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 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.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for a medical device called "PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP)". However, it does not contain the level of detail requested for AI/ML device studies (e.g., number of experts, adjudication methods, training/test set sample sizes, ground truth provenance for training set). This is because the document is a 510(k) premarket notification for a sterilization pouch, which is a physical medical device, not an AI/ML algorithm. Therefore, the questions related to AI/ML device performance are not applicable.

Here's the information that can be extracted from the document, presented in a format that aligns with the request where possible:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria / Requirement	Reported Device Performance (PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP))	Substantial Equivalence to Predicate Device (SIGMA Sterilization Pouch and Roll (K102158))
Intended Use	Single use device to enclose medical devices for sterilization by Steam and EO sterilization methods. Specific validated cycle parameters for Steam (132°C for 4 min) and EO (100% EO, 725mg/L, 55°C, 50-80% RH for 60 min, 8hr aeration). Chemical indicators show exposure to sterilization process. Sterility maintained for 30 days.	Functions as a single-use device for enclosing medical devices for sterilization. Conforms to specified validated Steam and EO sterilization cycle parameters. Chemical indicators change color to indicate exposure. Sterility maintained for 30 days.	YES (Similar intended use, though specific cycle parameters and sterility maintenance duration)
Design and Construction & Material Composition	Medical grade paper and heat-sealed laminated PET/PP plastic film. Externally printed Steam and EO process indicator ink. Heat-sealed on 3 sides, self-seal adhesive strip on 4th side.	Medical grade paper and heat-sealed laminated PET/PP plastic film. Externally printed Steam and EO process indicator ink. Heat-sealed on 3 sides, self-seal adhesive strip for manual closure.	YES
Sterilization Properties (Validated Parameters)	Steam: Pre-vacuum cycle at 132 °C for 4 minutes. EO: 100% ethylene oxide (EO) with a concentration of 725 mg/L at 55 °C and 50-80% relative humidity for 60 minutes. Aeration time is 8 hours.	Steam: Validated for pre-vacuum cycle at 132 °C for 4 minutes. EO: Validated for 100% ethylene oxide (EO) with a concentration of 725 mg/L at 55 °C and 50-80% relative humidity for 60 minutes. Aeration time is 8 hours.	YES (Different specific parameters than predicate, but still considered substantially equivalent for the capability of sterilization, with its own validated parameters).
Principle of Operation	Medical device placed in pouch, manually sealed with adhesive strip. Subjected to validated Steam & EO sterilization. Sterilant penetration through medical grade paper destroys microorganisms. Chemical process indicator changes color. Sterility maintained for 30 days.	Operates as described: device placed in pouch, sealed, sterilized (Steam/EO), sterilant penetrates paper. Chemical indicator changes color. Sterility maintained for 30 days.	YES
Principles of Operation for Chemical Indicators	Process Indicator Ink on medical grade paper changes color when exposed to sterilant vapor. Steam: pink to brown. EO: turquoise to yellow.	Steam indicator changes from pink to brown. EO indicator changes from turquoise to yellow.	YES
Shelf Life	5 years	5 years	YES (Longer than predicate's 3 years, but considered substantially equivalent as it meets or exceeds requirements).
Configurations & Dimensions	Various sizes (width and height)	Various sizes (width and height)	YES
Sterilant Penetration	Sterility assurance level (SAL) of 10^-6 achieved.	Sterility assurance level (SAL) of 10^-6 achieved for both steam and EO.	YES
Microbial Barrier Properties	Sterility maintained for at least 30 days after processing.	Sterility maintained for at least 30 days after processing in Steam and EO sterilizer.	YES
Material Compatibility	Suitability for use in Steam and EO sterilization processes and cycle parameters.	Suitable for use in Steam and EO sterilization processes and cycle parameters.	YES
Biocompatibility	Non-direct patient-contacting devices; materials non-toxic and meet ISO 10993-1.	Not direct patient-contacting devices; materials non-toxic and meet ISO 10993-1 requirements.	YES
Package Integrity	Porous material providing a microbial barrier.	Porous material providing a microbial barrier.	YES
Compliance with Standards	ANSI/AAMI/ISO 11140-1:2005 (for chemical indicators) and ANSI/AAMI/ISO 11607-1:2006 (for packaging)	Meets the requirements of ANSI/AAMI/ISO 11140-1:2005 and ANSI/AAMI/ISO 11607-1:2006.	YES

