(448 days)
The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. 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 sterilization.
The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.
Sterilization Pouch/Roll Made with Tyvek® is intended to contain medical devices to be terminally sterilized in the STERRAD® Sterilization Systems. The recommended Gas Plasma sterilization cycle parameter is 6 minutes (Injection volume: 2880µ L) at 50°C. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the STERRAD® 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 sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.
The proposed pouches are constructed from Tyvek® plastic films, with H2O2 Chemical Indicator printed onto the Tyvek" film. 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 STERRAD® Sterilization Systems.
The H2O2 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. H2O2 Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to blue (or lighter) when exposed to hydrogen peroxide.
The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:
- Self-sealing sterilization pouches .
- . Sterilization pouches, Flat
- . Sterilization pouches, Gusseted
- Sterilization rolls, Flat
- Sterilization rolls, Gusseted
This document is a 510(k) premarket notification for a medical device called "Sterilization Pouch/Roll Made with Tyvek®". It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence, which is the basis for its FDA clearance.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document presents performance data primarily in a comparative table (Table 5-2, continued on subsequent pages in the original document) comparing the new device against its predicate. It also lists the standards used for testing throughout the "Effectiveness and Safety" section.
| Performance Metric | Acceptance Criteria (Standard Reference and/or Implied Criterion) | Reported Device Performance |
|---|---|---|
| Sterilant Penetration | Meet the requirement of SAL 10-6 (ANSI/AAMI/ISO 14937:2009) | The test met the requirement of SAL 10-6 |
| Package Integrity (Physical Properties) | (Tested before and after Gas Plasma Sterilization) | |
| Thickness Variations (mm) | (ASTM F 2251-03) No specific numerical acceptance criteria provided, but "Small" values for both new and predicate are similar. | Small: 0.145 (before/after); Large: 0.146 (before/after) |
| Tear Resistance (g) | (ASTM D1922) No specific numerical acceptance criteria provided, but similar to predicate. | CD: 259 (before), 258 (after); MD: 282 (before), 280 (after) |
| Tensile strength of plastic film (kgf/mm2) | (ASTM D882) No specific numerical acceptance criteria provided, but similar to predicate. | CD: 575 (before), 531 (after); MD: 577 (before), 531 (after) |
| Tensile strength of Tyvek® (N/2.54cm) | (ASTM D 5035) No specific numerical acceptance criteria provided, but similar to predicate. | CD: 174 (before), 170 (after); MD: 163 (before), 162 (after) |
| Burst Strength (kPa) | (ASTM F1140-07) No specific numerical acceptance criteria provided, but similar to predicate. | Small: 21.4 (before), 17.95 (after); Large: 4.49 (before), 2.03 (after) |
| Seal Peel Test (g/15mm) | Pass (ASTM F88/F88M-09; ISO 11607-1) - The predicate also reports "Pass". | Upper: 340.3 (before), 493.6 (after); Down: 506.7 (before), 709.9 (after); Left: 345.7 (before), 436.0 (after); Right: 316.5 (before), 518.5 (after). Result: Pass |
| Dye penetration Test | No Channels identified on package (ASTM F 1929-12; ISO 11607-1) | No Channels identified on package |
| Microbial Barrier Test | < 1 (Result: Pass) (DIN 58953-6:2010-05) | < 1 (Result: Pass) |
| Toxicological Properties | Negative reaction (ANSI/AAMI/ISO 10993-10) | Negative reaction |
| Durability: Accelerated Aging Test | 3 Years (ASTM F 1980-2007; ISO 11607-1 2006) - The predicate also states "3 Years" | 3 Years |
| Shelf Life | 3 Years | 3 Years |
| Chemical Indicator Efficacy | Ability to effectively demonstrate stability of ink before use, lasting quality (color stability) of color change, completeness and uniformity of color change, and all or none color change (AAMI / ANSI / ISO 11140-1:2005) | Meets the requirements of ISO 11140-1:2005 |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each test (e.g., number of pouches/rolls tested for peel strength, burst strength, etc.). It mentions that "the test items were performed on materials of the products" for some physical property tests, implying samples of the materials were used.
The data provenance is from Taiwan (R.O.C.), as the manufacturer is Sigma Medical Supplies Corporation located in New Taipei City, Taiwan. The studies appear to be prospective as they involve testing the newly developed device against established standards and a predicate device.
