(64 days)
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 1 years post sterilization. The products are for single use only. The Steriking® LT-Blueline Pouches with Tyvek 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:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .094 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.194 pounds.
NX Advanced Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .096 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.224 pounds.
100NX Duo Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .116 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.222 pounds.
100NX Flex Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .202 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.220 pounds.
100NX Standard Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .202 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 4.478 pounds.
Max Count of lumens:
1 lumen max for All cycles
Max ID of lumens:
NX Standard Cycle:
1 mm ID for all pouch sizes
NX Advanced Cycle:
2 mm ID for all pouch sizes
100NX Cycle:
1 mm ID for all pouch sizes
100NX Flex Cycle:
1 mm ID for all pouch sizes
100NX Standard Cycle:
2 mm ID for all pouch sizes
Max lumen lengths:
NX Standard Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, 125 mm. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm.
NX Advanced Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, 125 mm. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm.
100NX Duo Cycle:
850 mm for all pouch sizes
100NX Flex Cycle:
850 mm for all pouch sizes
100NX Standard Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, 125 mm. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm.
Pouch Sizes:
300 x 450 mm
250 x 400 mm
190 x 330 mm
130 x 380 mm
130 x 270 mm
90 x 250 mm
90 x 200 mm
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 self-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 1 year post sterilization. The products are for single use only.
The pouches are constructed from Tyvek®/plastic films. The self-sealed pouches are self sealed prior to processing in the STERRAD® Sterilization Systems.
Sterilization Systems:
STERRAD® Cycles:
NX Standard
NX Advanced
100NX Duo
100NX Flex
100NX Standard
The document provided describes the Steriking® LT-Blueline Pouches with Tyvek®, which are intended to enclose devices for sterilization in STERRAD® Sterilizer Systems and maintain their sterility for up to one year. This device is a sterilization wrap, regulated as Class II.
The study presented is a non-clinical performance study to demonstrate that the proposed device, a self-seal pouch, is as safe and effective as its predicate device, a heat-seal pouch, with an added adhesive strip for sealing.
Here's an analysis of the acceptance criteria and the study results based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Test | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| Package Integrity, Pre-Sterilization Shelf Life | Dye Migration | No leaks detected after dye migration | All self-seal pouches passed the dye penetration at time zero | Pass |
| Package Integrity, Pre-Sterilization Shelf Life | Tensile | All samples are > 1.5N/15mm per ASTM F88 | All samples are > 1.5N/15mm per ASTM F88 | Pass |
| Package Integrity, Post-Sterilization | Tensile | All samples are > 1.5N/15mm per ASTM F88 | All samples are > 1.5N/15mm per ASTM F88 | Pass |
| Biocompatibility | Cytotoxicity | Not greater than Grade 2 reactivity (mildly reactive) | No reduction of cell growth and cell lysis | Pass |
| Package Integrity, Post-Sterilization | Microbial Aerosol Challenge | A sample which demonstrates that all items remain sterile following exposure | 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. | Pass |
| Sterilization Penetration | Sterilization Penetration | Demonstrating that a minimum of $1.0\times10^6$ Geobacillus stearothermophilus spores were killed in a half-cycle (6-log reduction) using a worst-case, end of shelf-life injection volume | Negative for growth following the minimum incubation period (for all STERRAD cycles: 100NX Standard, NX Standard, NX Advanced, 100NX Flex, 100NX Duo) | Pass |
| Post Sterilization Shelf Life | Maintenance of Sterility | No growth after exposure | Pass. No growth following exposure (for 100NX Standard cycle, aged 365 days) | Pass |
| Package Integrity, Post-Sterilization | Accelerated Aging | Seal maintains integrity | Pass. No suspect seals were observed, and the test samples remained intact. (for 100NX Standard cycle, aged 3 years accelerated aging) | Pass |
| Package Integrity, Post-Sterilization | Tensile (after accelerated aging) | All samples are > $1.5N/15mm$ per ASTM F88 | All samples are > $1.5N/15mm$ per ASTM F88 (for 100NX Standard cycle, aged 3 years accelerated aging) | Pass |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes ("N") for each test. Instead, it refers to "All self-seal pouches," "All samples," and "Each pouch." This implies that the tests were conducted on a sufficient number of samples according to the referenced standards (e.g., ASTM, AAMI, ISO), which typically specify minimum sample sizes.
