(51 days)
Not Found
No
The device is a physical sterilization wrap and the summary describes its material properties and performance in sterilization cycles, with no mention of AI or ML.
No.
This device is a sterilization wrap used to maintain sterility of medical devices, not to provide therapy itself.
No
Explanation: The device is a sterilization wrap intended to maintain the sterility of other medical devices, not to diagnose medical conditions.
No
The device description clearly states it is a physical, non-woven sterile wrap made of polypropylene, which is a hardware component.
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 and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of disease or other conditions.
- Device Description: The device is a sterilization wrap made of non-woven material. This material and its function are consistent with packaging for sterilization, not with in vitro diagnostic tests.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing information for diagnosis, monitoring, or screening of diseases.
The device's purpose is to facilitate the sterilization process and maintain the sterility of other medical devices, which falls under the category of medical device packaging and sterilization accessories, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Sterilization Wraps is intended to be used to enclose another medical device that is to be sterilized by a health care provider using: • Pre-vacuum steam at 270°F/132°C for 4 minutes
Types of medical devices to be sterilized in the pre-vacuum cycle:
General purpose reusable metal and nonmetal devices(No lumen) including devices with stainless steel diffusionrestricted spaces such as forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
The size of the Devices to be sterilized shall allow Sterilization Wraps pack and form a closed space. Validated for dry time is 30 minutes for Sterilization Wraps.
Color of wrap: Blue Size of wrap: 48 in x 48 in
The maximum validated weight of load for Sterilization Wraps is 12kg.
The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.
Product codes
FRG
Device Description
Sterilization Wraps is a 63gsm, latex-free, 3-layer (SMS) non-woven sterile wrap, manufactured with spun-bonded / meltblown polypropylenem. Sterilization Wraps provides a strong barrier which protects against cuts, tears with particularly heavy orthopedic sets. Sterilization Wraps is designed to be implemented as an outer sterilization wrap which can be used in combination with Clinipak choice.
Sterilization Wraps is made of polypropylene and blue pigment by non-woven process.
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ANSI AAMI ISO 17665-1:2006/(R)2013 Sterilization of health care products -- Moist heat --Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
- AATCC 127-18 Test Method for Water Resisitance: Hydrostatic Pressure
- ISO 11607:2019 Packaging for terminally sterilized medical devices
- ASTM D5587-15 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
- ASTM D5034-2009 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- ASTM D737-18 Standard test method for air permeability
- ASTM D3776/D3776M Standard test method for mass per unit area (weight) of fabric
- ASTM D3786/D3786M-18 Standard test method for Bursting Strength of Textile Fabrics-Diaphragm Bursting Strength Tester Method
- ASTM F2101-14 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- United States Pharmacopeia
- ANSI/ AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
No clinical study is included in this submission.
| Study | Standards | Description/Criteria | Results |
|---|---|---|---|
| Sterilization Validation - Steam PREVACUUM | ANSI AAMI ISO 17665-1:2006/(R)2013 | A method of steam sterilization was validated to a sterility assurance level (SAL) of 10-6 | Pass |
| Sterilant Penetration - Steam PREVACUUM | ANSI AAMI ISO 17665-1:2006/(R)2013 | The testing details the methods used in determining the internal temperature profile for wrapped sterilization packs when processed in a steam sterilization pre-vacuum cycle at 132°C (270°F) for four (4) minutes exposure. | Testing has demonstrated adequate sterilant penetration |
| Validation - Dry Time | ANSI AAMI ISO 17665-1:2006/(R)2013 | Determining the proper drying time required | Test samples meet or exceed the minimum criteria for dry time. |
| 90 Day Real Time Maintenance of Sterility Validation -Steam PREVACUUM | AATCC 127-18 ISO 11607:2019 ASTM D3776/D3776M ASTM D3786/D3786M-18 | The study details the methods used in verifying the test samples can maintain the integrity of its contents for an extended period of time following exposure to a steam sterilization process. | No growth |
| Package Integrity Test - Steam PREVACUUM | ASTM D5587-15 ASTM D5034-2009 ASTM D737-18 ASTM F2101-14 AATCC 127-18 ISO 11607:2019 ASTM D5587-15 ASTM D5034-2009 | The testing details the methods of the test sample in maintaining package integrity. | The subject wrap, were found to be effective barriers when processed in a Steam Pre-Vacuum cycle. |
| Bacterial Filtration Efficiency (BFE) of Non-Woven Sterilization Wrap When Processed In a Steam Sterilization Cycle | ISO 11607:2019 ASTM F2101-14 | BFE testing is a type of test used to determine the efficiency of filter materials to provide protection against microbial organisms. | Pass |
| Dimension testing | ISO 11607:2019 | 48 in X 48 in | Pass |
| Weight testing | ASTM D3776/D3776M | According to the standard test, the weight should meet the requirements | Pass |
| Air Permeability Test | ASTM D737 | Air permeability should meet the requirements of ASTM D737. | Pass |
| Package Integrity | AATCC 127-18 ISO 11607:2019 ASTM D5587-15 ASTM D5034-2009 | The purpose of the physical properties testing was to demonstrate passing results for the physical properties (contain Hydrostatic pressure, Weight, Bursting Strength, Tear Resistance, Tensile Strength ) for the wrap. | The physical properties testing met the acceptance criteria and demonstrated passing results |
| Shelf Life Testing | AATCC 127-18 ISO 11607:2019 ASTM D3786/D3786M-18 ASTM D5587-15 ASTM D5034-2009 ASTM D737-18 ASTM F2101-14 | Whole package integrity test of real time shelf life samples | Sterilization Wraps was capable of maintaining sterility and package sterilization wrapper) following an approximate 18 month period of real time shelf life prior to being sterilized in the steam sterilization cycles |
| Cytotoxicity testing | ISO 10993-5: 2009 | No cytotoxic potential | Pass |
| Irritation testing | ISO 10993-10: 2010 | No irritation on the skin | Pass |
| Sensitization testing | ISO 10993-10: 2010 | No skin sensitization | Pass |
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.
