(505 days)
Not Found
No
The 510(k) summary describes a sterilization pouch/roll and its performance characteristics, with no mention of AI or ML technology.
No.
This device is designed to enclose medical devices for sterilization, not to provide therapeutic treatment itself.
No
This device is a sterilization pouch/roll intended to enclose medical devices for terminal sterilization. It does not perform any diagnostic function.
No
The device described is a physical sterilization pouch/roll made of TYVEK and medical plastic film, intended for enclosing medical devices for sterilization. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "enclose medical devices that are to be terminally sterilized in the STERRAD 100NX Hydrogen Peroxide Gas Plasma sterilizer." This describes a device used in the sterilization process of other medical devices, not a device used to perform tests on biological samples to diagnose conditions.
- Device Description: The description details the materials and construction of a pouch designed for sterilization, not a device with components for analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
- Reagents or assays
The device is clearly intended for use in the sterilization of medical instruments, which falls under the category of a medical device used in the healthcare setting, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roll are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD 100NX Hydrogen Peroxide Gas Plasma sterilizer.
The recommended Hydrogen Peroxide Gas Plasma cycle parameter: STERRAD 100NX STANDARD Cycle
Sterilization load claim:
STERRAD 100NX Sterilizer Standard cycle:
· General medical instruments (metal and nonmetal, including hinged devices)
· Instruments with single-channel stainless steel lumens with an Internal diameter 3 mm or larger and length 150 mm or shorter.
· Polyethylene and Teflon lumentubing with an internal diameter of 3 mm or larger and length of 500 mm or shorter.
· These items must be sterilized without any additional load items
· Limit of 20 pieces of tubing per cycle
Load condition: One device per Sterilization Pouch.
Load chamber: Two shelves (total weight: 21.4 Ibs or 9.7 kg)
Load Pouch: Leave enough material beyond the seal for the opener to easily grasp (usually 1- 1 % inches).
SHELF LIFE: It is recommended that the products are put to their end use within 2 years of manyfacture. The recommended "best before" date and the manufacturing date are stated on the label. This device was demonstrated to maintain sterility of the contents for 30 days after Sterilization.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
The U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roll are manufactured from TYVEK 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 TYVEK conforms to recognized material standards and can be sterilized by STERRAD 100 NX Hydrogen Peroxide Gas Plasma. The Sterilization Pouch has the same intended use, Essential Component, Raw material, Sterilization method, manufacturing methods and same technological characteristics as these predicate devices. Substantial equivalent to the predicate device was established by physical testing of the TYVEK (pressure drop vs. flow and filtration efficiency) and film (thickness, tensile strength and elongation) from non-sterile, sterilized finished devices, as well as, performance of these finished devices (seal strength, package burst, dye migration).
The pouches are manufactured from TYVEK that is thermally sealed to laminated film on the left, right, and bottom of pouch. The fourth side has an adhesive tape that is used to that is used to seal the pouch or heat-sealed by the heat-seal machine prior to sterilization of the enclosed medical device.
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
Not Found
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 Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roll maintain sterility until the seal of the Pouch/Roll is opened.
Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roll Performance Tests:
- Sterilant Penetration: PASSED
- Package Integrity: PASSED
- Maintenance of Package Integrity: PASSED
- Material Compatibility: PASSED
- Shelf-Life: PASSED
- Biocompatibility: PASSED
- Performances: PASSED
- Biocompatibility: PASSED
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
FEB 2 6 2014
| 510(k) Submission |
|---|
| ------------------- |
U&U ChangZhou Modical Packaging Technology Co., Ltd Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China U&U (HONGKONG) Madical Technology Co., Limited RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN HONG KONG [Gas Plasma Sterilization Pouch / Roli]
21/02/14 Rev 1.02
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: 2014-01-05 Submission Numbers for Pre-Submission: K123162
1. Submitter Name and Address:
| Name: | U&U Medical Technology Co., Ltd |
|---|---|
| Address: | Dongzhou Village, Hengshanqiao, Changzhou, Jiangsu, China |
| Contactor Name: | Garfield Wang |
| TEL: | +86-13902471751 |
| E-mail: | Wangxuebo_11@hotmail.com |
| US Agent: | Pan Angels Corp: |
| Address: | 3330 Fowler Street, Los Angeles, CA 90063, U.S.A |
| TEL: | (323)422-8581 |
| Contact person : | Mr. Michael Kim |
2. Submission Devices Information:
Trade/Proprietary Name: U&J Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roll Common Name: Plasma Sterilization Pouch / Roll Classification name: Sterilization Wrap Class: Il FDA review panel code: INCB Product code: FRG - sterilization wrap CFR Regulation Number: 21CFR 880.6850
3. Predicate Devices Information:
Trade Name: Tyvek Pouch/Roll with STERRAD Chemical Indicator 510(K) Number: K103210 Manufacturer: Advanced Sterilization Products Company.
