Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus solely on the physical properties and function of packaging materials for sterilization, with no mention of software, algorithms, or data processing.

Therapeutic

No.
This device is a packaging material intended to maintain the sterility of medical devices, not to provide therapy or treatment.

Diagnostic

No

The device is packaging for medical devices, serving to maintain sterility after steam sterilization. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (paper backing, plastic film laminate, adhesive strip) and their material properties and dimensions. There is no mention of software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device serves as packaging for medical devices during steam sterilization to maintain their sterility. This is a function related to the processing and storage of medical devices, not the diagnosis of disease or other conditions.
Device Description: The description details the materials and construction of the packaging pouch. This aligns with a packaging product, not a diagnostic test or instrument.
Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis, monitoring, or treatment decisions.

The device is a Class II medical device (based on the predicate device K210810, which is classified as a Class II Sterilization Wrap). Its function is to ensure the sterility of other medical devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 self sealed once a device is inserted. Self-sealable pouches are featured with adhesive strip allowing tight, impermeable closing flap is pre-folded to facilitate the closure. When closing the self-seal pouch the paper flap shall be folded line. Flap should be pressed firmly against the laminate from the center working outwards to ensure a good, even seal.

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 875mm)

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 self sealed once a device is inserted. Self-sealable pouches are featured with adhesive strip allowing tight, impermeable closing of a pack. The closing flap is pre-folded to facilitate the closure. When closing the self-seal pouch the paper flap shall be folded along the pre-folded line. Flap should be pressed firmly against the laminate from the centre working outwards to ensure a good, even seal. Dimensional configurations as follows (2 sizes 200mm x 800mm, 250mm x 875mm).

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K210810, Steriking Packaging for Medical Devices

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

May 5, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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 % Steven Singleton Consultant Compliance Systems International LLC 7 Windham Hill Mendon, New York 14506

Re: K221016

Trade/Device Name: Steriking Packaging for Medical Devices Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: March 31, 2022 Received: April 5, 2022

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

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)

K221016

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 self sealed once a device is inserted. Self-sealable pouches are featured with adhesive strip allowing tight, impermeable closing flap is pre-folded to facilitate the closure. When closing the self-seal pouch the paper flap shall be folded line. Flap should be pressed firmly against the laminate from the center working outwards to ensure a good, even seal.

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 875mm)

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)	X

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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
Contacts:
Hanna Marttila, Phone: 358 (0)40 124 0290
Date Prepared: 2/18/2022
Mr. Steven Singleton, Phone: 716 440 7364 |
| 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
Regulation number (21 CFR 880.6850)
Product code (FRG) |
| a3 | Identification of the legally
marketed device to which
the submitter claims
equivalence
(predicate device) | K210810, Steriking Packaging for Medical Devices |
| 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 self sealed once a device is inserted. Self-sealable pouches are
featured with adhesive strip allowing tight, impermeable closing of a
pack. The closing flap is pre-folded to facilitate the closure. When closing the self-
seal pouch the paper flap shall be folded along the pre-folded line. Flap should be
pressed firmly against the laminate from the centre working outwards to ensure a
good, even seal.
Dimensional configurations as follows (2 sizes 200mm x 800mm, 250mm
x 875mm). |
| 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 132oC for 4 minutes; Drying time of 20 minutes
Pre-vacuum steam at 135oC 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 |

4

| a6 | technological
characteristics compared
to predicate (as
follows) | open end of the pouch is to be self sealed once a device is inserted. Self-sealable
pouches are featured with adhesive strip allowing tight, impermeable closing of a
pack. The closing flap is pre-folded to facilitate the closure. When closing the
self-seal pouch the paper flap shall be folded along the pre-folded line. Flap
should be pressed firmly against the laminate from the center working outwards
to ensure a good, even seal.
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, 250mm x 875mm)
See below as follows | | | |
|--------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| b1. | Comparison
Element | | Submission Device – Steriking
Packaging for Medical Devices | Comparison | Predicate Device –
Steriking Packaging for
Medical Devices
K210810 |
| Intended Use | | | To serve as an enclosure for medical
devices during steam sterilization that
maintains the sterility of the enclosed
devices until used. | No Change | To serve as an enclosure for
medical devices during steam or
gas sterilization that maintains
sterility of the enclosed device
until used. |

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Design	Pouches plastic film triple heat sealed to paper backing thumb notches chevron-type seal at end for opening Adhesive strip for self seal	Different	Pouches plastic film triple heat sealed to paper backing thumb notches chevron-type seal at end for opening
Principle of
Operation	Medical device to be sterilized is put
into pouch and the open parts of the
pouches are closed by self-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.	Different	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.
Dimensions	200mm x 800mm, 250mm x 875 mm	Different	200mm x 800mm, 250mm x 900 mm
Backing Paper	Bleached wood pulp, grammage:
100g/m2	No Change	Bleached wood pulp, grammage: 100 g/m2
Tensile Strength MD-
kNm	>66 N/15mm	No Change	>66 N/15mm
Tensile Strength CD-
kNm	>33 N/15mm	No Change	>33 N/15mm
Tear Strength MD-mN	>550 Nm	No Change	>550 Nm
Tear Strength CD-mN	>550 Nm	No Change	>550 Nm
Burst Strength-kPa	>230 kpa	No Change	>230 kpa
Porosity
ISO 5636-3
ISO 5636-5	3.9 – 5.7 µm/Pa·s
24-34 s	No Change	3.9 – 5.7 µm/Pa·s
24-34 s
Seal Strength – N/mm	Peel ≥ 1.5 N/15mm	No Change	Peel ≥ 1.5 N/15mm
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.	No Change	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 132° C or 3 minutes at
135° C	No Change	Steam sterilization conditions are 4
minutes at 132° C or 3 minutes at
135° C
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)	No Change	Full-cycle steam sterilization process
will produce sufficient lethality to
achieve a 12- log reduction, thus
providing a 10-6 Sterility Assurance
Level (SAL).
Material
Compatibility	Compatible with Steam Sterilization	No Change	Compatible with Steam Sterilization
Package Integrity
Test	Closure integrity maintained before
and after steam sterilization	No Change	Closure integrity maintained before
and after steam sterilization
Maintenance of
Sterility — Shelf life
post sterilization	12 months	No Change	12 months
Shelf Life - Pre-
sterilization	5 years	No Change	5 years
Drying Time	20 minutes	No Change	20 minutes
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"	No Change	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"
Biocompatibility	Non-Cytotoxic	No Change	Non-Cytotoxic

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