(323 days)
Reliance® Fusion 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
- Dry time of 12 minutes for Fusion Light O
- Dry time of 20 minutes for Fusion Heavy O
- Pre-vacuum steam sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in O length or less.
- 100% Ethylene Oxide (EO) with a concentration of 725-759 mg/L @ 131°F/55°C and 40% 70% relative ● humidity for 60 minutes
- Aeration time of 8 hours at 55oC O
- Ethylene oxide sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in O length or less.
The Reliance® Fusion Sterilization Wraps are square or rectangular nonwoven sheets consisting of two layers of nonwoven 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 Fusion wraps consist of two distinct nonwovens for each layer.
Outer Layer: SMS nonwoven layer produced using a spunbond-meltblown-spunbond process and composed of polypropylene with blue pigment and an anti-static treatment.
Inner Layer: Wetlaid nonwoven, produced using a wood pulp process, composed of natural wood pulp and synthetic fibers bonded with a synthetic binder, containing green pigment and treated to impart hydrophilic properties.
The Reliance® Fusion Sterilization Wraps allow a sterilized package of medical devices to be opened aseptically and are supplied in a variety of sheet sizes ranging from 12 in. x 12 in. The Sterilization Wraps have no intended patient contact and are supplied non-sterile. They are for Single Use Only.
The provided text describes the regulatory clearance for the Ahlstrom-Munksjo Nonwovens LLC's Reliance® Fusion Sterilization Wraps (K230137), not an AI/medical imaging device. Therefore, the details requested in the prompt, such as acceptance criteria for AI performance, sample sizes for test sets in AI studies, expert qualifications for ground truth in AI, MRMC studies, and training set details, are not applicable to this document.
This document focuses on the substantial equivalence of a physical medical device (sterilization wraps) to a predicate device, which is demonstrated through non-clinical performance data related to material science, sterilization efficacy, and biocompatibility.
Here's a breakdown of the information that is available in the document, framed in the context of the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria," but adapted for a physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a comprehensive table in Section VII "PERFORMANCE DATA" detailing the tests performed, the standards followed, the acceptance criteria, and the results for both the predicate and proposed devices.
| Test Performed | Standards | Acceptance Criteria | Proposed Device Performance | Comments |
|---|---|---|---|---|
| Sterilization Penetration / Efficacy | ANSI/AAMI ST79:2017 & ANSI/AAMI/ISO 14937:2009/(R)2013 | All Test Samples and Biological Indicators (BIs) negative for growth following minimum incubation period; Integrators/indicators demonstrate sterilant penetration | Pass | Similar to predicate |
| Dry Time Validation Study (Pre-Vacuum Steam) | ANSI/AAMI ST79:2017 | Average pre- and post-sterilization weight difference of less than 0.2% within 5 min of cycle completion; Tray, contents, and sterilization wrap free of visible moisture following cooling period | Pass | Similar to predicate |
| Maintenance of Package Sterility (180 Day Shelf Life) | ANSI/AAMI ST79:2017 & ANSI/AAMI/ISO 14937:2009/(R)2013 | Negative for growth | Pass | Same as predicate |
| Microbial Barrier | Microbial Aerosol Challenge Test (Pre-Vacuum Steam and Ethylene Oxide) | Gauze fallout samples ≥400 CFU/cm² | Pass | Same as predicate |
| Biocompatibility | ISO 10993-5:2009 Tests for in vitro cytotoxicity | Less than or equal to mild cellular reactivity | Pass | Same as predicate |
| Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) Residual Analysis | ISO 10993-7:2008/(R)2012 | EO residuals ≤ 4mg of EO/ADD; ECH residuals ≤ 9 mg of ECH/ADD; All EO Tolerable Contact Limits (TCL) ≤10µg/cm² of EO/ADD; All ECH Tolerable Contact Limits (TCL) ≤ 5 mg/cm² of ECH/ADD | Pass | Same as predicate |
