Sterisheet Sterilization Wrap

• K Number: K200335
• Device Name: Sterisheet Sterilization Wrap
• Manufacturer: Andersen Sterilizers, Inc.
• Date Cleared: 2020-11-12 ( 275 days)
• Product Code: FRG
• Regulation Number: 880.6850

Intended Use

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 3-hour and 6hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

Device Description

Sterisheet Sterilization Wraps are single use, non-sterilyzation 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 3-hour and 6-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Devices must be wrapped following manufacturer's instructions. After completion of the sterilization process. Sterisheet Sterilization Wraps maintain sterility of the enclosed medical devices for 6 month. AN85 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 EO Indicators changes from yellow-green to blue after exposure to ethylene oxide.

Predicate Devices

K152291

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and sterilization efficacy of the wraps, with no mention of AI or ML.

Therapeutic

No
The device is a sterilization wrap used to maintain the sterility of medical devices, not to treat a disease or condition in a patient.

Diagnostic

No

The device is a sterilization wrap used to maintain sterility of medical devices after sterilization, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states the device is a physical wrap made from cellulose, synthetic fibers, and binders, intended for enclosing medical devices for sterilization. It is a tangible product, 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 function related to the processing and storage of medical devices, not the diagnosis of diseases or conditions.
• Device Description: The description focuses on the physical properties and function of the wraps in the sterilization process. It does not mention any interaction with biological samples or diagnostic procedures.
• 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 specific analytes or markers
  • Providing information for diagnosis, monitoring, or prognosis of a disease or condition.

The AN85 EO Indicators mentioned are also not IVDs. They are chemical indicators used to confirm exposure to ethylene oxide, which is a process control, not a diagnostic test.

Therefore, the Sterisheet Sterilization Wraps are classified as a medical device used in the sterilization process, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 3-hour and 6hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

Product codes

FRG

Device Description

Sterisheet Sterilization Wraps are single use, non-sterilyzation 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 3-hour and 6-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Devices must be wrapped following manufacturer's instructions. After completion of the sterilization process. Sterisheet Sterilization Wraps maintain sterility of the enclosed medical devices for 6 month.

AN85 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 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

Performance testing was conducted to show that 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 106 using the half dose validation method under worst-case conditions. Shelf life studies demonstrated after completion of the EOGas 4 sterilization process, sterility is maintained for 6 months.

Summary of bench tests performed to demonstrate safety and effectiveness of Sterisheet Sterilization Wraps:

• Compliance to ISO 11607-1:
  • Physical and Chemical Properties: To evaluate the package integrity after EO sterilization. Results: There was no effect on the physical and chemical properties after EO sterilization.
  • Bacterial Filtration Efficiency and Germ Proofness dry and wet challenge test: To demonstrate that Sterisheet provide a microbial barrier property. Results: Sterisheet passed all tests and were effective for sterility assurance pre- and post-EO sterilization.
  • Material Compatibility: To demonstrate Sterisheet is suitable for use in EO sterilization processes and the associated cycle parameters. Results: The ability of the wraps to act as a microbial barrier was unaffected, and the contents of the packs remained sterile after EO sterilization.
  • Biocompatibility: To demonstrate that Sterisheet provides reasonable assurance for safety. Results: Not direct patient-contacting devices; Biological evaluation Showed that Sterisheet met all accepted performance criteria for non-toxicity. No pigment leaches out of Sterisheet during 6-hour EO exposures. With an additional 6-hour aeration, the residual EO detected in Sterisheet met ISO 10993-7 requirements.
  • Shelf Life: To evaluate the physical, chemical, and microbial barrier of the processed Sterisheet at the end of the claimed shelf life. Results: The physical, chemical, and microbial barrier properties of the wraps were verified at the end of 5 years and met specifications.
• Performance in the 6-hour Gas exposure in the EOGas 4 Ethylene Oxide Gas Sterilizer:
  • Sterilant Penetration: To demonstrate Sterisheet allow sterilization of the wrapped devices in half dose, full dose, simulated-use and in-use testing. Results: Data demonstrate that Sterisheet Sterilization Wraps allow penetration of EO and sterilization of the enclosed devices.
  • Maintenance of Package Sterility: To demonstrate Sterisheet maintain sterility of the enclosed medical device. Results: Sterility was maintained for 6 months after processing in Sterisheet wrapped endoscopes.

Key Metrics

Not Found

Predicate Device(s)

K152291

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

Image /page/0/Picture/0 description: The image contains 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.