3. 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)
This section is not applicable to this type of device and study. The "ground truth" for this medical device (sterilization pouches/rolls) is established through adherence to recognized international and national consensus standards for physical properties, sterilization efficacy, biocompatibility, and product performance, rather than through expert clinical assessment or interpretation of medical images. The studies are laboratory-based and measure objective physical and biological parameters. Therefore, there are no "experts" in the traditional sense of medical image interpretation (like radiologists) establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need to be resolved. For laboratory-based testing of physical and chemical properties of a medical device like a sterilization pouch, direct measurements are taken against predefined acceptance criteria from standards. There isn't a process of expert adjudication for these types of objective measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. MRMC studies are related to the evaluation of AI-powered diagnostic devices that involve human readers (e.g., radiologists, pathologists). This document is for a physical medical device (sterilization pouches/rolls) and does not involve AI or human "readers" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. This device is a physical product, not an algorithm related to AI or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of the Sterilization Pouch/Roll Made with Tyvek® is based on established international and national consensus standards for medical device packaging, sterilization processes, and biocompatibility. These include:
- Sterilant Penetration: Adherence to SAL 10-6 as per ANSI/AAMI/ISO 14937:2009.
- Package Integrity and Material Properties: Defined by standards like AAMI/ANSI/ISO 11607-1:2006/(R) 2010, ASTM D882, ISO 1924-2, ASTM D 5035, ASTM F 2251-03, ASTM D 1922, ASTM D 1004, ASTM F 1140-07, ASTM F 1929-98 (04), ASTM F88/F88M-09, ASTM F 1980-2007.
- Microbial Barrier: DIN 58953-6:2010-05.
- Biocompatibility: ISO 10993-10 Third Edition 2010-08-01.
- Chemical Indicator Efficacy: AAMI / ANSI / ISO 11140-1:2005.
These standards provide objective, measurable criteria for the device's performance, thereby defining the "ground truth" for its acceptability.
8. The sample size for the training set
This section is not applicable. This submission is for a physical medical device and does not involve machine learning algorithms that require a "training set." The materials and manufacturing processes are validated, not "trained."
9. How the ground truth for the training set was established
This section is not applicable as there is no training set involved for this device submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2015
Sigma Medical Supplies Corp. Mr. Uta Shih Official Correspondent C/O Sen Mu Technology Co., Ltd 15-2, Ln 26, Mineyuan 1st Rd, Lingya District Kaohsiung, 802, Taiwan (R.O.C)
Re: K133838 Trade/Device Name: Sterilization Pouch/Roll Made with Tyvek® (Type: Self-sealing sterilization pouches; Sterilization Pouches, Flat; Sterilization Pouches, Gusseted; Sterilization Rolls, Flat; Sterilization Rolls, Gusseted) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 27, 2015 Received: February 9, 2015
Dear Mr. 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.
{1}------------------------------------------------
Page 2 - Mr. Shih
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
{2}------------------------------------------------
Indications for use
510(k) Number: K133838
Device Name: Sterilization Pouch/Roll Made with Tyvek® (Type: Self-sealing sterilization pouches; Sterilization Pouches, Flat; Sterilization Pouches, Gusseted; Sterilization Rolls, Flat; Sterilization Rolls, Gusseted)
Indications for Use:
The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. 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 sterilization.
The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.
The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:
- O Self-sealing sterilization pouches
- Sterilization pouches, Flat
- Sterilization pouches, Gusseted
- 0 Sterilization rolls, Flat
- Sterilization rolls, Gusseted
Prescription Use AND/OR (Per 21 CFR 801 Subpart D)
Over-The-Counter Use × (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 3 Page of
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The following table (Table 4-1) lists the model numbers of the Sterilization Pouch/Roll Made with Tyvek® by type, model, dimensions and characteristics:
| Type | Model | Dimensions (mm) | Characteristics |
|---|---|---|---|
