(64 days)
Not Found
No
The device is a sterilization pouch and the description focuses on its physical properties and performance in sterilization cycles, with no mention of AI or ML.
No.
Explanation: The device, Steriking® LT-Blueline Pouches with Tyvek®, is intended for use in the sterilization and maintenance of sterility of other medical devices. It does not directly provide therapy or treatment to a patient.
No
This device, Steriking® LT-Blueline Pouches with Tyvek®, is intended to enclose and maintain the sterility of medical devices for sterilization, not for diagnostic purposes.
No
The device described is a physical medical device (pouches made of plastic film and Tyvek) intended for packaging devices for sterilization and maintaining sterility. It is not software.
Based on the provided information, the Steriking® LT-Blueline Pouches with Tyvek® are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the pouches are for enclosing devices intended for sterilization and maintaining their sterility. This is a function related to the preparation and storage of medical devices, not for performing diagnostic tests on samples taken from the human body.
- Device Description: The description reinforces that the pouches are used to contain medical devices for sterilization and maintain sterility.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or treatment decisions
- Reagents, calibrators, or controls
- Any form of analytical measurement or result
The device is a sterilization packaging system, which is a type of medical device, but not an IVD.
N/A
Intended Use / 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 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
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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Package Integrity, Pre-Sterilization Shelf Life
Test: Dye Migration
Sample Type: Unsterilized-Aged
Standard/Spec: ASTM F1929
Acceptance Criteria: No leaks detected after dye migration
Result Summary: All self-seal pouches passed the dye penetration at time zero
Conclusion: Pass
Study Type: Package Integrity, Pre-Sterilization Shelf Life
Test: Tensile
Sample Type: Unsterilized-Aged
Standard/Spec: ASTM F88-05, AAMI TIR12:2010, AAMI/ISO TIR16775:2014, ISO 11607
Acceptance Criteria: All samples are > 1.5N/15mm per ASTM F88
Result Summary: All samples are > 1.5N/15mm per ASTM F88
Conclusion: Pass
Study Type: Package Integrity, Post-Sterilization
Test: Tensile
Sample Type: Sterilized-Unaged
Standard/Spec: ASTM F88-05, AAMI TIR12:2010, AAMI/ISO TIR16775:2014, ISO 11607
Acceptance Criteria: All samples are > 1.5N/15mm per ASTM F88
Result Summary: All samples are > 1.5N/15mm per ASTM F88
Conclusion: Pass
Study Type: Biocompatibility
Test: Cytotoxicity
Sample Type: Sterilized-Unaged
Standard/Spec: ISO 10993-5, ISO 10993-12, ISO 11607-1
Acceptance Criteria: Not greater than Grade 2 reactivity (mildly reactive)
Result Summary: No reduction of cell growth and cell lysis
Conclusion: Pass
Study Type: Package Integrity, Post-Sterilization
Test: Microbial Aerosol Challenge
Sample Type: Sterilized-Unaged
Standard/Spec: AAMI TIR12:2010, ANSI/AAMI ST79:2017
Acceptance Criteria: A sample which demonstrates that all items remain sterile following exposure
Result Summary: 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.
Conclusion: Pass
Study Type: Sterilization Penetration
Test: Sterilization Penetration
Sample Type: Sterilized-Unaged
Standard/Spec: AAMI TIR12:2010, ANSI/AAMI ST79, ANSI/AAMI/ISO 14937:2009, ANSI/AAMI/ISO 17664:2017
Acceptance Criteria: Demonstrating that a minimum of 1.0x10^6 Geobacilus stearothermophilus spores were killed in a half-cycle (6-log reduction) using a worst-case, end of shelf-life injection volume
Result Summary: Negative for growth following the minimum incubation period
Conclusion: Pass (for 100NX Standard, NX Standard, NX Advanced, 100NX Flex, 100NX Duo cycles)
Study Type: Post Sterilization Shelf Life
Test: Maintenance of Sterility
Sample Type: Sterilized and Aged (365 days)
Standard/Spec: AAMI TIR12:2010, ANSI/AAMI ST79:2017, ISO 11607-1, ANSI/AAMI/ISO 14937
Acceptance Criteria: No growth after exposure
Result Summary: Pass No growth following exposure
Conclusion: Pass
Study Type: Package Integrity, Post-Sterilization
Test: Accelerated Aging
Sample Type: Sterilized and Aged (3 years accelerated aging)
Standard/Spec: ANSI/AAMI ST8:2013/(R)2018, AAMI TIR12:2010, ANSI/AAMI ST77:2017, ANSI/AAMI ST79:2017, ISO 11607-1, ASTM F1980
Acceptance Criteria: Seal maintains integrity
Result Summary: Pass No suspect seals were observed, and the test samples remained intact.
