(368 days)
Not Found
No
The device is a physical sterilization pouch with chemical indicators, and the description focuses on material properties and performance testing related to sterilization efficacy and package integrity. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
No
The device is a sterilization pouch/roll used to enclose other devices for sterilization. It does not directly provide therapy or treatment to a patient.
No.
The device is a sterilization pouch/roll intended to enclose other medical devices for sterilization and maintain sterility. It includes external chemical indicators to show that it has undergone a sterilization process, but it does not diagnose a medical condition or disease.
No
The device described is a physical sterilization pouch and roll, not a software-only medical device. The description focuses on the materials, construction, and physical performance of the pouches and rolls for sterilization.
Based on the provided information, the SIGMA sterilization pouch and roll is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to enclose devices for sterilization and maintain their sterility. This is a function related to the processing and storage of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description focuses on the materials, construction, and function of the pouches and rolls for sterilization purposes. It does not mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies evaluate aspects like sterilant penetration, package integrity, sterility maintenance, and chemical indicator efficacy. These are all relevant to the sterilization process and packaging, not to diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the SIGMA sterilization pouch and roll falls under the category of a medical device used in the sterilization process, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterlilization cycle parameters are 30 minutes at 121 C. The recommended EO sterilization cycle is 4 hours at 55 C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
The SIGMA sterilization pouch and roll is offered in the following 5 types:
- Self-sealing sterilization pouches
- . Sterilization pouches, Flat
- Sterilization pouches, Gusseted
- . Sterilization rolls, Flat
- Sterilization rolls, Gusseted
Product codes
FRG, JOJ
Device Description
The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121 ℃. The recommended EO sterilization cycle is 4 hours at 55 C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
The SIGMA sterilization pouch and roll is offered in the following 5 types:
- Self-sealing sterilization pouches: These pouches are made from a medical grade plastic film that . 0 is heat sealed on three sides. The forth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas.
- Sterilization pouches, Flat: These pouches has the same components with the Self-sealing . sterilization pouches, except the forth side is left opened instead of an adhesive strip and will be heat-sealed when using.
- Sterilization pouches, Gusseted: These pouches are the same with the Sterilization pouches, flat, . except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
- Sterilization rolls, Flat: These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.
- Sterilization rolls, Gusseted: These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
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
The SIGMA sterilization pouch and roll 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 SIGMA sterilization pouch and roll was validated to meet the requirements of ANSVAAMI/ISO 11607-1:2006, Version three, September 2008.
The results of the SIGMA sterilization pouch and roll validation studies demonstrate that the sterilization pouches perform as intended. The results are summarized as follows:
- The Sterilant Penetration, Drying Time, Aeration, testing performed as described in AAMI / ANSI / ISO 17665-1:2006, ISO TS 17665-2:2009, AAMI / ANSI / ISO 11135-1:2007, and AAMI / ANSI / ISO 10993-7:2008. The testing results demonstrate the ability of the Sigma Sterilization Pouch and Roll 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 Sigma Sterilization Pouch and Roll and sustain direct contact with the medical instrument inside the package. And the result of aeration time validation test meets the requirements AAMI / ANSI / ISO 10993-7:2008.
- The Biocompatibility testing performed as described in ISO 10993-10:2010(E), ISO 10993-1:2009/Cor. 1:2010(E), ISO 10993-12:2007(E), and ISO/IEC 17025:2005. The testing results demonstrate the Sigma Sterilization Pouch and Roll showed "negative reaction". And the SIGMA sterilization pouch and roll 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, ISO 1924-2, ISO 5636-3, ASTM D 3078-02, ASTM D882, ASTM F 2251-03, ASTMD 1004, ASTME 1140-07, ASTME 1929-98 (04), ASTME 88-2007, ASTM F 1980-2007, ASTMF 1980-2007, and ASTM F 1608-00. The testing results demonstrate the ability of the Sigma Sterilization Pouch and Roll 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 Sigma Sterilization Pouch and Roll 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 SIGMA sterilization pouch and roll meets the requirements ISO 11140-1:2005.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
AUG - 2 2011
510 (K) Summary For SIGMA Sterilization Pouch and Roll
SIGMA Medical Supplies Corp. NO.34, Ding-Ping Road, Ruei Fang Industrial Park Ruei Fang Chen, Taipei Hsien 224,Taiwan, R.O.C. Tel : 886-2-24974121 Fax: 886-2-24974122
Contact :
. .
