Sterilization Pouch and Roll

K221875 · Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. · FRG · Feb 13, 2023 · General Hospital

Device Facts

• Record ID: K221875
• Device Name: Sterilization Pouch and Roll
• Applicant: Qianjiang Kingphar Medical Packaging & Printing Co., Ltd.
• Product Code: FRG · General Hospital
• Decision Date: Feb 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: · Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. · Ethylene Oxide (EO) with a concentration of 800 mg/L at 55°C (131°F) and 40% to 90% relative humidity for 6 hour. Aeration time of 7 days at 20℃). The sterilization pouch and roll are made with medical compound film. The sterilization pouch and roll maintains the sterility of the enclosed devices for up to 24 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from pink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization.

Device Story

Sterilization Pouch and Roll consist of medical-grade paper and compound film; used by healthcare workers to enclose medical devices for terminal sterilization. Input: medical devices placed inside pouch/roll; sealed via heat. Transformation: device undergoes Steam (132°C, 4 min) or EO (800 mg/L, 55°C, 6 hrs) sterilization. Output: sterilized, sealed package maintaining sterility for 24 months. External chemical ink indicators provide visual verification of exposure to sterilization process (Steam: blue to dark grey; EO: pink to yellow). Benefits: provides effective barrier to maintain sterility of instruments until use. Used in clinical settings; manual operation by healthcare staff.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via ISO 11135 (EO) and ISO 17665-1 (Steam) achieving SAL 10^-6. Biocompatibility confirmed per ISO 10993. Package integrity, seal strength, and microbial barrier efficacy verified via ASTM standards (F2251, F1140, F1929, F88, F2096) and DIN 58953-6.

Technological Characteristics

Materials: medical grade paper (60g/m²) and medical compound film (52um). Configuration: heat-sealed pouches and rolls. Chemical indicators: ink-based color change (Steam: blue to dark grey; EO: pink to yellow). Sterilization: Steam (132°C) and EO (800 mg/L). Shelf life: 5 years. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for healthcare workers to enclose medical devices for terminal sterilization via Steam or Ethylene Oxide (EO) processes. Maintains sterility of enclosed devices for up to 24 months post-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

• SterileRight Sterilization Pouch and Roll (K212338)

Reference Devices

• SIGMA Sterilization Pouch and Roll (K180661)

Submission Summary (Full Text)

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Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China

Re: K221875

Trade/Device Name: Sterilization Pouch and Roll Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: January 17, 2023 Received: January 17, 2023

Dear Boyle Wang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Anne D. Talley -S for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K221875

Device Name Sterilization Pouch and Roll

The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: · Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.

· Ethylene Oxide (EO) with a concentration of 800 mg/L at 55°C (131°F) and 40% to 90% relative humidity for 6 hour. Aeration time of 7 days at 20℃).

The sterilization pouch and roll are made with medical compound film. The sterilization pouch and roll maintains the sterility of the enclosed devices for up to 24 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from pink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization.

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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The maximum validated pouch load is 1.1 lbs (0.5kg); The maximum validated roll load is 1.1 lbs (0.5kg).