The data provenance is not specified regarding country of origin. The study appears to be prospective as it's a performance study for a new iteration of a device (the addition of a self-sealing adhesive strip) on the market. The phrase "Studies on the self-seal pouch were performed concurrently to the heat-seal pouch studies" suggests newly generated data for the proposed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The tests performed are primarily laboratory-based physical, chemical, and microbiological evaluations against established standards, rather than expert-based assessments of images or patient data. Therefore, the concept of "ground truth" derived from human experts in the context of diagnostic interpretation is not applicable here.
4. Adjudication Method for the Test Set
This is not applicable as the tests are analytical and objective measurements against defined standards, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The device is a sterilization pouch and not a diagnostic imaging or AI-driven decision support tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone study in the context of an algorithm or AI is not applicable. The device is a physical product (sterilization pouch), and the performance assessments are for the device's physical and functional properties.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is based on established industry standards and scientific principles as outlined in various ASTM, AAMI, and ISO documents (e.g., ASTM F1929 for dye migration, ASTM F88 for tensile strength, ISO 10993-5 for cytotoxicity, AAMI TIR12 for microbial aerosol challenge and sterilization penetration). For biological tests like sterility, the "ground truth" is determined by the absence or presence of microbial growth under specified conditions (e.g., kill of $1.0\times10^6$ Geobacillus stearothermophilus spores, no growth after exposure).
8. The Sample Size for the Training Set
This is not applicable as there is no "training set" in the context of an AI/ML algorithm. The device is a physical product.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no "training set" for this type of device.
{0}------------------------------------------------
September 7, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Wipak OY % Amanda Singleton Consultant Compliance Systems International LLC 39 Lockhart Circle Amherst, New York 14228
Re: K231999
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: August 11, 2023 Received: August 11, 2023
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 medical devices and radiation-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,
Digitally signed
by Eileen Cadel
-S
Eileen
Cadel -S Date:
for
2023.09.07
13:49:47 -04'00'
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)
K231999
Device Name
Steriking® LT-Blueline Pouches with Tyvek®
Indications for Use (Describe)
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 1 years post sterilization. The products are for single use only. The Steriking® LT-Blueline Pouches with Tyvek 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: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 380 mm, .094 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.194 pounds.
NX Advanced Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 380 mm, .096 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.224 pounds.
100NX Duo Cycle: For pouch sizes 90 x 200 mm. 90 x 250 mm. 130 x 380 mm. .116 lbs. For pouch sizes 190 x 330 mm. 250 x 400 mm, 300 x 450 mm, 1.222 pounds.
100NX Flex Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 380 mm, .202 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.220 pounds.
100NX Standard Cycle: For pouch sizes 90 x 200 mm. 90 x 250 mm. 130 x 380 mm. .202 lbs. For pouch sizes 190 x 330 mm. 250 x 400 mm. 300 x 450 mm. 4.478 pounds.
Max Count of lumens: 1 lumen max for All cycles
Max ID of lumens:
NX Standard Cycle: 1 mm ID for all pouch sizes
NX Advanced Cycle: 2 mm ID for all pouch sizes
{3}------------------------------------------------
100NX Cycle: 1 mm ID for all pouch sizes
100NX Flex Cycle: 1 mm ID for all pouch sizes
100NX Standard Cycle: 2 mm ID for all pouch sizes
Max lumen lengths: NX Standard Cycle: For pouch sizes 90 x 200 mm. 90 x 250 mm. 130 x 380 mm. 125 mm. For pouch sizes 190 x 330 mm. 250 x 400 mm, 300 x 450 mm, 250 mm.
