(237 days)
Not Found
No
The device is a sterilization pouch, a passive containment and barrier product. The description focuses on material properties, sterilization cycle compatibility, and sterility maintenance, with no mention of computational analysis, algorithms, or learning processes.
No
The device is a sterilization pouch used to prepare other medical devices for sterilization and maintain their sterility; it does not directly treat or diagnose a medical condition in a patient.
No
The device, Steriking® LT-Blueline Pouches with Tyvek®, is intended to enclose and maintain sterility of medical devices for sterilization, not to diagnose medical conditions or provide diagnostic information.
No
The device is a physical pouch made of plastic film and Tyvek, intended to contain medical devices for sterilization. It is a hardware device, not software.
Based on the provided text, the Steriking® LT-Blueline Pouches with Tyvek® are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to enclose devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the physical properties of the pouch and its function in the sterilization process and maintaining sterility. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on biological analysis.
The device is clearly intended for use in the sterilization and storage of medical instruments, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERIS® V-PRO® Sterilizer Systems.
The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The products are for single use only.
The Steriking® LT-Blueline Pouches with Tyvek® are intended for use in the following STERIS® V-PRO® Sterilization Cycles:
Lumen Cycle Non Lumen Cycle Flexible Cycle
Product codes
FRG
Device Description
Steriking® LT-Blueline Pouches with Tyvek® are intended to be used to contain medical devices to be terminally sterilized in the STERIS® Sterilization System. The medical devices are inserted into the Pouch, sealed, and then sterilized in the STERIS® Sterilization System. Sterilization Cycles are noted below. After completion of the sterilization process, the Pouch maintains sterility of the enclosed medical devices until the seal is opened. These pouches are made from a plastic film and Tyvek that is heat-sealed on three sides. The fourth side is left opened and will be heat-sealed when used.
Steriking® LT-Blueline Pouches with Tyvek® are intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The products are for single use only.
The pouches are constructed from Tyvek®/plastic films. The heat-sealed pouches are heat sealed prior to processing in the STERIS® V-PRO® Sterilization Systems.
Sterilization Systems:
STERIS® V-PRO® Cycles:
Lumen Cycle,
Non Lumen Cycle
Flexible Cycle
Device lumen dimensions:
Flexible Cycle: 1 lumen x 1 mm min ID x 1050 mm max length for all pouch sizes.
Lumen Cycle: 1 lumen x 1 mm min ID for all pouch sizes. For pouch sizes 250x500mm, 250x390mm, 205x390mm, max length of 125 mm. For all other pouch sizes, max length of 50 mm.
Max Weights: 1.410 pounds for pouch sizes below (Flexible, Lumen, and Non Lumen Cycles)
250 mm x 500 mm
250 mm x 390 mm
205 mm x 390 mm
.114 pounds for pouch sizes below (Flexible and Lumen Cycles)
160 mm x 600 mm
160 mm x 440 mm
150 mm x 300 mm
100 mm x 250 mm
75 mm x 200 mm
.158 pounds for pouch sizes below (Non-Lumen Cycle)
160 mm x 600 mm
160 mm x 440 mm
150 mm x 300 mm
100 mm x 250 mm
75 mm x 200 mm
Pouch Sizes: 250 mm x 500 mm
250 mm x 390 mm
205 mm x 390 mm
160 mm x 600 mm
160 mm x 440 mm
150 mm x 300 mm
100 mm x 250 mm
75 mm x 200 mm
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
health care workers
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
The Steriking® LT-Blueline Pouches with Tyvek® (submission device) has the identical intended use and indications for use as the predicate devices. The subject device was compared to the predicate device by testing the Sterilant Penetration, Biocompatibility, Package Integrity, Material Compatibility, and Sterility Maintenance. The results of the Steriking® LT-Blueline Pouches with Tyvek® validation studies demonstrate that the sterilization pouches perform as intended.