Conclusion: Pass
Study Type: Package Integrity, Post-Sterilization
Test: Tensile
Sample Type: Sterilized and Aged (3 years accelerated aging)
Standard/Spec: ASTM F88, AAMI TIR12:2010, AAMI/ISO TIR16775:2014, ISO 11607
Acceptance Criteria: All samples are > 1.5N/15mm per ASTM F88
Result Summary: All samples are > 1.5N/15mm per ASTM F88
Conclusion: Pass
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
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.
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4
K231999 510(k) 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: September 6, 2023 | |
| Submitter: Amanda Singleton, Compliance Systems International, 716.440.7364 | |
| 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 | FRG |
| Device Classification | Class II |
| Regulation Number | 21 CFR 880.6850 |
| Identification of the legally | |
| marketed device to which | |
| the submitter claims | |
| equivalence | |
| (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 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 |
| 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 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 Standard Cycle:
1 mm ID for all pouch sizes |
5
6
| Technological Characteristics Comparison Table | |||
|---|---|---|---|
| Submission Device – | |||
| K231999 | |||
| Steriking® LT-Blueline Pouches | |||
| with Tyvek® | Comparison | Primary Predicate Device – | |
| K221377 | |||
| Steriking® LT-Blueline Pouches | |||
| with 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 Pouches | ||
| with Tyvek® are intended to | |||
| provide health care workers with | |||
| an effective method to enclose | |||
| devices intended for sterilization | |||
| in the STERRAD® | Different | 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 |
7
| Pouch Sizes: | Pouch Sizes: | ||||
|---|---|---|---|---|---|
| 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 | 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 | |||||
| Pouches with Tyvek are | |||||
| intended for use in the | |||||
| following STERRAD® | |||||
| Sterilization Cycles: | |||||
| NX Standard | |||||
| NX Advanced | |||||
| 100NX Duo | |||||
| 100NX Flex | |||||
| 100NX Standard | 300 x 450 mm | 250 mm x 390 mm | |||
| 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. | 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 | |||||
| 205 mm x 390 mm, 250 mm x | |||||
| 390 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, 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. | 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 | 190 x 330 mm | 160 mm x 600 mm | |||
| 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 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 | 130 x 380 mm | 160 mm x 440 mm | |||
| 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 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 pouch | |||||
| sizes 190 x 330 mm, 250 x 400 | |||||
| mm, 300 x 450 mm, 4.478 | |||||
| pounds. | 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 | 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 x | ||||
| 390 mm, 250 mm x 500 mm: | |||||
| 1.400 pounds | 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 self-sealed when used. | 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. | |||||
| 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 x | ||||
| 250 mm, 150 mm x 300 mm, | |||||
| 160 mm x 440 mm, 160 mm x | |||||
| 600 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 x | ||||
| 390 mm, 250 mm x 500 mm: | |||||
| 4.476 pounds | Sterilization Processes | H2O2 Sterilization Process as per: | |||
| STERRAD® | |||||