NX Advanced Cycle: For pouch sizes 90 x 200 mm. 90 x 250 mm. 130 x 380 mm. 125 mm. For pouch sizes 190 x 330 mm. 250 x 400 mm, 300 x 450 mm, 250 mm.
100NX Duo Cycle: 850 mm for all pouch sizes
100NX Flex Cycle: 850 mm for all pouch sizes
100NX Standard Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 380 mm, 125 mm. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm.
Pouch Sizes: 300 x 450 mm 250 x 400 mm 190 x 330 mm 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
K231999 510(k) Summary (in accordance with 21CFR807.92)
| 510K Summary Elements per21CFR807.92 | Summary |
|---|---|
| Submitter's name, address, telephonenumber, a contact person, and the datethe summary was prepared | Wipak OyWipaktie 2Nastola FinlandContact: Hanna MarttilaPhone: +358 (0)40 124 0290Date prepared: September 6, 2023Submitter: Amanda Singleton, Compliance Systems International, 716.440.7364 |
| Name of the deviceincluding the trade orproprietary name ifapplicable | 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 | FRG |
| Device Classification | Class II |
| Regulation Number | 21 CFR 880.6850 |
| Identification of the legallymarketed device to whichthe submitter claimsequivalence(Primary Predicate device) | K221377 -Steriking® LT-Blueline Pouches with Tyvek® |
| Description of the device | Steriking® LT-Blueline Pouches with Tyvek® are intended to be used to containmedical devices to be terminally sterilized in the STERRAD® SterilizationSystem. The medical devices are inserted into the Pouch, sealed, and thensterilized in the STERRAD ® Sterilization System. Sterilization Cycles are notedbelow. After completion of the sterilization process, the Pouch maintainssterility of the enclosed medical devices until the seal is opened. These pouchesare made from a plastic film and Tyvek that is heat-sealed on three sides. Thefourth side is left opened and will be self-sealed when used.Steriking® LT-Blueline Pouches with Tyvek® are intended to allow sterilizationof enclosed devices and to maintain sterility of the enclosed devices until usedup to 1 year post sterilization. The products are for single use only.The pouches are constructed from Tyvek®/plastic films. The self-sealedpouches are self sealed prior to processing in the STERRAD® SterilizationSystems.Sterilization Systems:STERRAD® Cycles:NX StandardNX Advanced100NX Duo100NX Flex100NX Standard |
| Indications for Use | 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 1 years post sterilization. The products are for single use only. The Steriking® LT-Blueline Pouches with Tyvek are intended for use in the following STERRAD® Sterilization Cycles:NX StandardNX Advanced100NX Duo100NX Flex100NX StandardMax weights:NX Standard Cycle:For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .094 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.194 pounds.NX Advanced Cycle:For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .096 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.224 pounds.100NX Duo Cycle:For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .116 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.222 pounds.100NX Flex Cycle:For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .202 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.220 pounds.100NX Standard Cycle:For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .202 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 4.478 pounds.Max Count of lumens:1 lumen max for All cyclesMax ID of lumens:NX Standard Cycle:1 mm ID for all pouch sizesNX Advanced Cycle:2 mm ID for all pouch sizes100NX Standard Cycle:1 mm ID for all pouch sizes |
