(283 days)
No
The device description and performance studies focus solely on the physical properties and sterilization efficacy of a medical device pouch, with no mention of AI or ML technologies.
No.
Explanation: The device is a sterilization pouch designed to maintain the sterility of other medical devices, not to provide therapy directly.
No
Explanation: The device is a sterilization pouch intended to enclose medical instruments for steam sterilization and maintain their sterility. It does not perform any diagnostic function.
No
The device description clearly details physical components (paper backing, plastic film laminate) and their material properties, indicating it is a physical medical device, not software-only.
Based on the provided information, the Steriking® Pouch for Robotic Instruments is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the pouch serves as an enclosure for medical devices (specifically robotic instruments) during steam sterilization and maintains their sterility. This is a function related to the processing and storage of medical devices, not the examination of specimens derived from the human body.
- Device Description: The description details the materials and construction of the pouch, which are designed for packaging and sterilization, not for performing diagnostic tests.
- Performance Studies: The performance studies focus on the pouch's ability to withstand sterilization, maintain sterility, and its physical properties (drying time, material compatibility, puncture resistance, package integrity, microbial barrier, shelf life, biocompatibility). These are all relevant to a sterilization packaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the pouch being used with biological specimens, reagents, or for the purpose of providing information about a physiological state, health, disease, or congenital abnormality.
In summary, the Steriking® Pouch for Robotic Instruments is a medical device used in the sterilization and storage of other medical devices. It does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
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 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 sterilization pouches allow sterilization, maintain sterility and enable aseptic presentation of packed medical device.
The Steriking® Pouch for Robotic Instruments consists of a paper backing (Bleached wood pulp, grammage 100g/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 self-sealed.
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 establishments
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: Non-clinical tests
Key Results:
- Sterilant Penetration: Demonstrates that a minimum of 1.0x10^6 Geobacilus stearothermophilus spores were killed in a half-cycle (6-log reduction) - Pass
- Drying Time: Test samples do not exceed a 3% weight gain - Pass
- Material Compatibility: no objections, no pinholes - Pass
- Puncture Resistance: Internal protocol, Accepted by Sponsor - Pass
- Package Integrity: No leaks detected after dye migration - Pass
- Microbial Barrier Properties: Evaluated as "sufficiently germ-proof" - Pass
- Shelf Life Prior to Sterilization: No leaks detected after dye migration, >= 1.5 N/15 mm, >=3.4 μm/Pa •s - Pass. Accelerated Aging executed as per standard.
- Shelf Life Post sterilization: No leaks detected after dye migration, >= 1.5 N/15 mm - Pass
- Bocompatibility: Not greater than Grade 2 reactivity (mildly reactive) - Pass
- Evidence that printing ink on paper material does not leach into the interior of the pouch: 5 Evaluation grades - Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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 |
| Date: 2024.06.07 16:22:04 -04'00' | |
| for: Christopher K. Dugard, MS | |
| Assistant Director | |
| DHT4B: Division of Infection Control | |
| 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.
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5
K232625 510K Summary
| 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 |
| Nastola Finland | |
| Contact: Amanda Singleton | |
| Phone: 716.440.7364 |
Date Prepared: 06/06/2024 |
| Name of the device,
including the trade or
proprietary name if
applicable, the
common or usual
name, and the
classification
name | Proprietary Name: Steriking® Pouch for Robotic Instruments
Common Name: Peel Pouch
Classification Name: Sterilization wrap
Regulation number (21 CFR 880.6850)
Product code (FRG) |
| Identification of
the legally
marketed device
to which the
submitter claims
equivalence
(Primary predicate
device, reference
predicate device) | Primary Predicate Device: K221016, Steriking® Packaging for Medical Devices
Reference Device: K210810, Steriking® Packaging for Medical Devices |
| Description of the
device | 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 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
sterilization pouches allow sterilization, maintain sterility and enable aseptic presentation of
packed medical device.