Studies conducted:
- Sterilant Penetration testing performed as described in AAMI / ANSI / ISO 14937:2009, "Sterilization of Health Care Products – General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices".
- Biocompatibility testing performed as described in ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity.
- Package Integrity, Material Compatibility, Sterility Maintenance, and Microbial Aerosol Challenge testing performed as described in ISO 11607.
Key Results:
- Sterilant Penetration: The results confirm that the sterilant is able to penetrate Steriking® LT-Blueline Pouches with Tyvek® and sustain direct contact with the medical instrument inside the subject device. Passed, Negative for growth.
- Biocompatibility: The testing results demonstrate the Steriking® LT-Blueline Pouches with Tyvek® did not elicit any cytotoxic effect. Passed.
- Package Integrity, Material Compatibility, Sterility Maintenance, and Microbial Aerosol Challenge: A sample which demonstrates that all items remain sterile following this test is considered safe and effective at maintaining package integrity. The use of stainless-steel coupons was based on several considerations. First, they offer a convenient way to identify specific pieces to be sterility tested and to confirm that samples were indeed in the specified locations. Second, coupons are relatively easy to manipulate, and reduces the likelihood of the introduction of adventitious growth into the sterility test results. Finally, the coupons are comprised of metals consistent with metals used to manufacture medical instruments. Passed, No leaks detected after dye migration, > 1.5N/15mm per ASTM F88. Each pouch met the sterility maintenance requirement as there was no growth in any of the culture tubes containing the stainless-steel coupons at the end of the incubation period.
Key Metrics
- Sterilant Penetration: Achieved a 10-6 Sterility Assurance Level (SAL) of Geobacillus stearothermophilus. Minimum of 1.0x10^6 Geobacillus stearothermophilus spores were killed in a half-cycle (6-log reduction).
- Dye Migration: No leaks detected after dye migration. Dye Penetration: none.
- Seal Strength: > 1.5N/15mm per ASTM F88. Seal peel: =/>1.5N/15mm.
- Microbial Barrier Properties: Pass. Each pouch met the sterility maintenance requirement as there was no growth in any of the culture tubes containing the stainless-steel coupons at the end of the incubation period.
- Biocompatibility: Pass. No reduction of cell growth or cell lysis was observed.
- Shelf-Life Pre-Sterilization: 5 years.
- Maintenance of Sterility – Accelerated Aging: 3 years.
- Material Compatibility: Meets specifications per Technical Data Sheets.
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
January 4, 2023
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Wipak OY % Amanda Singleton Consultant Compliance Systems International 53 Assembly Drive, Unit 149 Mendon, New York 14506
Re: K221379
Trade/Device Name: Steriking LT-Blueline Pouches with Tyvek Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: December 27, 2022 Received: December 27, 2022
Dear Amanda Singleton:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S
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
2
Indications for Use
510(k) Number (if known) K221379
Device Name Steriking® LT-Blueline Pouches with Tyvek®
Indications for Use (Describe)
The Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERIS® V-PRO® Sterilizer Systems.
The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The products are for single use only.
The Steriking® LT-Blueline Pouches with Tyvek® are intended for use in the following STERIS® V-PRO® Sterilization Cycles:
Lumen Cycle Non Lumen Cycle Flexible Cycle
Device lumen dimensions:
Flexible Cycle: 1 lumen x 1 mm min ID x 1050 mm max length for all pouch sizes.
Lumen Cycle: 1 lumen x 1 mm min ID for all pouch sizes. For pouch sizes 250x500mm, 250x390mm, 205x390mm, max length of 125 mm. For all other pouch sizes, max length of 50 mm.