| NX Standard | |||||
| NX Advanced | |||||
| 100NX Duo | |||||
| 100NX Flex | |||||
| 100NX Standard | No Change | H2O2 Sterilization Process as per: | |||
| STERRAD® | |||||
| NX Standard | |||||
| NX Advanced | |||||
| 100NX Duo | |||||
| 100NX Flex | |||||
| 100NX Standard | |||||
| 100NX Cycle: | |||||
| 1 mm ID for all pouch sizes | Max lumens: | ||||
| 1 mm min ID and Max 1 lumen | |||||
| for all cycles | Sterilant | ||||
| Validation | Achieved a 10-6 Sterility Assurance | ||||
| Level (SAL) of Geobacillus | |||||
| stearothermophilus. | |||||
| NX Standard | |||||
| NX Advanced | |||||
| 100NX Duo | |||||
| 100NX Flex | |||||
| 100NX Standard | No Change | Achieved a 10-6 Sterility Assurance | |||
| Level (SAL) of Geobacillus | |||||
| stearothermophilus. | |||||
| NX Standard | |||||
| NX Advanced | |||||
| 100NX Duo | |||||
| 100NX Flex | |||||
| 100NX Standard | |||||
| 100NX Flex Cycle: | |||||
| 1 mm ID for all pouch sizes | NX Standard Cycle: For pouch | ||||
| sizes 250x500mm, 250x390mm | |||||
| 205x390mm is 125 mm max | |||||
| length. Max length is 50 mm for | |||||
| all other pouch sizes. | Package Integrity | Pass | No Change | Pass | |
| 100NX Standard Cycle: | |||||
| 2 mm ID for all 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. | Biocompatibility | Pass | No Change | Pass | |
| 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. | 100NX Duo Cycle: For pouch | ||||
| sizes 250x500mm, 250x390mm | |||||
| 205x390mm is 875 mm max | |||||
| length. Max length is 850 mm | |||||
| for all other pouch sizes. | Shelf-Life Pre-Sterilization | 3 years | Different | 5 years | |
| 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 Flex Cycle: Max length | ||||
| is 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: For | ||||
| pouch sizes 250x500mm, | |||||
| 250x390mm, 205x390mm is | |||||
| 125 mm max length. Max | |||||
| length is 50 mm for all other | |||||
| pouch 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, 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. |
8
9
10
| Max weights | Different | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pouch size | NX | ||||||||||
| Advanced | |||||||||||
| Cycle | NX | ||||||||||
| Standard | |||||||||||
| Cycle | 100NX | ||||||||||
| Duo | |||||||||||
| Cycle | 100NX | ||||||||||
| Flex | |||||||||||
| Cycle | 100NX | ||||||||||
| Standard | |||||||||||
| Cycle | Pouch size | NX | |||||||||
| Advanced | |||||||||||
| Cycle | NX | ||||||||||
| Standard | |||||||||||
| Cycle | 100NX | ||||||||||
| Duo | |||||||||||
| Cycle | 100NX | ||||||||||
| Flex | |||||||||||
| Cycle | 100NX | ||||||||||
| Standard | |||||||||||
| Cycle | |||||||||||
| 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: For | ||||||||||
| pouch sizes 250x500mm, | |||||||||||
| 250x390mm, 205x390mm is | |||||||||||
| 125 mm max length. Max | |||||||||||
| NX Standard: | |||||||||||
| 1 mm ID for all pouch sizes | length is 50 mm for all other | ||||||||||
| pouch 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, 90 | |||||||||||
| x 250 mm, 130 x 270 mm, 130 x | |||||||||||
| 380 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, 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 |
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 | Sample
Type | Standard/Spec | FDA
Recognition
number | Acceptance
Criteria | Result Summary | Conclusion |
|-------------------|-------------------------------------------------------|-----------------------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| NA | Package Integrity,
Pre-Sterilization
Shelf Life | Dye
Migration | Unsterilized-
Aged | ASTM F1929 | 14-484 | No leaks detected