| Model | Item | Specification Size (WXL) | | Content/Max Load(lbs) | | |
|------------------------------------|--------|--------------------------|------------|-----------------------|---------|--------------|
| | NO. | Inch | mm*mm | Metal | Plastic | Gauze/Linens |
| | P-001 | 2.25"x3.5" | 57x90 | 0.02 | 0.01 | 0.003 |
| | P-002 | 2.25"x4" | 57x100 | 0.03 | 0.02 | 0.004 |
| | P-003 | 2.25"x5" | 57x130 | 0.04 | 0.03 | 0.005 |
| | P-004 | 2.75"x10" | 70x260 | 0.09 | 0.08 | 0.07 |
| | P-005 | 3.5"x5.25" | 90x135 | 0.10 | 0.09 | 0.08 |
| | P-006 | 3.5"x6.5" | 90x165 | 0.12 | 0.11 | 0.1 |
| | P-007 | 3.5"x10" | 90x260 | 0.14 | 0.13 | 0.11 |
| PLANE-01<br>Sterilization<br>Pouch | P-008 | 51/3"x10" | 135x260 | 0.48 | 0.46 | 0.45 |
| | P-009 | 51/3"x11 | 135x280 | 0.50 | 0.47 | 0.46 |
| | P-010 | 51/3"x13" | 135x330 | 0.55 | 0.53 | 0.50 |
| | P-011 | 7.5"x14" | 190x360 | 0.60 | 0.58 | 0.55 |
| | P-012 | 10"x14.5" | 250x370 | 1.06 | 1.05 | 0.62 |
| | P-013 | 10.25"x16" | 260x410 | 1.08 | 1.07 | 0.64 |
| | P-014 | 12"x17.7" | 300x450 | 1.10 | 1.09 | 0.66 |
| ROLL-01<br>Sterilization<br>Roll | R-101 | 2" | 50mm×200m | 0.02 | 0.01 | 0.003 |
| | R-102 | 3" | 75mm×200m | 0.09 | 0.05 | 0.004 |
| | R-103 | 4" | 100mm×200m | 0.14 | 0.13 | 0.11 |
| | R-104 | 6" | 150mm×200m | 0.55 | 0.53 | 0.50 |
| | R-105 | 8" | 200mm×200m | 0.60 | 0.58 | 0.55 |
| | R-106 | 10' | 250mm×200m | 1.06 | 1.05 | 0.62 |
| | R-107 | 12" | 300mm×200m | 0.60 | 0.58 | 0.55 |
| | R-108 | 14" | 350mm×200m | 1.06 | 1.05 | 0.62 |
| | R-109 | 16" | 400mm×200m | 1.08 | 1.07 | 0.64 |
| | R-110 | 17.7" | 450mm×200m | 1.10 | 1.09 | 0.66 |
| | R-111 | 20" | 500mm×200m | 1.10 | 1.09 | 0.66 |
| | GR-201 | 3" | 75mm×100m | 0.09 | 0.05 | 0.004 |
| | GR-202 | 4" | 100mm×100m | 0.14 | 0.13 | 0.11 |
| | GR-203 | 6" | 150mm×100m | 0.55 | 0.53 | 0.50 |
| | GR-204 | 8" | 200mm×100m | 0.60 | 0.58 | 0.55 |
| | GR-205 | 10" | 250mm×100m | 1.06 | 1.05 | 0.62 |
| | GR-206 | 12" | 300mm×100m | 0.60 | 0.58 | 0.55 |
| | GR-207 | 14" | 350mm×100m | 1.06 | 1.05 | 0.62 |
| | GR-208 | 16" | 400mm×100m | 1.08 | 1.07 | 0.64 |

(Model and Dimension and Content/Max. Load)

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# 510(k) Summary K221875

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

## 1.0 Submitter's Information

| Name: | Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. |
|----------|-----------------------------------------------------------------------------------|
| Address: | Dongjing Road 23, Yuanlin Office, 433100 Qianjiang,<br>PEOPLE'S REPUBLIC OF CHINA |
| Tel: | [phone] |
| Contact: | Zhao Fusong |

#### Designated Submission Correspondent

| Contact: | Mr. Boyle Wang |
|----------|-----------------------------------------------------------------------|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai<br>200120 China |
| Tel: | [phone] |
| Email: | [e-mail] |

Date Submitted: Feb.11,2023

### 2.0 Device Information

| Trade/Device name: | Sterilization Pouch and Roll |
|------------------------------|--------------------------------------------------------------|
| Common name: | Sterilization Pouch and Roll |
| Regulation Name: | 1) Sterilization Wrap;<br>2) Sterilization process indicator |
| Classification Product Code: | 1) FRG; |
| Subsequent Product Code: | 2) JOJ |
| Regulation number: | 1) 21 CFR880.6850<br>2) 21 CFR880.2800 |
| Classification: | Class II |
| Panel: | General Hospital |

## 3.0 Predicate Device Information

#### Predicate Device:

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| Manufacturer: | Sterileright Packaging Mfg., Inc |
|--------------------|-------------------------------------------|
| Trade/Device Name: | SterileRight Sterilization Pouch and Roll |
| 510(k) number: | K212338 |

#### Reference Device:

| Manufacturer: | Sigma Medical Supplies Corp. |
|--------------------|------------------------------------|
| Trade/Device Name: | SIGMA Sterilization Pouch and Roll |
| 510(k) number: | K180661 |

## 4.0 Device Description

The Sterilization pouch and roll is composed of medical grade paper(60g/m²) and medical compound film(52um), it is intended to be used to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process. The recommended sterilization cycle parameter is:

Steam: 4 minutes at 132°C (270°F); 20 minutes dry time.

