(83 days)
Not Found
No
The device is a sterilization pouch with chemical indicators, which are passive color-changing elements, not AI/ML technology.
No
The device is a sterilization pouch and roll intended to enclose and maintain sterility of medical devices, not to treat or diagnose patients.
No
Explanation: The device is a sterilization pouch and roll intended to enclose devices for sterilization and maintain their sterility, not to diagnose a condition. While it has chemical indicators, these only confirm exposure to a sterilant, not a diagnostic outcome.
No
The device is a physical sterilization pouch and roll with integrated chemical indicators, not a software application.
Based on the provided text, the SIGMA sterilization pouch and roll is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to enclose devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not for performing tests on samples taken from the human body.
- Device Description: The description focuses on the physical properties of the pouch/roll, its ability to withstand sterilization processes, maintain sterility, and the function of the chemical indicators to show exposure to sterilant. None of these functions involve analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Using reagents or assays
- Measuring analytes
The SIGMA sterilization pouch and roll is a medical device used in the sterilization process of other medical devices. Its function is to facilitate and maintain the sterility of those devices, not to perform a diagnostic test.
N/A
Intended Use / Indications for Use
The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
The SIGMA sterilization pouch and roll is offered in the following 5 types:
- Self-sealing sterilization pouches
- Sterilization pouches, Flat
- Sterilization pouches, Gusseted
- Sterilization rolls. Flat
- Sterilization rolls. Gusseted
Product codes (comma separated list FDA assigned to the subject device)
FRG, JOJ
Device Description
The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization.
The Self-seal pouch permits sealing of the pouch without need of heat- sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the steam/or EO Sterilization cycles.
The chemical indicators ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas. The color of Chemical Indicator changes from Blue to Greenish Black, when exposed to Steam. And the color changes from red to yellow, when exposed to EO gas.
The Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.
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
Health care workers / Not specified for care setting, but for sterilization of medical devices.
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 SIGMA sterilization pouch and roll has the identical intended use and indication for use as the predicate devices. The subject device was compared to the predicate device by testing the Sterilant Penetration, Drying Time, Aeration, Biocompatibility, Package Integrity, Material Compatibility, Sterility Maintenance, and Chemical Indicator Efficacy.
The results of the SIGMA sterilization pouch and roll validation studies demonstrate that the sterilization pouches perform as intended. The results are summarized as follows:
- The Sterilant Penetration, Drying Time, Aeration, testing performed as described in AAMI / ANSI / ISO 17665-1:2006/(R)2013 and ISO TS 17665-2:2009 for steam sterilization as well as AAMI / ANSI / ISO 11135:2014 for EO. The testing results demonstrate the ability of the sterilant to penetrate the Sigma Sterilization Pouch and Roll.
- The Biocompatibility testing performed as described in ISO 10993-10:2010(E), ISO 10993-1:2009/Cor. 1:2010(E), ISO 10993-12:2012(E), and ISO/IEC 17025:2005. The testing results demonstrate the Sigma Sterilization Pouch and Roll showed "hegative reaction". And the SIGMA sterilization pouch and roll meets the requirements ISO 10993-10:2010(E). The EO sterilization residuals meets the requirements AAMI / AN-SI / ISO 10993-7:2008 (R) 2012.
- The Package Integrity, Material Compatibility, Sterility Maintenance testing performed as described in AAMI / ANSI / ISO 11607-1:2006//A1:2014, "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems"; ASTM D882, "Standard Test Method for Tensile Properties of Thin Plastic Sheeting"; ASTM D 5035, "Standard Test Method for Breaking Force and Elongation of Textile Fabrics (Strip Method)": ASTM F 2251-03, "Standard Test Method for Thickness Measurement of Flexible Packaging Material"; ASTM D 1922. "Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method": ASTM F 1140-07, "Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages"; ASTM F 1929-98 (04), "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration"; ASTM F88/F88M-09, "Standard Test Method for Seal Strength of Flexible Barrier Materials"; ASTM F 1980-2007, "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices"; DIN 58953-6:2010-05, "Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized". The testing results demonstrate the ability of the Sigma Sterilization Pouch and Roll to maintain the package integrity over the claimed shelf life.
The Chemical Indicator Efficacy testing performed as described in AAMI / ANSI / ISO 11140-1:2014 "Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements". There are two types of the Process Indicator ink printed on the SIGMA sterilization pouch and roll. The description of the two types ink as follows:
- Class 1 Process Indicators for STEAM The testing demonstrates the ability of the Sigma Sterilization Pouch and Roll and its Class 1 Process Indicators for STEAM to remain stable before use based on its shelf life data, change color in the presence of the sterilant, and to maintain the endpoint stability of the color change after being in the presence of the sterilant. The STEAM Process Indicators ink printed on the SIGMA sterilization pouch and roll meets the requirements ISO 11140-1:2014.
- Class 1 Process Indicators for EO gas The testing demonstrates the ability of the Sigma Sterilization Pouch and Roll and its Class 1 Process Indicators for STEAM to remain stable before use based on its shelf life data, change color in the presence of the sterilant, and to maintain the endpoint stability of the color change after being in the presence of the sterilant. The EO gas Process Indicators ink printed on the SIGMA sterilization pouch and roll meets the requirements ISO 11140-1:2014.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 5, 2018
Sigma Medical Supplies Corp. % Uta Shih Regulatory Affairs Manager Sen Mu Technology Co., LTD. 15F .- 2, No.1, Lane 26, Mincyuan 1st Rd., Lingya District Kaohsiung City, 802 Taiwan
Re: K180661
Trade/Device Name: SIGMA Sterilization Pouch and Roll Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: February 27, 2018 Received: March 14, 2018
Dear Uta Shih:
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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in 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.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Geeta K. Pamidimukkala -S
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
Indications for Use
510(k) Number (if known) K180661
Device Name SIGMA sterilization pouch and roll
Indications for Use (Describe)
The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
The SIGMA sterilization pouch and roll is offered in the following 5 types:
- Self-sealing sterilization pouches
- Sterilization pouches, Flat
- Sterilization pouches, Gusseted
- Sterilization rolls. Flat
- Sterilization rolls. Gusseted
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
3
The defining characteristics of the 5 types as follows:
- · Self-sealing sterilization pouches: These pouches are made from a medical grade plastic film that is heat sealed on three sides. The forth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas.