{5}------------------------------------------------
{6}------------------------------------------------
| Technological Characteristics Comparison Table | |||
|---|---|---|---|
| Submission Device –K231999Steriking® LT-Blueline Poucheswith Tyvek® | Comparison | Primary Predicate Device –K221377Steriking® LT-Blueline Poucheswith Tyvek® | |
| Device Classification | Class II | Same | Class II |
| Classification Name | Sterilization wrap | Same | Sterilization wrap |
| Regulation Name | 21 CFR 880.6850 | Same | 21 CFR 880.6850 |
| Product Code | FRG | Same | FRG |
| Indications for Use | Steriking® LT-Blueline Poucheswith Tyvek® are intended toprovide health care workers withan effective method to enclosedevices intended for sterilizationin the STERRAD® | Different | The Steriking® LT-BluelinePouches with Tyvek areintended to provide health careworkers with an effectivemethod to enclose devicesintended for sterilization in the |
{7}------------------------------------------------
| Pouch Sizes: | Pouch Sizes: | ||||
|---|---|---|---|---|---|
| Sterilizer Systems. The device isintended to allow sterilization ofenclosed devices and tomaintain sterility of the encloseddevices until used up to 1 yearspost sterilization. The productsare for single use only. TheSteriking® LT-Blueline Poucheswith Tyvek are intended for usein the following STERRAD®Sterilization Cycles:NX StandardNX Advanced100NX Duo100NX Flex100NX Standard | STERRAD® Sterilizer Systems.The device is intended to allowsterilization of enclosed devicesand to maintain sterility of theenclosed devices until used upto 3 years post sterilization. Theproducts are for single use onlyThe Steriking® LT-BluelinePouches with Tyvek areintended for use in thefollowing STERRAD®Sterilization Cycles:NX StandardNX Advanced100NX Duo100NX Flex100NX Standard | 300 x 450 mm | 250 mm x 390 mm | ||
| Max weights:NX Standard Cycle:For pouch sizes 90 x 200 mm, 90x 250 mm, 130 x 270 mm, 130 x380 mm, .094 lbs. For pouchsizes 190 x 330 mm, 250 x 400mm, 300 x 450 mm, 1.194pounds. | Max weights:NX Standard Cycle:75 mm x 200 mm, 100 mm x250 mm, 150 mm x 300 mm,160 mm x 440 mm, 160 mm x600 mm: .088 pounds205 mm x 390 mm, 250 mm x390 mm, 250 mm x 500 mm:1.382 pounds | 250 x 400 mm | 205 mm x 390 mm | ||
| NX Advanced Cycle:For pouch sizes 90 x 200 mm, 90x 250 mm, 130 x 270 mm, 130 x380 mm, .096 lbs. For pouchsizes 190 x 330 mm, 250 x 400mm, 300 x 450 mm, 1.224pounds. | NX Advanced Cycle:75 mm x 200 mm, 100 mm x250 mm, 150 mm x 300 mm,160 mm x 440 mm, 160 mm x600 mm: .084 pounds205 mm x 390 mm, 250 mm x390 mm, 250 mm x 500 mm:1.393 pounds | 190 x 330 mm | 160 mm x 600 mm | ||
| 100NX Duo Cycle:For pouch sizes 90 x 200 mm, 90x 250 mm, 130 x 270 mm, 130 x380 mm, .116 lbs. For pouchsizes 190 x 330 mm, 250 x 400mm, 300 x 450 mm, 1.222pounds. | 100NX Duo Cycle:75 mm x 200 mm, 100 mm x250 mm, 150 mm x 300 mm,160 mm x 440 mm, 160 mm x600 mm: .104 pounds205 mm x 390 mm, 250 mm x390 mm, 250 mm x 500 mm:1.400 pounds | 130 x 380 mm | 160 mm x 440 mm | ||
