(239 days)
The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam Sterilizer and via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
- · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 30 minutes.
- · Gravity steam at 132°C (270°F) for 15 minutes; Drying time of 30 minutes.
- · Gravity steam at 135°C (275°F) for 10 minutes; Drying time of 30 minutes.
- · Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
- · Pre-vacuum steam at 135°C (275°F) for 3 minutes; Drying time of 16 minutes.
· EO sterilization cycle is 4 hours at 55°C (131°F) 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 pouch has undergone either a steam or EO sterilization process.
The SIGMA sterilization pouches and rolls 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.
The provided document is a 510(k) premarket notification for the SIGMA Sterilization Pouch and Roll. It does not describe an AI/ML medical device, but rather a sterilization packaging product. Therefore, the questions related to AI/ML device performance metrics such as sample size for test set, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device (K180661) through non-clinical performance testing.
Here's an analysis of the acceptance criteria and study as presented for this non-AI/ML medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported device performance are extensively detailed across multiple tables, primarily Table 2 ("Summary of the Proposed and Predicate Devices Technological Characteristics") and Table 3 ("Summary of Non-Clinical Testing"). I will extract the key information from these tables.
| Feature | Test/Standard | Acceptance Criteria | Reported Device Performance (Proposed Device) | Result |
|---|---|---|---|---|
| Sterilant Penetration / Drying Time / Aeration | ||||
| Steam Sterilization - SAL | ANSI/AAMI/ISO 17665-1:2006/(R)2013, ANSI/AAMI/ISO TIR 17665-2:2009 (R2016) | Meet the requirement of SAL 10-6, test BI (Steam processed): No bacterial growth | Using half-cycle and full-cycle analysis. Test BI: No bacterial growth | Pass |
| Steam Sterilization - Drying Time | ANSI/AAMI/ISO 17665-1:2006/(R)2013, ANSI/AAMI/ISO TIR 17665-2:2009 (R2016) | Weight difference before sterilization and after drying shall not exceed 0% | Weight difference = 0% | Pass |
| Steam Sterilization - Visual Drying | (Standard not explicitly listed for this specific bullet, but falls under the general standards above) | (Implied visual dryness) | Visual are drying. | Pass |
| EO Gas Sterilization - SAL | AAMI / ANSI / ISO 11135:2014 | Meet the requirement of SAL 10-6, test BI (EO processed): No bacterial growth | Using half-cycle analysis. Test BI: No bacterial growth | Pass |
| EO Gas Sterilization - Residuals | ISO 10993-7:2008 (R) 2012 | EO < 4mg, ECH < 9mg (Within 72 hours) | EO = 2mg (Average), ECH = 0.3mg (Within 72 hours) | Pass |
| Biocompatibility Testing | ||||
| Irritation and Skin Sensitization | ISO 10993-10 Third Edition 2010-08-01 | Response Category: Negligible | Negligible (negative reaction) | Pass |
| Package Integrity / Material Compatibility / Sterility Maintenance | ||||
| Tensile strength of plastic film | ASTM D882-12 | CD > 400 (kgf/mm2), MD > 450 (kgf/mm2) | CD = 458, MD = 462 (min. value after Steam Sterilization) | Pass |
| Tear Resistance Test (Plastic Film) | ASTM D 1004 -13 | CD > 300 (kgf/mm2), MD > 350 (kgf/mm2) | CD = 443, MD = 453 (min. value after Steam Sterilization) | Pass |
| Thickness Variation | ASTM F 2251-13 | ±0.02 | ±0.003 | Pass |
| Internal Pressurization Failure Resistance | ASTM F1140/F1140M-13 | Pressurize to 80% of burst value and hold for 30s. Burst value > 5.0 (kPa) | Average Burst pressure = 5.8 (kPa) (after Accelerated Aging) | Pass |
| Dye Penetration Test (Seal Leaks) | ASTM F1929-15 | No leakage across the seal width of sterile barrier system | No Channels identified on package | Pass |
| Seal Strength | ASTM F88/F88M-15 | Strength > 356 (gf /25.4mm) | Site 1= 588, Site 2= 598, Site 3= 909, Site 4= 1016 (min. value of test results) | Pass |
| Accelerated Aging (Steam) | ASTM F 1980-07 | Incubated for 22.5 days under controlled conditions (Temp: 55°C / RH: 50%) simulating 6 months post-steam sterilization storage. | a. Test articles (no product included and steam sterilized 135°C/15min) were accelerated aged at 55°C and 50% R.H to simulate the real time aging of 6 months. b. Test articles (product included and steam sterilized 135°C/15min) were accelerated aged at 55°C and 50% R.H to simulate the real time aging of 6 months. (Implied that package integrity was maintained after aging, as it "Pass"ed) | Pass |
| Accelerated Aging (EO Gas, Sterility) | ASTM F 1980-07 | Incubated for 137 days under controlled conditions (Temp: 55°C / RH: 50%) simulating 3 years post-EO gas sterilization storage. | a. Test articles (no product included) were accelerated aged at 55°C and 50% R.H to simulate the real time aging of 3 years. b. Test articles (product included and EO sterilized) were accelerated aged at 55°C and 50% R.H to simulate the real time aging of 3 years. (Implied that package integrity was maintained after aging, as it "Pass"ed) | Pass |
| Accelerated Aging (General Shelf Life) | ASTM F 1980-07 | Incubated for 137 days under controlled conditions (Temp: 55°C / RH: 50%) simulating 3 years storage. | a. Test articles (no product included) were accelerated aged at 55°C, and 75% RH to simulate the real time aging of 3 years. b. Test articles (product included) were accelerated aged at 55°C, and 75% RH to simulate the real time aging of 3 years. (Implied that package integrity was maintained after aging, as it "Pass"ed) | Pass |
| Bubble Emission (Gross Leaks) | ASTM D3078-02(R2013) | No Leakage | No Leakage | Pass |
| Internal Pressurization (Gross Leaks) | ASTM F2096-11 | No Leakage | No Leakage | Pass |
| Microbial Barrier Test | DIN 58953-6 | CFU < 1 | CFU < 1 | Pass |
| Microbial Ranking (Porous Packaging) | ASTM F 1608 | LRV > 1.7 | Average LRV = 3.31 | Pass |