- · Sterilization pouches, Flat: These pouches has the same components with the Self-sealing sterilization pouches, except the forth side is left opened instead of an adhesive strip and will be heat-sealed when using.
- · Sterilization pouches, Gusseted: These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
- · Sterilization rolls, Flat: These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heatsealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.
- · Sterilization rolls, Gusseted: These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
4
The following table (Table 1) lists the model numbers of the SIGMA sterilization pouch and roll by type, model, dimensions, and content/max load (1bs):
| Type | Dimension in S.I. | *Content / Max Load (lbs) |
|---|---|---|
| Self-Sealing Sterilization Pouches | 57 mm × 133 mm | Metal 0.02 |
| Self-Sealing Sterilization Pouches | 70 mm × 257 mm | Plastic 0.01 |
| Self-Sealing Sterilization Pouches | 90 mm × 162 mm | Linens and Gauze 0.01 |
| Self-Sealing Sterilization Pouches | 90 mm × 168 mm | |
| Self-Sealing Sterilization Pouches | 70 mm × 257mm | |
| Self-Sealing Sterilization Pouches | 90 mm × 257 mm | |
| Self-Sealing Sterilization Pouches | 90 mm × 265 mm | |
| Self-Sealing Sterilization Pouches | 90 mm × 594 mm | |
| Self-Sealing Sterilization Pouches | 133 mm × 289 mm | Metal 0.23 |
| Self-Sealing Sterilization Pouches | 133 mm × 391 mm | Plastic 0.27 |
| Self-Sealing Sterilization Pouches | 135 mm × 193 mm | Linens and Gauze 0.10 |
| Self-Sealing Sterilization Pouches | 135mm × 283 mm | |
| Self-Sealing Sterilization Pouches | 135 mm × 335 mm | |
| Self-Sealing Sterilization Pouches | 150mm × 610 mm | |
| Self-Sealing Sterilization Pouches | 190 mm × 358 mm | |
| Self-Sealing Sterilization Pouches | 190 mm × 365 mm | |
| Self-Sealing Sterilization Pouches | 200 mm x 435 mm | |
| Self-Sealing Sterilization Pouches | 300 mm × 380 mm | |
| Self-Sealing Sterilization Pouches | 300 mm × 474 mm | Metal 1.13 |
| Self-Sealing Sterilization Pouches | 300 mm × 485 mm | Plastic 2.92 |
| Self-Sealing Sterilization Pouches | 303 mm × 474 mm | Linens and Gauze 1.00 |
| Self-Sealing Sterilization Pouches | 305 mm × 416 mm | |
| Self-Sealing Sterilization Pouches | 356 mm × 483 mm | Metal 1.31 Plastic 3.38 |
| Linens and Gauze 1.16 | ||
| Self-Sealing Sterilization Pouches | 380 mm × 635 mm | Metal 1.48 Plastic 4.42 |
| Linens and Gauze 1.51 | ||
| Self-Sealing Sterilization Pouches | 460 mm × 610 mm | Metal 1.79 Plastic 5.34 |
| Linens and Gauze 1.82 | ||
| Type | Dimension in S.I. | *Content / Max Load (lbs) |
| Sterilization Pouches, Flat | 75 mm x 150 mm | Metal 0.13 |
| Sterilization Pouches, Flat | 75 mm × 200 mm | Plastic 0.02 |
| Sterilization Pouches, Flat | 75 mm x 300 mm | Linens and Gauze 0.02 |
| Sterilization Pouches, Flat | 100 mm × 200 mm | |
| Sterilization Pouches, Flat | 100 mm × 300 mm | |
| Sterilization Pouches, Flat | 100 mm ×550 mm | |
| Sterilization Pouches, Flat | 120 mm x 250 mm | |
| Sterilization Pouches, Flat | 120 mm × 280 mm | |
| Sterilization Pouches, Flat | 150 mm × 200 mm | |
| Sterilization Pouches, Flat | 150 mm x 250 mm | |
| Sterilization Pouches, Flat | 150 mm x 300 mm | |
| Sterilization Pouches, Flat | 150 mm x 380 mm | |
| Sterilization Pouches, Flat | 150 mm x 550 mm | Metal 0.23 Plastic 0.03 |
| Linens and Gauze 0.03 | ||
| Sterilization Pouches, Flat | 180 mm x 300 mm | Metal 0.13 Plastic 0.02 |
| Sterilization Pouches, Flat | 200 mm x 330 mm | Linens and Gauze 0.02 |
| Sterilization Pouches, Flat | 200 mm x 400 mm | Metal 0.86 Plastic 1.13 |
| Linens and Gauze 0.51 | ||
| Sterilization Pouches, Flat | 200 mm x 600 mm | Metal 1.29 Plastic 1.69 |
| Linens and Gauze 0.76 | ||
| Sterilization Pouches, Flat | 205 mm x 400 mm | Metal 0.86 |
| Sterilization Pouches, Flat | 250 mm x 300 mm | Plastic 1.13 |
| Sterilization Pouches, Flat | 250 mm x 450 mm | Linens and Gauze 0.51 |
| Sterilization Pouches, Flat | 300 mm × 380 mm | Metal 0.75 |
| Sterilization Pouches, Flat | 300 mm × 460 mm | Plastic 3.28 |
| Sterilization Pouches, Flat | 300 mm x 500 mm | Linens and Gauze 1.61 |
| Sterilization Pouches, Flat | 420 mm x 400 mm | |
| Sterilization Pouches, Flat | 420 mm × 600 mm | Metal 1.12 Plastic 4.92 |
| Linens and Gauze 2.41 | ||
| Sterilization Pouches, Gusseted | 100 mm × 40 mm ×300 mm | Metal 0.21 Plastic 0.05 |
| Sterilization Pouches, Gusseted | 150 mm × 50 mm × 400 mm | Linens and Gauze 0.08 |
| Sterilization Pouches, Gusseted | 200 mm × 50 mm × 400 mm | Metal 0.87 Plastic 1.68 |
