(312 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and sterilization efficacy of packaging materials, with no mention of AI or ML.
No.
The device is described as packaging for medical devices to maintain sterility after sterilization, not as a device that provides therapy.
No
The device is packaging used for sterilizing other medical devices, not for diagnosing conditions. Its function is to maintain the sterility of enclosed medical devices, not to perform any diagnostic measurements or analysis.
No
The device description clearly outlines physical components (paper backing, plastic film laminate) and manufacturing processes (heat sealing), indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Steriking Packaging's Function: The intended use of the Steriking Packaging is to serve as a sterile barrier for medical devices during and after steam sterilization. It does not interact with or analyze biological specimens from a patient. Its purpose is to maintain the sterility of other medical devices.
The provided information clearly describes a packaging material for sterilizing and storing medical devices, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Steriking Packaging for Medical Devices serve as an enclosure for medical devices during steam sterilization that maintains the sterility of the enclosed medical devices until use of the medical devices with a combined weight of metal and plastics of 2.6 pounds or less. The recommended sterilization cycles are as follows: Pre-vacuum steam at 132oC for 4 minutes; Drying time of 20 minutes Pre-vacuum steam at 1350C for 3 minutes; Drying time of 16 minutes
The Steriking Packaging for medical devices consists of a paper backing (Bleached wood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2 sheets of laminated plastic with a total grammage of 55 g/m2, 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealed to the backing paper. The open end of the pouch is to be heat sealed once a device is inserted. Heat sealing parameters to provide a sterile barrier are 165oC-200oC (329oF-392oF).
Steriking Packaging for Medical Devices maintains the sterility of the enclosed devices for up to 12 months post Steam sterilization and before sterilization has a maximum shelf life of 5 years from the date of manufacture. Steriking Packaging for Medical Devices Dimensional configurations (2 sizes 200mm x 800mm)
Product codes
FRG
Device Description
The Steriking Packaging for Medical Devices consists of a paper backing (Bleached wood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2 sheets of laminated plastic with a total grammage of 55 g/m2 , 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealed to the backing paper. The open end of the pouch is to be heat sealed once a device is inserted. Heat sealing parameters to provide a sterile barrier are 165°C – 200°C (329°F - 392°F) Dimensional configurations as follows (2 sizes 200mm x 800mm, 250mm x 900mm).
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
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)
Non-Clinical Testing:
- Puncture Resistance (ISO 14477): Acceptable => 13.1N
- SHELF LIFE Prior to Sterilization (ASTM F1929-15, EN 868-5, ISO 5636-3): Pass (Seal Strength: >=1.5N/15mm; Seal Integrity: No dye leaks; Air Permeability: >=3.4um/Pa; Peel Properties: free of fibers after peeling)
- Sterilant Penetration & Drying Time (AAMI TIR 12:2010): Pass (Biological indicator 6-log reduction in half cycle providing 10-6 SAL; Drying time post sterilization moisture content weight gain =1.5N/15mm)
- Package Integrity (ASTM F1929): Pass (No dye penetration/channeling travelling full width of seal in ~5 seconds)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.
January 23, 2022
Wipak OY % Steven Singleton Consultant Compliance Systems International LLC. 7 Windham Hill Mendon, New York 14056
Re: K210810
Trade/Device Name: Steiking Packaging for Medical Devices Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: December 14, 2021 Received: December 23, 2021
Dear Steven 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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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,
For Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210810
Device Name Steriking Packaging for Medical Devices
Indications for Use (Describe)
Steriking Packaging for Medical Devices serve as an enclosure for medical devices during steam sterilization that maintains the sterility of the enclosed medical devices until use of the medical devices with a combined weight of metal and plastics of 2.6 pounds or less. The recommended sterilization cycles are as follows: Pre-vacuum steam at 132oC for 4 minutes; Drying time of 20 minutes Pre-vacuum steam at 1350C for 3 minutes; Drying time of 16 minutes
The Steriking Packaging for medical devices consists of a paper backing (Bleached wood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2 sheets of laminated plastic with a total grammage of 55 g/m2, 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealed to the backing paper. The open end of the pouch is to be heat sealed once a device is inserted. Heat sealing parameters to provide a sterile barrier are 165oC-200oC (329oF-392oF).
