(261 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization efficacy of a sterilization pouch and roll, with no mention of AI or ML technology.
No
This device is a sterilization pouch and roll, used to enclose other devices for sterilization. It does not exert any therapeutic effect on a patient.
No
Explanation: The device is a sterilization pouch and roll, designed to enclose devices for sterilization and maintain their sterility. It does not perform any diagnostic function.
No
The device is a physical sterilization pouch and roll made of paper and plastic 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 devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not for performing diagnostic tests on biological samples.
- Device Description: The device is a pouch/roll made of paper and plastic film with an adhesive seal and chemical indicators. This description aligns with packaging materials for sterilization, not diagnostic reagents or instruments.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies focus on the ability of the pouch to withstand sterilization, maintain sterility, and the integrity of the packaging. These are relevant to sterilization packaging, not diagnostic performance metrics like sensitivity or specificity.
In summary, the U&U sterilization pouch and roll is a medical device used in the sterilization process of other medical devices. It does not perform any diagnostic function.
N/A
Intended Use / Indications for Use
The U&U sterilization pouch and roll are intended to provide with an effective method to enclose devices intended for sterlization in steam and Ethylene Oxide (EtO). The recommended g r a vi t y steam sterilization vole parameters at 121°C. The recommended EiO sterlization cycle is 4 hours at 5°C with a relative humidity between 50%-55% and a sterilant of 600 mgL. Furthernon, the sterlization pouch and roll maintains the enclosed devices up until 90Days post sterial chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.
STERILIZATION CYCLE:
The recommended g r a v i t y steam sterilization cycle parameters Steam sterilization temperature: 121°C (250 °F) Steam sterilization time: 30 minutes.
Drying time: 25 minutes The recommended EtO sterilization cycle parameters EtO sterilization temperature: 55℃ (130 °F) EtO sterilization time: 4 hour EtO sterilization humidity: 50% to 85% RH EtO sterilization concentration: 600mg/L Aeration time: 8 hours. Aeration Temperature: 60°C
Sterilization load claim:
Two types of sterilization loads were validated. Load A: Metal medical instruments and Hand-control pen, the total weight is 24lbs. Load B: Tubing (Silicone) and Surgical Towels. The total weight is 181bs.
Product codes (comma separated list FDA assigned to the subject device)
FRG, JOJ
Device Description
The U&U Sterilization Pouch and Roll are manufactured from paper and medical plastic film that are heat sealed on three sides. The fourth side has an adhesive tape that is used to seal the pouch or heat-sealed by the heat-seal machine. The paper conforms to recognized material standards and can be sterilized by steam and Eto. The Sterilization Pouch has the same intended use, Essential Component, Raw material, Sterilization method, manufacturing methods and same technological characteristics as the predicate device. Substantial equivalent to the predicate device was established by physical testing of the sterilized finished devices, as well as, performance of these finished devices (seal strength, package burst, and dye migration).
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 workers
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 U&U Sterilization Pouch and Roll maintain sterility until the seal of the Pouch/Roll is opened.
Performance Tests Elements and Results:
- Sterilant Penetration: PASSED
- Package Integrity: PASSED
- Maintenance of Package Integrity: PASSED
- Material Compatibility: PASSED
- Shelf-Life: PASSED
- Biocompatibility: PASSED
- Labeling: PASSED
- Configurations /Dimensions: PASSED
- Air permeance: PASSED
- Maintenance of Sterility: PASSED
- Endpoint stability of process indicator: PASSED
- Shelf Life of Process Indicator: PASSED
- Chemical Indicator Efficacy: PASSED
- Seal strength: PASSED
- Peel-open characteristic: PASSED
- Seal width: PASSED
- Self seal strength: PASSED
- Visual inspection: PASSED
- Ethylene oxide residuals: PASSED
Side by side testing was conducted on the U&U Sterilization Pouch and Roll and SIGMA Sterilization pouch and roll - K102158 to determine substantial equivalence. Sterilant Penetration, Biocompatibility, Package Integrity, Material Compatibility, Sterility Maintenance were the parameters used to determine substantial equivalence and validate the safety and efficacy of the device.