| Sterilization Pouches, Gusseted | 250 mm × 60 mm × 480 mm | Linens and Gauze 0.90 |
| Sterilization Pouches, Gusseted | 300 mm × 70 mm × 500 mm | Metal 1.45 Plastic 3.78 |
| Linens and Gauze 1.82 |
Table 1. Recommended Sterilization Load
5
| Table 1. (Continued) Recommended Sterilization Load | |||||
|---|---|---|---|---|---|
| -- | -- | -- | ----------------------------------------------------- | -- | -- |
6
| Type | Dimension in S.I. | *Content / Max Load (lbs) |
|---|---|---|
| Sterilization Rolls, Flat | 50 mm × 200 M | Metal 0.02 |
| Sterilization Rolls, Flat | 50.8 mm × 200 M | Plastic 0.01 |
| Sterilization Rolls, Flat | 75 mm × 200 M | Linens and Gauze 0.01 |
| Sterilization Rolls, Flat | 76.2 mm × 200 M | |
| Sterilization Rolls, Flat | 100 mm × 200 M | |
| Sterilization Rolls, Flat | 101.6 mm × 200 M | |
| Sterilization Rolls, Flat | 150 mm × 200 M | |
| Sterilization Rolls, Flat | 152.4 mm × 200 M | |
| Sterilization Rolls, Flat | 200 mm × 200 M | Metal 0.86 |
| Sterilization Rolls, Flat | 203.2 mm × 200 M | Plastic 1.13 |
| Sterilization Rolls, Flat | 250 mm × 200 M | Linens and Gauze 0.51 |
| Sterilization Rolls, Flat | 254 mm × 200 M | |
| Sterilization Rolls, Flat | 300 mm × 200 M | |
| Sterilization Rolls, Flat | 304.8 mm × 200 M | |
| Sterilization Rolls, Flat | 350 mm × 200 M | |
| Sterilization Rolls, Flat | 400 mm × 200 M | Metal 6.24 Plastic 2.99 Linens and Gauze 2.94 |
| Sterilization Rolls, Flat | 50.8 mm × 30.5 M | Metal 0.02 |
| Sterilization Rolls, Flat | 76.2 mm × 30.5 M | Plastic 0.01 |
| Sterilization Rolls, Flat | 101.6 mm × 30.5 M | Linens and Gauze 0.01 |
| Sterilization Rolls, Flat | 152.4 mm × 30.5 M | |
| Sterilization Rolls, Flat | 203.2 mm × 30.5 M | Metal 0.86 Plastic 1.13 |
| Sterilization Rolls, Flat | 254 mm × 30.5 M | Linens and Gauze 0.51 |
| Sterilization Rolls, Gusseted | 75 mm × 35 mm × 100 M | Metal 0.12 |
| Sterilization Rolls, Gusseted | 100 mm × 40 mm × 100 M | Plastic 0.02 |
| Sterilization Rolls, Gusseted | 150 mm × 50 mm × 100 M | Linens and Gauze 0.03 |
| Sterilization Rolls, Gusseted | 200 mm × 50 mm × 100 M | Metal 0.87 |
| Sterilization Rolls, Gusseted | 250 mm × 60 mm × 100 M | Plastic 1.68 |
| Sterilization Rolls, Gusseted | 300 mm × 70 mm × 100 M | Linens and Gauze 0.90 |
| Sterilization Rolls, Gusseted | 350 mm × 80 mm × 100 M | |
| Sterilization Rolls, Gusseted | 400 mm × 80 mm × 100 M | Metal 3.67 Plastic 3.00 Linens and Gauze 3.44 |
Table 1. (Continued) Recommended Sterilization Load
*Content:
- Metal: For example, scalpels, clips, forceps and trays. 2. Plastic: For example, infusion tubes, syringes, foley tubes and gloves, etc. 3. Linens and Cotton: For example, linens, drapes, and cotton wool, etc.
7
K180661 510(k) Summary
1 Sumitter's Information
| Name: | SIGMA Medical Supplies Corp. |
|---|---|
| Address: | NO.34, Ding-Ping Road, Rui Fang Industrial Park, Rui Fang |
| Dist., New Taipei City 224, Taiwan (R.O.C.) | |
| Establishment | |
| Registration Number: | 3004970050 |
| Contact: | Mason Huang |
| Regulatory Affair Specialist | |
| 886-4-24366111 ext. 127 | |
| E-mail: mason@sigma-medical.com.tw | |
| Or | |
| Jack Wang | |
| President /C.E.O | |
| Date Prepared: | May 30, 2018 |
| 2 Device Name | |
| Trade Name: | SIGMA Sterilization Pouch and Roll |
| Common/usual Name: | SIGMA Sterilization Pouch and Roll |
| Device Classification Names: | 1) Wrap, Sterilization. |
- Indicator, Physical/Chemical Sterilization Pro-
cess |
| Panel: | General Hospital |
| Classification Product Code:
Subsequent Product Code: | 1) FRG - JOJ |
| Device Classification: | Class II |
| Regulation Number: | 1) 21 CFR 880.6850 - 21 CFR 880.2800 |
3 Predicate Devices
The predicate device [510(k) Notification K102158, cleared August 02, 2011] is the SIGMA Sterilization Pouch and Roll.
Manufacturer: SIGMA Medical Supplies Corp.
Product Code:1) FRG 2) JOJ
8
510(k) number:K102158
9
4 Indications for Use
The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121℃. The recommended EO sterilization cycle is 4 hours at 55℃ with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
The SIGMA sterilization pouch and roll is offered in the following 5 types:
- · Self-sealing sterilization pouches
- · Sterilization pouches, Flat
- Sterilization pouches, Gusseted
- Sterilization rolls, Flat
- Sterilization rolls, Gusseted
The defining characteristics of the 5 types as follows:
- · Self-sealing sterilization pouches: These pouches are made from a medical grade plastic film that is heat sealed on three sides. The forth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas.