Ethylene oxide: 6 hours at 55 ℃; relative humidity between 40%- 90%; ethylene oxide concentration is 800 mg/L, 7 days aeration time at 20 ℃.

The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the EtO or Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.

The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 24 months post sterilization.

The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to Yellow (EtO) or Blue to Dark grey (Steam) when exposed to EtO gas or Steam vapor during process. The EtO and Steam Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.

### 5.0 Indication for Use Statement

The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

• Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.

• Ethylene Oxide (EO) with a concentration of 800 mg/L at 55° C (131° F) and 40% to 90% relative humidity for 6 hour. Aeration time of 7 days at 20℃).

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The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintains the sterility of the enclosed devices for up to 24 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from prink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark grey after sterilization.

The maximum validated pouch load is 1.1 lbs (0.5kg); The maximum validated roll load is 1.1 lbs (0.5kg).

| Model | Item<br>No. | Specification Size (WXL) | | Content/Max Load(lbs) | | |
|------------------------------------|-------------|--------------------------|------------|-----------------------|---------|--------------|
| | | Inch | mm*mm | Metal | Plastic | Gauze/Linens |
| | P-001 | 2.25"x3.5" | 57x90 | 0.02 | 0.01 | 0.003 |
| | P-002 | 2.25"x4" | 57x100 | 0.03 | 0.02 | 0.004 |
| | P-003 | 2.25"x5" | 57x130 | 0.04 | 0.03 | 0.005 |
| | P-004 | 2.75"x10" | 70x260 | 0.09 | 0.08 | 0.07 |
| | P-005 | 3.5"x5.25" | 90x135 | 0.10 | 0.09 | 0.08 |
| | P-006 | 3.5"x6.5" | 90x165 | 0.12 | 0.11 | 0.1 |
| | P-007 | 3.5"x10" | 90x260 | 0.14 | 0.13 | 0.11 |
| PLANE-01<br>Sterilization<br>Pouch | P-008 | 51/3"x10" | 135x260 | 0.48 | 0.46 | 0.45 |
| | P-009 | 51/3"x11 | 135x280 | 0.50 | 0.47 | 0.46 |
| | P-010 | 51/3"x13" | 135x330 | 0.55 | 0.53 | 0.50 |
| | P-011 | 7.5"x14" | 190x360 | 0.60 | 0.58 | 0.55 |
| | P-012 | 10"x14.5" | 250x370 | 1.06 | 1.05 | 0.62 |
| | P-013 | 10.25"x16" | 260x410 | 1.08 | 1.07 | 0.64 |
| | P-014 | 12"x17.7" | 300x450 | 1.10 | 1.09 | 0.66 |
| | R-101 | 2" | 50mm×200m | 0.02 | 0.01 | 0.003 |
| | R-102 | 3" | 75mm×200m | 0.09 | 0.05 | 0.004 |
| | R-103 | 4" | 100mm×200m | 0.14 | 0.13 | 0.11 |
| | R-104 | 6" | 150mm×200m | 0.55 | 0.53 | 0.50 |
| ROLL-01<br>Sterilization<br>Roll | R-105 | 8" | 200mm×200m | 0.60 | 0.58 | 0.55 |
| | R-106 | 10' | 250mm×200m | 1.06 | 1.05 | 0.62 |
| | R-107 | 12" | 300mm×200m | 0.60 | 0.58 | 0.55 |
| | R-108 | 14" | 350mm×200m | 1.06 | 1.05 | 0.62 |
| | R-109 | 16" | 400mm×200m | 1.08 | 1.07 | 0.64 |
| | R-110 | 17.7" | 450mm×200m | 1.10 | 1.09 | 0.66 |

(Model and Dimension and Content/Max. Load)

