(248 days)
Not Found
No
The device is a chemical indicator that changes color based on exposure to steam sterilization, with no mention of AI or ML in the description or performance studies.
No.
The device is a sterilization indicator used to verify the effectiveness of a sterilization process, not to treat a medical condition or disease.
No
Explanation: The device is a chemical indicator used to confirm exposure to a sterilization process, not to diagnose a medical condition.
No
The device is a physical chemical indicator tape and strip, not software.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is designed to "demonstrate that the unit or load has been exposed to a sterilization process and to distinguish between processed and unprocessed units or loads." This is a diagnostic function – it's providing information about the state of a sterilization process.
- Mechanism: The device uses a chemical indicator that changes color based on exposure to steam sterilization. This is a chemical reaction used to provide a diagnostic result.
- Regulatory Context: The document mentions following the "FDA Guidance document for Industry and FDA Staff entitled, 'Premarket Notification [5 10(k)] Submissions for Chemical Indicators,'" and "AAMI.ISO 11140-1: Sterilization of health care products — Chemical indicators Part 1: General requirements." These are standards and guidance documents specifically relevant to medical devices, including those used in sterilization processes, which often fall under the IVD category when they provide information about the effectiveness of a process related to patient care.
- Predicate Devices: The listed predicate devices (3m Autoclave Tapes and 3m Steam Sterilization Indicator) are also typically classified as IVDs.
While the device doesn't directly test a biological sample from a patient, it is used to assess the effectiveness of a process (sterilization) that is critical for patient safety in a healthcare setting. Devices used to monitor and validate sterilization processes are commonly regulated as IVDs because they provide diagnostic information about the process's success.
N/A
Intended Use / Indications for Use
The U&U Sterilization indicator tapes and strips are designed to demonstrate that the unit or load has been exposed to a sterilization process and to distinguish between processed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from off yellow to Dark brown/Black.
Use the U&U Sterilization indicator tapes and strips in steam sterilization processes described below.
-
- 121°C, 30 minutes; Gravity Steam
-
- 132°C, 4 minutes; Dynamic Air Removal Steam
-
- 135°C, 3 minutes; Dynamic Air Removal Steam
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The U&U Sterilization Indicator Tape is designed for use with steam sterilization as a method of securing packs and identifying processed from unprocessed items.
The U&U Sterilization Indicator Strip is a paper strip printed with a chemical indicator ink that turns from yellow to dark brown/black when exposed to the steam sterilization process. It is designed to indicate whether steam has penetrated to the point of placement of the strip, An internal chemical indicator should be used inside each pack to be sterilized.
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)
Validation of the U&U Sterilization Indicator Tape and Strip included performance testing in steam sterilizer, biocompatibility, storage condition, shelf life. All results, from testing meet the predetermined acceptance criteria.
All testing followed the FDA Guidance document for Industry and FDA Staff entitled, "Premarket Notification [5 10(k)] Submissions for Chemical Indicators,". And AAMI.ISO 11140-1: Sterilization of health care products — Chemical indicators Part 1: General requirements
Based on the nonclinical tests performed the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device, K932129 3m Autoclave Tapes and K801057 3m Steam Sterilization Indicator (21 CFR 880.2800 (b), Product code JOJ)
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
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains two logos. The first logo is the Department of Health & Human Services - USA logo, which features a stylized human figure. The second logo is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration in blue text to the right of the square.
February 22, 2018
U&U Medical Technology Co., Ltd Xuebo Wang Gm Dongzhou Village Hengshanqiao Changzhou, 213119 CN
Re: K171823
Trade/Device Name: U&U Indicator Tape and Strip Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: December 26, 2017 Received: January 4, 2018
Dear Xuebo 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Michael J. Ryan -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) K171832
Device Name U&U Indicator tape and strip
Indications for Use (Describe)
The U&U Sterilization indicator tapes and strips are designed to demonstrate that the unit or load has been exposed to a sterilization process and to distinguish between processed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from off yellow to Dark brown/Black.
Use the U&U Sterilization indicator tapes and strips in steam sterilization processes described below.
