SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS

K112591 · Safe Secure Packaging Co., Ltd. · FRG · Feb 7, 2012 · General Hospital

Device Facts

• Record ID: K112591
• Device Name: SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS
• Applicant: Safe Secure Packaging Co., Ltd.
• Product Code: FRG · General Hospital
• Decision Date: Feb 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Models: ABHSP, ABSSP, is intended to be used to enclose another medical device that is to be sterilized by a health provider by gravity steam and ethylene oxide (EtO). The recommended steam sterilization cycle parameters are 30 minutes at 121° C (250 °F). The recommended EtO gas sterilization cycle is 735mg/L of ethylene oxide (EtO) for 1 hour at 55°C (130 ° F) and 50% to 80%RH. The pouch's external chemical ink indicators on the pouches are intended to demonstrate that the device has been exposed to the steam or EtO sterilization process and to distinguish between processed and unprocessed devices. The pouch is intended to allow sterilization of the enclosed medical device and also to maintain sterility (SAL=10-6) of the enclosed device until used.

Device Story

Sterilization pouch consisting of medical-grade paper and plastic film; heat-seal or self-seal adhesive closure. Encloses medical devices for sterilization by healthcare providers using gravity steam or ethylene oxide (EtO). Features external chemical ink indicators that change color upon exposure to sterilization processes to distinguish processed from unprocessed items. Maintains sterility (SAL 10^-6) of enclosed devices until point of use. Used in clinical settings; operated by healthcare staff. Benefits include protection of sterile integrity of instruments post-sterilization.

Clinical Evidence

Bench testing only. No clinical data. Performance validated via physical testing of materials and sterilization efficacy testing per ANSI/AAMI/ISO 11140-1:2005, including sterilant penetration, drying time, aeration, biocompatibility, package integrity, and chemical indicator efficacy.

Technological Characteristics

Medical-grade paper and laminated plastic film. Heat-seal or adhesive tape closure. External chemical ink indicators. Complies with ANSI/AAMI/ISO 11140-1:2005 for sterilization indicators. Dimensions range from 2"-30" width and 2"-20" length.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization via gravity steam (121°C for 30 min) or ethylene oxide (735mg/L at 55°C, 50-80% RH). Intended to maintain sterility of enclosed devices until use and provide visual indication of exposure to sterilization processes.

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

• STERILIZATION POUCH WITH INDICATORS (K062704)
• WINNER SELF SEAL STERILIZATION POUCH (K051242)

Submission Summary (Full Text)

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K112591

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# PREMARKET NOTIFICATION

## 510(K) Summary

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Models: ABHSP,
Indication Pouch De Kanal) Sale Socure (Heat-seal and Self-seal)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

| Submitter's Identification: | Safe Secure Packaging (Shenzhen) Co., Ltd |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Chengguang Industrial Park, No.4, Kukeng Po<br>New Village, Guanian Town, Baoan District,<br>518110, Shenzhen City P.R.C. |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Mr. Garfield Wang |
| Email: | [e-mail] |
| Date | Dec. 01 2010 |
| Device Name: | Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process<br>Indicators Models: ABHSP, ABSSP. (Heat-seal and Self-seal). |
| Classification Name: | Pack, Sterilization Wrapper, Bag and Accessories |
| Classification: | Class II |
| Intended Use: | Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process<br>Indicators Models: ABHSP, ABSSP, is intended to be used to enclose<br>another medical device that is to be sterilized by a health provider by<br>gravity steam and ethylene oxide (EtO). The recommended steam<br>sterilization cycle parameters are 30 minutes at 121° C (250 °F). The<br>recommended EtO gas sterilization cycle is 735mg/L of ethylene oxide<br>(EtO) for 1 hour at 55°C (130 ° F) and 50% to 80%RH. The pouch's<br>external chemical ink indicators on the pouches are intended to<br>demonstrate that the device has been exposed to the steam or EtO |

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sterilization process and to distinguish between processed and otenized.
unprocessed devices. The pouch is intended to allow sterilization of the anproses .
enclosed medical device and also to maintain sterility (SAL=10+) of the enclosed device until used.

# Predicate Device Information:

| Company Name: | Winner Medical USA, Inc. |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1900-H Proforma Ave. Ontario, CA 92861 |
| 510(k) number: | K062704 |
| Device Name: | STERILIZATION POUCH WITH INDICATORS |
| Intended Use: | Sterilization Pouch with indicators is intended to be used to enclose<br>another medical device that is to be sterilized by a health provider by<br>steam 121oC for 15 minutes or ethylene oxide (EtO). It is intended to<br>allow sterilization of the enclosed medical device and also to maintain<br>sterility of the enclosed device until used. |
| Company Name: | Winner Medical USA, Inc. |
| Address: | 1900-H Proforma Ave. Ontario, CA 92861 |
| 510(k) number: | K051242 |
| Device Name: | WINNER SELF SEAL STERILIZATION POUCH |
| Intended Use: | Winner Self Seal Sterilization Pouches are intended to be used to<br>enclose another medical device that is to be sterilized by a health<br>provider by steam 121oC for 15 minutes or ethylene oxide (EtO). It is<br>intended to allow sterilization of the enclosed medical device and also to<br>maintain sterility of the enclosed device until used. |