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| R-111 | 20" | 500mm×200m | 1.10 | 1.09 | 0.66 |
|--------|-----|------------|------|------|-------|
| GR-201 | 3" | 75mm×100m | 0.09 | 0.05 | 0.004 |
| GR-202 | 4" | 100mm×100m | 0.14 | 0.13 | 0.11 |
| GR-203 | 6" | 150mm×100m | 0.55 | 0.53 | 0.50 |
| GR-204 | 8" | 200mm×100m | 0.60 | 0.58 | 0.55 |
| GR-205 | 10" | 250mm×100m | 1.06 | 1.05 | 0.62 |
| GR-206 | 12" | 300mm×100m | 0.60 | 0.58 | 0.55 |
| GR-207 | 14" | 350mm×100m | 1.06 | 1.05 | 0.62 |
| GR-208 | 16" | 400mm×100m | 1.08 | 1.07 | 0.64 |

# 6.0 Summary of Non-Clinical Testing

Summary of non-clinical and performance testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The test results demonstrated the subject device is confirmed to be safe and effective for the intended use.

| Test Item | Test Methodology | Acceptance Criteria or End Point | Results |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Sterilization<br>Process Validation | ISO 11135:2014 | Ethylene oxide: 6 hours at 55 °C; relative<br>humidity between 40%- 90%;<br>ethylene oxide concentration<br>is 800 mg/L, 7days aeration<br>time at 20°C.<br>SAL=10-6 | SAL=10-6<br>Pass |
| | ISO 17665-1:2006;<br>ISO TS 17665-2:2009 | Steam; 8 minutes at 134°C; 8<br>minutes dry time.<br>SAL=10-6 | SAL=10-6<br>Pass |
| EO/ECH Residuals | ISO 10993-7:2008 | EO < 4mg<br>ECH < 9mg | Pass |
| Biocompatibility<br>testing | ISO 10993-5:2009 | Non-cytotoxic | Under conditions of the<br>study, did not show<br>potential toxicity to L-929<br>cells.<br>Pass |
| | ISO 10993-10:2010 | Non-irritating | Under the conditions of<br>the study, not an irritant.<br>Pass |
| | ISO 10993-10:2010 | Non-sensitizing | Under conditions of the<br>study, not a sensitizer.<br>Pass |
| Package Integrity /<br>Material<br>Compatibility<br>/Sterility<br>Maintenance | ASTM F 2251-13<br>ASTM F1140/F1140M-13 | 52μm±12%<br>Burst value > 3 Kpa or No Burst | Pass<br>Minimum of Burst pressure = 6.4 (kPa)<br>Pass |
| | ASTM F1929-15 | The dye solution is no any leakage across the seal width of sterile barrier system.<br>(No Infiltration) | No Infiltration<br>Pass |
| | ASTM F88/F88M-15 | Seal strength > 2.5 (N/15mm) | Minimum of Seal strength = 2.9<br>Pass |
| | ISO 1924-2:2008 | Tensile strength:<br>CD $≧$ 2.2KN/m,MD $≧$ 4.4KN/m | Pass |
| | Real time aging | 5 years real time aging<br>Incubation 24 months real time aging Incubation for post steam/EO sterilization storage | The test results of all samples are meet the requirements.<br>Pass |
| | ASTM F2096-11 | No Leakage | No Leakage<br>Pass |
| | DIN 58953-6 | CFU = 0 | CFU = 0<br>Pass |
| Chemical Indicator<br>Efficacy Testing | ISO 11140-1:2014 Steam:<br>The color of CI changes from Blue to Dark Grey, when exposed to Steam; | Steam<br>Change the color:<br>Color of indicator changes from blue to dark grey after Steam sterilization | Color of indicator changes from blue to dark grey under indicated condition and no changed under other condition.<br>Pass |
| | EO:<br>The color of CI changes from Pink to Yellow, when exposed to EO gas. | EO gas<br>Color of indicator changes from pink to yellow after EO sterilization | Color of indicator changes from pink to yellow under indicated condition and no changed under other condition.<br>Pass |
| 1. Remain stable<br>before use based on<br>its shelf life.<br><br>2. Maintain the<br>endpoint stability of the<br>color change after<br>being in the presence<br>of the sterilant. | All performance attributes<br>should maintain the original<br>color : 5 years shelf life | The real-time test was<br>carried out from Jan. 08,<br>2020 to Jan.20, 2022 that<br>demonstrates: the test<br>device which exposed to<br>Steam maintain the color<br>of Dark Grey, the test<br>group which exposed to<br>EO maintain the color of<br>Yellow, and the real-time<br>test was carried out on<br>the empty pouch that<br>demonstrates the test<br>device maintain the<br>original color from Jan.<br>08, 2017 to Jan.28, 2022. | |