Jeff Huang Quality Assurance / Regulatory Affairs Manager
Or
· Jack Chu President /C.E.O
Tel: 886-2-24974121 ext. 281 Fax: 886-2-24974122 E-mail: jeff@sigma-medical.com.tw
Summary Date:
January 3, 2011
1
1. Device Name
| Trade Name: | SIGMA Sterilization Pouch and Roll |
|---|---|
| Common/usual Name: | SIGMA Sterilization Pouch and Roll |
| Device Classification | |
| Names: | 1) Sterilization wraps containers, trays, cassettes & |
| accessories. |
- Indicator, Physical/Chemical Sterilization Process |
| Classification/Panel: | Class II, 21 CFR 880.6850 & 21 CFR 880.2800 |
| Classification Advisory
Committee: | General Hospital |
| Product Code: | 1) FRG 2) JOJ |
| Recognized Performance
Standard | 1) ANSI/AAMI/ISO 11607-1:2006 (KCT) - ISO 11140-1:2005 (JOJ) |
2. Predicate Devices
- K070428, Medicom Self Sealing Sterilization Pouch, Product Code [KCT; JO]] .
- K051242, Winner® Self Seal Sterilization pouch, Product Code [KCT] .
3. Intended Use
The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121 ℃. The recommended EO sterilization cycle is 4 hours at 55 C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
The SIGMA sterilization pouch and roll is offered in the following 5 types:
- Self-sealing sterilization pouches .
- . Sterilization pouches, Flat
- . Sterilization pouches, Gusseted
- . Sterilization rolls, Flat
- . Sterilization rolls, Gusseted
The defining characteristics of the 5 types as follows:
2
- Self-seating sterilization powches: These pouches are made from a medical grade plastic film that � is heat sealed on three sides. The forth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas.
- Sterilization pouches, Flat: These pouches has the same components with the Self-sealing . sterilization pouches, except the forth side is left opened instead of an adhesive strip and will be heat-sealed when using.
- Sterilization pouches, Gusseted: These pouches are the same with the Sterilization pouches, flat, . except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
- Sterilization rolls, Flat: These rolls are made from a medical grade paper and plastic film that are ● heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.
- Sterilization rolls, Gusseted: These rolls are the same with the flat sterilization roll, except that the ● plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
The following table (Table 2-1) lists the model numbers of the SIGMA sterilization pouch and roll by type, model, dimension and characteristics:
| Type | Model | Dimension in S.I. | Characteristics |
|---|---|---|---|
| Self-Sealing | |||
| Sterilization | |||
| Pouches | SMSE057133 | 57 mm × 133 mm | 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 | |||
| paper and used to seal the pouch. | |||
| SMSE090162 | 90 mm × 162 mm | 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 | |||
| SMSE070257 | 70 mm × 257mm | ||
| SMSE090257 | 90 mm × 257 mm | ||
| SMSE135283 | 135 mm × 283 mm | ||
| SMSE180335 | 135 mm × 335 mm | medical grade paper conforms to | |
| recognized material standards and | |||
| SMSE190358 | 190 mm × 358 mm | can be sterilized by steam or | |
| ethylene oxide gas. The Process | |||
| SMSE300380 | 300 mm × 380 mm | Indicators Ink printed on the medical | |
| grade paper will exhibit a color | |||
| SMSE300474 | 300 mm × 474 mm | change after the pouch is exposed to | |
| steam or ethylene oxide gas. |
Table 2-1 The model numbers of SIGMA sterilization pouch and roll ne Model Dimension and Characteristics)
3
| Sterilization