| 100NX Flex Cycle:For pouch sizes 90 x 200 mm, 90x 250 mm, 130 x 270 mm, 130 x380 mm, .202 lbs. For pouchsizes 190 x 330 mm, 250 x 400mm, 300 x 450 mm, 1.220pounds. | 100NX Flex Cycle: | 130 x 270 mm | 150 mm x 300 mm | ||
| 100NX Standard Cycle:For pouch sizes 90 x 200 mm, 90 | 90 x 250 mm | 100 mm x 250 mm | |||
| 380 mm, .202 lbs. For pouchsizes 190 x 330 mm, 250 x 400mm, 300 x 450 mm, 4.478pounds. | 75 mm x 200 mm, 100 mm x250 mm, 150 mm x 300 mm,160 mm x 440 mm, 160 mm x600 mm: .158 pounds | 90 x 200 mm | 75 mm x 200 mm | ||
| Max Count of lumens:1 lumen max for All cycles | 205 mm x 390 mm, 250 mm x390 mm, 250 mm x 500 mm:1.400 pounds | Design | These pouches are made from aplastic film and Tyvek that isheat sealed on three sides. Thefourth side is left opened andwill be self-sealed when used. | These pouches are made froma plastic film and Tyvek that isheat sealed on three sides. Thefourth side is left opened andwill be heat-sealed when used. | |
| Max ID of lumens: | 100NX Standard Cycle: | Backing Material | Tyvek® | No Change | Tyvek® |
| NX Standard Cycle:1 mm ID for all pouch sizes | 75 mm x 200 mm, 100 mm x250 mm, 150 mm x 300 mm,160 mm x 440 mm, 160 mm x600 mm: .158 pounds | Transparent Film | BOPET/PE | No Change | BOPET/PE |
| NX Advanced Cycle:2 mm ID for all pouch sizes | 205 mm x 390 mm, 250 mm x390 mm, 250 mm x 500 mm:4.476 pounds | Sterilization Processes | H2O2 Sterilization Process as per:STERRAD®NX StandardNX Advanced100NX Duo100NX Flex100NX Standard | No Change | H2O2 Sterilization Process as per:STERRAD®NX StandardNX Advanced100NX Duo100NX Flex100NX Standard |
| 100NX Cycle:1 mm ID for all pouch sizes | Max lumens:1 mm min ID and Max 1 lumenfor all cycles | SterilantValidation | Achieved a 10-6 Sterility AssuranceLevel (SAL) of Geobacillusstearothermophilus.NX StandardNX Advanced100NX Duo100NX Flex100NX Standard | No Change | Achieved a 10-6 Sterility AssuranceLevel (SAL) of Geobacillusstearothermophilus.NX StandardNX Advanced100NX Duo100NX Flex100NX Standard |
| 100NX Flex Cycle:1 mm ID for all pouch sizes | NX Standard Cycle: For pouchsizes 250x500mm, 250x390mm205x390mm is 125 mm maxlength. Max length is 50 mm forall other pouch sizes. | Package Integrity | Pass | No Change | Pass |
| 100NX Standard Cycle:2 mm ID for all pouch sizes | NX Advanced Cycle: For pouchsizes 250x500mm, 250x390mm205x390mm is 125 mm maxlength. Max length is 50 mm forall other pouch sizes. | Biocompatibility | Pass | No Change | Pass |
| Max lumen lengths:NX Standard Cycle:For pouch sizes 90 x 200 mm, 90x 250 mm, 130 x 270 mm, 130 x380 mm, 125 mm. For pouchsizes 190 x 330 mm, 250 x 400mm, 300 x 450 mm, 250 mm. | 100NX Duo Cycle: For pouchsizes 250x500mm, 250x390mm205x390mm is 875 mm maxlength. Max length is 850 mmfor all other pouch sizes. | Shelf-Life Pre-Sterilization | 3 years | Different | 5 years |
| NX Advanced Cycle:For pouch sizes 90 x 200 mm, 90x 250 mm, 130 x 270 mm, 130 x380 mm, 125 mm. For pouchsizes 190 x 330 mm, 250 x 400mm, 300 x 450 mm, 250 mm. | 100NX Flex Cycle: Max lengthis 850 mm for all pouch sizes. | Maintenance of Sterility | 1 year | Different | 3 years |
| 100NX Duo Cycle:850 mm for all pouch sizes | 100NX Standard Cycle: Forpouch sizes 250x500mm,250x390mm, 205x390mm is125 mm max length. Maxlength is 50 mm for all otherpouch sizes. | ||||
| 100NX Flex Cycle:850 mm for all pouch sizes | Pouch Sizes:250 mm x 500 mm | ||||