| Self-sealingSterilizationPouches | TYSE057133 | 57mmx133mm | These pouches are made from a medicalgrade plastic film that is heat sealed on threesides. The forth side has an adhesive stripthat is Tyvek® and used to seal the pouch.Release Tyvek® used in the pouch is alaminated sheet with composing structure ofTyvek®, PET, PE. It is a strip to cover theadhesive area and is released before seal thepouch. The Tyvek® conforms to recognizedmaterial standards and can be sterilized byGas plasma. The Process Indicators Inkprinted on the Tyvek® will exhibit a colorchange after the pouch is exposed to Gasplasma. |
| TYSE090162 | 90mmx162mm | ||
| TYSE070257 | 70mmx257mm | ||
| TYSE090257 | 90mmx257mm | ||
| TYSE135283 | 135mmx283mm | ||
| TYSE135335 | 135mmx335mm | ||
| TYSE190358 | 190mmx358mm | ||
| TYSE300380 | 300mmx380mm | ||
| TYSE300474 | 300mmx474mm | ||
| SterilizationPouches, Flat | TYFP075200 | 75mmx200mm | These pouches has the samecomponents with the Self-sealingsterilization pouches, except the forthside is left opened instead of anadhesive strip and will be heat-sealedwhen using. |
| TYFP075300 | 75mmx300mm | ||
| TYFP100200 | 100mmx200mm | ||
| TYFP100300 | 100mmx300mm | ||
| TYFP150300 | 150mmx300mm | ||
| TYFP200400 | 200mmx400mm | ||
| TYFP250450 | 250mmx450mm | ||
| TYFP300500 | 300mmx500mm | ||
| SterilizationPouches,Gusseted | TYGP100300 | 100mmx40mmx300mm | These rolls are the same with theSterilization pouches, flat, except thatthe plastic film is folded on bothlongest sides instead of flat. Thisdesign is convenient to enclose themedical devices with certain height. |
| TYGP150400 | 150mmx50mmx400mm | ||
| TYGP200400 | 200mmx50mmx400mm | ||
| TYGP250480 | 250mmx60mmx480mm | ||
| TYGP300500 | 300mmx70mmx500mm | ||
| Type | Model | Dimensions (mm) | Characteristics |
| SterilizationRolls, Flat | TYFR050070 | 50mmx70M | These rolls are made from a Tyvek®and plastic film that are heat-sealedon opposite two sides. It will be cutinto the suitable length and theopened sides will be heat-sealed. Theindicators printed on the Tyvek® arethe same with the self-sealingsterilization pouches. |
| TYFR075070 | 75mmx70M | ||
| TYFR100070 | 100mmx70M | ||
| TYFR150070 | 150mmx70M | ||
| TYFR200070 | 200mmx70M | ||
| TYFR250070 | 250mmx70M | ||
| TYFR300070 | 300mmx70M | ||
| TYFR350070 | 350mmx70M | ||
| TYFR400070 | 400mmx70M | ||
| TYFR450070 | 450mmx70M | ||
| TYFR500070 | 500mmx70M | ||
| TYFR050100 | 50mmx100M | ||
| TYFR075100 | 75mmx100M | ||
| TYFR100100 | 100mmx100M | ||
| TYFR150100 | 150mmx100M | ||
| TYFR200100 | 200mmx100M | ||
| TYFR250100 | 250mmx100M | ||
| TYFR300100 | 300mmx100M | ||
| TYFR350100 | 350mmx100M | ||
| TYFR400100 | 400mmx100M | ||
| TYFR450100 | 450mmx100M | ||
| TYFR500100 | 500mmx100M | ||
| TYFR050200 | 50mmx200M | ||
| TYFR075200 | 75mmx200M | ||
| TYFR100200 | 100mmx200M | ||
| TYFR150200 | 150mmx200M | ||
| TYFR200200 | 200mmx200M | ||
| TYFR250200 | 250mmx200M | ||
| TYFR300200 | 300mmx200M | ||
| TYFR350200 | 350mmx200M | ||
| TYFR400200 | 400mmx200M | ||
| SterilizationRolls, Gusseted | TYGR075100 | 75mmx35mmx100M | These rolls are the same with the flatsterilization roll, except that theplastic film is folded on both longestsides instead of flat. This design isconvenient to enclose the medicaldevices with certain height. |
| TYGR100100 | 100mmx40mmx100M | ||
| TYGR150100 | 150mmx50mmx100M | ||
| TYGR200100 | 200mmx50mmx100M | ||
| TYGR250100 | 250mmx60mmx100M | ||
| TYGR300100 | 300mmx70mmx100M | ||
| TYGR350100 | 350mmx80mmx100M | ||
| TYGR400100 | 400mmx80mmx100M |
Table 4-1. The model numbers of Sterilization Pouch/Roll Made with Tyvek® (Type, Model, Dimension and Characteristics)
of_3 2 Page
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510(K) Summary
| 5.0 Prepared Date: | March 11, 2015. |
|---|---|
| 5.1 Device Trade Name: | Sterilization Pouch/Roll Made with Tyvek®(Type: Self-sealing sterilization pouches; Sterilization Pouches, Flat; Sterilization Pouches, Gusseted; Sterilization Rolls, Flat; Sterilization Rolls, Gusseted) |
| 5.2 Named and Address of Manufacturer: | Sigma Medical Supplies CorporationNO.34, Ding-Ping Road, Ruei Fang Industrial ParkRuei Fang Dist., New Taipei City 224, Taiwan, R.O.C |
| Establishment Registration Number: | 3004970050 |
| Contact Person: | Rose ChienQuality Assurance / Regulatory Affairs ManagerTel: 886-2-24974121 ext. 283Fax: 886-2-24974122E-mail: qa_manager@sigma-medical.com.tw |
| 5.3 Device Classification Names: | 1) Sterilization wrap containers, trays, cassettes & accessories.2) Indicator, Physical/Chemical Sterilization Process |
| Classification/Panel: | Class II, 21CFR 880.6850 |
| Classification Advisory Committee: | General Hospital |
| Product Code: | FRG |
| Recognized Performance Standard: | ANSI/AAMI/ISO 11607-1:2006 (FRG) |
5.4 Predicate Devices:
K103210, Tyvek® Pouch/Roll with STERRAD® Chemical Indicator (FRG)
{6}------------------------------------------------
5.5 Intended Use
The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. 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 sterilization.