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
March 10, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo 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 are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" in a smaller font below.
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No. 5, YiHe North Rd. FangShan District Beijing, Bejing 102401 China
Re: K220133
Trade/Device Name: Sterilization Wraps Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: January 12, 2022 Received: January 18, 2022
Dear Ray Wang:
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
1
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 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,
Colin O'Neill, M.B.E. Assistant Director DHT6C: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220133
Device Name Sterilization Wraps
Indications for Use (Describe)
Sterilization Wraps is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
• Pre-vacuum steam at 270°F/132°C for 4 minutes
Types of medical devices to be sterilized in the pre-vacuum cycle:
General purpose reusable metal and nonmetal devices(No lumen) including devices with stainless steel diffusionrestricted spaces such as forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
The size of the Devices to be sterilization Wraps pack and form a closed space. Validated for dry time is 30 minutes for Sterilization Wraps.
Color of wrap: Blue Size of wrap: 48 in x 48 in
The maximum validated weight of load for Sterilization Wraps is 12kg.
The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.
| 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) |
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3
The assigned 510(k) Number: K220133
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
-
- Date of Preparation: 03/01/2022
-
- Sponsor Identification
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
No.567, Gushan Road, Area of Economy and Technique, Weihai City, Shandong Province, China, 264207
Contact Person: Bin Dong Position: Manager Tel: +86-15662383633 Fax: +86-0631-3636910 Email: dbfeel@163.com
Designated Submission Correspondent 3.
Mr. Ray Wang
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com
4
4. Identification of Proposed Device
Trade Name: Sterilization Wraps Common Name: Sterilization Wrap
Regulatory Information Classification Name: Sterilization wrap (21 CFR part 880.6850) Classification: 2 Product Code: FRG - Wrap, sterilization Regulation Number: 21 CFR 880.6850 Review Panel: General Hospital
Indication For Use Statement:
Sterilization Wraps is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
• Pre-vacuum steam at 270°F/132°C for 4 minutes
Types of medical devices to be sterilized in the pre-vacuum cycle:
General purpose reusable metal and nonmetal devices(No lumen) including devices with stainless steel diffusion-restricted spaces such as forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
The size of the Devices to be sterilized shall allow Sterilization Wraps pack and form a closed space. Validated for dry time is 30 minutes for Sterilization Wraps.
Color of wrap: Blue Size of wrap: 48 in x 48 in
The maximum validated weight of load for Sterilization Wraps is 12kg.
The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.
Identification of Predicate Device(s) 5.
Predicate Device
510(k) Number: K182656
Product Name: JAMBRO Single Core A Sterilization Wrap Manufacturer: Jiangsu Zhande Medical Supplies Co., Ltd
Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as 2 of 9
5
was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro > Cytotoxicity
-
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
-
ANSI AAMI ISO 17665-1:2006/(R)2013 Sterilization of health care products -- Moist heat --Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
-
AATCC 127-18 Test Method for Water Resisitance: Hydrostatic Pressure
- ISO 11607:2019 Packaging for terminally sterilized medical devices >
-
ASTM D5587-15 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
-
ASTM D5034-2009 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
-
ASTM D737-18 Standard test method for air permeability
-
ASTM D3776/D3776M Standard test method for mass per unit area (weight) of fabric
- ASTM D3786/D3786M-18 Standard test method for Bursting Strength of Textile A Fabrics-Diaphragm Bursting Strength Tester Method
-
ASTM F2101-14 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
-
United States Pharmacopeia
- A ANSI/ AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
8. Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Intended Use | Sterilization Wraps is intended to be used to enclose | ||
| another medical device that is to be sterilized by a health | |||
| care provider using: | |||
| • Pre-vacuum steam at 270°F/132°C for 4 minutes |
Types of medical devices to be sterilized in the
pre-vacuum cycle:
General purpose reusable metal and nonmetal devices(No
lumen) including devices with stainless steel
diffusion-restricted spaces such as forceps and scissors, as
well as other general medical instruments having mated
surfaces, knurled areas etc.
