(350 days)
No
The device is a physical sterilization pouch with chemical indicators, and the description focuses on material properties, sterilization methods, and performance testing related to maintaining sterility. There is no mention of any computational or analytical functions that would involve AI/ML.
No
The device is a sterilization pouch intended to enclose other medical devices for sterilization and maintain their sterility. It does not provide any therapeutic benefit or exert any action on the body itself.
No
Explanation: The device is a sterilization pouch used to enclose medical devices for sterilization and maintain their sterility. While it includes chemical indicators that change color to show exposure to a sterilization process, these indicators only confirm that the device has been processed, not that it is disease-free or for diagnosing a medical condition. Therefore, it is not a diagnostic device.
No
The device is a physical sterilization pouch with integrated chemical indicators, not a software-only device. The description focuses on material properties, physical testing, and sterilization validation of a tangible product.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the pouches and rolls are used to enclose another medical device for sterilization. They are designed to facilitate and maintain the sterility of other instruments or devices used in healthcare settings.
- Function: The primary function is to act as a sterile barrier and to indicate exposure to a sterilization process.
- Lack of Diagnostic Purpose: The device does not perform any tests on biological samples (blood, urine, tissue, etc.) to diagnose a disease or condition. It does not provide information about a patient's health status.
- Device Description: The description focuses on the materials and construction of the pouch and the function of the chemical indicators, all related to sterilization and maintaining sterility.
- Performance Studies: The performance studies focus on package integrity, material compatibility, biocompatibility, shelf life, and sterilization validation – all relevant to a sterilization packaging device, not an IVD.
In summary, the device's purpose is to prepare and maintain the sterility of other medical devices, which is a crucial step in healthcare but does not fall under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Safe Secure Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:
- · Gravity steam at 121°C (250°F) for 30 minutes: 25 minutes dry time
- · Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
- · Pre-vacuum steam at 134°C (273°F) for 3 minutes: 20 minutes dry time
- · Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time
· Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60oC (140oF).
- · The recommended hydrogen peroxide vapor sterilization cycle is the STERRAD® 100S Short Cycle.
The steam and EO device is not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen; the 100S has been validated for medical devices with a single stainless steel lumen with an inside diameter of ≥1mm and an length of ≤125mm as well as lumens with an inside diameter ≥2mm and a length of ≤250mm only.
The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam. EO, or hydrogen peroxide sterilization process and to distinguish between processed devices. The chemical indicators change from green to purple after exposure to steam, from yellow to brown after exposure to ethylene oxide, and from blue to pink for hydrogen peroxide.
The Tyvek version of the pouch is for EO and hydrogen peroxide sterilization only.
If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 6 months after steam sterilization (for paper pouch), two years after hydrogen peroxide sterilization and five years for EO sterilization (for Tyvek Pouch). The maximum validated pouch load is 2.64 pounds (1.2kg).
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
Tyvek Sterilization Pouches with Chevron Seal are constructed 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- vinylacetate copolymer film.
The pouches are used to enclose medical devices that are to be sterilized by a healthcare provider 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.
Chemical Indicators, are placed on the outside of the sterilization pouches indicate sterilant exposure, and a way to differentiate pouches that have been processed in sterilization cycles from unprocessed units.
The color of the Indicators (3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248) changes from blue to pink after exposer to hydrogen peroxide sterilization. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for at least five years.
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
Health care provider
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)
Summary of Non-Clinical Testing:
- Package Integrity:
- Seal Strength Test: ASTM F88/F88M-15, Result: Pass
- Seal Leak Test: ASTM F1929-15, Result: Pass
- Sterilization Chemical Indicator Test and Visual Inspection: Visual examination, Result: Pass
- 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. Result: Pass
- Biocompatibility: Not direct patient-contacting devices; Materials are non-toxic. Biological evaluations meet acceptable criteria; Provides reasonable assurance for safety. Standards referenced include: ISO 10993-1 and ISO 10993-5. Result: Pass
- Shelf Life: Physical properties and microbial barrier of the processed Tyvek Pouches was verified at the end of shelf life of 2 years. Result: Pass
- Sterilization Validation: Full, half, and partial/fail cycles were used to validate the cycle. The following standards were used in the submission. Standards referenced include: ISO 11140-1, ISO 11138, ISO 14161. Result: Pass
- Chemical Indicator: Testing was performed to demonstrate compliance to Submissions for Chemical Indicators - Guidance for Industry and FDA Staff as applicable under K170321. Result: Pass
Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device cleared under K153540.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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/0 description: The image shows 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.
January 3, 2019
Safe Secure Packing Co., Ltd. Howard Jia, President Yaoshan Industrial Park Xiegang Town, Dongguan City, CN 523601
Re: K180139
Trade/Device Name: Safe Secure Sterilization Pouches and Rolls Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: November 27, 2018 Received: November 28, 2018
Dear Howard Jia:
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/cdrl/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Elizabeth F. Claverie -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
2
Indications for Use
510(k) Number (if known) K180139
Device Name
Safe Secure Sterilization Pouches and Rolls
Indications for Use (Describe)
Safe Secure Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:
- · Gravity steam at 121°C (250°F) for 30 minutes: 25 minutes dry time
- · Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
- · Pre-vacuum steam at 134°C (273°F) for 3 minutes: 20 minutes dry time
- · Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time
· Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60oC (140oF).
