Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators

K153540 · Safe Secure Packaging Co., Ltd. · FRG · Aug 4, 2016 · General Hospital

Device Facts

• Record ID: K153540
• Device Name: Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators
• Applicant: Safe Secure Packaging Co., Ltd.
• Product Code: FRG · General Hospital
• Decision Date: Aug 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Safe Secure Paper Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using: - Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time . - Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time . - . Pre-vacuum steam at 134°C (273°F) for 3 minutes; 20 minutes dry time - . Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time - . Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃ (140°F). The device is not intended and has not been validated for sterilization of devices that contain lumens. The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed devices. The chemical indicators change from green to purple after exposure to steam and from yellow to brown after exposure to ethylene oxide. The Tyvek version of the pouch is for EO sterilization only. If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 5 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10 4). The subject device is intended and has been validated to maintain sterlity of the enclosed devices for 6 months after steam sterilization and 24 months after EO sterilization. The maximum validated pouch load is 2.64 pounds (1.2kg).

Device Story

Sterilization pouches/rolls constructed of medical-grade paper or Tyvek thermally sealed to plastic film; used by healthcare providers to enclose non-lumened medical devices for sterilization. Pouches feature external chemical indicators (steam: green-to-purple; EO: yellow-to-brown) to verify exposure to sterilization cycles. Subject device supports gravity steam, pre-vacuum steam, and EO sterilization. Device maintains sterility (SAL 10^-6) for 6 months post-steam or 24 months post-EO. Maximum load 1.2kg. Output is a sterile-packaged device; indicators provide visual confirmation of processing to assist clinical staff in distinguishing processed from unprocessed items.

Clinical Evidence

Bench testing only. Performance validated via visual inspection, seal integrity, dimensional analysis, seal leak, seal strength, sterilization indicator testing, biological indicator testing, accelerated aging/shelf-life, and full/half-cycle sterilization validation using worst-case loads. Biocompatibility testing included cytotoxicity, sensitization, and irritation. No clinical data.

Technological Characteristics

Materials: Porous paper or Tyvek, PET/CPP high-temperature blue compound film, high-temperature adhesive paper, medical double-sided tape. Indicators: Steam (green-to-purple), EO (yellow-to-brown). Dimensions: 2-20 inches length, 8-30 inches width. Sterilization: Gravity steam, pre-vacuum steam, EO. Testing per ASTM/ISO standards.

Indications for Use

Indicated for healthcare providers to enclose non-lumened medical devices for sterilization via gravity steam, pre-vacuum steam, or ethylene oxide (EO) gas. Not for devices with lumens.

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

• Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators (K112591)

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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design that suggests movement or progress.

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

August 4, 2016

Safe Secure Packaging Co., Ltd % Mr. Brian Edwards Senior Medical Research Manager, Regulatory NAMSA 4050 Olson Memorial Highway Golden Valley, MN 55422

Re: K153540

Trade/Device Name: Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: July 11, 2016 Received: July 12, 2016

Dear Mr. Edwards:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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.

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,

Susan Runne, DDS, MA

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) K153540

### Device Name

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators

### Indications for Use (Describe)

Safe Secure Paper Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:

- Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time .
- Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time .
- . Pre-vacuum steam at 134°C (273°F) for 3 minutes; 20 minutes dry time
- . Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time
- . Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃ (140°F).

The device is not intended and has not been validated for sterilization of devices that contain lumens.

The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed devices. The chemical indicators change from green to purple after exposure to steam and from yellow to brown after exposure to ethylene oxide.

The Tyvek version of the pouch is for EO sterilization only.

If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 5 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10 4). The subject device is intended and has been validated to maintain sterlity of the enclosed devices for 6 months after steam sterilization and 24 months after EO sterilization.

The maximum validated pouch load is 2.64 pounds (1.2kg).