- · Sterilization pouches, Flat: These pouches has the same components with the Self-sealing sterilization pouches, except the forth side is left opened instead of an adhesive strip and will be heat-sealed when using.
- · Sterilization pouches, Gusseted: These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
- · Sterilization rolls, Flat: These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.
- · Sterilization rolls, Gusseted: These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
The following table (Table 1) lists the model numbers of the SIGMA sterilization pouch and roll by type, model, dimensions, and content/max load(lbs):
10
| Type | Model | Dimension in S.I. | *Content/Max Load (lbs) |
|---|---|---|---|
| Self-Sealing | |||
| Sterilization | |||
| Pouches | SMSE057133 | 57 mm × 133 mm | Metal 0.02 |
| SMSE070257 | 70 mm × 257 mm | Plastic 0.01 | |
| SMSE090162 | 90 mm × 162 mm | Lines and Gauze 0.01 | |
| SMSE090168 | 90 mm × 168 mm | ||
| SMSE070257 | 70 mm × 257mm | ||
| SMSE090257 | 90 mm × 257 mm | ||
| SMSE090265 | 90 mm × 265 mm | ||
| SMSE090594 | 90 mm × 594 mm | Metal 0.23 | |
| SMSE133289 | 133 mm × 289 mm | Plastic 0.27 | |
| SMSE133391 | 133 mm × 391 mm | Lines and Gauze 0.10 | |
| SMSE135193 | 135 mm × 193 mm | ||
| SMSE135283 | 135 mm × 283 mm | ||
| SMSE180335 | 135 mm × 335 mm | ||
| SMSE150610 | 150 mm × 610 mm | ||
| SMSE190358 | 190 mm × 358 mm | ||
| SMSE190365 | 190 mm × 365 mm | ||
| SMSE200435 | 200 mm × 435 mm | ||
| SMSE300380 | 300 mm × 380 mm | ||
| SMSE300474 | 300 mm × 474 mm | Metal 1.13 | |
| SMSE300485 | 300 mm × 485 mm | Plastic 2.92 | |
| SMSE303474 | 303 mm × 474 mm | Lines and Gauze 1.00 | |
| SMSE305416 | 305 mm × 416 mm | ||
| SMSE356483 | 356 mm × 483 mm | Metal 1.31 Plastic 3.38 | |
| Linens and Gauze 1.16 | |||
| SMSE380635 | 380 mm × 635 mm | Metal 1.48 Plastic 4.42 | |
| Lines and Gauze 1.51 | |||
| SMSE460610 | 460 mm × 610 mm | Metal 1.79 Plastic 5.34 | |
| Lines and Gauze 1.82 | |||
| Type | Model | Dimension in S.I. | *Content/Max Load (lbs) |
| Sterilization Pouches, Flat | SMFP075150 | 75 mm × 150 mm | Metal 0.13 |
| Plastic 0.02 | |||
| SMFP075200 | 75 mm × 200 mm | Linens and Gauze 0.02 | |
| SMFP075300 | 75 mm × 300 mm | ||
| SMFP100200 | 100 mm × 200 mm | ||
| SMFP100300 | 100 mm × 300 mm | ||
| SMFP100550 | 100 mm × 550 mm | ||
| SMFP120250 | 120 mm × 250 mm | ||
| SMFP120280 | 120 mm × 280 mm | ||
| SMFP150200 | 150 mm × 200 mm | ||
| SMFP150250 | 150 mm × 250 mm | ||
| SMFP150300 | 150 mm × 300 mm | ||
| SMFP150380 | 150 mm × 380 mm | ||
| Sterilization Pouches, Flat | SMFP150550 | 150 mm × 550 mm | Metal 0.23 Plastic 0.03 |
| Linens and Gauze 0.03 | |||
| SMFP180300 | 180 mm × 300 mm | Metal 0.13 Plastic 0.02 | |
| Linens and Gauze 0.02 | |||
| SMFP200330 | 200 mm × 330 mm | Linens and Gauze 0.02 | |
| SMFP200400 | 200 mm × 400 mm | Metal 0.86 Plastic 1.13 | |
| Linens and Gauze 0.51 | |||
| SMFP200600 | 200 mm × 600 mm | Metal 1.29 Plastic 1.69 | |
| Linens and Gauze 0.76 | |||
| SMFP205400 | 205 mm × 400 mm | Metal 0.86 | |
| SMFP250300 | 250 mm × 300 mm | Plastic 1.13 | |
| SMFP250450 | 250 mm × 450 mm | Linens and Gauze 0.51 | |
| SMFP300380 | 300 mm × 380 mm | Metal 0.75 | |
| SMFP300460 | 300 mm × 460 mm | Plastic 3.28 | |
| Linens and Gauze 1.61 | |||
| SMFP300500 | 300 mm × 500 mm | ||
| SMFP420400 | 420 mm × 400 mm | ||
| SMFP420600 | 420 mm × 600 mm | Metal 1.12 Plastic 4.92 | |
| Linens and Gauze 2.41 | |||
| Sterilization | |||
| Pouches, Gus- | |||
| seted | SMGP100300 | 100 mm × 40 mm × 300 mm | Metal 0.21 Plastic 0.05 |
| Linens and Gauze 0.08 | |||
| SMGP150400 | 150 mm × 50 mm × 400 mm | ||
| SMGP200400 | 200 mm × 50 mm × 400 mm | Metal 0.87 Plastic 1.68 | |
| Linens and Gauze 0.90 | |||
| SMGP250480 | 250 mm × 60 mm × 480 mm | ||
| SMGP300500 | 300 mm × 70 mm × 500 mm | Metal 1.45 Plastic 3.78 | |
| Linens and Gauze 1.82 |
Table 1. The model numbers of SIGMA sterilization pouch and roll (Type, Model and Dimension and Content/Max Load)
11
Table 1. (Continued) The model numbers of SIGMA sterilization pouch and roll (Type, Model and Dimension and Content/Max Load)
12
| Type | Model | Dimension in S.I. | *Content/Max Load (lbs) |
|---|---|---|---|
| Sterilization | |||
| Rolls, Flat | SMFR 022 | 50 mm × 200 M | Metal 0.02 |
| Plastic 0.01 | |||
| SMFR 902 | 50.8 mm × 200 M | Linens and Gauze 0.01 | |
| SMFR 032 | 75 mm × 200 M | ||
| SMFR 912 | 76.2 mm × 200 M | ||
| SMFR 042 | 100 mm × 200 M | ||
| SMFR 922 | 101.6 mm × 200 M | ||
| SMFR 062 | 150 mm × 200 M | ||
| SMFR 932 | 152.4 mm × 200 M | ||
| SMFR 082 | 200 mm × 200 M | Metal 0.86 | |
| SMFR 942 | 203.2 mm × 200 M | Plastic 1.13 | |
| Linens and Gauze 0.51 | |||
| SMFR 102 | 250 mm × 200 M | ||
| SMFR 952 | 254 mm × 200 M | ||
| SMFR 122 | 300 mm × 200 M | ||
| SMFR 962 | 304.8 mm × 200 M | ||
| SMFR 142 | 350 mm × 200 M | ||
| SMFR 162 | 400 mm × 200 M | Metal 6.24 Plastic 2.99 | |
| Linens and Gauze 2.94 | |||
| Sterilization | |||
