PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)

K152669 · Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std · FRG · Jan 15, 2016 · General Hospital

Device Facts

• Record ID: K152669
• Device Name: PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)
• Applicant: Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std
• Product Code: FRG · General Hospital
• Decision Date: Jan 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are intended to provide healthcare workers with an effective method to enclose medical devices intended for sterilization with steam or ethylene oxide (EO) applying the below validated sterilization cycle parameters. The indicated sterilization parameters for either steam or EO are the only validated sterilization parameters to be used/applied. The recommended (and validated) sterilization cycle parameters are; For steam sterilization pre-vacuum cycle at 132 degrees C for 4 minutes. For EO sterilization: 100% ethylene oxide (EO) with a concentration of 725mg/l at 55 degrees C and 50-80% relative humidity for 60 minutes. Aeration time is 8 hours. Chemical process indicator on the exterior of the pouch indicates by color change that the pouch has undergone either a steam or ethylene oxide sterilization process. After the sterilization process is completed the sterility of the enclosed medical device is maintained for 30 days.

Device Story

Device consists of medical-grade paper and laminated PET/PP plastic film pouch; three sides heat-sealed; fourth side features self-seal adhesive strip for manual closure by healthcare personnel. Pouch acts as microbial barrier for medical devices during steam or EO sterilization. Exterior features Class 1 chemical process indicator ink (ISO 11140-1) that changes color upon exposure to sterilant vapor, allowing visual differentiation between processed and unprocessed units. Sterilant penetrates through medical-grade paper to destroy microorganisms on device surfaces. Used in clinical settings; provides 30-day post-sterilization sterility maintenance. Benefits include effective containment, microbial protection, and visual confirmation of sterilization exposure.

Clinical Evidence

Bench testing only. Performance validated for sterilant penetration (SAL 10^-6), microbial barrier properties, package integrity, and material compatibility with steam and EO cycles. Chemical indicator efficiency verified per ISO 11140-1. Biocompatibility assessed per ISO 10993-1 requirements.

Technological Characteristics

Materials: Medical-grade paper and laminated PET/PP plastic film. Construction: Heat-sealed 3 sides, self-seal adhesive strip. Indicator: Class 1 chemical process indicator (ISO 11140-1) printed on exterior paper. Standards: ANSI/AAMI/ISO 11140-1:2005, ANSI/AAMI/ISO 11607-1:2006. Connectivity: None. Sterilization: Steam (132°C, 4 min) or EO (100% EO, 725mg/l, 55°C, 50-80% RH, 60 min).

Indications for Use

Indicated for healthcare workers to enclose medical devices for steam or ethylene oxide (EO) sterilization. Steam: pre-vacuum cycle at 132°C for 4 minutes. EO: 100% EO, 725mg/l, 55°C, 50-80% RH for 60 minutes, 8-hour aeration. Maintains sterility for 30 days 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

• SIGMA Sterilization Pouch and Roll (K102158)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

January 15, 2016

PMS Tip Teknolojileri Sanavi Ve Ticaret Limited. STI Ms. Derya Dikici Business Development Manager Mersin Tarsus Organize Sanayi Bolgesi, 12 CAD, No. 2 Huzurkent, Mersin, TR 33020

Re: K152669

Trade/Device Name: PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) Regulation Number: 21 CFR 880.6850 Regulation Name: Wrap, Sterilization Regulatory Class: II Product Code: FRG; JOJ Dated: December 10, 2015 Received: December 16, 2015

Dear Ms. Dikici,

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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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known) K152669

#### Device Name

PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP)

#### Indications for Use (Describe)

PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are intended to provide healthcare workers with an effective method to enclose medical devices intended for sterilization with steam or ethylene oxide (EO) applying the below validated sterilization cycle parameters. The indicated sterilization parameters for either steam or EO are the only validated sterilization parameters to be used/applied.

The recommended (and validated) sterilization cycle parameters are;

· For steam sterilization pre-vacuum cycle at 132 degrees C for 4 minutes.

· For EO sterilization: 100% ethylene oxide (EO) with a concentration of 725mg/l at 55 degrees C and 50-80% relative humidity for 60 minutes. Aeration time is 8 hours.

Chemical process indicator on the exterior of the pouch indicates by color change that the pouch has undergone either a steam or ethylene oxide sterilization process.