#### Table 1: Performance testing summary – Bench

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## 7.0 Technological Characteristic Comparison Table

| Item | Subject Device | Predicate Device | Reference Device | Comparison<br>Analysis |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Sterilization Pouch and Roll | SterileRight sterilization pouch<br>and roll | SIGMA Sterilization Pouch and<br>Roll | ---- |
| 510(k) No. | K221875 | K 212338 | K180661 | ---- |
| Product Code | FRG,JOJ | FRG,JOJ | FRG | Same |
| Regulation No. | 21 CFR 880.6850<br>21 CFR 880.2800 | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| Class | II | II | II | Same |
| Intended Use | The Sterilization Pouch and Roll<br>are intended to provide health care<br>workers with an effective method<br>to enclose devices intended for<br>sterilization in the Steam or via<br>Ethylene Oxide (EO). The<br>recommended sterilization cycles<br>are as follows:<br>- Steam Sterilization at 132°C<br>(270°F) for 4 minutes; Drying time<br>of 30 minutes.<br>- Ethylene Oxide (EO) with a | The SterileRight Sterilization<br>Pouch and Roll are intended to<br>provide health care workers<br>with an effective method to<br>enclose devices intended for<br>sterilization in the Steam or via<br>Ethylene Oxide (EO). The<br>recommended sterilization cycles<br>are as follows:<br>- Gravity steam at 121°C (250°F)<br>for 30 minutes; Drying time of 25<br>minutes. | The SIGMA sterilization pouch<br>and roll are intended to provide<br>health care workers with an<br>effective method to enclose<br>devices intended for sterilization<br>in steam auto claves and via<br>Ethylene Oxide (EO). The<br>recommended steam sterilization<br>cycle parameters are 30 minutes<br>at 121°C. The recommended EO<br>sterilization cycle is 4 hours at<br>55°C with a relative humidity | Similar |