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2015
U&U Medical Technology Co., Ltd Mr. Garfield Wang General Manager Dongzhou Village, Hengshanqiao RM EE1092 1/F Building 1, No 1755 Hongmei Road Changzhou, Jiangsu China
Re: K143637
Trade/Device Name: U&U Sterilization Pouch and Roll Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG, JOJ Dated: August 2, 2015 Received: August 5, 2015
Dear Mr. 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. 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.
1
Page 2 - Mr. Wang
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
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) K143637
Device Name U&U Sterilization Pouch and Roll
Indications for Use (Describe)
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
The U&U sterilization pouch and roll are intended to provide with an effective method to enclose devices intended for sterlization in steam and Ethylene Oxide (EtO). The recommended g r a vi t y steam sterilization vole parameters at 121°C. The recommended EiO sterlization cycle is 4 hours at 5°C with a relative humidity between 50%-55% and a sterilant of 600 mgL. Furthernon, the sterlization pouch and roll maintains the enclosed devices up until 90Days post sterial chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.
STERILIZATION CYCLE:
The recommended g r a v i t y steam sterilization cycle parameters Steam sterilization temperature: 121°C (250 °F) Steam sterilization time: 30 minutes.
Drying time: 25 minutes The recommended EtO sterilization cycle parameters EtO sterilization temperature: 55℃ (130 °F) EtO sterilization time: 4 hour EtO sterilization humidity: 50% to 85% RH EtO sterilization concentration: 600mg/L Aeration time: 8 hours. Aeration Temperature: 60°C
Sterilization load claim:
Two types of sterilization loads were validated. Load A: Metal medical instruments and Hand-control pen, the total weight is 24lbs. Load B: Tubing (Silicone) and Surgical Towels. The total weight is 181bs.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda. hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Load Types:
The following matrix is the types of medical instruments used for steam and EtO sterilization.
| Medical Device | Steam | EtO Gas |
|---|---|---|
| Reusable surgical instruments such as clamps, scissors, retractors, pliers | X | X |
| Endoscopes (thermostable) | X | X |
| Endoscopes | ||
| (thermolabile) | - | X |
| Reusable containers | X | - |
| Elastic Products such as Rubber or latex (also combined), siliconelastomer, plastics, closed hollow bodies | X | X |
| HF-cable and handpieces | X | X |
| Powertools | X | X |
| Textile Material such as surgical towels | X | X |
5
U&U ChangZhou Medical Packaging Technology Co., Ltd Dongzhou Village,Hengshangiao,Changzhou,Jiangsu,China U&U (Shanghai) Medical Technology Co., Limited RM EE1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China [Sterilization Pouch]
Rev 1.00 09/09/15
Sec 005_510(K) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
Date Prepared: 2015-09-09 Submission Numbers for Pre-Submission: K143637
1. Submitter Name and Address:
| Name: | U&U Medical Technology Co., Ltd |
|---|---|
| Address: | Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China |
| RM EE1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China | |
| Contactor Name: | Garfield Wang |
| TEL: | +86-13902471751 |
| E-mail: | Wangxuebo_11@hotmail.com |
US Agent:
| Name: | CARELIFE (USA) INC. |
|---|---|
| Address: | 1580 Boggs Rd, Suite 500/600 Duluth GA 30096 |
| TEL: | 404 6612228 |
| Contact person : | Ms. LI QIAN liqian@shanghaicarelife.com |
2. Submission Devices Information:
Trade/Proprietary Name: U&U Sterilization Pouch and Roll Common Name: Sterilization Pouch Classification name: 1) Sterilization wrap 2) Indicator, Physical/Chemical Sterilization Process 21 CFR 880.6850 & 21 CFR 880.2800 Class: Il FDA review panel code: General Hospital Product code: 1) FRG 2) JOJ
3. Predicate Devices Information:
| Trade Name: | SIGMA Sterilization Pouch and Roll |
|---|---|
| 510(K) Number: | K102158 |
| Manufacturer: | SIGMA Medical Supplies Corp. |
4. Devices Description:
The U&U Sterilization Pouch and Roll are manufactured from paper and medical plastic film that are heat sealed on three sides. The fourth side has an adhesive tape that is used to seal the pouch or heat-sealed by the heat-seal machine. The paper conforms to recognized material standards and can be sterilized by steam and Eto. The Sterilization Pouch has the same intended use, Essential Component, Raw material, Sterilization method, manufacturing methods and same technological characteristics as the predicate device. Substantial equivalent to the predicate device was established by physical testing of the sterilized finished devices, as well as, performance of these finished devices (seal strength, package burst, and dye migration).