The Steriking® Pouch for Robotic Instruments consists of a paper backing (Bleached wood pulp,
grammage 100g/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 self-sealed. |
| 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. |
| | 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 maximum load for the Steriking® Pouch for Robotic Instruments is a single 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 self-sealed. |
| | 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 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® Pouch for Robotic Instruments have Dimensional self-seal configurations (2 sizes
200mm x 800mm, 250mm 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. |
6
7
| Technological Characteristics Comparison Table | |||
|---|---|---|---|
| Comparison Element | Submission Device K232625 | ||
| Steriking® Pouch for Intuitive Endowrist | |||
| Robotic Instruments | Comparison | Primary Predicate Device | |
| K221016 | |||
| Steriking® Packaging for | |||
| 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 | ||
| Endowrist Robotic Instruments or | |||
| medical devices during steam sterilization | |||
| that maintains the sterility of the | |||
| enclosed device until used. | Similar | ||
| The | |||
| difference is | |||
| the added | |||
| claim to | |||
| sterilize | |||
| 'Intuitive | |||
| Endowrist | |||
| Robotic | |||
| Instruments' | To serve as an enclosure for medical | ||
| devices during steam sterilization that | |||
| maintains the sterility of the enclosed | |||
| device until used. | |||
| Design | • Pouches | ||
| • plastic film triple heat sealed to paper | |||
| backing | |||
| • thumb notches | |||
| • chevron-type seal at end foropening | |||
| • adhesive strip (self seal pouches only) | Same | • Pouches | |
| • plastic film triple heat sealed to paper | |||
| backing | |||
| • thumb notches | |||
| • chevron-type seal at end for opening | |||
| • adhesive strip | |||
| Principle of Operation | Intuitive Endowrist Robotic | ||
| Instrument to be sterilized is put | |||
| into pouch and the open parts of | |||
| the pouches are closed by heat | |||
| sealing or 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. | Similar | ||
| The | |||
| difference is | |||
| the added | |||
| claim to | |||
| sterilize | |||
| 'Intuitive | |||
| Endowrist | |||
| Robotic | |||
| Instruments' | 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. | |||
| 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 | |||
| MD-kNm0 | >66 N/15mm | Same | >66 N/15mm |
| Tensile Strength | |||
| CD- kNm | >33 N/15mm | Same | >33 N/15mm |
| Tear Strength MD- | |||
| mN | >550 Nm | Same | >550 Nm |
| Tear Strength CD-mN | >550 Nm | Same | >550 Nm |
| Burst Strength-kPa | >230 kpa | Same | >230 kpa |
| Porosity | |||
| 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 - | |||
| N/mm | Peel ≥ 1.5 N/15mm | Same | 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. | 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 132° C or 3 minutes at 135° C | Same | 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). | Same | 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 | 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 | 1 year | Same | 1 year |
| Shelf Life - Pre- | |||
| sterilization | 3 years | Same | 3 years |
| Drying Time | 20 minutes for 132° C/4 minutes condition | ||
| 16 minutes for 135° C/3 minutes condition | Same | 20 minutes for 132° C/4 minutes condition | |
| 16 minutes for 135° C/3 minutes condition | |||
| 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" | Same | The paper of the sterile barrier system was | |
| examined on the packaging outer side for it | |||
| germ proofness with air permeance after | |||
| steam sterilization and is evaluated as | |||
| "sufficiently germ-proof" | |||
| Biocompatibility | Non-Cytotoxic | Same | Non-Cytotoxic |
| Technological Characteristics Comparison Table | |||
| Comparison Element | Submission Device K232625 | ||
| Steriking® Pouch for Intuitive Endowrist | |||
| Robotic Instruments | Comparison | Predicate Device K210810 | |
| Steriking® Packaging for | |||
| 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 | ||
| Endowrist Robotic Instruments or | |||
| medical devices during steam sterilization | |||
| that maintains the sterility of the | |||
| enclosed device until used. | Similar | ||
| The | |||
| difference is | |||
| the added | |||
| claim to | |||
| sterilize | |||
| 'Intuitive | |||
| Endowrist | |||
| Robotic | |||
| Instruments' | To serve as an enclosure for medical | ||
| devices during steam sterilization that | |||
| maintains the sterility of the enclosed | |||
| device until used. | |||
| Design | • Pouches | ||
| • plastic film triple heat sealed to paper | |||
| backing | |||
| • thumb notches | |||
| • chevron-type seal at end for opening | Same | • Pouches | |
| • plastic film triple heat sealed to paper | |||
| backing | |||
| • thumb notches | |||
| • chevron-type seal at end for opening | |||
| Principle of | |||