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### Device Description:

These pouches are manufactured from a medical grade paper and plastic film that is aged to are heat sealed on three sides. The fourth side has an addesive tape that is wed to seal the pouch or heat-seated by the heat-seel machine. The modical brade pager conforms to recognized material standards and can be steellized by steam or conforms fo recognized material starkers childreators has the same intended use, Essential Component, Raw material, Sterillzator method, manufacturing mellods and same technological characteristics as these predical testing of Substantial equivalent to the predicate device was established by physical testing of the medical grade paper (pressure drop vs. five and fifthelion officiency) and tilln (thickness, tensile strength and elongation) from non-stermanner of these linished ellygene oxice sterlilzed linished devices, as well as, performance diatribution for devices (seal strength, package burst, dye migralian cride sterfitzalion for steam and ethytene oxide sterlilzabions, ataam and ethylene oxide storibalion of shoum and einytene balde bennizators meet the performance requirements of ANSI/AAMMSO 11140-1:2005 standard entitled "Sterlizztion of health caro products-ANOMANICAL indications- Part 1: General requirements".

The pouches are manufactured from modical grade paper that is the fourth side an to laminated film on the left, right, and bottom of pouch. The fourth side has an edhealve tape that is used to that is used to see to see to section dealers. The pouches heat-seal machine prior to sterlization of the enclosed medical devices were processed contain extennal chemical indicators used to indicato the pouches were processed to via steam or EIO sterilization. See Chatper 10 for a detailed device description via steam or ENO sterility achievement and compatibility with stearn and EIO starilization processes and Bill of Materialis.

| Ref Number | Model<br>Number | Description | Dimensions | Packaging |
|-------------|-----------------|----------------------------------|---------------------------------|----------------------|
| ABHSP100001 | ABHSP | Heat-Seal<br>Sterilization Pouch | Length: 2"-20"<br>Width: 3"-30" | 400pcs/cs-6000pcs/cs |
| ABHSP100002 | ABHSP | Sterilization<br>Tubing Pouch | Width: 2"-30" | / |
| ABSSP100001 | ABSSP | Self-Seal<br>Sterilization Pouch | Length: 2"-20"<br>Width: 3"-30" | 400pcs/cs-6000pcs/cs |

## Model numbers of the pouches:

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### Device Comparison:

Side by side testing was conducted on the Safe Secure Sterilization Pouch with Side by side testing was conducted on the case of CH WITH INDICATORS,
Indicators and the WINNER STERILLATION POUCH WITH INDICATION Indicators and the WINNER OTERILIZATION POUCH to determine substantial WINNER SELF SEAL STERILIZATION POON to ation, Biocompatibility, Package
equivalence. Sterilant Penetration, Drying Time, Aeration, Biocompatibility, Package equivalence. Stemant Potitity, Sterility Maintenance, and Integrity, Material Compatibility, Stehlic Manterd ISO 11140-1:2005) were the
Chemical Indicator Efficacy (recognized standard ISO 11140-1:2005) were the Chemical Indicator Efficacy (recognized standard 10 - 11 million in the safety and efficacy of the device.

## Proposed Labeling:

A comparison with the predicate labeling confirms our claim of substantial equivalence with the predicate.

### Conclusion:

Conclusion:
The materials, performance, and functions of both the submitted device and the The materials, performance, and functions of are safe and effective for their predicate devices are substantially equivalorit and are and produced by the manufacturer.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness. The design is simple and iconic, conveying the department's focus on health and human well-being.

Public Health Service

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

Safe Secure Packaging Company, Limited C/O Ms. Paula Wilkerson Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

FEB - 7 2012

Re: K112591

Trade/Device Name: Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Models: ABHSP, ABSSP Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 23, 2012 Received: January 24, 2012

Dear Ms. Wilkerson:

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. Wilkerson

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. . Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

#### 510(k) Number (if known): K112591

Device Name: Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Models: ABHSP. ABSSP.

#### Indications For Use:

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Models: ABHSP, ABSSP, is intended to be used to enclose another medical device that is to be sterilized by a health provider by gravity steam and ethylene oxide (EtO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C (250 °F). The recommended EtO gas sterilization cycle is 735mg/L of ethylene oxide (EtO) for 1 hour at 55℃ (130 ° F) and 50% to The pouch's external chemical ink indicators on the pouches are intended to 80%RH. demonstrate that the device has been exposed to the steam or EtO sterilization process and to distinguish between processed and unprocessed devices. The pouch is intended to allow sterilization of the enclosed medical device and also to maintain sterility (SAL=109) of the enclosed device until used.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Edith S. Clainin-Wall

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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| 510(k) Number: | K112591 |
|----------------|---------|
|----------------|---------|