Max Weights: 1.410 pounds for pouch sizes below (Flexible, Lumen, and Non-Lumen Cycles) 250 mm x 500 mm 250 mm x 390 mm 205 mm x 390 mm
.114 pounds for pouch sizes below (Flexible and Lumen Cycles) 160 mm x 600 mm 160 mm x 440 mm 150 mm x 300 mm 100 mm x 250 mm 75 mm x 200 mm
.158 pounds for pouch sizes below (Non-Lumen Cycle) 160 mm x 600 mm 160 mm x 440 mm 150 mm x 300 mm 100 mm x 250 mm 75 mm x 200 mm
3
Pouch Sizes: 250 mm x 500 mm 250 mm x 390 mm 205 mm x 390 mm 160 mm x 600 mm 160 mm x 440 mm 150 mm x 300 mm 100 mm x 250 mm 75 mm x 200 mm
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K221379 Page 1 of 7
5. 510K Summary (in accordance with 21CFR807.92)
| 510K Summary elements per
| 21CFR807.92 | Summary |
|---|---|
| Submitter's name, address, telephone | |
| number, a contact person, and the date the | |
| summary was prepared | Wipak Oy |
| Wipaktie 2 | |
| Nastola Finland | |
| Contacts: | |
| Hanna Marttila Phone: +358 (0)40 124 0290 | |
| Consultant: Amanda Singleton, CSI LLC. Phone: 716.4407364 | |
| 53 Assembly Drive, Unit 149, Mendon, NY 14506 | |
| Date prepared: January 4, 2023 | |
| Name of the device including | |
| the trade or proprietary name | |
| if applicable | Proprietary Name: Steriking® LT-Blueline Pouches with Tyvek® |
| Common or usual name | Common Name: Peel Pouch |
| Classification name | Classification Name: Sterilization wrap |
| Classification Product Code | |
| Device Classification | |
| Regulation Number | FRG |
| Class II | |
| 21 CFR 880.6850 | |
| Identification of the legally | |
| marketed device to which | |
| the submitter claims | |
| equivalence (Primary | |
| Predicate device) | K180672, Sterilization Pouch/Roll Made With Tyvek® |
| Description of the device | Steriking® LT-Blueline Pouches with Tyvek® are intended to be used to contain |
| medical devices to be terminally sterilized in the STERIS® Sterilization System. The | |
| medical devices are inserted into the Pouch, sealed, and then sterilized in the | |
| STERIS® Sterilization System. Sterilization Cycles are noted below. After | |
| completion of the sterilization process, the Pouch maintains sterility of the | |
| enclosed medical devices until the seal is opened. These pouches are made from | |
| a plastic film and Tyvek that is heat-sealed on three sides. The fourth side is left | |
| opened and will be heat-sealed when used. |
Steriking® LT-Blueline Pouches with Tyvek® are intended to allow sterilization of
enclosed devices and to maintain sterility of the enclosed devices until used up
to 3 years post sterilization. The products are for single use only.
The pouches are constructed from Tyvek®/plastic films. The heat-sealed pouches
are heat sealed prior to processing in the STERIS® V-PRO® Sterilization Systems.
Sterilization Systems:
STERIS® V-PRO® Cycles:
Lumen Cycle,
Non Lumen Cycle |
5
| | Flexible Cycle | | | | mm. For all other pouch sizes, max
length of 50 mm.
Max Weights:
1.410 pounds for pouch sizes
below (Flexible, Lumen, and Non-
Lumen Cycles)
250 mm x 500 mm
250 mm x 390 mm
205 mm x 390 mm
.114 pounds for pouch sizes
below (Flexible and Lumen
Cycles)
160 mm x 600 mm
160 mm x 440 mm
150 mm x 300 mm
100 mm x 250 mm
75 mm x 200 mm
.158 pounds for pouch sizes
below (Non-Lumen Cycle)
160 mm x 600 mm
160 mm x 440 mm
150 mm x 300 mm
100 mm x 250 mm
75 mm x 200 mm
Flat Sterilization Pouch Sizes:
75 x 200 mm
100x 250 mm
150 x 300 mm
160 x 440 mm
160 x 600 mm
205 x 390 mm
250 x 390 mm
250 x 500 mm | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Intended use of the device | The Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health
care workers with an effective method to enclose devices intended for
sterilization in the STERIS® V-PRO® Sterilizer Systems.