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document is for a physical medical device (sterilization pouch), not an AI/ML device. Therefore, a "test set" in the context of an AI/ML algorithm is not applicable. The performance data is based on various standard tests for sterilization packaging and indicators. The provenance mentioned is PMS Tıp Teknolojileri Sanayi ve Ticaret Limited Şirketi, located in Mersin, Turkey. The testing would have been conducted as part of the device's development and validation, which is prospective in nature, but specific sample sizes for each test are not detailed in this summary document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to a physical medical device like a sterilization pouch, as "ground truth" established by experts in the context of AI/ML algorithms does not apply here. Performance is evaluated against established physical, chemical, and microbiological standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable to a physical medical device. Performance is evaluated against objective, measurable criteria and standards, not expert adjudication of complex interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable to a physical medical device. MRMC studies are relevant for imaging or diagnostic AI where human readers interact with the AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable to a physical medical device. There is no AI algorithm involved. The device operates independently of human interpretation in terms of its core function (sterilization and indication).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this physical device, the "ground truth" used for testing would be based on:

Physical/Chemical Standards: Adherence to material specifications, seal strength, and indicator color change criteria as defined by international standards (e.g., ISO 11140-1, ISO 11607-1).
Microbiological Standards: Demonstrated sterility assurance level (SAL) of 10^-6, typically confirmed through biological indicator tests and sterility testing after exposure to validated sterilization cycles.
Performance Standards: Ability to maintain sterility for the stated shelf life (30 days in this case).

8. The sample size for the training set

This question is not applicable, as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable, as this is not an AI/ML device that requires a training set or its associated ground truth establishment.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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 : derya.dikici@pmsmedikal.com
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