| Chemical Indicator Efficacy Testing (Type 1 Process Indicators) | ||||
| Steam CI Color Change (Low Exposure) | AAMI/ANSI/ISO 11140-1:2014 | 121°C / 3.0 min & 134°C / 0.5 min: Unacceptable result (Color should not change significantly) | 121°C / 3.0 min & 134°C / 0.5 min: the result of color is Blue (No change) | Pass |
| Steam CI Color Change (High Exposure) | AAMI/ANSI/ISO 11140-1:2014 | 121°C / 10.0 min & 134°C / 2.0 min: Acceptable result (Color should change to endpoint color) | 121°C / 10.0 min & 134°C / 2.0 min: the result of color is from Blue to Greenish Black (Endpoint color) | Pass |
| Steam CI Color Change (Dry Heat Control) | AAMI/ANSI/ISO 11140-1:2014 | Dry heat 140°C / 30 min: Unacceptable result (Color should not change significantly) | Dry heat 140°C / 30 min: the result of color is Blue (No change) | Pass |
| EO Gas CI Color Change (Absence of EO) | AAMI/ANSI/ISO 11140-1:2014 | Absence of EO gas / 90 min: Unacceptable result (Color should not change significantly) | Absence of EO gas / 90 min: the result of color is Red (No change) | Pass |
| EO Gas CI Color Change (Low Exposure) | AAMI/ANSI/ISO 11140-1:2014 | EO gas Teat / 2 min: Unacceptable result (Color should not change significantly) | EO gas Teat / 2 min: the result of color is Red (No change) | Pass |
| EO Gas CI Color Change (High Exposure) | AAMI/ANSI/ISO 11140-1:2014 | EO gas Teat / 20 min: Acceptable result (Color should change to endpoint color) | EO gas Teat / 20 min: the result of color is Yellow (Endpoint color) | Pass |
| Chemical Indicator Shelf Life | AAMI/ANSI/ISO 11140-1:2014 | All performance attributes should maintain the original color: 3 years shelf life | The real-time test was carried out from October 15, 2007 to December 15, 2010. Test group exposed to Steam maintained Dark Green; test group exposed to EO maintained Yellow; Control group maintained original color. | Pass |
Regarding the sections that are not applicable to non-AI/ML devices (points 2-9):
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this is a physical medical device. The testing involves laboratory evaluations of material properties and sterilization efficacy, not interpretation of data. The document does not specify general "sample sizes" in terms of number of patients/cases, but rather the number of units tested for specific physical and chemical properties. The provenance is likely from the manufacturer's testing facilities in Taiwan.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the context of AI/ML refers to expert-labeled data. For this device, "ground truth" is established by adherence to recognized international standards (e.g., ASTM, ISO, AAMI) and their specified pass/fail criteria for physical and chemical properties.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling of AI/ML data. The "acceptance criteria" here are objective measurements against defined standards.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a standalone physical product, not an AI-assisted diagnostic or therapeutic device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no AI algorithm. The device's performance is inherently standalone in its function as a sterilization pouch.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI device. For this physical device, the "ground truth" for its performance is determined by adherence to established international and national standards for sterilization packaging, material science, and chemical indicators (e.g., microbial barrier, tensile strength, peel strength, chemical indicator color change).
-
The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML model for which a training set would be required.
-
How the ground truth for the training set was established: Not applicable. Same reason as point 8.
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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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Sigma Medical Supplies Corporation % Uta Shih Regulatory Affairs Manager Sen Mu Technology Co., LTD. I5F-2, No.I, Lane 26, Mincyuan 1st Rd., Lingya District, Kaohsiung City, 802 Taiwan
Re: K202462
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: August 21, 2020 Received: August 27, 2020
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Clarence W. Murray, III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202462
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 the Steam Sterilizer and via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
- · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 30 minutes.
- · Gravity steam at 132°C (270°F) for 15 minutes; Drying time of 30 minutes.
- · Gravity steam at 135°C (275°F) for 10 minutes; Drying time of 30 minutes.
- · Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
- · Pre-vacuum steam at 135°C (275°F) for 3 minutes; Drying time of 16 minutes.
· EO sterilization cycle is 4 hours at 55°C (131°F) 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 pouch has undergone either a steam or EO sterilization process.
The SIGMA sterilization pouch and roll is offered in the following 6 types:
- · Self-sealing sterilization pouches
- · Self-sealing sterilization multi 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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| Type | Size | Model |
|---|---|---|
| Self-sealing sterilization pouches | L: 133 mm ~ 610 mmW: 57 mm ~ 460 mm | SMSE |
| Self-sealing sterilization multi pouches | L: 283 mm ~ 335 mmW: 90 mm ~ 240 mm | SMSE |
| Sterilization pouches, Flat | L: 150 mm ~ 600 mmW: 75 mm ~ 420 mm | SMFP |
| Sterilization pouches, Gusseted | L: 300 mm ~ 500 mmW: 100 mm ~ 300 mmH: 40 mm ~ 70 mm | SMGP |
| Sterilization rolls, Flat | L: 30.5M~200 MW: 50 mm ~ 400 mm | SMFR |
| Sterilization rolls, Gusseted | L: ~100 MW: 75 mm ~ 400 mmH: 35 mm ~ 80 mm | SMGR |
The maximum validated pouch load is 3.53 pounds (1.6 kg).