| Rolls, Gusseted | SMFR 02-1 | 50.8 mm × 30.5 M | Metal 0.02 |
| Plastic 0.01 | |||
| SMFR 03-1 | 76.2 mm × 30.5 M | Linens and Gauze 0.01 | |
| SMFR 04-1 | 101.6 mm × 30.5 M | ||
| SMFR 06-1 | 152.4 mm × 30.5 M | ||
| SMFR 08-1 | 203.2 mm × 30.5 M | Metal 0.86 Plastic 1.13 | |
| Linens and Gauze 0.51 | |||
| SMFR 10-1 | 254 mm × 30.5 M | ||
| SMGR 031 | 75 mm × 35 mm × 100 M | Metal 0.12 | |
| Plastic 0.02 | |||
| SMGR 041 | 100 mm × 40 mm × 100M | Linens and Gauze 0.03 | |
| SMGR 061 | 150 mm × 50 mm × 100 M | ||
| SMGR 081 | 200 mm × 50 mm × 100 M | Metal 0.87 | |
| SMGR 101 | 250 mm × 60 mm × 100 M | Plastic 1.68 | |
| Linens and Gauze 0.90 | |||
| SMGR 121 | 300 mm × 70 mm × 100 M | ||
| SMGR 141 | 350 mm × 80 mm × 100 M | ||
| SMGR 161 | 400 mm × 80 mm × 100 M | Metal 3.67 Plastic 3.00 | |
| Linens and Gauze 3.44 |
Table 1. (Continued) The model numbers of SIGMA sterilization pouch and roll (Type, Model and Dimension and Content/Max Load)
*Content:
1.Metal: For example, scalpels, clips, pins, forceps and trays. 2. Plastic: For example, infusion tubes, syringes, foley tubes and gloves, etc. 3. Linens and Cotton: For example, linens, drapes, and cotton wool, etc.
13
5 Device Description
The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization.
The Self-seal pouch permits sealing of the pouch without need of heat- sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the steam/or EO Sterilization cycles.
The chemical indicators ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas. The color of Chemical Indicator changes from Blue to Greenish Black, when exposed to Steam. And the color changes from red to yellow, when exposed to EO gas.
The Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.
14
6 Technological Characteristic Comparison
A summary of the technological characteristics of the device subject of this premarket notification in comparison to those of the predicate devices is included in Table 2.
| Feature | Proposed device | Predicate device | Comparison | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device name | SIGMA sterilization pouch and roll | SIGMA sterilization pouch and roll (K102158) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Material Composition | Medical Grade Paper, CPP, PET, PU adhesive, EO and Steam Process Indicator | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Print Ink | Medical Grade Paper, CPP, PET, PU adhesive, EO and Steam Process Indicator | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Print Ink | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Intended use | The sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. | The sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. | Only the maintenance of sterility is different. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| The proposed device maintains the enclosed devices up until 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pouch Types | Self-sealing sterilization pouches Sterilization pouches, Flat Sterilization pouches, Gusseted Sterilization rolls, Flat Sterilization rolls, Gusseted | Self-sealing sterilization pouches Sterilization pouches, Flat Sterilization pouches, Gusseted Sterilization rolls, Flat Sterilization rolls, Gusseted | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Device models (Configurations/Dimensions) | Self-Sealing Sterilization Pouches Model Dimension (mm) SMSE057133 $57 \text{ mm } \times 133 \text{ mm}$ SMSE070257 $70 \text{ mm } \times 257 \text{ mm}$ SMSE090162 $90 \text{ mm } \times 162 \text{ mm}$ SMSE090168 $90 \text{ mm } \times 168 \text{ mm}$ SMSE070257 $70 \text{ mm } \times 257 \text{ mm}$ SMSE090257 $90 \text{ mm } \times 257 \text{ mm}$ SMSE090265 $90 \text{ mm } \times 265 \text{ mm}$ SMSE090594 $90 \text{ mm } \times 594 \text{ mm}$ SMSE133289 $133 \text{ mm } \times 289 \text{ mm}$ SMSE133391 $133 \text{ mm } \times 391 \text{ mm}$ SMSE135193 $135 \text{ mm } \times 193 \text{ mm}$ SMSE135283 $135 \text{ mm } \times 283 \text{ mm}$ SMSE180335 $135 \text{ mm } \times 335 \text{ mm}$ SMSE150610 $150 \text{ mm } \times 610 \text{ mm}$ SMSE190358 $190 \text{ mm } \times 358 \text{ mm}$ SMSE190365 $190 \text{ mm } \times 365 \text{ mm}$ SMSE200435 $200 \text{ mm } \times 435 \text{ mm}$ SMSE300380 $300 \text{ mm } \times 380 \text{ mm}$ SMSE300474 $300 \text{ mm } \times 474 \text{ mm}$ SMSE300485 $300 \text{ mm } \times 485 \text{ mm}$ SMSE303474 $303 \text{ mm } \times 474 \text{ mm}$ SMSE305416 $305 \text{ mm } \times 416 \text{ mm}$ SMSE356483 $356 \text{ mm } \times 483 \text{ mm}$ SMSE380635 $380 \text{ mm } \times 635 \text{ mm}$ SMSE460610 $460 \text{ mm } \times 610 \text{ mm}$ | Self-Sealing Sterilization Pouches Model Dimension (mm) SMSE057133 $57 \text{ mm } \times 133 \text{ mm}$ SMSE090162 $90 \text{ mm } \times 162 \text{ mm}$ SMSE070257 $70 \text{ mm } \times 257 \text{ mm}$ SMSE090257 $90 \text{ mm } \times 257 \text{ mm}$ SMSE135283 $135 \text{ mm } \times 283 \text{ mm}$ SMSE180335 $135 \text{ mm } \times 335 \text{ mm}$ SMSE190358 $190 \text{ mm } \times 358 \text{ mm}$ SMSE300380 $300 \text{ mm } \times 380 \text{ mm}$ SMSE300474 $300 \text{ mm } \times 474 \text{ mm}$ | The models (dimensions) of type "Self-Sealing Sterilization Pouches" are different. There are 16 additional models in Proposed device. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| The additional models (Type, Model and Dimension) of Proposed device are shown in Table 3. |