- · The recommended hydrogen peroxide vapor sterilization cycle is the STERRAD® 100S Short Cycle.
The steam and EO device is not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen. The hydrogen peroxide device has been validated for devices that contain a lumen; the 100S has been validated for medical devices with a single stainless steel lumen with an inside diameter of ≥1mm and an length of ≤125mm as well as lumens with an inside diameter ≥2mm and a length of ≤250mm only.
The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam. EO, or hydrogen peroxide sterilization process and to distinguish between processed devices. The chemical indicators change from green to purple after exposure to steam, from yellow to brown after exposure to ethylene oxide, and from blue to pink for hydrogen peroxide.
The Tyvek version of the pouch is for EO and hydrogen peroxide sterilization only.
If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 6 months after steam sterilization (for paper pouch), two years after hydrogen peroxide sterilization and five years for EO sterilization (for Tyvek Pouch). The maximum validated pouch load is 2.64 pounds (1.2kg).
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)
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3
| Pouch Material | Sterilization Method | Size | Model
Number |
|------------------------|--------------------------------------------------------|--------------------------|------------------------|
| Medical Grade
Paper | Steam or EO Sterilization Pouch/Roll
Products | L: 2 – 30"
W: 2 – 30" | ABHSP1TAB
ABSSP1TAB |
| Tyvek | EO Sterilization Pouch/Roll Products | W: 2 – 30" | ABSST1TAB
ABHST1TAB |
| Tyvek | Hydrogen Peroxide Sterilization
Pouch/Roll Products | L: 2 – 30"
W: 2 – 30" | ABSST2TAB
ABHST2TAB |
The maximum validated pouch load is 2.64 pounds (1.2kg).
4
K180139
510(k) Summary
Submission Sponsor
Safe Secure Packing (Shenzhen) Co., Ltd Yaoshan Industrial Park, Xiegang Town, Dongguan City, Guangdong Province, 523601 China.
Date Prepared
November 27, 2018
Device Identification
Trade/Proprietary Name: Safe Secure Sterilization Pouches and Rolls Common/Usual Name: Sterilization Pouch Classification Name: Sterilization Wrap Classification Regulation: 21 CFR Part 880.6850 Product Code: FRG Device Class: 2 Classification Panel: General and Plastic Surgery
Predicate Device
K153540 - Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators
Device Description
Tyvek Sterilization Pouches with Chevron Seal are constructed 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- vinylacetate copolymer film.
The pouches are used to enclose medical devices that are to be sterilized by a healthcare provider 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.
Chemical Indicators, are placed on the outside of the sterilization pouches indicate sterilant exposure, and a way to differentiate pouches that have been processed in sterilization cycles from unprocessed units.
The color of the Indicators (3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248) changes from blue to pink after exposer to hydrogen peroxide sterilization. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for at least five years.
Indications for Use
Safe Secure Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:
- . Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
- . Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes drytime
- . Pre-vacuum steam at 134°C (273°F) for 3 minutes; 20 minutes dry time
- . Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time
- Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% relative humidity for 60 . minutes. Aeration time of 8 hours at 60oC (140°F).
- The recommended hydrogen peroxide vapor sterilization cycle is the STERRAD® 100S Short Cycle. .
The steam and EO device is not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen; the 100S has been validated for medical devices with a single stainless steel lumen with an inside diameter of ≥1mm and an length of ≤125mm as well as lumens with an inside diameter ≥2mm and a length of ≤250mm only.
Howard Jia, President Tel: 86-755-27040498 Fax: 86-755-27040488 howard.jia@anbaopack.com
5
The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam, EO, or hydrogen peroxide sterilization process and to distinguish between processed and unprocessed devices. The chemical indicators change from green to purple after exposure to steam, from yellow to brown after exposure to ethylene oxide, and from blue to pink for hydrogen peroxide.
The Tyvek version of the pouch is for EO and hydrogen peroxide sterilization only.
If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 6 months after steam sterilization, 24 months after EO sterilization (for paper pouch), two years after hydrogen peroxide sterilization and five years for EO sterilization (for Tyvek Pouch).
The maximum validated pouch load is 2.64 pounds (1.2kg).