6
U&U ChangZhou Medical Packaging Technology Co., Ltd Dongzhou Village,Hengshangiao,Changzhou,Jiangsu,China U&U (Shanghai) Medical Technology Co., Limited RM EE1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China [Sterilization Pouch]
Rev 1.00 09/09/15
5. Model numbers of the pouches:
| Ref
Number | Model
Number | Description | Size |
|---------------|-----------------|---------------------------------------------|--------------|
| UUPP0001 | UUPP | STERILIZATION Pouch-Heat-Seal and Self-Seal | 3" X 8" |
| UUPP0002 | UUPP | STERILIZATION Pouch-Heat-Seal and Self-Seal | 4" X 10.25" |
| UUPP0003 | UUPP | STERILIZATION Pouch-Heat-Seal and Self-Seal | 6" X 12.5" |
| UUPP0004 | UUPP | STERILIZATION Pouch-Heat-Seal and Self-Seal | 4" X 14" |
| UUPP0005 | UUPP | STERILIZATION Pouch-Heat-Seal and Self-Seal | 8" X 16" |
| UUPP0006 | UUPP | STERILIZATION Pouch-Heat-Seal and Self-Seal | 6" X 16.5" |
| UUPP0007 | UUPP | STERILIZATION Pouch-Heat-Seal and Self-Seal | 10" X 19" |
| UUPP0008 | UUPP | STERILIZATION Pouch-Heat-Seal and Self-Seal | 12.5" X 22" |
| UUPR0001 | UUPR | STERILIZATION Roll-Heat-seal | 3" X 228' |
| UUPR0002 | UUPR | STERILIZATION Roll-Heat-seal | 4" X 228' |
| UUPR0003 | UUPR | STERILIZATION Roll-Heat-seal | 6" X 228' |
| UUPR0004 | UUPR | STERILIZATION Roll-Heat-seal | 14" X 228' |
| UUPR0005 | UUPR | STERILIZATION Roll-Heat-seal | 16.5" X 228' |
| UUPR0006 | UUPR | STERILIZATION Roll-Heat-seal | 20" X 228' |
5. Intended Use:
The U&U sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam and Ethylene Oxide (EtO). The recommended gravity steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EtO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 90 Davs post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.
STERILIZATION CYCLE:
The recommended gravity steam sterilization cycle parameters Steam sterilization temperature: 121°C (250 °F) Steam sterilization time: 30 minutes. Drying time: 25 minutes The recommended EtO sterilization cycle parameters EtO sterilization temperature: 55°C (130 ° F) EtO sterilization time: 4 hour EtO sterilization humidity: 50% to 85%RH EtO sterilization concentration: 600mg/L Aeration time: 8 hours. Aeration Temperature: 60°C
Sterilization load claim:
Two types of sterilization loads were validated
Load A: Metal medical instruments and Hand-control pen, the total weight are 24lb. The double pouched devices are placed into the baskets. Load B: Tubing (Silicone) and Surgical Towels. The total weight is 18lbs.
ISEC 0051
7
Rev 1.00 09/09/15
Load Types:
The following matrix is the types of medical instruments used to the sterilization:
| Medical Device | Steam | EtO Gas |
|---|---|---|
| Reusable surgical instruments such as | ||
| clamps, scissors, retractors, pliers | X | X |
| Reusable containers | X | - |
| Elastic Products such as Rubber or latex | ||
| (also combined), siliconelastomer, | ||
| plastics, closed hollow bodies | X | X |
| HF-cable and handpieces | X | X |
| Powertools | X | X |
| Textile Material such as surgical towels | X | X |
6. Technological Characteristics:
All testing followed the following standards.