Pouches, Flat | SMFP075200 | 75 mm × 200 mm | These pouches has the same
components with the Self-sealing
sterilization pouches, except the
forth side is left opened instead of a
adhesive strip and will be heat-
sealed when using. |
|------------------------------------|------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SMFP075300 | 75 mm × 300 mm | |
| | SMFP100200 | 100 mm × 200 mm | |
| | SMFP100300 | 100 mm × 300 mm | |
| | SMFP150300 | 150 mm × 300 mm | |
| | SMFP200400 | 200 mm × 400 mm | |
| | SMFP250450 | 250 mm × 450 mm | |
| | SMFP300500 | 300 mm × 500 mm | |
| Sterilization
Pouches, Gusseted | SMGP100300 | 100 mm × 40 mm× 300 mm | 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 |
| | SMGP150400 | 150 mm × 50 mm× 400 mm | |
| | SMGP200400 | 200 mm × 50 mm× 400 mm | |
| | SMGP250480 | 250 mm × 60 mm× 480 mm | |
| | SMGP300500 | 300 mm × 70 mm× 500 mm | |
| | | | |
| Sterilization Rolls,
Flat | SMFR 022 | 50 mm × 200 M | 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. |
| | SMFR 032 | 75 mm × 200 M | |
| | SMFR 042 | 100 mm × 200 M | |
| | SMFR 062 | 150 mm × 200 M | |
| | SMFR 082 | 200 mm × 200 M | |
| | SMFR 102 | 250 mm × 200 M | |
| | SMFR 122 | 300 mm × 200 M | |
| | SMFR 142. | 350 mm × 200 M | |
| | SMFR 162 | 400 mm × 200 M | |
| Sterilization Rolls,
Gusseted | SMGR 031 | 75 mm × 35 mm ×100 M | 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. |
| | SMGR 041 | 100 mm × 40 mm ×100M | |
| | SMGR 061 | 150 mm × 50 mm ×100 M | |
| | SMGR 081 | 200 mm × 50 mm ×100 M | |
| | SMGR 101 | 250 mm × 60 mm ×100 M | |
| | SMGR 121 | 300 mm × 70 mm × 100 M | |
| | SMGR 141 | 350 mm × 80 mm ×100 M | |
| | SMGR 161 | 400 mm × 80 mm ×100 M | |
4. 510(k) Statement
A 510(k) statement for the new device, as required by 21 CFR 93, is replaced with this 510(k) summary.
5. Proposed Labeling
A comparison with the predicate labeling confirms our claim of substantial equivalence with the predicate. A draft copy of the proposed and predicate device labeling may be found in Section 13.
6. Device Description
January 3, 2011
4
The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121 ℃. The recommended EO sterilization cycle is 4 hours at 55 C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
The SIGMA sterilization pouch and roll is offered in the following 5 types:
- Self-sealing sterilization pouches: These pouches are made from a medical grade plastic film that . 0 is heat sealed on three sides. The forth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas.
- Sterilization pouches, Flat: These pouches has the same components with the Self-sealing . sterilization pouches, except the forth side is left opened instead of an adhesive strip and will be heat-sealed when using.
- Sterilization pouches, Gusseted: These pouches are the same with the Sterilization pouches, flat, . except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
- Sterilization rolls, Flat: These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.
- Sterilization rolls, Gusseted: These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
The following table (Table 2-2) lists the model numbers of the SIGMA sterilization pouch and roll by type, model, and dimension:
| Type | Model | Dimension in S.I. |
|---|---|---|
| Self-Sealing Sterilization Pouches | SMSE057133 | 57 mm × 133 mm |
| SMSE090162 | 90 mm × 162 mm | |
| SMSE070257 | 70 mm × 257mm | |
| SMSE090257 | 90 mm × 257 mm | |
| SMSE135283 | 135 mm × 283 mm | |
| SMSE180335 | 135 mm × 335 mm | |
| SMSE190358 | 190 mm × 358 mm | |
