BH Sterilization Pouch

K172280 · Bh Medical Products Co., Ltd. · FRG · Aug 3, 2018 · General Hospital

Device Facts

• Record ID: K172280
• Device Name: BH Sterilization Pouch
• Applicant: Bh Medical Products Co., Ltd.
• Product Code: FRG · General Hospital
• Decision Date: Aug 3, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The BH sterilization pouch is intended to provide dentists with an effective method to enclose devices intended for sterilization in steam auto claves. The recommended pre-vacuum steam sterilization cycle parameters are 4 minutes at 132°C (270°F). The sterilization pouch maintains the enclosed devices up until 180 days post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the pouch has undergone a steam sterilization process. Only one instrument can be sterilized in one pouch and only instruments that are be metal, hinged, or knurled can be sterilized in the pouch.

Device Story

Disposable sterilization pouch; medical-grade paper and plastic film (CPP/PET); heat-sealed on three sides with adhesive strip for closure. Used by dentists to enclose single metal, hinged, or knurled instruments for steam autoclave sterilization (4 min at 132°C). External chemical ink indicator changes color upon steam exposure to confirm processing. Maintains sterility for up to 180 days. Bench testing confirms seal integrity, sterilant penetration, and biocompatibility.

Clinical Evidence

Bench testing only. Evaluated sterility maintenance (180 days), thermal profile/sterilant penetration (ANSI/AAMI ST8, ST79), microbial aerosol challenge (ASTM 1608), seal strength (ASTM F88), seal leaks (ASTM F1929), internal pressurization (ASTM F1140), chemical indicator efficacy (ISO 11140-1), and biocompatibility (ISO 10993-5, 10993-10). All tests met acceptance criteria.

Technological Characteristics

Materials: Medical grade paper, CPP/PET film, PU adhesive, steam process indicator ink. Dimensions: Various sizes (e.g., 190mmx330mm to 90mmx230mm). Sterilization: Pre-vacuum steam (132°C). Standards: ISO 11140-1 (indicators), ISO 10993 (biocompatibility), ASTM F88/F1929/F1140 (performance). Single-use, disposable.

Indications for Use

Indicated for dentists to enclose single metal, hinged, or knurled instruments for steam autoclave sterilization.

Regulatory Classification

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.

Predicate Devices

• Medicom Self Sealing Sterilization Pouch (K070428)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Next to the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

BH Medical Products Co., Ltd. Edward Tao Manager No.90 Shenjiang Villagers Group, Zhangjiacunwei, Xilin Street Changzhou, 213024 Cn

Re: K172280

Trade/Device Name: BH Sterilization Pouch Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT, JOJ Dated: July 7, 2018 Received: July 9, 2018

Dear Edward Tao:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Clarence W. Murray lii III -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) K172280

Device Name BH Sterilization Pouch

#### Indications for Use (Describe)

The BH sterilization pouch is intended to provide dentists with an effective method to enclose devices intended for sterilization in steam auto claves. The recommended pre-vacuum steam sterilization cycle parameters are 4 minutes at 132°C (270°F). The sterilization pouch maintains the enclosed devices up until 180 days post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the pouch has undergone a steam sterilization process. Only one instrument can be sterilized in one pouch and only instruments that are be metal, hinged, or knurled can be sterilized in the pouch.

| Product Code # | Size | Maximum load size(LxWxH)/mm | Maximum load weight/kg |
|----------------|-------------------------|-----------------------------|------------------------|
| 990618 | 7 1/2"x13"(190mmx330mm) | 147mmx255mmx18mm | 2 |
| 990617 | 5 1/4"x10"(135mmx260mm) | 92mmx190mmx18mm | 2 |
| 990613 | 4 1/4"x11"(110mmx300mm) | 73mmx240mmx12mm | 2 |
| 990616 | 3 1/2"x9"(90mmx230mm) | 47mmx175mmx18mm | 1.2 |

Type of Use (Select one or both, as applicable)

| <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> |
|--------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# 510(k) Summary

