Tyvek Sterilization Pouches with Chevron Seal

K170429 · Andersen Sterilizers, Inc. · FRG · Oct 27, 2017 · General Hospital

Device Facts

• Record ID: K170429
• Device Name: Tyvek Sterilization Pouches with Chevron Seal
• Applicant: Andersen Sterilizers, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Oct 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Tyvek Sterilization Pouches with Chevron Seal are intended to enclose medical devices that are to be sterilized in a single pouch configuration at a healthcare facility. They are used in the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer.

Device Story

Tyvek Sterilization Pouches with Chevron Seal are packaging accessories for medical devices undergoing ethylene oxide (EO) sterilization. Constructed from uncoated high-density polyethylene (Tyvek) backing and clear laminated PET/LDPE or LDPE-EVA film fronts. Healthcare providers insert devices into pouches, seal them (via self-seal adhesive or heat-sealing), and process them in an Anprolene AN75 EO sterilizer. The pouches allow EO gas penetration while maintaining a microbial barrier. Optional AN85/AN86 EO indicators placed on the pouch exterior change color (yellow-green to blue) to confirm EO exposure. Post-sterilization, pouches maintain device sterility for at least 3 months. The device facilitates safe storage and transport of sterilized instruments within clinical environments.

Clinical Evidence

Bench testing only. Testing included package integrity (seal strength, microbial barrier, burst, peel), material compatibility, biocompatibility (ISO 11607-1), and shelf-life verification. Sterilization efficacy was validated using a half-dose method in the Anprolene AN75 system, demonstrating a 12-log reduction and SAL of 10^-6. Sterility maintenance was confirmed for at least 3 months post-processing.

Technological Characteristics

Materials: Uncoated HDPE Tyvek (back), laminated PET/LDPE or LDPE-EVA film (front). Design: Chevron seal, self-seal or heat-seal configurations. Standards: ISO 11607-1, ASTM requirements for seal strength and microbial barrier. Sterilization: Ethylene Oxide (EO) gas. Connectivity: None.

Indications for Use

Indicated for enclosing medical devices for sterilization in a single pouch configuration at healthcare facilities using the 12-hour cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer.

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

• Tyvek Sterilization Pouches with Chevron Seal (K152058)

Submission Summary (Full Text)

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October 27, 2017

Andersen Sterilizers, Inc. William Andersen President 3154 Caroline Drive Haw River, North Carolina 27258

Re: K170429

Trade/Device Name: Tyvek Sterilization Pouches with Chevron Seal Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: September 28, 2017 Received: October 6, 2017

## Dear William Andersen:

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.

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); 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Ryan -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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K170429

Device Name

Tyvek® Sterilization Pouches with Chevron Seal

Indications for Use (Describe)

Tyvek Sterilization Pouches with Chevron Seal are intended to enclose that are to be sterlized in a single pouch configuration at a healthcare facility. They are used in the 12 hour sterlization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 1.

Table 1. Critical sterilization cycle parameters in the Anprolene AN75 Ethylene Oxide Gas Sterilizer

| EO Amount | Temperature | Relative Humidity | EO Exposure Time | Total Cycle Time |
|-------------|-------------|-------------------|------------------|------------------|
| 17.6 g ± 5% | 20-29°C | 35-90% | 12 hours | 14 hours |

The product codes for Tyvek Sterilization Pouches are listed in Table 2.

Table 2. Product codes for Tyvek Sterilization Pouches

| Product Type | Self-Seal, Heat Seal, Tubing |
|---------------|---------------------------------------------|
| Product Codes | TLP-030, TLP-031, TLP-033, TLP-058, TLP-059 |

The 12 hour cycle in the Anprolene AN75 Ethylene Oxide Gas Sterilizer has been validated to sterilize a load of up to 24 Us of metal surgical instruments, 3 lbs of fabric, or 3.5 lbs of plastic devices (combined weight of pouched devices and tray). Sterility was maintained for at least 3 months after processing in an Anprolene AN75 sterilizer.

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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## K170429 510(k) Summary

| 5.1 Applicant's Name and Address | Andersen Sterilizers, Inc.<br>Establishment Registration Number 3004634710<br>3154 Caroline Drive<br>Haw River, NC 27258 | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| 5.2 Contact Person | William K. Andersen, BE, MD, FAAOS<br>President<br>Phone: [phone], Fax: [phone] | |
| 5.3 Date of Preparation | September 28, 2017 | |
| 5.4 Device | | |
| | Proprietary Name | Tyvek® Sterilization Pouches with Chevron Seal |
| | Common Name | Sterilization Pouch |
| | Classification | Class II (21 CFR 880.6850) |
| | Product Code | FRG |
| 5.5 Predicate Device | | |
| | Device Name | Tyvek Sterilization Pouches with Chevron Seal |
| | 510(k) number | K152058 |
| | Manufacturer | Amcor Flexibles, Inc. |

accessory for use in the EOGas 4® Ethylene Oxide Gas Sterilization System manufactured by Andersen Sterilizers, Inc.