The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.
5.6 Device Description
Sterilization Pouch/Roll Made with Tyvek® is intended to contain medical devices to be terminally sterilized in the STERRAD® Sterilization Systems. The recommended Gas Plasma sterilization cycle parameter is 6 minutes (Injection volume: 2880µ L) at 50°C. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the STERRAD® 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 sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.
The proposed pouches are constructed from Tyvek® plastic films, with H2O2 Chemical Indicator printed onto the Tyvek" film. 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 STERRAD® Sterilization Systems.
The H2O2 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. H2O2 Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to blue (or lighter) when exposed to hydrogen peroxide.
The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:
- Self-sealing sterilization pouches .
- . Sterilization pouches, Flat
- . Sterilization pouches, Gusseted
- Sterilization rolls, Flat
- Sterilization rolls, Gusseted
{7}------------------------------------------------
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 Tyvek® and used to seal the pouch. Release Tyvek® used in the pouch is a laminated sheet with composing structure of Tyvek®, PET, PE. It is a strip to cover the adhesive area and is released before seal the pouch. The Tyvek" conforms to recognized material standards and can be sterilized by Gas plasma. The Process Indicators Ink printed on the Tyvek® will exhibit a color change after the pouch is exposed to Gas plasma.
- . Sterilization pouches, Flat: These pouches has the same components with the Selfsealing 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 rolls 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 Tyvek® 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 Tyvek" 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 5-1) lists the model numbers of the Sterilization Pouch/Roll Made with Tyvek® by type, model, dimensions:
{8}------------------------------------------------
| Table 5-1. The model numbers of Sterilization Pouch/Roll Made with Tyvek |
|---|
| (Type, Model and Dimension) |
| Type | Model | Dimensions (mm) |
|---|---|---|
| Self-sealing Sterilization Pouches | TYSE057133 | 57mmx133mm |
| TYSE090162 | 90mmx162mm | |
| TYSE070257 | 70mmx257mm | |
| TYSE090257 | 90mmx257mm | |
| TYSE135283 | 135mmx283mm | |
| TYSE135335 | 135mmx335mm | |
| TYSE190358 | 190mmx358mm | |
| TYSE300380 | 300mmx380mm | |
| TYSE300474 | 300mmx474mm | |
| Sterilization Pouches, Flat | TYFP075200 | 75mmx200mm |
| TYFP075300 | 75mmx300mm | |
| TYFP100200 | 100mmx200mm | |
| TYFP100300 | 100mmx300mm | |
| TYFP150300 | 150mmx300mm | |
| TYFP200400 | 200mmx400mm | |
| TYFP250450 | 250mmx450mm | |
| TYFP300500 | 300mmx500mm | |
| Model | Dimensions (mm) | |
| Sterilization Pouches, Gusseted | TYGP100300 | 100mmx40mm300mm |
| TYGP150400 | 150mmx50mmx400mm | |
| TYGP200400 | 200mmx50mmx400mm | |
| TYGP250480 | 250mmx60mmx480mm | |
| TYGP300500 | 300mmx70mmx500mm | |
| Type | Model | Dimensions (mm) |
| Sterilization Rolls, Flat | TYFR050070 | 50mmx70M |
| TYFR075070 | 75mmx70M | |
| TYFR100070 | 100mmx70M | |
| TYFR150070 | 150mmx70M | |
| TYFR200070 | 200mmx70M | |
| TYFR250070 | 250mmx70M | |
| TYFR300070 | 300mmx70M | |
| TYFR350070 | 350mmx70M | |
| TYFR400070 | 400mmx70M | |
| TYFR450070 | 450mmx70M | |
| TYFR500070 | 500mmx70M | |
| TYFR050100 | 50mmx100M | |
| TYFR075100 | 75mmx100M | |
| TYFR100100 | 100mmx100M | |
| TYFR150100 | 150mmx100M | |
| TYFR200100 | 200mmx100M | |
| TYFR250100 | 250mmx100M | |
| TYFR300100 | 300mmx100M | |
| TYFR350100 | 350mmx100M | |
| TYFR400100 | 400mmx100M | |
| TYFR450100 | 450mmx100M | |
| TYFR500100 | 500mmx100M | |
| TYFR050200 | 50mmx200M | |
| TYFR075200 | 75mmx200M | |
| TYFR100200 | 100mmx200M | |
| TYFR150200 | 150mmx200M | |
| TYFR200200 | 200mmx200M | |
| TYFR250200 | 250mmx200M | |
| TYFR300200 | 300mmx200M | |
| TYFR350200 | 350mmx200M | |
| TYFR400200 | 400mmx200M | |
| Type | Model | Dimensions (mm) |
| Sterilization Rolls, Gusseted | TYGR075100 | 75mmx35mmx100M |
| TYGR100100 | 100mmx40mmx100M | |
| TYGR150100 | 150mmx50mmx100M | |
| TYGR200100 | 200mmx50mmx100M | |
| TYGR250100 | 250mmx60mmx100M | |
| TYGR300100 | 300mmx70mmx100M | |
| TYGR350100 | 350mmx80mmx100M | |
| TYGR400100 | 400mmx80mmx100M |
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SECTION 5
5.7 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 5-2.