after dye migration | All self-seal pouches
passed the dye
penetration at time
zero | Pass |
| NA | Package Integrity,
Pre-Sterilization
Shelf Life | Tensile | Unsterilized-
Aged | ASTM F88-05
AAMI TIR12:2010
AAMI/ISO
TIR16775:2014
ISO 11607 | 14-482
14-530 | All samples are >
1.5N/15mm per
ASTM F88 | All samples are >
1.5N/15mm per
ASTM F88 | Pass |
| 100NX
Standard | Package Integrity,
Post-Sterilization | Tensile | Sterilized-
Unaged | ASTM F88-05
AAMI TIR12:2010
AAMI/ISO
TIR16775:2014
ISO 11607 | 14-482
14-530 | All samples are >
1.5N/15mm per
ASTM F88 | All samples are >
1.5N/15mm per
ASTM F88 | Pass |
| 100NX
Standard | Biocompatibility | Cytotoxicity | Sterilized-
Unaged | ISO 10993-5
ISO 10993-12
ISO 11607-1 | 14-530
2-245
2-289 | Not greater than
Grade 2 reactivity
(mildly reactive) | No reduction of cell
growth and cell lysis | Pass |
| 100NX
Standard | Package Integrity,
Post-Sterilization | Microbial
Aerosol
Challenge | Sterilized-
Unaged | AAMI TIR12:2010
ANSI/AAMI
ST79:2017 | 14-511 | 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 |
| 100NX
Standard | Sterilization
Penetration | Sterilization
Penetration | Sterilized-
Unaged | AAMI TIR12:2010
ANSI/AAMI ST79
ANSI/AAMI/ISO
14937:2009
ANSI/AAMI/ISO
17664:2017 | 14-511
14-337
14-515 | Demonstrating that
a minimum of
$1.0x10^6$
Geobacilus
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 | Pass |
| NX
Standard | Sterilization
Penetration | Sterilization
Penetration | Sterilized-
Unaged | AAMI TIR12:2010
ANSI/AAMI ST79
ANSI/AAMI/ISO
14937:2009
ANSI/AAMI/ISO
17664:2017 | 14-511
14-337
14-515 | Demonstrating that
a minimum of
$1.0x10^6$
Geobacilus
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 | Pass |
| NX
Advanced | Sterilization
Penetration | Sterilization
Penetration | Sterilized-
Unaged | AAMI TIR12:2010
ANSI/AAMI ST79
ANSI/AAMI/ISO
14937:2009
ANSI/AAMI/ISO
17664:2017 | 14-511
14-337
14-515 | Demonstrating that
a minimum of
$1.0x10^6$
Geobacilus
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 | Pass |
| 100NX
Flex | Sterilization
Penetration | Sterilization
Penetration | Sterilized-
Unaged | AAMI TIR12:2010
ANSI/AAMI ST79
ANSI/AAMI/ISO
14937:2009
ANSI/AAMI/ISO
17664:2017 | 14-511
14-337
14-515 | Demonstrating that
a minimum of
$1.0x10^6$
Geobacilus
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 | Pass |
| 100NX
Duo | Sterilization
Penetration | Sterilization
Penetration | Sterilized-
Unaged | AAMI TIR12:2010
ANSI/AAMI ST79
ANSI/AAMI/ISO
14937:2009
ANSI/AAMI/ISO
17664:2017 | 14-511
14-337
14-515 | Demonstrating that
a minimum of
$1.0x10^6$
Geobacilus
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 | Pass |
| 100NX
Standard | Post Sterilization
Shelf Life | Maintenance
of Sterility | Sterilized
and Aged
(365 days) | AAMI TIR12:2010
ANSI/AAMI
ST79:2017
ISO 11607-1
ANSI/AAMI/ISO
14937 | 14-511
14-530
14-337 | No growth after
exposure | Pass
No growth following
exposure | Pass |
| 100NX
Standard | Package Integrity,
Post-Sterilization | Accelerated
Aging | Sterilized
and Aged (3
years
accelerated
aging) | ANSI/AAMI
ST8:2013/(R)2018
AAMI TIR12:2010
ANSI/AAMI
ST77:2017
ANSI/AAMI
ST79:2017
ISO 11607-1
ASTM F1980 | 14-406
14-396
14-511
14-530
14-497 | Seal maintains
integrity | Pass
No suspect seals
were observed, and
the test samples
remained intact. | Pass |
| 100NX
Standard | Package Integrity,
Post-Sterilization | Tensile | Sterilized
and Aged (3
years
accelerated
aging) | ASTM F88
AAMI TIR12:2010
AAMI/ISO
TIR16775:2014
ISO 11607 | 14-482
14-530 | All samples are >
$1.5N/15mm$ per
ASTM F88 | All samples are >
$1.5N/15mm$ per
ASTM 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.