This 510(k) submission modifies the indications for use of the predicate device in order to include Tyvek Sterilization Pouches with Chevron Seal as an accessory for use in the Anprolene® AN75 Ethylene Oxide Sterilization System manufactured by Andersen Sterilizers, Inc. No modifications were made to the manufacturing method, technology, or intended use.

#### 5.6 Device Description

Tyvek Sterilization Pouches with Chevron Seal are constructed from an uncoated 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-ethylenevinylacetate copolymer film. The pouches are used to enclose medical devices that are to be sterilized by a healthcare provider in the 12 hour sterilization cycle at 20-29°C in an Anprolene AN75 Ethylene Oxide Gas Sterilizer. 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

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prior to the cycle. Andersen Sterilizers' AN85/AN86 EO Indicators, when placed on the outside of the sterilization pouches, indicate EO exposure and offer a convenient way to differentiate pouches that have been processed in EO sterilization cycles from unprocessed units. The color of the AN85/AN86 EO Indicators changes from yellow-green to blue after exposure to EO. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for at least 3 months (90 days).

## 5.7 Indications for Use

Tyvek Sterilization Pouches with Chevron Seal are intended to enclose medical devices that are to be sterilized in a single pouch configuration at a healthcare facility. They are used in the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 5-1.

Table 5-1. Critical parameters for the 12 hour cycle in the Anprolene AN75 Ethylene Oxide Gas Sterilizer

| Ethylene Oxide | Temperature | Relative<br>Humidity | Ethylene Oxide<br>Exposure Time | Total Cycle Time |
|----------------|-------------|----------------------|---------------------------------|------------------|
| 17.6 g ± 5% | 20-29°C | 35-90% | 12 hours | 14 hours |

The product codes for Tyvek Sterilization Pouches are listed in Table 5-2.

| Table 5-2. Product codes for Tyvek Sterilization Pouches |
|----------------------------------------------------------|
|----------------------------------------------------------|

| Product Type | Self-Seal, Heat Seal, Tubing |
|---------------|---------------------------------------------|
| Product Codes | TLP-030, TLP-031, TLP-033, TLP-058, TLP-059 |

The 12 hour cycle in the Anprolene AN75 Ethylene Oxide Gas Sterilizer has been validated to sterilize a load of up to 24 lbs of metal surgical instruments, 3 lbs of fabric, or 3.5 lbs of plastic devices (combined weight of pouched devices and tray). Sterility was maintained for at least 3 months after processing in an Anprolene AN75 sterilizer.

#### 5.8 Device Comparison

The technological characteristics of Tyvek Sterilization Pouches with Chevron Seal are identical to the predicate device - both are intended for the same use, use the same technology, and are designed in the same way.

The subject Tyvek Sterilization Pouches with Chevron Seal differ from the predicate device only in the indicated sterilization cycle. The difference raises no issues related to safety or effectiveness of the subject device in the cycle. A comparison between the devices is listed in Table 5-3.