After the sterilization process is completed the sterility of the enclosed medical device is maintained for 30 days.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------------|
| | |
| Prescription Use (Part 21 CFR 801 Subpart D) | 区 Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for PMS. The logo consists of a red and gray graphic on the left, followed by the letters "PMS" in gray. The graphic on the left is a combination of red and gray shapes, with the red shape on top and the gray shape on the bottom.

# 510 (k) Summary for PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP)

## 1. Name, address and contact

| PMS Tıp Teknolojileri Sanayi ve Ticaret Limited Şirketi | | |
|---------------------------------------------------------|---|-----------------------------------|
| Mersin Tarsus Organize Sanayi Bölgesi 12.Cad.No:2 | | |
| Huzurkent 33020 Mersin-TURKEY | | |
| Phone | : | 90 324 2387042 – 90 542 648 6312 |
| Fax | : | 90 324 2386549 |
| Prepared by | : | Taner Ersen |
| | | Quality Management Representative |
| Contact | : | Derya Dikici |
| | | Business Development Manager |
| Phone | : | 90 324 2387042- 90 542 648 6312 |
| Fax | : | 90 324 2386549 |
| E-mail : [e-mail] | | |
| Date Prepared: | | December 07, 2015 |

## 2. Device Name

Trade Name: PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator

Common/Usual Name: Sterilization Pouch (Self Seal)

Device Classification Name: Wrap, Sterilization; Indicator, Physical/Chemical Sterilization Process

Product Code: 1) FRG 2) JOJ

Product Classification: Class II

21 CFR 880.6850, General Hospital (FRG) 21 CFR 880.2800(b), General Hospital (JOJ)

## 3. Predicate Device

K102158, SIGMA Sterilization Pouch and Roll

## 4. Indications for Use/Intended Use

PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP) are intended to provide healthcare workers with an effective method to enclose medical devices intended for sterilization with steam or ethylene oxide (EO) applying the below validated sterilization cycle parameters. The indicated sterilization parameters for either steam or EO are the only validated sterilization parameters to be used/applied.

The recommended (and validated) sterilization cycle parameters are:

- · For steam sterilization pre-vacuum cycle at 132 degrees □C for 4 minutes.
- · For EO sterilization; 100% ethylene oxide (EO) with a concentration of 725mg/l 55 degrees C and 50-80% relative humidity for 60 minutes. Aeration time is 8hrs.

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Chemical process indicator on the exterior of the pouch indicates by color change that the pouch has undergone either a steam or ethylene oxide sterilization process. After the sterilization process is completed the sterility of the enclosed medical device is maintained for 30 days.

## 5. Device Description

PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are manufactured from medical grade paper/plastic film that are heat sealed on 3 sides, the fourth side has a self-seal adhesive strip and left opened. This side is manually sealed by the user with the self-seal adhesive strip. Triple band seal provides three independent barriers to contamination, while reducing the risk of fibre tear. PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are presented as 60 gsm model.

# Representative Engineering Drawing: "PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP)"

Image /page/4/Figure/4 description: The image shows a technical drawing of a part with several dimensions labeled. The overall height is labeled as 'B', and the overall width is labeled as 'A'. At the bottom, 'P=2' and 'L=10' are indicated, along with 'V=2' on the right side and 'K' indicating the height of a section. The top of the drawing has a feature labeled 'S'.

A: Total width

- B: Total height
- L: Seal width (mm)
- V: Single seal width (mm)
- P: Distance between 2 seals (mm)
- S: Diameter
- K: Strip width

#### 6. Description of the Principle of Operation

PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP) are used to enclose medical devices that are to be sterilized by health care provider via sterilization methods. Medical device to be sterilized is put into pouch and the open parts of the packages are manually closed with the self-seal adhesive strip. Sterilization packages then are subjected to sterilization operation in related sterilization devices (steam sterilizers, EO sterilization devices). Sterilant penetration is carried out through

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the medical grade paper into the packages and microorganisms on the surface of the medical devices are destroyed with the effect of the sterilant vapors. Other parameters of the sterilization process are temperature, pressure; humidity and time are determined according to the sterilization type.

The process indicator on the pouches are intended to be used by a health care provider with sterilization pouches to distinguish between processed and unprocessed units by changing color. Chemical process indicators on the pouch indicate that the pouch has been exposed to sterilization process by changing color.

Chemical process indicators are printed on the pouch exterior (printed on medical grade paper component) changes color when exposed to sterilant vapor during processing. After the sterilization is completed, the sterility of the enclosed medical device is maintained for 30 days. Chemical indicator pars printed on to the medical grade paper component of the pouches are 100 mm- size, having dimensions of 5 mmx20 mm.