| SMSE300380 | 300 mm × 380 mm | |
| SMSE300474 | 300 mm × 474 mm |
| Table 2-2 The model numbers of SIGMA sterilization pouch and roll |
|---|
| (Type, Model and Dimension) |
5
| Sterilization Pouches, Flat | SMFP075200 | 75 mm × 200 mm |
|---|---|---|
| SMFP075300 | 75 mm × 300 mm | |
| SMFP100200 | 100 mm × 200 mm | |
| SMFP100300 | 100 mm × 300 mm | |
| SMFP150300 | 150 mm × 300 mm | |
| SMFP200400 | 200 mm × 400 mm | |
| SMFP250450 | 250 mm × 450 mm | |
| SMFP300500 | 300 mm × 500 mm | |
| Sterilization Pouches, Gusseted | SMGP100300 | 100 mm × 40 mm × 300 mm |
| SMGP150400 | 150 mm × 50 mm × 400 mm | |
| SMGP200400 | 200 mm × 50 mm × 400 mm | |
| SMGP250480 | 250 mm × 60 mm × 480 mm | |
| SMGP300500 | 300 mm × 70 mm × 500 mm | |
| Sterilization Rolls, Flat | SMFR 022 | 50 mm × 200 M |
| SMFR 032 | 75 mm × 200 M | |
| SMFR 042 | 100 mm × 200 M | |
| SMFR 062 | 150 mm × 200 M | |
| SMFR 082 | 200 mm × 200 M | |
| SMFR 102 | 250 mm × 200 M | |
| SMFR 122 | 300 mm × 200 M | |
| SMFR 142 | 350 mm × 200 M | |
| SMFR 162 | 400 mm × 200 M | |
| Sterilization Rolls, Gusseted | SMGR 031 | 75 mm × 35 mm ×100 M |
| SMGR 041 | 100 mm × 40 mm ×100M | |
| SMGR 061 | 150 mm × 50 mm ×100 M | |
| SMGR 081 | 200 mm × 50 mm ×100 M | |
| SMGR 101 | 250 mm × 60 mm ×100 M | |
| SMGR 121 | 300 mm × 70 mm ×100 M | |
| SMGR 141 | 350 mm × 80 mm ×100 M | |
| SMGR 161 | 400 mm × 80 mm ×100 M |
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 2-3.
6
| Device | New Device | Predicate devices | |||
|---|---|---|---|---|---|
| Device name | SIGMA sterilization pouch and roll | Medicom® Self Sealing | |||
| sterilization pouch | Winner® Self Seal | ||||
| Sterilization pouch | |||||
| 510(k) Number | K102158 | K070428 | K051242 | ||
| Material | |||||
| Composition | Medical Grade Paper, CPP, PET, PU | ||||
| adhesive, EO and Steam Process Indicator | |||||
| Print Ink | Medical Grade Paper, CPP, | ||||
| PET, PU adhesive, EO and | |||||
| Steam Process Indicator | |||||
| Print Ink | Medical Grade paper, PP, | ||||
| PE, PU adhesive, EO and | |||||
| Steam Process Indicator | |||||
| Print Ink | |||||
| Intended use | The sterilization pouch and roll are | ||||
| intended to provide health care workers | |||||
| with an effective method to enclose devices | |||||
| intended for sterilization in steam auto | |||||
| claves and via Ethylene Oxide (EO). The | |||||
| recommended steam sterilization cycle | |||||
| parameters are 30 minutes at 121 C. The | |||||
| recommended EO sterilization cycle is 4 | |||||
| hours at 55C with a relative humidity | |||||
| between 50%-85% and a sterilant | |||||
| concentration of 600 mg/L. Furthermore, | |||||
| the sterilization, pouch and roll maintains | |||||
| the enclosed devices up until 3 years post | |||||
| sterilization. Lastly, the pouch's external | |||||
| chemical ink indicators are designed to | |||||
| indicate to the user that the pouch has | |||||
| undergone either a steam or EO sterilization | |||||
| process | The self-sealing sterilization | ||||
| pouches are intended to provide | |||||
| health care workers with an | |||||
| effective method to enclose | |||||
| devices intended for | |||||
| sterilization in steam auto | |||||
| claves and via Ethylene Oxide | |||||
| (EO). The recommended steam | |||||
| sterilization cycle parameters | |||||
| are 30 minutes at 121°C. The | |||||
| recommended EO sterilization | |||||
| cycle is 100 - 120 minutes at | |||||
| 50 0C with a relative humidity | |||||
| between 60 - 85% and a | |||||