4. Devices Description:
The U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roll are manufactured from TYVEK 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 TYVEK conforms to recognized material standards and can be sterilized by STERRAD 100 NX Hydrogen Peroxide Gas Plasma. The Sterilization Pouch has the same intended use, Essential Component, Raw material, Sterilization method, manufacturing methods and same technological characteristics as these predicate devices. Substantial equivalent to the predicate device was established by physical testing of the TYVEK (pressure drop vs. flow and filtration efficiency) and film (thickness, tensile strength and elongation) from non-sterile, sterilized finished devices, as well as, performance of these finished devices (seal strength, package burst, dye migration).
The pouches are manufactured from TYVEK that is thermally sealed to laminated film on the left, right, and bottom of pouch. The fourth side has an adhesive tape that is used to that is
[PMN-510(K) SUBMISSION]
1
510(k) Submission
U&U ChangZhou Medical Packaging Technology Co., Ltd Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China U&U (HONGKONG) Medical Technology Co., Limited RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN HONG KONG [Gas Plasma Sterillzation Pouch / Roll]
Rev 1.02 21/02/14
used to seal the pouch or heat-sealed by the heat-seal machine prior to sterilization of the enclosed medical device.
5. Model numbers of the pouches:
| Ref | Model | Description | Size |
|---|---|---|---|
| Number | Number | ||
| UUP0001 | UUP | TYVEK Pouch-Heat-Seal and Self-Seal | 3" X 8" |
| UUP0002 | UUP | TYVEK Pouch-Heat-Seal and Self-Seal | 4" X 10.25" |
| UUP0003 | UUP | TYVEK Pouch-Heat-Seal and Self-Seal | 6" X 12.5" |
| UUP0004 | UUP | TYVEK Pouch-Heat-Seal and Self-Seal | 4" X 14" |
| UUP0005 | UUP | TYVEK Pouch-Heat-Seal and Self-Seal | 8" X 16" |
| UUP0006 | UUP | TYVEK Pouch-Heat-Seal and Self-Seal | 6" X 16.5" |
| UUP0007 | UUP | TYVEK Pouch-Heat-Seal and Self-Seal | 10" X 19" |
| UUP0008 | UUP | TYVEK Pouch-Heat-Seal and Self-Seal | 12.5" X 22" |
| UUR0001 | UUR | TYVEK Roll-Heat-seal | 3" X 228' |
| UUR0002 | UUR | TYVEK Roll-Heat-seal | 4" X 228' |
| UUR0003 | UUR | TYVEK Roll-Heat-seal | 6" X 228' |
| UUR0004 | UUR | TYVEK Roll-Heat-seal | 14" X 228' |
| UUR0005 | UUR | TYVEK Roll-Heat-seal | 16.5" X 228' |
| UUR0006 | UUR | TYVEK Roll-Heat-seal | 20" X 228' |
5. Intended Use:
U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roll are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD 100NX Hydrogen Peroxide Gas Plasma sterilizer.
The recommended Hydrogen Peroxide Gas Plasma cycle parameter: STERRAD 100NX STANDARD Cycle
Sterlization load claim:
STERRAD 100NX Sterilizer Standard cycle:
· General medical instruments (metal and nonmetal, including hinged devices)
· Instruments with single-channel stainless steel lumens with an Internal diameter 3 mm or larger and length 150 mm or shorter.
• Polyethylene and Teflon lumen tubing with an internal diameter of 3 mm or larger and length of 500 mm or shorter.
· These items must be sterilized without any additional load items
• Limit of 20 pieces of tubing per cycle
Load condition: One device per Sterilization Pouch.
Load chamber: Two shelves (total weight: 21.4 Ibs or 9.7 kg)
Load Pouch: Leave enough material beyond the seal for the opener to easily grasp (usually 1- 1 % inches).
SHELF LIFE: It is recommended that the products are put to their end use within 2 years of manufacture. The recommended "best before" date and the manufacturing date are stated on the label. This device was demonstrated to maintain sterility of the contents for 30 days after Sterilization.