The device is intended to allow sterilization of enclosed devices and to maintain
sterility of the enclosed devices until used up to 3 years post sterilization. | | Design | These pouches are made from a
plastic film and Tyvek that is heat
sealed on three sides. The fourth
side is left opened and will be
heat-sealed when used. | Same | These pouches are made from a
medical grade plastic film that is
heat sealed on three sides. The
fourth side is left opened and will
be heat-sealed when used. | |
| Technological
characteristics compared
to predicate (as
follows) | See below as follows: | | Backing Material | Tyvek® | Same | Tyvek® | |
| Discussion of nonclinical tests
submitted, referenced, or
utilized in the premarket
notification submission for a
determination of substantial
equivalence | Submission Device –
Steriking® LT-Blueline Pouches
with Tyvek® | SE
Determination | Predicate Device –
K180672 –
Sterilization Pouch/Roll Made With
Tyvek | Transparent Film | BOPET/PE | Same | PE |
| Indications for Use | The Steriking® LT-Blueline Pouches
with Tyvek® are intended to
provide health care workers with an
effective method to enclose devices
intended for sterilization in the
STERIS® V-PRO® Sterilizer Systems.
The device is intended to allow
sterilization of enclosed devices and
to maintain sterility of the enclosed
devices until used up to 3 years
post sterilization. The products are
for single use only.
The Steriking® LT-Blueline Pouches
with Tyvek® are intended for use in
the following STERIS® V-PRO®
Sterilization Cycles:
Lumen Cycle
Non Lumen Cycle
Flexible Cycle
Device lumen dimensions:
Flexible Cycle: 1 lumen x 1 mm min
ID x 1050 mm max length for all
pouch sizes.
Lumen Cycle: 1 lumen x 1 mm min
ID for all pouch sizes. For pouch
sizes 250x500mm, 250x390mm,
205x390mm, max length of 125 | Similar | The Sterilization Pouch/Roll
Made with Tyvek® are intended
to provide health care workers
with an effective method to
enclose devices intended for
sterilization in the STERRAD ®
100S Sterilizer. The device is
intended to allow sterilization of
enclosed devices and also to
maintain sterility of the
enclosed devices until used up
to 3 years post sterilization. The
pouches and rolls are printed
with a chemical indicator bar
which is a process indicator (ISO
11140-1:2005) that changes
from red to blue (or lighter)
when exposed to hydrogen
peroxide vapor during
processing in the STERRAD®
100S Sterilizer. The Sterilization
Pouch/Roll Made with Tyvek® is
offered in the follow 5 types:
Self-sealing sterilization pouches
Sterilization pouches, Flat
Sterilization pouches, Gusseted
Sterilization rolls, Flat
Sterilization rolls, Gusseted | Sterilization Processes | H2O2 Sterilization Process as per:
STERIS® V-PRO®
Lumen Cycle
Non-Lumen Cycle | Similar | H2O2 Sterilization Process as per:
STERRAD® 100S |
6
7
| Flexible Cycle | |||
|---|---|---|---|
| Sterilant | |||
| Validation | |||
| AAMI TIR12:2010 | |||
| ANSI/AAMI ST79 | |||
| ANSI/AAMI/ISO 14937:2009 | |||
| ANSI/AAMI/ISO 17664:2017 | Achieved a 10-6 Sterility Assurance | ||
| Level (SAL) of Geobacillus | |||
| stearothermophilus. |
V-Pro® MAX and Max 2 Flexible
Cycle
V-Pro® 1 Plus Lumen Cycle