The following tables list the available model numbers of the Safe Secure Sterilization Pouches and Rolls.

| Model | Type | Sterilization Cycle(s) | Dimensions(mm) | |
|-------------|-----------------------------------|-------------------------|----------------|-------------|
| | | | Width (mm) | Length (mm) |
| ABHSP100001 | POUCH PAPER HEAT SEAL 3.5X10 | Steam or Ethylene Oxide | 89 | 254 |
| ABHSP100002 | POUCH PAPER HEAT SEAL 7.5X13 | Steam or Ethylene Oxide | 191 | 330 |
| ABHSP100003 | POUCH PAPER HEAT SEAL 6X10 | Steam or Ethylene Oxide | 152 | 254 |
| ABHSP100004 | POUCH PAPER HEAT SEAL 4.5X11 | Steam or Ethylene Oxide | 114 | 279 |
| ABHSP100005 | POUCH PAPER HEAT SEAL 5X15 | Steam or Ethylene Oxide | 127 | 381 |
| ABHSP100006 | POUCH PAPER HEAT SEAL 10X15 | Steam or Ethylene Oxide | 254 | 381 |
| ABHSP100007 | POUCH PAPER HEAT SEAL 18X22 | Steam or Ethylene Oxide | 457 | 559 |
| ABHSP100008 | POUCH PAPER HEAT SEAL 12X18 | Steam or Ethylene Oxide | 305 | 457 |
| ABHSP100009 | POUCH PAPER HEAT SEAL 4X8 | Steam or Ethylene Oxide | 102 | 203 |
| ABHSP100010 | POUCH PAPER HEAT SEAL 3X8 | Steam or Ethylene Oxide | 76 | 203 |
| ABHSP100011 | POUCH PAPER HEAT SEAL 16X16 | Steam or Ethylene Oxide | 406 | 406 |
| ABHSP100012 | POUCH PAPER HEAT SEAL 4X22 | Steam or Ethylene Oxide | 102 | 559 |
| ABHSP100013 | POUCH PAPER HEAT SEAL 13X15 | Steam or Ethylene Oxide | 330 | 381 |
| ABHSP100014 | POUCH PAPER HEAT SEAL 8X10 | Steam or Ethylene Oxide | 203 | 254 |
| ABHSP100015 | POUCH PAPER HEAT SEAL 8X16 | Steam or Ethylene Oxide | 203 | 406 |
| ABHSP110001 | TUBING PAPER 6IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 151 | 30500 |

Table 1: Safe Secure Medical Grade Paper Sterilization Pouch/Roll Products

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| Model | Type | Sterilization Cycle(s) | Dimensions(mm) | |
|-------------|-----------------------------------------|-------------------------|----------------|-------------|
| | | | Width (mm) | Length (mm) |
| ABHSP110002 | TUBING PAPER 9IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 228 | 30500 |
| ABHSP110003 | TUBING PAPER 4IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 101 | 30500 |
| ABHSP110004 | TUBING PAPER 3IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 75 | 30500 |
| ABHSP110005 | TUBING PAPER 12IN WIDTH 100FT<br>ROLL | Steam or Ethylene Oxide | 305 | 30500 |
| ABHSP110006 | TUBING PAPER 2IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 51 | 30500 |
| ABHSP120001 | POUCH MULTIPLE INNER 8 POUCHES<br>SHEET | Steam or Ethylene Oxide | 230 | 415 |
| ABHSP120002 | POUCH MULTIPLE INNER 4 POUCHES<br>SHEET | Steam or Ethylene Oxide | 230 | 415 |
| ABSSP100001 | POUCH PAPER SELF SEAL 7.5X13 | Steam or Ethylene Oxide | 191 | 353 |
| ABSSP100002 | POUCH PAPER SELF SEAL 5.25X10 | Steam or Ethylene Oxide | 140 | 277 |
| ABSSP100003 | POUCH PAPER SELF SEAL 13X18 | Steam or Ethylene Oxide | 330 | 480 |
| ABSSP100004 | POUCH PAPER SELFSEAL 12X15 | Steam or Ethylene Oxide | 305 | 404 |
| ABSSP100005 | POUCH PAPER SELF SEAL 3.5X8.75 | Steam or Ethylene Oxide | 89 | 245 |
| ABSSP100006 | POUCH PAPER SELF SEAL 5X15 | Steam or Ethylene Oxide | 127 | 404 |
| ABSSP100007 | POUCH PAPER SELF SEAL 3.5X9.875 | Steam or Ethylene Oxide | 89 | 274 |
| ABSSP100008 | POUCH PAPER SELF SEAL 8X16 | Steam or Ethylene Oxide | 203 | 429 |
| ABSSP100009 | POUCH PAPER SELF SEAL 3.5X22 | Steam or Ethylene Oxide | 89 | 582 |
| ABSSP100010 | POUCH PAPER SELF SEAL 9.125X25.5 | Steam or Ethylene Oxide | 232 | 671 |
| ABSSP100011 | POUCH PAPER SELF SEAL 4X11 | Steam or Ethylene Oxide | 102 | 302 |

