(256 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 the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 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-ethylenevinylacetate copolymer film. The pouches are used to enclose medical devices that are to be sterilized by a healthcare provider in the 12 hour sterilization cycle at 20-29°C in an Anprolene AN75 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 heat-sealing equipment, whereas the heat-sealable pouches must be heat sealed prior to the cycle. Andersen Sterilizers' AN85/AN86 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/AN86 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 at least 3 months (90 days).
The provided text describes the acceptance criteria and the study proving the device meets these criteria for Tyvek Sterilization Pouches with Chevron Seal (K170429), when used with the Anprolene AN75 Ethylene Oxide Gas Sterilizer.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance to ISO 11607-1 | |
| Seal strength maintained | Met: Seal strength performance characteristics were maintained for the manufactured seal. |
| Microbial Barrier | Met: The contents of pouches were sterile when the processed pouches were subjected to the microbial aerosol challenge test. |
| Burst resistance | Met: Ability to withstand the internal pressurization was maintained. |
| Peel open characteristics maintained | Met: Peel open characteristics were maintained. |
| Material Compatibility | |
| Seal strength, microbial barrier, burst, and peel open tests pass | Met: Pass (Demonstrated material compatibility characteristics of the Tyvek Sterilization Pouches) |
| Biocompatibility | |
| Materials non-toxic, FDA compliant, meet ISO 11607-1; Biological and residual evaluations meet acceptable criteria | Met: Pass (Provides reasonable assurance for safety) |
| Shelf Life | |
| Physical properties and microbial barrier maintained for 5 years | Met: Pass (Verified at the end of shelf life of 5 years; Stability demonstrates reasonable assurance for effectiveness) |
| Performance in the Anprolene AN75 Cycle | |
| Sterilant Penetration (EO penetrates pouch, inactivates 6-Log biological indicators) | Met: Allow a Sterility Assurance Level (SAL) of 10^-6 for the sterilization cycle. |
| Maintenance of Package Sterility | Met: Sterility was maintained for at least 3 months after processing in an Anprolene AN75 sterilizer. |
| Overall substantial equivalence to predicate device | Met: Based on the intended use, technological characteristics, performance data, and nonclinical tests performed, the subject device is substantially equivalent to the predicate device (Tyvek Sterilization Pouches with Chevron Seal, K152058) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each test (e.g., number of pouches tested for seal strength, microbial barrier, etc.). It refers to "performance testing" and "studies" but doesn't quantify the number of units/samples used in these tests.
- Data Provenance: The context of the document (FDA 510(k) submission) implies these studies were conducted by the manufacturer, Andersen Sterilizers, Inc., likely in the United States (their address is Haw River, North Carolina). The studies appear to be prospective in nature, designed to demonstrate the safety and effectiveness of the device for the specific new indication (use with Anprolene AN75).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The studies described are primarily bench tests and performance testing against industry standards (ISO, ASTM) and internal validation. They do not involve expert human interpretation of data in the same way a diagnostic AI device would. "Ground truth" here is established through scientific testing methods (e.g., biological indicator inactivation for sterility, physical property measurements for package integrity).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the evaluation of this device is based on objective physical and microbiological test results, not on human interpretation or consensus. Therefore, no adjudication method was used or needed.
5. 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 device is a sterilization pouch, not an AI or diagnostic imaging device. Therefore, MRMC studies involving human readers are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical device product, not a software algorithm. The "performance" described is purely the physical and biological efficacy of the pouch itself in the sterilization process, independent of human interpretation or automated algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance is established through objective scientific measurements and standardized testing methodologies, including:
- Microbiological testing: Such as microbial aerosol challenge tests and biological indicator inactivation assays to demonstrate sterility assurance levels.
- Physical property testing: Measurements of seal strength, burst strength, and peel open characteristics to assess package integrity.
- Chemical/Material analysis: To confirm material compatibility and biocompatibility against established standards (e.g., ISO 11607-1).
- Time-based stability testing: To demonstrate shelf life and maintenance of sterility over time.