| 100NX Standard Cycle:For pouch sizes 90 x 200 mm, 90x 250 mm, 130 x 270 mm, 130 x380 mm, 125 mm. For pouchsizes 190 x 330 mm, 250 x 400mm, 300 x 450 mm, 250 mm. |
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
| Max weights | Different | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pouch size | NXAdvancedCycle | NXStandardCycle | 100NXDuoCycle | 100NXFlexCycle | 100NXStandardCycle | Pouch size | NXAdvancedCycle | NXStandardCycle | 100NXDuoCycle | 100NXFlexCycle | 100NXStandardCycle |
| 300 x 450 mm | 1.224 | 1.194 | 1.222 | 1.220 | 4.748 | 250 x 500 mm | 1.393 | 1.382 | 1.400 | 1.400 | 4.476 |
| 250 x 400 mm | 1.224 | 1.194 | 1.222 | 1.220 | 4.748 | 250 x 390 mm | 1.393 | 1.382 | 1.400 | 1.400 | 4.476 |
| 190 x 330 mm | 1.224 | 1.194 | 1.222 | 1.220 | 4.748 | 205 x 390 mm | 1.393 | 1.382 | 1.400 | 1.400 | 4.476 |
| 130 x 380 mm | 0.096 | 0.094 | 0.116 | 0.202 | 0.202 | 160 x 600 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 |
| 130 x 270 mm | 0.096 | 0.094 | 0.116 | 0.202 | 0.202 | 160 x 440 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 |
| 90 x 250 mm | 0.096 | 0.094 | 0.116 | 0.202 | 0.202 | 150 x 300 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 |
| 90 x 200 mm | 0.096 | 0.094 | 0.116 | 0.202 | 0.202 | 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 | Max Count of lumens: | Different | 1 mm min ID Lumen and Max 1 lumen for all cycles | ||||||||
| 1 lumen max for all pouch sizes | |||||||||||
| Max lumen Id: | For NX Standard Cycle: Forpouch sizes 250x500mm,250x390mm, 205x390mm is125 mm max length. Max | ||||||||||
| NX Standard: | |||||||||||
| 1 mm ID for all pouch sizes | length is 50 mm for all otherpouch sizes. | ||||||||||
| NX Advanced: | NX Advanced Cycle: For pouch | ||||||||||
| 2 mm ID for all pouch sizes | sizes 250x500mm, 250x390mm,205x390mm is 125 mm max | ||||||||||
| length. Max length is 50 mm for | |||||||||||
| 100NX Duo: | all other pouch sizes. | ||||||||||
| 1 mm ID for all pouch sizes | |||||||||||
| 100NX Duo Cycle: For pouch | |||||||||||
| 100NX Flex: | sizes 250x500mm, 250x390mm, | ||||||||||
| 1 mm ID for all pouch sizes | 205x390mm is 875 mm max | ||||||||||
| length. Max length is 850 mm | |||||||||||
| 100NX Standard: | for all other pouch sizes. | ||||||||||
| 2 mm ID for all pouch sizes | |||||||||||
| 100NX Flex Cycle: Max length | |||||||||||
| Max lumen lengths: | is 850 mm for all pouch sizes. | ||||||||||
| NX Standard Cycle: | 100NX Standard Cycle: For pouch | ||||||||||
| For pouch sizes 90 x 200 mm, 90x 250 mm, 130 x 270 mm, 130 x380 mm, 125 mm. | sizes 250x500mm, 250x390mm, | ||||||||||
| 205x390mm is 125 mm max | |||||||||||
| For pouch sizes 190 x 330 mm,250 x 400 mm, 300 x 450 mm,250 mm. | length. Max length is 50 mm for all | ||||||||||
| other pouch sizes. | |||||||||||
| NX Advanced Cycle: | |||||||||||
| For pouch sizes 90 x 200 mm, 90x 250 mm, 130 x 270 mm, 130 x380 mm, 125 mm. | |||||||||||
| For pouch sizes 190 x 330 mm,250 x 400 mm, 300 x 450 mm,250 mm. | |||||||||||
| 100NX Duo Cycle: | |||||||||||
| 850 mm for all pouch sizes | |||||||||||
| 100NX Flex Cycle: | |||||||||||
| 850 mm for all pouch sizes |
{11}------------------------------------------------
| 100NX Standard Cycle:For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, 125 mm.For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm. | ||