| Table 5-2 Summary of the Proposed and Predicate Devices Technological Characteristics | ||||
|---|---|---|---|---|
| Device | New Device | Predicate Devices | ||
| Device name | Sterilization Pouch/Roll Made with Tyvek® | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator | ||
| 510(k) number | K133838 | K103210 | ||
| MaterialComposition | Tyvek®, PET, PE, Water, CH3COOH, Alcohol, n-Heptane adhesive, Hydrogen peroxide vapor Process Indicator Print Ink | Tyvek®, PET, PE, Water, CH3COOH, Alcohol, n-Heptane adhesive, Hydrogen peroxide vapor Process Indicator Print Ink | ||
| Intended use | Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. 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 sterilization. The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System. | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are be terminally sterilized in the STERRAD® 100NXTM Sterilizer and to indicate, by color change, that the pouch has exposed to sterilant. After completion of sterilization process, the Pouch/Roll maintain sterility until the seal of the Pouch/Roll is opened. The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to yellow (or lighter) when exposed to hydrogen peroxide vapor processing in the STERRAD® Sterilization Systems. | ||
| Device models(Configurations/Dimensions) | Self-sealing Sterilization Pouches | Tyvek® Pouch with STERRAD® Chemical Indicator, Self Seal, | ||
| Model | Dimensions (mm) | Model (Code) | Dimensions (mm) | |
| TYSE057133 | 57mmx133mm | 12320 | 76mm x 203 mm | |
| TYSE090162 | 90mmx162mm | 12326 | 102mm x 260 mm | |
| TYSE070257 | 70mmx257mm | 12332 | 152mm x 318 mm | |
| TYSE090257 | 90mmx257mm | 12335 | 102mm x 356 mm | |
| TYSE135283 | 135mmx283mm | 12340 | 203mm x 406 mm | |
| TYSE135335 | 135mmx335mm | 12342 | 152mm x 419 mm | |
| TYSE190358 | 190mmx358mm | 12348 | 254mm x 483 mm | |
| TYSE300380 | 300mmx380mm | 12356 | 318mm x 559 mm | |
| TYSE300474 | 300mmx474mm | |||
| Sterilization Pouches, Flat | Tyvek® Pouch with STERRAD® Chemical Indicator, Heat Seal, | |||
| Model | Dimensions (mm) | Model (Code) | Dimensions (mm) | |
| TYFP075200 | 75mmx200mm | 12521 | 76mm x 203 mm | |
| TYFP075300 | 75mmx300mm | 12526 | 102mm x 260 mm | |
| TYFP100200 | 100mmx200mm | 12532 | 152mm x 318 mm | |
| TYFP100300 | 100mmx300mm | 12541 | 203mm x 406 mm | |
| TYFP150300 | 150mmx300mm | 12548 | 254mm x 483 mm | |
| TYFP200400 | 200mmx400mm | |||
| TYFP250450 | 250mmx450mm | |||
| TYFP300500 | 300mmx500mm |
Table 5-2 Summary of the Proposed and Predicate Devices Technological Characteristics
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SECTION 5
510(K) SUMMARY
| Device | New Device | Predicate Devices | ||
|---|---|---|---|---|
| Device models(Configurations/Dimensions) | Model | Dimensions (mm) | Tyvek® Roll with STERRAD®Chemical IndicatorModel (Code) | Dimensions (mm) |
| Sterilization Rolls, Flat | ||||
| TYFR050070 | 50mmx70M | 12407 | 76mm × 70 M | |
| TYFR075070 | 75mmx70M | 12410 | 102mm × 70 M | |
| TYFR100070 | 100mmx70M | 12415 | 152mm × 70 M | |
| TYFR150070 | 150mmx70M | 12420 | 203mm x 70 M | |
| TYFR200070 | 200mmx70M | 12425 | 254mm x 70 M | |
| TYFR250070 | 250mmx70M | 12435 | 357mm x 70 M | |
| TYFR300070 | 300mmx70M | 12442 | 419mm x 70 M | |
| TYFR350070 | 350mmx70M | 12450 | 508mm x 70 M | |
| TYFR400070 | 400mmx70M | |||
| TYFR450070 | 450mmx70M | |||
| TYFR500070 | 500mmx70M | |||
| TYFR050100 | 50mmx100M | |||
| TYFR075100 | 75mmx100M | |||
| TYFR100100 | 100mmx100M | |||
| TYFR150100 | 150mmx100M | |||
| TYFR200100 | 200mmx100M | |||
| TYFR250100 | 250mmx100M | |||
| TYFR300100 | 300mmx100M | |||
| TYFR350100 | 350mmx100M | |||
| TYFR400100 | 400mmx100M | |||
| TYFR450100 | 450mmx100M | |||
| TYFR500100 | 500mmx100M | |||
| TYFR050200 | 50mmx200M | |||
| TYFR075200 | 75mmx200M | |||
| TYFR100200 | 100mmx200M | |||
| TYFR150200 | 150mmx200M | |||
| TYFR200200 | 200mmx200M | |||
| TYFR250200 | 250mmx200M | |||
| TYFR300200 | 300mmx200M | |||