8. The sample size for the training set
Not applicable. This device is a physical product (sterilization pouch), not a machine learning model. Therefore, there is no "training set" in the context of AI/ML development.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the words "U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the text.
October 27, 2017
Andersen Sterilizers, Inc. William Andersen President 3154 Caroline Drive Haw River, North Carolina 27258
Re: K170429
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: September 28, 2017 Received: October 6, 2017
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. 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 801); medical device 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 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 Industry and Consumer Education (DICE) 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K170429
Device Name
Tyvek® Sterilization Pouches with Chevron Seal
Indications for Use (Describe)
Tyvek Sterilization Pouches with Chevron Seal are intended to enclose that are to be sterlized in a single pouch configuration at a healthcare facility. They are used in the 12 hour sterlization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 1.
Table 1. Critical sterilization cycle parameters in the Anprolene AN75 Ethylene Oxide Gas Sterilizer
| EO Amount | Temperature | Relative Humidity | EO Exposure Time | Total Cycle Time |
|---|---|---|---|---|
| 17.6 g ± 5% | 20-29°C | 35-90% | 12 hours | 14 hours |
The product codes for Tyvek Sterilization Pouches are listed in Table 2.
Table 2. Product codes for Tyvek Sterilization Pouches
| Product Type | Self-Seal, Heat Seal, Tubing |
|---|---|
| Product Codes | TLP-030, TLP-031, TLP-033, TLP-058, TLP-059 |
The 12 hour cycle in the Anprolene AN75 Ethylene Oxide Gas Sterilizer has been validated to sterilize a load of up to 24 Us of metal surgical instruments, 3 lbs of fabric, or 3.5 lbs of plastic devices (combined weight of pouched devices and tray). Sterility was maintained for at least 3 months after processing in an Anprolene AN75 sterilizer.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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K170429 510(k) Summary
| 5.1 Applicant's Name and Address | Andersen Sterilizers, Inc.Establishment Registration Number 30046347103154 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 | September 28, 2017 | |
| 5.4 Device | ||
| Proprietary Name | Tyvek® Sterilization Pouches with Chevron Seal | |
| Common Name | Sterilization Pouch | |
| Classification | Class II (21 CFR 880.6850) | |
| Product Code | FRG | |
| 5.5 Predicate Device | ||
| Device Name | Tyvek Sterilization Pouches with Chevron Seal | |
| 510(k) number | K152058 | |
| Manufacturer | Amcor Flexibles, Inc. |
accessory for use in the EOGas 4® Ethylene Oxide Gas Sterilization System manufactured by Andersen Sterilizers, Inc.
This 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 the Anprolene® AN75 Ethylene Oxide Sterilization System manufactured by Andersen Sterilizers, Inc. No modifications were made to the manufacturing method, technology, or intended use.
5.6 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-ethylenevinylacetate copolymer film. The pouches are used to enclose medical devices that are to be sterilized by a healthcare provider in the 12 hour sterilization cycle at 20-29°C in an Anprolene AN75 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 heat-sealing equipment, whereas the heat-sealable pouches must be heat sealed
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prior to the cycle. Andersen Sterilizers' AN85/AN86 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/AN86 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 at least 3 months (90 days).
5.7 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 the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 5-1.
Table 5-1. Critical parameters for the 12 hour cycle in the Anprolene AN75 Ethylene Oxide Gas Sterilizer
| Ethylene Oxide | Temperature | RelativeHumidity | Ethylene OxideExposure Time | Total Cycle Time |
|---|---|---|---|---|
| 17.6 g ± 5% | 20-29°C | 35-90% | 12 hours | 14 hours |
The product codes for Tyvek Sterilization Pouches are listed in Table 5-2.
| Table 5-2. Product codes for Tyvek Sterilization Pouches |
|---|
| ---------------------------------------------------------- |
| Product Type | Self-Seal, Heat Seal, Tubing |
|---|---|
| Product Codes | TLP-030, TLP-031, TLP-033, TLP-058, TLP-059 |
The 12 hour cycle in the Anprolene AN75 Ethylene Oxide Gas Sterilizer has been validated to sterilize a load of up to 24 lbs of metal surgical instruments, 3 lbs of fabric, or 3.5 lbs of plastic devices (combined weight of pouched devices and tray). Sterility was maintained for at least 3 months after processing in an Anprolene AN75 sterilizer.