| Material Compatibility: Physical Property Testing (Non-Sterile & Sterile) | Air Permeability (ASTM D737-04), Basis Weight (ASTM D3776-96), Bursting Strength (WSP 30.1.R3 (12)), Grab Tensile CD (ASTM D5034-95), Trapezoid Tear MD (ISO 9073-4), Hydrohead (WSP.080.6.R4 (12)), Bacterial Filtration Efficiency (ASTM F2101-19 and ASTM F2101-23), Gelbo Linting (ISO 9073-10:2003) | Meets physical property specifications, Non-Sterile and after Pre-vacuum Steam or Ethylene Oxide Sterilization Processes | Pass | Differences in test standard revision numbers have no impact on test methodology and therefore no impact on safety or efficacy. |
2. Sample size used for the test set and the data provenance:
The document does not specify exact sample sizes for each test. For a physical device like sterilization wraps, individual tests (e.g., sterilization efficacy, dry time, physical properties) would involve a certain number of units or replicates to demonstrate statistical validity. The provenance is not explicitly stated beyond being part of the manufacturer's non-clinical testing performed for regulatory submission. It is inherently "prospective" in the sense that these are specific tests conducted by the manufacturer for this submission, rather than retrospective analysis of existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this is not an AI/medical imaging device. Ground truth in this context would be established by validated laboratory testing procedures and adherence to the specified standards (e.g., ISO, ASTM, AAMI).
4. Adjudication method for the test set:
This is not applicable as there are no human interpretations or judgments to adjudicate in the performance testing of a physical sterilization wrap. The results are quantitative measurements against defined criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
This is not applicable as this is not an AI/medical imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as there is no algorithm or AI involved. The "performance" is the physical functional performance of the wrap itself.
7. The type of ground truth used:
The "ground truth" for this device's performance is established by validated laboratory testing methods against recognized industry standards (e.g., ANSI/AAMI, ISO, ASTM). For example:
- Sterilization Efficacy: Determined by the absence of microbial growth from biological indicators and test samples.
- Dry Time: Quantified by weight difference and visual assessment of moisture.
- Physical Properties: Measured using standardized mechanical and material testing methods (e.g., tensile strength, burst strength, air permeability).
- Biocompatibility & Residuals: Determined by laboratory assays per ISO standards.
8. The sample size for the training set:
This is not applicable as there is no training set for a physical medical device like this.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set.
In conclusion: The provided document details the non-clinical performance testing of a physical medical device (sterilization wraps) to demonstrate substantial equivalence to a predicate device for FDA clearance. The acceptance criteria and "studies" are laboratory and physical tests, not AI model evaluations.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" on the first line and "ADMINISTRATION" on the second line.
December 7, 2023
Ahlstrom-Munksjo Nonwovens LLC % Ryan Burke Quality and Regulatory Consultant AJW Technology Consultants, Inc. 11705 Boyette Road, Suite 503 Riverview. Florida 33569
Re: K230137
Trade/Device Name: Reliance® Fusion Sterilization Wraps Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: November 8, 2023 Received: November 9, 2023
Dear Ryan Burke:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Colin
O'neill -S
FDA
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K230137
Device Name Reliance® Fusion Sterilization Wraps
Indications for Use (Describe)
Reliance® Fusion 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
- Dry time of 12 minutes for Fusion Light O
- Dry time of 20 minutes for Fusion Heavy O
- Pre-vacuum steam sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in O length or less.
- 100% Ethylene Oxide (EO) with a concentration of 725-759 mg/L @ 131°F/55°C and 40% 70% relative ● humidity for 60 minutes
- Aeration time of 8 hours at 55oC O
- Ethylene oxide sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in O length or less.
