The Sterilucent Self-Seal Sterilization Pouch is intended to be used to enclose medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterlity of the enclosed device until used. The pouches are intended to be used in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen and Non-Lumen Cycles.

Device Description

The Sterilucent Self-Seal Sterilization Pouch is a self sealing pouch used to enclose another medical device that is to be sterilized by a healthcare provider. It is available in sizes to suit the healthcare provider. Devices are inserted into the pouch, sealed, and then sterilized in the Sterilucent low temperature vaporized hydrogen peroxide (VHP) process. After completion of the sterilization process, the pouch maintains sterility of the enclosed medical devices until the seal is opened.

The pouches are constructed of a Tyvek backing with a clear, laminated polyethylene terephthalate (PET)/low density polyethylene (LDPE) film material front. The self-seal pouch permits sealing of the pouch without need of heat-sealing equipment.

AI/ML Overview

The provided text describes the Sterilucent Self-Seal Sterilization Pouch and its non-clinical performance data. Here's an analysis of the requested information based on the text:

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

The document doesn't explicitly list acceptance criteria in a table format with corresponding reported device performance values. Instead, it describes the outcome of studies, stating that "all acceptance criteria were met."

However, we can infer criteria and performance from the "Summary of Non-Clinical Performance Data" section:

Acceptance Criteria (Inferred)	Reported Device Performance
Sterilization Efficacy	A 12 log reduction achieved, resulting in a Sterility Assurance Level (SAL) of 10-6.
Shelf Life	Sterility maintenance demonstrated for a 180-day time period.
Microbial Barrier Properties	Appropriate microbial barrier properties demonstrated.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the test set or the number of pouches used for each test.
The data provenance is from non-clinical studies, which typically means laboratory testing rather than human patient data. The country of origin of the data is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. Given that the studies are non-clinical, it's unlikely that "experts" in the sense of clinical specialists were used to establish ground truth. Ground truth for sterilization efficacy and microbial barrier properties would typically be established by established microbiological testing standards and results.

4. Adjudication method for the test set

This information is not provided as it's not applicable to non-clinical laboratory tests as described. Adjudication methods like "2+1" are typically used for interpreting human-read data (e.g., medical images).

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools with human readers, which is not the nature of this device (a sterilization pouch).

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

This question is not applicable to the Sterilucent Self-Seal Sterilization Pouch. This device is a physical product (a pouch) used in a sterilization process, not an algorithm or AI system. Its performance is evaluated through its physical and biological properties.

7. The type of ground truth used

The ground truth used for the non-clinical studies was based on:

Biological Indication (BI) overkill method and half-cycle validation: For sterilization efficacy (determining a 12 log reduction and SAL of 10-6).
Real-time event-related shelf life studies: For sterility maintenance over time.
Whole package microbial challenge testing: Exposing pouches to a specified concentration of Bacillus atrophaeus CFU to assess microbial barrier properties.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" in the context of validating a medical device like a sterilization pouch, as it's not an AI or machine learning model. Its performance is evaluated through physical and biological testing.

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

This information is not applicable/not provided for the same reasons as #8.

Summary

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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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.

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

December 3,2014

Sterilucent, Inc % Peter Kalkbrenner Director of Engineering 1400 Marshall Street Ne Minneapolis, Minnesota 55413

Re: K141412

Trade/Device Name: Sterilucent Self-Seal Sterilization Pouch Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: October 31, 2014 Received: November 5, 2014

Dear Peter Kalkbrenner.

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

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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 (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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runner DDS, MA

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) K141412

Device Name

Sterilucent Self-Seal Sterilization Pouch

Indications for Use (Describe)

Pouch Models and Sizes

Catalog No. Size SL264 3.5" x 9" SL265 4" x 22" SL266 5.25" x 10" SL267 5" x 15" 7.5" x 13" SL268 SL269 12" x 15" SL270 12" x 18"

The PSD-85 Lumen Cycle has been validated to sterilize a load of up to ten (10) pounds (combined pouch and wrapped tray load) containing a maximum of ten (10) single channel stainless steel lumens per load with the following dimensions:

· An inside diameter of 1 mm or larger and a length of 60 mm or shorter;

· An inside diameter of 2 mm or larger and a length of 250 mm or shorter;

· An inside diameter of 3 mm or larger and a length of 350 mm or shorter.

The PSD-85 Non-Lumen Cycle has been validated to sterilize a load of up to 25 pounds (combined pouch and wrapped tray load).

The maximum validated pouch load is two (2) pounds.

