Steriking® Pouch for Robotic Instruments
Device Facts
| Record ID | K232625 |
|---|---|
| Device Name | Steriking® Pouch for Robotic Instruments |
| Applicant | Wipak OY |
| Product Code | FRG · General Hospital |
| Decision Date | Jun 7, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
Indications for Use
Steriking® Pouch for Robotic Instruments serve as an enclosure for Intuitive Endowrist Robotic Instruments during steam sterilization that maintains the sterility of the enclosed medical devices until they are used. Pouches are intended for use as packaging material of Intuitive Endowrist Robotic Instruments for steam sterilization in health care establishments. The products are for single use only. The pouches allow sterilization, maintain sterility and enable aseptic presentation of packed medical device.
Device Story
Steriking® Pouch for Robotic Instruments are single-use packaging containers for Intuitive Endowrist Robotic Instruments. The device consists of a bleached wood pulp paper backing and a transparent plastic film laminate (oriented polyester and coextruded polypropylene) triple heat-sealed to the paper. The pouch is used in healthcare facilities to enclose instruments prior to steam sterilization. The user inserts the instrument, then seals the pouch via heat-sealing (165°C-200°C) or an integrated adhesive strip (self-seal). During steam sterilization, the paper allows sterilant penetration while maintaining a microbial barrier. The pouch maintains sterility of the enclosed device for up to 1 year post-sterilization. The output is a sterile, aseptically presented instrument ready for clinical use. The device ensures patient safety by preventing recontamination of sterilized robotic instruments.
Clinical Evidence
Bench testing only. Performance validated against AAMI TIR 12:2020, ISO 17665-1, EN 868-5, ASTM D 882, ISO 1924-3, ISO 1974, DIN 53363, ISO 2758, ISO 5636-3, ISO 14477, ASTM F1929, ASTM F1980, ASTM F88/F88M, and ISO 10993-5. Results demonstrated successful 6-log reduction (SAL 10^-6), package integrity post-dye penetration, and non-cytotoxicity (Grade 2 or less).
Technological Characteristics
Materials: Bleached wood pulp paper (100 g/m²), oriented polyester (12 microns), coextruded polypropylene (40 microns). Construction: Triple heat-sealed laminate to paper. Dimensions: 200mm x 800mm, 250mm x 900mm (heat-seal); 200mm x 800mm, 250mm x 875mm (self-seal). Sterilization: Steam (132°C/4 min or 135°C/3 min). Standards: ISO 11607-1, EN 868-5, ASTM F1929, ISO 10993-5.
Indications for Use
Indicated for use as a single-use sterile barrier system for Intuitive Endowrist Robotic Instruments during steam sterilization in healthcare facilities. Maximum load capacity is 2.6 lbs (combined metal/plastic).
Regulatory Classification
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.
Predicate Devices
- Steriking® Packaging for Medical Devices (K221016)
Reference Devices
- Steriking® Packaging for Medical Devices (K210810)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 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.
June 7, 2024
Wipak OY % Amanda Singleton Consultant Compliance Systems International LLC 1083 Delaware Road Buffalo, New York 14209
Re: K232625
Trade/Device Name: Steriking® Pouch for Robotic Instruments Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: April 30, 2024 Received: May 1, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
{1}------------------------------------------------
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, | |
|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Stephen A. Anisko -S | Digitally signed by Stephen A. Anisko -S<br>Date: 2024.06.07 16:22:04 -04'00' |
| for: Christopher K. Dugard, MS | |
| Assistant Director | |
| DHT4B: Division of Infection Control<br>and Plastic and Reconstructive Surgery Devices | |
| OHT4: Office of Surgical and Infection Control Devices | |
{2}------------------------------------------------
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
## Indications for Use
510(k) Number (if known) K232625
Device Name Steriking® Pouch for Robotic Instruments
#### Indications for Use (Describe)
Steriking® Pouch for Robotic Instruments serve as an enclosure for Intuitive Endowrist Robotic Instruments during steam sterilization that maintains the sterility of the enclosed medical devices until they are used.