# [As Required by 21 CFR 807.92]

Submission Number: K172280

- BH Medical Products Co., Ltd. Submitter: No.90 Shenjiang Villagers' group, Zhangjiacunwei, Xilin Street, Zhonglou District, Changzhou City, Jiangsu Province, People's Republic of China (Establishment registration number: 3009307523)
- Contact Person: Xiaohua TAO President Tel: [phone] Fax: [phone] Email: [e-mail]

Device/Trade Name: BH Sterilization Pouch Common Name: Sterilization wrap Device Panel: General Hospital Basis for Submission: New Device Regulation Name: 1) Sterilization wrap 2) Physical/chemical sterilization process indicator

Device Classification: Class II

Regulation Number: 21 CFR 880.6850 Product Code: 1) KCT

21CFR 880.2800 Product Code: 2) JOJ

# Predicate Device to BH Sterilization Pouch:

Trade Name: Medicom Self Sealing Sterilization Pouch 510(k) Number: K070428 Manufactured by: A.R. Medicom Inc. 1200 55th Avenue, Lachine, Quebec, H8T 3J8, Canada

### Device Description:

The pouches are made from a medical grade paper and plastic film that is heat sealed on three sides. The forth side has an adhesive strip that is used to seal the paper to the film prior to sterilization of the enclosed medical device. The medical grade paper conforms to recognized material standards and can be steam sterilized. The process indicator ink printed on the medical paper will exhibit a color change after the pouch is exposed to steam sterilization. The device is disposable, single use only.

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The process indicator of the pouch is a necessary visual component utilized by endusers to identify devices or products that have been subjected to a sterilization process. It complies with the requirements of ISO 11140-1 and the Guidance for Industry and FDA staff: Premarket Notification [510(k)] Submission for Chemical Indicators.

# Indications for Use:

The BH sterilization pouch is intended to provide dentists with an effective method to enclose devices intended for sterilization in steam autoclaves. The recommended prevacuum steam sterilization cycle parameters are 4 minutes at 132°C (270°F). The sterilization pouch maintains the enclosed devices up until 180 days post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. Only one instrument can be sterilized in one pouch and only instruments that are be metal, hinged, or knurled can be sterilized in the pouch.

| Product Code<br># | Size | Maximum load<br>weight/kg |
|-------------------|-------------------------|---------------------------|
| 990618 | 7 1/2"x13"(190mmx330mm) | 2 |
| 990617 | 5 1/4"x10"(135mmx260mm) | 2 |
| 990613 | 4 1/4"x11"(110mmx300mm) | 2 |
| 990616 | 3 1/2"x9"(90mmx230mm) | 1.2 |

