(188 days)
Not Found
No
The summary describes a sterilization pouch and its performance in a hydrogen peroxide sterilization process. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is a sterilization pouch used to enclose other medical devices for sterilization and maintain their sterility, it does not directly provide therapy.
No
This device is a sterilization pouch, intended to enclose other medical devices for sterilization and maintain their sterility. It does not perform any diagnostic function.
No
The device is a physical sterilization pouch made of Tyvek and film, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose medical devices for sterilization and maintain their sterility. This is a function related to the sterilization process and maintaining the sterility of other medical devices, not for performing tests on samples taken from the human body.
- Device Description: The description focuses on the physical construction and function of the pouch for sterilization and sterility maintenance. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes
- Using reagents
The device is a sterilization accessory, designed to facilitate and maintain the sterility of other medical devices.
N/A
Intended Use / Indications for 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.
Pouch Models and Sizes
- Catalog No. SL264, Size 3.5" x 9"
- Catalog No. SL265, Size 4" x 22"
- Catalog No. SL266, Size 5.25" x 10"
- Catalog No. SL267, Size 5" x 15"
- Catalog No. SL268, Size 7.5" x 13"
- Catalog No. SL269, Size 12" x 15"
- Catalog No. SL270, Size 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.
Product codes
FRG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. No clinical tests were conducted for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
12 log reduction and a sterility assurance level (SAL) of 106.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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)
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.
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)
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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4
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 East |
| Suite 201A | |
| Mississauga, ON L5G 1H9 | |
| Canada | |
| Telephone: | 905-271-1523 |
| Fax: | 905-271-1526 |
| Contact: | Peter Kalkbrenner |
| Director of Engineering | |
| Sterilucent, Inc. | |
| 1400 Marshall St. NE | |
| Minneapolis, MN 55413 | |
| Telephone: | 612-767-3253 |
| Fax: | 612-767-3260 |
| Summary Date: | 25 November, 2014 |
5
1. Device Name and Classification
| Trade Name: | Sterilucent Self-Seal Sterilization Pouch |
|---|---|
| Common/Usual Name: | Sterilization Pouch |
| Classification Name: | Sterilization Wrap, Containers, Trays, Cassettes & Other |
| Accessories | |
| Product Code: | FRG (21 CFR 880.6850) |
| Class: | II |
2. Predicate Device
Steris Vis-U-All Self Seal Pouch (K070765)
3. 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.
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 | ||
|---|---|---|
| ------------------------ | -- | -- |
6
| SL268 | 7.5" x 13" |
|---|---|
| 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.
7
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 the
| Predicate Device | ||
|---|---|---|
| Characteristic | New Device | Predicate Device |
| Indications for | ||
| 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 Sterilucent | ||
| vaporized hydrogen peroxide (VHP) | ||
| sterilization processes | The Vis-U-All Self Seal Pouch is a | |
| sterilization containment pouch | ||
| designed for devices to be sterilized by | ||
| the health care provider by the AMSCO | ||
| V-PRO 1 Low Temperature | ||
| Sterilization System. It is intended to | ||
| allow sterilization of the enclosed | ||
| medical device and also to maintain | ||
| sterility of the enclosed device until | ||
| used. | ||
| Materials | Clear laminated PET/LDPE | |
| film (front) and Tyvek® (back) | Same | |
| Construction | Front and back materials are sealed on | |
| three (3) sides. Fourth side (end) remains | ||
| open for filling. End is sealed by | ||
| removing protective liner strip, folding | ||
| along the pre-fold, and pressing to the | ||
| film. | Same | |
| Sterilization | ||
| Modality | Low temperature vaporized hydrogen | |
| peroxide | Same | |
| Process | ||
| Indicator | None (requires external ISO 11140, Class | |
| 1 process indicator) | ISO 11140, Class 1 | |
| Presentation | Clean peel chevron seal on one end for | |
| aseptic 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.
8
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.