Sterisheet Sterilization Wrap

K152291 · Andersen Sterilizers, Inc. · FRG · Dec 17, 2015 · General Hospital

Device Facts

• Record ID: K152291
• Device Name: Sterisheet Sterilization Wrap
• Applicant: Andersen Sterilizers, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Dec 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Sterisheet Sterilization Wraps are single use non woven sterilization wraps intended to enclose medical devices that are to be sterilized at a healthcare facility. They are used in the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

Device Story

Sterisheet Sterilization Wraps are single-use, non-woven wraps; constructed from cellulose, polypropylene, and synthetic binders. Used in healthcare facilities to enclose medical devices (metal instruments, plastics, fabrics, endoscopes) prior to sterilization in EOGas 4 Ethylene Oxide (EO) Gas Sterilizer. Wraps allow EO penetration while maintaining microbial barrier post-sterilization. AN85/AN86 EO indicators (yellow-green to blue color change) used to secure wrap and verify EO exposure. Healthcare providers wrap devices per instructions; process in 3-hour cycle at 50°C; maintain sterility for at least 3 months. Benefits include effective sterilization and sterile storage of surgical instruments and endoscopes.

Clinical Evidence

Bench testing only. Testing included ISO 11607-1 compliance for package integrity, material compatibility, and biocompatibility. Sterilization efficacy validated using overkill method and half-cycle/half-dose methods to achieve a sterility assurance level (SAL) of 10^-6. Shelf life studies confirmed sterility maintenance for at least 3 months post-processing.

Technological Characteristics

Materials: cellulose, polypropylene, synthetic binders. Form factor: square/rectangular non-woven sheets. Principle: porous microbial barrier allowing EO gas penetration. Connectivity: none. Sterilization: intended for use in EOGas 4 EO sterilizer. Standards: ISO 11607-1.

Indications for Use

Indicated for use in healthcare facilities to enclose medical devices for sterilization in the EOGas 4 Ethylene Oxide Gas Sterilizer (3-hour cycle at 50°C).

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

• Sterisheet® Sterilization Wrap (K931202)

Submission Summary (Full Text)

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES • USA

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

December 17, 2015

Andersen Sterilizers, Inc. William K. Andersen, B.E., M.D. President 3154 Caroline Dr. Haw River, NC 27258

Re: K152291

Trade/Device Name: Sterisheet® Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: November 16, 2015 Received: November 19, 2015

Dear Dr. 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

*Tejashri Purohit-Sheth, M.D.*

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K152291

| K152291 | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name<br>Sterisheet® Sterilization Wrap | | | | |
| Indications for Use ( <i>Describe</i> )<br>The Sterisheet Sterilization Wraps are single use non woven sterilization wraps intended to enclose medical devices that are to be<br>sterilized at a healthcare facility. They are used in the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. | | | | |
| Critical process parameters for the cycle are summarized below in Table 1.<br>Table 1. Critical parameters for the 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilizer | | | | |
| EO Amount | Temperature | Relative Humidity | EO Exposure Time | Total Cycle Time |
| $17.6 g \pm 5%$ | $50°C \pm 3°C$ | 35-90% | 3 hours | 3.5 hours |
| The product code for the Sterisheet Sterilization Wraps is listed in Table 2.<br>Table 2. Product code for the Sterisheet Sterilization Wraps | | | | |
| Product Designation | Sterisheet S88 Blue | | | |
| Product Code | 0129 | | | |
| Maximum loads of specific materials and devices that have been validated are listed in Table 3. All validated maximum loads were<br>processed without additional devices in the sterilizer. Sterility was maintained for at least 3 month after processing in an EOGas 4<br>sterilizer. | | | | |
| Table 3. Load and material types validated in the EOGas 4 Ethylene Oxide Gas Sterilizer | | | | |
| Device Type | Maximum Load | Device Examples | | Required Aeration |
| Metal | 24 lbs (11 kg) | Surgical instruments,<br>delicate sharps, including those<br>with hinges and mated surfaces | | Metal instruments do not absorb EO;<br>Follow pouch or wrap manufacturer's<br>instructions (Example: Tyvek® pouches and<br>Sterisheet® wrap require ≥ 6 hours at 50°C). |
| Plastic | 7.0 lbs (3.2 kg) | Reusable power cords, trocars | | 24 hours at 50°C; |
| Fabric | 6.1 lbs (2.8 kg) | Reusable cloth gowns, towels | | Follow manufacturer's instructions |
| Single-lumen<br>Endoscope(s) | One (1) ≥ 2.0mm ID<br>≤ 1100mm length;<br>No additional devices | Gastrovideoscopes, gastrointestinal<br>videoscopes | | 12 hours at 50°C;<br>Follow manufacturer's instructions |
| | Four (4) ≥ 1.2 mm ID<br>≤ 700 mm length;<br>No additional devices | Bronchoscopes, bronchovideoscopes,<br>cystoscopes, ureteroscopes,<br>choledocoscopes | | Follow manufacturer's instructions |