The maximum validated pouch load is 2.64 pounds (1.2kg).
| Pouch Material | Sterilization Method | Size | Model Number |
|---|---|---|---|
| Medical Grade Paper | Steam or EO Sterilization Pouch/Roll Products | L: 2 - 30" | |
| W: 2 - 30" | ABHSP1TAB | ||
| ABSSP1TAB | |||
| Tyvek | EO Sterilization Pouch/Roll Products | W: 2 - 30" | ABSST1TAB |
| ABHST1TAB | |||
| Tyvek | Hydrogen Peroxide Sterilization Pouch/Roll Products | L: 2 - 30" | |
| W: 2 - 30" | ABSST2TAB | ||
| ABHST2TAB |
Technological Characteristics Comparison Table
The subject device has the same intended use of the device as its predicate and the same technological characteristics.
The primary difference is the addition of the STERRAD® 100S Short Cycle to the indications for use.
A hydrogen peroxide sterilization chemical indicator cleared under K170321 has been included for monitoring.
| | Subject Device | Predicate Device | Comparison of subject
device with the predicate
device |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Name of Company | Safe Secure | Safe Secure | Identical |
| Device Name | Sterilization Tyvek Sterilization
Pouches | Sterilization Tyvek Sterilization
Pouches | Identical |
| Intended use | The device is intended to be used to
enclose another medical device, in a
single or double pouch configuration,
that is to be sterilized by a health
care provider | The device is intended to be used
to enclose another medical
device, in a single or double
pouch configuration, that is to be
sterilized by a health care
provider | Identical |
| Material Composition | Tyvek and PET/PE Film Medical
Double Side Tape (for self-seal pouches
only) | Tyvek and PET/PE Film Medical
Double Side Tape (for self-seal
pouches only) | Tyvek and PET/PE Film
Medical Double Side Tape
(for self-seal pouches only) |
| Hydrogen Peroxide
Chemical Indicator
Supplier | 3MTM ComplyTM Hydrogen Peroxide
Chemical Indicator 1248 (K170321) | NA | NA |
| Biocompatibility | Materials and biological evaluations
Cytotoxicity Test (ISO 10993-5) – Post
Sterilization | Materials and biological evaluations
– Post Sterilization: Cytotoxicity
Test (ISO 10993-5)
Pre-Sterilization: Cytotoxicity (ISO
10993-5), Maximization
Sensitization (ISO 10993-10),
Irritation/Intracutaneous Reactivity
(ISO 10993-10) | Both were non-cytotoxic
post sterilization. |
| Configuration | Single pouch configuration with
chemical indicator | Single pouch configuration with
chemical indicator | Identical |
| Configurations/
Dimensions | Various | Various | Same - both
have various
configurations |
6
| | Subject Device | Predicate Device | Comparison of subject
device with the predicate
device |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Design | Adhesive laminated film is a clear, high
strength material; Uncoated
Tyvek is compatible with
sterilization, resistant to microbial
penetration, and resistant to puncture | Adhesive laminated film is a clear,
high strength material; Uncoated
Tyvek is compatible with
sterilization, resistant to microbial
penetration, and resistant to
puncture | 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. | 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) | Clear laminated PET/LDPE or
LDPE-EVA film (front) and
uncoated HDPE Tyvek (back) | Identical |
| 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 | Identical |
| Pouch Types | Self-seal pouch; Heat seal pouch; Heat
seal tubing | Self-seal pouch; Heat seal pouch;
Heat seal tubing | Identical |
| Shelf Life | 2 years from date of manufacture for
hydrogen peroxide chemical indicator | 5 years for EO chemical indicator | The hydrogen peroxide CI
has a two year shelf life. |
| Validated for use in
Sterilization System | Validated to be used with
hydrogen peroxide
sterilization, EO and Steam
Sterilization | Validated to be used with EO
and Steam Sterilization | The new CI is
validated to be used
with hydrogen
peroxide sterilization |
| Chemical Indicator | Hydrogen Peroxide CI attached to
outside of pouch | EO or Steam CI attached to
outside of pouch | The new CI is
validated to be used
with hydrogen
peroxide sterilization |
Summary of Non-Clinical Testing
This section includes a brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission to support a determination of substantial equivalence.
| Test | Description | Result | |
|---|---|---|---|
| Package | |||
| Integrity | Seal Strength Test | ASTM F88/F88M-15 | |
| Seal Leak Test | ASTM F1929-15 | Pass | |
| Sterilization Chemical Indicator Test and Visual Inspection | Visual examination | ||
| 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. Biological evaluations meet | ||
| acceptable criteria; Provides reasonable assurance for safety. Standards referenced include: ISO | |||
| 10993-1 and ISO 10993-5. | Pass | ||
| Shelf Life | Physical properties and microbial barrier of the processed Tyvek Pouches was verified at the | ||
| end of shelf life of 2 years | Pass |
7
| Test | Description | Result |
|---|---|---|
| Sterilization Validation | Full, half, and partial/fail cycles were used to validate the cycle. The following standards were used in the submission. Standards referenced include: ISO 11140-1, ISO 11138, ISO 14161 | Pass |
| Chemical Indicator | Testing was performed to demonstrate compliance to Submissions for Chemical Indicators - Guidance for Industry and FDA Staff as applicable under K170321 | Pass |
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device cleared under K153540.