Pouches are intended for use as packaging material of Intuitive Endowrist Robotic Instruments for steam sterilization in health care establishments. The products are for single use only. The pouches allow sterilization, mamtain sterility and enable aseptic presentation of packed medical device.
The recommended sterilization cycles are as follows: Pre-vacuum steam at 132ºC for 4 minutes; Drying time of 20 minutes Pre-vacuum steam at 135℃ for 3 minutes: Drying time of 16 minutes
The maximum load for the Steriking® Pouch for Robotic Intuitive Endowrist Robotic Instrument or other medical devices with a combined weight of metal and plastics of 2.6 pounds or less.
Steriking® Pouch for Robotic Instruments 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.
Steriking® Pouch for Robotic Instruments consists of pouch sizes that can be heat sealed, and pouch sizes that are selfsealed.
For heat-sealed sizes: 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).
Steriking® Pouch for Robotic Instruments have Dimensional heat-seal configurations (2 sizes 200mm x 800mm, 250mm x 900mm).
Steriking® Pouch for Robotic Instruments with heat-seal maintains the sterility of the enclosed devices for up to 1 year post Steam sterilization and before sterilization has a maximum shelf life of 5 years from the date of manufacture.
For self-sealed sizes: 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® Pouch for Robotic Instruments have Dimensions (2 sizes 200mm x 800mm x 800mm x 875mm).
Steriking® Pouch for Robotic Instruments with self-seal maintains the sterility of the enclosed devices for up to 1 year post Steam sterilization and before sterilization has a maximum shelf life of 3 years from the date of manufacture.
{4}------------------------------------------------
Prescription Use (Part 21 CFR 801 Subpart D)
- 区 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."
{5}------------------------------------------------
# K232625 510K Summary
| 510K Summary<br>Elements per<br>21CFR807.92 | Summary |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's name,<br>address,<br>telephone<br>number, a contact<br>person, and the<br>date the summary<br>was prepared | Wipak Oy<br>Nastola Finland<br>Contact: Amanda Singleton<br>Phone: 716.440.7364<br><br>Date Prepared: 06/06/2024 |
| Name of the device,<br>including the trade or<br>proprietary name if<br>applicable, the<br>common or usual<br>name, and the<br>classification<br>name | Proprietary Name: Steriking® Pouch for Robotic Instruments<br>Common Name: Peel Pouch<br>Classification Name: Sterilization wrap<br>Regulation number (21 CFR 880.6850)<br>Product code (FRG) |
| Identification of<br>the legally<br>marketed device<br>to which the<br>submitter claims<br>equivalence<br>(Primary predicate<br>device, reference<br>predicate device) | Primary Predicate Device: K221016, Steriking® Packaging for Medical Devices<br><br>Reference Device: K210810, Steriking® Packaging for Medical Devices |
| Description of the<br>device | Steriking® Pouch for Robotic Instruments serve as an enclosure for Intuitive Endowrist Robotic<br>Instruments during steam sterilization that maintains the sterility of the enclosed medical devices<br>until used.<br><br>Pouches are intended for use as packaging material of Intuitive Endowrist Robotic Instruments for<br>steam sterilization in health care establishments. The products are for single use only. The<br>sterilization pouches allow sterilization, maintain sterility and enable aseptic presentation of<br>packed medical device.<br><br>The Steriking® Pouch for Robotic Instruments consists of a paper backing (Bleached wood pulp,<br>grammage 100g/m²) with transparent plastic film laminate front (2 sheets of laminated plastic with<br>a total grammage of 55 g/m², 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded<br>polypropylene 40 microns thick. The plastic laminate is triple heat sealed to the backing paper.<br><br>Steriking® Pouch for Robotic Instruments consists of pouch sizes that can be heat sealed, and<br>pouch sizes that are self-sealed. |