| sterilant concentration of 600 | |||||
| mg/L. Furthermore, the | |||||
| sterilization pouch maintains | |||||
| the enclosed devices sterile up | |||||
| until one-year post sterilization. | |||||
| Lastly, the pouch's external | |||||
| chemical ink indicators are | |||||
| designed to indicate to the user | |||||
| that the pouch has undergone | |||||
| either a steam or EO | |||||
| sterilization process. | Winner® Self Seal | ||||
| Sterilization Pouches are | |||||
| intended to be used to | |||||
| enclose another medical | |||||
| device that is to be sterilized | |||||
| by a health provider by | |||||
| steam 121°C for 15 minutes | |||||
| or ethylene oxide (EtO). It is | |||||
| intended to allow | |||||
| sterilization of the enclosed | |||||
| medical device and also to | |||||
| maintain sterility of the | |||||
| enclosed device until used. | |||||
| Device models | |||||
| (Configurations/Di | |||||
| mensions) | Model | Product | |||
| Code | Description | Model | Description | ||
| SMSE057133 57mm × 133mm | |||||
| SMSE090162 70mm×257mm | |||||
| SMSE070257 90mm × 162mm | |||||
| SMSE090257 90mm×257mm, | |||||
| SMSE135283 135mm×283mm | |||||
| SMSE180335 135mm×335mm | |||||
| SMSE190358 190mm×358mm | |||||
| SMSE300380 300mm × 380mm | |||||
| SMSE300474 300mm x 474mm | |||||
| SMFP075200 75 mm × 200 mm | |||||
| SMFP075300 75 mm x 300 mm | |||||
| SMFP100200 100 mm × 200 mm | |||||
| SMFP100300 100 mm x 300 mm | |||||
| SMFP150300 150 mm x 300 mm | |||||
| SMFP200400 200 mm x 400 mm | |||||
| SMFP250450 250 mm × 450 mm | |||||
| SMFP300500 300 mm x 500 mm | 68015 | ||||
| 68000 | |||||
| 88015 | |||||
| 68005 | |||||
| 68020 | |||||
| 68010 | |||||
| 88000 | |||||
| 88005 | |||||
| 88010 | |||||
| 68025 | |||||
| 68030 | |||||
| 88030 | |||||
| 88035 | |||||
| 68035 | |||||
| 88040 | |||||
| 68040 | 35mm x 73mm | ||||
| 49mm x 200mm. | |||||
| 57mm x 100 mm | |||||
| 62mm x 103mm | |||||
| 62mm x 220mm | |||||
| 69mm x 200mm | |||||
| 70mm x 229 mm | |||||
| 89mm x 133 mm | |||||
| 89mm x 229 mm | |||||
| 116mm x 219mm | |||||
| 133 mm. x 254 mm. | |||||
| 170mm x 237mm | |||||
| 190 mm x 330 mm | |||||
| 254mm x 356 mm | |||||
| 305 mm x 432 mm | |||||
| 230mm x 305mm | N/A | 76mm x 203mm | |||
| 89mm x 203mm | |||||
| 89mm x 229mm | |||||
| 89mm x 559mm | |||||
| 102 mmx 203mm | |||||
| 102mm x 279mm | |||||
| 102 mmx 559mm | |||||
| 127mm x 381mm | |||||
| 133mm x 254mm | |||||
| 191mm x 330mm | |||||
| 203mm x 254mm | |||||
| 203mm x 406mm | |||||
| 232mm x 648mm | |||||
| 254mmx 381mm | |||||
| 267 mmx 211mm | |||||
| 305mm x 381mm | |||||
| 305 mmx 457mm | |||||
| 330mm x 381mm | |||||
| 330 mmx 457mm | |||||
| 406mm x 406mm | |||||
| SMGP100300 100 mm × 40 mm× 300 mm | N/A | N/A | |||
| SMGP150400 150 mm × 50 mm× 400 mm | |||||
| SMGP200400 200 mm × 50 mm× 400 mm | |||||
| SMGP250480 250 mm × 60 mm× 480 mm | |||||
| SMGP300500 300 mm × 70 mm× 500 mm | |||||
| SMFR.022 | 50 mm × 200 M | ||||
| SMFR 032 | 75 mm × 200 M | ||||
| SMFR 042 | 100 mm × 200 M | ||||
| SMFR 062 | 150 mm × 200 M | ||||
| SMFR 082 | 200 mm × 200 M | ||||
| SMFR 102 | 250 mm × 200 M | ||||
| SMFR 122 | 300 mm × 200 M | ||||
| SMFR 142 | 350 mm × 200 M | ||||
| SMFR 162 | 400 mm × 200 M | ||||
| SMGR 031 | 75 mm × 35 mm ×100 M | ||||
| SMGR 041 | 100 mm × 40 mm ×100M | ||||
| SMGR 061 | 150 mm × 50 mm ×100 M | ||||
| SMGR 081 | 200 mm × 50 mm×100 M | ||||
| SMGR 101 | 250 mm × 60 mm ×100 M | ||||
| SMGR 121 | 300 mm × 70 mm ×100 M | ||||
| SMGR 141 | 350 mm × 80 mm ×100 M | ||||