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Submitter'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: | Isabel TsaiRALegal & Regulatory Affairs Dept.886-3-3748880 ext. 3561email: Isabel.Tsai@Benqmaterials.comOrEthan LinSr. SpecialistMarket Planning Sec.886-3-3648880 ext. 3572email: Ethan.Lin @sigma-medical.com.tw |
| Date Prepared: | August 21, 2020 |
| Device Name | |
| Trade Name: | SIGMA Sterilization Pouch and Roll |
| Common/usual Name: | SIGMA Sterilization Pouch and Roll |
| Device Classification Names: | 1) Wrap, Sterilization.2) Indicator, Physical/Chemical Sterilization Process |
| Panel: | General Hospital |
| Classification Product Code: | 1) FRG |
| Subsequent Product Code: | 2) JOJ |
| Device Classification: | Class II |
| Regulation Number: | 1) 21 CFR 880.68502) 21 CFR 880.2800 |
Predicate Devices
The predicate device [510(k) Notification K180661, cleared June 05, 2018] is the SIGMA Sterilization Pouch and Roll.
Manufacturer: SIGMA Medical Supplies Corp.
{5}------------------------------------------------
Product Code: 1) FRG 2) JOJ 510(k) number: K180661
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 the Steam Sterilizer and via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
- Gravity steam at 121℃ (250°F) for 30 minutes; Drying time of 30 minutes. .
- Gravity steam at 132℃ (270°F) for 15 minutes; Drying time of 30 minutes. .
- · Gravity steam at 135℃ (275°F) for 10 minutes; Drying time of 30 minutes.
- Pre-vacuum steam at 132℃ (270°F) for 4 minutes; Drying time of 20 minutes. .
- · Pre-vacuum steam at 135°C (275°F) for 3 minutes; Drying time of 16 minutes.
- EO sterilization cycle is 4 hours at 55℃ (131 °F) 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 6 types:
- Self-sealing sterilization pouches ●
- Self-sealing sterilization multi pouches
- . Sterilization pouches. Flat
- Sterilization pouches, Gusseted
- Sterilization rolls,
- Flat Sterilization rolls, Gusseted
The defining characteristics of the 6 types are 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.
- · Self-sealing sterilization multi pouches: These pouches have the same components as the Self-sealing sterilization pouches, except that the interior of the pouch is divided into several compartments for packaging multiple instruments separately.
{6}------------------------------------------------
- · Sterilization pouches, Flat: These pouches have 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.):
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| Type | Model | Dimension in S.I. | *Content / Max Load (lbs.) | ||
|---|---|---|---|---|---|
| Metal | Plastic | Linens andGauze | |||
| SMSE057133 | 57 mm x 133 mm | 0.11 | 0.03 | 0.03 | |
| SMSE070257 | 70 mm × 257 mm | 0.39 | 0.11 | 0.10 | |
| SMSE090162 | 90 mm x 162 mm | 0.30 | 0.09 | 0.08 | |
| SMSE090168 | 90 mm × 168 mm | 0.32 | 0.09 | 0.08 | |
| SMSE090257 | 90 mm × 257 mm | 0.57 | 0.16 | 0.14 | |
| SMSE090265 | 90 mm x 265 mm | 0.59 | 0.17 | 0.15 | |
| SMSE090594 | 90 mm x 594 mm | 1.35 | 0.45 | 0.39 | |
| SMSE133289 | 133 mm × 289 mm | 1.00 | 0.33 | 0.28 | |
| SMSE133391 | 133 mm x 391 mm | 1.43 | 0.48 | 0.41 | |
| SMSE135193 | 135 mm x 193 mm | 0.67 | 0.19 | 0.17 | |
| SMSE135283 | 135 mm × 283 mm | 0.99 | 0.33 | 0.28 | |
| Self-SealingSterilizationPouches | SMSE180335 | 135 mm x 335 mm | 1.20 | 0.40 | 0.34 |
| SMSE150610 | 150 mm x 610 mm | 2.08 | 0.83 | 0.69 | |
| SMSE190358 | 190 mm x 358 mm | 1.75 | 0.64 | 0.54 | |
| SMSE190365 | 190 mm x 365 mm | 1.79 | 0.65 | 0.55 | |
| SMSE200435 | 200 mm x 435 mm | 2.00 | 0.80 | 0.67 | |
| SMSE300380 | 300 mm x 380 mm | 2.48 | 1.10 | 0.90 | |
| SMSE300474 | 300 mm x 474 mm | 2.63 | 1.50 | 1.17 | |
| SMSE300485 | 300 mm x 485 mm | 2.70 | 1.54 | 1.20 | |
| SMSE303474 | 303 mm x 474 mm | 2.66 | 1.52 | 1.18 | |
| SMSE305416 | 305 mm x 416 mm | 2.56 | 1.28 | 1.02 | |
| SMSE356483 | 356 mm x 483 mm | 2.88 | 1.92 | 1.44 | |
| SMSE380635 | 380 mm x 635 mm | 3.16 | 2.53 | 1.80 | |
| SMSE460610 | 460 mm x 610 mm | 3.40 | 2.83 | 2.00 | |
| SMSE090283 | 90 mm × 283 mm | 0.24 | 0.07 | 0.06 | |
| Self-sealingSterilizationMulti Pouches | SMSE097314 | 97 mm x 314 mm | 0.31 | 0.09 | 0.08 |
| SMSE152314 | 152 mm x 314 mm | 0.41 | 0.12 | 0.10 | |
| SMSE228314 | 228 mm × 314 mm | 0.64 | 0.18 | 0.16 | |
| SMSE240335 | 240 mm x 335mm | 0.78 | 0.22 | 0.20 | |
| Type | Model | Dimension in S.I. | *Content / Max Load (lbs.) | ||
| Metal | Plastic | Linens andGauze | |||
| SMFP075150 | 75 mm × 150 mm | 0.25 | 0.07 | 0.06 | |
| SMFP075200 | 75 mm × 200 mm | 0.36 | 0.10 | 0.09 | |
| SMFP075300 | 75 mm × 300 mm | 0.57 | 0.16 | 0.14 | |
| SMFP100200 | 100 mm × 200 mm | 0.55 | 0.16 | 0.14 | |
