Safe Secure Sterilization Pouches and Rolls
Device Facts
| Record ID | K180139 |
|---|---|
| Device Name | Safe Secure Sterilization Pouches and Rolls |
| Applicant | Safe Secure Packing Co., Ltd. |
| Product Code | FRG · General Hospital |
| Decision Date | Jan 3, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
Indications for Use
Safe Secure Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using: - Gravity steam at 121°C (250°F) for 30 minutes: 25 minutes dry time - Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time - Pre-vacuum steam at 134°C (273°F) for 3 minutes: 20 minutes dry time - Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time - Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60oC (140oF). - The recommended hydrogen peroxide vapor sterilization cycle is the STERRAD® 100S Short Cycle. The steam and EO device is not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen. The hydrogen peroxide device has been validated for devices that contain a lumen; the 100S has been validated for medical devices with a single stainless steel lumen with an inside diameter of ≥1mm and an length of ≤125mm as well as lumens with an inside diameter ≥2mm and a length of ≤250mm only. The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam. EO, or hydrogen peroxide sterilization process and to distinguish between processed devices. The chemical indicators change from green to purple after exposure to steam, from yellow to brown after exposure to ethylene oxide, and from blue to pink for hydrogen peroxide. The Tyvek version of the pouch is for EO and hydrogen peroxide sterilization only. If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 6 months after steam sterilization (for paper pouch), two years after hydrogen peroxide sterilization and five years for EO sterilization (for Tyvek Pouch). The maximum validated pouch load is 2.64 pounds (1.2kg).
Device Story
Sterilization pouches/rolls enclose medical devices for sterilization by healthcare providers. Inputs: medical devices placed inside pouches. Transformation: pouches provide microbial barrier; external chemical indicators (CI) change color upon exposure to specific sterilants (steam, EO, hydrogen peroxide) to distinguish processed from unprocessed units. Output: sterilized, sealed medical device. Used in clinical settings; operated by healthcare staff. CIs provide visual confirmation of sterilant exposure; sterility maintenance (SAL 10^-6) ensured for validated durations. Benefits: maintains sterility of instruments post-processing.
Clinical Evidence
Bench testing only. No clinical data. Testing included seal strength (ASTM F88/F88M-15), seal leak (ASTM F1929-15), material compatibility, biocompatibility (ISO 10993-1/5), shelf life, and sterilization validation (ISO 11140-1, ISO 11138, ISO 14161).
Technological Characteristics
Materials: Medical grade paper or Tyvek (HDPE) backing with clear PET/LDPE or LDPE-EVA film front. Self-seal (adhesive strip) or heat-seal configurations. Includes external chemical indicators for steam, EO, or hydrogen peroxide. Sterilization validation per ISO 11140-1, 11138, 14161. Seal integrity per ASTM F88, F1929.
Indications for Use
Indicated for healthcare providers to enclose medical devices for sterilization via gravity steam, pre-vacuum steam, ethylene oxide, or hydrogen peroxide vapor (STERRAD 100S). Validated for non-lumen devices (steam/EO) and specific lumen dimensions (hydrogen peroxide).
Regulatory Classification
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.
Predicate Devices
- Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators (K153540)
Reference Devices
- 3M Comply Hydrogen Peroxide Chemical Indicator 1248 (K170321)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 3, 2019
Safe Secure Packing Co., Ltd. Howard Jia, President Yaoshan Industrial Park Xiegang Town, Dongguan City, CN 523601
Re: K180139
Trade/Device Name: Safe Secure Sterilization Pouches and Rolls Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: November 27, 2018 Received: November 28, 2018
Dear Howard Jia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Elizabeth F. Claverie -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K180139
#### Device Name
Safe Secure Sterilization Pouches and Rolls
#### Indications for Use (Describe)
Safe Secure Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:
- · Gravity steam at 121°C (250°F) for 30 minutes: 25 minutes dry time
- · Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
- · Pre-vacuum steam at 134°C (273°F) for 3 minutes: 20 minutes dry time
- · Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time
· Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60oC (140oF).