| Operation | Intuitive Endowrist Robotic | ||
| Instrument to be sterilized is put | |||
| into pouch and the open parts of | |||
| the pouches are closed by heat | |||
| sealing or 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. | Similar | 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 12
months
The difference is
the added
claim to
sterilize
'Intuitive
Endowrist
Robotic
Instruments' |
| Dimensions | 200mm x 800mm, 250mm x 900 mm | Same | 200mm x 800mm, 250mm x 900 mm |
| Backing Paper | Bleached wood pulp, grammage:
100g/m² | Same | Bleached wood pulp, grammage: 100 g/m² |
| Tensile Strength
MD-kNm0 | >66 N/15mm | Same | >66 N/15mm |
| Tensile Strength
CD- kNm | >33 N/15mm | Same | >33 N/15mm |
| Tear Strength MD-
mN | >550 Nm | Same | >550 Nm |
| Tear Strength CD-mN | >550 Nm | Same | >550 Nm |
| Burst Strength-kPa | >230 kpa | Same | >230 kpa |
| Porosity
ISO 5636-3
ISO 5636-5 | 3.9 – 5.7 µm/Pa·s
24-34 s | Same | 3.9 – 5.7 µm/Pa·s
24-34 s |
| Seal Strength –
N/mm | Peel ≥ 1.5 N/15mm | Same | 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. | 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 132° C or 3 minutes at 135° C | Same | 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). | Same | 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 | 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 | 1 year | Same | 1 year |
| Shelf Life - Pre-
sterilization | 5 years | Same | 5 years |
| Drying Time | 20 minutes for 132° C/4 minutes condition
16 minutes for 135° C/3 minutes condition | Same | 20 minutes for 132° C/4 minutes condition
16 minutes for 135° C/3 minutes condition |
| 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" | Same | 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 | Same | Non-Cytotoxic |
8
9
10
11
12
Summary of Performance Tests:
| Element | Standard reference | Acceptance Criteria | Results |
|---|---|---|---|
| Sterilant | |||
| Penetration | AAMI TIR 12:2020, | ||
| Designing, testing, and | |||
| labeling medical devices | |||
| intended for processing by | |||
| health care facilities | Demonstrates that a minimum of 1.0x10^6 | ||
| Geobacilus stearothermophilus spores were | |||
| killed in a half-cycle (6-log reduction) | Pass | ||
| Drying Time | ISO 17665-1: 2006/2016 - | ||
| Sterilization of health care | |||
| products - Moist Heat- Part | |||
| 1: Requirements for the | |||
| development, validation, | |||
| and routine control of a | |||
| sterilization process for | |||
| medical devices | Test samples do not exceed a 3% weight gain | Pass | |
| Material | |||
| Compatibility | EN 868-5: 2009 4.2.2.1, | ||
| Annex B | no objections | Pass | |
| EN 868-5: 2009 4.2.2.1, | |||
| Annex C | no pinholes | ||
| ASTM D 882:2012, | |||
| procedure A | >= 20 N/15 mm | ||
| ISO 1924-3 | > 66 N/15 mm | ||
| > 33 N/15 mm | |||
| Internal Method | 152 μm +/- 10% | ||
| ISO 1974 | > 550 N | ||
| DIN 53363 | > 10 N | ||
| ISO 2758 | > 230 kPa | ||
| ISO 5636-3 | >=3.9 - 5.7 μm/Pa•s | ||
| Puncture | |||
| Resistance | ISO 14477 - Packaging. | ||
| Flexible packaging material. | |||
| Determination of puncture | |||
| resistance. | Internal protocol, Accepted by Sponsor | Pass | |
| Package | |||
| Integrity | ASTM F1929 - Standard | ||
| Test Method for Detecting | |||
| Seal Leaks in Porous | |||
| Medical Packaging by Dye | |||
| Penetration | No leaks detected after dye migration | Pass | |
| Microbial | |||
| Barrier | |||
| Properties | DIN EN ISO -11607-1:2017- | ||
| 10 Section 5.1.6. a) | |||
| microbial barrier | |||
| DIN 953-6, section 4.8.6. | Evaluated as "sufficiently germ-proof" | Pass | |
| Shelf Life Prior | |||
| to Sterilization | ASTM F1929-15 "Standard | ||
| Test Method for Detecting | |||
| Seal Leaks in Porous | |||
| Medical Packaging by Dye | |||
| Penetration | No leaks detected after dye migration | ||
| 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 | >= 1.5 N/15 mm | Pass | |
| ISO 5636-3 Paper and board | |||
| — Determination of air | |||
| permeance | >=3.4 $\mu$ m/Pa •s | ||
| ASTM F1980 - 16 Standard | |||
| Guide for Accelerated Aging | |||
| of Sterile Barrier Systems | |||
| for Medical Devices | Executed as per standard, No Acceptance Criteria | ||
| Shelf Life Post | |||
| sterilization | ASTM F1929-15 "Standard | ||
| Test Method for Detecting | |||
| Seal Leaks in Porous | |||
| Medical Packaging by Dye | |||
| Penetration | No leaks detected after dye migration | Pass | |
| ASTM F88/F88M-15: | |||
| Standard Test Method for | |||
| Seal Strength of Flexible | |||
| Barrier Materials | >= 1.5 N/15 mm | ||
| Biocompatibility | ISO 10993-5, Biological | ||
| evaluation of medical | |||
| devices — Part 5: Tests for | |||
| in vitro cytotoxicity | Not greater than Grade 2 reactivity (mildly | ||
| reactive) | Pass | ||
| Evidence that | |||
| printing ink on | |||
| paper material | |||
| does not leach | |||
| into the interior | |||
| of the pouch | DIN EN 646 | 5 Evaluation grades | Pass |
13
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 legally marketed predicate device K221016.