5.8 Device Comparison
The technological characteristics of Tyvek Sterilization Pouches with Chevron Seal 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 subject Tyvek Sterilization Pouches with Chevron Seal differ from the predicate device only in the indicated sterilization cycle. The difference raises no issues related to safety or effectiveness of the subject device in the cycle. A comparison between the devices is listed in Table 5-3.
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| Table 5-3. Device ComparisonElements | Predicate Device: Tyvek SterilizationPouches (K152058) | Subject Device: Tyvek SterilizationPouches (K170429) |
|---|---|---|
| Intended Use | To enclose medical devices, allowsterilization of the enclosed devices, andmaintain sterility of the enclosed devices | Identical |
| Indications forUse | Tyvek Sterilization Pouches withChevron Seal are intended to enclosemedical devices that are to be sterilizedin a single pouch configuration at ahealthcare facility. They are used in the3 hour sterilization cycle at 50°C in theEOGas 4 Ethylene Oxide Gas Sterilizer. | Tyvek Sterilization Pouches withChevron Seal are used to enclosemedical devices that are to be sterilizedin a single pouch configuration at ahealthcare facility. They are used in the12 hour sterilization cycle at 20-29°C inthe Anprolene AN75 Ethylene OxideGas Sterilizer. |
| Design | Adhesive laminated film is a clear, highstrength material;Uncoated Tyvek is compatible with EOsterilization, resistant to microbialpenetration, and resistant to puncture | Identical |
| Pouch Types | Self-seal pouch; Heat seal pouch; Heatseal tubing | Identical |
| DeviceConstruction | Self-seal and heat seal pouches: front andback materials are heat sealed togetheron three sides; fourth side (end) remainsopen for filling; end is sealed by heat(heat seal pouches) or by removingprotective liner strip, folding along thepre-fold, and pressing to the film (self-seal pouches).Heat seal tubing: front and backmaterials are heat sealed together on twosides; two ends are open for selectingsize and filling; ends are sealed by heat. | Identical |
| Materials | Clear laminated PET/LDPE or LDPE-EVA film (front) and uncoated HDPETyvek (back) | Identical |
| Configuration | Single pouch configuration | Identical |
| Shelf Life | 5 years from date of manufacture | Identical |
| Biocompatibility | Materials and biological evaluations(Agar Diffusion Test, Cytotoxicity Test)meet ISO 11607-1 requirements | Identical |
| Maintenance ofSterility | Sterility is maintained for at least 3months after processing in an EOGas 4sterilizer | Sterility is maintained for at least 3months after processing in an AnproleneAN75 sterilizer |
| Aeration Time | ≥ 6 hours | No additional time other than the 2 hrmandatory ventilation |
| PackageIntegrity | Seal strength, microbial barrier, burst,and peel open characteristics meet ISOand ASTM requirements | Identical |
Table 5-3. Device Comparison
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5.9 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 12-Log reduction and a sterility assurance level of 10-6 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 Anprolene AN75 sterilization process, sterility is maintained for at least 3 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, FDA compliant, 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 Anprolene AN75 Cycle | ||
| SterilantPenetration | EO penetrated the pouch under worst-case half-doseconditions or an extreme biological challenge scenario, andinactivated 6-Log biological indicators | Allow a SAL of$10^{-6}$ for thesterilization cycle |
| Maintenance ofPackageSterility | Sterility was maintained for at least 3 months after processingin an Anprolene AN75 sterilizer. | Pass |
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5.10 Conclusion
Based on the intended use, technological characteristics, performance data, and nonclinical tests performed, the subject Tyvek Sterilization Pouches with Chevron Seal, indicated for use in the Anprolene AN75 sterilization system, are substantially equivalent to the predicate devices, Tyvek Sterilization Pouches with Chevron Seal (K152058), indicated for use in the EOGas 4 sterilization system.
§ 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).