November 12, 2020

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

Re: K200335

Trade/Device Name: Sterisheet Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: October 8, 2020 Received: October 13, 2020

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. 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/cdrh/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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

CAPT Elizabeth Claverie, MS Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K200335

Device Name Sterisheet Sterilization Wrap

Indications for Use (Describe)

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 3-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

Critical process parameters for the cycle are summarized in Table 1.

Table 1. Critical sterilization cycle parameters in the EOGas 4 Ethylene Oxide Gas Sterilizer

Ethylene Oxide	Temperature	Relative Humidity	EO Exposure Time	Total Cycle Time
17.6 g ± 5%	50°C ± 3°C	35-70%	3 hours	3.5 hours
			6 hours	7 hours

The EOGas 4 Ethylene Oxide Gas Sterilizer 3-hour gas exposure is used for surface sterilization of medical devices, including instruments with diffusion-restricted spaces (hinges or mated surfaces), as well as for the sterilization of endoscopes working length shorter than 1100 mm as specified in the sterilizer labeling.

The EOGas 4 Ethylene Oxide Gas Sterilizer 6-hour gas exposure is used for sterilization of duodenoscopes and colonoscopes with working length longer than 1100 mm as specified in the sterilizer labeling.

3

Table 2. Load and material types validated in the EOGas 4 Ethylene Oxide Gas Sterilizer
Device Type	Maximum Load	Device Examples	Required Aeration
	3-Hour EO Exposure, EOGas 4 SteriTest PCD (Blue Purge Probe)
Metal	24 lbs (11 kg)	Surgical instruments,
delicate sharps,
including those with
hinges and mated
surfaces	No additional aeration
required;
Follow pouch or wrap
manufacturer's
instructions (Example: Tyve
pouches require ≥ 6 hours
at 50°C)
Plastic	7.0 lbs (3.2 kg)	Reusable power cords,
trocars, and similar
devices	24 hours at 50°C;
Follow manufacturer's
instructions
Fabric	6.1 lbs (2.8 kg)	Reusable cloth gowns,
towels, and similar devices
≤ 1100 mm
Working
Lumen
Length
Endoscopes	One (1)
≥ 2.0 mm ID biopsy channel
≤ 1100 mm working length	Gastrovideoscopes,
gastrointestinal videoscopes,
and similar devices	8 hours at 50°C;
Follow manufacturer's
instructions
Length
Endoscopes	Four (4)
≥ 1.2 mm ID biopsy channel
≤ 700 mm working length	Bronchoscopes,
bronchovideoscopes, cystoscopes,
ureteroscopes, choledocoscopes,
and similar devices

6-Hour EO Exposure, EOGas 4 Endo-SteriTest PCD (Gold Purge Probe)

>1100 mm	Two (2) Duodenoscopes*	Olympus TJF-Q180V,	6 hours at 50°C for
Working	≥ 2.0 mm ID biopsy channel	Olympus TJF-Q160VF,	Olympus and Pentax
Lumen	≤ 1250 mm working length	Olympus TJF-Q190V,	endoscopes in Sterisheet
Length	≥ 1.2 mm ID, ≤ 3530 mm
maximum length of any
channel	Olympus PJF-160,
Fujifilm ED-530XT,
Pentax ED34-i10T2,
Pentax ED-3490TK	8 hours at 50°C for
Fujifilm endoscopes
in Sterisheet
Endoscopes	Two (2) Colonoscopes*	Olympus CF-Q180AL,	Follow manufacturer's
	≥ 3.7 mm ID biopsy channel	Fujifilm EC-600HL,	instructions
	≤ 1700 mm working length	Pentax EC-3490Li
	≥ 1.2 mm ID, ≤ 3530 mm
maximum length of any channel

• One (1) duodenoscope may also be paired with one (1) colonoscope

After completion of the EOGas 4 sterilization process, sterility is months in Sterisheet sterilization wraps.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	区 Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

4

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

5

510(k) Summary K200335

Applicant's Name and Address

Andersen Sterilizers, Inc. Establishment Registration Number 3004634710 3154 Caroline Drive Haw River, NC 27258

Contact Person

William K. Andersen, BE, MD, FAAOS President Phone: [phone], Fax: [phone]

Date of Preparation

October 8, 2020

Device

Proprietary Name Common Name Classification Product Code

Sterisheet Sterilization Wrap Sterilization Wrap Class II (21 CFR 880.6850) FRG

Predicate Device

Device Name	Sterisheet Sterilization Wrap
510(k) number	K152291
Manufacturer	Arjowiggins Medical Inc.

The predicate Sterilization Wrap (K152291) was cleared for use in 3-hour gas exposures in the EOGas 4 Ethylene Oxide Gas Sterilization system manufactured by Andersen Sterilizers, Inc.