Table 2. Summary of the Proposed and Predicate Devices Technological Characteristics
15
| Feature | Proposed device: SIGMA sterilization pouch and roll | Predicate devices: SIGMA sterilization pouch and roll (K102158) | Comparison |
|---|---|---|---|
| Device models | |||
| (Configurations/Dimensions) | Sterilization Pouches, Flat | The models (dimensions) of type "Sterilization Pouches, Flat" are different. There are 17 additional models in Proposed device. The additional models (Type, Model and Dimension) of Proposed device are shown in Table 3. | |
| Model | Dimension (mm) | ||
| SMFP075150 | 75 mm × 150 mm | ||
| SMFP075200 | 75 mm × 200 mm | ||
| SMFP075300 | 75 mm × 300 mm | ||
| SMFP100200 | 100 mm × 200 mm | ||
| SMFP100300 | 100 mm × 300 mm | ||
| SMFP100550 | 100 mm ×550 mm | ||
| SMFP120250 | 120 mm × 250 mm | ||
| SMFP120280 | 120 mm × 280 mm | ||
| SMFP150200 | 150 mm × 200 mm | ||
| SMFP150250 | 150 mm × 250 mm | ||
| SMFP150300 | 150 mm × 300 mm | ||
| SMFP150380 | 150 mm × 380 mm | ||
| SMFP150550 | 150 mm × 550 mm | ||
| SMFP180300 | 180 mm × 300 mm | ||
| SMFP200330 | 200 mm × 330 mm | ||
| SMFP200400 | 200 mm × 400 mm | ||
| SMFP200600 | 200 mm × 600 mm | ||
| SMFP205400 | 205 mm × 400 mm | ||
| SMFP250300 | 250 mm × 300 mm | ||
| SMFP250450 | 250 mm × 450 mm | ||
| SMFP300380 | 300 mm × 380 mm | ||
| SMFP300460 | 300 mm × 460 mm | ||
| SMFP300500 | 300 mm × 500 mm | ||
| SMFP420400 | 420 mm × 400 mm | ||
| SMFP420600 | 420 mm × 600 mm | ||
| Sterilization Pouches, Gusseted | |||
| Model | Dimension (mm) | Same | |
| SMGP100300 | 100mm×40mm×300mm | ||
| SMGP150400 | 150mm×50mm×400mm | ||
| SMGP200400 | 200mm×50mm×400mm | ||
| SMGP250480 | 250mm×60mm×480mm | ||
| SMGP300500 | 300mm×70mm×500mm |
Table 2. (Continued) Summary of the Proposed and Predicate Devices Technological Characteristics
16
Table 2 (Continued) Summary of the Proposed and Predicate Devices Technological Characteristics
| Feature | Proposed device: SIGMA sterilization pouch and roll | Predicate devices: SIGMA sterilization pouch and roll (K102158) | Comparison | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device models (Configurations/Dimensions) | Sterilization Rolls, Flat Model Dimension (mm) SMFR 022 50 mm × 200 M SMFR902 50.8 mm × 200 M SMFR 032 75 mm × 200 M SMFR912 76.2 mm × 200 M SMFR 042 100 mm × 200 M SMFR922 101.6 mm × 200 M SMFR 062 150 mm × 200 M SMFR932 152.4 mm × 200 M SMFR 082 200 mm × 200 M SMFR942 203.2 mm × 200 M SMFR 102 250 mm × 200 M SMFR952 254 mm × 200 M SMFR 122 300 mm × 200 M SMFR962 304.8 mm × 200 M SMFR 142 350 mm × 200 M SMFR 162 400 mm × 200 M SMFR02-1 50.8 mm x 30.5 M SMFR03-1 76.2 mm x 30.5 M SMFR04-1 101.6 mm x 30.5 M SMFR06-1 152.4 mm x 30.5 M SMFR08-1 203.2 mm × 30.5 M SMFR10-1 254 mm x 30.5 M | Sterilization Rolls, Flat Model Dimension (mm) SMFR 022 50 mm × 200 M SMFR 032 75 mm × 200 M SMFR 042 100 mm × 200 M SMFR 062 150 mm × 200 M SMFR 082 200 mm × 200 M SMFR 102 250 mm × 200 M SMFR 122 300 mm × 200 M SMFR 142 350 mm × 200 M SMFR 162 400 mm × 200 M | The models (dimensions) of type "Sterilization Rolls, Flat" are different. There are 13 additional models in Proposed device. The additional models (Type, Model and Dimension) of Proposed device are shown in Table 3. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Sterilization Rolls, Gusseted Model Dimension (mm) SMGR 031 75mm×35mm×100 M SMGR 041 100mm×40mm×100M SMGR 061 150mm×50mm×100M SMGR 081 200mm×50mm×100M SMGR 101 250mm×60mm×100M SMGR 121 300mm×70mm×100M SMGR 141 350mm×80mm×100M SMGR 161 400mm×80mm×100M | Sterilization Rolls, Gusseted Model Dimension (mm) SMGR 031 75mm×35mm×100 M SMGR 041 100mm×40mm×100M SMGR 061 150mm×50mm×100M SMGR 081 200mm×50mm×100M SMGR 101 250mm×60mm×100M SMGR 121 300mm×70mm×100M SMGR 141 350mm×80mm×100M SMGR 161 400mm×80mm×100M | Same |
17
| Feature | Proposed Device:
SIGMA sterilization pouch and roll | Predicate devices:
SIGMA sterilization pouch and roll (K102158) | Comparison | |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------|
| Steam
Sterilization
cycle | The recommended steam sterilization cycle parameters are 30 minutes at 121°C. | The recommended steam sterilization cycle parameters are 30 minutes at 121°C. | Same | |
| EO gas
Sterilization
cycle | The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. | The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. | Same | |
| Design
features | Self-sealing sterilization pouches:
These pouches are made from a medical grade plastic film that is heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas.