| Wrap Sheet Size, Maximum Recommended Wrapped Package Content | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Weight: Pre-Vacuum Steam and Ethylene Oxide¹ | ||||||||||||
| Wrap Code | Material | Intended | 12" x | 15" x | 18" x | 24" x | 30" x | 36" x | 40" x | 48" x | 54" x | 54" x |
| Type | Load | 12" | 15" | 18" | 24" | 30" | 36" | 40" | 48" | 54" | 72" | |
| Reliance®Fusion Light | Outer SMS / InnerAbsorbentWetlaid Layer | Light to ModerateWeight Package(e.g. general usemedicalinstruments) | 1.8 lb | 2.0 lb | 2.4 lb | 3.2 lb | 4.3 lb | 5.7 lb | 6.7 lb | 9 lb | 9 lb | 9 lb |
| Reliance®Fusion Heavy | Outer SMS / InnerAbsorbentWetlaid Layer | Very HeavyWeight Package(e.g. general usemedicalinstruments) | 1.8 lb | 2.6 lb | 3.7 lb | 6.4 lb | 9.9 lb | 14.2 lb | 17.5 lb | 25 lb | 25 lb | 25 lb |
Table 1: Reliance® Fusion Models and Load Recommendations
1 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 for Reliance® Fusion Sterilization Wraps (i.e. wrapped contents).
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Table 2: Fusion Wrap Models, sheet color
| Reliance®FusionModels | Wrap Layer | IndividualSheetColor |
|---|---|---|
| Light | Outer Layer | Light Blue |
| Light | Inner Layer | Green |
| Heavy | Outer Layer | Dark Blue |
| Heavy | Inner Layer | Green |
Type of Use (Select one or both, as applicable)
| X Over-The-Counter Use (21 CFR 801 Subpart C)
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l. SUBMITTER
AHLSTROM NONWOVENS LLC 2 Elm Street Windsor Locks, CT 06096 Phone: (860) 654-8556
Contact Person: Gary Jackson Regulatory Affairs gary.jackson@ahlstrom.com Date Prepared: December 6, 2023
II. DEVICE
| Name of Device: | Reliance® Fusion Sterilization Wraps |
|---|---|
| Common or Usual Name: | Sterilization Wrap |
| Classification Name: | Sterilization Wrap (21 CFR 880.6850) |
| Regulatory Class: | 2 |
| Product Code: | FRG |
PREDICATE DEVICE lll.
Primary Predicate:
Reliance® Solo and Reliance® Tandem Sterilization Wrap, K171533
| 510(k) | Device Name | Regulation Number andClassification Name | Device Class andProduct Code |
|---|---|---|---|
| K171533 | Reliance® Solo Sterilization Wrap,Reliance® Tandem Sterilization Wrap | 21 CFR 880.6850Wrap, Sterilization | Class 2, FRG |
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Reliance® Fusion Sterilization Wraps are square or rectangular nonwoven sheets consisting of two layers of nonwoven 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 Fusion wraps consist of two distinct nonwovens for each layer.
Outer Layer: SMS nonwoven layer produced using a spunbond-meltblown-spunbond process and composed of polypropylene with blue pigment and an anti-static treatment.
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Inner Layer: Wetlaid nonwoven, produced using a wood pulp process, composed of natural wood pulp and synthetic fibers bonded with a synthetic binder, containing green pigment and treated to impart hydrophilic properties.
The Reliance® Fusion Sterilization Wraps allow a sterilized package of medical devices to be opened aseptically and are supplied in a variety of sheet sizes ranging from 12 in. x 12 in. The Sterilization Wraps have no intended patient contact and are supplied non-sterile. They are for Single Use Only.
V. INDICATIONS FOR USE
Reliance® Fusion 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
- Dry time of 12 minutes for Fusion Light O
- o Dry time of 20 minutes for Fusion Heavy
- Pre-vacuum steam sterilization of two stainless steel lumens о 3 mm in diameter or larger and 400 mm in length or less.