| TYFR350200 | 350mmx200M | |||
| TYFR400200 | 400mmx200M |
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| Device | New Device | Predicate Devices |
|---|---|---|
| Device models(Configurations/Dimensions) | Sterilization Rolls, Gusseted | N/A |
| Model | ||
| TYGR075100 | ||
| 75mmx35mmx100M | ||
| TYGR100100 | ||
| 100mmx40mmx100M | ||
| TYGR150100 | ||
| 150mmx50mmx100M | ||
| TYGR200100 | ||
| 200mmx50mmx100M | ||
| TYGR250100 | ||
| 250mmx60mmx100M | ||
| TYGR300100 | ||
| 300mmx70mmx100M | ||
| TYGR350100 | ||
| 350mmx80mmx100M | ||
| TYGR400100 | ||
| 400mmx80mmx100M | ||
| Sterilization Pouches, Gusseted | ||
| Model | N/A | |
| Dimensions (mm) | ||
| TYGP100300 | ||
| 100mmx40mm300mm | ||
| TYGP150400 | ||
| 150mmx50mmx400mm | ||
| TYGP200400 | ||
| 200mmx50mmx400mm | ||
| TYGP250480 | ||
| 250mmx60mmx480mm | ||
| TYGP300500 | ||
| 300mmx70mmx500mm | ||
| Sterilizationcycles | The recommended Gas Plasma Sterilization Cycleparameters are exposure time: 6 minutes (Injectionvolume: 2880μ L), exposure Temperature: 50°C,Plasma Stage - Delivered power: 450 Watt. | The recommended Gas Plasma Sterilization Cycleparameters are exposure time: 6 minutes (Injectionvolume: 2880µ L), exposure Temperature: 50°C,Plasma Stage - Delivered power: 450 Watt. |
| Design features | ||
| Self-sealing sterilization pouches: These pouches aremade from a medical grade plastic film that is heatsealed on three sides. The forth side has an adhesivestrip that is Tyvek® and used to seal the pouch. ReleaseTyvek® used in the pouch is a laminated sheet withcomposing structure of Tyvek®, PET, PE. It is a strip tocover the adhesive area and is released before seal thepouch. The Tyvek® conforms to recognized materialstandards and can be sterilized by Gas plasma. TheProcess Indicators Ink printed on the Tyvek® willexhibit a color change after the pouch is exposed to Gasplasma.Sterilization pouches, Flat: These pouches has thesame components with the Self-sealing sterilizationpouches, except the forth side is left opened instead ofan adhesive strip and will be heat-sealed when using.Sterilization rolls, Flat: These rolls are made from aTyvek and plastic film that are heat sealed on oppositetwo sides. It will be cut into the suitable length and theopened sides will be heat-sealed. The indicators printedon the Tyvek® are the same with the self-sealingsterilization pouches.Sterilization pouches, Gusseted: These rolls are thesame with the Sterilization pouches, flat, except that theplastic film is folded on both longest sides instead offlat. This design is convenient to enclose the medical | Self-sealing sterilization pouches: These pouchesare made from a medical grade plastic film that isheat sealed on three sides. The forth side has anadhesive strip that is Tyvek® and used to seal thepouch. Release Tyvek used in the pouch is alaminated sheet with composing structure ofTyvek®, PET, PE. It is a strip to cover the adhesivearea and is released before seal the pouch. TheTyvek® conforms to recognized material standardsand can be sterilized by Gas plasma. The ProcessIndicators Ink printed on the Tyvek® will exhibit acolor change after the pouch is exposed to Gasplasma.Sterilization pouches, Flat: These pouches has thesame components with the Self-sealing sterilizationpouches, except the forth side is left opened insteadof an adhesive strip and will be heat-sealed whenusing.Sterilization rolls, Flat: These rolls are made froma Tyvek and plastic film that are heat sealed onopposite two sides. It will be cut into the suitablelength and the opened sides will be heat-sealed. Theindicators printed on the Tyvek® are the same withthe self-sealing sterilization pouches.N/A | |
| devices with certain height.Sterilization rolls, Gusseted: These rolls are the samewith the flat sterilization roll, except that the plasticfilm is folded on both longest sides instead of flat. Thisdesign is convenient to enclose the medical devices | N/A |
Note: Tyvek® is a registered trademark of Du Pont.