Sterilization pouches, Flat:
These pouches has the same components with the Self-sealing sterilization pouches, except the fourth side is left opened instead of an adhesive strip and will be heat-sealed when using.
Sterilization pouches, Gusseted:
These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
Sterilization rolls, Flat:
These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.
Sterilization rolls, Gusseted:
These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height. | Self-sealing sterilization pouches:
These pouches are made from a medical grade plastic film that is heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas.
Sterilization pouches, Flat:
These pouches has the same components with the Self-sealing sterilization pouches, except the fourth side is left opened instead of an adhesive strip and will be heat-sealed when using.
Sterilization pouches, Gusseted:
These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
Sterilization rolls, Flat:
These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.
Sterilization rolls, Gusseted:
These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height. | Same | |
| Steam
Chemical
Indicator Device Design | The color of Chemical Indicator changes from Blue to Greenish Black, when exposed to Steam. | The color of Chemical Indicator changes from Blue to Greenish Black, when exposed to Steam. | Same | |
| EO gas
Chemical
Indicator Device Design | The color changes from red to yellow, when exposed to EO gas. | The color changes from red to yellow, when exposed to EO gas. | Same | |
| Feature | | Proposed Device:
SIGMA sterilization | Predicate Devices:
SIGMA sterilization pouch | Compar- |
| Performance Testing | | pouch and roll | and roll (K102158) | ison |
| Sterilant
Penetration | Half-Cycle Efficacy | The test meet the require-
ment of SAL 10-6 | The test meet the require-
ment of SAL 10-6 | Same |
| | Chemical Indicator (CI) Func-
tionality and Endpoint | The sterilant penetrated
through the pouch configu-
ration and affected the CI
color change to the end-
point color | The sterilant penetrated
through the pouch configu-
ration and affected the CI
color change to the end-
point color | Same |
| Package
Integrity
(Physical
Properties) | Thickness Variations (mm)
ASTM F 2251 | Passed | Passed | Same |
| | Tensile strength of plastic film *
(kgf/mm2)
ASTM D882 | Passed | Passed | Same |
| | Tensile strength of paper*
(N/15mm)
ISO 1924-2 | Passed | Passed | Same |
| | Air permeance of paper* (lb/in)
ISO 5636-3 | Passed | Passed | Same |
| | Thickness Variation (mm)
ASTM F2251 | Passed | Passed | Same |
| | Tear Resistance Test (kgf/cm2)
ASTM D 1004 | Passed | Passed | Same |
| | Burst Strength (kPa)
ASTM F1140 ; ISO 11607-1 | Passed | Passed | Same |
| | Bubble Leak Test
ASTM D 3078 ; ASTM-F 2096 | Passed | Passed | Same |
| | Seal Peel Test (g/15mm)
ASTM F88/F88M ; ISO 11607-1 | Passed | Passed | Same |
| | Dye penetration Test
ASTM F 1929 ;ISO 11607-1 | Passed | Passed | Same |
| | Microbial Barrier Test
DIN 58953-6 ;or ASTM F 1608 | Passed | Passed | Same |
| | Toxicological Properties
(Biocompatibility Test)
ANSI/AAMI/ISO 10993-10 | Passed | Passed | Same |
| | Durability: Accelerated Aging
Test
ASTM F 1980 ; ISO 11607-1 | Passed | Passed | Same |
| End Point /
Post Pro-
cessing Col-
or Stability | after steam sterilization | 6 months | 6 months | Same |
| | after EO sterilization | 3 Years | 3 Years | Same |
| Shelf Life | Chemical Indicator (CI)
Functionality | 3 Years | 3 Years | Same |
| | Accelerated aging test
(Seal Strength) | 3 Years | 3 Years | Same |
Table 2. (Continued) Summary of the Proposed and Predicate Devices Technological Characteristics
18
Table 2 (Continued) Summary of the Proposed and Predicate Devices Technological Characteristics
Note: *the test items were performed on materials of the products; there is no specification requirements.