- · The recommended hydrogen peroxide vapor sterilization cycle is the STERRAD® 100S Short Cycle.
The steam and EO device is not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen. The hydrogen peroxide device has been validated for devices that contain a lumen; the 100S has been validated for medical devices with a single stainless steel lumen with an inside diameter of ≥1mm and an length of ≤125mm as well as lumens with an inside diameter ≥2mm and a length of ≤250mm only.
The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam. EO, or hydrogen peroxide sterilization process and to distinguish between processed devices. The chemical indicators change from green to purple after exposure to steam, from yellow to brown after exposure to ethylene oxide, and from blue to pink for hydrogen peroxide.
The Tyvek version of the pouch is for EO and hydrogen peroxide sterilization only.
If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 6 months after steam sterilization (for paper pouch), two years after hydrogen peroxide sterilization and five years for EO sterilization (for Tyvek Pouch). The maximum validated pouch load is 2.64 pounds (1.2kg).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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| Pouch Material | Sterilization Method | Size | Model<br>Number |
|------------------------|--------------------------------------------------------|--------------------------|------------------------|
| Medical Grade<br>Paper | Steam or EO Sterilization Pouch/Roll<br>Products | L: 2 – 30"<br>W: 2 – 30" | ABHSP1TAB<br>ABSSP1TAB |
| Tyvek | EO Sterilization Pouch/Roll Products | W: 2 – 30" | ABSST1TAB<br>ABHST1TAB |
| Tyvek | Hydrogen Peroxide Sterilization<br>Pouch/Roll Products | L: 2 – 30"<br>W: 2 – 30" | ABSST2TAB<br>ABHST2TAB |
The maximum validated pouch load is 2.64 pounds (1.2kg).
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## K180139
## 510(k) Summary
#### Submission Sponsor
Safe Secure Packing (Shenzhen) Co., Ltd Yaoshan Industrial Park, Xiegang Town, Dongguan City, Guangdong Province, 523601 China.
#### Date Prepared
November 27, 2018
#### Device Identification
Trade/Proprietary Name: Safe Secure Sterilization Pouches and Rolls Common/Usual Name: Sterilization Pouch Classification Name: Sterilization Wrap Classification Regulation: 21 CFR Part 880.6850 Product Code: FRG Device Class: 2 Classification Panel: General and Plastic Surgery
#### Predicate Device
K153540 - Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators
#### Device Description
Tyvek Sterilization Pouches with Chevron Seal are constructed Tyvek backing of fine, continuous, high-density polyethylene fibers, with front material consisting of a clear, laminated polyethylene terephthalate / low density polyethylene (LDPE) or LDPE-ethylene- vinylacetate copolymer film.
The pouches are used to enclose medical devices that are to be sterilized by a healthcare provider following manufacturer's instructions, devices are inserted into Tyvek Sterilization Pouches and sealed.
The self-seal pouch permits sealing of the pouch without heat-sealing equipment, whereas the heat-sealable pouches must be heat sealed prior to the cycle.
Chemical Indicators, are placed on the outside of the sterilization pouches indicate sterilant exposure, and a way to differentiate pouches that have been processed in sterilization cycles from unprocessed units.
The color of the Indicators (3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248) changes from blue to pink after exposer to hydrogen peroxide sterilization. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for at least five years.
## Indications for Use
Safe Secure Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:
- . Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
- . Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes drytime
- . Pre-vacuum steam at 134°C (273°F) for 3 minutes; 20 minutes dry time
- . Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time
- Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% relative humidity for 60 . minutes. Aeration time of 8 hours at 60oC (140°F).
- The recommended hydrogen peroxide vapor sterilization cycle is the STERRAD® 100S Short Cycle. .
The steam and EO device is not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen; the 100S has been validated for medical devices with a single stainless steel lumen with an inside diameter of ≥1mm and an length of ≤125mm as well as lumens with an inside diameter ≥2mm and a length of ≤250mm only.
