U&U Bowie-Dick Test Pack

K143629 · U&U Medical Technology Co, Ltd. · JOJ · May 19, 2015 · General Hospital

Device Facts

• Record ID: K143629
• Device Name: U&U Bowie-Dick Test Pack
• Applicant: U&U Medical Technology Co, Ltd.
• Product Code: JOJ · General Hospital
• Decision Date: May 19, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

U&U Bowie-Dick Test Pack are designed for testing air removal efficiency of dynamic-air-removal prevacuum steam sterilizers operating at 134 degree C (273 degree F) for 3.5 minutes. The U&U Bowie-Dick Test Pack is for single use and will demonstrate a uniform color change from yellow to dark brown/black when proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C (+1°C /-0°C) temperature difference between the center of the Bowie-Dick Test Pack, as identified in ANSI/AAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the U&U Bowie-Dick Test Pack will demonstrate a non-uniform color change

Device Story

Single-use chemical indicator pack for steam sterilizer performance monitoring. Input: steam and air within sterilizer chamber. Operation: porous substrate and reticulated foam layers simulate towel pack air resistance; steam-sensitive chemical indicator ink (lithium carbonate, triethylamine, n-propanol) on paper sheet changes color based on steam penetration. Output: uniform color change (yellow to dark brown/black) indicates successful air removal; non-uniform color change indicates air removal failure (air leak). Used in clinical/hospital sterilization departments. Healthcare providers visually inspect the indicator sheet post-cycle to verify sterilizer function; failure to achieve uniform color indicates potential sterilization cycle inadequacy, prompting investigation of sterilizer performance before use of processed items.

Clinical Evidence

Bench testing only. Validation included performance testing in dynamic-air-removal steam sterilizers, biocompatibility (MTT cytotoxicity test), storage stability, and shelf life. Testing confirmed the device meets ANSI/AAMI/ISO 11140-5 and AAMI ST66 requirements for Class 2 indicators. Results demonstrated uniform color change at 134°C for 3.5 minutes and non-uniform color change under fault conditions (2°C temperature differential). Biocompatibility testing showed no cytotoxic potential.

Technological Characteristics

Single-use pack containing a chemical indicator sheet, porous substrate (food packaging board), and reticulated polyurethane foam. Dimensions: 140x140x18mm. Indicator ink contains lithium carbonate, triethylamine, and n-propanol. Operates via steam-sensitive color change. Complies with ANSI/AAMI/ISO 11140-5 and AAMI ST66. No electronic components or software.

Indications for Use

Indicated for testing air removal efficiency in dynamic-air-removal prevacuum steam sterilizers operating at 134°C for 3.5 minutes.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• 3M Comply Bowie-Dick Type Lead Free Test Pack (K093199)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 19, 2015

U&U Medical Technology Co., Ltd. C/O Ms. Li Qian Official Correspondent CARELIFE (USA), Inc. 1580 Boggs Rd. Suite 500/600 Duluth, Georgia 30096

Re: K143629

Trade/Device Name: U&U Bowie-Dick Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Chemical Indicator/Physical/Chemical sterilization process indicator Regulatory Class: II Product Code: JOJ Dated: April 15, 2015 Received: April 20, 2015

Dear Ms. Li Qian:

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.

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Page 2 - Ms. Li Qian

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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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

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# Indications for Use

510(k) Number (if known) K143629

Device Name U&U Bowie-Dick Test Pack

#### Indications for Use (Describe)

U&U Bowie-Dick Test Pack are designed for testing air removal efficiency of dynamic-air-removal prevacuum steam sterilizers operating at 134 degree C (273 degree F) for 3.5 minutes. The U&U Bowie-Dick Test Pack is for single use and will demonstrate a uniform color change from yellow to dark brown/black when proper sterilization are met and no air is present. If enough air is present to create a 2°C (+1°C /-0°C) temperature difference between the center of the Bowie-Dick Test Pack, as identified in ANSI/AAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the U&U Bowie-Dick Test Pack will demonstrate a non-uniform color change

| 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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Rev 0.03 15/05/15

## 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: 2015-05-15 Submission Numbers for Pre-Submission: K143629

#### 1. Submitter Name and Address:

| Name: | U&U Medical Technology Co., Ltd |
|-----------------|---------------------------------------------------------------------------------------------------------------------------|
| Address: | Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China<br>RM EE1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China |
| Contactor Name: | Garfield Wang |
| TEL: | [phone] |
| E-mail: | [e-mail] |

