(224 days)
No
The device description and performance studies focus on the physical properties and sterilization efficacy of the pouches, with no mention of AI or ML technology.
No.
The device's purpose is to enclose medical devices for sterilization and maintain their sterility, not to treat or diagnose patients.
No
Explanation: The device is a sterilization pouch intended to enclose devices for sterilization and maintain their sterility. It does not perform any diagnostic function.
No
The device description clearly indicates it is a physical product (pouches made from plastic film and Tyvek) intended to contain medical devices for sterilization. It does not describe any software component.
Based on the provided information, the SteriKing® LT Blueline with Tyvek® pouches 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 tests on biological samples to diagnose conditions.
- Device Description: The description focuses on the physical properties of the pouches (materials, sealing) and their function in the sterilization process and maintaining sterility. There is no mention of any components or features related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological samples (blood, urine, tissue, etc.)
- Diagnostic purposes (identifying diseases, conditions, etc.)
- Measurement of analytes
The device is clearly intended to be a packaging and barrier system for medical devices undergoing sterilization.
N/A
Intended Use / Indications for Use
The SteriKing R LT Blueline with Tyvek R pouches are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD R 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 R LT Blueline with Tyvek R pouches are intended for use in the following STERRAD R Sterilization Cycles:
NX Standard
NX Advanced
100NX Duo
100NX Flex
100NX Standard
Max weights:
NX Standard Cycle:
75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm . 088 pounds
205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.382 pounds
NX Advanced Cycle:
75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm . 084 pounds
205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.393 pounds
100NX Duo Cycle:
75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm : 104 pounds
205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.400 pounds
100NX Flex Cycle:
75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm, 160 mm x 600 mm: .158 pounds
205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.400 pounds
100NX Standard Cycle:
75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm: .158 pounds
205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 4.476 pounds
Max lumens:
1 mm min ID and 1 max lumen for all cycles
NX Standard Cycle: For pouch sizes 250x500mm, 205x390mm is 125 mm max length. Max length is 50 mm for all other pouch sizes.
Product codes
FRG
Device Description
Steriking R LT-Blueline Pouches with Tyvek R are intended to be used to contain medical devices to be terminally sterilized in the STERRAD R Sterilization System. The medical devices are inserted into the Pouch, sealed, and then sterilized in the STERRAD R 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 R LT-Blueline Pouches with Tyvek R 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 R /plastic films. The heat-sealed pouches are heat sealed prior to processing in the STERRAD R Sterilization Systems.
Sterilization Systems:
STERRAD R Cycles:
NX Standard
NX Advanced
100NX Duo
100NX Flex
100NX Standard
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 / Not Found
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)
The Steriking R LT-Blueline Pouches with Tyvek R (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 R LT-Blueline Pouches with Tyvek R 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 R LT-Blueline Pouches with Tyvek R and sustain 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 R LT-Blueline Pouches with Tyvek R 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.
- The Microbial Aerosol Challenge study is a whole package test which challenges all aspects of the pouch in its final state. Conversely the ISO 11607 tests (Dye Migration and Seal Peel) test only one component of the pouch at time as it is not a whole package test. The Microbial Aerosol Challenge is a rigorous whole package test, and therefore the results are more comprehensive and supersede the results from Dye Migration and Seal Peel tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
December 22, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Wipak OY % Amanda Singleton Consultant Compliance Systems International 53 Assembly Drive, Unit 149 Mendon, New York 14506
Re: K221377
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: November 29, 2022 Received: November 29, 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
1
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) 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 (OS) 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,
Anne D. Talley -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)
K221377
Device Name SteriKing® LT Blueline Pouch with Tyvek®
Indications for Use (Describe)
The SteriKing® LT Blueline with Tyvek® pouches are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 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 with Tyvek® pouches are intended for use in the following STERRAD® Sterilization Cycles:
NX Standard NX Advanced 100NX Duo 100NX Flex 100NX Standard
Max weights:
NX Standard Cycle:
75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm . 088 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.382 pounds
NX Advanced Cycle:
75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm . 084 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.393 pounds
100NX Duo Cycle: 75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm : 104 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.400 pounds
100NX Flex Cycle: 75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm, 160 mm x 600 mm: .158 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.400 pounds
100NX Standard Cycle: 75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm: .158 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 4.476 pounds
Max lumens:
1 mm min ID and 1 max lumen for all cycles
NX Standard Cycle: For pouch sizes 250x500mm, 205x390mm is 125 mm max length. Max length is 50 mm for all other pouch sizes.
