(117 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization efficacy of the pouches, with no mention of AI or ML.
No
The device is a sterilization pouch used to enclose medical devices for sterilization and maintain their sterility, not to treat or diagnose a medical condition.
No
Explanation: The device is a sterilization pouch intended to enclose medical devices for sterilization and maintain their sterility, not to diagnose medical conditions.
No
The device is a physical sterilization pouch made of Tyvek and film, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose medical devices for sterilization in a healthcare facility. This is a process related to preparing medical devices for use, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the physical construction and function of the pouches for sterilization and maintaining sterility. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Tyvek Sterilization Pouches with Chevron Seal are intended to enclose medical devices that are to be sterlized in a single pouch configuration 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 ± 5% | 50°C ± 3°C | 35-90% | 3 hours | 3.5 hours |
The 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilize a load of up to 24 lbs of metal surgical instruments or 7 lbs of plastic devices (combined weight of pouched devices and tray).
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 |
Product codes (comma separated list FDA assigned to the subject device)
FRG, TLP-030, TLP-031, TLP-033, TLP-058, TLP-059
Device Description
The Tyvek Sterilization Pouches with Chevron Seal are constructed from an uncoated Tyvek backing of fine, continuous high-density polyethylene (HDPE) fibers, with front material consisting of a clear, laminated polyethylene terephthalate (PET) / low density polyethylene (LDPE) or LDPE-ethylene-vinylacetate copolymers (EVA) film. 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 inserted into the pouches and sealed. The self-seal pouch permits sealing of the pouch without heat-sealing equipment, while the heat sealed pouches are heat sealed prior to the cvcle. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for at least 3 months (90 days) or until used.
The AN85/AN86 EO Indicators, when placed on the outside of the sterilization pouches, indicate ethylene oxide exposure and offer 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to show that the Tyvek Sterilization Pouches with Chevron Seal perform as intended to allow sterilization of the enclosed medical device. Sterilization efficacy testing demonstrated a 12-Log reduction and a sterility assurance level of 10-6 using the overkill method and half cycle or half dose validation methods under worst case conditions. The Tyvek Sterilization Pouches with Chevron Seal also maintain sterility of the enclosed device as intended. Shelf life studies demonstrated sterility maintenance for up to 5 years after completion of an ethylene oxide sterilization process.
Summary of bench tests performed to demonstrate safety and effectiveness:
- Compliance to ISO 11607-1:
- Package Integrity: Seal strength, microbial barrier, burst, and peel open characteristics meet ISO and ASTM requirements.
- Material Compatibility: Seal strength test, microbial barrier properties, burst test, and peel open test were studied to demonstrate material compatibility characteristics and passed.
- Biocompatibility: Materials are non-toxic, FDA compliant, and meet ISO 11607-1 requirements. Biological evaluations meet acceptable criteria and passed.
- Shelf Life: Physical properties and microbial barrier of the processed Tyvek Pouches was verified at the end of shelf life of 5 years, demonstrating reasonable assurance for effectiveness and passed.
- Performance in the EOGas 4 Cycle:
- Sterilant Penetration: The sterilant penetrated the pouch under worst case half-dose conditions and inactivated 6-Log biological indicators, allowing a sterility assurance level of 10-6 for the sterilization cycle.
- Maintenance of Package Integrity: Sterility was maintained for at least 3 months (90 days) after the EOGas 4 processing, and passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Sterilization efficacy: 12-Log reduction
- Sterility assurance level: 10-6
- Sterility maintenance: at least 3 months (90 days) after processing in an EOGas 4 sterilizer.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized human figure in profile, with three faces overlapping to represent the department's focus on health and human well-being. The emblem is simple and modern in design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2015
Andersen Sterilizers, Inc. William Andersen, BE, MD, FAAOS President 3154 Caroline Drive Haw River, North Carolina 27258
Re: K152058
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 20, 2015 Received: October 22, 2015
Dear Dr. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education 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. 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 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,
Erin I. Keith -S
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) K152058
Device Name
Tyvek® Sterilization Pouches with Chevron Seal
Indications for Use (Describe)
The Tyyek Sterilization Pouches with Chevron Seal are intended to enclose medical devices that are to be sterlized in a single pouch configuration 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 ± 5% | 50°C ± 3°C | 35-90% | 3 hours | 3.5 hours |
The 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilize a load of up to 24 lbs of metal surgical instruments or 7 lbs of plastic devices (combined weight of pouched devices and tray).