19
| Type | Model | Dimension in S.I. |
|---|---|---|
| Self-Sealing Sterilization Pouches | SMSE070257 | 70 mm × 257 mm |
| SMSE090168 | 90 mm × 168 mm | |
| SMSE090265 | 90 mm × 265 mm | |
| SMSE090594 | 90 mm × 594 mm | |
| SMSE133289 | 133 mm × 289 mm | |
| SMSE133391 | 133 mm × 391 mm | |
| SMSE135193 | 135 mm × 193 mm | |
| SMSE150610 | 150 mm × 610 mm | |
| SMSE190365 | 190 mm × 365 mm | |
| Self-Sealing Sterilization Pouches | SMSE200435 | 200 mm × 435 mm |
| Self-Sealing Sterilization Pouches | SMSE300485 | 300 mm × 485 mm |
| Self-Sealing Sterilization Pouches | SMSE303474 | 303 mm × 474 mm |
| Self-Sealing Sterilization Pouches | SMSE305416 | 305 mm × 416 mm |
| Self-Sealing Sterilization Pouches | SMSE356483 | 356 mm × 483 mm |
| Self-Sealing Sterilization Pouches | SMSE380635 | 380 mm × 635 mm |
| Self-Sealing Sterilization Pouches | SMSE460610 | 460 mm × 610 mm |
| Sterilization Pouches, Flat | SMFP075150 | 75 mm × 150 mm |
| SMFP100550 | 100 mm ×550 mm | |
| SMFP120250 | 120 mm × 250 mm | |
| SMFP120280 | 120 mm × 280 mm | |
| SMFP150200 | 150 mm × 200 mm | |
| SMFP150250 | 150 mm × 250 mm | |
| SMFP150380 | 150 mm × 380 mm | |
| SMFP150550 | 150 mm × 550 mm | |
| SMFP180300 | 180 mm × 300 mm | |
| SMFP200330 | 200 mm × 330 mm | |
| SMFP200600 | 200 mm × 600 mm | |
| SMFP205400 | 205 mm × 400 mm | |
| SMFP250300 | 250 mm × 300 mm | |
| SMFP300380 | 300 mm × 380 mm | |
| SMFP300460 | 300 mm × 460 mm | |
| SMFP420400 | 420 mm × 400 mm | |
| Sterilization Pouches, Flat | SMFP420600 | 420 mm × 600 mm |
| Sterilization Rolls, Flat | SMFR 902 | 50.8 mm × 200 M |
| SMFR 912 | 76.2 mm × 200 M | |
| SMFR 922 | 101.6 mm × 200 M | |
| SMFR 932 | 152.4 mm × 200 M | |
| SMFR 942 | 203.2 mm × 200 M | |
| SMFR 952 | 254 mm × 200 M | |
| SMFR 962 | 304.8 mm × 200 M | |
| SMFR 02-1 | 50.8 mm × 30.5 M | |
| SMFR 03-1 | 76.2 mm × 30.5 M | |
| SMFR 04-1 | 101.6 mm × 30.5 M | |
| SMFR 06-1 | 152.4 mm × 30.5 M | |
| SMFR 08-1 | 203.2 mm × 30.5 M | |
| Sterilization Rolls, Flat | SMFR 10-1 |
Table 3 Additional models of SIGMA sterilization pouch and roll (Type, Model and Dimension)
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7 Summary of Non-Clinical Testing
The SIGMA sterilization pouch and roll has the identical intended use and indication for use as the predicate devices. The subject device was compared to the predicate device by testing the Sterilant Penetration, Drying Time, Aeration, Biocompatibility, Package Integrity, Material Compatibility, Sterility Maintenance, and Chemical Indicator Efficacy.
The results of the SIGMA sterilization pouch and roll validation studies demonstrate that the sterilization pouches perform as intended. The results are summarized as follows:
- · The Sterilant Penetration, Drying Time, Aeration, testing performed as described in AAMI / ANSI / ISO 17665-1:2006/(R)2013 and ISO TS 17665-2:2009 for steam sterilization as well as AAMI / ANSI / ISO 11135:2014 for EO. The testing results demonstrate the ability of the sterilant to penetrate the Sigma Sterilization Pouch and Roll.
- · The Biocompatibility testing performed as described in ISO 10993-10:2010(E), ISO 10993-1:2009/Cor. 1:2010(E), ISO 10993-12:2012(E), and ISO/IEC 17025:2005. The testing results demonstrate the Sigma Sterilization Pouch and Roll showed "hegative reaction". And the SIGMA sterilization pouch and roll meets the requirements ISO 10993-10:2010(E). The EO sterilization residuals meets the requirements AAMI / AN-SI / ISO 10993-7:2008 (R) 2012.
- · The Package Integrity, Material Compatibility, Sterility Maintenance testing performed as described in AAMI / ANSI / ISO 11607-1:2006//A1:2014, "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems"; ASTM D882, "Standard Test Method for Tensile Properties of Thin Plastic Sheeting"; ASTM D 5035, "Standard Test Method for Breaking Force and Elongation of Textile Fabrics (Strip Method)": ASTM F 2251-03, "Standard Test Method for Thickness Measurement of Flexible Packaging Material"; ASTM D 1922. "Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method": ASTM F 1140-07, "Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages"; ASTM F 1929-98 (04), "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration"; ASTM F88/F88M-09, "Standard Test Method for Seal Strength of Flexible Barrier Materials"; ASTM F 1980-2007, "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices"; DIN 58953-6:2010-05, "Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized". The testing results demonstrate the ability of the Sigma Sterilization Pouch and Roll to maintain the package integrity over the claimed shelf life.
The Chemical Indicator Efficacy testing performed as described in AAMI / ANSI / ISO 11140-1:2014 "Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements". There are two types of the Process Indicator ink printed on the SIGMA sterilization pouch and roll. The description of the two types ink as follows: - Class 1 Process Indicators for STEAM
The testing demonstrates the ability of the Sigma Sterilization Pouch and Roll and its Class 1 Process Indicators for STEAM to remain stable before use based on its shelf life data, change color in the presence of the sterilant, and to maintain the endpoint stability of the color change after being in the presence of the sterilant. The STEAM Pro
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cess Indicators ink printed on the SIGMA sterilization pouch and roll meets the requirements ISO 11140-1:2014.
- Class 1 Process Indicators for EO gas
The testing demonstrates the ability of the Sigma Sterilization Pouch and Roll and its Class 1 Process Indicators for STEAM to remain stable before use based on its shelf life data, change color in the presence of the sterilant, and to maintain the endpoint stability of the color change after being in the presence of the sterilant. The EO gas Process Indicators ink printed on the SIGMA sterilization pouch and roll meets the requirements ISO 11140-1:2014.
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8 CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that SIGMA Sterilization Pouch and Roll is as safe, as effective, and performs as well as or better than the predicate K102158.