3
NX Advanced Cycle: For pouch sizes 250x500mm, 205x390mm is 125 mm max length is 50 mm for all other pouch sizes.
100NX Duo Cycle: For pouch sizes 250x500mm, 250x390mm is 875 mm max length. Max length is 850 mm for all other pouch sizes.
100NX Flex Cycle: Max length is 850 mm for all pouch sizes.
100NX Standard Cycle: For pouch sizes 250x500mm, 205x390mm is 125 mm max length, Max length is 50 mm for all other pouch sizes.
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
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
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 | |
| Contact: Hanna Marttila Phone: +358 (0)40 124 0290 | |
| Date prepared: December 21, 2022 | |
| Consultant: Amanda Singleton, CSI LLC. Phone: 716.4407364 | |
| 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 | |
| (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 STERRAD® Sterilization System. The medical devices are inserted into the Pouch, sealed, and then sterilized in the STERRAD® 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 STERRAD® Sterilization Systems.
Sterilization Systems:
STERRAD® Cycles:
NX Standard
NX Advanced
100NX Duo
100NX Flex
100NX Standard |
5
| Intended use of the device
Technological
characteristics
compared to predicate
(as
follows) | 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 STERRAD® 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.
See below as follows: | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| Indications for Use | The SteriKing® LT Blueline with
Tyvek® pouches are intended to
provide health care workers
with an effective method to
enclose devices intended for
sterilization in the STERRAD®
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 with
Tyvek® pouches are intended for
use in the following STERRAD®
Sterilization Cycles:
NX Standard
NX Advanced
100NX Duo
100NX Flex
100NX Standard
Max weights:
NX Standard Cycle:
75 mm x 200 mm, 100 mm x 250
mm, 150 mm x 300 mm, 160
mm x 440 mm, 160 mm x 600
mm: .088 pounds | 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® 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 |
6
| 390 mm, 250 mm x 500 mm:
1.382 pounds | rolls, Flat Sterilization
rolls, Gusseted |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| NX Advanced Cycle:
75 mm x 200 mm, 100 mm x 250
mm, 150 mm x 300 mm, 160
mm x 440 mm, 160 mm x 600
mm: .084 pounds | |
| 205 mm x 390 mm, 250 mm x
390 mm, 250 mm x 500 mm:
1.393 pounds | |
| 100NX Duo Cycle:
75 mm x 200 mm, 100 mm x 250
mm, 150 mm x 300 mm, 160
mm x 440 mm, 160 mm x 600
mm: .104 pounds | |
| 205 mm x 390 mm, 250 mm x
390 mm, 250 mm x 500 mm:
1.400 pounds | |
| 100NX Flex Cycle:
75 mm x 200 mm, 100 mm x 250
mm, 150 mm x 300 mm, 160
mm x 440 mm, 160 mm x 600
mm: .158 pounds | |
| 205 mm x 390 mm, 250 mm x
390 mm, 250 mm x 500 mm:
1.400 pounds | |
| 100NX Standard Cycle:
75 mm x 200 mm, 100 mm x 250
mm, 150 mm x 300 mm, 160
mm x 440 mm, 160 mm x 600
mm: .158 pounds | |
| 205 mm x 390 mm, 250 mm x
390 mm, 250 mm x 500 mm:
4.476 pounds | |
| Max lumens:
1 mm min ID and Max 1 lumen.
for all cycles | |
| NX Standard Cycle: For pouch
sizes 250x500mm, 250x390mm,
205x390mm is 125 mm max
length. Max length is 50 mm for
all other pouch sizes. | |
7
| | NX Advanced Cycle: For pouch
sizes 250x500mm, 250x390mm,
205x390mm is 125 mm max
length. Max length is 50 mm for
all other pouch sizes.
100NX Duo Cycle: For pouch
sizes 250x500mm, 250x390mm,
205x390mm is 875 mm max
length. Max length is 850 mm
for all other pouch sizes.
100NX Flex Cycle: Max length is
850 mm for all pouch sizes.
100NX Standard Cycle: For
pouch sizes 250x500mm,
250x390mm, 205x390mm is 125
mm max length. Max length is
50 mm for all other pouch sizes.