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| Table 5-3. Device Comparison<br>Elements | Predicate Device: Tyvek Sterilization<br>Pouches (K152058) | Subject Device: Tyvek Sterilization<br>Pouches (K170429) |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To enclose medical devices, allow<br>sterilization of the enclosed devices, and<br>maintain sterility of the enclosed devices | Identical |
| Indications for<br>Use | Tyvek Sterilization Pouches with<br>Chevron Seal are intended to enclose<br>medical devices that are to be sterilized<br>in a single pouch configuration at a<br>healthcare facility. They are used in the<br>3 hour sterilization cycle at 50°C in the<br>EOGas 4 Ethylene Oxide Gas Sterilizer. | Tyvek Sterilization Pouches with<br>Chevron Seal are used to enclose<br>medical devices that are to be sterilized<br>in a single pouch configuration at a<br>healthcare facility. They are used in the<br>12 hour sterilization cycle at 20-29°C in<br>the Anprolene AN75 Ethylene Oxide<br>Gas Sterilizer. |
| Design | Adhesive laminated film is a clear, high<br>strength material;<br>Uncoated Tyvek is compatible with EO<br>sterilization, resistant to microbial<br>penetration, and resistant to puncture | Identical |
| Pouch Types | Self-seal pouch; Heat seal pouch; Heat<br>seal tubing | Identical |
| Device<br>Construction | Self-seal and heat seal pouches: front and<br>back materials are heat sealed together<br>on three sides; fourth side (end) remains<br>open for filling; end is sealed by heat<br>(heat seal pouches) or by removing<br>protective liner strip, folding along the<br>pre-fold, and pressing to the film (self-<br>seal pouches).<br>Heat seal tubing: front and back<br>materials are heat sealed together on two<br>sides; two ends are open for selecting<br>size and filling; ends are sealed by heat. | Identical |
| Materials | Clear laminated PET/LDPE or LDPE-<br>EVA film (front) and uncoated HDPE<br>Tyvek (back) | Identical |
| Configuration | Single pouch configuration | Identical |
| Shelf Life | 5 years from date of manufacture | Identical |
| Biocompatibility | Materials and biological evaluations<br>(Agar Diffusion Test, Cytotoxicity Test)<br>meet ISO 11607-1 requirements | Identical |
| Maintenance of<br>Sterility | Sterility is maintained for at least 3<br>months after processing in an EOGas 4<br>sterilizer | Sterility is maintained for at least 3<br>months after processing in an Anprolene<br>AN75 sterilizer |
| Aeration Time | ≥ 6 hours | No additional time other than the 2 hr<br>mandatory ventilation |
| Package<br>Integrity | Seal strength, microbial barrier, burst,<br>and peel open characteristics meet ISO<br>and ASTM requirements | Identical |

Table 5-3. Device Comparison

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## 5.9 Performance Testing

Performance testing was conducted to demonstrate that Tyvek Sterilization Pouches with Chevron Seal perform as intended to allow sterilization of the enclosed medical devices. Sterilization efficacy testing demonstrated a 12-Log reduction and a sterility assurance level of 10-6 using the half dose validation method under worst-case conditions. Tyvek Sterilization Pouches with Chevron Seal also maintain sterility of the enclosed devices as intended. Shelf life studies demonstrated after completion of the Anprolene AN75 sterilization process, sterility is maintained for at least 3 months. The performance of Tyvek Sterilization pouches is summarized in Table 5-4.

| | Table 5-4. Summary of bench tests performed to demonstrate safety and effectiveness of Tyvek |
|-----------------------|----------------------------------------------------------------------------------------------|
| Sterilization Pouches | |

| Test | Description | Results |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Compliance to ISO 11607-1 | | |
| Package<br>Integrity | Seal strength performance characteristics were maintained for<br>the manufactured seal.<br>Microbial Barrier: the contents of pouches were sterile when<br>the processed pouches were subjected to the microbial aerosol<br>challenge test.<br>Burst: ability to withstand the internal pressurization was<br>maintained.<br>Peel open characteristics were maintained. | Meet ISO and<br>ASTM<br>requirements |
| Material<br>Compatibility | Seal strength test, microbial barrier properties, burst test, and<br>peel open test were studied to demonstrate material<br>compatibility characteristics of the Tyvek<br>Sterilization Pouches | Pass |
| Biocompatibility | Not direct patient-contacting devices;<br>Materials are non-toxic, FDA compliant, and meet ISO 11607-<br>1 requirements;<br>Biological and residual evaluations meet acceptable criteria;<br>Provides reasonable assurance for safety | Pass |
| Shelf Life | Physical properties and microbial barrier of the processed<br>Tyvek Pouches was verified at the end of shelf life of 5 years;<br>Stability demonstrates reasonable assurance for effectiveness | Pass |
| Performance in the Anprolene AN75 Cycle | | |
| Sterilant<br>Penetration | EO penetrated the pouch under worst-case half-dose<br>conditions or an extreme biological challenge scenario, and<br>inactivated 6-Log biological indicators | Allow a SAL of<br>$10^{-6}$ for the<br>sterilization cycle |
| Maintenance of<br>Package<br>Sterility | Sterility was maintained for at least 3 months after processing<br>in an Anprolene AN75 sterilizer. | Pass |

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# 5.10 Conclusion

Based on the intended use, technological characteristics, performance data, and nonclinical tests performed, the subject Tyvek Sterilization Pouches with Chevron Seal, indicated for use in the Anprolene AN75 sterilization system, are substantially equivalent to the predicate devices, Tyvek Sterilization Pouches with Chevron Seal (K152058), indicated for use in the EOGas 4 sterilization system.