| SMFP100300 | 100 mm × 300 mm | 0.78 | 0.24 | 0.21 | |
| SMFP100550 | 100 mm × 550 mm | 1.32 | 0.44 | 0.33 | |
| SMFP120250 | 120 mm × 250 mm | 0.81 | 0.25 | 0.22 | |
| SMFP120280 | 120 mm × 280 mm | 0.92 | 0.28 | 0.25 | |
| SMFP150200 | 150 mm × 200 mm | 0.82 | 0.25 | 0.22 | |
| SMFP150250 | 150 mm × 250 mm | 1.07 | 0.33 | 0.29 | |
| SMFP150300 | 150 mm × 300 mm | 1.16 | 0.39 | 0.33 | |
| SMFP150380 | 150 mm × 380 mm | 1.51 | 0.50 | 0.43 | |
| SterilizationPouches, Flat | SMFP150550 | 150 mm × 550 mm | 1.94 | 0.70 | 0.60 |
| SMFP180300 | 180 mm × 300 mm | 1.44 | 0.48 | 0.41 | |
| SMFP200330 | 200 mm × 330 mm | 1.56 | 0.57 | 0.48 | |
| SMFP200400 | 200 mm × 400 mm | 1.94 | 0.70 | 0.60 | |
| SMFP200600 | 200 mm × 600 mm | 2.75 | 1.10 | 0.92 | |
| SMFP205400 | 205 mm × 400 mm | 2.48 | 1.10 | 0.90 | |
| SMFP250300 | 250 mm × 300 mm | 2.26 | 1.00 | 0.82 | |
| SMFP250450 | 250 mm × 450 mm | 2.61 | 1.04 | 0.87 | |
| SMFP300380 | 300 mm × 380 mm | 2.65 | 1.06 | 0.88 | |
| SMFP300460 | 300 mm × 460 mm | 2.98 | 1.49 | 1.19 | |
| SMFP300500 | 300 mm × 500 mm | 3.26 | 1.63 | 1.30 | |
| SMFP420400 | 420 mm × 400 mm | 3.32 | 2.21 | 1.66 | |
| SMFP420600 | 420 mm × 600 mm | 3.44 | 2.86 | 2.02 | |
| SterilizationPouches,Gusseted | SMGP100300 | 100 mm × 40 mm × 300 mm | 2.26 | 1.88 | 1.33 |
| SMGP150400 | 150 mm × 50 mm × 400 mm | 2.55 | 2.13 | 1.50 | |
| SMGP200400 | 200 mm × 50 mm × 400 mm | 2.68 | 2.23 | 1.58 | |
| SMGP250480 | 250 mm × 60 mm × 480 mm | 3.06 | 2.55 | 1.80 | |
| SMGP300500 | 300 mm × 70 mm × 500 mm | 3.45 | 2.88 | 2.03 | |
| Type | Model | Dimension in S.I. | *Content / Max Load (lbs.) | ||
| Metal | Plastic | Linens andGauze | |||
| SterilizationRolls, Flat | SMFR 022 | 50 mm × 200 M | 0.26 | 0.08 | 0.07 |
| SMFR902 | 50.8 mm × 200 M | 0.27 | 0.08 | 0.07 | |
| SMFR 032 | 75 mm × 200 M | 0.57 | 0.16 | 0.14 | |
| SMFR912 | 76.2 mm × 200 M | 0.58 | 0.17 | 0.15 | |
| SMFR 042 | 100 mm × 200 M | 0.87 | 0.25 | 0.22 | |
| SMFR922 | 101.6 mm × 200 M | 0.89 | 0.26 | 0.22 | |
| SMFR 062 | 150 mm × 200 M | 1.40 | 0.47 | 0.40 | |
| SMFR932 | 152.4 mm × 200 M | 1.43 | 0.48 | 0.41 | |
| SMFR 082 | 200 mm × 200 M | 1.86 | 0.75 | 0.62 | |
| SMFR942 | 203.2 mm × 200 M | 1.90 | 0.76 | 0.63 | |
| SMFR 102 | 250 mm × 200 M | 2.41 | 0.96 | 0.80 | |
| SMFR952 | 254 mm × 200 M | 2.45 | 0.98 | 0.82 | |
| SMFR 122 | 300 mm × 200 M | 2.77 | 1.38 | 1.11 | |
| SMFR962 | 304.8 mm × 200 M | 2.82 | 1.41 | 1.13 | |
| SMFR 142 | 350 mm × 200 M | 3.28 | 1.64 | 1.31 | |
| SMFR 162 | 400 mm × 200 M | 3.53 | 2.36 | 1.77 | |
| SMFR02-1 | 50.8 mm × 30.5 M | 0.27 | 0.08 | 0.07 | |
| SMFR03-1 | 76.2 mm × 30.5 M | 0.58 | 0.17 | 0.15 | |
| SMFR04-1 | 101.6 mm × 30.5 M | 0.89 | 0.26 | 0.22 | |
| SMFR06-1 | 152.4 mm × 30.5 M | 1.43 | 0.48 | 0.41 | |
| SMFR08-1 | 203.2 mm × 30.5 M | 1.90 | 0.76 | 0.63 | |
| SMFR10-1 | 254 mm × 30.5 M | 2.45 | 0.98 | 0.82 | |
| SterilizationRolls,Gusseted | SMGR 031 | 75 mm × 35 mm × 100 M | 2.21 | 1.84 | 1.30 |
| SMGR 041 | 100 mm × 40 mm × 100M | 2.26 | 1.88 | 1.33 | |
| SMGR 061 | 150 mm × 50 mm × 100 M | 2.47 | 2.06 | 1.45 | |
| SMGR 081 | 200 mm × 50 mm × 100 M | 2.56 | 2.13 | 1.51 | |
| SMGR 101 | 250 mm × 60 mm × 100 M | 2.73 | 2.27 | 1.61 | |
| SMGR 121 | 300 mm × 70 mm × 100 M | 2.93 | 2.44 | 1.73 | |
| SMGR 141 | 350 mm × 80 mm × 100 M | 3.17 | 2.64 | 1.87 | |
| SMGR 161 | 400 mm × 80 mm × 100 M | 3.32 | 2.76 | 1.95 |
Table 1. The model numbers of SIGMA sterilization pouch and roll (Type, Model and Dimension and Content/Max. Load)
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Table 1. (Continued) The model numbers of SIGMA sterilization pouch and roll (Type, Model and Dimension and Content/Max Load)
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Table 1. (Continued) The model numbers of SIGMA sterilization pouch and roll (Type, Model and Dimension and Content/Max Load)
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Device Description
The SIGMA sterilization pouches and rolls 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.
Description of Comparison and Substantial Equivalence
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 | ||
|---|---|---|---|---|
| Device name | SIGMA sterilization pouch and roll(K202462) | SIGMA sterilization pouch androll (K180661) | Comparison | |
| MaterialComposition | Medical Grade Paper, CPP, PET, PU adhesive, EO and SteamProcess Indicator, Print Ink | Medical Grade Paper, CPP, PET, PUadhesive, EO and Steam ProcessIndicator, Print Ink | Same | |