Steriking Packaging for Medical Devices maintains the sterility of the enclosed devices for up to 12 months post Steam sterilization and before sterilization has a maximum shelf life of 5 years from the date of manufacture. Steriking Packaging for Medical Devices Dimensional configurations (2 sizes 200mm x 800mm)
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510k Summary K210810
4
4. 510K Summary (in accordance with 21CFR807.92)
| | 510K Summary Elements per
21CFR807.92 | Summary |
|----|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| a1 | 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 40 124 0290
Date Prepared: 02/03/21 |
| a2 | Name of the device, including
the trade or proprietary name
if applicable, the common or
usual name, and the
classification
name | Proprietary Name: Steriking Packaging for Medical Devices
Common Name: Peel Pouch
Classification Name: Sterilization wrap, Peel Pouch |
| a3 | Identification of the legally
marketed device to which
the submitter claims
equivalence
(predicate device) | K953776, Wipak Steriking Sterilization Pouches & Rolls |
| a4 | Description of the device | The Steriking Packaging for Medical Devices consists of a paper backing
(Bleached wood pulp, grammage $100 g/m2$ ) with transparent plastic film
laminate front (2 sheets of laminated plastic with a total grammage of $55 g/m2$ , 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded
polypropylene 40 microns thick. The plastic laminate is triple heat sealed to
the backing paper. The open end of the pouch is to be heat sealed once a
device is inserted. Heat sealing parameters to provide a sterile barrier are
$165°C – 200°C (329°F - 392°F)$
Dimensional configurations as follows (2 sizes 200mm x 800mm, 250mm
x 900mm). |
| a5 | Indications for use | Steriking Packaging for Medical Devices serve as an enclosure for
medical devices during steam sterilization that maintains the sterility
of the enclosed medical devices until use of the medical devices with a
combined weight of metal and plastics of 2.6 pounds or less. The
recommended sterilization cycles are as follows:
Pre-vacuum steam at 132°C for 4 minutes; Drying time of 20 minutes
Pre-vacuum steam at 135°C for 3 minutes; Drying time of 16 minutes
The Steriking Packaging for medical devices consists of a paper
backing (Bleached wood pulp, grammage $100 g/m2$ ) with transparent
plastic film laminate front (2 sheets of laminated plastic with a total
grammage of $55 g/m2$ , 1 sheet of oriented polyester 12 microns thick,
1 sheet of coextruded polypropylene 40 microns thick. The plastic
laminate is triple heat sealed to the backing paper. The open end of
the pouch is to be heat sealed once a device is inserted. Heat sealing |
5
| | | | parameters to provide a sterile barrier are 165°C-200°C (329°F-392°F).
Steriking Packaging for Medical Devices maintains the sterility of the
enclosed devices for up to 12 months post Steam sterilization and
before sterilization has a maximum shelf life of 5 years from the date
of manufacture. | | | Design | Pouches
• plastic film triple heat sealed to
paper backing
• thumb notches
• chevron-type seal at end for opening | Similar | Pouches
• plastic film triple heat sealed to
paper backing
• self-seal flap
• thumb notches
• chevron-type seal at end for opening |
|-----------------------------|---------------------------------------------------------------------------|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | Steriking Packaging for Medical Devices Dimensional configurations (2
sizes 200mm x 800mm, 250mm x 900mm) | | | Principle of
Operation | Medical device to be sterilized is put
into pouch and the open parts of the
pouches are closed by heat sealing.
Sterilization packages then are
subjected to validated sterilization
operation of steam. Sterilant
penetration is carried out through the
medical grade paper into the package
and microorganisms on the surface of
the medical device are destroyed with
the effect of the sterilant process.
Other parameters of the sterilization
process are temperature, pressure,
humidity, time and are determined
according to the sterilization type.
After the sterilization is completed, the
sterility of the enclosed medical device
is maintained for 12 months. | Same | Medical device to be sterilized is
put into pouch and the open parts
of the pouches are closed by heat
sealing. Sterilization packages then
are subjected to validated
sterilization operation of steam.
Sterilant penetration is carried out
through the medical grade paper
into the package and
microorganisms on the surface of
the medical device are destroyed
with the effect of the sterilant
process.
Other parameters of the
sterilization process are
temperature, pressure, humidity,
time and are determined
according to the sterilization type.
Chemical process indicator is
printed exterior on the pouch
(printed on medical grade paper)
changes color when exposed to
sterilant vapor during processing.