| SMGR 161 | 400 mm × 80 mm ×100 M | ||||
| Sterilization cycles | The recommended steam sterilization cycle | ||||
| parameters are 30 minutes at 121 °C. The | |||||
| recommended EO sterilization cycle is 4 | |||||
| hours at 55 °C with a relative humidity | |||||
| between 50%-85% and a sterilant | |||||
| concentration of 600 mg/L. | The recommended steam | ||||
| sterilization cycle parameters | |||||
| are 30 minutes at 121°C. The | |||||
| recommended EO sterilization | |||||
| cycle is 100 - 120 minutes at | |||||
| 50 °C with a relative humidity | |||||
| between 60 - 85% and a | |||||
| sterilant concentration of 600 | |||||
| mg/L. | It is to be sterilized by a | ||||
| health provider by steam | |||||
| 121°C for 15 minutes or | |||||
| ethylene oxide (EtO). | |||||
| Design features | Self-sealing sterilization pouches: These | ||||
| pouches are made from a medical grade | The pouches are manufactured | ||||
| from a medical grade paper that | These pouches are | ||||
| manufactured from a | |||||
| plastic film that is heat sealed on three | |||||
| sides. The forth side has an adhesive strip | is thermally sealed to a | ||||
| laminated film on the left, | medical grade paper and | ||||
| plastic film that are heat | |||||
| that is used to seal the pouch. Release | right, and bottom of pouch. The | sealed on three sides. The | |||
| paper used in the pouch is a laminated | |||||
| sheet with composing structure of | forth side has an adhesive strip | ||||
| that is used to seal the paper to | forth side has an adhesive | ||||
| PE/paper/PE. It is a strip to cover the | the film prior to sterilization of | strip that is used to seal | |||
| pouch. The medical grade | |||||
| adhesive area and is released before seal | the enclosed medical device. | paper conform to | |||
| the pouch. The medical grade paper | The pouches contain external | recognized material | |||
| conforms to recognized material standards | |||||
| and can be sterilized by steam or ethylene | indicators used to indicate the | ||||
| pouches were processed via | standards and can be | ||||
| sterilized by team or | |||||
| oxide gas. The Process Indicators Ink | steam or EO sterilization. | ethylene oxide gas. | |||
| printed on the medical grade paper will | |||||
| exhibit a color change after the pouch is | |||||
| exposed to steam or ethylene oxide gas. | |||||
-Table 2-3 Summary of the Proposed and Predicate Devices Technological Characteristics
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SIGMA Response to Request for Additional Information K102158 / SIGMA Sterilization Pouch and Roll
January 3, 2011
B- 8 -
8
SIGMA Response to Request for Additional Information K102158 / SIGMA Sterilization Pouch and Roll
| Sterilization pouches, Flat: These pouches has the same components with the Self-sealing sterilization pouches, except the forth side is left opened instead of an adhesive strip and will be heat-sealed when using.
Sterilization pouches, Gusseted: These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
Sterilization rolls, Flat: These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-seating 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. | N/A | N/A |
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ----- | ----- |
CONCLUSION:
The SIGMA sterilization pouch and roll, Medicom Self Sealing sterilization pouch and Winner® Self Seal Sterilization pouch are all intended for provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO).
