(131 days)
No reference devices were used in this submission.
No
The device is a physical sterilization wrap and the description focuses on its material composition and physical properties, with no mention of software, algorithms, or data processing.
No
The device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain their sterility, not to provide therapy directly.
No
This device is a sterilization wrap used to enclose other medical devices for sterilization and maintain their sterility, not to diagnose medical conditions.
No
The device description clearly states it is a physical, nonwoven sheet product made of polypropylene, intended for wrapping medical devices for sterilization. It is a hardware product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose other medical devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of disease or other conditions.
- Device Description: The device is a sterilization wrap made of nonwoven material. This description aligns with packaging for medical devices, not a diagnostic test or instrument.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Detecting the presence or absence of specific analytes
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, or controls
The device's function is purely related to the physical protection and maintenance of sterility for other medical devices.
N/A
Intended Use / 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.
- 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 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
FRG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider / Health Care Facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K082177, K082554, K091685, K141071, K092167, K112805, K113806, K141612
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines beneath them.
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
1
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
2
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.
3
| 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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EF PSC Publishing Services(301) 443-6740
5
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.
6
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
7
| 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
| Sterilization
Wrap
Models | Intended Load | Pre-Vacuum
and Gravity*
Steam and
EO | Maximum Recommended Wrapped Package Content Weights2
Advanced
Sterilization
Products (ASP)
Sterrad®
100S | Advanced
Sterilization
Products
(ASP)
Sterrad®
100NX | Steris
Amsco®
V-PRO
Lumen and
Non Lumen
Cycle | Steris
Amsco®
V-PRO
Flex
Cycle |
|---------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------|
| T100
and
S100 | Very Light Weight
Package (for example:
gauze or towel packs or
batteries) | 3 lbs* | 10.7 lbs | 10.7 lbs | 10.7 lbs | 3 lbs |
| T200
and
S200 | Light Weight Package
(for example: standard
linen packs or
telescope with light
cord) | 6 lbs* | 10.7 lbs | 10.7 lbs | 10.7 lbs | 6.5 lbs |
| T300
and
S300 | Light to Moderate
Weight
Package (for example:
general use medical
instruments) | 9 lbs* | 10.7 lbs | 10.7 lbs | 10.7 lbs | 9 lbs |
| T400
and
S400 | Moderate to Heavy
Weight Package (for
example: general use
medical instruments) | 13 lbs* | 10.7 lbs | 10.7 lbs | 10.7 lbs | 9 lbs |
| T500
and
S500 | Heavy Weight Package
(for example: general
use medical
instruments) | 17 lbs | 10.7 lbs | 10.7 lbs | 10.7 lbs | 9 lbs |
| T600
and
S600 | Very Heavy Weight
Package (for example:
general use medical
instruments) | 25 lbs | 10.7 lbs | 10.7 lbs | 10.7 lbs | 9 lbs |
8
*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.
9
- 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
10
| 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 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
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/ISO | ||
| 14937:2009 | Substantially Equivalent | |
| Validated for use in | ||
| Sterilization System | Pre-vacuum Steam 270°F/132°C | |
| for 4 minutes | Substantially Equivalent | |
| Gravity Steam 250°F/121°C for 30 | ||
| minutes | Same, Plus | |
| KC500/KC600 | ||
| 100% Ethylene Oxide (EO) with a | ||
| concentration 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 Flex | ||
| cycles) | Same, Plus | |
| STERRAD® 50 | ||
| STERRAD® 200 | ||
| STERRAD® NX (Standard and | ||
| Advanced Cycles) | ||
| STERRAD® 100NX DUO cycle | ||
| STERIS Amsco® V-PRO 1 & V-PRO | ||
| 1 Plus (Non-Lumen and Lumen | ||
| cycles) and V-PRO maX cycle | Substantially Equivalent | |
| Microbial Barrier | ||
| Properties (Packaging | ||
| Integrity) | 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 Solo | |
| Models T100/S100, T200/S200, | ||
| T300/S300: 20 minutes | ||
| Reliance® Tandem and Solo | ||
| Models T400/S400, T500/S500, | ||
| T600/S600: 30 minutes | Kimguard® Models | |
| KC100, KC200, KC300: 20 | ||
| minutes | ||
| Kimguard® Models | ||
| KC400, KC500, KC600: 30 | ||
| minutes | ||
| Kimguard® ONE-STEP® Models | ||
| KC100, KC200: 20 minutes | ||
| Kimguard® ONE-STEP® Models | ||
| KC300, 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.