After the sterilization is completed,
the sterility of the enclosed
medical device is
maintained for 60 months. |
| a6 | technological
characteristics compared
to predicate (as
follows) | | See below as follows | | | Dimensions | 200mm x 800mm, 250mm x 875mm | Different | 130 mm X 300 mm,
90 mm X 250 mm, 75mmX300mm |
| b1. | Comparison
Element | | Submission Device - Steriking
Packaging for Medical Devices | Comparison | Predicate Device - Wipak
Steriking
Peel Pouch, K953776 | Backing Paper | Bleached wood pulp, grammage:
100g/m2 | Similar | Bleached wood pulp, grammage: 70
g/m2 |
| | Intended Use | | To serve as an enclosure for medical
devices during steam sterilization that
maintains the sterility of the enclosed
devices until used. | Same | To serve as an enclosure for
medical devices during steam or
gas sterilization that maintains
sterility of the enclosed device
until used | Tensile Strength MD-
kNm | 12.7 | Similar | 10 |
| Tensile Strength CD-
kNm | 6.7 | Similar | 5.3 | | | | | | |
| Tear Strength MD-mN | 1000 | Similar | 750 | | | | | | |
| Tear Strength CD-mN | 1100 | Similar | 800 | | | | | | |
| Burst Strength-kPa | 690 | Similar | 550 | | | | | | |
6
7
| Porosity - Bendtsen | 425 | Same | 425 |
|---|---|---|---|
| Seal Strength – N/mm | >6.09N/15mm | Similar | 2,1 N/15 mm |
| (Pouch up to 100mm wide) | |||
| 2,5 N/15 mm | |||
| (pouch greater than 100mm wide) | |||
| Transparent Film | Two sheets of laminated plastic with a | ||
| total grammage of 55 g/m2. | |||
| One sheet of oriented polyester 12 | |||
| microns thick. One sheet of coextruded | |||
| polypropylene 40 microns | |||
| Thick. | Same | Two sheets of laminated plastic | |
| with a total grammage of 55 g/m2. | |||
| one sheet of oriented polyester | |||
| 12 microns thick. | |||
| one sheet of coextruded | |||
| polypropylene 40 microns | |||
| thick. | |||
| Sterilization Properties | Steam sterilization conditions are 4 | ||
| minutes at 132º C or 3 minutes at | |||
| 135º C | Different | Steam sterilization conditions | |
| are 3 minutes at 134º C or 15 | |||
| minutes at | |||
| 121º C | |||
| Sterilization Process | |||
| Indicator | NA | Different | Steam Sterilization Process: |
| blue indicators turn brown | |||
| after steam sterilization. | |||
| ISO 11140-1:2005 class 1: | |||
| Sterilant | |||
| Penetration | Full-cycle steam sterilization process will | ||
| produce sufficient lethality to achieve a 12- | |||
| log reduction, thus providing a 10-6 | |||
| Sterility Assurance Level (SAL). Pouches | |||
| heat sealable do not impede sterilant | |||
| penetration to the double pouched | |||
| contents. | Different | Not listed in 510K Summary | |
| Material | |||
| Compatibility | Compatible with Steam Sterilization | Same | Compatible with Steam Sterilization |
| Package Integrity | |||
| Test | Closure integrity maintained before | ||
| and after steam sterilization | Same | Closure integrity maintained before | |
| and after steam sterilization | |||
| Maintenance of | |||
| Sterility - Shelf life | |||
| post sterilization | 12 months | Different | Not listed in 510K Summary |
| Shelf Life - Pre- | |||
| sterilization | 5 years | Same | 5 Years |
| Drying Time | 20 minutes | Different | Not listed in 510K Summary |
| Microbial | |||
| Barrier | |||
| Properties | The paper of the sterile barrier system was | ||
| examined on the packaging outer side for | |||
| its germ proofness with air permeance | |||
| after steam sterilization and is evaluated | |||
| as "sufficiently germ-proof" | Different | Not listed in 510K Summary | |
| Biocompatibility | Non-Cytotoxic | Different | Not listed in 510K Summary |
8
Summary of Non-Clinical Testing:
Provided below are a listing of performance testing that was used to evaluate the subject device to demonstrate that the device met the specification and the acceptance criteria of the standards and test methodology found in the table below.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 14477 - Packaging. Flexible packaging | |||
| material. Determination of puncture resistance. | Punture Resistance | No pass/fail criteria | Acceptable |
| =/> 13.1N | |||
| ASTM F1929-15 "Standard Test Method for | |||
| Detecting Seal Leaks in Porous Medical | |||
| Packaging by Dye Penetration | |||
| EN 868-5 Packaging for terminally sterilized | |||
| medical devices - Part 5: | |||
| Sealable pouches and reels of porous materials | |||
| and plastic film | |||
| construction - Requirements and test methods | |||
| ISO 5636-3 Paper and board — Determination of | |||
| air permeance | SHELF LIFE Prior to Sterilizaton | Seal Strength: =/>1.5N/15mm | |
| Seal Integrity: No dye leaks | |||
| Air Permeability: =/>3.4um/Pa | |||
| Peel Properties: free of of fibers | |||
| after peeling | Pass | ||
| AAMI TIR 12:2010, Designing, Testing, | |||
| and Labeling Reusable Medical Devices for | |||
| Reprocessing in Health Care Facilities: | |||
| A Guide for Medical Device Manufacturers | Sterilant Penetration & Drying Time | Biological indicator 6-log | |
| reduction in half cycle providing | |||
| 10-6 SAL | |||
| Drying time post sterilization | |||
| moisture content weight gain 20N/15mm |
- =/>66N/15mm
- =/>33N/15mm
- =152 +/- 10% μm
-
550mN (MD & CD)
-
10N
-
230kPa
- 3.9 – 5.7 µm/PAS
- Corresponds
- 1.5N/15mm
- No irregularities or splitting >10mm
- evaluation grade = 5
- No objections
- No pinholes | Pass |
| ISO 10993-5, Biological evaluation of medical
devices - Part 5: Tests for in vitro cytotoxicity | Biocompatibility | If viability is reduced to 1.5N/15mm | Pass |
| ASTM F1929 - Standard Test Method for
Detecting Seal Leaks in Porous Medical
Packaging by Dye
Penetration | Package Integrity | No dye penetration/channeling
travelling full width of seal in ~5
seconds | Pass |
9
Conclusion
The conclusions drawn from the non-clinical performance data demonstrate that the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device (K953776), Class II 21 CFR 880.6850, ProCode FRG.