V-Pro® 1 Plus Non-Lumen Cycle | Similar | Showed a 6 log reduction of
Geobacillus stearothermophilus. |
| Dye Migration
ISO 11607
ASTM F1929
AAMI TIR12:2010 | No leaks detected after dye
migration | Same | No leaks detected after dye
migration |
| Seal Strength
ASTM F88
AAMI TIR12:2010
AAMI/ISO TIR16775:2014
ISO 11607 | > 1.5N/15mm per ASTM F88 | Same | > 1.5N/15mm per ASTM F88 |
| Microbial Barrier
Properties
ISO 11607-1
AAMI TIR12:2010
ANSI/AAMI ST79:2017 | Pass
Each pouch met the sterility
maintenance requirement as there
was no growth in any of the culture
tubes containing the stainless-steel
coupons at the end of the
incubation period. | Similar | Pass |
| Biocompatibility | Pass
ISO 10993-5 | Similar | Pass
ISO 10993-12 |
| Shelf-Life Pre-Sterilization
ASTM F1929-15
ASTM F88 | 5 years | Similar | 3 years |
| Maintenance of Sterility –
Accelerated Aging
ANSI/AAMI ST8:2013/(R)2018
AAMI TIR12:2010
ANSI/AAMI ST77:2017
ANSI/AAMI ST79:2017
ISO 11607-1
ASTM F1980
ASTM F1929-15
ASTM F88 | 3 years | Same | 3 Years |
8
| Dimensions and max load weight | Similar | Not Listed | |||||
|---|---|---|---|---|---|---|---|
| Non- | |||||||
| Flexible Cycle | Lumen Cycle | Lumen Cycle | |||||
| Pouch size | max weight (pounds) | ||||||
| 250 x 500 mm | 1.410 | 1.410 | 1.410 | ||||
| 250 x 390 mm | 1.410 | 1.410 | 1.410 | ||||
| 205 x 390 mm | 1.410 | 1.410 | 1.410 | ||||
| 160 x 600 mm | 0.114 | 0.114 | 0.158 | ||||
| 160 x 440 mm | 0.114 | 0.114 | 0.158 | ||||
| 150 x 300 mm | 0.114 | 0.114 | 0.158 | ||||
| 100 x 250 mm | 0.114 | 0.114 | 0.158 | ||||
| 75 x 200 mm | 0.114 | 0.114 | 0.158 | ||||
| Max Lumen Dimensions | Flexible Cycle: 1 lumen x 1 mm min | ||||||
| ID x 1050 mm max length for all | |||||||
| pouch sizes. | Different | Not Listed | |||||
| Lumen Cycle: 1 lumen x 1 mm min | |||||||
| ID for all pouch sizes. For pouch | |||||||
| sizes 250x500mm, 250x390mm, | |||||||
| 205x390mm, max length of 125 | |||||||
| mm. For all other pouch sizes, max | |||||||
| length of 50 mm. |
Summary of Non-Clinical Testing
The Steriking® LT-Blueline Pouches with Tyvek® (submission device) has the identical intended use and indications for use as the predicate devices. The subject device was compared to the predicate device by testing the Sterilant Penetration, Biocompatibility, Package Integrity, Material Compatibility, and Sterility Maintenance. The results of the Steriking® LT-Blueline Pouches with Tyvek® validation studies demonstrate that the sterilization pouches perform as intended. The results are summarized as follows:
- . The Sterilant Penetration testing performed as described in AAMI / ANSI / ISO 14937:2009, "Sterilization of Health Care Products – General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices". The results confirm that the sterilant is able to penetrate Steriking® LT-Blueline Pouches with Tyvek® and sustain direct contact with the medical instrument inside the subject device.
- . The Biocompatibility testing performed as described in ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity. The testing results demonstrate the Steriking® LT-Blueline Pouches with Tyvek® did not elicit any cytotoxic effect.