Howard Jia, President Tel: 86-755-27040498 Fax: 86-755-27040488 howard.jia@anbaopack.com
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The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam, EO, or hydrogen peroxide sterilization process and to distinguish between processed and unprocessed devices. The chemical indicators change from green to purple after exposure to steam, from yellow to brown after exposure to ethylene oxide, and from blue to pink for hydrogen peroxide.
The Tyvek version of the pouch is for EO and hydrogen peroxide sterilization only.
If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 6 months after steam sterilization, 24 months after EO sterilization (for paper pouch), two years after hydrogen peroxide sterilization and five years for EO sterilization (for Tyvek Pouch).
The maximum validated pouch load is 2.64 pounds (1.2kg).
The maximum validated pouch load is 2.64 pounds (1.2kg).
| Pouch Material | Sterilization Method | Size | Model Number |
|---------------------|-----------------------------------------------------|--------------------------|------------------------|
| Medical Grade Paper | Steam or EO Sterilization Pouch/Roll Products | L: 2 - 30"<br>W: 2 - 30" | ABHSP1TAB<br>ABSSP1TAB |
| Tyvek | EO Sterilization Pouch/Roll Products | W: 2 - 30" | ABSST1TAB<br>ABHST1TAB |
| Tyvek | Hydrogen Peroxide Sterilization Pouch/Roll Products | L: 2 - 30"<br>W: 2 - 30" | ABSST2TAB<br>ABHST2TAB |
#### Technological Characteristics Comparison Table
The subject device has the same intended use of the device as its predicate and the same technological characteristics.
The primary difference is the addition of the STERRAD® 100S Short Cycle to the indications for use.
A hydrogen peroxide sterilization chemical indicator cleared under K170321 has been included for monitoring.
| | Subject Device | Predicate Device | Comparison of subject<br>device with the predicate<br>device |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Name of Company | Safe Secure | Safe Secure | Identical |
| Device Name | Sterilization Tyvek Sterilization<br>Pouches | Sterilization Tyvek Sterilization<br>Pouches | Identical |
| Intended use | The device is intended to be used to<br>enclose another medical device, in a<br>single or double pouch configuration,<br>that is to be sterilized by a health<br>care provider | The device is intended to be used<br>to enclose another medical<br>device, in a single or double<br>pouch configuration, that is to be<br>sterilized by a health care<br>provider | Identical |
| Material Composition | Tyvek and PET/PE Film Medical<br>Double Side Tape (for self-seal pouches<br>only) | Tyvek and PET/PE Film Medical<br>Double Side Tape (for self-seal<br>pouches only) | Tyvek and PET/PE Film<br>Medical Double Side Tape<br>(for self-seal pouches only) |
| Hydrogen Peroxide<br>Chemical Indicator<br>Supplier | 3MTM ComplyTM Hydrogen Peroxide<br>Chemical Indicator 1248 (K170321) | NA | NA |
| Biocompatibility | Materials and biological evaluations<br>Cytotoxicity Test (ISO 10993-5) – Post<br>Sterilization | Materials and biological evaluations<br>– Post Sterilization: Cytotoxicity<br>Test (ISO 10993-5)<br>Pre-Sterilization: Cytotoxicity (ISO<br>10993-5), Maximization<br>Sensitization (ISO 10993-10),<br>Irritation/Intracutaneous Reactivity<br>(ISO 10993-10) | Both were non-cytotoxic<br>post sterilization. |
| Configuration | Single pouch configuration with<br>chemical indicator | Single pouch configuration with<br>chemical indicator | Identical |
| Configurations/<br>Dimensions | Various | Various | Same - both<br>have various<br>configurations |
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| | Subject Device | Predicate Device | Comparison of subject<br>device with the predicate<br>device |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Design | Adhesive laminated film is a clear, high<br>strength material; Uncoated<br>Tyvek is compatible with<br>sterilization, resistant to microbial<br>penetration, and resistant to puncture | Adhesive laminated film is a clear,<br>high strength material; Uncoated<br>Tyvek is compatible with<br>sterilization, resistant to microbial<br>penetration, and resistant to<br>puncture | Identical |
