(275 days)
Tyvek Sterilization Pouches with Chevron Seal are intended to enclose medical devices that are to be sterilized in a single pouch configuration 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.
Tyvek Sterilization Pouches with Chevron Seal are constructed from an uncoated Tyvek backing of fine, continuous, high-density polyethylene fibers, with front material consisting of a clear, laminated polyethylene terephthalate / low density polyethylene (LDPE) or LDPE-ethylene-vinyl acetate copolymer film. The pouches 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. Following manufacturer's instructions, devices are inserted into Tyvek Sterilization Pouches and sealed. The self-seal pouch permits sealing of the pouch without heatsealing equipment, whereas the heat-sealable pouches must be heat sealed prior to the cycle. Andersen Sterilizers' AN85 EO Indicators, when placed on the outside of the sterilization pouches. indicate EO exposure and offer a convenient way to differentiate pouches that have been processed in EO sterilization cycles from unprocessed units. The color of the AN85 EO Indicators changes from yellow-green to blue after exposure to EO. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for 6 months.
The provided document is a 510(k) premarket notification for a medical device (Tyvek Sterilization Pouches with Chevron Seal), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics for a novel AI/ML-driven device.
Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth establishment for an AI/ML device is not applicable to this document.
This submission is for a physical product (sterilization pouches) and details non-clinical performance testing related to its material properties, sterilization efficacy, and shelf life, not an AI/ML algorithm.
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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: K200336
Trade/Device Name: Tyvek Sterilization Pouches with Chevron Seal 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
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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
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Indications for Use
510(k) Number (if known) K200336
Device Name
Tyvek Sterilization Pouches with Chevron Seal
Indications for Use (Describe)
Tyvek Sterilization Pouches with Chevron Seal are intended to enclose medical devices that are to be sterilized in a single pouch configuration 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.
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| Device Type | Maximum Load | Device Examples | Required Aeration |
|---|---|---|---|
| Metal | 24 lbs (11 kg) | Surgical instruments,delicate sharps,including those withhinges and matedsurfaces | No additional aerationrequired;Follow pouch or wrapmanufacturer'sinstructions (Example: Tyvepouches require ≥ 6 hoursat 50°C) |
| Plastic | 7.0 lbs (3.2 kg) | Reusable power cords,trocars, and similardevices | 24 hours at 50°C;Follow manufacturer'sinstructions |
| Fabric | 6.1 lbs (2.8 kg) | Reusable cloth gowns,towels, and similar devices | |
| ≤ 1100 mmWorkingLumenLengthEndoscopes | 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'sinstructions |
| Four (4)> 1.2 mm ID biopsy channel≤700 mm working length | Bronchoscopes,bronchovideoscopes, cystoscopes,ureteroscopes, choledocoscopes, |
6-Hour EO Exposure, EOGas 4 Endo-SteriTest PCD (Gold Purge Probe)
| Two (2) Duodenoscopes* | Olympus TJF-Q180V, | ||
|---|---|---|---|
| ≥ 2.0 mm ID biopsy channel | Olympus TJF-Q160VF, | 6 hours at 50°C for | |
| ≤ 1250 mm working length | Olympus TJF-Q190V, | Olympus and Pentax | |
| ≥ 1.2 mm ID, ≤ 3530 mmmaximum length of anychannel | Olympus PJF-160,Fujifilm ED-530XT, | endoscopes in Sterisheet | |
| Pentax ED34-i10T2, | |||
| >1100 mm | Pentax ED-3490TK | 8 hours at 50°C for | |
| Working | Two (2) Colonoscopes* | Fujifilm endoscopes | |
| Lumen | ≥ 3.7 mm ID biopsy channel | Olympus CF-Q180AL, | in Sterisheet |
| Length | ≤ 1700 mm working length | Fujifilm EC-600HL, | Follow manufacturer's |
| Endoscopes | ≥ 1.2 mm ID, ≤ 3530 mmmaximum length of any channel | Pentax EC-3490Li | instructions |
- One (1) duodenoscope may also be paired with one (1) colonoscope
After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for 6 months. 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary K200336
| Applicant's Name and Address | Andersen Sterilizers, Inc.Establishment Registration Number 30046347103154 Caroline DriveHaw River, NC 27258 |
|---|---|
| Contact Person | William K. Andersen, BE, MD, FAAOSPresidentPhone: 336-376-8622, Fax: 336-376-5428 |
| Date of Preparation | February 3, 2020 |
| Device | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Proprietary NameTyvek Sterilization Pouches with Chevron SealCommon NameSterilization PouchClassificationClass II (21 CFR 880.6850)Product CodeFRG | Proprietary Name | Tyvek Sterilization Pouches with Chevron Seal | Common Name | Sterilization Pouch | Classification | Class II (21 CFR 880.6850) | Product Code | FRG | |
| Proprietary Name | Tyvek Sterilization Pouches with Chevron Seal | ||||||||
| Common Name | Sterilization Pouch | ||||||||
| Classification | Class II (21 CFR 880.6850) | ||||||||
| Product Code | FRG |
| Predicate Device | |||||||
|---|---|---|---|---|---|---|---|
| Device NameTyvek Sterilization Pouches with Chevron Seal510(k) numberK152058ManufacturerAmcor Flexibles, Inc. | Device Name | Tyvek Sterilization Pouches with Chevron Seal | 510(k) number | K152058 | Manufacturer | Amcor Flexibles, Inc. | |
| Device Name | Tyvek Sterilization Pouches with Chevron Seal | ||||||
| 510(k) number | K152058 | ||||||
| Manufacturer | Amcor Flexibles, Inc. |
The predicate Tyvek Sterilization Pouches with Chevron Seal (K152058) were cleared as an
accessory for use in 3-hour gas exposures in the EOGas 4 Ethylene Oxide Gas SterilizationSystem manufactured by Andersen Sterilizers, Inc.
