(448 days)
Not Found
No
The device is a passive sterilization pouch with a chemical indicator. There is no mention of any computational analysis, learning, or decision-making processes that would involve AI/ML.
No
The device is a pouch/roll designed for sterilizing other medical devices and maintaining their sterility, not for directly treating a medical condition.
No
The device is a sterilization pouch/roll intended to enclose and maintain sterility of medical devices after sterilization. While it has a chemical indicator, this indicator only verifies exposure to hydrogen peroxide, not sterilization, and it does not diagnose a condition or disease.
No
The device is a physical sterilization pouch/roll made of Tyvek® with a chemical indicator printed on it. It is a tangible product used for packaging medical devices for sterilization and maintaining sterility.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to enclose medical devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the examination of specimens derived from the human body for diagnostic purposes.
- Device Description: The device is a pouch/roll designed to contain medical devices during sterilization. It includes a chemical indicator to verify exposure to the sterilant. This aligns with a sterilization packaging system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing information for diagnosis, monitoring, or screening.
The device is clearly intended for the sterilization and sterile storage of medical devices used in healthcare settings.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FRG
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 verify 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care workers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 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 test meeting the requirement of SAL 10-6.
- 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.
- Thickness Variations (mm) ASTM F 2251-03: Small 0.145 (before sterilization), 0.145 (after Gas Plasma Sterilization); Large 0.146 (before sterilization), 0.146 (after Gas Plasma Sterilization)
- Tear Resistance (g) * ASTM D1922: CD 259 (before sterilization), 258 (after Gas Plasma Sterilization); MD 282 (before sterilization), 280 (after Gas Plasma Sterilization)
- Tensile strength of plastic film (kgf/mm2) * ASTM D882: CD 575 (before sterilization), 531 (after Gas Plasma Sterilization); MD 577 (before sterilization), 531 (after Gas Plasma Sterilization)
- Tensile strength of Tyvek® (N/2.54cm) * ASTM D 5035: CD 174 (before sterilization), 170 (after Gas Plasma Sterilization); MD 163 (before sterilization), 162 (after Gas Plasma Sterilization)
- Burst Strength (kPa) Small ASTM F1140-07: 21.4 (before sterilization), 17.95 (after Gas Plasma Sterilization)
- Burst Strength (kPa) Large ASTM F1140-07: 4.49 (before sterilization), 2.03 (after Gas Plasma Sterilization)
- Seal Peel Test (g/15mm) ASTM F88/F88M-09;ISO 11607-1:
- Before Sterilization: Upper: 340.3, Down: 506.7, Left: 345.7, Right: 316.5. Result: Pass. Upper: 434.7, Down: 420.4, Left: 424.4, Right: 431.7. Result: Pass.
- After Gas plasma Sterilization: Upper: 493.6, Down: 709.9, Left: 436.0, Right: 518.5. Result: Pass. Upper: 577.2, Down: 489.3, Left: 600.8, Right: 612.9. Result: Pass.
- Dye penetration Test ASTM F 1929-12;ISO 11607-1 (Seal Integrity Test): No Channels identified on package (both before and after Gas plasma Sterilization).
- Microbial Barrier Test *DIN 58953-6:2010-05: Small:
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo 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
3
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-sealing | |||
| Sterilization | |||
| Pouches | TYSE057133 | 57mmx133mm | 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. | |||
| TYSE090162 | 90mmx162mm | ||
| TYSE070257 | 70mmx257mm | ||
| TYSE090257 | 90mmx257mm | ||
| TYSE135283 | 135mmx283mm | ||
| TYSE135335 | 135mmx335mm | ||
| TYSE190358 | 190mmx358mm | ||
| TYSE300380 | 300mmx380mm | ||
| TYSE300474 | 300mmx474mm | ||
| Sterilization | |||
| Pouches, Flat | TYFP075200 | 75mmx200mm | These pouches has the same |
| components with the Self-sealing | |||
| sterilization pouches, except the forth | |||
| side is left opened instead of an | |||
| adhesive strip and will be heat-sealed | |||
| when using. | |||
| TYFP075300 | 75mmx300mm | ||
| TYFP100200 | 100mmx200mm | ||
| TYFP100300 | 100mmx300mm | ||
| TYFP150300 | 150mmx300mm | ||
| TYFP200400 | 200mmx400mm | ||
| TYFP250450 | 250mmx450mm | ||
| TYFP300500 | 300mmx500mm | ||
| Sterilization | |||
| Pouches, | |||
| Gusseted | TYGP100300 | 100mmx40mmx300mm | 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. | |||
| TYGP150400 | 150mmx50mmx400mm | ||
| TYGP200400 | 200mmx50mmx400mm | ||
| TYGP250480 | 250mmx60mmx480mm | ||
| TYGP300500 | 300mmx70mmx500mm | ||
| Type | Model | Dimensions (mm) | Characteristics |
| Sterilization | |||