#### US Agent:

| Name: | CARELIFE (USA) INC. |
|------------------|----------------------------------------------|
| Address: | 1580 Boggs Rd, Suite 500/600 Duluth GA 30096 |
| TEL: | 404 6612228 |
| Contact person : | Ms. LI QIAN [e-mail] |

#### 2. Submission Devices Information:

Trade/Proprietary Name: U&U Bowie-Dick Test Pack Common Name: Bowie-Dick Test Pack Classification name: indicator, physical/chemical sterilization process Class: II FDA review panel code: General Hospital Product code: JOJ Regulation Number: 21 CFR 880.2800

#### 3. Predicate Devices Information:

| Trade Name: | 3M Comply Bowie-Dick Type Lead Free Test Pack |
|----------------|-----------------------------------------------|
| 510(K) Number: | K093199 |
| Manufacturer: | 3M Health Care |

#### 4. Devices Description:

The U&U Bowie-Dick Test Pack is equivalent in performance to the Bowie-Dick towel pack described in AAMI ST66. The test pack consists of a chemical indicator test sheet positioned within a pack of porous sheets. The test sheet contains a steam-sensitive chemical indicator ink printed on paper as a yellow-colored pattern. The test sheet will turn a uniform dark brown/black color except when air removal failures such as air leaks occur. An air removal failure is indicated by a lighter-colored area in the indicator ink pattern of an otherwise dark-colored test sheet.

Model Number:

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510(k) Submission

U&U ChangZhou Medical Packaging Technology Co., Ltd Dongzhou Village,Hengshangiao,Changzhou,Jiangsu,China U&U (Shanghai) Medical Technology Co., Limited RM EÈ1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China [Bowie-Dick Test Pack]

Rev 0.03 15/05/15

| Ref<br>Number | Model<br>Number | Description | Size |
|---------------|-----------------|--------------------------|--------------|
| UUBD0001 | UUBDTP | U&U Bowie-Dick Test Pack | 140X140X18mm |

### 5. Intended Use:

U&U Bowie-Dick Test Pack are designed for testing air removal efficiency of dynamic-airremoval prevacuum steam sterilizers operating at 134 degree C (273 degree F) for 3.5 minutes. The U&U Bowie-Dick Test Pack is for single use and will demonstrate a uniform color change from yellow to dark brown/black when proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C (+1°C /-0°C) temperature difference between the center of the Bowie-Dick Test Pack, as identified in ANSI/AAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the U&U Bowie-Dick Test Pack will demonstrate a non-uniform color change

## 6. Technical Design and Performance Characteristics:

The U&U Bowie-Dick Test Pack uses impermeable lavers on the top and bottom to direct steam and enhances the air capture qualities. A precisely controlled pad of porous substrate is used to establish a matrix for the formation of an air bubble and to act as a reservoir of air simulating the towels in a conventional large towel pack.

The reticulated foam layer acts as a steam pathway for the control of air bubble alignment and insulates the indicator from radiant heat emanating from the hot surface of the sterilizer chamber. Air is evacuated from the chamber and the test pack during the pre-vacuum cycle. If an air leak is present, air will bleed back into the chamber as a vacuum is pulled. Since air is much cooler and heavier than steam, it will be forced to the bottom of the chamber near the drain when the steam valves opens. As pressure begins to increase, the air and then the steam enters the pack from the sides and top of the reticulated foam pathway at the top of the pack. The steam pressure compresses the air into a bubble and pushes it toward the bottom of the pack. As the steam pressure increases, the air bubble is squeezed smaller and smaller until the pressure stabilizes.

## 7. SUBSTANTIAL EQUIVALENCE DISCUSSION:

U&U Medical Technology Co., Ltd is claiming substantial equivalence for its U&U Bowie-Dick Test Pack to the 3M Comply Bowie-Dick Type Lead Free Test Pack (K093199) based on test data obtained during validation studies. We have demonstrated with testing that the U&U Bowie-Dick Test Pack performs consistently with results which indicate that the indicator is sensitive enough to detect when enough air is left within the sterilizer chamber to create a 2°C (+1° /-0°C) temperature difference between the center of the Bowie-Dick Test Pack, as identified in ANSI/AAMI/ISO 11140-5. Under these conditions, the indicator sheet would demonstrate a non-uniform color change. The U&U Bowie-Dick Test Pack is also comparable to other commercially available Bowie Dick test packs cleared by the FDA.