| Intended use | The SIGMA sterilization pouch and roll are intended toprovide health care workers with an effective method toenclose devices intended for sterilization in the SteamSterilizer and via Ethylene Oxide (EO). Therecommended sterilization cycles are as follows:• Gravity steam at 121 °C for 30 min; Drying time of 30 min.• Gravity steam at 132°C for 15 min; Drying time of 30 min.• Gravity steam at 135°C for 10 min; Drying time of 30 min.• Pre-vacuum steam at 132°C for 4 min; Drying time of 20 min.• Pre-vacuum steam at 135°C for 3 min; Drying time of 16 min.• EO sterilization cycle is 4 hours at 55°C with a relativehumidity between 50%-85% and a sterilant concentration of600 mg/L.Furthermore, the sterilization pouch and roll maintainsthe enclosed devices up until 3 years post EO gassterilization and maintains the enclosed devices up until6 months post Steam sterilization. Lastly, the pouch'sexternal chemical ink indicators are designed toindicate to the user that the pouch has undergone eithera steam or EO sterilization process. | The sterilization pouch and roll areintended to provide health careworkers with an effective method toenclose devices intended forsterilization in steam auto claves andvia Ethylene Oxide (EO). Therecommended steam sterilizationcycle parameters are 30 minutes at121°C. The recommended EOsterilization cycle is 4 hours at 55°Cwith a relative humidity between50%-85% and a sterilantconcentration of 600 mg/L.Furthermore, the sterilization pouchand roll maintains the encloseddevices up until 3 years poststerilization. Lastly, the pouch'sexternal chemical ink indicators aredesigned to indicate to the user thatthe pouch has undergone either asteam or EO sterilization process. | Only the Steamrecommendedsterilization cyclesare different.The recommendedSteam sterilizationcycles of proposeddevice increase 4types ofsterilization cycle,which are Gravity132°C/15 min,Gravity 135°C/10min, Pre-vacuum132°C/ 4 min andPre-vacuum135°C/ 3 min. | |
| Feature | Subject device: SIGMA sterilization pouch and roll | Predicate devices: SIGMA sterilization pouch and roll (K180661) | Comparison | |
| Pouch Types | Self-sealing sterilization pouches Self-sealing sterilization multi 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 | The proposed device increase one type of the sterilization pouch, which is "Self-sealing sterilization multi pouches". | |
| Device models (Configurations/Dimensions) | Self-Sealing Sterilization Pouches | Self-Sealing Sterilization Pouches | ||
| SizeL: 133 mm ~ 610 mmW: 57 mm ~ 460 mm | ModelSMSE | SizeL: 133 mm ~ 610 mmW: 57 mm ~ 460 mmModelSMSE | Same | |
| Self-Sealing Sterilization Multi Pouches | N/A | The proposed device increase one type and the size is different. | ||
| SizeL: 283 mm ~ 335 mmW: 90 mm ~ 240 mm | ModelSMSE | |||
| Sterilization Pouches, Flat | Sterilization Pouches, Flat | Same | ||
| SizeL: 150 mm ~ 600 mmW: 75 mm ~ 420 mm | ModelSMFP | SizeL: 150 mm ~ 600 mmW: 75 mm ~ 420 mmModelSMFP | ||
| Sterilization pouches, Gusseted | Sterilization pouches, Gusseted | Same | ||
| SizeL: 300 mm ~ 500 mmW: 100 mm ~ 300 mmH: 40 mm ~ 70 mm | ModelSMGP | SizeL: 300 mm ~ 500 mmW: 100 mm ~ 300 mmH: 40 mm ~ 70 mmModelSMGP | ||
| Sterilization rolls, Flat | Sterilization rolls, Flat | Same | ||
| SizeL: 30.5M ~ 200 MW: 50 mm ~ 400 mm | ModelSMFR | SizeL: 30.5M ~ 200 MW: 50 mm ~ 400 mmModelSMGP | ||
| Sterilization Rolls, Gusseted | Sterilization Rolls, Gusseted | Same | ||
| SizeL: ~100 MW: 75 mm ~ 400 mmH: 35 mm ~ 80 mm | ModelSMGR | SizeL: ~100 MW: 75 mm ~ 400 mmH: 35 mm ~ 80 mmModelSMGR |
Table 2. Summary of the Proposed and Predicate Devices Technological Characteristics
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| Table 2. (Continued) Summary of the Proposed and Predicate Devices Technological Characteristics | |||||
|---|---|---|---|---|---|
| Feature | Subject devices:SIGMA sterilization pouch and roll(K202462) | Predicate devices:SIGMA sterilization pouch and roll(K180661) | Comparison | ||
| SteamSterilizationcycle | The recommended steam sterilization cycle parameters are asfollows:• Gravity steam at 121 °C for 30 min; Drying time of 30 min.• Gravity steam at 132°C for 15 min; Drying time of 30 min.• Gravity steam at 135°C for 10 min; Drying time of 30 min.• Pre-vacuum steam at 132°C for 4 min; Drying time of 20 min.• Pre-vacuum steam at 135°C for 3 min; Drying time of 16 min. | The recommended steam sterilization cycle parametersare 30 minutes at 121°C; Drying time of 30 minutes. | The recommendedSteam sterilizationcycles of proposeddevice increase 4types of sterilizationcycle, which areGravity 132°C/15min, Gravity135°C/10 min, Pre-vacuum 132°C/ 4min and Pre-vacuum135°C/ 3 min. | ||