## The BH sterilization pouch varies in the following sizes:

### Comparison of Technological Characteristics:

| | Predicate Device | Subject Device | Comments |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Device | Medicom Self Sealing<br>Sterilization<br>Pouch(K070428) | BH Sterilization Pouch | / |
| Product Code | KCT & JOJ | KCT & JOJ | Same |
| Indications for<br>Use | The self-sealing<br>sterilization pouches are<br>intended to provide<br>health care workers with<br>an effective method to<br>enclose devices intended<br>for sterilization in steam<br>auto claves and via<br>Ethylene Oxide(EO). The<br>recommended steam<br>sterilization cycle<br>parameters are 30 | The BH sterilization pouch<br>is intended to provide<br>dentists with an effective<br>method to enclose devices<br>intended for sterilization in<br>steam auto claves. The<br>recommended pre-vacuum<br>steam sterilization cycle<br>parameters are 4 minutes<br>at 132°C (270°F). The<br>sterilization pouch<br>maintains the enclosed<br>devices up until 180 days | Similar |
| | minutes at 121°C. The | post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. | |
| | recommended EO<br>sterilization cycle is<br>100-120 minutes at 50°C<br>with a relative humidity<br>between 60-85% and a<br>sterilant concentration of<br>600mg/L. Furthermore,<br>the sterilization pouch<br>maintains the enclosed<br>devices sterile up until<br>one year post<br>sterilization. Lastly, the<br>pouch's external<br>chemical ink indicators<br>are designed to indicate<br>to the user that the pouch<br>has undergone either a<br>steam or EO sterilization<br>process. | | |
| Material<br>Composition | Medical Grade Paper,<br>CPP, PET, PU adhesive,<br>EO and Steam Process<br>Indicator Print Ink | Medical Grade Paper,<br>Film(CPP/PET), PU<br>adhesive, Steam Process<br>Indicator Print Ink | Similar |
| Sterilization<br>cycles | The recommended steam<br>sterilization cycle<br>parameters are 30<br>minutes at 121°C. The<br>recommended EO<br>sterilization cycle is<br>100-120 minutes at 50°C<br>with a relative humidity<br>between 60%-85% and a<br>sterilant concentration of<br>600mg/L. | The recommended<br>Pre-vacuum steam<br>sterilization cycle<br>parameters are 4 minutes<br>at 132°C. | Different<br>sterilization<br>cycles |
| Design features | The pouches are<br>manufactured from a<br>medical grade paper that<br>is thermally sealed to a | The pouches are made<br>from a medical grade<br>paper and plastic film that<br>is heat sealed on three | Same |
| | left, right, and bottom of | adhesive strip that is used | |
| | pouch. The fourth side | to seal the paper to the | |
| | has an adhesive strip that | film prior to sterilization | |
| | is used to seal the paper | of the enclosed medical | |
| | to the film prior to | device. The medical grade | |
| | sterilization of the | paper conforms to | |
| | enclosed medical device. | recognized material | |
| | The pouches contain | standards and can be steam | |
| | external indicators used | sterilized. The process | |
| | to indicate the pouches | indicator ink printed on the | |
| | were processed via steam | | |
| | | medical paper will exhibit | |
| | or EO sterilization. | a color change after the | |
| | | pouch is exposed to steam | |
| | | sterilization. | |
| Sterility | Pouches maintain | Pouches maintain sterility | Similar |
| maintenance | sterility of the enclosure | of the enclosure device for | |
| | device for up to one year | up to 180 days post | |
| | post sterilization. | sterilization. | |
| Process | ANSI/AAMI/ISO | ANSI/AAMI/ISO | Same |
| Type 1 | 11140-1:2014 | 11140-1:2014 | |
| Chemical | Sterilization of health | Sterilization of health | |
| Indicator | care products- | care products- | |
| Efficacy | Chemical indicators- | Chemical indicators- | |
| | Part 1: General | Part 1:General | |
| | requirements. | requirements | |
| Process Type 1<br>Chemical<br>Indicator<br>Efficacy<br>Endpoint<br>Stability | 6 months | 180 days | Same |
| Process Type 1<br>Chemical<br>Indicator Shelf<br>Life | 2 years | 2 years | Same |
| Pouch<br>performance | The following test<br>methods were used in the<br>pouch performance<br>testing:<br>1. ASTM F88<br>2. ASTM F1929<br>3. ASTM F1140<br>In addition, the<br>process indicators<br>were evaluated in the<br>claimed EO and<br>Steam sterilization<br>cycle. | The following test<br>methods were used in<br>pouch performance<br>testing:<br>1. ASTM F88<br>2. ASTM F1929<br>3. ASTM F1140<br>In addition, the process<br>indicators were<br>evaluated in the<br>claimed steam<br>sterilization cycle. | Same |
| Sterilant<br>penetration | Sterilant penetration was<br>demonstrated in the<br>device. | Test results indicate that<br>sterilant penetration was<br>demonstrated Also the<br>device maintained steady<br>state thermal conditions<br>throughout the<br>recommended sterilization<br>cycle. | Same |

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| Biocompatibility | The following<br>biocompatibility testing<br>were performed on this<br>device:<br>1. ISO 10993-5<br>2. ISO10993-10<br>Based on the test<br>conditions of the test the<br>device was found to be<br>non-cytotoxic, non-<br>sensitizing and non-<br>irritating. | The following<br>biocompatibility testing<br>were performed on this<br>device:<br>1. ISO 10993-5<br>2. ISO10993-10<br>Based on the test<br>conditions the device was<br>found to be non-cytotoxic,<br>non-sensitizing and non-<br>irritating. | Same |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Usage | For single use only | For single use only | Same |
| Device models | Code Dimension | Model Size | Similar |