### Table 2- Comparison of Technology Characteristics

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| concentration of 800 mg/L at 55°<br>C (131 ° F) and 40% to 90%<br>relative humidity for 6 hour.<br>Aeration time of 7 days at 20°C).<br><br>The sterilization pouch and roll are<br>made with medical grade paper<br>and medical compound film.The<br>sterilization pouch and roll<br>maintains the sterility of the<br>enclosed devices for up to 24<br>months post Steam or EO gas<br>sterilization, and before<br>sterilization has a maximum shelf<br>life of 5 years from the date of<br>manufacture.<br><br>The pouch's external chemical ink<br>indicators are designed to indicate<br>to the user that the pouch has<br>undergone either a steam or EO<br>sterilization process. Sterilization<br>indicator will change color<br>according to the sterilization<br>method (ethylene oxide, steam).<br>Ethylene oxide sterilization<br>indicator color change from Prink | • Pre-vacuum steam at 132°C<br>(270°F) for 4 minutes; Drying time<br>of 20 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 minutes.<br>Aeration time of 8 hours at 60°C<br>(140°F).<br><br>The SterileRight provide<br>sterilization pouch and roll made<br>with Paper/Film or Tyvek® /Film.<br>The SterileRight sterilization<br>pouch and roll which are made<br>with Paper maintains the sterility<br>of the enclosed devices for up to<br>6 months post Steam or EO gas<br>sterilization, and before<br>sterilization has a maximum shelf<br>life of 3 years from the date of<br>manufacture. The pouch's<br>external chemical ink indicators<br>are designed to indicate to the<br>user that the pouch has<br>undergone either a steam or EO<br>sterilization process. | between 50%-85% and a sterilant<br>concentration of 600 mg/L.<br>Furthermore, the sterilization<br>pouch and roll maintains the<br>enclosed devices up until 3 years<br>post EO gas sterilization<br>and maintains the enclosed<br>devices up until 6 months post<br>Steam sterilization. Lastly, the<br>pouch's external chemical ink<br>indicators are designed to<br>indicate to the user that the pouch<br>has undergone either a steam or<br>EO sterilization process.<br><br>The SIGMA sterilization pouch<br>and roll is offered in the following<br>5 types:<br>• Self-sealing sterilization<br>pouches<br>• Sterilization pouches, Flat<br>• Sterilization pouches,<br>Gusseted<br>•Sterilization rolls, Flat<br>•Sterilization rolls, Gusseted |
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| | before sterilization to Yellow after sterilization. The steam<br>sterilization indicator color change from Blue before sterilization to<br>Dark Grey after sterilization. | The SterileRight sterilization<br>pouch and roll which are made with Tyvek® is for EO gas<br>sterilization only. It also maintains the sterility of the enclosed<br>devices for up to 6 months post EO gas sterilization, and<br>before sterilization has a maximum shelf life of 3 years<br>from the date of manufacture. | | |
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| Material<br>Composition | Composed of medical grade paper<br>and medical compound film, EO<br>and Steam Process Indicator | Medical Grade Paper, CPP, PET,<br>adhesive,EO and Steam Process<br>Indicator, Print Ink.<br>Tyvek®, PET, PE, adhesive. | Medical Grade Paper, CPP, PET,<br>PU adhesive, EO and Steam<br>Process Indicator<br>Print Ink | Same |
| Sterilization<br>Cycles | • Steam Sterilization at 132°C<br>(270°F) for 4 minutes; Drying time<br>of 20 minutes.<br>• Ethylene Oxide (EO) with a<br>concentration of 800 mg/L at 55°<br>C (131 ° F) and 40% to 90%<br>relative humidity for 6 hour.<br>Aeration time of 7 days at 20°C). | • Gravity steam at 121°C (250°F)<br>for 30 minutes; Drying time of 25<br>minutes.<br>• Pre-vacuum steam at 132°C<br>(270°F) for4 minutes; Drying time<br>of 20 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 minutes.<br>Aeration time of 8hours at 60°C<br>(140°F). | • Steam sterilization cycle<br>parameters are 30 minutes at<br>121°C.<br>• EO sterilization cycle is 4<br>hours at 55 °C with a relative<br>humidity between 50%-85%<br>and a sterilant concentration of<br>600 mg/L | Different |
| Configuration/<br>Dimension | Various Size, Heat Sealing | Various Size, Heat Sealing and<br>Self Sealing | Various Size, Heat Sealing | Same |
| Performance Testing | | | | |
| Sterilant<br>Penetration<br>Efficacy | The test meet the requirement of<br>SAL 10-6 | The test meet the requirement of<br>SAL 10-6 | The test meet the requirement of<br>SAL 10-6 | Same |
| Chemical<br>Indicator (CI)<br>Functionality<br>and Endpoint | The sterilant penetrated through<br>the pouch configuration and<br>affected the Cl color change to<br>the endpoint color | The sterilant penetrated through<br>the pouch configuration and<br>affected the CI color change to the<br>endpoint color | The sterilant penetrated through<br>the pouch configuration and<br>affected the Cl color change to the<br>endpoint color | Same |