| Indications for use | Steriking® Pouch for Robotic Instruments serve as an enclosure for Intuitive Endowrist Robotic<br>Instruments during steam sterilization that maintains the sterility of the enclosed medical<br>devices until they are used. |
| | Pouches are intended for use as packaging material of Intuitive Endowrist Robotic Instruments<br>for steam sterilization in health care establishments. The products are for single use only. The<br>pouches allow sterilization, maintain sterility and enable aseptic presentation of packed<br>medical device. |
| | The recommended sterilization cycles are as follows:<br>Pre-vacuum steam at 132°C for 4 minutes; Drying time of 20 minutes<br>Pre-vacuum steam at 135°C for 3 minutes; Drying time of 16 minutes |
| | The maximum load for the Steriking® Pouch for Robotic Instruments is a single Intuitive<br>Endowrist Robotic Instrument or other medical devices with a combined weight of metal and<br>plastics of 2.6 pounds or less. |
| | Steriking® Pouch for Robotic Instruments consists of a paper backing (Bleached wood pulp,<br>grammage 100 g/m2) with transparent plastic film laminate front (2 sheets of laminated<br>plastic) with a total grammage of 55 g/m2, 1 sheet of oriented polyester 12 microns thick, 1<br>sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealed<br>to the backing paper. |
| | Steriking® Pouch for Robotic Instruments consists of pouch sizes that can be heat sealed, and<br>pouch sizes that are self-sealed. |
| | For heat-sealed sizes: The open end of the pouch is to be heat sealed once a device is inserted.<br>Heat sealing parameters to provide a sterile barrier are 165°C-200°C (329°F - 392°F). |
| | Steriking® Pouch for Robotic Instruments have Dimensional heat-seal configurations (2 sizes<br>200mm x 800mm, 250mm x 900mm). |
| | Steriking® Pouch for Robotic Instruments with heat-seal maintains the sterility of the enclosed<br>devices for up to 1 year post Steam sterilization and before sterilization has a maximum shelf<br>life of 5 years from the date of manufacture. |
| | For self-sealed sizes: The open end of the pouch is to be self sealed once a device is inserted.<br>Self-sealable pouches are featured with adhesive strip allowing tight, impermeable closing of a<br>pack. The closing flap is pre-folded to facilitate the closure. When closing the self-seal pouch<br>the paper flap shall be folded along the pre-folded line. Flap should be pressed firmly against<br>the laminate from the center working outwards to ensure a good, even seal. |
| | Steriking® Pouch for Robotic Instruments have Dimensional self-seal configurations (2 sizes<br>200mm x 800mm, 250mm x 875mm). |
| | Steriking® Pouch for Robotic Instruments with self-seal maintains the sterility of the enclosed<br>devices for up to 1 year post Steam sterilization and before sterilization has a maximum shelf<br>life of 3 years from the date of manufacture. |
{6}------------------------------------------------
{7}------------------------------------------------
| Technological Characteristics Comparison Table | | | |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison Element | Submission Device K232625<br>Steriking® Pouch for Intuitive Endowrist<br>Robotic Instruments | Comparison | Primary Predicate Device<br>K221016<br>Steriking® Packaging for<br>Medical Devices |
| 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 |
| Intended Use | To serve as an enclosure for Intuitive<br>Endowrist Robotic Instruments or<br>medical devices during steam sterilization<br>that maintains the sterility of the<br>enclosed device until used. | Similar<br>The<br>difference is<br>the added<br>claim to<br>sterilize<br>'Intuitive<br>Endowrist<br>Robotic<br>Instruments' | To serve as an enclosure for medical<br>devices during steam sterilization that<br>maintains the sterility of the enclosed<br>device until used. |