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

× Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

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

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# 510(k) Summary

| 5.1 | Applicant's Name and Address | | Andersen Sterilizers, Inc.<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 | | November 16, 2015 | |
| 5.4 | Device | Proprietary Name<br>Common Name<br>Classification<br>Product Code | Sterisheet® Sterilization Wrap<br>Sterilization Wrap<br>Class II (21 CFR 880.6850)<br>FRG | |
| ર રે | Predicate Device | | | |
| | | Device Name<br>510(k) number<br>Manufacturer | Sterisheet® Sterilization Wrap<br>K931202<br>Arjowiggins Medical Inc. | |

This 510(k) submission modifies the indications for use of the predicate device in order to include it as a component in the EOGas 4 ethylene oxide sterilization system. No modifications were made to the technology or intended use.

5.6 Device Description

The Sterisheet Sterilization Wraps are single use, non-sterilization wraps constructed from cellulose, synthetic fibers (polypropylene), and synthetic binders, with the addition of pigmentation. They are used to enclose medical devices that are to be sterilized by a healthcare provider in the 3 hour sterilization cycle at 50°C in an EOGas 4 Ethylene Oxide Gas Sterilizer. Devices are wrapped following manufacturer's instructions. After completion of the sterilization process, the Sterisheet Sterilization Wraps maintain sterility of the enclosed medical devices for at least 3 month.

The AN85/AN86 EO Indicators, when placed on the outside of the sterilization wraps, may be used to secure the wrapping material on the devices and to indicate ethylene oxide exposure, offering a convenient way to verify processing in the sterilization cycle. The color of the AN85/AN86 EO Indicators changes from yellow-green to blue after exposure to ethylene oxide.

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#### 5.7 Indications for Use

The Sterisheet Sterilization Wraps are single use non-woven sterilization wraps intended to enclose medical devices that are to be sterilized at a healthcare facility. They are used in the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 5-1.

Table 5-1. Critical parameters for the 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilizer

| Ethylene Oxide | Temperature | Relative Humidity | Ethylene Oxide Exposure Time | Total Cycle Time |
|----------------|-------------|-------------------|------------------------------|------------------|
| 17.6 g ± 5% | 50°C ± 3°C | 35-90% | 3 hours | 3.5 hours |

The product code for the Sterilization Wraps is listed in Table 5-2.

| Table 5-2. Product code for the Sterisheet Sterilization Wraps | | | | |
|----------------------------------------------------------------|--|--|--|--|
|----------------------------------------------------------------|--|--|--|--|

| Product Designation | Sterisheet S88 Blue |
|---------------------|---------------------|
| Product Code | 0129 |

Maximum loads of specific materials and devices that have been validated are listed in Table 5-3. All validated maximum loads were processed without additional devices in the sterilizer. Sterility was maintained for at least 3 month after processing in an EOGas 4 sterilizer.

| Device Type | Maximum Load | Device Examples | Required Aeration |
|------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Metal | 24 lbs (11 kg) | Surgical instruments,<br>delicate sharps, including<br>those with hinges and<br>mated surfaces | Metal instruments do not<br>absorb EO;<br>Follow pouch or wrap<br>manufacturer's instructions<br>for aeration requirements<br>(Examples: Tyvek® pouches<br>and Sterisheet® wrap require<br>$\geq$ 6 hours aeration at 50°C). |
| Plastic | 7.0 lbs (3.2 kg) | Reusable power cords,<br>trocars | 24 hours at 50°C; Follow<br>manufacturer's instructions |
| Fabric | 6.1 lbs (2.8 kg) | Reusable cloth gowns,<br>towels | manufacturer's instructions |
| Single-lumen<br>Endoscope(s) | One (1)<br>$\geq$ 2.0 mm internal<br>diameter<br>$\leq$ 1100 mm length;<br>No additional devices | Gastrovideoscopes,<br>gastrointestinal videoscopes | 12 hours at 50°C; Follow<br>manufacturer's instructions |
| | Four (4)<br>$\geq$ 1.2 mm internal<br>diameter<br>$\leq$ 700 mm length;<br>No additional devices | Bronchoscopes,<br>bronchovideoscopes,<br>cystoscopes, ureteroscopes,<br>choledocoscopes | manufacturer's instructions |