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/4/Picture/0 description: The image is a logo for Sterilucent. The logo consists of a blue square with a white design inside of it, followed by the word "sterilucent" in blue. Below the word "sterilucent" is the phrase "scientific sterilization solutions" in a smaller blue font.

510(k) Summary for the Sterilucent Self-Seal Sterilization Pouch K141412

Owner:	GS Medical Packaging, Inc.
Address:	501 Lakeshore Road EastSuite 201AMississauga, ON L5G 1H9Canada
Telephone:	905-271-1523
Fax:	905-271-1526
Contact:	Peter KalkbrennerDirector of EngineeringSterilucent, Inc.1400 Marshall St. NEMinneapolis, MN 55413
Telephone:	612-767-3253
Fax:	612-767-3260
Summary Date:	25 November, 2014

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1. Device Name and Classification

Trade Name:	Sterilucent Self-Seal Sterilization Pouch
Common/Usual Name:	Sterilization Pouch
Classification Name:	Sterilization Wrap, Containers, Trays, Cassettes & OtherAccessories
Product Code:	FRG (21 CFR 880.6850)
Class:	II

2. Predicate Device

Steris Vis-U-All Self Seal Pouch (K070765)

3. Device Description

4. Statement of Intended Use:

The Sterilucent Self-Seal Sterilization Pouch is intended to be used to enclose medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The pouches are intended to be used in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen and Non-Lumen Cycles.

Catalog No.	Size
SL264	3.5" x 9"
SL265	4" x 22"
SL266	5.25" x 10"
SL267	5" x 15"

Pouch Models and Sizes
------------------------	--	--

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SL268	7.5" x 13"
SL269	12" x 15"
SL270	12" x 18"

An inside diameter of 1 mm or larger and a length of 60 mm or shorter;
An inside diameter of 2 mm or larger and a length of 250 mm or shorter; ●
An inside diameter of 3 mm or larger and a length of 350 mm or shorter. ●

The PSD-85 Non-Lumen Cycle has been validated to sterilize a load of up to 25 pounds (combined pouch and wrapped tray load).

The maximum validated pouch load is two (2) pounds.

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5. Technological Characteristics Summary Comparison

The Sterilucent Self-Seal Sterilization Pouch has similar technological characteristics as the predicate device:

Summary of Technological Characteristics of the Device Compared to thePredicate Device
Characteristic	New Device	Predicate Device
Indications forUse	The Sterilucent Self-Seal SterilizationPouch is intended to be used to enclosemedical devices that are to be sterilized bya healthcare provider. It is intended toallow sterilization of the enclosed medicaldevice and also to maintain sterility of theenclosed device until used. The pouchesare intended to be used in Sterilucentvaporized hydrogen peroxide (VHP)sterilization processes	The Vis-U-All Self Seal Pouch is asterilization containment pouchdesigned for devices to be sterilized bythe health care provider by the AMSCOV-PRO 1 Low TemperatureSterilization System. It is intended toallow sterilization of the enclosedmedical device and also to maintainsterility of the enclosed device untilused.
Materials	Clear laminated PET/LDPEfilm (front) and Tyvek® (back)	Same
Construction	Front and back materials are sealed onthree (3) sides. Fourth side (end) remainsopen for filling. End is sealed byremoving protective liner strip, foldingalong the pre-fold, and pressing to thefilm.	Same
SterilizationModality	Low temperature vaporized hydrogenperoxide	Same
ProcessIndicator	None (requires external ISO 11140, Class1 process indicator)	ISO 11140, Class 1
Presentation	Clean peel chevron seal on one end foraseptic presentation	Same

6. Summary of Non-Clinical Performance Data

Sterilization performance studies were conducted for the Sterilucent Self-Seal Sterilization Pouch and all acceptance criteria were met. Sterilization efficacy testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 106 using the biological (BI) overkill method and half-cycle validation under worst case conditions. Real time event related shelf life studies demonstrated sterility maintenance for a 180 day time period. Whole package microbial challenge testing, exposing pouches to a minimum of 1 x 106 Bacillus atrophaeus colony forming units (CFU) via an aerosol challenge, demonstrated appropriate microbial barrier properties following exposure to the Sterilucent hydrogen peroxide sterilization processes under worst case conditions.

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7. Summary of Clinical Performance Data

N/A – No clinical tests were conducted for this submission.

8. Overall Performance Conclusion Statement

The non-clinical studies demonstrated that the Sterilucent Self-Seal Sterilization Pouch is substantially equivalence to the 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).