The 510(k) submission modifies the indications for use of the predicate device in order to include it as an accessory for 6-hour gas exposures in the EOGas 4 Ethylene Oxide Gas Sterilization system manufactured by Andersen Sterilizers, Inc. No modifications were made to the manufacturing method, technology, or intended use.

6

Device Description

Sterisheet Sterilization Wraps are single use, non-sterilyzation 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 3-hour and 6-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Devices must be wrapped following manufacturer's instructions. After completion of the sterilization process. Sterisheet Sterilization Wraps maintain sterility of the enclosed medical devices for 6 month.

AN85 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 EO Indicators changes from yellow-green to blue after exposure to ethylene oxide.

Indications for Use

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 3-hour and 6hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 5-1.

| 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 |
| | | | 6 hours | 7 hours |

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

The EOGas 4 Ethylene Oxide Gas Sterilizer 3-hour gas exposure is used for surface sterilization of medical devices, including instruments with diffusion-restricted spaces (hinges or mated surfaces), as well as for the sterilization of endoscopes working length shorter than 1100 mm as specified in the sterilizer labeling.

The EOGas 4 Ethylene Oxide Gas Sterilizer 6-hour gas exposure is used for sterilization of duodenoscopes and colonoscopes with working length longer than 1100 mm as specified in the sterilizer labeling.

7

Device Type	Maximum Load	Device Examples	Required Aeration
3-Hour EO Exposure, EOGas 4 SteriTest PCD (Blue Purge Probe)
Metal	24 lbs
(11 kg)	Surgical instruments,
delicate sharps,
including those with
hinges and mated
surfaces	No additional aeration
required;
Follow pouch or wrap
manufacturer's
instructions (Example:
Tyvek pouches require
≥ 6 hours at 50°C)
Plastic	7.0 lbs
(3.2 kg)	Reusable power cords,
trocars, and similar
devices	24 hours at 50°C;
Fabric	6.1 lbs
(2.8 kg)	Reusable cloth gowns,
towels, and similar
devices	Follow manufacturer's
instructions
≤ 1100 mm
Working
Lumen
Length
Endoscopes	One (1)
≥ 2.0 mm ID biopsy channel
≤ 1100 mm working length	Gastrovideoscopes,
gastrointestinal
videoscopes, and similar
devices	8 hours at 50°C if in
Sterisheet;
	Four (4)
≥ 1.2 mm ID biopsy channel
≤ 700 mm working length	Bronchoscopes,
bronchovideoscopes,
cystoscopes,
ureteroscopes,
choledocoscopes, and
similar devices	Follow manufacturer's
instructions
6-Hour EO Exposure, EOGas 4 Endo-SteriTest PCD (Gold Purge Probe)
>1100 mm
Working
Lumen
Length
Endoscopes	Two (2) Duodenoscopes *
≥ 2.0 mm ID biopsy channel
≤ 1250 mm working length
≥ 1.2 mm ID, ≤ 3530 mm
maximum length of any channel
Two (2) Colonoscopes *
≥ 3.7 mm ID biopsy channel
≤ 1700 mm working length
≥ 1.2 mm ID, ≤ 3530 mm
maximum length of any channel	Olympus TJF-Q180V,
Olympus TJF-Q160VF,
Olympus TJF-Q190V,
Olympus PJF-160,
Fujifilm ED-530XT,
Pentax ED34-i10T2
Pentax ED-3490TK
Olympus CF-Q180AL,
Fujifilm EC-600HL,
Pentax EC-3490Li	6 hours at 50°C for
Olympus and Pentax
endoscopes in
Sterisheet;
8 hours at 50°C for
Fujifilm endoscopes in
Sterisheet;
Follow manufacturer's
instructions
	* One (1) duodenoscope may also be paired with one (1)
colonoscope

Table 5- 2. Load and material types validated in the EOGas 4 Ethylene Oxide Gas Sterilizer

After completion of the EOGas 4 sterilization process, sterility is maintained for 6 months in Sterisheet sterilization wraps.

8

Technological Characteristics Comparison

The technological characteristics of the subject Sterilization Wraps are identical to the predicate device (K152291) - both are intended for the same use, use the same technology, and are designed in the same way.