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 |
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
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4
510(k) Summary
| 5.1 Applicant's Name and Address | Andersen Sterilizers, Inc.
3154 Caroline Drive
Haw River, NC 27258 |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.2 Contact Person | William K. Andersen, BE, MD, FAAOS
President
Phone: 336-376-8622, Fax: 336-376-5428 |
| 5.3 Date of Preparation | November 17, 2015 |
| 5.4 Device
Proprietary Name
Common Name
Classification
Product Code | Tyvek® Sterilization Pouches with Chevron Seal
TLP-030, TLP-031, TLP-033, TLP-058, TLP-059
Sterilization Pouch
Class II (21 CFR 880.6850)
FRG |
| 5.5 Predicate Device
Device Name
510(k) number
Manufacturer | Tyvek Sterilization Pouches with Chevron Seal
K831425
Amcor Flexibles |
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.
ર : ર Device Description
The Tyvek Sterilization Pouches with Chevron Seal are constructed from an uncoated Tyvek backing of fine, continuous high-density polyethylene (HDPE) fibers, with front material consisting of a clear, laminated polyethylene terephthalate (PET) / low density polyethylene (LDPE) or LDPE-ethylene-vinylacetate copolymers (EVA) film. 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 inserted into the pouches and sealed. The self-seal pouch permits sealing of the pouch without heat-sealing equipment, while the heat sealed pouches are heat sealed prior to the cvcle. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for at least 3 months (90 days) or until used.
The AN85/AN86 EO Indicators, when placed on the outside of the sterilization pouches, indicate ethylene oxide exposure and offer a convenient way to verify processing in the sterilization
5
cycle. The color of the AN85/AN86 EO Indicators changes from yellow-green to blue after exposure to ethylene oxide.
Indications for Use 5.7
The Tyvek Sterilization Pouches with Chevron Seal are intended to be used to enclose medical devices that are to be sterilized in a single pouch configuration 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 3 hour cvcle in the EOGas 4 Ethylene Oxide Gas Sterilizer has been validated to sterilize a load of up to 24 lbs of metal surgical instruments or 7 lbs of plastic devices (combined weight of pouched devices and trav).
The product codes for Tyvek Sterilization Pouches are listed in Table 5-2.
| Product Type | Self-Seal | Heat Seal | Tubing | ||
|---|---|---|---|---|---|
| Product Codes | TLP-030 | TLP-031 | TLP-033 | TLP-058 | TLP-059 |
Table 5-2. Product codes for Tyvek Sterilization Pouches
Device Comparison ર .8
The technological characteristics of the 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 Tyvek Sterilization Pouches with Chevron Seal differ from the predicate device in the sterilization cycles 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: Tyvek
Sterilization Pouches | Subject Device: Tyvek Sterilization
Pouches |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K831425 | K152058 |
| Intended Use | To enclose medical devices, allow
sterilization of the enclosed devices,
and maintain sterility of the enclosed
devices | Identical |
| Indications for
Use | To be used in ethylene oxide
sterilization systems | The Tyvek Sterilization Pouches with
Chevron Seal are intended to be used to
enclose medical devices that are to be
sterilized in a single pouch configuration 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 3 hour cycle in the EOGas 4 Ethylene
Oxide Gas Sterilizer has been validated to
sterilize a load of up to 24 lbs of metal
surgical instruments or 7 lbs of plastic
devices (combined weight of pouched
devices and tray). |
| Design | Adhesive laminated film is a clear,
high strength material;
Uncoated Tyvek is compatible with
EO sterilization, resistant to microbial
penetration, and resistant to puncture | Identical |
| Pouch Types | Self-seal pouch; Heat seal pouch; Heat
seal tubing | Identical |
| Device
Construction | Self-seal and heat seal pouches: front
and back materials are heat sealed
together on three sides; fourth side
(end) remains open for filling; end is
sealed by heat (heat seal pouches) or
by removing protective liner strip,
folding along the pre-fold, and
pressing to the film (self-seal pouches).