The indicators used on the pouches are classified as Class 1 type process indicator according to the ISO 11140-1 standard.

## 7. Comparison of Submission Device and Predicate Device and Substantial Equivalence:

Technological characteristics of the submission device and the comparison with predicate devices are given in Table 7.1. as a summary.

| TABLE 7.1. Comparison of Submission Device and Predicate Device |
|-----------------------------------------------------------------|
| (Characteristics) |

| DEVICE NAME | SUBMISSION<br>DEVICE | PREDICATE DEVICE | SE |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| CHARACTERISTICS | PMSSteripack Self Seal<br>Sterilization Pouch with<br>Chemical Indicator<br>(KP) | SIGMA Sterilization Pouch and<br>Roll (K102158) | YES |
| DESIGN AND<br>CONSTRUCTION &<br>MATERIAL<br>COMPOSITION | Medical grade paper and heat<br>sealed laminated PET/PP<br>plastic film. Externally printed<br>Steam and EO process<br>indicator ink. Pouches are<br>manufactured from medical<br>grade paper/plastic film that<br>are heat sealed on 3 sides, the<br>fourth side is left opened and<br>has an adhesive strip which is<br>used to seal the pouch. | Medical Grade Paper and<br>heat<br>sealed plastic film. EO and Steam<br>Process Indicator Print ink. Pouches<br>are made from a medical grade<br>plastic film that is heat sealed on<br>three sides. The forth side is left<br>opened and is heat- sealed when<br>using. In gusseted pouches, plastic<br>film is folded on both longest sides.<br>Self seal pouch has an adhesive<br>strip that is used to seal the pouch.<br>Release paper used in the pouch is a<br>laminated sheet with composing<br>structure of FE/paper/PE. It is a strip<br>to cover the adhesive area and is<br>released befre seal the pouch. The<br>medical grade paper conforms to<br>recognized material standards and<br>can be sterilized by steam<br>or<br>ethylene oxide gas. | YES |
| INTENDED USE | Single use devices to enclose<br>other medical devices that are to<br>be sterilized by health care<br>provider via Steam and Ethylene<br>Oxide (EO) sterilization methods.<br>The recommended (and<br>validated) sterilization cycle<br>parameters are:<br>For Steam sterilization pre-<br>vacuum cycle at 132 °C for 4<br>minutes.<br>For EO sterilization; 100%<br>ethylene oxide with a<br>concentration of 725 mg/L, at 55<br>°C and 50-80% relative humidity<br>for 60 minutes. Aeration time is 8<br>hours.<br>Chemical process indicators on<br>the pouch indicate that the pouch<br>has been exposed to sterilization<br>process by changing color. After<br>the sterilization is completed, the<br>sterility of the enclosed medical<br>device is maintained for 30 days. | Single use devices, to enclose<br>another medical devices that is to<br>be sterilized by a health provider.<br>Sterilization pouch and roll are<br>intended to provide health care<br>workers with an effective method<br>to enclose devices intended for<br>sterilization in steam auto claves<br>and via Ethylene Oxide (EO).<br><br>The recommended steam<br>sterilization cycle parameters are<br>30 minutes at 121 °C.<br><br>The recommended EO<br>sterilization cycle is 4 hours at 55<br>°C with a relative humidity<br>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 sterilization. | YES |
| STERILIZATION<br>PROPERTIES | The recommended (and<br>validated) sterilization cycle<br>parameters are:<br>For Steam sterilization pre-<br>vacuum cycle at 132 °C for 4<br>minutes.<br>For EO Sterilization; 100%<br>ethylene oxide (EO) with a<br>concentration of 725 mg/L at 55<br>°C and 50-80% relative humidity<br>for 60 minutes. Aeration time is 8<br>hours. | The recommended steam<br>sterilization cycle parameters are<br>30 minutes at 121 °C.<br><br>The recommended EO sterilization<br>cycle is 4 hours at 55 °C with a<br>relative humidity between<br>50%/85% and a sterilant<br>concentration of 600 mg/L. | YES |
| PRINCIPLE OF<br>OPERATION | Medical device to be sterilized is<br>put into pouch and the open part<br>of the package is closed<br>manually with an adhesive strip.<br>Sterilization packages then are<br>subjected to validated sterilization<br>operation of steam & EO.<br>Sterilant penetration is carried out<br>through the medical grade paper<br>into the package and<br>microorganisms on the surface of<br>the medical device are destroyed<br>with the effect of the sterilant<br>vapors. Other parameters of the<br>sterilization process are<br>temperature, pressure, humidity,<br>time and are deteminded<br>according to the sterilization type.<br>Chemical process indicator is<br>printed exterior on the pouch<br>(printed on medical grade paper)<br>changes color when exposed to<br>sterilant vapor during processing.<br>After the sterilization is<br>completed, the sterility of the<br>enclosed medical device is<br>maintained for 30 days. | Medical device to be sterilized is<br>put into roll or pouch and the open<br>parts of the packages are closed<br>by self sealing. Sterilization<br>packages then are subjected to<br>sterilization operation in related<br>sterilization devices (steam<br>autoclaves, EO sterilization).<br><br>The process Indicators Ink printed<br>on the medical grade paper will<br>exhibit a color change after the<br>pouch is exposed to steam or<br>ethylene oxide gas.<br>The SIGMA sterilization pouch<br>and roll is offered in the following 5<br>types:<br>* Self-sealing sterilization pouches<br>* Sterilization pouches, Flat<br>* Sterilization pouches, Gusseted<br>* Sterilization rolls, Flat<br>* Sterilization rolls, Gusseted | YES |
| PRINCIPLES OF<br>OPERATION FOR<br>CHEMICAL<br>INDICATORS | The Process Indicator Ink printed<br>on the medical grade paper will<br>exhibit a color change after the<br>pouch is exposed to steam and<br>ethylene oxide gas. In steam<br>sterilization, printed indicator bar<br>changes from pink to brown<br>when exposed to steam. In EO<br>sterilization, printed indicator bar<br>changes from turquoise to yellow<br>when exposed to EO gas. | The Process Indicators Ink printed<br>on the medical grade paper will<br>exhibit a color change after the<br>pouch is exposed to steam or<br>ethylene oxide gas. | YES |
| SHELF LIFE | 5 years | 3 years | YES |
| CONFIGURATIONS&<br>DIMENSIONS | Various sizes (width and<br>height) | Various sizes (width, height<br>and gusset) | YES |