AAMI/ANSI ST77 Containment devices for reusable medical device sterilization AAMI TIR22 Guidance for ANSI/AAMI/ISO 11607-Packaging for terminally sterilized medical devices-Part 1 and Part 2:2006
AAMI/ANS//ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements
7. Performance Testing:
Performance testing was conducted to show that the U&U Sterilization Pouch and Roll maintain sterility until the seal of the Pouch/Roll is opened. Performance Tests
| Element | Results |
|---|---|
| Sterilant Penetration | PASSED |
| Package Integrity | PASSED |
| Maintenance of Package Integrity | PASSED |
| Material Compatibility | PASSED |
| Shelf-Life | PASSED |
| Biocompatibility | PASSED |
| Labeling | PASSED |
| Configurations /Dimensions | PASSED |
| Air permeance | PASSED |
| Maintenance of Sterility | PASSED |
| Endpoint stability of process indicator | PASSED |
| Shelf Life of Process Indicator | PASSED |
| Chemical Indicator Efficacy | PASSED |
| Seal strength | PASSED |
| Peel-open characteristic | PASSED |
| Seal width | PASSED |
| Self seal strength | PASSED |
| Visual inspection | PASSED |
8
| U&U ChangZhou Medical Packaging Technology Co., Ltd
Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China
U&U (Shanghai) Medical Technology Co., Limited
| RM EE1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China | 510(k) Submission | ||
|---|---|---|---|
| [Sterilization Pouch] | Rev 1.00 | 09/09/15 | |
| Ethylene oxide residuals | PASSED |
8. SUBSTANTIAL EQUIVALENCE DISCUSSION:
Our Sterilization Pouch and the predicate device are same in intended use, components, materials, sterilization, and function.
Side by side testing was conducted on the U&U Sterilization Pouch and Roll and SIGMA Sterilization pouch and roll - K102158 to determine substantial equivalence. Sterilant Penetration, Biocompatibility, Package Integrity, Material Compatibility, Sterility Maintenance were the parameters used to determine substantial equivalence and validate the safety and efficacy of the device.
| Element of
Comparison | Submission Device | Predicate Device
K102158 | | | | | | | | | | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|
| Intended Use | The U&U sterilization pouch and roll are
intended to provide health care workers
with an effective method to enclose
devices intended for sterilization in
steam and Ethylene Oxide (EtO). The
recommended gravity steam sterilization
cycle parameters are 30 minutes at
121 °C. The recommended Eto
sterilization cycle is 4 hours at 55 °C
with a relative humidity between 50%-
85% and a sterilant concentration of 600
mg/L. Furthermore, the sterilization
pouch and roll maintains the enclosed
devices up until 90Days post sterilization.
Lastly, the pouch's external chemical ink
indicators are designed to indicate to the
user that the pouch has undergone either
a steam or Eto sterilization process
STERILIZATION CYCLE:
The recommended gravity steam sterilization cycle
parameters
Steam sterilization temperature: 121°C (250 °F)
Steam sterilization time: 30 minutes.
Drying time: 25 minutes
The recommended Eto sterilization cycle parameters
Eto sterilization temperature: 55°C (130 ° F)
Eto sterilization time: 4 hour
Eto sterilization humidity: 50% to 85%RH
Eto sterilization concentration: 600mg/L
Aeration time: 8 hours.
Aeration Temperature: 60°C
Sterilization load claim:
Two types of sterilization loads were validated.
Load A: Metal medical instruments and Hand-control pen,
the total weight are 24lb. The double pouched devices are
placed into the baskets.
Load B: Tubing (Silicone) and Surgical Towels. The total
weight is 18lbs. | The SIGMA sterilization pouch and roll
are intended to provide health care
workers with an effective method to
enclose devices intended for sterilization
in steam and Ethylene Oxide (EtO). The
recommended steam sterilization cycle
parameters are 30 minutes at 121 °C.
The recommended Eto sterilization cycle
is 4 hours at 55 °C with a relative
humidity between 50%-85% and a
sterilant concentration of 600 mg/L.