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	SUBMISSIONDEVICE	PREDICATE DEVICE	SE
CHARACTERISTICS	PMSSteripack Self SealSterilization Pouch withChemical Indicator(KP)	SIGMA Sterilization Pouch andRoll (K102158)	YES
DESIGN ANDCONSTRUCTION &MATERIALCOMPOSITION	Medical grade paper and heatsealed laminated PET/PPplastic film. Externally printedSteam and EO processindicator ink. Pouches aremanufactured from medicalgrade paper/plastic film thatare heat sealed on 3 sides, thefourth side is left opened andhas an adhesive strip which isused to seal the pouch.	Medical Grade Paper andheatsealed plastic film. EO and SteamProcess Indicator Print ink. Pouchesare made from a medical gradeplastic film that is heat sealed onthree sides. The forth side is leftopened and is heat- sealed whenusing. In gusseted pouches, plasticfilm is folded on both longest sides.Self seal pouch has an adhesivestrip that is used to seal the pouch.Release paper used in the pouch is alaminated sheet with composingstructure of FE/paper/PE. It is a stripto cover the adhesive area and isreleased befre seal the pouch. Themedical grade paper conforms torecognized material standards andcan be sterilized by steamorethylene oxide gas.	YES
INTENDED USE	Single use devices to encloseother medical devices that are tobe sterilized by health careprovider via Steam and EthyleneOxide (EO) sterilization methods.The recommended (andvalidated) sterilization cycleparameters are:For Steam sterilization pre-vacuum cycle at 132 °C for 4minutes.For EO sterilization; 100%ethylene oxide with aconcentration of 725 mg/L, at 55°C and 50-80% relative humidityfor 60 minutes. Aeration time is 8hours.Chemical process indicators onthe pouch indicate that the pouchhas been exposed to sterilizationprocess by changing color. Afterthe sterilization is completed, thesterility of the enclosed medicaldevice is maintained for 30 days.	Single use devices, to encloseanother medical devices that is tobe sterilized by a health provider.Sterilization pouch and roll areintended to provide health careworkers with an effective methodto enclose devices intended forsterilization in steam auto clavesand via Ethylene Oxide (EO).The recommended steamsterilization cycle parameters are30 minutes at 121 °C.The recommended EOsterilization cycle is 4 hours at 55°C with a relative humiditybetween 50%-85% and a sterilantconcentration of 600 mg/L.Furthermore, the sterilizationpouch and roll maintains theenclosed devices up until 3 yearspost sterilization.	YES
STERILIZATIONPROPERTIES	The recommended (andvalidated) sterilization cycleparameters are:For Steam sterilization pre-vacuum cycle at 132 °C for 4minutes.For EO Sterilization; 100%ethylene oxide (EO) with aconcentration of 725 mg/L at 55°C and 50-80% relative humidityfor 60 minutes. Aeration time is 8hours.	The recommended steamsterilization cycle parameters are30 minutes at 121 °C.The recommended EO sterilizationcycle is 4 hours at 55 °C with arelative humidity between50%/85% and a sterilantconcentration of 600 mg/L.	YES
PRINCIPLE OFOPERATION	Medical device to be sterilized isput into pouch and the open partof the package is closedmanually with an adhesive strip.Sterilization packages then aresubjected to validated sterilizationoperation of steam & EO.Sterilant penetration is carried outthrough the medical grade paperinto the package andmicroorganisms on the surface ofthe medical device are destroyedwith the effect of the sterilantvapors. Other parameters of thesterilization process aretemperature, pressure, humidity,time and are detemindedaccording to the sterilization type.Chemical process indicator isprinted exterior on the pouch(printed on medical grade paper)changes color when exposed tosterilant vapor during processing.After the sterilization iscompleted, the sterility of theenclosed medical device ismaintained for 30 days.	Medical device to be sterilized isput into roll or pouch and the openparts of the packages are closedby self sealing. Sterilizationpackages then are subjected tosterilization operation in relatedsterilization devices (steamautoclaves, EO sterilization).The process Indicators Ink printedon the medical grade paper willexhibit a color change after thepouch is exposed to steam orethylene oxide gas.The SIGMA sterilization pouchand roll is offered in the following 5types:* Self-sealing sterilization pouches* Sterilization pouches, Flat* Sterilization pouches, Gusseted* Sterilization rolls, Flat* Sterilization rolls, Gusseted	YES
PRINCIPLES OFOPERATION FORCHEMICALINDICATORS	The Process Indicator Ink printedon the medical grade paper willexhibit a color change after thepouch is exposed to steam andethylene oxide gas. In steamsterilization, printed indicator barchanges from pink to brownwhen exposed to steam. In EOsterilization, printed indicator barchanges from turquoise to yellowwhen exposed to EO gas.	The Process Indicators Ink printedon the medical grade paper willexhibit a color change after thepouch is exposed to steam orethylene oxide gas.	YES
SHELF LIFE	5 years	3 years	YES
CONFIGURATIONS&DIMENSIONS	Various sizes (width andheight)	Various sizes (width, heightand gusset)	YES

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

DEVICENAME	PROPOSED DEVICE	PREDICATEDEVICE	SUBSTANTIALLEQUIVALENCE
PERFROMANCE	PMS Steripack Self SealSterilization pouch withChemical Indicator	SIGMA sterilizationPouch and Roll(K102158)	YES
SterilantPenetration	The sterilization (steam and EO)was validated to a sterilityassurance level (SAL) of 10-6	Sterility assurance levelof 10-6 achieved.	YES
Microbial BarrierProperties	Sterility was maintained for at least30 days after processing in Steamand EO sterilizer.	Meetsrequirements	YES
MaterialCompatibility	Suitability for use in Steam and EO Meetssterilization processes and cycleparameters.	requirements	YES
Biocompatibility	Not direct patient-contactingdevices; Materials are non-toxicand meet ISO 10993-1requirements.	Meetsrequirements	YES
Package Integrity	Porous material providing amicrobial barrier.	Meetsrequirements	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.

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
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.(b)
Classification. Class II (performance standards).