### Table 2: Safe Secure Tyvek Sterilization Pouch/Roll Products

| Model | Type | Sterilization Cycle(s) | Dimensions(mm) | |
|-------------|----------------------------------|------------------------|----------------|-------------|
| | | | Width (mm) | Length (mm) |
| ABSST100001 | POUCH TYVEK SELF SEAL 8X12 | Ethylene Oxide Only | 203 | 345 |
| ABSST100002 | POUCH TYVEK SELF SEAL 6X10 | Ethylene Oxide Only | 152 | 294 |
| ABSST100003 | POUCH TYVEK SELF SEAL 12X18 | Ethylene Oxide Only | 305 | 497 |
| ABSST100004 | POUCH TYVEK SELF SEAL 10X15 | Ethylene Oxide Only | 254 | 421 |
| ABSST100005 | POUCH TYVEK SELF SEAL 4X9 | Ethylene Oxide Only | 102 | 269 |
| ABSST100006 | POUCH TYVEK SELF SEAL 3X7 | Ethylene Oxide Only | 76 | 218 |
| ABSST100007 | POUCH TYVEK SELF SEAL 4X12 | Ethylene Oxide Only | 102 | 345 |
| ABSST100008 | POUCH TYVEK SELF SEAL 4X22 | Ethylene Oxide Only | 102 | 599 |
| ABHST100001 | POUCH TYVEK HEAT SEAL 8X12 | Ethylene Oxide Only | 203 | 305 |
| ABHST100002 | POUCH TYVEK HEAT SEAL 6X10 | Ethylene Oxide Only | 152 | 254 |
| ABHST100003 | POUCH TYVEK HEAT SEAL 10X15 | Ethylene Oxide Only | 254 | 381 |
| ABHST100004 | POUCH TYVEK HEAT SEAL 12X18 | Ethylene Oxide Only | 305 | 457 |
| ABHST100005 | POUCH TYVEK HEAT SEAL 4X12 | Ethylene Oxide Only | 102 | 305 |
| ABHST100006 | POUCH TYVEK HEAT SEAL 4X9 | Ethylene Oxide Only | 102 | 229 |
| ABHST100007 | POUCH TYVEK HEAT SEAL 4X22 | Ethylene Oxide Only | 102 | 559 |
| ABHST100008 | POUCH TYVEK HEAT SEAL 3X7 | Ethylene Oxide Only | 76 | 178 |
| ABHST110001 | TUBING TYVEK 9IN WIDTH 75FT ROLL | Ethylene Oxide Only | 228 | 22900 |
| ABHST110002 | TUBING TYVEK 6IN WIDTH 75FT ROLL | Ethylene Oxide Only | 151 | 22900 |
| ABHST110003 | TUBING TYVEK 4IN WIDTH 75FT ROLL | Ethylene Oxide Only | 101 | 22900 |
| ABHST110004 | TUBING TYVEK 3IN WIDTH 75FT ROLL | Ethylene Oxide Only | 75 | 22900 |

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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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#### 510(k) Summary 5.0

#### Submission Sponsor 5.1

Safe Secure Packaging (Shenzhen) Co., Ltd No.4 Chengguang Industrial Park Guanlan Street Baoan District, Shenzhen Guangdon Province, 518110 China Tel: [phone] Fax: [phone] Howard Jia, President [e-mail]

#### 5.2 Submission Correspondent

NAMSA 4050 Olson Memorial Hwy Suite 450 Minneapolis, MN 55422

Brian J. Edwards Principal Medical Research Manager, Regulatory Phone: [phone] Fax: [phone] [e-mail]