-
- 121°C, 30 minutes; Gravity Steam
-
- 132°C, 4 minutes; Dynamic Air Removal Steam
-
- 135°C, 3 minutes; Dynamic Air Removal Steam
| 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
Rev 1.00 12/12/17
K171823 510(K) Summary
This 510(k) summary is being submitted in accordance with 21 CFR §807.92
Date Prepared: 2017-12-12 Submission Numbers for 510(k) Submission: K171823
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: | Xuebo Wang |
| TEL: | +86-13564751751 |
| E-mail: | wangxuebo_11@hotmail.com |
US Agent:
| Name: | U&U Medical Inc.. |
|---|---|
| Address: | 1580 Boggs Rd, Suite 500, Duluth, GA 30096 |
| TEL: | 404 426 1248 |
| Contact person : | Ms. LI QIAN li@UU-Medicalus.com |
2. Submission Devices Information:
Trade/Proprietary Name: U&U Indicator Tape and Strip Common Name: Process Indicator Tape, Process indicator Strip Classification name: indicator, physical/chemical sterilization process Class: II, 21CFR 880.2800(b) FDA review panel code: General Hospital Product code: JOJ
3. Predicate Devices Information:
| Trade Name: | 3m Autoclave Tapes |
|---|---|
| 510(K) Number: | K932129 |
| Manufacturer: | 3M Health Care |
| Trade Name: | 3m Steam Sterilization Indicator |
| 510(K) Number: | K801057 |
| Manufacturer: | 3M Health Care |
4. Device Description:
The U&U Sterilization Indicator Tape is designed for use with steam sterilization as a method of securing packs and identifying processed from unprocessed items.
The U&U Sterilization Indicator Strip is a paper strip printed with a chemical indicator ink that turns from yellow to dark brown/black when exposed to the steam sterilization process. It is designed to indicate whether steam has penetrated to the point of placement of the strip, An internal chemical indicator should be used inside each pack to be sterilized.
4
Rev 1.00 12/12/17
Model Number:
| Ref
Number | Model
Number | Description | Size |
|---------------|-----------------|-----------------------------------|--------------|
| UUST0001 | UUST | U&U Sterilization Indicator Tape | 12mm X 55m |
| UUST0002 | UUST | U&U Sterilization Indicator Tape | 18mm X 55m |
| UUST0003 | UUST | U&U Sterilization Indicator Tape | 24mm X 55m |
| UUST0004 | UUST | U&U Sterilization Indicator Tape | 48mm X 55m |
| UUSS0001 | UUSS | U&U Sterilization Indicator Strip | 15mm X 200mm |
5. Intended Use:
The U&U Sterilization indicator tapes and strips are designed to demonstrate that the unit or load has been exposed to a sterilization process and to distinguish between processed and unprocessed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from off yellow to Dark brown/Black.
Use the U&U Sterilization Indicator tapes and strips in steam sterilization processes described below.
-
- 121 ℃, 30 minutes; Gravity Steam
-
- 132°C , 4 minutes; Dynamic Air Removal Steam
-
- 135°C , 3 minutes; Dynamic Air Removal Steam
6. TECHNOLOGICAL CHARACTERISTICS COMPARISON:
the U&U Sterilization Indicator Tape and Strip Comparison table:
| Element of
| Comparison | Submission Device | Predicate Device K932129 | Predicate Device K801057 |
|---|---|---|---|
| Intended Use | U&U Sterilization indicator tapes | ||
| are designed to demonstrate that | |||
| the unit or load has been | |||
| exposed to a sterilization process | |||
| and to distinguish between | |||
| processed and unprocessed units | |||
| or loads.. | 3m Autoclave Tapes is a | ||
| single use device intended to | |||
| be used to exposed to the | |||
| sterilization process and to | |||
| distinguish between | |||
| processed and unprocessed | |||
| packs.. | 3m Steam Sterilization Indicator | ||
| is a single use device intended | |||
| to be used to exposed to the | |||
| sterilization process and to | |||
| distinguish between processed | |||
| and unprocessed packs.. | |||
| Class | Class 1 | Class 1 | Class 1 |
| Device Design | Crepe paper printed with indicator | ||
| lines. Provided in beige colored | Crepe paper printed with | ||
| indicator lines. Provided in | |||
| beige colored | paper printed with indicator | ||
| lines. Provided in beige colored | |||
| Size | Tape: (12mm, 18mm ,24mm and | ||
| 48mm) X 55m | |||
| Strip: 15mm X 200mm | (12mm, 18mm ,24mm and | ||
| 48mm) X 55m | 15mm X 200mm | ||
| Indicator Agent | Indicator Ink | Indicator Ink | Indicator Ink |
| Endpoint Color | Dark brown/Black | Dark brown/Black | Dark brown/Black |
| Sterilization | |||
| Method | Steam | Steam | Steam |
| Endpoint | 121 °C, 10 minutes; | ||
| 132 °C, 2 minutes; | |||
| 135 °C, 2 minutes; | 121 °C, 10 minutes; | ||
| 134 °C, 2 minutes; | 121 °C, 10 minutes; | ||
| 134 °C, 2 minutes; |
5
510(k) Submission
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
| Indictor Color
Change
Performance | Shall show a visible color change
when exposure to endpoint
parameters. | Shall show a visible color change
when exposure to endpoint
parameters. | Shall show a visible color change
when exposure to endpoint
parameters. | Rev 1.00
12/12/17 |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Recommended
Storage
Conditions: | Store in a dry (