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 | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 plastic film and
Tyvek that is heat sealed
on three sides. The fourth
side is left opened and will
be heat-sealed when
used. |
| Backing Material | Tyvek® | Same | Tyvek® |
| Transparent Film | BOPET/PE | Similar | PE |
| Sterilization Processes | H2O2 Sterilization Process as per:
STERRAD® | Similar | STERRAD® 100S |
| | NX Standard | | |
| | NX Advanced | | |
| | 100NX Duo | | |
| | 100NX Flex | | |
| | 100NX Standard | | |
| Sterilant | Achieved a 10-6 Sterility Assurance | Similar | Showed a 6 log reduction of |
| Validation | Level (SAL) of Geobacillus | | Geobacillus |
| | stearothermophilus. | | stearothermophilus |
| AAMI TIR12:2010
ANSI/AAMI ST79
ANSI/AAMI/ISO 14937:2009
ANSI/AAMI/ISO 17664:2017 | NX Standard
NX Advanced
100NX Duo
100NX Flex
100NX Standard | | |
| 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 if 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
9
K221377 Page 6 of 8
| Dimensions and max load weight | Similar | Not listed | |||||
|---|---|---|---|---|---|---|---|
| Pouch size | NX | ||||||
| Advanced | |||||||
| Cycle | NX | ||||||
| Standard | |||||||
| Cycle | 100NX | ||||||
| Duo | |||||||
| Cycle | 100NX | ||||||
| Flex | |||||||
| Cycle | 100NX | ||||||
| Standard | |||||||
| Cycle | |||||||
| weight (pounds) | |||||||
| 250 x 500 mm | 1.393 | 1.382 | 1.400 | 1.400 | 4.476 | ||
| 250 x 390 mm | 1.393 | 1.382 | 1.400 | 1.400 | 4.476 | ||
| 205 x 390 mm | 1.393 | 1.382 | 1.400 | 1.400 | 4.476 | ||
| 160 x 600 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | ||
| 160 x 440 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | ||
| 150 x 300 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | ||
| 100 x 250 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | ||
| 75 x 200 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | ||
| Max Lumen Dimensions | 1 mm min ID Lumen and Max 1 | ||||||
| lumen for all cycles |
For NX Standard Cycle: For
pouch sizes 250x500mm,
250x390mm, 205x390mm is 125
mm max length. Max length is
50 mm for all other pouch sizes.
NX Advanced Cycle: For pouch
sizes 250x500mm, 250x390mm,
205x390mm is 125 mm max
length. Max length is 50 mm for
all other pouch sizes.
100NX Duo Cycle: For pouch
sizes 250x500mm, 250x390mm,
205x390mm is 875 mm max
length. Max length is 850 mm
for all other pouch sizes.
100NX Flex Cycle: Max length is
850 mm for all pouch sizes.
100NX Standard Cycle: For
pouch sizes 250x500mm,
250x390mm, 205x390mm is 125
mm max length. Max length is
50 mm for all other pouch sizes. | | | | | Different | Not listed |
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 6 of 8
10
sterilant is able to penetrate Steriking® LT-Blueline Pouches with Tyvek® and sustain 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.
- The Microbial Aerosol Challenge study is a whole package test which challenges all aspects of the pouch in its final state. Conversely the ISO 11607 tests (Dye Migration and Seal Peel) test only one component of the pouch at time as it is not a whole package test. The Microbial Aerosol Challenge is a rigorous whole package test, and therefore the results are more comprehensive and supersede the results from Dye Migration and Seal Peel tests.
| 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 | |||
| Geobacilus | |||
| 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 | Shelf Life Pre Sterilization | Dye Penetration: none
Seal peel: =/>1.5N/15mm | Pass |
11
| ASTM F88: Standard Test Method for Seal
| Strength of Flexible Barrier Materials | |||
|---|---|---|---|
| ASTM F1980 – 16 Standard Guide for | |||
| Accelerated Aging of Sterile Barrier Systems | |||
| for Medical Devices | Shelf Life Post Sterilization | Dye Penetration: none | |
| Seal peel: =/>1.5N/15mm | Pass | ||
| 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 | |||
| 1. ASTM F1608, ASTM F2638 - Microbial | |||
| Barrier |
- ASTM D3776 - Basis Weight of Tyvek
- ASTM D2724 - Delamination of Tyvek
- TAPPI T460 - Gurly Hill porosity of Tyvek
- ISO 1924-2 - Tensile Strength, MD of Tyvek
- ISO 1924-2 - Elongation, MD of Tyvek
- ASTM D1424 - Elmendorf Tear, MD of
Tyvek - ISO 534 - Thickness of Tyvek
- ISO 5636-3 - Bendtsen air permeability of
Tyvek - TAPPI T523 - Moisture vapor transmission
Rate of Tyvek - ISO 2758 - Mullen, burst of Tyvek
- ASTM D3420 - Spencer puncture of Tyvek | Material Compatibility | Meets specifications per
Technical Data Sheets.
Included in Bench Testing
Summary. | Pass |
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.