#### 5.3 Date Prepared

August 1, 2016

#### 5.4 Device Identification

Trade/Proprietary Name: Safe Secure Sterilization Pouches with Steam and Ethylene Oxide Process Indicators Common/Usual Name: Sterilization Pouch Classification Name: Sterilization Wrap Classification Regulation: 21 CFR Part 880.6850 Product Code: FRG Device Class: II Classification Panel: General Hospital Model Numbers: ABHSP, ABSSP, ABHST, ABSST

#### ર્સ્ડ Predicate Devices

K112591 - Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators

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#### 5.6 Device Description

The Safe Secure Sterilization Pouches are made from either a medical grade porous paper or Tyvek thermally sealed to a plastic film on the left, right, and bottom of the pouch. The top side is open in order to receive the medical device to be sterilized and to seal the pouch. They are available either pre-manufactured self-seal or heat-seal sizes or in a roll of heat-seal tubing for the customer to cut the pouches to their required size.

The base model numbers for the subject device are described as follows, where the last three letters corresponds to the type of material:

- ABSST - Self seal Tyvek
- ABHST Heat seal Tyvek .
- ABHSP Heat seal paper ●
- ABSSP Self seal paper .

The pouches also contain external chemical indicators used to indicate that the pouches have been processed by either a steam or ethylene oxide sterilization process.

The medical grade paper versions can be used in either gravity steam, pre-vacuum steam, or ethylene oxide (EO) sterilization cycles. The Tyvek version is only for EO sterilization.

#### 5.7 Indication for Use

Safe Secure Paper Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:

- Gravity Steam at 121°C (250°F) for 30 minutes: 25 minutes dry time .
- . Pre-vacuum Steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
- . Pre-vacuum Steam at 134°C (273°F) for 3 minutes; 20 minutes dry time
- . Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time
- . Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).

The device is not intended and has not been validated for sterilization of devices that contain lumens.

The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the Steam or EO sterilization process and to distinguish between processed and unprocessed devices. The chemical indicators change from green to purple after exposure to steam and from yellow to brown after exposure to ethylene oxide.

{7}------------------------------------------------

The Tyvek version of the pouch is for EO sterilization only.

If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 5 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10 %). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 6 months after steam sterilization and 24 months after EO sterilization.

The maximum validated pouch load is 2.64 pounds (1.2kg).

These products are to be used for medical products without lumens.

The follow table list the available model numbers of the Safe Secure Sterilization Pouches and Rolls.

| | | | Dimensions (mm) | |
|-------------|---------------------------------------|-------------------------|-----------------|----------------|
| Model | Type | Sterilization Cycle(s) | Width<br>(mm) | Length<br>(mm) |
| ABHSP100001 | POUCH PAPER HEAT SEAL 3.5X10 | Steam or Ethylene Oxide | 89 | 254 |
| ABHSP100002 | POUCH PAPER HEAT SEAL 7.5X13 | Steam or Ethylene Oxide | 191 | 330 |
| ABHSP100003 | POUCH PAPER HEAT SEAL 6X10 | Steam or Ethylene Oxide | 152 | 254 |
| ABHSP100004 | POUCH PAPER HEAT SEAL 4.5X11 | Steam or Ethylene Oxide | 114 | 279 |
| ABHSP100005 | POUCH PAPER HEAT SEAL 5X15 | Steam or Ethylene Oxide | 127 | 381 |
| ABHSP100006 | POUCH PAPER HEAT SEAL 10X15 | Steam or Ethylene Oxide | 254 | 381 |
| ABHSP100007 | POUCH PAPER HEAT SEAL 18X22 | Steam or Ethylene Oxide | 457 | 559 |
| ABHSP100008 | POUCH PAPER HEAT SEAL 12X18 | Steam or Ethylene Oxide | 305 | 457 |
| ABHSP100009 | POUCH PAPER HEAT SEAL 4X8 | Steam or Ethylene Oxide | 102 | 203 |
| ABHSP100010 | POUCH PAPER HEAT SEAL 3X8 | Steam or Ethylene Oxide | 76 | 203 |
| ABHSP100011 | POUCH PAPER HEAT SEAL 16X16 | Steam or Ethylene Oxide | 406 | 406 |
| ABHSP100012 | POUCH PAPER HEAT SEAL 4X22 | Steam or Ethylene Oxide | 102 | 559 |
| ABHSP100013 | POUCH PAPER HEAT SEAL 13X15 | Steam or Ethylene Oxide | 330 | 381 |
| ABHSP100014 | POUCH PAPER HEAT SEAL 8X10 | Steam or Ethylene Oxide | 203 | 254 |
| ABHSP100015 | POUCH PAPER HEAT SEAL 8X16 | Steam or Ethylene Oxide | 203 | 406 |
| ABHSP110001 | TUBING PAPER 6IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 151 | 30500 |
| ABHSP110002 | TUBING PAPER 9IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 228 | 30500 |
| ABHSP110003 | TUBING PAPER 4IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 101 | 30500 |
| ABHSP110004 | TUBING PAPER 3IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 75 | 30500 |
| ABHSP110005 | TUBING PAPER 12IN WIDTH 100FT<br>ROLL | Steam or Ethylene Oxide | 305 | 30500 |

