gravity steam ASSAC sterilization.
Ethylene Oxide Sterilization:
- Validated for aeration time of 8 hours at 55°C
- All models of Reliance® Tandem and Solo validated for ethylene oxide sterilization . with stainless steel lumens (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model.
Advanced Sterilization Products (ASP) STERRAD® 100S Sterilization
- All models of Reliance® Tandem and Solo validated with ASP STERRAD® 100S . sterilization with stainless steel lumens (2 mm inside diameter or larger and a length of 250mm or less) as part of the load with a maximum weight of 10.7lbs dependent on the model.
Advanced Sterilization Products (ASP) STERRAD® 100NX Sterilization
- All models of Reliance® Tandem and Solo validated with ASP STERRAD® 100NX ● sterilization cycles detailed in Table 1.
| Advanced Sterilization Products (ASP)STERRAD® System and Cycle | Intended Load |
|---|---|
| 100NX Standard Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:An inside diameter of 0.7mm or larger and a length of 500mm or shorter of single-channel stainless steel lumens. |
| 100NX Flex Cycle | One or two single-channel flexible endoscopes with or without a silicone mat. Flexible endoscope may contain:A single channel Teflon/PE/PTFE lumen with an inside diameter of 1 mm or larger and a length of 850mm or shorter. (A maximum of two flexible endoscopes, one per tray per sterilization cycle) |
Table 1: Validated Advanced Sterilization Products (ASP) STERRAD® 100NX Cycles
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| 100NX Express Cycle | Non-lumened reusable metal and non-metalmedical devices requiring surface sterilization,or sterilization of mated stainless steel andtitanium surfaces, and rigid or semi-rigidendoscopes without lumens. |
|---|---|
| --------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems
- All models of Reliance® Tandem and Solo Sterilization Wraps have been validated . for use with STERIS V-PRO® cycles detailed in Table 2.
- . Reliance® Tandem and Solo Sterilization Wraps were validated to be effectively aerated during the pre-programmed STERIS Amsco V-PRO® Sterilization Cycles.
| STERIS Amsco® V-PRO Cycle | Intended Load |
|---|---|
| Lumen Cycle | Reusable metal and non-metal medicaldevices, including up to 20 stainless steellumens with dimensions of 3.0mm diameter orlarger and a length of 400mm or shorter. |
| Non Lumen Cycle | Non lumened reusable metal and non-metalmedical devices. |
| Flexible Cycle | Single lumen surgical flexible endoscopes andbronchoscopes in the following loadconfiguration:1.) One tray containing a flexible endoscopewith a light cord (if not integral to endoscope)and mat. The flexible endoscope having aninside diameter of 1 mm or larger and a lengthof 850 mm or shorter.2.) An additional tray containing non-lumenedmedical devices. |
Table 2: Validated STERIS Amsco® V-PRO Cycles
VI. COMPARISON OF TECHNOLIGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Manufacturer | Ahlstrom Nonwovens, LLC | Kimberly-Clark |
|---|---|---|
| Device Name | RELIANCE® Tandem and Solo Sterilization Wrap | Kimguard® and Kimguard® ONE-STEP® Sterilization wraps |
| Intended use | Reliance® Tandem and Solo Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider | Kimguard® Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider |
| Material Composition | Polypropylene spunbond-meltblown-spunbond (SMS) fabric | Polypropylene spunbond-meltblown-spunbond (SMS) fabric |
| Configurations/Dimensions | Various | Various |
| Sterilant Penetration | Pass per ANSI/AAMI ST79:2010 &A1:2010 and ANSI/AAMI/ISO14937:2009 | Substantially Equivalent |
| Validated for use inSterilization System | Pre-vacuum Steam 270°F/132°Cfor 4 minutes | Substantially Equivalent |
| Gravity Steam 250°F/121°C for 30minutes | Same, PlusKC500/KC600 | |
| 100% Ethylene Oxide (EO) with aconcentration of 725-735 mg/L@ 131°F/55°C and 40% - 80%relative humidity for 60 minutes | Substantially Equivalent | |
| (ASP) STERRAD® 100S, and 100NX(STANDARD, EXPRESS and Flexcycles) | Same, PlusSTERRAD® 50STERRAD® 200STERRAD® NX (Standard andAdvanced Cycles)STERRAD® 100NX DUO cycle | |
| STERIS Amsco® V-PRO 1 & V-PRO1 Plus (Non-Lumen and Lumencycles) and V-PRO maX cycle | Substantially Equivalent | |
| Microbial BarrierProperties (PackagingIntegrity) | Pass | Pass |
| Material Compatibility | Pass | Pass |
| Toxicological Properties(Biocompatibility) | Pass | Pass |
| Maintenance of Sterility | 90 days | 30 days (KC100, KC200, KC300,KC400, KC500, KC600)180 days (KC300, KC400, KC500,and KC600)365 days (KC300, KC400, KC500,and KC600) |
| Dry Time | Reliance® Tandem and SoloModels T100/S100, T200/S200,T300/S300: 20 minutesReliance® Tandem and SoloModels T400/S400, T500/S500,T600/S600: 30 minutes | Kimguard® ModelsKC100, KC200, KC300: 20minutesKimguard® ModelsKC400, KC500, KC600: 30minutesKimguard® ONE-STEP® ModelsKC100, KC200: 20 minutesKimguard® ONE-STEP® ModelsKC300, KC400, KC500, KC600:30 minutes |
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VII. PERFORMANCE DATA
Summary of Testing:
The Reliance® Tandem and Reliance® Solo Sterilization wrap performance has been tested in accordance with the applicable requirements recommended in Premarket Notification {510(k)} Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002). Testing included: biocompatibility (i.e., cytotoxicity) in compliance with the methods of ISO 10993, sterilant penetration, dry time, and physical integrity. The Sterilization wrap has also been tested for the ability to maintain sterility of pack contents after sterilization for up to 90 days under standard conditions. All results of testing met acceptance criteria.
Standards Utilized
- . AAMI / ANSI ST79: 2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities.
- . ASTM D737 - 04(2008): Standard Test Method for Air Permeability of Textile Fabrics
- ASTM D3776 - 96 (2002): Standard Test Methods for Mass Per Unit Area (Weight) of Fabric
- . ASTM D5034 - 95(2001): Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- . ASTM F2101-14, Standard Test Method For Evaluating The Bacterial Filtration Efficiency (Bfe) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus. (General Plastic Surgery/General Hospital)
- . BS EN 868-2:2009 Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods
- . ISO 9073-4:1997; Textiles -- Test methods for nonwovens -- Part 4: Determination of tear resistance
- . AAMI / ANSI / ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices --Part 5: Tests For In Vitro Cytotoxicity
- . AAMI / ANSI / ISO 10993-7:2008(R)2012, Biological Evaluation Of Medical Devices -Part 7: Ethylene Oxide Sterilization Residuals
- ISO 14937 Second Edition 2009-10-15, Sterilization Of Health Care Products - General Requirements For Characterization Of A Sterilizing Agent And The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices
VIII. CONCLUSIONS
In conclusion, the Reliance® Tandem and Solo Sterilization wraps are substantially equivalent to the Kimberly-Clark Kimguard® and Kimguard® ONE-STEP® in terms of general intended use, material composition, and configuration. Based on the results of the sterilization validation, shelf-life and physical performance testing, Ahlstrom Reliance® Tandem and Solo sterilization wraps are as safe and as effective, and perform as well as the predicate device, Kimberly-Clark Kimguard® and Kimguard® ONE-STEP®, for their intended use.
§ 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).