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The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD" 100S Sterilizer. 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 sterilization.
The Sterilization Pouch/Roll Made with Tyvek® has many similar technological characteristics when compared to the predicate devices. The material composition of Sterilization Pouch/Roll Made with Tyvek" is similar to the predicate devices. Besides parameters of sterilization, the intended use of Sterilization Pouch/Roll Made with Tyvek® is similar to the predicate devices. The device models and design features of Self-sealing sterilization pouches, Sterilization pouches, Flat, and Sterilization rolls, Flat of The Sterilization Pouch/Roll Made with Tyvek" are similar to the predicate devices. The design features that Sterilization Pouch/Roll Made with Tyvek" s external chemical ink indicators are designed to indicate to the user that the pouch has undergone the Gas Plasma sterilization process (hydrogen peroxide vapor) is also similar to the predicate devices.
The Sterilization Pouch/Roll Made with Tyvek® has some different design features from the predicate device. The Sterilization Pouch/Roll Made with Tyvek" is offered 5 types pouches, however, the predicate device is offered 3 types pouches. The Sterilization Pouch/Roll Made with Tyvek" is offered more two types which are Sterilization pouches, Gusseted and Sterilization rolls, Gusseted. The type of Sterilization pouches, Gusseted of Sterilization Pouch/Roll Made with Tyvek" is 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. The type of Sterilization rolls, Gusseted of Sterilization Pouch/Roll Made with Tyvek" is 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.
| PERFORMANCE | NEW DEVICE | PREDICATE | ||
|---|---|---|---|---|
| Device | Sterilization Pouch/Roll Made withTyvek®(Type: Self-sealing sterilization pouches;Sterilization Pouches, Flat; SterilizationPouches, Gusseted; Sterilization Rolls, Flat;Sterilization Rolls, Gusseted) | Tyvek® Pouch/Roll with STERRAD®Chemical Indicator(Type: Self-sealing sterilization pouches;Sterilization Pouches, Flat; Sterilization Rolls,Flat) | ||
| SterilantPenetration | Gas plasmaSterilizationValidationANSI/AAMI/ISO 14937:2009 | The test meet the requirement ofSAL 10-6 | The test meet the requirement ofSAL 10-6 | |
| Package Integrity (PhysicalProperties) | Before Sterilization | After Gas plasmaSterilization | Before Sterilization | After Gas plasmaSterilization |
| Thickness Variations(mm) ASTM F 2251-03 | Small0.145Large0.146 | Small0.145Large0.146 | Small0.143Large0.147 | Small0.143Large0.145 |
| Tear Resistance (g)* ASTM D1922 | CD 259MD 282 | CD 258MD 280 | CD 262MD 283 | CD 260MD 281 |
| Tensile strength of plasticfilm (kgf/mm2) * ASTMD882 | CD 575MD 577 | CD 531MD 531 | CD 563MD 556 | CD 527MD 513 |
The complete substantial equivalence comparison table as follows:
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| PERFORMANCE | NEW DEVICE | PREDICATE | ||
|---|---|---|---|---|
| Tensile strength of Tyvek®(N/2.54cm) * ASTM D 5035 | CD 174 | CD 170 | CD 175 | CD 173 |
| MD 163 | MD 162 | MD 166 | MD 164 | |
| Burst Strength (kPa) SmallASTM F1140-0 7 | 21.4 | 17.95 | 20.8 | 17.0 |
| Large | 4.49 | 2.03 | 4.1 | 2.0 |
| Seal Peel Test(g/15mm)ASTM F88/F88M-09;ISO 11607-1 | Upper: 340.3Down: 506.7Left: 345.7Right: 316.5Result: Pass | Upper: 493.6Down: 709.9Left: 436.0Right: 518.5Result: Pass | Pass | Pass |
| Upper: 434.7Down: 420.4Left: 424.4Right: 431.7Result: Pass | Upper: 577.2Down: 489.3Left: 600.8Right: 612.9Result: Pass | Pass | Pass | |
| Dye penetration TestASTM F 1929-12;ISO11607-1(Seal Integrity Test) | No Channelsidentified on package | No Channelsidentified onpackage | No Channelsidentified onpackage | No Channelsidentified onpackage |
| Microbial BarrierTest*DIN 58953-6:2010-05Small | N/A | < 1Result: Pass | N/A | Pass |
| Large | N/A | < 1Result: Pass | N/A | Pass |
| Toxicological Properties(Biocompatibility, Tests forTests for irritation and skinsensitization)ANSI/AAMI/ISO 10993-10 | Negative reaction | Negativereaction | ToxicologicalProperties(Biocompatibility, Testsfor Tests for irritationand skin sensitization)ANSI/AAMI/ISO 10993-10 | Negative reaction |
| Durability: AcceleratedAging TestASTM F 1980-2007; ISO 11607-1 2006 | 3 Years | 1 Years | Durability:Accelerated AgingTestASTM F 1980-2007:ISO 11607-1 2006 | 3 Years |
| Shelf Life | 3 Years | 1 Years | Shelf Life | 3 Years |
Note: *the test items were performed on materials of the products; there is no specification requirements.