The size of the Devices to be sterilized shall allow
Sterilization Wraps pack and form a closed space.
Validated for dry times of 30 minutes for Sterilization
Wraps.
Color of wrap: Blue
Size of wrap: 48 in x 48 in | JAMBRO Single Core A is intended to be used to enclose
another medical device that is to be sterilized by a health care
provider using:
Gravity steam at 250°F/121°C for 30 minutes
Pre-vacuum steam at 270°F/132°C for 4 minutes
Types of medical devices to be sterilized in the gravity cycle;
General purpose non-lumened reusable metal and nonmetal
devices including devices with stainless steel diffusionrestricted
spaces such as the hinged portion of forceps and scissors, as
well as other general medical instruments having mated
surfaces, knurled areas etc.
Types of medical devices to be sterilized in the pre-vacuum
cycle are;
General purpose reusable metal and nonmetal devices including
devices with stainless steel diffusion-restricted spaces such as
the hinged portion of forceps and scissors, as well as other
eneral medical instruments having mated surfaces, knurled
areas etc.
Up to 2 single channel stainless steel lumened devices of the | SIMILAR |
| | The maximum validated weight of load for Sterilization
Wraps is 12kg. | following dimensions; An inside diameter of 3 mm or larger and
a length of 400 mm or shorter; | |
| | | | |
| | The wrap is intended to allow sterilization of the enclosed
medical device(s) and also to maintain sterility of the
enclosed device(s) until used. | Color of wrap: Blue
Size of wrap: 48 in x 48 in | |
| | | The maximum validated weight of load for JAMBRO Single
Core A is 25 lbs. | |
| | | | |
| | | The wrap is intended to allow sterilization of the enclosed
medical device(s) and also to maintain sterility of the enclosed
device(s) until used. | |
| Product Code | FRG | FRG | SAME |
| Regulation
Number | 880.6850 | 880.6850 | SAME |
| Use | Single Use; Disposable | Single Use; Disposable | SAME |
| Design Features | Sterilization Wraps is a 63gsm, latex-free, 3-layer (SMS)
non-woven sterile wrap, manufactured with spun-bonded /
meltblown polypropylenem. Sterilization Wraps provides a
strong barrier which protects against cuts, tears with
particularly heavy orthopedic sets. Sterilization Wraps is
designed to be implemented as an outer sterilization wrap
which can be used in combination with Clinipak choice. | The JAMBRO® Single Core A Sterilization wrap are square
nonwoven sheets produces using a three-layer SMS
(spunbond-meltblown-spunbond) process.
• JAMBRO® Single Core A Consists of single sheets of SMS
wrap, where two sheets are used together for the sequential
wrapping of one or a collection of medical devices that will be
sterilized following standard healthcare practices. | SIMILAR |
| Materials | Sterilization Wraps is made of polypropylene and blue
pigment by non-woven process. | The JAMBRO® Single Core A Sterilization wrap are composed
of polypropylene with blue pigments and an anti-static
treatment. The JAMBRO® Single Core A Sterilization wrap | SAME |
| | | allows a sterilized package of medical devices to be opened | |
| | | aseptically. | |
| Prescription vs.