| Device<br>Construction | Self-seal and heat seal pouches:<br>front and back materials are heat<br>sealed together on three sides; fourth<br>side (end) remains open for filling;<br>end is sealed by heat (heat seal<br>pouches) or by removing protective<br>liner strip, folding along the pre-<br>fold, and pressing to the film (self-<br>seal pouches). Heat seal tubing:<br>front and back materials are heat<br>sealed together on two sides; two<br>ends are open for selecting size and<br>filling; ends are sealed by heat. | Self-seal and heat seal pouches:<br>front and back materials are heat<br>sealed together on three sides;<br>fourth side (end) remains open<br>for filling; end is sealed by heat<br>(heat seal pouches) or by<br>removing protective liner strip,<br>folding along the pre-fold, and<br>pressing to the film (self- seal<br>pouches). Heat seal tubing: front<br>and back materials are heat<br>sealed together on two sides; two<br>ends are open for selecting size<br>and filling; ends are sealed by<br>heat. | Identical |
| Materials | Clear laminated PET/LDPE or LDPE-<br>EVA film (front) and uncoated HDPE<br>Tyvek (back) | Clear laminated PET/LDPE or<br>LDPE-EVA film (front) and<br>uncoated HDPE Tyvek (back) | Identical |
| Package Integrity | Seal strength, microbial barrier,<br>burst, and peel open<br>characteristics meet ISO and<br>ASTM requirements | Seal strength, microbial<br>barrier, burst, and peel open<br>characteristics meet ISO and<br>ASTM requirements | Identical |
| Pouch Types | Self-seal pouch; Heat seal pouch; Heat<br>seal tubing | Self-seal pouch; Heat seal pouch;<br>Heat seal tubing | Identical |
| Shelf Life | 2 years from date of manufacture for<br>hydrogen peroxide chemical indicator | 5 years for EO chemical indicator | The hydrogen peroxide CI<br>has a two year shelf life. |
| Validated for use in<br>Sterilization System | Validated to be used with<br>hydrogen peroxide<br>sterilization, EO and Steam<br>Sterilization | Validated to be used with EO<br>and Steam Sterilization | The new CI is<br>validated to be used<br>with hydrogen<br>peroxide sterilization |
| Chemical Indicator | Hydrogen Peroxide CI attached to<br>outside of pouch | EO or Steam CI attached to<br>outside of pouch | The new CI is<br>validated to be used<br>with hydrogen<br>peroxide sterilization |
# Summary of Non-Clinical Testing
This section includes a brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission to support a determination of substantial equivalence.
| Test | Description | | Result |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--------|
| Package<br>Integrity | Seal Strength Test | ASTM F88/F88M-15 | |
| | Seal Leak Test | ASTM F1929-15 | Pass |
| | Sterilization Chemical Indicator Test and Visual Inspection | Visual examination | |
| Material<br>Compatibility | Seal strength test, microbial barrier properties, burst test, and peel open test were studied to<br>demonstrate material compatibility characteristics of the Tyvek Sterilization Pouches | | Pass |
| Biocompatibility | Not direct patient-contacting devices; Materials are non-toxic. Biological evaluations meet<br>acceptable criteria; Provides reasonable assurance for safety. Standards referenced include: ISO<br>10993-1 and ISO 10993-5. | | Pass |
| Shelf Life | Physical properties and microbial barrier of the processed Tyvek Pouches was verified at the<br>end of shelf life of 2 years | | Pass |
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| Test | Description | Result |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Sterilization Validation | Full, half, and partial/fail cycles were used to validate the cycle. The following standards were used in the submission. Standards referenced include: ISO 11140-1, ISO 11138, ISO 14161 | Pass |
| Chemical Indicator | Testing was performed to demonstrate compliance to Submissions for Chemical Indicators - Guidance for Industry and FDA Staff as applicable under K170321 | Pass |
# Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device cleared under K153540.
