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

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.

AI/ML Overview

The provided text is a 510(k) summary for the U&U Indicator Tape and Strip, a chemical sterilization process indicator. It describes the device, its intended use, comparison to predicate devices, and non-clinical testing. However, it does not contain information about an AI/ML-based medical device study.

Therefore, I cannot extract the detailed information requested regarding acceptance criteria and study data for an AI/ML device, as the document is about a different type of medical device (chemical indicator).

Here's why the requested information cannot be found in the provided text:

Device Type: The device is a "U&U Indicator Tape and Strip," a "Sterilization Process Indicator." These are chemical indicators that change color based on exposure to sterilization conditions. They are not AI/ML-based devices.
Study Type: The document refers to "Non-Clinical Testing" including performance testing in a steam sterilizer, biocompatibility, storage conditions, and shelf life. This is typical testing for physical/chemical indicators, not for AI/ML algorithm validation.
No Mention of AI/ML: There is no mention of algorithms, machine learning, artificial intelligence, datasets, human readers, or any other terms associated with AI/ML device studies.
No Human Interpretation Component: The device's function is a direct color change, not an interpretation of complex data that would require AI or human experts for ground truth.

Therefore, I cannot fill in the table or answer the specific questions about AI/ML device studies based on the provided text.

Summary

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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);

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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

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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.

1. 121°C, 30 minutes; Gravity Steam
1. 132°C, 4 minutes; Dynamic Air Removal Steam
1. 135°C, 3 minutes; Dynamic Air Removal Steam

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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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,ChinaRM 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.

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Rev 1.00 12/12/17

Model Number:

RefNumber	ModelNumber	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:

Use the U&U Sterilization Indicator tapes and strips in steam sterilization processes described below.

1. 121 ℃, 30 minutes; Gravity Steam
1. 132°C , 4 minutes; Dynamic Air Removal Steam
1. 135°C , 3 minutes; Dynamic Air Removal Steam

6. TECHNOLOGICAL CHARACTERISTICS COMPARISON:

the U&U Sterilization Indicator Tape and Strip Comparison table:

Element ofComparison	Submission Device	Predicate Device K932129	Predicate Device K801057
Intended Use	U&U Sterilization indicator tapesare designed to demonstrate thatthe unit or load has beenexposed to a sterilization processand to distinguish betweenprocessed and unprocessed unitsor loads..	3m Autoclave Tapes is asingle use device intended tobe used to exposed to thesterilization process and todistinguish betweenprocessed and unprocessedpacks..	3m Steam Sterilization Indicatoris a single use device intendedto be used to exposed to thesterilization process and todistinguish between processedand unprocessed packs..
Class	Class 1	Class 1	Class 1
Device Design	Crepe paper printed with indicatorlines. Provided in beige colored	Crepe paper printed withindicator lines. Provided inbeige colored	paper printed with indicatorlines. Provided in beige colored
Size	Tape: (12mm, 18mm ,24mm and48mm) X 55mStrip: 15mm X 200mm	(12mm, 18mm ,24mm and48mm) X 55m	15mm X 200mm
Indicator Agent	Indicator Ink	Indicator Ink	Indicator Ink
Endpoint Color	Dark brown/Black	Dark brown/Black	Dark brown/Black
SterilizationMethod	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;

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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 ColorChangePerformance	Shall show a visible color changewhen exposure to endpointparameters.	Shall show a visible color changewhen exposure to endpointparameters.	Shall show a visible color changewhen exposure to endpointparameters.
RecommendedStorageConditions:	Store in a dry (<50% RH)condition at room temperature[15-30°C (59-86°F)] and protectfrom direct light. Do not storenear strong alkaline or acidicproducts such as cleaning ordisinfecting agents.	Store in a dry (<50% RH)condition at roomtemperature [15-30°C (59-86°F)] and protect fromdirect light. Do not store nearstrong alkaline or acidicproducts such as cleaning ordisinfecting agents.	Store in a dry (<50% RH)condition at room temperature[15-30°C (59-86°F)] and protectfrom direct light. Do not storenear strong alkaline or acidicproducts such as cleaning ordisinfecting agents.
Shelf Life	After use the indicator will notchange visually within 6 monthswithin Recommended StorageConditions.	After use the indicator willnot change visually within 6months withinRecommended StorageConditions.	After use the indicator will notchange visually within 6 monthswithin Recommended StorageConditions.
PerformanceStandards	AAMI 11140-1	AAMI 11140-1	AAMI 11140-1

7. Non-Clinical Testing:

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

8. Conclusion:

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)

Regulation Number and Section

§ 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).