| Rolls, Flat | TYFR050070 | 50mmx70M | 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. | |||
| 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 | ||
| Sterilization | |||
| Rolls, Gusseted | TYGR075100 | 75mmx35mmx100M | 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. | |||
| 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
4
5
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 Corporation |
| NO.34, Ding-Ping Road, Ruei Fang Industrial Park | |
| Ruei Fang Dist., New Taipei City 224, Taiwan, R.O.C | |
| Establishment Registration Number: | 3004970050 |
| Contact Person: | Rose Chien |
| Quality Assurance / Regulatory Affairs Manager | |
| Tel: 886-2-24974121 ext. 283 | |
| Fax: 886-2-24974122 | |
| E-mail: qa_manager@sigma-medical.com.tw | |
| 5.3 Device Classification Names: | 1) Sterilization wrap containers, trays, cassettes & accessories. |
- 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 |
9
10
11
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 | ||
| Material | ||||
| Composition | 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
12
SECTION 5
510(K) SUMMARY
| Device | New Device | Predicate Devices | ||
|---|---|---|---|---|
| Device models | ||||
| (Configurations/Dimensions) | Model | Dimensions (mm) | Tyvek® Roll with STERRAD® | |
| Chemical Indicator | ||||
| Model (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 |
13
| Device | New Device | Predicate Devices |
|---|---|---|
| Device models | ||
| (Configuration | ||
| s/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 | ||
| Sterilization | ||
| cycles | The recommended Gas Plasma Sterilization Cycle | |
| parameters are exposure time: 6 minutes (Injection | ||
| volume: 2880μ L), exposure Temperature: 50°C, | ||
| Plasma Stage - Delivered power: 450 Watt. | The recommended Gas Plasma Sterilization Cycle | |
| parameters are exposure time: 6 minutes (Injection | ||
| volume: 2880µ L), exposure Temperature: 50°C, | ||
| Plasma Stage - Delivered power: 450 Watt. | ||
| Design features | ||
| 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 Self-sealing sterilization | ||
| pouches, except the forth side is left opened instead of | ||
| an adhesive strip and will be heat-sealed when using. | ||
| 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 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 | 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 Self-sealing sterilization | ||
| pouches, except the forth side is left opened instead | ||
| of an adhesive strip and will be heat-sealed when | ||
| using. | ||
| 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. | ||
| N/A | ||
| devices with certain height. | ||
| 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 | N/A |
Note: Tyvek® is a registered trademark of Du Pont.
14
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 with | |||
| Tyvek® | ||||
| (Type: Self-sealing sterilization pouches; | ||||
| Sterilization Pouches, Flat; Sterilization | ||||
| Pouches, 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) | ||||
| Sterilant | ||||
| Penetration | Gas plasma | |||
| Sterilization | ||||
| Validation | ||||
| ANSI/AAMI/I | ||||
| SO 14937:2009 | The test meet the requirement of | |||
| SAL 10-6 | The test meet the requirement of | |||
| SAL 10-6 | ||||
| Package Integrity (Physical | ||||
| Properties) | Before Sterilization | After Gas plasma | ||
| Sterilization | Before Sterilization | After Gas plasma | ||
| Sterilization | ||||
| Thickness Variations | ||||
| (mm) ASTM F 2251-03 | Small | |||
| 0.145 | ||||
| Large | ||||
| 0.146 | Small | |||
| 0.145 | ||||
| Large | ||||
| 0.146 | Small | |||
| 0.143 | ||||
| Large | ||||
| 0.147 | Small | |||
| 0.143 | ||||
| Large | ||||
| 0.145 | ||||
| Tear Resistance (g) |
- ASTM D1922 | CD 259
MD 282 | CD 258
MD 280 | CD 262
MD 283 | CD 260
MD 281 |
| Tensile strength of plastic
film (kgf/mm2) * ASTM
D882 | CD 575
MD 577 | CD 531
MD 531 | CD 563
MD 556 | CD 527
MD 513 |
The complete substantial equivalence comparison table as follows:
15
| 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) Small | ||||
| ASTM 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: 340.3 | |||
| Down: 506.7 | ||||
| Left: 345.7 | ||||
| Right: 316.5 | ||||
| Result: Pass | Upper: 493.6 | |||
| Down: 709.9 | ||||
| Left: 436.0 | ||||
| Right: 518.5 | ||||
| Result: Pass | Pass | Pass | ||
| Upper: 434.7 | ||||
| Down: 420.4 | ||||
| Left: 424.4 | ||||
| Right: 431.7 | ||||
| Result: Pass | Upper: 577.2 | |||
| Down: 489.3 | ||||
| Left: 600.8 | ||||
| Right: 612.9 | ||||
| Result: Pass | Pass | Pass | ||
| Dye penetration Test | ||||
| ASTM F 1929-12;ISO | ||||
| 11607-1 | ||||
| (Seal Integrity Test) | No Channels | |||
| identified on package | No Channels | |||
| identified on | ||||
| package | No Channels | |||
| identified on | ||||
| package | No Channels | |||
| identified on | ||||
| package | ||||
| Microbial Barrier | ||||
| Test | ||||
| *DIN 58953-6:2010-05 | ||||
| Small | N/A |