| EO gasSterilizationcycle | The recommended EO sterilization cycle is 4 hours at 55°C witha relative humidity between 50%-85% and a sterilantconcentration of 600 mg/L. | The recommended EO sterilization cycle is 4 hours at55°C with a relative humidity between 50%-85% and asterilant concentration of 600 mg/L. | Same | ||
| Designfeatures | Self-sealing sterilization pouches:These pouches are made from a medical grade plasticfilm that is heat sealed on three sides. The forth side hasan adhesive strip that is used to seal the pouch. Releasepaper used in the pouch is a laminated sheet withcomposing structure of PE/paper/PE. It is a strip to coverthe adhesive area and is released before seal the pouch.The medical grade paper conforms to recognizedmaterial standards and can be sterilized by steam orethylene oxide gas. The Process Indicators Ink printed onthe medical grade paper will exhibit a color change afterthe pouch is exposed to steam or ethylene oxide gas.Self-sealing sterilization multi pouches:These pouches have the same components as the Self-sealing sterilization pouches, except that the interior ofthe pouch is divided into several compartments forpackaging multiple instruments separately.Sterilization pouches, Flat:These pouches has the same components with the Self-sealing sterilization pouches, except the forth side is leftopened instead of an adhesive strip and will be heat-sealed when using.Sterilization pouches, Gusseted:These pouches are the same with the Sterilizationpouches, flat, except that the plastic film is folded onboth longest sides instead of flat. This design isconvenient to enclose the medical devices with certainheight.Sterilization rolls, Flat:These rolls are made from a medical grade paper andplastic film that are heat sealed on opposite two sides. Itwill be cut into the suitable length and the opened sideswill be heat-sealed. The indicators printed on the medicalgrade paper are the same with the self-sealingsterilization pouches.Sterilization rolls, Gusseted:These rolls are the same with the flat sterilization roll,except that the plastic film is folded on both longest sidesinstead of flat. This design is convenient to enclose themedical devices with certain height. | Self-sealing sterilization pouches:These pouches are made from a medical gradeplastic film that is heat sealed on three sides. Theforth side has an adhesive strip that is used toseal the pouch. Release paper used in the pouchis a laminated sheet with composing structure ofPE/paper/PE. It is a strip to cover the adhesivearea and is released before seal the pouch. Themedical grade paper conforms to recognizedmaterial standards and can be sterilized by steamor ethylene oxide gas. The Process Indicators Inkprinted on the medical grade paper will exhibit acolor change after the pouch is exposed to steamor ethylene oxide gas.Sterilization pouches, Flat:These pouches has the same components with theSelf-sealing sterilization pouches, except theforth side is left opened instead of an adhesivestrip and will be heat-sealed when using.Sterilization pouches, Gusseted:These pouches are the same with the Sterilizationpouches, flat, except that the plastic film isfolded on both longest sides instead of flat. Thisdesign is convenient to enclose the medicaldevices with certain height.Sterilization rolls, Flat:These rolls are made from a medical grade paperand plastic film that are heat sealed on oppositetwo sides. It will be cut into the suitable lengthand the opened sides will be heat-sealed. Theindicators printed on the medical grade paper arethe same with the self-sealing sterilizationpouches.Sterilization rolls, Gusseted:These rolls are the same with the flat sterilizationroll, except that the plastic film is folded on bothlongest sides instead of flat. This design isconvenient to enclose the medical devices withcertain height. | The proposeddevice increaseone type of thesterilizationpouch, which is"Self-sealingsterilizationmulti pouches".These poucheshave the samecomponents asthe Self-sealingsterilizationpouches, exceptthat the interiorof the pouch isdivided intoseveralcompartmentsfor packagingmultipleinstrumentsseparately. | ||
| Steam CIDevice Design | The color of Chemical Indicator changes from Blue to GreenishBlack, when exposed to Steam. | The color of Chemical Indicator changes from Blue toGreenish Black, when exposed to Steam. | Same | ||
| EO gas CIDevice Design | The color changes from red to yellow, when exposed to EO gas. | The color changes from red to yellow, when exposed toEO gas. | Same | ||
| Feature | Performance Testing | Proposed Device:SIGMA sterilizationpouch and roll | Predicate Devices:SIGMA sterilizationpouch and roll (K180661) | Comparison | |
| SterilantPenetration | Half-Cycle Efficacy | The test meet therequirement of SAL 10-6 | The test meet therequirement of SAL 10-6 | Same | |
