(126 days)
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.
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 provided text describes the performance testing and acceptance criteria for the Sterisheet® Sterilization Wrap (K152291).
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance to ISO 11607-1 | Met requirements |
| - Package Integrity: Porous material providing a microbial barrier; physical and chemical properties are maintained. | Met 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. | Met requirements |
| - Biocompatibility: 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 verified at the end of the 5-year claimed shelf life. | Pass |
| Performance in the EOGas 4 Cycle | Met requirements |
| - Sterilant Penetration: Sterilant penetrated the pouch under worst-case half-dose conditions or an extreme biological challenge scenario, and inactivated 6-Log biological indicators. | Allowed a sterility assurance level of $10^{-6}$ for the sterilization cycle |
| - Maintenance of Package Integrity: Sterility maintained for at least 3 months after processing in an EOGas 4 sterilizer. | Pass |
Study Details
The provided document describes non-clinical performance testing to demonstrate the safety and effectiveness of the Sterisheet® Sterilization Wrap. This is a technical validation rather than a clinical study involving human patients or ground truth established by medical experts for diagnostic purposes. Therefore, some of the requested information (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, training set details) is not applicable or cannot be extracted from this type of document.
The study focuses on demonstrating the physical, chemical, and biological performance of the sterilization wrap itself.
-
Sample size used for the test set and the data provenance: Not explicitly stated in terms of a "test set" as would be used for an AI/diagnostic device. The testing involves physical samples of the sterilization wrap subjected to various conditions and analyses. The provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a sterilization wrap is established through adherence to standards (e.g., ISO 11607-1) and objective measurements of sterility, material integrity, and biological efficacy, not expert consensus on an image or clinical finding.
-
Adjudication method for the test set: Not applicable. Performance is evaluated against objective standards and biological indicators, not through human adjudication of differing opinions.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/diagnostic device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm.
-
The type of ground truth used:
- Objective Standards: Compliance with ISO 11607-1 requirements for packaging of terminally sterilized medical devices.
- Biological Efficacy: Inactivation of 6-Log biological indicators to demonstrate a sterility assurance level of $10^{-6}$ (using the overkill method and half cycle or half dose validation methods under worst-case conditions).
- Physical and Chemical Properties: Bench testing to verify package integrity, material compatibility, and shelf-life stability.
-
The sample size for the training set: Not applicable. This is not an AI/algorithm and therefore does not have a "training set" in that context.
-
How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
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.
{1}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K152291
| K152291 | ||||
|---|---|---|---|---|
| Device NameSterisheet® 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 besterilized 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 wereprocessed without additional devices in the sterilizer. Sterility was maintained for at least 3 month after processing in an EOGas 4sterilizer. | ||||
| 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 thosewith hinges and mated surfaces | Metal instruments do not absorb EO;Follow pouch or wrap manufacturer'sinstructions (Example: Tyvek® pouches andSterisheet® 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-lumenEndoscope(s) | One (1) ≥ 2.0mm ID≤ 1100mm length;No additional devices | Gastrovideoscopes, gastrointestinalvideoscopes | 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)
{3}------------------------------------------------
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."
{4}------------------------------------------------
510(k) Summary
| 5.1 | Applicant's Name and Address | Andersen Sterilizers, Inc.3154 Caroline DriveHaw River, NC 27258 | ||
|---|---|---|---|---|
| 5.2 | Contact Person | William K. Andersen, BE, MD, FAAOSPresidentPhone: 336-376-8622, Fax: 336-376-5428 | ||
| 5.3 | Date of Preparation | November 16, 2015 | ||
| 5.4 | Device | Proprietary NameCommon NameClassificationProduct Code | Sterisheet® Sterilization WrapSterilization WrapClass II (21 CFR 880.6850)FRG | |
| ર રે | Predicate Device | |||
| Device Name510(k) numberManufacturer | Sterisheet® Sterilization WrapK931202Arjowiggins 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.
{5}------------------------------------------------
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, includingthose with hinges andmated surfaces | Metal instruments do notabsorb EO;Follow pouch or wrapmanufacturer's instructionsfor aeration requirements(Examples: Tyvek® pouchesand 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; Followmanufacturer's instructions |
| Fabric | 6.1 lbs (2.8 kg) | Reusable cloth gowns,towels | manufacturer's instructions |
| Single-lumenEndoscope(s) | One (1)$\geq$ 2.0 mm internaldiameter$\leq$ 1100 mm length;No additional devices | Gastrovideoscopes,gastrointestinal videoscopes | 12 hours at 50°C; Followmanufacturer's instructions |
| Four (4)$\geq$ 1.2 mm internaldiameter$\leq$ 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
{6}------------------------------------------------
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 SterilizationWraps (K931202) | Subject Device: SterisheetSterilization Wraps |
|---|---|---|
| Manufacturer | Arjowiggins Healthcare | Arjowiggins Healthcare |
| Intended Use | To enclose medical devices, allow sterilization ofthe enclosed devices, and maintain sterility of theenclosed devices | Identical |
| Indications for Use | To be used in ethylene oxide sterilizationsystems | To be used in the 3 hour cycleat 50°C in an EOGas 4Ethylene Oxide Gas Sterilizer |
| Materials | Cellulose, synthetic fibers (polypropylene), andsynthetic binders | Identical |
| Design | Cellulose allows EO to pass through the wrap butprevents microorganisms from crossing throughthe wrap, providing a microbial barrier for thewrapped devices;Synthetic fibers increase mechanical resistance;Synthetic binders enhance drape ability, strength,softness, and fluid repellency | Identical |
| Wrap Shape | Square or rectangular | Identical |
| Configuration inLoad | Double sequential envelope wrap isrecommended | Identical |
| Shelf Life | 5 years from date of manufacture | Identical |
Table 5-3. Device Comparison
{7}------------------------------------------------
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 | |||
| PackageIntegrity | Porous material providing a microbial barrier;Physical and chemical properties are maintained | Meet requirements | |
| MaterialCompatibility | Compatibility with respect to forming and sealingprocesses-suitable folding and drape ability;Suitability for use in EO sterilization processes andcycle parameters | Meet requirements | |
| Biocompatibility | Not direct patient-contacting devices;Materials are non-toxic and meet ISO 11607-1requirements;Biological evaluation meets acceptable criteria;Bio-burden control;Provides reasonable assurance for safety | Pass | |
| Shelf Life | Physical properties and microbial barrier of theprocessed Sterisheet Sterilization Wraps were verifiedat the end of the clamed shelf life of 5 years;Stability demonstrates reasonable assurance foreffectiveness | Pass | |
| Performance in the EOGas 4 Cycle | |||
| SterilantPenetration | The sterilant penetrated the pouch under worst casehalf-dose conditions or an extreme biologicalchallenge scenario, and inactivated 6-Log biologicalindicators | Allow a sterility assurancelevel of $10^{-6}$ for thesterilization cycle | |
| Maintenance ofPackageIntegrity | Sterility was maintained for at least 3 month afterprocessing 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.
§ 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).