- 100% Ethylene Oxide (EO) with a concentration of 725-759 mg/L @ 131°F/55°C and 40% - 70% relative humidity for 60 minutes
- O Aeration time of 8 hours at 55ºC
- Ethylene oxide sterilization of two stainless steel lumens 3 mm in O diameter or larger and 400 mm in length or less.
| Wrap Code | MaterialType | IntendedLoad | 12" x12" | 15" x15" | 18" x18" | 24" x24" | 30" x30" | 36" x36" | 40" x40" | 48" x48" | 54" x54" | 54" x72" |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Reliance®Fusion Light | Outer SMS / InnerAbsorbentWetlaid Layer | Light to ModerateWeight Package(e.g. general usemedicalinstruments) | 1.8 lb | 2.0 lb | 2.4 lb | 3.2 lb | 4.3 lb | 5.7 lb | 6.7 lb | 9 lb | 9 lb | 9 lb |
| Reliance®Fusion Heavy | Outer SMS / InnerAbsorbentWetlaid Layer | Very HeavyWeight Package(e.g. general usemedicalinstruments) | 1.8 lb | 2.6 lb | 3.7 lb | 6.4 lb | 9.9 lb | 14.2 lb | 17.5 lb | 25 lb | 25 lb | 25 lb |
Table 1: Reliance® Fusion Models and Load Recommendations
41 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 valiance® Fusion Sterilization Wraps (i.e. wrapped contents).
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Table 2: Fusion Wrap Models, sheet color
| Reliance®FusionModels | Wrap Layer | IndividualSheetColor |
|---|---|---|
| Light | Outer Layer | Light Blue |
| Inner Layer | Green | |
| Heavy | Outer Layer | Dark Blue |
| Inner Layer | Green |
VI. TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE
| Element ofComparison | PREDICATE:RELIANCE® Solo and TandemSterilization Wrap | SUBJECT (Modified Device):RELIANCE® FusionSterilization Wrap | Comparisonto Predicate |
|---|---|---|---|
| 510(k) Number | K171553 | K230137 | NA |
| Regulation Number | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| Product Code | FRG | FRG | Same |
| Device Classification | 2 | 2 | Same |
| Classification Name | Wrap, Sterilization | Wrap, Sterilization | Same |
| Indications for Use | Ahlstrom Reliance® Tandem andSolo Sterilization Wraps areintended to be used to encloseanother medical device that is tobe sterilized by a healthcareprovider via the following:Pre-vacuum Steam 270°F/132°Cfor 4 minutes:Validated for dry time of 20minutes for Models T100/S100,T200/S200, T300/S300. x Validatedfor dry time of 30 minutes forModels T400/S400, T500/S500,T600/S600. All models of Reliance®Tandem and Solo validated for pre-vacuum steam sterilization withstainless steel lumens as part ofthe load with a maximum weightof 25lbs dependent on the model | Ahlstrom Reliance® FusionSterilization Wraps are intendedto be used to enclose anothermedical device that is to besterilized by a healthcareprovider via thefollowing:Pre-vacuum Steam 270°F/132°Cfor 4 minutes:-Dry time of 12 minutes forReliance® Fusion Light-Dry time of 20 minutes forFusion Heavy-Pre-vacuum steam sterilizationusing two stainless steel lumens3 mm in diameter or larger and400 mm in length or less. | SimilarSee note 1A |
| 100% Ethylene Oxide (EO) with aconcentration of 725-735 mg/L @131°F/55°C and 40% - 80% relativehumidity for 60 minutesValidated for aeration time of 8 | 100% Ethylene Oxide (EO) with aconcentration of 725-759 mg/L@ 131°F/55°C and 40% - 70%relative humidity for 60 minutes: | ||
| hours at 55°C. All models ofReliance® Tandem and Solovalidated for ethylene oxidesterilization with stainless steellumens as part of the load with amaximum weight of 25lbsdependent on the model. | -Aeration time of 8 hours at 55°C-Two stainless steel lumens 3mm in diameter or larger and400 mm in length or less. | ||