| Full-Cycle Efficacy | The test meet therequirement of SAL 10-6 | NA | The proposed deviceperforms SterilantPenetration of Full-Cycle Efficacy. | ||
| Chemical Indicator (CI)Functionality and Endpoint | The sterilant penetrated throughthe pouch configuration andaffected the CI color change tothe endpoint color. | The sterilant penetratedthrough the pouchconfiguration and affected theCI color change to theendpoint color. | Same | ||
| PackageIntegrity(PhysicalProperties) | 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 TestASTM D 3078 ; ASTM-F 2096 | Passed | Passed | Same | ||
| Seal Peel Test (g/15mm)ASTM F88/F88M ; ISO 11607-1 | Passed | Passed | Same | ||
| Dye penetration TestASTM F 1929 ;ISO 11607-1 | Passed | Passed | Same | ||
| Microbial Barrier TestDIN 58953-6 ;or ASTM F 1608 | Passed | Passed | Same | ||
| Toxicological Properties(Biocompatibility Test)ANSI/AAMI/ISO 10993-10 | Passed | Passed | Same | ||
| Durability: Accelerated Aging TestASTM F 1980 ; ISO 11607-1 | Passed | Passed | Same | ||
| End Point / PostProcessing | after Steam sterilization | 6 months | 6 months | Same | |
| Color Stability | after EO sterilization | 3 Years | 3 Years | Same | |
| Chemical Indicator (CI)Functionality | 3 Years | 3 Years | Same | ||
| Shelf Life | Accelerated aging test | 3 Years | 3 Years | Same | |
| Testcompleted | Standards followed | Acceptancecriteria | Results | ||
| SterilantPenetration/Drying Time/Aeration | ANSI/AAMI/ISO 17665-1:2006/(R)2013, "Sterilization OfHealth Care Products -Moist Heat - Part 1: Requirements ForThe Development, Validation, And Routine Control Of ASterilization Process For Medical Devices"ANSI/AAMI/ISO TIR 17665-2:2009 (R2016), "Sterilization OfHealth Care Products - Moist Heat - Part 2: Guidance On TheApplication Of ANSI/AAMI/ISO 17665-1" | - Meet the requirementof SAL 10-6, the test BI(the Steam processed ) :No bacterial growth-The weight differencebefore sterilization andafter drying shall notexceed 0 % | Using half-cycle and full-cycle analysis.Test BI: No bacterialgrowthWeight difference = 0%Visual are drying. | Pass | |
| AAMI / ANSI / ISO 11135:2014, "Sterilization Of Health CareProducts - Ethylene Oxide - Requirements For Development,Validation And Routine Control Of A Sterilization Process ForMedical Devices". | Meet the requirement ofSAL 10-6, the test BI(the EO processed ) : Nobacterial growth | Using half-cycle analysis.Test BI: No bacterialgrowth | Pass | ||
| ISO 10993-7:2008 (R) 2012, "Biological Evaluation of MedicalDevices - Part 7: Ethylene Oxide Sterilization Residuals | EO < 4mgECH < 9mgWithin 72 hours | EO = 2mg (Average)ECH = 0.3 mgWithin 72 hours | Pass | ||
| Biocompatibilitytesting | ISO 10993-10 Third Edition 2010-08-01, "Biological Evaluationof Medical Devices- Part 10: Tests for irritation and skinsensitization". | Response Category:Negligible | Negligible(negative reaction) | Pass | |
| PackageIntegrity/ | ANSI/AAMI/ISO 11607-1:2006/(R)2010/A1:2014, "Packaging for terminally sterilized medical devices- Part 1: Requirements formaterials, sterile barrier systems and packaging systems" | ||||
| MaterialCompatibility/SterilityMaintenance | ASTM D882-12, "Standard Test Method for Tensile Propertiesof Thin Plastic Sheeting" | CD > 400MD > 450(kgf/mm2) | CD = 458MD =462Note: the data is the min.value of test results afterSteam Sterilization. | Pass | |
| ASTM D 1004 -13, "Standard Test Method for Tear Resistance(Graves Tear) of Plastic Film and Sheeting" | CD > 300MD > 350(kgf/mm2) | CD = 443MD =453Note: the data is the min.value of test results afterSteam Sterilization. | Pass | ||
| ASTM F 2251-13, "Standard Test Method for ThicknessMeasurement of Flexible Packaging Material" | ±0.02 | ±0.003 | Pass | ||
| ASTM F1140/F1140M-13, "Standard Test Methods for InternalPressurization Failure Resistance of Unrestrained Packages"; | It pressurize to the 80%of the burst value andhold for 30s.Burst value > 5.0 (kPa) | Average Burst pressure =5.8 (kPa)Note: the data is afterAccelerated Aging. | Pass | ||
| ASTM F1929-15, "Standard Test Method for Detecting SealLeaks in Porous Medical Packaging by Dye Penetration" | The dye solution is noany leakage across theseal width of sterilebarrier system. | No Channels identified onpackage | Pass | ||
| ASTM F88/F88M-15, "Standard Test Method for Seal Strengthof Flexible Barrier Materials" | The strength > 356(gf /25.4mm) | Site 1= 588Site 2= 598Site 3= 909Site 4= 1016Note: themin. value oftest results. | Pass | ||