|---|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | -- |
Performance Data:
| Cycle | Test Category | Test | SampleType | Standard/Spec | FDARecognitionnumber | AcceptanceCriteria | Result Summary | Conclusion |
|---|---|---|---|---|---|---|---|---|
| NA | Package Integrity,Pre-SterilizationShelf Life | DyeMigration | Unsterilized-Aged | ASTM F1929 | 14-484 | No leaks detectedafter dye migration | All self-seal pouchespassed the dyepenetration at timezero | Pass |
| NA | Package Integrity,Pre-SterilizationShelf Life | Tensile | Unsterilized-Aged | ASTM F88-05AAMI TIR12:2010AAMI/ISOTIR16775:2014ISO 11607 | 14-48214-530 | All samples are >1.5N/15mm perASTM F88 | All samples are >1.5N/15mm perASTM F88 | Pass |
| 100NXStandard | Package Integrity,Post-Sterilization | Tensile | Sterilized-Unaged | ASTM F88-05AAMI TIR12:2010AAMI/ISOTIR16775:2014ISO 11607 | 14-48214-530 | All samples are >1.5N/15mm perASTM F88 | All samples are >1.5N/15mm perASTM F88 | Pass |
| 100NXStandard | Biocompatibility | Cytotoxicity | Sterilized-Unaged | ISO 10993-5ISO 10993-12ISO 11607-1 | 14-5302-2452-289 | Not greater thanGrade 2 reactivity(mildly reactive) | No reduction of cellgrowth and cell lysis | Pass |
| 100NXStandard | Package Integrity,Post-Sterilization | MicrobialAerosolChallenge | Sterilized-Unaged | AAMI TIR12:2010ANSI/AAMIST79:2017 | 14-511 | A sample whichdemonstrates thatall items remainsterile followingexposure | Each pouch met thesterility maintenancerequirement as therewas no growth in anyof the culture tubescontaining thestainless-steelcoupons at the end ifthe incubationperiod. | Pass |
| 100NXStandard | SterilizationPenetration | SterilizationPenetration | Sterilized-Unaged | AAMI TIR12:2010ANSI/AAMI ST79ANSI/AAMI/ISO14937:2009ANSI/AAMI/ISO17664:2017 | 14-51114-33714-515 | Demonstrating thata minimum of$1.0x10^6$Geobacilusstearothermophilusspores were killedin a half-cycle (6-log reduction)using a worst-case,end of shelf-lifeinjection volume | Negative for growthfollowing theminimum incubationperiod | Pass |
| NXStandard | SterilizationPenetration | SterilizationPenetration | Sterilized-Unaged | AAMI TIR12:2010ANSI/AAMI ST79ANSI/AAMI/ISO14937:2009ANSI/AAMI/ISO17664:2017 | 14-51114-33714-515 | Demonstrating thata minimum of$1.0x10^6$Geobacilusstearothermophilusspores were killedin a half-cycle (6-log reduction)using a worst-case,end of shelf-lifeinjection volume | Negative for growthfollowing theminimum incubationperiod | Pass |
| NXAdvanced | SterilizationPenetration | SterilizationPenetration | Sterilized-Unaged | AAMI TIR12:2010ANSI/AAMI ST79ANSI/AAMI/ISO14937:2009ANSI/AAMI/ISO17664:2017 | 14-51114-33714-515 | Demonstrating thata minimum of$1.0x10^6$Geobacilusstearothermophilusspores were killedin a half-cycle (6-log reduction)using a worst-case,end of shelf-lifeinjection volume | Negative for growthfollowing theminimum incubationperiod | Pass |
| 100NXFlex | SterilizationPenetration | SterilizationPenetration | Sterilized-Unaged | AAMI TIR12:2010ANSI/AAMI ST79ANSI/AAMI/ISO14937:2009ANSI/AAMI/ISO17664:2017 | 14-51114-33714-515 | Demonstrating thata minimum of$1.0x10^6$Geobacilusstearothermophilusspores were killedin a half-cycle (6-log reduction)using a worst-case,end of shelf-lifeinjection volume | Negative for growthfollowing theminimum incubationperiod | Pass |