Comparison table:

| Element of<br>Comparison | Submission Device | Predicate Device K093199 |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | U&U Bowie-Dick Test Pack are designed<br>for testing air removal efficiency of | The 3MTM Comply Tm Bowie-Dick Type Lead<br>Free Test Pack is designed for testing air |
| | | |
| | dynamic-air-removal prevacuum steam<br>sterilizers operating at 134 °C (273°F) for<br>3.5 minutes. The U&U Bowie-Dick Test<br>Pack is for single use and will demonstrate<br>a uniform color change from yellow to dark<br>brown/black when proper sterilization<br>conditions are met and no air is present. If<br>enough air is present to create a 2°C (+1°<br>/-0°C) temperature difference between the<br>center of the Bowie-Dick Test Pack, as<br>identified in ANSI/AAMI/ISO 11140-5, and<br>the drain temperature at the beginning of<br>the final one minute of a three and half<br>minute cycle the U&U Bowie-Dick Test<br>Pack will demonstrate a non-uniform color<br>change | removal efficiency of 132- 134 °C(270- 273 F )<br>dynamic-air-removal steam sterilizers. |
| Raw Materials | Impermeable Layer - Frame Board<br>Reticulated Foam - Polyurethane<br>Porous Substrate - Food Packaging Board<br>Indicator Sheet - Indicator ink & paper<br>Disposable Wrap - Polypropylene Wrap<br>Label - Paper & Hotmelt Adhesive | Impermeable Layer - Frame Board<br>Reticulated Foam - Polyurethane<br>Porous Substrate - Food Packaging Board<br>Indicator Sheet - Inicator ink & paper<br>Disposable Wrap - Polypropylene Wrap<br>Label - Paper & Hotmelt Adhesive |
| Indicator Agent | Indicator Ink - Lithium carbonate (5-10%),<br>Triethylamine(1-5%) , Normal Propanol(1-<br>5%) | Indicator Ink - unknown |
| Chemical<br>Indicator Type | Air Removal Indicator For Test Pack | Air Removal Indicator For Test Pack |
| Endpoint Color | Dark brown/Black | Dark brown/Black |
| Sterilization<br>Method | dynamic-air-removal steam sterilizer | dynamic-air-removal steam sterilizer |
| Indictor Color<br>Change<br>Performance | The bowie-dick internal indicator system<br>shall show a uniform color after exposure<br>to saturated steam at 134°C for 3.5 min. | The bowie-dick internal indicator system shall<br>show a uniform color after exposure to saturated<br>steam at 134°C for 3.5 min. |
| Internal<br>Indicator Color<br>Change Fault<br>Performance | Color change fault condition (the<br>temperature at the center of the bowie-<br>dick test pack is 2°C lower than the<br>temperature of the chamber drain at the<br>beginning of the final 1 min of a 3.5 min<br>cycle at 134 °C). After exposure to<br>conditions used to produce a color change<br>fault condition in the bowie-dick test pack.<br>the internal indicator shall show a non-<br>uniform color change. | Color change fault condition (the temperature at<br>the center of the bowie-dick test pack is 2°C<br>lower than the temperature of the chamber drain<br>at the beginning of the final 1 min of a 3.5 min<br>cycle at 134 °C). After exposure to conditions<br>used to produce a color change fault condition in<br>the bowie-dick test pack. the internal indicator<br>shall show a non-uniform color change. |
| Recommended<br>Storage<br>Conditions: | Store in a dry (<50% RH) condition at room<br>temperature [15-30°C (59-86°F)] and<br>protect from direct light. Do not store near<br>strong alkaline or acidic products such as<br>cleaning or disinfecting agents. After use<br>the indicator will not change visually within<br>24 months when stored at above conditions. | Store in a dry (<50% RH) condition at room<br>temperature [15-30°C (59-86°F)] and protect<br>from direct light. Do not store near strong<br>alkaline or acidic products such as cleaning or<br>disinfecting agents. After use the indicator will<br>not change visually within 24 months when<br>stored at above conditions. |
| Shelf Life | The U&U BOWIE-DICK Test Pack has a 2-<br>year shelf life from the date of manufacture<br>when stored at recommended conditions.<br>The expiration date is printed on the label<br>that secures the test pack. | The 3M™ Comply™ Bowie-Dick Type Lead Free<br>Test Pack has a 2-year shelf life from the date of<br>manufacture when stored at recommended<br>conditions. The expiration date is printed on the<br>label that secures the test pack. |