| The wrap is intended to allowsterilization of the enclosedmedical device(s) and maintainsterility of the enclosed device(s)until used. | The wrap is intended to allowsterilization of the enclosedmedical device(s) and maintainsterility of the enclosed device(s)until used. | ||
| See also the Indications for Usestatement in Section V forTables 1 & 2. | |||
| Indications for Use | -Gravity Steam 250°F/121°C for 30minutes | Not to be Used | DifferentSee note 5A |
| -Advanced Sterilization Products(ASP) STERRAD® 100S-Advanced Sterilization Products(ASP) STERRAD® 100NX (Standard,Express and Flex cycles)-STERIS Amsco® V-PRO 1, STERISAmsco® V-PRO 1 Plus, STERISAmsco® V-PRO maX LowTemperature Sterilization Systems(Lumen, Non Lumen and FlexibleCycles) | |||
| Advanced Sterilization Products(ASP) STERRAD® 100SSterilization: All models ofReliance® Tandem and Solovalidated with ASP STERRAD® 100Ssterilization with stainless steellumens as part of the load with amaximum weight of 10.7lbsdependent on the model. | |||
| Advanced Sterilization Products(ASP) STERRAD® 100NXSterilization: All models ofReliance® Tandem and Solovalidated with ASP STERRAD®100NX sterilization cycles |
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| Validated Advanced Sterilization | |
|---|---|
| Products (ASP) STERRAD® 100NX | |
| Cycles Advanced Sterilization | |
| Products (ASP) STERRAD® System | |
| and Cycle: | |
| 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. | |
| 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 VPRO® cycles. | |
| Reliance® Tandem and Solo | |
| Sterilization Wraps were validated | |
| to be effectively aerated during | |
| the preprogrammed STERIS Amsco | |
| V-PRO® Sterilization Cycles. | |
| Validated STERIS Amsco® V-PRO | |
| Cycles STERIS Amsco® V-PRO | |
| Cycle: | |
| Lumen Cycle: | |
| Reusable metal and non-metal | |
| medical devices, including up to 20 | |
| stainless steel lumens with |
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| dimensions of 3.0mm diameter orlarger and a length of 400mm orshorter.Non Lumen Cycle:Non lumened reusable metal andnon-metal medical devices.Flexible Cycle:Single lumen surgical flexibleendoscopes and bronchoscopes inthe following load configuration:1.) One tray containing a flexibleendoscope with a light cord (if notintegral to endoscope) and mat.The flexible endoscope having aninside diameter of 1 mm or largerand a length of 850 mm or shorter.2.) An additional tray containingnon-lumened medical devices. | |||
|---|---|---|---|
| Manufacturer | Ahlstrom Nonwovens LLC | Ahlstrom Nonwovens LLC | Same |
| Intended Use | Reliance® Tandem andSolo Sterilization Wrap is intendedto be used to enclose anothermedical device that is to besterilized by a health care provider | Reliance® Fusion SterilizationWrap is intended to be used toenclose another medical devicethat is to be sterilized by a healthcare provider | Similar |
| Product Name | Reliance® Solo S100, Reliance®Solo S200, Reliance® Solo S300,Reliance® Solo S400, Reliance®Solo S500, Reliance® Solo, S600 | Reliance® Fusion Light, Reliance®Fusion Heavy | Different.No productimpact. |
| MaterialComposition | OUTER LAYER: Polypropylenespunbond-meltblown-spunbond(SMS) nonwoven fabricINNER LAYER: Polypropylenespunbond-meltblown-spunbond(SMS) nonwoven fabric | OUTER LAYER: Polypropylenespunbond-meltblown-spunbond(SMS) nonwoven fabricINNER LAYER: Absorbent Wetlaidnonwoven fabric | Different.See note 2A. |
| Drying Time | Reliance® Tandem and SoloModels T100/S100, T200/S200,T300/S300: 20 minutesReliance® Tandem and SoloModels T400/S400, T500/S500,T600/S600: 30 minutes | Reliance® Fusion Light:12 minutesReliance® Fusion Heavy:20 minutes | Different.See note 3A |