Table 1: Safe Secure Medical Grade Paper Sterilization Pouch/Roll Products

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# Safe Secure Packaging Co. Ltd.
Sterilization Pouch

| Model | Type | Sterilization Cycle(s) | Dimensions (mm) | |
|-------------|-----------------------------------------|-------------------------|-----------------|-------------|
| | | | Width (mm) | Length (mm) |
| ABHSP110006 | TUBING PAPER 2IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 51 | 30500 |
| ABHSP120001 | POUCH MULTIPLE INNER 8 POUCHES<br>SHEET | Steam or Ethylene Oxide | 230 | 415 |
| ABHSP120001 | POUCH MULTIPLE INNER 4 POUCHES<br>SHEET | Steam or Ethylene Oxide | 230 | 415 |
| ABSSP100001 | POUCH PAPER SELF SEAL 7.5X13 | Steam or Ethylene Oxide | 191 | 353 |
| ABSSP100002 | POUCH PAPER SELF SEAL 5.25X10 | Steam or Ethylene Oxide | 140 | 277 |
| ABSSP100003 | POUCH PAPER SELF SEAL 13X18 | Steam or Ethylene Oxide | 330 | 480 |
| ABSSP100004 | POUCH PAPER SELFSEAL 12X15 | Steam or Ethylene Oxide | 305 | 404 |
| ABSSP100005 | POUCH PAPER SELF SEAL 3.5X8.75 | Steam or Ethylene Oxide | 89 | 245 |
| ABSSP100006 | POUCH PAPER SELF SEAL 5X15 | Steam or Ethylene Oxide | 127 | 404 |
| ABSSP100007 | POUCH PAPER SELF SEAL 3.5X9.875 | Steam or Ethylene Oxide | 89 | 274 |
| ABSSP100008 | POUCH PAPER SELF SEAL 8X16 | Steam or Ethylene Oxide | 203 | 429 |
| ABSSP100009 | POUCH PAPER SELF SEAL 3.5X22 | Steam or Ethylene Oxide | 89 | 582 |
| ABSSP100010 | POUCH PAPER SELF SEAL 9.125X25.5 | Steam or Ethylene Oxide | 232 | 671 |
| ABSSP100011 | POUCH PAPER SELF SEAL 4X11 | Steam or Ethylene Oxide | 102 | 302 |