The applicant device is Substantially Equivalent (SE) to the predicate device in terms of Effectiveness and Safety.
{16}------------------------------------------------
Effectiveness and Safety
The Sterilization Pouch/Roll Made with Tyvek® has the identical intended use and indication for use as the predicate devices. Substantial equivalence to predicate devices was established by testing the Sterilant Penetration, Biocompatibility, Package Integrity, Material Compatibility, Sterility Maintenance, and Chemical Indicator Efficacy.
The Sterilization Pouch/Roll Made with Tyvek validates its effectiveness and safety using recommended practice, standards and guidelines developed by independent organizations such as the Association for the advancement of Medical Instrumentation (AAMI), International Organization for Standardization (ISO), and American Society for Testing and Materials (ASTM). The Sterilization Pouch/Roll Made with Tyvek" was validated to meet the requirements of AAMI / ANSI / ISO 11607-1:2006/(R) 2010, March 2012.
The results of the Sterilization Pouch/Roll Made with Tyvek" validation studies demonstrate that the sterilization pouches perform as intended. The results are summarized as follows:
- The Sterilant Penetration testing performed as described in AAMI / ANSI / ISO 14937:2009. The testing results demonstrate the ability of the Sterilization Pouch/Roll Made with Tyvek" to effectively adequate sterilant penetration to the most difficult areas to reach inside the packaging. The results confirm that the sterilant is able to penetrate the Sterilization Pouch/Roll Made with Tyvek" and sustain direct contact with the medical instrument inside the package.
- The Biocompatibility testing performed as described in ISO 10993-10 Third Edition 2010-08-01. The testing results demonstrate the Sigma Sterilization Pouch and Roll showed "negative reaction". And the Sterilization Pouch/Roll Made with Tyvek" meets the requirements ISO 10993-10:2010(E).
- . The Package Integrity, Material Compatibility, Sterility Maintenance testing performed as described in AAMI / ANSI / ISO 11607-1:2006/(R) 2010, ASTM D882, ISO 1924-2, ASTM D 5035, ASTM F 2251-03, ASTM D 1922, ASTM D 1004, ASTM F 1140-07, ASTM F 1929-98 (04), ASTM F88/F88M-09, ASTM F 1980-2007, ASTM F 1608-00, DIN 58953-6:2010-05.The testing results demonstrate the ability of the Sterilization Pouch/Roll Made with Tyvek® to effectively adequate Package Integrity.
- The Chemical Indicator Efficacy testing performed as described in AAMI / ANSI / ISO 11140-1:2005. The testing demonstrates the ability of the Sterilization Pouch/Roll Made with Tyvek® to effectively stability of the Process Indicators Ink before use, the lasting quality (color stability) of the color change, the completeness and uniformity of the color change and color change is all or none at the conditions measured, unless a color standard is provided on the indicator. And the Sterilization Pouch/Roll Made with Tyvek® meets the requirements ISO 11140-1:2005.
Conclusion:
Basis for Determination of Substantial Equivalence: Based on the intended use, indications for use, technological characteristics, performance data and nonclinical tests performed, the subject Sterilization Pouch/Roll Made with Tyvek® is substantially equivalent and is as safe and as effective as the legally marketed predicate devices. K103210. Tyvek® Pouch/Roll with STERRAD® Chemical Indicator (FRG).
§ 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).