| Configurations /Dimensions | Sheet sizes:12 inch x 12 inch,15 inch x 15 inch,18 inch x 18 inch,24 inch x 24 inch,30 inch x 30 inch,36 inch x 36 inch,40 inch x 40 inch, | Sheet sizes:12 inch x 12 inch,15 inch x 15 inch,18 inch x 18 inch,24 inch x 24 inch,30 inch x 30 inch,36 inch x 36 inch,40 inch x 40 inch, | Same |
| 48 inch x 48 inch,54 inch x 54 inch,54 inch x 72 inch | 48 inch x 48 inch,54 inch x 54 inch,54 inch x 72 inch | ||
| Sterilant Penetration | Pass per ANSI/AAMI ST79:2010 &A1:2010 and ANSI/AAMI/ISO14937:2009 | Pass per ANSI/AAMI ST79:2017,ANSI/AAMI/ISO14937:2009/(R)2013 | Similar. Seenote 4A |
| Maintenance ofSterility | 180 days | 180 days | Similar |
| SterilizationParameters | 100% Ethylene Oxide (EO) with aconcentration of 725-735 mg/L @131°F/55°C and 40% - 80% relativehumidity for 60 minutes | 100% Ethylene Oxide (EO) with aconcentration of 725-759 mg/L@ 131°F/55°C and 40% - 70%relative humidity for 60 minutes | Similar |
| Pre-vacuum Steam 270ºF/132ºCfor 4 minutes | Pre-vacuum Steam 270ºF/132ºCfor 4 minutes | Same | |
| Gravity Steam 250°F/121°C for 30minutes | N/A - Not for use with GravitySteam | Different.See note 5A | |
| (ASP) STERRAD® 100S, and 100NX(STANDARD, EXPRESS and FLEXcycles) | N/A - Not for use with STERRADSterilizers | Different.See note 5A | |
| STERIS Amsco® V-PRO 1 & V-pro 1Plus (Non-Lumen and LumenCycles) and V-PRO maX cycle | N/A – Not for use with V-PROSterilizers | Different.See note 5A | |
| Microbial BarrierProperties(Packaging Integrity) | Microbial Aerosol Challenge Test,Pre-Vacuum Steam and EthyleneOxideGauze fallout samples ≥400CFU/cm²Pass | Microbial Aerosol Challenge Test,Pre-Vacuum Steam and EthyleneOxideGauze fallout samples ≥400CFU/cm²Pass | Same |
| MaterialCompatibility | Pass | Pass | Same |
| ToxicologicalProperties(Biocompatibility) | Pass | Pass | Same |
| Pigment Contents | Pigment Blue, Pigment Violet,Pigment Red, Pigment White,Pigment Black, Pigment Green | Pigment Blue, Pigment Violet,Pigment Red, Pigment White,Pigment Black, Pigment Green,Pigment Yellow | Different.See note 6A |
| Composition ofMaterials | Polypropylene | Polypropylene, Cellulose,Polyester, & Acrylic binder | Different.See Note 7A |
| Shelf Life(Nonsterile) | 5 years | 3 years | Different.See Note 8A |
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Note 1A: Differences for Pre-vacuum Steam: Testing of modified device confirms safety and efficacy for intended use at modified dry time. For Ethylene Oxide, concentration and humidity were similar due to worst case validation sterilization parameters for the modified device studies. For predicate peroxide sterilization: different, due to peroxide sterilization being incompatible with the inner wetlaid layer.
Note 2A: No impact on safety or efficacy for intended use based on biocompatibility and simulated use testing.
Note 3A: Dry Time validations and simulated use testing confirm safety and efficacy for intended use.
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Note 4A: Changes in standard revision did not impact test methodology used.
Note 5A: Differences are outside the scope of the proposed devices intended use and will not affect the safety and efficacy for its intended use.
Note 6A: No impact on safety or efficacy for intended use based on biocompatibility and simulated use testing.
Note 7A: No impact on safety or efficacy for intended use based on results of biocompatibility and validation testing.
Note 8A: No impact on safety or efficacy for intended use within the shelf-life period based on performance testing.