### Table 2: Safe Secure Tyvek Sterilization Pouch/Roll Products

| Model | Type | Sterilization Cycle(s) | Dimensions (mm) | |
|-------------|----------------------------------|------------------------|-----------------|-------------|
| | | | Width (mm) | Length (mm) |
| ABSST100001 | POUCH TYVEK SELF SEAL 8X12 | Ethylene Oxide Only | 203 | 345 |
| ABSST100002 | POUCH TYVEK SELF SEAL 6X10 | Ethylene Oxide Only | 152 | 294 |
| ABSST100003 | POUCH TYVEK SELF SEAL 12X18 | Ethylene Oxide Only | 305 | 497 |
| ABSST100004 | POUCH TYVEK SELF SEAL 10X15 | Ethylene Oxide Only | 254 | 421 |
| ABSST100005 | POUCH TYVEK SELF SEAL 4X9 | Ethylene Oxide Only | 102 | 269 |
| ABSST100006 | POUCH TYVEK SELF SEAL 3X7 | Ethylene Oxide Only | 76 | 218 |
| ABSST100007 | POUCH TYVEK SELF SEAL 4X12 | Ethylene Oxide Only | 102 | 345 |
| ABSST100008 | POUCH TYVEK SELF SEAL 4X22 | Ethylene Oxide Only | 102 | 599 |
| ABHST100001 | POUCH TYVEK HEAT SEAL 8X12 | Ethylene Oxide Only | 203 | 305 |
| ABHST100002 | POUCH TYVEK HEAT SEAL 6X10 | Ethylene Oxide Only | 152 | 254 |
| ABHST100003 | POUCH TYVEK HEAT SEAL 10X15 | Ethylene Oxide Only | 254 | 381 |
| ABHST100004 | POUCH TYVEK HEAT SEAL 12X18 | Ethylene Oxide Only | 305 | 457 |
| ABHST100005 | POUCH TYVEK HEAT SEAL 4X12 | Ethylene Oxide Only | 102 | 305 |
| ABHST100006 | POUCH TYVEK HEAT SEAL 4X9 | Ethylene Oxide Only | 102 | 229 |
| ABHST100007 | POUCH TYVEK HEAT SEAL 4X22 | Ethylene Oxide Only | 102 | 559 |
| ABHST100008 | POUCH TYVEK HEAT SEAL 3X7 | Ethylene Oxide Only | 76 | 178 |
| ABHST110001 | TUBING TYVEK 9IN WIDTH 75FT ROLL | Ethylene Oxide Only | 228 | 22900 |

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## Safe Secure Packaging Co. Ltd. Sterilization Pouch

| Model | Type | Sterilization Cycle(s) | Dimensions (mm) | |
|-------------|----------------------------------|------------------------|-----------------|-------------|
| | | | Width (mm) | Length (mm) |
| ABHST110002 | TUBING TYVEK 6IN WIDTH 75FT ROLL | Ethylene Oxide Only | 151 | 22900 |
| ABHST110003 | TUBING TYVEK 4IN WIDTH 75FT ROLL | Ethylene Oxide Only | 101 | 22900 |
| ABHST110004 | TUBING TYVEK 3IN WIDTH 75FT ROLL | Ethylene Oxide Only | 75 | 22900 |

#### Comparison to Predicates 5.8

The Safe Secure Sterilization Pouches are substantially equivalent to the previous pouch version cleared under K112591 – Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators.