The 510(k) submission modifies the indications for use of the predicate device in order to include Tyvek Sterilization Pouches with Chevron Seal as an accessory for use in 6-hour gas exposures in the EOGas 4 Ethylene Oxide Sterilization System manufactured by Andersen Sterilizers, Inc. No modifications were made to the manufacturing method, technology, or intended use.
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Device Description
Tyvek Sterilization Pouches with Chevron Seal are constructed from an uncoated Tyvek backing of fine, continuous, high-density polyethylene fibers, with front material consisting of a clear, laminated polyethylene terephthalate / low density polyethylene (LDPE) or LDPE-ethylene-vinyl acetate copolymer film. The pouches 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. Following manufacturer's instructions, devices are inserted into Tyvek Sterilization Pouches and sealed. The self-seal pouch permits sealing of the pouch without heatsealing equipment, whereas the heat-sealable pouches must be heat sealed prior to the cycle. Andersen Sterilizers' AN85 EO Indicators, when placed on the outside of the sterilization pouches. indicate EO exposure and offer a convenient way to differentiate pouches that have been processed in EO sterilization cycles from unprocessed units. The color of the AN85 EO Indicators changes from yellow-green to blue after exposure to EO. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for 6 months.
Indications for Use
Tyvek Sterilization Pouches with Chevron Seal are intended to enclose medical devices that are to be sterilized in a single pouch configuration 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. Critical process parameters for the cycle are summarized in Table 5-1.
| Ethylene Oxide | Temperature | RelativeHumidity | Ethylene OxideExposure 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 for 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.
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| 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 withhinges and matedsurfaces | No additional aerationrequired;Follow pouch or wrapmanufacturer'sinstructions (Example:Tyvek pouches require≥ 6 hours at 50°C) |
| Plastic | 7.0 lbs(3.2 kg) | Reusable power cords,trocars, and similardevices | 24 hours at 50°C; |
| Fabric | 6.1 lbs(2.8 kg) | Reusable cloth gowns,towels, and similardevices | Follow manufacturer'sinstructions |
| ≤ 1100 mmWorkingLumenLengthEndoscopes | One (1)≥ 2.0 mm ID biopsy channel≤ 1100 mm working length | Gastrovideoscopes,gastrointestinalvideoscopes, and similardevices | 8 hours at 50°C if inSterisheet; |
| Four (4)≥ 1.2 mm ID biopsy channel≤ 700 mm working length | Bronchoscopes,bronchovideoscopes,cystoscopes,ureteroscopes,choledocoscopes, andsimilar devices | Follow manufacturer'sinstructions | |
| 6-Hour EO Exposure, EOGas 4 Endo-SteriTest PCD (Gold Purge Probe) | |||
| >1100 mmWorkingLumenLengthEndoscopes | Two (2) Duodenoscopes *≥ 2.0 mm ID biopsy channel≤ 1250 mm working length≥ 1.2 mm ID, ≤ 3530 mmmaximum length of anychannel | Olympus TJF-Q180V,Olympus TJF-Q160VF,Olympus TJF-Q190V,Olympus PJF-160,Fujifilm ED-530XT,Pentax ED34-i10T2Pentax ED-3490TK | 6 hours at 50°C forOlympus and Pentaxendoscopes inSterisheet; |
| Two (2) Colonoscopes ≥ 3.7 mm ID biopsy channel≤ 1700 mm working length≥ 1.2 mm ID, ≤ 3530 mmmaximum length of anychannel One (1) duodenoscope may also be paired with one (1) | Olympus CF-Q180AL,Fujifilm EC-600HL,Pentax EC-3490Li | 8 hours at 50°C forFujifilm endoscopes inSterisheet;Follow manufacturer'sinstructions | |
| colonoscope |
Table 5- 2. Load and material types validated in the EOGas 4 Ethylene Oxide Gas Sterilizer
After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for 6 months.
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Technological Characteristics
The technological characteristics of Tyvek Sterilization Pouches with Chevron Seal are identical to the predicate device (K152058) - both are intended for the same use, use the same technology, and are designed in the same way.
The subject Tyvek Sterilization Pouches with Chevron Seal differ from the predicate device only in the indicated sterilization cycles. A comparison between the devices is listed in Table 5-3.