| Design | • Pouches<br>• plastic film triple heat sealed to paper<br>backing<br>• thumb notches<br>• chevron-type seal at end foropening<br>• adhesive strip (self seal pouches only) | Same | • Pouches<br>• plastic film triple heat sealed to paper<br>backing<br>• thumb notches<br>• chevron-type seal at end for opening<br>• adhesive strip |
| Principle of Operation | Intuitive Endowrist Robotic<br>Instrument to be sterilized is put<br>into pouch and the open parts of<br>the pouches are closed by heat<br>sealing or self-sealing. Sterilization<br>packages then are subjected to<br>validated sterilization operation of<br>steam. Sterilant penetration is<br>carried out through the medical<br>grade paper into the package and<br>microorganisms on the surface of<br>the medical device are destroyed<br>with the effect of the sterilant<br>process.<br>Other parameters of the sterilization<br>process are temperature, pressure,<br>humidity, time and are determined<br>according to the sterilization type. | Similar<br>The<br>difference is<br>the added<br>claim to<br>sterilize<br>'Intuitive<br>Endowrist<br>Robotic<br>Instruments' | Medical device to be sterilized is put into<br>pouch and the open parts of the pouches<br>are closed by self-sealing. Sterilization<br>packages then are subjected to validated<br>sterilization operation of steam. Sterilant<br>penetration is carried out through the<br>medical grade paper into the package and<br>microorganisms on the surface of the<br>medical device are destroyed with the<br>effect of the sterilant process. Other<br>parameters of the sterilization process are<br>temperature, pressure, humidity, time and<br>are determined according to the<br>sterilization type.<br>After the sterilization is completed, the<br>sterility of the enclosed medical device is<br>maintained for 12 months. |
| Dimensions | 200mm x 800mm 250 mm x 875 mm | Same | 200mm x 800mm, 250mm x 875 mm |
| Backing Paper | Bleached wood pulp, grammage: 100g/m² | Same | Bleached wood pulp, grammage: 100 g/m² |
| Tensile Strength<br>MD-kNm0 | >66 N/15mm | Same | >66 N/15mm |
| Tensile Strength<br>CD- kNm | >33 N/15mm | Same | >33 N/15mm |
| Tear Strength MD-<br>mN | >550 Nm | Same | >550 Nm |
| Tear Strength CD-mN | >550 Nm | Same | >550 Nm |
| Burst Strength-kPa | >230 kpa | Same | >230 kpa |
| Porosity<br>ISO 5636-3 | 3.9 – 5.7 µm/Pa·s | Same | 3.9 – 5.7 µm/Pa·s |
| ISO 5636-5 | 24-34 s | Same | 24-34 s |
| Seal Strength -<br>N/mm | Peel ≥ 1.5 N/15mm | Same | Peel ≥ 1.5 N/15mm |
| Transparent Film | Two sheets of laminated plastic with a<br>total grammage of 55 g/m2. One sheet of<br>oriented polyester 12 microns thick. One<br>sheet of coextruded polypropylene 40<br>microns thick. | Same | Two sheets of laminated plastic with a total<br>grammage of 55 g/m2. One sheet of<br>oriented polyester 12 microns thick. One<br>sheet of coextruded polypropylene 40<br>microns thick. |
| Sterilization<br>Properties | Steam sterilization conditions are 4<br>minutes at 132° C or 3 minutes at 135° C | Same | Steam sterilization conditions are 4 minutes<br>at 132° C or 3 minutes at 135° C |
| Sterilant Penetration | Full-cycle steam sterilization process will<br>produce sufficient lethality to achieve a<br>12- log reduction, thus providing a 10-6<br>Sterility Assurance Level (SAL). | Same | Full-cycle steam sterilization process will<br>produce sufficient lethality to achieve a 12-<br>log reduction, thus providing a 10-6 Sterility<br>Assurance Level (SAL). |
| Material<br>Compatibility | Compatible with Steam Sterilization | Same | Compatible with Steam Sterilization |
| Package Integrity<br>Test | Closure integrity maintained before<br>and after steam sterilization | Same | Closure integrity maintained before<br>and after steam sterilization |
| Maintenance of<br>Sterility — Shelf life<br>post sterilization | 1 year…