## Safe Secure Sterilization Pouch Substantial Equivalence Table

| Item<br># | | Safe Secure Sterilization Pouch<br>(Predicate Device) | Safe Secure Sterilization Pouch<br>(Subject Device) | |
|-----------|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| 1 | 510(k) Number | K112591 | TBD | |
| 2 | Manufacturer | Safe Secure Packaging<br>(Shenzhen) Co., Ltd<br>No.4 Chengguang Industrial<br>Park,Guanlan Street, Baoan<br>District,Shenzhen,518110 China | Safe Secure Packaging<br>(Shenzhen) Co., Ltd<br>No.4 Chengguang Industrial<br>Park, Guanlan Street, Baoan<br>District,Shenzhen,518110 China | Same |
| 3 | Model<br>Numbers | ABHSP, ABSSP | ABHSP, ABSSP, ABHST,<br>ABSST | Substantial<br>Equivalent |
| 4 | Classification | II | II | Same |
| 5 | Product Code | FRG | FRG | Same |
| 6 | Regulation | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| Item | | Safe Secure Sterilization Pouch<br>(Predicate Device) | Safe Secure Sterilization Pouch<br>(Subject Device) | |
| # | | | | |
| 7 | Indications for<br>Use | Safe Secure Sterilization Pouch<br>with Steam and Ethylene Oxide<br>Process Indicators (Heat-seal<br>and Self-seal) is intended to be<br>used to enclose another medical<br>device that is to be sterilized by a<br>health provider by gravity steam<br>and ethylene oxide (EO). The<br>recommended steam<br>sterilization cycle parameters is<br>30 minutes at 121°C (250°F).<br>The recommended EO gas<br>sterilization cycle is greater<br>than or equal to 735mg/L of<br>ethylene oxide (EO) for 1 hour at<br>55°C (130 °F)) and 50% to<br>80%RH. The pouch's external<br>chemical ink indicators on the<br>pouches are intended to<br>demonstrate that the device has<br>been expose to the steam<br>or EO sterilization process and<br>to distinguish between processed<br>and unprocessed devices. The<br>pouch is intended to allow<br>sterilization of the enclosed<br>medical device and also to<br>maintain sterility (SAL= 10-6) of<br>the enclosed device until used. | Safe Secure Paper Sterilization<br>Pouches and Rolls are intended<br>to be used to enclose another<br>medical device, in a single or<br>double pouch configuration, that<br>is to be sterilized by a health<br>care provider using:<br>• Gravity Steam at 121°C<br>(250°F) for 30 minutes<br>• Pre-vacuum Steam at 132°C<br>(270°F) for 4 minutes<br>• Pre-vacuum Steam at 134°C<br>(273°F) for 3 minutes<br>• Pre-vacuum steam at 135°C<br>(275°F) for 3 minutes<br>• Ethylene Oxide (EO) with a<br>concentration of 735 mg/L at<br>55°C (131°F) and 50% to 80%<br>relative humidity for 60<br>minutes. Aeration time<br>of 8 hours at 60°C<br>(140°F).<br>The external chemical indicators<br>on the pouches/rolls are intended<br>to demonstrate that the device<br>has been exposed to the Steam<br>or EO sterilization process and<br>to distinguish between processed<br>and unprocessed devices.<br>The Tyvek version of the pouch<br>is for EO sterilization only.<br>If stored according to the<br>recommended conditions, the<br>products before sterilization<br>have a maximum shelf life of 5<br>years from the date of<br>manufacture. The pouches are<br>intended to allow sterilization of<br>the enclosed medical device(s)<br>and also to maintain sterility<br>(SAL=10-6).<br>The maximum validated pouch<br>load is 2.64 pounds (1.2kg).<br>These products are to be used for | Substantially<br>Equivalent |
| 8 | Material<br>Composition | Porous paper or Tyvek,<br>PET/CPP high-temperature<br>blue compound film, High<br>temperature adhesive paper,<br>Medical Double Side Tape, EO<br>gas indicator ink, Steam<br>indicator ink. | Porous paper or Tyvek,<br>PET/CPP high-temperature<br>blue compound film, High<br>temperature adhesive paper,<br>Medical Double Side Tape, EO<br>gas indicator ink, Steam<br>indicator ink. | Same |
| Item | | Safe Secure Sterilization Pouch<br>(Predicate Device) | Safe Secure Sterilization Pouch<br>(Subject Device) | |
| # | | | | |
| 9 | Pouch<br>Dimensions* | Length: 2 to 20 inches<br>Width: 8 to 30 inches | Length: 2 to 20 inches<br>Width: 8 to 30 inches | Same |
| 10 | Roll<br>Dimensions | Width: 8 to 30 inches | Width: 8 to 30 inches | Same |
| 11 | Air Permeance | The maximum equivalent pore<br>size diameter shall not exceed<br>50um. | The maximum equivalent pore<br>size diameter shall not exceed<br>50um. | Same |
| 12 | Shelf Life | 5 years before sterilization; 6<br>months after gravity steam<br>sterilization or 24 months after<br>EOsterilization | 5 years before sterilization; 6<br>months after steam sterilization<br>(gravity or pre-vacuum) or 24<br>months after EOsterilization | Same |
| 13 | Paper and Film<br>Thickness &<br>Density | Paper: ±2 gm/m²<br>Film: +0.002 mm<br>Tyvek: ±2 gm/m² | Paper: ±2 gm/m²<br>Film: +0.002 mm<br>Tyvek: ±2 gm/m² | Same |
| 14 | Seal Strength<br>before<br>sterilization | 2.5 to 5.5 N/15mm | 2.5 to 5.5 N/15mm | Same |
| 15 | Seal strength<br>after steam<br>sterilization | 2.5 to 5.5 N/15mm | > 1.5 N / 15mm | Substantially<br>Equivalent |
| 16 | Seal strength<br>after EO<br>sterilization | 2.5 to 5.5 N/15mm | > 1.5 N / 15mm | Substantially<br>Equivalent |
| 17 | Burst Strength | 2.5 to 5.5 N/15mm…