| 100NXDuo | SterilizationPenetration | SterilizationPenetration | Sterilized-Unaged | AAMI TIR12:2010ANSI/AAMI ST79ANSI/AAMI/ISO14937:2009ANSI/AAMI/ISO17664:2017 | 14-51114-33714-515 | Demonstrating thata minimum of$1.0x10^6$Geobacilusstearothermophilusspores were killedin a half-cycle (6-log reduction)using a worst-case,end of shelf-lifeinjection volume | Negative for growthfollowing theminimum incubationperiod | Pass |
| 100NXStandard | Post SterilizationShelf Life | Maintenanceof Sterility | Sterilizedand Aged(365 days) | AAMI TIR12:2010ANSI/AAMIST79:2017ISO 11607-1ANSI/AAMI/ISO14937 | 14-51114-53014-337 | No growth afterexposure | PassNo growth followingexposure | Pass |
| 100NXStandard | Package Integrity,Post-Sterilization | AcceleratedAging | Sterilizedand Aged (3yearsacceleratedaging) | ANSI/AAMIST8:2013/(R)2018AAMI TIR12:2010ANSI/AAMIST77:2017ANSI/AAMIST79:2017ISO 11607-1ASTM F1980 | 14-40614-39614-51114-53014-497 | Seal maintainsintegrity | PassNo suspect sealswere observed, andthe test samplesremained intact. | Pass |
| 100NXStandard | Package Integrity,Post-Sterilization | Tensile | Sterilizedand Aged (3yearsacceleratedaging) | ASTM F88AAMI TIR12:2010AAMI/ISOTIR16775:2014ISO 11607 | 14-48214-530 | All samples are >$1.5N/15mm$ perASTM F88 | All samples are >$1.5N/15mm$ perASTM F88 | Pass |
{12}------------------------------------------------
Non-Clinical Testing 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 K221377.
{13}------------------------------------------------
Discussion:
Any differences between the predicate's and the proposed device's performance testing has no impact on the safety or effectiveness of the subject device. The modification of the Steriking Blueline Pouch with Tyvek from its predicate is the addition of an adhesive strip to seal the pouch. The addition of an adhesive strip allows the user to close the pouch quickly and securely, without the use of heat-sealing equipment.
The Tyvek and BOPET materials used to make the proposed self seal pouch are identical to the materials used to make the predicate heat-seal pouch. The plastic film and Tyvek are sealed together with heat and then the web is cut to specific lengths during the assembly process for both the heat-sealed and self-sealed pouches. The fourth side is left open and is sealed when used. The Tyvek material and the film are not modified during the construction of pouches.
The proposed self seal pouches have undergone the same testing as the predicate heat seal pouches, including Sterilization Penetration, Sterility Maintenance, and Package Integrity. The self-seal pouch allows for devices to be sterilized, and sterility to be maintained. Studies on the self-seal pouch were performed concurrently to the heat-seal pouch studies.
Self-seal pouches have also undergone Cytotoxicity testing following Sterilization. Studies were executed in the same manner as the heat-seal predicate device. The proposed self seal pouch was determined not to have a cytotoxic effect.
Differences in validated loads, count of lumens, and inner diameter (ID) of lumens is a result of the pouch sizes differing from the heat sealed and self sealed pouches.
Instructions for Self-Sealing the pouch are noted in the Instructions for Use.
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 K221377.
§ 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).