OTC | OTC | OTC | SAME |
| Color | Blue | Blue | SAME |
| Wrapping
Technique | Sequential | Sequential | SAME |
| Sterilization | • Pre-vacuum steam at 270°F/132°C for 4 minutes
• Drying time: 30 minutes | • pre-vacuum steam at 270°F/132°C for 4 minutes
• Gravity Steam at 250°F/121°C for 30 minutes
• Drying time: 30 minutes | SAME |
| Size | 48 in X 48 in | 48 in X 48 in | SAME |
| Maintenance of
Package Sterility | 90 days | 90 days | SAME |
| Shelf Life | 18 months | 18 months | SAME |
7
8
9. Performance data
For the sterlization wap performance testing, the following standards were that the device met the accepance criteria in the following standards below:
ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ANSI AAM ISO 1766-1:2006(R)2013 Sterlization of heath care -- Part 1: Requirems for the development, validation, and routine control of a sterilization process for medical devices
AATCC 127-18 Test Method for Water Resisitance: Hydrostatic Pressure
ISO 11607:2019 Packaging for terminally sterilized medical devices
ASTM D5587-15 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
9
ASTM D5034-2009 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
ASTM D737-18 Standard test method for air permeability
ASTM D3776/D3776M Standard test method for mass per unit area (weight) of fabric
ASTM D3786/D3786M-18 Standard test method for Bursting Strength of Textile Fabrics-Diaphragm Bursting Strength Tester Method
ASTM F2101-14 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Make Material, Using a Biological Aerool of Staphylococcus aureus
United States Pharmacopeia
ANSI/ AAMI ST79:2017, Comprehensive guide to steam sterility assurance in health care facilities
Following testing have been performed:
| Study | Standards | Description/Criteria | Results |
|---|---|---|---|
| Sterilization Validation - | |||
| Steam PREVACUUM | ANSI AAMI ISO 17665-1:2006/(R)2013 | A method of steam sterilization was validated to | |
| a sterility assurance level (SAL) of 10-6 | Pass | ||
| Sterilant Penetration - | |||
| Steam PREVACUUM | ANSI AAMI ISO 17665-1:2006/(R)2013 | The testing details the methods used in | |
| determining the internal temperature profile for | |||
| wrapped sterilization packs when processed in a | |||
| steam sterilization pre-vacuum cycle at 132°C | |||
| (270°F) for four (4) minutes exposure. | Testing has demonstrated adequate | ||
| sterilant penetration | |||
| Validation - Dry Time | ANSI AAMI ISO 17665-1:2006/(R)2013 | Determining the proper drying time required | Test samples meet or exceed the |
| minimum criteria for dry time. | |||
| 90 Day Real Time | |||
| Maintenance of Sterility | |||
| Validation -Steam | |||
| PREVACUUM | AATCC 127-18 | ||
| ISO 11607:2019 | |||
| ASTM D3776/D3776M | |||
| ASTM D3786/D3786M-18 | The study details the methods used in verifying | ||
| the test samples can maintain the integrity of its | |||
| contents for an extended period of time | |||
| following exposure to a steam sterilization | No growth | ||
| Package Integrity Test - | |||
| Steam PREVACUUM | ASTM D5587-15 | ||
| ASTM D5034-2009 | |||
| ASTM D737-18 | |||
| ASTM F2101-14 | |||
| AATCC 127-18 | |||
| ISO 11607:2019 | |||
| ASTM D5587-15 | |||
| ASTM D5034-2009 | process. | ||
| The testing details the methods of the test | |||
| sample in maintaining package integrity. | The subject wrap, were found to be | ||
| effective barriers when processed in a | |||
| Steam Pre-Vacuum cycle. | |||
| Bacterial Filtration | |||
| Efficiency (BFE) of | |||
| Non-Woven Sterilization | |||
| Wrap When Processed In a | |||
| Steam Sterilization Cycle | ISO 11607:2019 | ||
| ASTM F2101-14 | BFE testing is a type of test used to determine | ||
| the efficiency of filter materials to provide | |||
| protection against microbial organisms. | Pass | ||
| Dimension testing | ISO 11607:2019 | 48 in X 48 in | Pass |
| Weight testing | ASTM D3776/D3776M | According to the standard test, the weight | |
| should meet the requirements | Pass | ||
| Air Permeability Test | ASTM D737 | Air permeability should meet the requirements | |
| of ASTM D737. | Pass | ||
| Package Integrity | AATCC 127-18 | ||
| ISO 11607:2019 | |||
| ASTM D5587-15 | |||
| ASTM D5034-2009 | The purpose of the physical properties testing | ||
| was to demonstrate passing results for the | |||
| physical properties (contain Hydrostatic | |||
| pressure, Weight, Bursting Strength, Tear | |||
| Resistance, Tensile Strength ) for the wrap. | The physical properties testing met the | ||
| acceptance criteria and demonstrated | |||
| passing results | |||
| Shelf Life Testing | AATCC 127-18 | ||
| ISO 11607:2019 | Whole package integrity test of real time shelf | ||
| life samples | Sterilization Wraps was capable of | ||
| maintaining sterility and package | |||
| ASTM D3786/D3786M-18 | sterilization wrapper) following an | ||
| ASTM D5587-15 | approximate 18 month period of real | ||
| ASTM D5034-2009 | time shelf life prior to being sterilized in | ||
| ASTM D737-18 | the steam sterilization cycles | ||
| ASTM F2101-14 | |||
| Cytotoxicity testing | ISO 10993-5: 2009 | No cytotoxic potential | Pass |
| Irritation testing | ISO 10993-10: 2010 | No irritation on the skin | Pass |
| Sensitization testing | ISO 10993-10: 2010 | No skin sensitization | Pass |
Table 11-2
10
11
10. Substantially Equivalent (SE) Conclusion
Based on the nonclinical tests performed, the safe, as effective, and performs as well as the legally marketed proclicate device, IAMBRO Single Core A Sterilization Wrap cleared under K182656.