The only difference between the subject Sterilization Wrap and the predicate device is the sterilization cycle for which the subject Sterisheet Sterilization Wrap is indicated.. A comparison between the devices is listed in Table 5-3.

| Elements | Predicate Sterisheet Sterilization
Wraps (K152291) | Subject Sterisheet Sterilization
Wraps (K200335) | Remarks |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Manufacturer | Arjowiggins Healthcare | Arjowiggins Healthcare | Same |
| Intended Use | To enclose medical devices, allow
sterilization of the enclosed
devices, and maintain sterility of
the enclosed devices | Identical | Identical |
| Indications for
Use | 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 3-hour gas exposures at 50°C in
the EOGas 4 Ethylene Oxide Gas
Sterilizer. | 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 3-hour
and 6-hour gas exposures at
50°C in the EOGas 4 Ethylene
Oxide Gas Sterilizer. | Similar |
| Sterilization
Cycle Time | 3-hour gas exposure | 3-hour and 6-hour gas exposure | Different |
| Materials | Cellulose, synthetic fibers
(polypropylene), and synthetic
binders | Identical | 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 after sterilization;
Synthetic fibers increase
mechanical resistance;
Synthetic binders enhance
drapeability, strength, softness, and
fluid repellency | Identical | Identical |
| Wrap Shape | Square or rectangular | Identical | Identical |
| Configuration in
Load | Double sequential envelope wrap is
recommended | Identical | Identical |
| Shelf Life | 5 years from date of manufacture | Identical | Identical |
| Aeration Time | $\ge$ 6 hours | $\ge$ 6 hours | Similar |
| Sterility
Maintenance | 3 months after cycle | 6 months after cycle | Similar |

Table 5-3. Device Comparison

9

10

Summary of Non-Clinical Testing

Performance Testing

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 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 106 using the half dose validation method under worst-case conditions. Shelf life studies demonstrated after completion of the EOGas 4 sterilization process, sterility is maintained for 6 months. The performance of Sterisheet Sterilization Wraps is summarized in Table 5-4.

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

Test	Purpose	Acceptance Criteria	Results
Compliance to ISO 11607-1
Physical and
Chemical
Properties	To evaluate the
package integrity
after EO sterilization	Various standards for
various properties. For
example, ISO 536 for
Substance, ISO 5636-3
for Permeability, EN
868-2 for Fluorescence
and Water repellency	There was no effect on the
physical and chemical properties
after EO sterilization.
Bacterial Filtration
Efficiency and
Germ Proofness
dry and wet
challenge test	To demonstrate that
Sterisheet provide a
microbial barrier
property	Bacterial Filtration
Efficiency (ASTM
F2101)

Germ Proofness dry and
wet challenge test (DIN
58953-6) | Sterisheet passed all tests and
were effective for sterility
assurance pre- and post-EO
sterilization. |
| Material
Compatibility | To demonstrate
Sterisheet is suitable
for use in EO
sterilization
processes and the
associated cycle
parameters | The physical, chemical,
and microbial barrier
properties of Sterisheet
are compatible for
intended use in EO
sterilization per ISO
10993 and USP | The ability of the wraps to act as a
microbial barrier was unaffected,
and the contents of the packs
remained sterile after EO
sterilization |

11

Test	Purpose	Acceptance Criteria	Results
Biocompatibility	To demonstrate that
Sterisheet provides
reasonable assurance
for safety	Biological evaluation
(MEM Elution,
Sensitization and
Irritation Test) per ISO
10993 and USP	Not direct patient-contacting
devices;
Biological evaluation Showed that
Sterisheet met all accepted
performance criteria for non-
toxicity.
No pigment leaches out of
Sterisheet during 6-hour EO
exposures.
With an additional 6-hour
aeration, the residual EO detected
in Sterisheet met ISO 10993-7
requirements.
Shelf Life	To evaluate the
physical, chemical,
and microbial barrier
of the processed
Sterisheet at the end
of the claimed shelf
life	Stability demonstrates
reasonable assurance for
effectiveness	The physical, chemical, and
microbial barrier properties of the
wraps were verified at the end of
5 years and met specifications.
Performance in the 6-hour Gas exposure in the EOGas 4 Ethylene Oxide Gas Sterilizer
Sterilant
Penetration	To demonstrate
Sterisheet allow
sterilization of the
wrapped devices in
half dose, full dose,
simulated-use and in-
use testing	Inactivation of 6-Log
biological indicators at
the worst-case location
in the endoscope load
wrapped in the
Sterisheet for all the
testing performed	Data demonstrate that Sterisheet
Sterilization Wraps allow
penetration of EO and
sterilization of the enclosed
devices.
Maintenance of
Package Sterility	To demonstrate
Sterisheet maintain
sterility of the
enclosed medical
device	The sterilized devices
wrapped in Sterisheet
remain sterile	Sterility was maintained for 6
months after processing in
Sterisheet wrapped endoscopes.

Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K200335, the Sterisheet Sterilization Wrap is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K152291.