- The Package Integrity, Material Compatibility, Sterility Maintenance, and Microbial Aerosol Challenge testing was performed as described in ISO 11607. The use of the aerosol challenge test to analyze the microbial barrier properties of the samples was considered to be rigorous. By exposing the sealed test samples' exterior with aerosolized spores, the permeability of the samples to microorganisms was challenged. A sample which demonstrates that all items remain sterile following this test is considered safe and effective at maintaining package integrity. The use of stainless-steel coupons was based on several considerations. First, they offer a convenient way to identify specific pieces to be sterility tested and to confirm that samples were indeed in the specified locations. Second, coupons are relatively easy to manipulate, and reduces the likelihood of the introduction of adventitious growth into the sterility test results. Finally, the coupons are comprised of metals consistent with metals used to manufacture medical instruments.
9
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-5 Biological Evaluation of medical | |||
| devices - Part 5: Tests for in vitro cytotoxicity | Biocompatibility | no reduction of cell growth | |
| or cell lysis was observed | Pass | ||
| AAMI TIR12:2010 - Designing, testing, and | |||
| labeling reusable medical devices for | |||
| reprocessing in health care facilities | Sterilant Penetration | Demonstrating that a | |
| minimum of 1.0x10^6 | |||
| Geobacillus | |||
| stearothermophilus spores | |||
| were killed in a half-cycle (6- | |||
| log reduction) | Pass | ||
| Negative for growth | |||
| ASTM F1929-15: Standard test method for | |||
| detecting seal leaks in porous medical | |||
| packaging by dye migration | Package Integrity | Dye Penetration: none | Pass |
| ANSI/AAMI ST79:2017 - Comprehensive guide | |||
| to steam sterilization and sterility assurance | |||
| in health care facilities | |||
| AAMI TIR12:2010 - Designing, testing, and | |||
| labeling reusable medical devices for | |||
| reprocessing in health care facilities | Microbial Barrier Properties | A sample which | |
| demonstrates that all items | |||
| remain sterile following | |||
| exposure | Pass | ||
| Each pouch met the | |||
| sterility maintenance | |||
| requirement as there | |||
| was no growth in any | |||
| of the culture tubes | |||
| containing the | |||
| stainless-steel | |||
| coupons at the end if | |||
| the incubation period. | |||
| ASTM F1929-15: Standard test method for | |||
| detecting seal leaks in porous medical | |||
| packaging by dye migration | |||
| ASTM F88: Standard Test Method for Seal | |||
| Strength of Flexible Barrier Materials | Shelf Life Pre Sterilization | Dye Penetration: none | |
| Seal peel: =/>1.5N/15mm | Pass | ||
| ASTM F1980 – 16 Standard Guide for | |||
| Accelerated Aging of Sterile Barrier Systems | |||
| for Medical Devices | |||
| ASTM F1929-15: Standard test method for | |||
| detecting seal leaks in porous medical | |||
| packaging by dye migration | |||
| ASTM F88: Standard Test Method for Seal | |||
| Strength of Flexible Barrier Materials | Shelf Life Post Sterilization | Dye Penetration: none | |
| Seal peel: =/>1.5N/15mm | Pass | ||
| 1. ASTM F1608, ASTM F2638 - Microbial | |||
| Barrier 2. ASTM D3776 - Basis Weight of Tyvek 3. ASTM D2724 - Delamination of Tyvek 4. TAPPI T460 - Gurly Hill porosity of Tyvek 5. ISO 1924-2 - Tensile Strength, MD of Tyvek 6. ISO 1924-2 - Elongation, MD of Tyvek 7. ASTM D1424 - Elmendorf Tear, MD of | |||
| Tyvek 8. ISO 534 - Thickness of Tyvek 9. ISO 5636-3 - Bendtsen air permeability of | |||
| Tyvek 10. TAPPI T523 - Moisture vapor transmission | |||
| Rate of Tyvek 11. ISO 2758 - Mullen, burst of Tyvek 12. ASTM D3420 - Spencer puncture of Tyvek | Material Compatibility | Meets specifications per | |
| Technical Data Sheets. | |||
| Included in Bench Testing | |||
| Summary. | Pass |
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K221379 Page 7 of 7
Conclusion:
The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicate device K180672.