VII. PERFORMANCE DATA
Performance data for the Reliance Fusion Sterilization Wraps confirm that the device conforms to design specifications. Clinical data was not required for this submission.
| Predicate | Proposed | ||||
|---|---|---|---|---|---|
| Test Performed | Standards | Acceptance Criteria | Device | Device | Comments |
| SterilizationPenetration / Efficacy | Sterilization EfficacyValidation, half-cycle,Pre-Vacuum Steam andEthylene OxideANSI/AAMI ST79:2010& A1:2010 (Predicate)ANSI/AAMI ST79:2017(Proposed Device)ANSI/AAMI/ISO14937:2009/(R)2013 | All Test Samples and Blsnegative for growthfollowing minimumincubation period;Integrators/indicatorsdemonstrate sterilantpenetration | Pass | Pass | Similar |
| Dry Time ValidationStudy | Dry Time ValidationStudy,Pre-Vacuum Steam (4min. @ 132C)ANSI/AAMI ST79:2010& A1:2010 (Predicate)ANSI/AAMI ST79:2017(Proposed Device) | Average pre- and post-sterilization weightdifference of less than0.2% within 5 min ofcycle completion; Tray,contents andsterilization wrap free ofvisible moisturefollowing cooling period | Pass | Pass | Similar |
| Maintenance ofPackage Sterility | 180 Day Event RelatedShelf Life Study,Pre-Vacuum Steam andEthylene OxideANSI/AAMI ST79:2010& A1:2010 (Predicate)ANSI/AAMI ST79:2017(Proposed Device)ANSI/AAMI/ISO14937:2009/(R)2013 | Negative for growth | Pass | Pass | Same |
| Test Performed | Standards | Acceptance Criteria | PredicateDevice | ProposedDevice | Comments |
| Microbial Barrier | Microbial AerosolChallenge Test,Pre-Vacuum Steam andEthylene Oxide | Gauze fallout samples$≥400 CFU/cm²$ | Pass | Pass | Same |
| Biocompatibility | ISO 10993-5:2009 Testsfor in vitro cytotoxicity | Less than or equal tomild cellular reactivity | Pass | Pass | Same |
| Ethylene Oxide (EO)and EthyleneChlorohydrin (ECH)Residual Analysis | ISO 10993-7:2008/(R)2012 | EO residuals ≤ 4mg ofEO/ADDECH residuals ≤ 9 mg ofECH/ADDAll EO Tolerable ContactLimits (TCL) ≤10µg/cm²of EO/ADDAll ECH TolerableContact Limits (TCL) ≤ 5mg/cm² of ECH/ADD | Pass | Pass | Same |
| MaterialCompatibility:Physical PropertyTesting Non-Sterile &Sterile | Air PermeabilityASTM D737-04 | Meets physical propertyspecifications, Non-Sterile and after Pre-vacuum Steam orEthylene OxideSterilization Processes | Pass | Pass | Different,See note 1B |
| Basis Weight ASTMD3776-96 | Pass | Pass | |||
| Bursting StrengthWSP 30.1.R3 (12) | Pass | Pass | |||
| Grab Tensile CDASTM D5034-95 | Pass | Pass | |||
| Trapezoid TearMD ISO 9073-4 | Pass | Pass | |||
| HydroheadWSP.080.6.R4 (12) | Pass | Pass | |||
| Bacterial FiltrationEfficiency | Pass | Pass | |||
| ASTM F2101-07 /EN14683:2014(Predicate) | Pass | Pass | |||
| ASTM F2101-19 andASTM F2101-23 (SubjectDevice) | Pass | Pass | |||
| Gelbo LintingISO 9073-10:2003 | Pass | Pass |
Summary of Non-Clinical Testing
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Note 1B: Differences in test standard revision numbers have no impact on test methodology and therefore no impact on safety or efficacy of the proposed device.
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NON-CLINCIAL TEST CONCLUSION
In summary, pre-, and post-sterilization physical performance test results of Reliance® Fusion wrap models demonstrate the robustness required of sterilization wraps. The non-clinical tests were selected to evaluate the overall performance criteria needed to ensure safety and efficacy of the proposed device.
VIII. CONCLUSIONS
The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicate device K171533.
§ 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).