| Device Design<br>of Steam CI | The color of Chemical Indicator<br>changes from Blue to<br>dark grey, when exposed to<br>Steam | The color of Chemical Indicator<br>changes from Pink to<br>Brown/Black, when exposed to<br>Steam | The color of Chemical Indicator<br>changes from Blue to<br>Greenish Black, when exposed to<br>Steam | Similar |
| Device Design<br>of EO gas CI | The color of Chemical Indicator<br>changes from Pink to Yellow,<br>when exposed to Steam | The color changes from Blue to<br>Yellow/Brown, when exposed to<br>EO gas | The color changes from - Red to<br>Yellow, when exposed to EO gas | Similar |
| Thickness<br>Variations (mm)<br>ASTM F 2251 | Passed | Passed | Passed | Same |
| Tensile strength<br>ISO 1924-2 | Passed | Passed | Passed | Same |
| Burst Strength<br>(kPa)<br>ASTM F1140 : | > 3.0 Kpa<br>Passed | Passed | Passed | Same |
| ISO 11607-1 | | | | |
| Bubble Leak<br>Test<br>ASTM D 3078<br>or ASTM-F<br>2096 | No Leakage<br><br>Passed | Passed | Passed | Same |
| Seal Peel Test<br>(N/15mm)<br>ASTM<br>F88/F88M ;<br>ISO 11607-1 | Min value= 2.08<br><br>Passed | Passed | Passed | Same |
| Dye penetration<br>Test ASTM<br>F1929 ;ISO<br>11607-1 | No Infiltration<br><br>Passed | Passed | Passed | Same |
| Microbial<br>Barrier Test<br>DIN 58953-6 | CFU = 0<br><br>Passed | Passed | Passed | Same |
| End point<br>stability<br>testing results | The color of chemical indicator for<br>EO sterilization indicator ink is<br>Pink, and the color of chemical<br>indicator for steam sterilization<br>indicator ink is Blue after 5 year<br>shelf life before sterilization. | The color of chemical indicator for<br>EO sterilization indicator ink is<br>Blue, and the color of chemical<br>indicator for steam sterilization<br>indicator ink is Pink after 2<br>year shelf life before sterilization. | The color of chemical indicator for<br>EO sterilization indicator ink is<br>Red, and the color of chemical<br>indicator for steam sterilization<br>indicator ink is Blue after 2 year<br>shelf life before sterilization. | Similar |
| | The color of chemical indicator for | The color of chemical indicator for | The color of chemical indicator for | Similar |
| | EO sterilization indicator ink is<br>Yellow, and the color of chemical<br>indicator for steam sterilization<br>indicator ink is Blue after EO<br>sterilized and 24 months shelf life. | EO sterilization indicator ink is<br>Yellow/Brown , and the color of<br>chemical indicator for steam<br>sterilization indicator ink is Pink<br>after EO sterilized and 6 months<br>shelf life | EO sterilization indicator ink is<br>yellow, and the color of chemical<br>indicator for steam sterilization<br>indicator ink is Blue after EO<br>sterilized and 3 years shelf life | |
| | The color of chemical indicator for<br>EO sterilization indicator ink is<br>Pink, and the color of chemical<br>indicator for steam sterilization<br>indicator ink is Dark Grey after<br>steam sterilized and 24 months<br>shelf life. | The color of chemical indicator for<br>EO sterilization indicator ink is<br>Blue, and the color of chemical<br>indicator for steam sterilization<br>indicator ink is Brown/Black after<br>steam sterilized and 6 months<br>shelf life. | The color of chemical indicator for<br>EO sterilization indicator ink is<br>Red, and the color of chemical<br>indicator for steam sterilization<br>indicator ink is Greenish Black<br>after steam sterilized and 6<br>months shelf life. | Similar |
| Maintenance of<br>Sterility | 24 months | 6 months | 3 years post EO gas sterilization<br>6 months post Steam sterilization | Different |
| Shelf Life | 5 years from date of manufacture<br>for EO and Steam Indicators | 3 years from date of manufacture<br>for EO and Steam Indicators | 3 years from date of manufacture<br>for EO and Steam Indicators | Different |
| Biocompatibility | Conform with ISO10993-1<br>(ISO10993-4, ISO10993-5,<br>ISO10993-10, ISO10993-11) | Conform with ANSI/AAMI/ISO<br>10993-10 | Conform with ISO 10993<br>standards | Same |

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The technological characteristics of the subject device are identical to those of predicate device. The subject device has the same basic design as the predicate device.

The comparison between the subject and predicate devices is based on the following:

- Same intended use
- · Same indications for use
- · Similar material types that meet ISO 10993 biocompatibility requirements
- · Same sterilization methods (EO and Steam sterilization process)
- Same fundamental technology/principal of operation/user interface

The sterilization parameters of the subject device is different with those of the predicate device, but the EO sterilization results demonstrate the subject device fully meet the requirements of ISO 11135 and the steam sterilization validation results fully meet the requirements of ISO 17665-1. The subjec…