Furthermore, the sterilization pouch and
roll maintains the enclosed devices up
until 2 years post sterilization. Lastly, the
pouch's external chemical ink indicators
are designed to indicate to the user that
the pouch has undergone either a steam
or EtO sterilization process | | | | | | | | | | |
| | | | | | | | | | | | | |
| | Medical Device Steam EtO Gas Reusable
surgical
instruments
such as clamps,
scissors,
retractors, pliers X X Reusable
containers X - | | | | | | | | | | | |
9
U&U ChangZhou Medical Packaging Technology Co., Ltd Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China (Shanghai) Medical Technology Co., Limited
U&U (Shanghai) Medical Technology Co., Limited
RM EEE0092 1/F Building 1, No 1755, HONGMEl Road, Shanghai, China [Sterilization Pouch]
510(k) Submission
09/09/15 Rev 1.00
| | Elastic Products
such as Rubber
or latex (also
combined).
siliconelastomer
, plastics,
closed hollow
bodies
HF-cable and | × | X | |
|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | handpieces | × | X | |
| | Powertools | × | X | |
| | Textile Material
such as surgical
towels | × | X | |
| Material
Composition | Top Web - Medical Porous Paper
Bottom Web - Medical Plastic film(CPP)
Bottom Web - Medical two-sided adhesive tape
EtO gas indicator ink-Process Indicators class 1 | | | Top Web - Medical Porous Paper
Bottom Web - Medical Plastic film(CPP)
Bottom Web -Medical two-sided adhesive tape
EtO gas indicator ink-Process Indicators class 1 |
| | Steam indicator ink-Process Indicators class 1 | | | Steam indicator ink-Process Indicators class 1 |
| Sterilization
Cycles | The recommended gravity steam sterilization cycle
parameters are 30 minutes at 121 ℃. The
recommended EtO sterilization cycle is 4 hours at
55 ℃ with a relative humidity between 50%-85% and
a sterilant concentration of 600 mg/L. | | The recommended steam sterilization cycle parameters
are 30 minutes at 121 ℃. The recommended EtO
sterilization cycle is 4 hours at 55 ℃ with a relative
humidity between 50%-85% and a sterilant
concentration of 600 mg/L. | |
| Confiqurations
/Dimensions | For Pouch:
Width: ±0.1"" Length ± 0.2""
For Roll:
Width: ±0.1"" Length ± 3% | | | For Pouch:
Width: ±0.1"" Length ± 0.2""
For Roll:
Width: ±0.1"" Length ± 3% |
| Air permeance | The maximum equivalent pore size diameter shall not
exceed 50um. | | | The maximum equivalent pore size diameter shall not
exceed 50um. |
| Sterilant
Penetration | Use the EN 868-2:1999 Annex C: Method for the
determination of the pore size, the pore size diameter is
40 to 44 um
The data is a little higher than the predicated device, The
difference can be accepted. | | Use the EN 868-2:1999 Annex C: Method for the
determination of the pore size, the pore size diameter is
38 to 43 um | |
| Microbial Barrier
Properties
(Packaging
Integrity) | Use ASTM 1608 method, the LRV is more than 3.5
Use ASTM 1929 method, the inspection result is PASS
The data is a little higher than the predicated device, The
difference can be accepted. | | Use ASTM 1608 method, the LRV is 3.3
Use ASTM 1929 method, the inspection result is PASS | |
| Material
Compatibility | After sterilization, the materials were not degraded | | After sterilization, the materials were not degraded | |
| Toxicological
Properties(Bioco
mpatibility,
including
Sterilant Residue
Limits) | Meet ISO10993-4.Haemolysis Test (Direct-contract
Method), ISO10993-10, Test for Irritation (Intractaneous
Reactivity Test) and ISO10993-10, Test for Skin
sensitization (Maximization test) | | Meet ISO10993-4,Haemolysis Test (Direct-contract
Method), ISO10993-10, Test for Irritation (Intractaneous
Reactivity Test) and ISO10993-10, Test for Skin
sensitization (Maximization test) | |
| Maintenance of
Sterility | 90 Days | | | 2 years |
| Endpoint stability
of process
indicator | 90 Days | | 2 years | |
| Shelf Life of
Process Indicator | 18 months | | 2 years | |
| Drying time | 25 minutes | | 25 minutes | |
| Aeration time | 8 hours at 60°C | | 8 hours at 60°C | |
| Chemical
Indicator Efficacy | Changed color
EtO- YELLOW to COCOA; Steam- GREEN to PURPLE | | Changed color | |
| | | | | |
9. Conclusion:
The performance testing data for the U&U Sterilization Pouch and Roll demonstrates substantial equivalence to the SIGMA Sterilization Pouch and Roll (K102158).
END