[PMN-510(K) SUBMISSION]
2
| U&U ChangZhou Medical Packaging Technology Co., Ltd
Dongzhou Village, Hengshanglao, Changzhou, Jiangsu, China
U&U (HONGKONG) Medical Technology Co., Limited
RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN HONG KONG
[Gas Plasma Sterilization Pouch / Roll] | | 510(k) Submission
|
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|-----------------------|
| | | |
| | | |
| | Rev 1.02 | 21/02/14 |
6. Technological Characteristics:
Performance testing was conducted to show that the U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roll maintain sterility until the seal of the Pouch/Roll is opened.
6.1 Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roll Performance Tests
| Element | Results |
|---|---|
| Sterilant Penetration | PASSED |
| Package Integrity | PASSED |
| Maintenance of Package Integrity | PASSED |
| Material Compatibility | PASSED |
| Shelf-Life | PASSED |
| Biocompatibility | PASSED |
| Performances | PASSED |
| Biocompatibility | PASSED |
6.2 Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roll Comparison Table
| Element of Comparison | Submission Device | Predicate Device
K103210 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Pouch Construction:
Tyvek | YES | YES |
| Film | YES | YES |
| User Heat Seal | YES | YES |
| User Self Seal | YES | YES |
| Single Use Device | YES | YES |
| Shelf-Life | 2 Years, This device was
demonstrated to
maintain sterility of the
contents for 30 days
after Sterilization. | 2 Years |
| Labeling | Meet the requirements of
21 CFR Part 801 | Meet the requirements of
21 CFR Part 801 |
7. Conclusion:
The materials, intended use, performance, function, and operational features of both the submitted device and the predicate device are substantially equivalent.
END
โคพท-240(K) ลักษณะระเวณ์
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a stylized human figure embracing a sphere, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2014
U&U Medical Technology Company, Limited Mr. Garfield Wang General Manager Dongshou Village, Hengshangiao, Changzhou, Jiengsu 213119 CHINA
Re: K123162
Trade/Device Name: U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roll Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 23, 2014 Received: January 29, 2014
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. Iisting 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.
4
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 (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 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/ResourcesforYou/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/Safetv/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/Resourcesfor You/Industry/default.htm.
Image /page/4/Picture/7 description: The image shows a signature and some text. The text includes "Sincerely yours," "Tejashri Purohit-Sheth, M.D.," "Clinical Deputy Director," and "DAGRID." There is also a large, stylized signature to the left of the text. The word "FOR" is at the bottom right.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
610(k) Submission
U&U ChangZhou Modical Packaging Tochnology Co., Ltd
Dongzhou Village,Hengshanqfao,Changzhou,Jiangsu,China U&U (HONGKONG) Modical Technology Co., Limited RM C1-D &F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN HONG KONG [Gas Plasma Sterllization Pouch / Roll]
Rev 1.02 21/02/14
Sec 004 Indications for Use
510(k) Number (if known): K123162
Device Name: U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roll
Indications for Use
U&U Hydrogen Peroxide Gas Plasma Sterillzation Pouch / Roll are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD 100NX Hydrogen Peroxide Gas Plasma sterilizer.
The recommended Hydrogen Peroxide Gas Plasma cycle parameter: STERRAD 100NX STANDARD Cycle
Sterilization load claim:
STERRAD 100NX Sterilizer Standard cycle:
· General medical instruments (metal and nonmetal, including hinged devices)
· Instruments with single-channel stalniess steel lumens with an Internal diameter 3 mm or larger and length 150 mm or shorter.
· Polyethylene and Teflon lumentubing with an internal diameter of 3 mm or larger and length of 500 mm or shorter.
· These items must be sterilized without any additional load items
· Limit of 20 pieces of tubing per cycle
Load condition: One device per Sterilization Pouch.
Load chamber: Two shelves (total weight: 21.4 Ibs or 9.7 kg)
Load Pouch: Leave enough material beyond the seal for the opener to easily grasp (usually 1- 1 % inches).
SHELF LIFE: It is recommended that the products are put to their end use within 2 years of manyfacture. The recommended "best before" date and the manufacturing date are stated on the label. This device was demonstrated to maintain sterility of the contents for 30 days after Sterilization.
AND/OR Over-The-Counter Use Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Elizabeth F. Gave 2014.02.24 17:35:14 =05'00'
[PMN-510{K) SUBMISSION]
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