Heat seal tubing: front and back
materials are heat sealed together on
two sides; two ends are open for
selecting size and filling; ends are
sealed by heat. | Identical |
| Materials | Clear laminated PET/LDPE or LDPE-
EVA film (front) and uncoated HDPE
Tyvek (back) | Identical |
| Configuration in
Load | 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 | Materials and biological evaluations (Agar
Diffusion Test, Cytotoxicity Test) meet
ISO 11607-1 requirements |
| Maintenance of
Sterility | Tyvek pouches are capable of
maintaining sterility for at least 5 years | Sterility is maintained for at least 3 months
(90 days) after processing in an EOGas 4 sterilizer |
| Aeration Time | ≥ 6 hours | ≥ 6 hours |
| Package Integrity | Seal strength, microbial barrier, burst,
and peel open characteristics meet ISO
and ASTM requirements | Seal strength, microbial barrier, burst, and
peel open characteristics meet ISO and
ASTM requirements |
Table 5-3. Device Comparison
6
Г
7
5.9 Performance Testing
Performance testing was conducted to show that the Tyvek Sterilization Pouches with Chevron Seal perform as intended to allow sterilization of the enclosed medical device. Sterilization efficacy testing demonstrated a 12-Log reduction and a sterility assurance level of 10° using the overkill method and half cycle or half dose validation methods under worst case conditions. The Tyvek Sterilization Pouches with Chevron Seal also maintain sterility of the enclosed device as intended. Shelf life studies demonstrated sterility maintenance for up to 5 years after completion of an ethylene oxide sterilization process. The performance of the Tyvek Sterilization pouches is summarized in Table 5-4.
| Table 5-4. Summary of bench tests performed to demonstrate safety and effectiveness of the | |||
|---|---|---|---|
| Tyvek Sterilization Pouches |
| Test | Description | Results |
|---|---|---|
| Compliance to ISO 11607-1 | ||
| Package | ||
| Integrity | Seal strength performance characteristics were | |
| maintained for the manufactured seal. | ||
| Microbial Barrier: the contents of pouches were sterile | ||
| when the processed pouches were subjected to the | ||
| microbial aerosol challenge test. | ||
| Burst: ability to withstand the internal pressurization | ||
| was maintained. | ||
| Peel open characteristics were maintained. | Meet ISO and ASTM | |
| requirements | ||
| Material | ||
| Compatibility | Seal strength test, microbial barrier properties, burst | |
| test, and peel open test were studied to demonstrate | ||
| material compatibility characteristics of the Tyvek | ||
| Sterilization Pouches | Pass | |
| Biocompatibility | Not direct patient-contacting devices; | |
| Materials are non-toxic, FDA compliant, and meet | ||
| ISO 11607-1 requirements; | ||
| Biological evaluations meet acceptable criteria; | ||
| Provides reasonable assurance for safety | Pass | |
| Shelf Life | Physical properties and microbial barrier of the | |
| processed Tyvek Pouches was verified at the end of | ||
| shelf life of 5 years; | ||
| Stability demonstrates reasonable assurance for | ||
| effectiveness | Pass | |
| Performance in the EOGas 4 Cycle | ||
| Sterilant | ||
| Penetration | The sterilant penetrated the pouch under worst case | |
| half-dose conditions and inactivated 6-Log biological | ||
| indicators | Allow a sterility assurance | |
| level of 10-6 for the | ||
| sterilization cycle | ||
| Maintenance of | ||
| Package | ||
| Integrity | Sterility was maintained for at least 3 months | |
| (90 days) after the EOGas 4 processing. | Pass |
8
5.10 Conclusion
Based on the intended use, technological characteristics, performance data and nonclinical tests performed, the subject Tyvek Sterilization Pouches with Chevron Seal is substantially equivalent to the predicate device - Tyvek Sterilization Pouches with Chevron Seal (K831425).