The SIGMA sterilization pouch and roll has many similar technological characteristics when compared to the predicate devices. The material composition of SIGMA sterilization pouch and roll is similar to the predicate devices. Besides parameters of sterilization, the intended use of SIGMA sterilization pouch and roll is similar to the predicate devices. The first type of SIGMA sterilization pouch and roll is Self-sealing sterilization pouches. The device models and design features of Self-sealing sterilization pouches are similar to the predicate devices. The design features that SIGMA sterilization pouch and roll's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process is also similar to the predicate devices.
The SIGMA sterilization pouch and roll has some different design features from the predicate device. The SIGMA sterilization pouch and roll is offered 5 types pouches. The first type of SIGMA sterlization pouch and roll is Self-sealing sterilization pouches. And the design features of Self-sealing sterilization pouches are similar to the predicate devices. The second type of SIGMA sterilization pouch and roll is Sterilization pouches, Flat. "The Sterilization pouches, Flat" 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. The third type of SIGMA sterilization pouch and roll is Sterilization pouches, Gusseted. "The Sterilization pouches, Gusseted" 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. The fourth type of SIGMA sterilization pouch and roll is Sterilization rolls, Flat. "The Sterilization rolls, Flat" 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 seff-sealing sterlization pouches. The fifth type of SIGMA sterilization pouch and roll is Sterilization rolls, Gusseted. "The Sterilization rolls, Gusseted" 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.
Effectiveness and Safety
9
The SIGMA sterilization pouch and roll has the identical intended use and indication for use as the predicate devices. Substantial equivalence to prodicate devices was established by testing the Sterilant Penetration: Drying Time: Aeration-Biocompatibility, Package Integrity, Material Compatibility, Sterility Maintenance, and Chemical Indicator Efficacy.
The SIGMA sterilization pouch and roll 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 SIGMA sterilization pouch and roll was validated to meet the requirements of ANSVAAMI/ISO 11607-1:2006, Version three, September 2008.
The results of the SIGMA sterilization pouch and roll validation studies demonstrate that the sterilization pouches perform as intended. The results are summarized as follows:
- . The Sterilant Penetration, Drying Time, Aeration, testing performed as described in AAMI / ANSI / ISO 17665-1:2006, ISO TS 17665-2:2009, AAMI / ANSI / ISO 11135-1:2007, and AAMI / ANSI / ISO 10993-7:2008. The testing results demonstrate the ability of the Sigma Sterilization Pouch and Roll 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 Sigma Sterilization Pouch and Roll and sustain direct contact with the medical instrument inside the package. And the result of aeration time validation test meets the requirements AAMI / ANSI / ISO 10993-7:2008.
- � The Biocompatibility testing performed as described in ISO 10993-10:2010(E), ISO 10993-1:2009/Cor. 1:2010(E), ISO 10993-12:2007(E), and ISO/IEC 17025:2005. The testing results demonstrate the Sigma Sterilization Pouch and Roll showed "negative reaction". And the SIGMA sterilization pouch and roll 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, ISO 1924-2, ISO 5636-3, ASTM D 3078-02, ASTM D882, ASTM F 2251-03, ASTMD 1004, ASTME 1140-07, ASTME 1929-98 (04), ASTME 88-2007, ASTM F 1980-2007, ASTMF 1980-2007, and ASTM F 1608-00. The testing results demonstrate the ability of the Sigma Sterilization Pouch and Roll 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 Sigma Sterilization Pouch and Roll 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 SIGMA sterilization pouch and roll meets the requirements ISO 11140-1:2005.
10
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sigma Medical Supplies Corporation C/O Ms. Uta Shih Regulatory Affairs Manager Sen Mu Technology Company, Limited # 15-2, LN 26, Mineyuan 1st Road Lingya District Kaohsiung China (Taiwan) 802
AUG - 2 2011
Re: K102158
Trade/Device Name: SIGMA Sterilization Pouch and Roll Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: July 20, 2011 Received: July 27, 2011
Dear Ms. 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 ffor 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.