| ASTM F 1980-07, "Standard Guide for Accelerated Aging ofSterile Barrier Systems for Medical Devices"; | Incubated for 22.5 daysunder controlledconditions (Temp: 55°C/ RH: 50%) simulatingthe real time for post-steam sterilization(135°C/15min) storageof 6 months. | a. Test articles (no productincluded and steam sterilized135°C/15min) wereaccelerated aged at 55°C and50% R.H to simulate the realtime aging of 6 months.b. Test articles (productincluded and steam sterilized135°C/15min) wereaccelerated aged at 55°C and50% R.H to simulate the realtime aging of 6 months. | Pass | ||
| Testcompleted | Standards followed | Acceptancecriteria | Results | ||
| PackageIntegrity/MaterialCompatibility/SterilityMaintenance | ASTM F 1980-07, "Standard Guide for Accelerated Aging ofSterile Barrier Systems for Medical Devices"; | Incubated for 137 daysunder controlledconditions (Temp: 55°C/ RH: 50%) simulatingthe real time for post-EOgas sterilization storageof 3 years. | a. Test articles (no productincluded) were acceleratedaged at 55°C and 50% R.H tosimulate the real time aging of3 years.b. Test articles (productincluded and EO sterilized)were accelerated aged at 55°Cand 50% R.H to simulate thereal time aging of 3 years. | Pass | |
| ASTM F 1980-07, "Standard Guide for Accelerated Aging ofSterile Barrier Systems for Medical Devices"; | Incubated for 137 daysunder controlledconditions (Temp: 55°C/ RH: 50%) simulatingthe real time storage of 3years. | a. Test articles (no productincluded) were acceleratedaged at 55°C, and75% RH to simulate the realtime aging of 3 years.b. Test articles (productincluded) were acceleratedaged at 55°C, and75% RH to simulate the realtime aging of 3 years. | Pass | ||
| ASTM D3078-02(R2013), "Standard Test Method ForDetermination Of Leaks In Flexible Packaging By BubbleEmission" | No Leakage | No Leakage | Pass | ||
| ASTM F2096-11, "Standard Test Method For Detecting GrossLeaks In Packaging By Internal Pressurization (Bubble Test) | No Leakage | No Leakage | Pass | ||
| DIN 58953-6, "Sterilization -Sterile supply-Part 6: Microbialbarrier testing of packaging materials for medical devices whichare to be sterilized" | CFU < 1 | CFU < 1 | Pass | ||
| ASTM F 1608, "Standard Test Method for Microbial Ranking ofPorous Packaging Materials (Exposure Chamber Method)" | LRV > 1.7 | Average LRV =3.31 | Pass | ||
| ChemicalIndicatorEfficacy testing(Type 1 ProcessIndicators ) | AAMI/ANSI/ISO 11140-1:2014 "Sterilization of Health CareProducts-Chemical Indicators-Part 1: General Requirements"Change color in the presence of the sterilant (After steam | SteamChange color121°C / 3.0 min & 134°C/0.5 min: Unacceptableresult121°C/10.0 min & 134°C/2.0 min: Acceptable resultDry heat 140°C/30 min:Unacceptable result | 121°C / 3.0 min & 134°C/ 0.5min: the result of color is Blue121°C/10.0 min & 134°C/ 2.0min: the result of color is fromBlue to Greenish BlackDry heat 140°C/30 min: theresult of color is Blue. | Pass | |
| sterilization cycles. The color of Chemical Indicator changesfrom Blue to Greenish Black; After EO sterilization cycles. Thecolor of Chemical Indicator changes from Red to Yellow.) | EO gasChange colorAbsence of EO gas / 90min: Unacceptable resultEO gas Teat / 2 min :Unacceptable resultEO gas Teat /20 min:Acceptable result | Absence of EO gas / 90 min:the result of color is Red.EO gas Teat / 2 min: the resultof color is Red.EO gas Teat /20 min: theresult of color is Yellow. | Pass | ||
| 1. Remain stable before use based on its shelf life.2. Maintain the endpoint stability of the color change after beingin the presence of the sterilant. | All performance attributesshould maintain the originalcolor : 3 years shelf life | The real-time test was carriedout from October 15, 2007 toDecember 15, 2010 thatdemonstrates: the test groupwhich exposed to Steammaintain the color of DarkGreen, the test group whichexposed to EO maintain thecolor of Yellow, and theControl group maintain theoriginal color from October15, 2007, to December 15,2010. | Pass |
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Table 2. (Continued) Summary of the Proposed and Predicate Devices Technological Characteristics
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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.
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Summary of Non-Clinical Testing
The SIGMA sterilization pouch and roll have 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 following Table 3:
Table 3. Summary of Non-Clinical Testing
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Table 3. (Continued) Summary of Non-Clinical Testing
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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 K180661.
§ 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).