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| Elements | Predicate Device: Tyvek SterilizationPouches (K152058) | Subject Device: TyvekSterilization Pouches (K200336) |
|---|---|---|
| Intended Use | To enclose medical devices, allow sterilizationof the enclosed devices, and maintain sterilityof the enclosed devices | Identical |
| Indications forUse | Tyvek Sterilization Pouches with Chevron Sealare intended to enclose medical devices thatare to be sterilized in a single pouchconfiguration at a healthcare facility. They areused in 3-hour gas exposures at 50°C in theEOGas 4 Ethylene Oxide Gas Sterilizer. | Tyvek Sterilization Pouches withChevron Seal are intended toenclose medical devices that areto be sterilized in a single pouchconfiguration at a healthcarefacility. They are used in 3-hourand 6-hour gas exposures at 50°Cin the EOGas 4 Ethylene OxideGas Sterilizer. |
| Design | Adhesive laminated film is a clear, highstrength material;Uncoated Tyvek is compatible with EOsterilization, resistant to microbial penetration,and resistant to puncture | Identical |
| Pouch Types | Self-seal pouch; Heat seal pouch; Heat sealtubing | Identical |
| DeviceConstruction | Self-seal and heat seal pouches: front and backmaterials are heat sealed together on threesides; fourth side (end) remains open forfilling; end is sealed by heat (heat sealpouches) or by removing protective liner strip,folding along the pre-fold, and pressing to thefilm (self-seal pouches).Heat seal tubing: front and back materials areheat sealed together on two sides; two ends areopen for selecting size and filling; ends aresealed by heat. | Identical |
| Materials | Clear laminated PET/LDPE or LDPE-EVAfilm (front) and uncoated HDPE Tyvek (back) | Identical |
| Configuration | Single pouch configuration | Identical |
| Shelf Life | 5 years from date of manufacture | Identical |
| Biocompatibility | Materials and biological evaluations (AgarDiffusion Test, Cytotoxicity Test) meet ISO11607-1 requirements | Identical |
| Maintenance ofSterility | Sterility is maintained for 3 months afterprocessing in the EOGas 4 Ethylene Oxide GasSterilizer | Sterility is maintained for 6months after processing in theEOGas 4 Ethylene Oxide GasSterilizer |
| Aeration Time | ≥ 6 hours | ≥ 6 hours |
| PackageIntegrity | Seal strength, microbial barrier, burst, and peelopen characteristics meet ISO and ASTMrequirements | Identical |
Table 5-3. Device Comparison
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Summary of Non-Clinical Testing
Performance Testing
Performance testing was conducted to demonstrate that Tyvek Sterilization Pouches with Chevron Seal perform as intended to allow sterilization of the enclosed medical devices. Sterilization efficacy testing demonstrated a sterility assurance level of 10 ° using the half dose validation method under worst-case conditions. Tyvek Sterilization Pouches with Chevron Seal also maintain sterility of the enclosed devices as intended. Shelf life studies demonstrated after completion of the EOGas 4 sterilization process, sterility is maintained for 6 months. The performance of Tyvek Sterilization pouches is summarized in Table 5-4.
| Table 5-4. Summary of bench tests performed to demonstrate safety and effectiveness of Tyvek | ||
|---|---|---|
| Sterilization Pouches | ||
| Test | Description | Results |
| Compliance to ISO 11607-1 | ||
| PackageIntegrity | Seal strength performance characteristics were maintained forthe manufactured seal.Microbial Barrier: the contents of pouches were sterile whenthe processed pouches were subjected to the microbial aerosolchallenge test.Burst: ability to withstand the internal pressurization wasmaintained.Peel open characteristics were maintained. | Meet ISO andASTMrequirements |
| MaterialCompatibility | Seal strength test, microbial barrier properties, burst test, andpeel open test were studied to demonstrate materialcompatibility characteristics of the TyvekSterilization Pouches | Pass |
| Biocompatibility | Not direct patient-contacting devices;Materials are non-toxic and meet ISO 11607-1 requirements;Biological and residual evaluations meet acceptable criteria;Provides reasonable assurance for safety | Pass |
| Shelf Life | Physical properties and microbial barrier of the processedTyvek Pouches was verified at the end of shelf life of 5 years;Stability demonstrates reasonable assurance for effectiveness | Pass |
| Performance in the 6-hour Gas exposure in the EOGas 4 Ethylene Oxide Gas Sterilizer | ||
| SterilantPenetration | EO penetrated the pouch under worst-case half-doseconditions or a worst-case biological challenge, andinactivated 6-Log biological indicators | Confirmed SALof 10-6 in 6-hourgas exposures |
| Maintenance ofPackageSterility | Sterility was maintained for 6 months after processing in 6-hour gas exposures in the EOGas 4 Ethylene Oxide GasSterilizer. | Pass |
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Conclusion
The conclusions drawn from the nonclinical test demonstrate that the Tyvek Sterilization Pouches with Chevron Seal is as safe, as effective, and performs as well as or better than the legally marketed Tyvek Sterilization Pouches with Chevron Seal (K152058)
§ 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).