Sterisheet Sterilization Wrap

• K Number: K152291
• Device Name: Sterisheet Sterilization Wrap
• Manufacturer: ANDERSEN STERILIZERS, INC.
• Date Cleared: 2015-12-17 ( 126 days)
• Product Code: FRG
• Regulation Number: 880.6850

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 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.

Predicate Devices

K931202

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical sterilization wrap and its performance characteristics, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

No
The device is a sterilization wrap used to enclose medical devices for sterilization and maintain sterility, not to treat or diagnose a disease or condition in a patient.

Diagnostic

No
The device is a sterilization wrap used to enclose medical devices for sterilization and maintain their sterility, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical sterilization wrap made of cellulose and synthetic fibers, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to enclose medical devices for sterilization and maintain their sterility. This is a process related to the preparation and storage of medical devices, not a diagnostic test performed on biological samples.
• Device Description: The description focuses on the material and function of the wrap in the sterilization process. There is no mention of analyzing biological samples or providing diagnostic information.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting or measuring analytes
  • Providing information for diagnosis, monitoring, or prognosis of a disease or condition.

The device is clearly intended for the sterilization and storage of medical devices, which falls under a different regulatory category than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

FRG

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.

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

healthcare facility

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 10-6 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.

Table 5-4. Summary of bench tests performed to demonstrate safety and effectiveness of the Sterisheet Sterilization Wraps:

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sterility assurance level of 10-6

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K931202

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

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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
Sterisheet® Sterilization Wrap
Indications for Use ( Describe )
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 below in Table 1.
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.
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
processed without additional devices in the sterilizer. Sterility was maintained for at least 3 month after processing in an EOGas 4
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,
delicate sharps, including those
with hinges and mated surfaces		Metal instruments do not absorb EO;
Follow pouch or wrap manufacturer's
instructions (Example: Tyvek® pouches and
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
Endoscope(s)	One (1) ≥ 2.0mm ID
≤ 1100mm length;
No additional devices	Gastrovideoscopes, gastrointestinal
videoscopes		12 hours at 50°C;
Follow manufacturer's instructions
	Four (4) ≥ 1.2 mm ID
≤ 700 mm length;
No additional devices	Bronchoscopes, bronchovideoscopes,
cystoscopes, ureteroscopes,
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.
3154 Caroline Drive
Haw River, NC 27258 | |
|------|------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--|
| 5.2 | Contact Person | | William K. Andersen, BE, MD, FAAOS
President
Phone: [phone], Fax: [phone] | |
| 5.3 | Date of Preparation | | November 16, 2015 | |
| 5.4 | Device | Proprietary Name
Common Name
Classification
Product Code | Sterisheet® Sterilization Wrap
Sterilization Wrap
Class II (21 CFR 880.6850)
FRG | |
| ર રે | Predicate Device | | | |
| | | Device Name
510(k) number
Manufacturer | Sterisheet® Sterilization Wrap
K931202
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,
delicate sharps, including
those with hinges and
mated surfaces	Metal instruments do not
absorb EO;
Follow pouch or wrap
manufacturer's instructions
for aeration requirements
(Examples: Tyvek® pouches
and Sterisheet® wrap require
$\geq$ 6 hours aeration at 50°C).
Plastic	7.0 lbs (3.2 kg)	Reusable power cords,
trocars	24 hours at 50°C; Follow
manufacturer's instructions
Fabric	6.1 lbs (2.8 kg)	Reusable cloth gowns,
towels	manufacturer's instructions
Single-lumen
Endoscope(s)	One (1)
$\geq$ 2.0 mm internal
diameter
$\leq$ 1100 mm length;
No additional devices	Gastrovideoscopes,
gastrointestinal videoscopes	12 hours at 50°C; Follow
manufacturer's instructions
	Four (4)
$\geq$ 1.2 mm internal
diameter
$\leq$ 700 mm length;
No additional devices	Bronchoscopes,
bronchovideoscopes,
cystoscopes, ureteroscopes,
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
Wraps (K931202) | Subject Device: Sterisheet
Sterilization Wraps |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Manufacturer | Arjowiggins Healthcare | Arjowiggins Healthcare |
| Intended Use | To enclose medical devices, allow sterilization of
the enclosed devices, and maintain sterility of the
enclosed devices | Identical |
| Indications for Use | To be used in ethylene oxide sterilization
systems | To be used in the 3 hour cycle
at 50°C in an EOGas 4
Ethylene Oxide Gas Sterilizer |
| Materials | Cellulose, synthetic fibers (polypropylene), and
synthetic binders | Identical |
| Design | Cellulose allows EO to pass through the wrap but
prevents microorganisms from crossing through
the wrap, providing a microbial barrier for the
wrapped devices;
Synthetic fibers increase mechanical resistance;
Synthetic binders enhance drape ability, strength,
softness, and fluid repellency | Identical |
| Wrap Shape | Square or rectangular | Identical |
| Configuration in
Load | Double sequential envelope wrap is
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
Integrity	Porous material providing a microbial barrier;
Physical and chemical properties are maintained	Meet requirements
Material
Compatibility	Compatibility with respect to forming and sealing
processes-suitable folding and drape ability;
Suitability for use in EO sterilization processes and
cycle parameters	Meet requirements
Biocompatibility	Not direct patient-contacting devices;
Materials are non-toxic and meet ISO 11607-1
requirements;
Biological evaluation meets acceptable criteria;
Bio-burden control;
Provides reasonable assurance for safety	Pass
Shelf Life	Physical properties and microbial barrier of the
processed Sterisheet Sterilization Wraps were verified
at the end of the clamed shelf life of 5 years;
Stability demonstrates reasonable assurance for
effectiveness	Pass
Performance in the EOGas 4 Cycle
Sterilant
Penetration	The sterilant penetrated the pouch under worst case
half-dose conditions or an extreme biological
challenge scenario, and inactivated 6-Log biological
indicators	Allow a sterility assurance
level of $10^{-6}$ for the
sterilization cycle
Maintenance of
Package
Integrity	Sterility was maintained for at least 3 month after
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.