11
Page 2 - Ms. 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH Offices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
O Swan Ruoier
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
12
-Indications-for-use --
510(k) Number: K102158
Device Name: SIGMA sterilization pouch and roll
Indications for Use:
The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterlilization cycle parameters are 30 minutes at 121 C. The recommended EO sterilization cycle is 4 hours at 55 C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
The SIGMA sterilization pouch and roll is offered in the following 5 types:
- Self-sealing sterilization pouches
- . Sterilization pouches, Flat
- Sterilization pouches, Gusseted
- . Sterilization rolls, Flat
- Sterilization rolls, Gusseted
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (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)
Dairee S. Mayhall In EFC
Division of Anesthesio!og; General Hospital Infection Control, Dental Devices
510(k) Number: K102158
Page 1 of 3
13
K102 158
The defining characteristics of the 5 types as follows:
- Self-sealing sterilization pouches: These pouches are made from a medical grade plastic film that is heat sealed on .
- three sides. The forth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a - laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas.
- Sterilization pouches, Flat: These pouches has the same components with the Self-sealing sterilization pouches, except the forth side is left opened instead of an adhesive strip and will be heat-seated 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 2-1) lists the model numbers of the SIGMA sterilization pouch and roll by type, model, dimension and characteristics:
Page 2 of 3
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| Table 2-1 The model numbers of SIGMA sterilization pouch and roll | |
|---|---|
| (Type, Model, Dimension and Characteristics) |
| Type | Model | Dimension in S.I. | Characteristics |
|---|---|---|---|
| SMSE057133 | 57 mm × 133 mm | ||
| Self-Sealing | |||
| Sterilization | |||
| Pouches | SMSE090162 | 90 mm × 162 mm | 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 paper | |||
| and 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. | |||
| SMSE070257 | 70 mm × 257mm | ||
| SMSE090257 | 90 mm × 257 mm | ||
| SMSE135283 | 135 mm × 283 mm | ||
| SMSE180335 | 135 mm × 335 mm | ||
| SMSE190358 | 190 mm × 358 mm | ||
| SMSE300380 | 300 mm × 380 mm | ||
| SMSE300474 | 300 mm × 474 mm | ||
| SMFP075200 | 75 mm × 200 mm | ||
| SMFP075300 | 75 mm × 300 mm | ||
| SMFP100200 | 100 mm × 200 mm | These pouches has the same components with the Self-sealing sterilization pouches, except the forth side is left opened instead of an adhesive strip and will be heat-sealed when using. | |
| Sterilization | |||
| Pouches, Flat | SMFP100300 | 100 mm × 300 mm | |
| SMFP150300 | 150 mm × 300 mm | ||
| SMFP200400 | 200 mm × 400 mm | ||
| SMFP250450 | 250 mm × 450 mm | ||
| SMFP300500 | 300 mm × 500 mm | ||
| Sterilization | |||
| Pouches, Gusseted | SMGP100300 | 100 mm × 40 mm× 300 mm | |
| SMGP150400 | 150 mm × 50 mm× 400 mm | 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. | |||
| SMGP200400 | 200 mm × 50 mm× 400 mm | ||
| SMGP250480 | 250 mm × 60 mm× 480 mm | ||
| SMGP300500 | 300 mm × 70 mm× 500 mm | ||
| SMFR 022 | 50 mm × 200 M | ||
| SMFR 032 | 75 mm × 200 M | 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. | |
| SMFR 042 | 100 mm × 200 M | ||
| Sterilization Rolls, | |||
| Flat | SMFR 062 | 150 mm × 200 M | |
| SMFR 082 | 200 mm × 200 M | ||
| SMFR 102 | 250 mm × 200 M | ||
| SMFR 122 | 300 mm × 200 M | ||
| SMFR 142 | 350 mm × 200 M | ||
| SMFR 162 | 400 mm × 200 M | ||
| Sterilization Rolls, | |||
| Gusseted | SMGR 031 | 75 mm × 35 mm × 100 M | |
| SMGR 041 | 100 mm × 40 mm × 100M | ||
| SMGR 061 | 150 mm × 50 mm ×100 M | 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. | |
| SMGR 081 | 200 mm × 50 mm ×100 M | ||
| SMGR 101 | 250 mm × 60 mm × 100 M | ||
| SMGR 121 | 300 mm × 70 mm × 100 M | ||
| SMGR 141 | 350 mm × 80 mm ×100 M | ||
| SMGR 161 | 400 mm × 80 mm × 100 M |
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