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| 68015 | 35mmx73mm | 990613 | 110mmx300mm |
|-------|-------------|--------|-------------|
| 68000 | 49mmx200mm | 990616 | 90mmx230mm |
| 88015 | 57mmx100mm | 990617 | 135mmx260mm |
| 68005 | 62mmx103mm | 990618 | 190mmx330mm |
| 68020 | 62mmx220mm | | |
| 68010 | 69mmx200mm | | |
| 88000 | 70mmx229mm | | |
| 88005 | 89mmx133mm | | |
| 88010 | 89mmx229mm | | |
| 68025 | 116mmx219mm | | |
| 88025 | 133mmx254mm | | |
| 68030 | 170mmx237mm | | |
| 88030 | 190mmx330mm | | |
| 88035 | 254mmx356mm | | |
| 68035 | 305mmx432mm | | |
| 88040 | 230mmx305mm | | |
| 68040 | 285mmx370mm | | |

# Discussion of similarities and differences between the Proposed Device and the Predicate Device

The BH sterilization pouch and Self Sealing Sterilization Pouch are both intended for provide end users with an effective method to enclose devices intended for sterilization. The pouch's process indicators are designed to indicate to the user that the pouch has undergone a sterilization process.

The most different technological characteristic between the predicate device and the subject device is the sterilization method. The predicate device is intended for both sterilization in steam autoclaves and via EO, but the subject device is only intended for steam sterilization. The target users of the subject device are dentists, and steam sterilization is the most common sterilization method used by dentists. As the sterilization method is different, the chemical indicators of the two devices are also different. The indicator of the predicate device is EO and steam process indicator, as for the subject device, it is steam process indicator. The sterilization parameters are different, but the sterilization cycles are validated.

Besides the differences, there are many similarities. The devices have similar indications for use, materials and sterilant maintenance period. Also, the devices both have the same design features, material compatibility, and biocompatibility. Furthermore, the process indicators and performance of the two devices are qualified in accordance with ISO

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standards. Finally, the devices are both devices are single use devices and come in various model sizes as described in this summary.

## Biocompatibility Test:

Tests were conducted to evaluate the potential cytotoxicity, hypersensitivity and irritation of the BH Sterilization Pouch based on the requirements of ISO

10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity, ISO 10993-10:2010 Biological evaluation of medical device - Part 10: Tests for irritation and delayed -- type hypersensitivity. The tests results indicate that the device does not have the potential cytotoxicity, hypersensitivity and irritation.

## Performance Test:

The following tests were conducted to evaluate the performance of BH Sterilization Pouch:

- . 180 Day Shelf Life of Sterility Maintenance Test (ANSI/AAMI ST 79:2010 Comprehensive guide to steam sterilization and sterility assurance in health care facilities.)
- . Thermal Profile / Sterilant Penetration Test (ANSI/AAMI ST8:2008 Hospital Steam Sterilizers), ANSI/AAMI ST 79:2010 Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
- . Microbial Aerosol Challenge Test (ASTM 1608 Standard Test Method for Microbial Ranking of Porous Packaging Materials)
- Performance Property Test (ASTM F88- Standard Test Method for Seal Strength of ● Flexible Barrier Materials (Peel Test), ASTM F1929- Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration (Dye Migration), ASTM F1140- Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages))
- Steam Chemical Indicator Test (ANSI/AAMI/ISO 11140-1:2014 Sterilization of . health care products-Chemical Indicators-Part 1: General requirement)

### Summary of Non-Clinical Testing:

Based on the results of the non-clinical testing which included: maintenance of sterility testing, chemical indicator testing, shelf life testing, pouch performance testing, sterilant penetration testing and biocompatibility testing, the subject device demonstrated that it met the acceptance criteria for each test.

### Conclusion:

The conclusions drawn from the non-clinical tests demonstrate that the subject device (K172280) is as safe, as effective and performs as well or better than the legally marketed predicate device (K070428).