Who is the manufacturer of Sterisheet Sterilization Wrap?

Andersen Sterilizers, Inc. filed the 510(k) submission for Sterisheet Sterilization Wrap (K200335).

What is the FDA product code for Sterisheet Sterilization Wrap?

FRG. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Sterisheet Sterilization Wrap?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Sterisheet Sterilization Wrap?

Sterisheet Sterilization Wrap (K152291).

Who can help prepare an FDA 510(k) submission like Sterisheet Sterilization Wrap?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Sterisheet Sterilization Wrap

K200335 · Andersen Sterilizers, Inc. · FRG · Nov 12, 2020 · General Hospital

Device Facts

Record ID	K200335
Device Name	Sterisheet Sterilization Wrap
Applicant	Andersen Sterilizers, Inc.
Product Code	FRG · General Hospital
Decision Date	Nov 12, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

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

Device Story

Sterisheet Sterilization Wraps; single-use non-woven material (cellulose, polypropylene, binders); used to enclose medical devices for ethylene oxide (EO) sterilization in EOGas 4 system. Healthcare providers wrap devices; place in sterilizer for 3-hour or 6-hour cycles at 50°C. Wraps allow EO penetration while maintaining microbial barrier post-sterilization. Optional AN85 EO indicators (yellow-green to blue) verify exposure. Sterility maintained for 6 months. Benefits include effective sterilization of complex instruments (hinged, mated surfaces) and endoscopes (duodenoscopes, colonoscopes) while ensuring device sterility until use.

Clinical Evidence

Bench testing only. Testing included ISO 11607-1 compliance, bacterial filtration efficiency (ASTM F2101), germ proofness (DIN 58953-6), biocompatibility (ISO 10993), and shelf-life studies. Sterilization efficacy demonstrated a 6-log sterility assurance level (SAL) using half-dose validation. Sterility maintenance verified for 6 months post-processing.

Technological Characteristics

Non-woven wrap composed of cellulose, polypropylene, and synthetic binders. Dimensions: square/rectangular. Connectivity: None. Sterilization: Ethylene Oxide (EO) gas. Software: None. Standards: ISO 11607-1, ISO 10993, ASTM F2101, DIN 58953-6.

Indications for Use

Indicated for use as a single-use non-woven wrap to enclose medical devices for sterilization in a healthcare facility using the EOGas 4 Ethylene Oxide Gas Sterilizer (3-hour or 6-hour cycles 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 (K152291)

Related Devices

K152291 — Sterisheet Sterilization Wrap · Andersen Sterilizers, Inc. · Dec 17, 2015
K170437 — Sterisheet Sterilization Wrap · Andersen Sterilizers, Inc. · Nov 1, 2017
K200336 — Tyvek Sterilization Pouches with Chevron Seal · Andersen Sterilizers, Inc. · Nov 12, 2020
K152058 — Tyvek Sterilization Pouches with Chevron Seal · Andersen Sterilizers, Inc. · Nov 18, 2015
K220133 — Sterilization Wraps · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · Mar 10, 2022

Submission Summary (Full Text)

{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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 PRAStaff@fda.hhs.gov "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: 336-376-8622, Fax: 336-376-5428 # 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.

Sterisheet Sterilization Wrap

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Predicate Devices

Related Devices

Submission Summary (Full Text)

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Submission Summary (Full Text)

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