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510(k) Submission

U&U ChangZhou Medical Packaging Technology Co., Ltd
Dongzhou Village,Hengshanqiao,Changzhou,Liangsu,China
U&U (Shanghai) Medical Technology Co., Limited
RM EE1002 1/F Buildin

15/05/15 Rev 0.03

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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

[Bowie-Dick Test Pack]

| Package<br>Material | Paper Box |
|---------------------|-----------|
|---------------------|-----------|

| | Paper Box |
|--|-----------|
|--|-----------|

510(k) Submission

Rev 0.03 15/05/15

## 8. Recommended Storage Conditions:

Store in a dry (<50% RH) condition at room temperature [15-30°C (59-86°F)] and protect from direct light. Do not store near strong alkaline or acidic products such as cleaning or disinfecting agents. After use the indicator will not change visually within 24 months when stored at above conditions.

## 9. Non-Clinical Testing:

Validation of the U&U Bowie-Dick Test Pack included performance testing in dynamic-airremoval 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 ST66: Sterilization of healthcare products - Chemical indicators - Part 2: Class 2 indicators for air removal test. And AAMI/ANSI/ISO 11140-5 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal test sheets and packs

| Testing Items | Code Requirement | Test Result |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Visual inspection | Inspect the Cleanliness of Bowie-dick test pack. | PASS |
| Dimensions | Width: 140±1mm<br>Length: 140±1mm<br>Height: 18±1mm | PASS |
| Endpoint Color | Dark brown/black | Black |
| Indicator Format | The bowie-dick internal indicator ink shall be<br>uniformly distributed on its substrate paper to<br>cover not less than 30 % of the test area of the<br>substrate paper. the indicator ink printed / the<br>substrate paper ≥ 30% | 66% |
| Indicator Color<br>Change<br>Performance | The bowie-dick internal indicator system shall<br>show a uniform color after exposure to saturated<br>steam at 134°C for 3.5 min. | PASS |
| Internal Indicator<br>Color Change Fault<br>Performance | Color change fault condition (the temperature at<br>the center of the bowie-dick test pack is 2°C<br>lower than the temperature of the chamber drain<br>at the beginning of the final 1 min of a 3.5 min<br>cycle at 134 °C). After exposure to conditions<br>used to produce a color change fault condition in<br>the bowie-dick test pack. the internal indicator<br>shall show a non-uniform color change. | PASS |
| Air Permeance<br>Performance | The bowie-dick test pack shall have an air<br>porosity not less than 1.7 µm/(Pa·s) when tested<br>in accordance with ISO 5636-3 at an air pressure<br>of 1.47 kPa | PASS |
| Toxicity | Non-toxic; In Vitro Cytotoxicity (MTT cytotoxicity<br>test) Test Result: Under the conditions of<br>cytotoxicity study, the viability of 100% extract of | PASS |

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510(k) Submission

15/05/15

Rev 0.03

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 [Bowie-Dick Test Pack]

| the test article was 76 %. It can be considered<br>that the article extracts had not a cytotoxic<br>potential. | | |
|----------------------------------------------------------------------------------------------------------------|--|--|
|----------------------------------------------------------------------------------------------------------------|--|--|

## 10. Conclusion:

U&U Medical Technology Co., Ltd is claiming substantial equivalence for its U&U Bowie-Dick Test Pack to the 3M Comply Bowie-Dick Type Lead Free Test Pack (K093199) based on test data obtained during validation studies. We have demonstrated with testing that the U&U Bowie-Dick Test Pack performs consistently with results which indicate that the indicator is sensitive enough to detect when enough air is left within the sterilizer chamber to create a 2°C (+1° /-0°C) temperature difference between the center of the Bowie-Dick Test Pack, as identified in ANSI/AAMI/ISO 11140-5. Under these conditions, the indicator sheet would demonstrate a non-uniform color change.

## 11. BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

Based on the intended use, technological characteristics, performance data and nonclinical tests performed, the subject U&U Bowie-Dick Test Pack is substantially equivalent and is as safe and as effective as the legally marketed predicate device, 3M Comply Bowie-Dick Type Lead Free Test Pack cleared under K093199'.

END