Table 5-3. Load and material types validated in the EOGas 4 Ethylene Oxide Gas Sterilizer

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### 5.8 Device Comparison

The technological characteristics of the Sterilization Wraps 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 Sterisheet Sterilization Wraps differ from the predicate device in the sterilization cycle used. The difference raises no issues related to safety or effectiveness of the subject device in the sterilization cycle. A comparison between the devices is listed in Table 5-3.

| Elements | Predicate Device: Sterisheet Sterilization<br>Wraps (K931202) | Subject Device: Sterisheet<br>Sterilization Wraps |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Manufacturer | Arjowiggins Healthcare | Arjowiggins Healthcare |
| Intended Use | To enclose medical devices, allow sterilization of<br>the enclosed devices, and maintain sterility of the<br>enclosed devices | Identical |
| Indications for Use | To be used in ethylene oxide sterilization<br>systems | To be used in the 3 hour cycle<br>at 50°C in an EOGas 4<br>Ethylene Oxide Gas Sterilizer |
| Materials | Cellulose, synthetic fibers (polypropylene), and<br>synthetic binders | Identical |
| Design | Cellulose allows EO to pass through the wrap but<br>prevents microorganisms from crossing through<br>the wrap, providing a microbial barrier for the<br>wrapped devices;<br>Synthetic fibers increase mechanical resistance;<br>Synthetic binders enhance drape ability, strength,<br>softness, and fluid repellency | Identical |
| Wrap Shape | Square or rectangular | Identical |
| Configuration in<br>Load | Double sequential envelope wrap is<br>recommended | Identical |
| Shelf Life | 5 years from date of manufacture | Identical |

Table 5-3. Device Comparison

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#### 5.9 Performance Testing

The Sterisheet Sterilization Wraps conform to all applicable requirements for packaging for terminally sterilized medical devices for EO sterilization, based on ISO 11607-1. Performance testing was conducted to show that the Sterisheet Sterilization Wraps perform as intended to allow sterilization and maintain sterility of the enclosed medical device. Sterilization efficacy testing demonstrated a sterility assurance level of 10 ° using the overkill method and half cycle or half dose validation methods under worst case conditions. Shelf life studies demonstrated after completion of the sterilization process, sterility is maintained for at least 3 month. The performance of the Sterisheet Sterilization Wraps is summarized in Table 5-4.

| Table 5-4. Summary of bench tests performed to demonstrate safety and effectiveness of the | | | |
|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--|
| Sterisheet Sterilization Wraps | | | |
| Test | Description | Results | |
| Compliance to ISO 11607-1 | | | |
| Package<br>Integrity | Porous material providing a microbial barrier;<br>Physical and chemical properties are maintained | Meet requirements | |
| Material<br>Compatibility | Compatibility with respect to forming and sealing<br>processes-suitable folding and drape ability;<br>Suitability for use in EO sterilization processes and<br>cycle parameters | Meet requirements | |
| Biocompatibility | Not direct patient-contacting devices;<br>Materials are non-toxic and meet ISO 11607-1<br>requirements;<br>Biological evaluation meets acceptable criteria;<br>Bio-burden control;<br>Provides reasonable assurance for safety | Pass | |
| Shelf Life | Physical properties and microbial barrier of the<br>processed Sterisheet Sterilization Wraps were verified<br>at the end of the clamed shelf life of 5 years;<br>Stability demonstrates reasonable assurance for<br>effectiveness | Pass | |
| Performance in the EOGas 4 Cycle | | | |
| Sterilant<br>Penetration | The sterilant penetrated the pouch under worst case<br>half-dose conditions or an extreme biological<br>challenge scenario, and inactivated 6-Log biological<br>indicators | Allow a sterility assurance<br>level of $10^{-6}$ for the<br>sterilization cycle | |
| Maintenance of<br>Package<br>Integrity | Sterility was maintained for at least 3 month after<br>processing in an EOGas 4 sterilizer. | Pass | |

Based on the intended use, technological characteristics, performance data, and nonclinical tests performed, the subject Sterilization Wrap is substantially equivalent and is as safe and as effective as the legally marketed predicate device.