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#### TABLE 7.2. Comparison of Submission Device and Predicate Device (Performance)

| DEVICE<br>NAME | PROPOSED DEVICE | PREDICATE<br>DEVICE | SUBSTANTIALL<br>EQUIVALENCE |
|---------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-----------------------------|
| PERFROMANCE | PMS Steripack Self Seal<br>Sterilization pouch with<br>Chemical Indicator | SIGMA sterilization<br>Pouch and Roll<br>(K102158) | YES |
| Sterilant<br>Penetration | The sterilization (steam and EO)<br>was validated to a sterility<br>assurance level (SAL) of 10-6 | Sterility assurance level<br>of 10-6 achieved. | YES |
| Microbial Barrier<br>Properties | Sterility was maintained for at least<br>30 days after processing in Steam<br>and EO sterilizer. | Meets<br>requirements | YES |
| Material<br>Compatibility | Suitability for use in Steam and EO Meets<br>sterilization processes and cycle<br>parameters. | requirements | YES |
| Biocompatibility | Not direct patient-contacting<br>devices; Materials are non-toxic<br>and meet ISO 10993-1<br>requirements. | Meets<br>requirements | YES |
| Package Integrity | Porous material providing a<br>microbial barrier. | Meets<br>requirements | YES |

# 8. Conclusion

PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) (subject device) and SIGMA Sterilization pouch and roll (predicate device) are both single use devices that are used to enclose another medical device to be sterilized in required sterilization methods.

PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) and predicate device have many similar technological characteristics. SIGMA Sterilization pouch and rolls are made from medical grade paper and laminated plastic film by heat sealing. On the other hand, PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) and SIGMA Sterilization pouch and roll have the same design features and they all have various size.

PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) and predicate device have similar sterilization methods (Steam and EO).

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PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) and predicate device have similar performance characteristics considering Sterilant Penetration, Drying Time, Aeration time, Package Integrity, Sterility Maintenance, Biocompatibility and Chemical Indicator Efficiency.

Both the subject device PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) and the predicate devices SIGMA Sterilization pouch and roll meet the requirements of ANSI/ AAMI/ ISO 11140-1:2005 and ANSI/ AAMI/ ISO 11607-1:2006.

In conclusion, the subject device PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) is substantially equivalent to predicate device K102158 SIGMA Sterilization Pouches and Rolls. Based on the intended use, technological characteristics, and performance data, the subject PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) is substantially equivalent and is as safe and as effective as the legally marketed predicate device.