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.

Device Description

Steriking® Pouch for Robotic Instruments consist 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.

AI/ML Overview

The provided text describes the acceptance criteria and the results of performance tests for the "Steriking® Pouch for Robotic Instruments". However, it does not include information about any AI-powered function, a "study that proves the device meets the acceptance criteria" in the context of an algorithm's performance, or details regarding ground truth establishment, expert involvement, or sample sizes related to AI/algorithm development.

The document is a 510(k) Premarket Notification from the FDA for a medical device (sterilization pouch), which is a physical product, not a software or AI device. Therefore, the questions about AI, algorithms, ground truth, expert consensus, and training/test set sizes are not applicable to this document.

Here's a summary of the available information regarding acceptance criteria and performance, as it relates to a physical medical device.

1. Table of acceptance criteria and the reported device performance:

Element	Standard Reference	Acceptance Criteria	Results
Sterilant Penetration	AAMI TIR 12:2020	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	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	No result listed, but "Pass" can be inferred from conclusion.
	ASTM D 882:2012, procedure A	>= 20 N/15 mm	No result listed, but "Pass" can be inferred from conclusion.
	ISO 1924-3	> 66 N/15 mm	No result listed, but "Pass" can be inferred from conclusion.
		> 33 N/15 mm	No result listed, but "Pass" can be inferred from conclusion.
	Internal Method	152 μm +/- 10%	No result listed, but "Pass" can be inferred from conclusion.
	ISO 1974	> 550 N	No result listed, but "Pass" can be inferred from conclusion.
	DIN 53363	> 10 N	No result listed, but "Pass" can be inferred from conclusion.
	ISO 2758	> 230 kPa	No result listed, but "Pass" can be inferred from conclusion.
	ISO 5636-3	>=3.9 - 5.7 μm/Pa•s	No result listed, but "Pass" can be inferred from conclusion.
Puncture Resistance	ISO 14477	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	No leaks detected after dye migration	No result listed, but "Pass" can be inferred from conclusion.
	EN 868-5 Packaging for terminally sterilized medical devices — Part 5	>= 1.5 N/15 mm	Pass
	ISO 5636-3 Paper and board — Determination of air permeance	>=3.4 μm/Pa •s	No result listed, but "Pass" can be inferred from conclusion.
	ASTM F1980 - 16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices	Executed as per standard, No Acceptance Criteria	No result listed, likely because it's a guide, not a pass/fail test.
Shelf Life Post sterilization	ASTM F1929-15	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	No result listed, but "Pass" can be inferred from conclusion.
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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample sizes used for each test. The data provenance is not explicitly stated, but the submission is from Wipak Oy, Nastola, Finland, suggesting the testing was conducted or overseen by this company. The tests are for device performance, not a dataset in the context of an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is a physical medical device; the performance tests are based on established international and national standards for sterilization packaging, not on expert interpretation or ground truth derived from clinical data in the way an AI algorithm would be.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is for a physical medical device, not an algorithm where adjudication of results would be relevant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device's performance is objective measurement against established industry standards and regulations for sterilization, package integrity, microbial barriers, and biocompatibility.

8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device, not an AI algorithm.

Summary

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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"

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(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 -SDate: 2024.06.07 16:22:04 -04'00'
for: Christopher K. Dugard, MS
Assistant Director
DHT4B: Division of Infection Controland Plastic and Reconstructive Surgery Devices
OHT4: Office of Surgical and Infection Control Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232625

Device Name Steriking® Pouch for Robotic Instruments

Indications for Use (Describe)

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 have Dimensions (2 sizes 200mm x 800mm x 800mm x 875mm).

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Prescription Use (Part 21 CFR 801 Subpart D)

区 Over-The-Counter Use (21 CFR 801 Subpart C)

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K232625 510K Summary

510K SummaryElements per21CFR807.92	Summary
Submitter's name,address,telephonenumber, a contactperson, and thedate the summarywas prepared	Wipak OyNastola FinlandContact: Amanda SingletonPhone: 716.440.7364Date Prepared: 06/06/2024
Name of the device,including the trade orproprietary name ifapplicable, thecommon or usualname, and theclassificationname	Proprietary Name: Steriking® Pouch for Robotic InstrumentsCommon Name: Peel PouchClassification Name: Sterilization wrapRegulation number (21 CFR 880.6850)Product code (FRG)
Identification ofthe legallymarketed deviceto which thesubmitter claimsequivalence(Primary predicatedevice, referencepredicate device)	Primary Predicate Device: K221016, Steriking® Packaging for Medical DevicesReference Device: K210810, Steriking® Packaging for Medical Devices
Description of thedevice	Steriking® Pouch for Robotic Instruments serve as an enclosure for Intuitive Endowrist RoboticInstruments during steam sterilization that maintains the sterility of the enclosed medical devicesuntil used.Pouches are intended for use as packaging material of Intuitive Endowrist Robotic Instruments forsteam sterilization in health care establishments. The products are for single use only. Thesterilization pouches allow sterilization, maintain sterility and enable aseptic presentation ofpacked 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 witha total grammage of 55 g/m², 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextrudedpolypropylene 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, andpouch sizes that are self-sealed.
Indications for use	Steriking® Pouch for Robotic Instruments serve as an enclosure for Intuitive Endowrist RoboticInstruments during steam sterilization that maintains the sterility of the enclosed medicaldevices until they are used.
	Pouches are intended for use as packaging material of Intuitive Endowrist Robotic Instrumentsfor steam sterilization in health care establishments. The products are for single use only. Thepouches allow sterilization, maintain sterility and enable aseptic presentation of packedmedical device.
	The recommended sterilization cycles are as follows:Pre-vacuum steam at 132°C for 4 minutes; Drying time of 20 minutesPre-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 IntuitiveEndowrist Robotic Instrument or other medical devices with a combined weight of metal andplastics 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 laminatedplastic) with a total grammage of 55 g/m2, 1 sheet of oriented polyester 12 microns thick, 1sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealedto the backing paper.
	Steriking® Pouch for Robotic Instruments consists of pouch sizes that can be heat sealed, andpouch 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 sizes200mm x 800mm, 250mm x 900mm).
	Steriking® Pouch for Robotic Instruments with heat-seal maintains the sterility of the encloseddevices for up to 1 year post Steam sterilization and before sterilization has a maximum shelflife 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 apack. The closing flap is pre-folded to facilitate the closure. When closing the self-seal pouchthe paper flap shall be folded along the pre-folded line. Flap should be pressed firmly againstthe laminate from the center working outwards to ensure a good, even seal.
	Steriking® Pouch for Robotic Instruments have Dimensional self-seal configurations (2 sizes200mm x 800mm, 250mm x 875mm).
	Steriking® Pouch for Robotic Instruments with self-seal maintains the sterility of the encloseddevices for up to 1 year post Steam sterilization and before sterilization has a maximum shelflife of 3 years from the date of manufacture.

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Technological Characteristics Comparison Table
Comparison Element	Submission Device K232625Steriking® Pouch for Intuitive EndowristRobotic Instruments	Comparison	Primary Predicate DeviceK221016Steriking® Packaging forMedical 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 IntuitiveEndowrist Robotic Instruments ormedical devices during steam sterilizationthat maintains the sterility of theenclosed device until used.	SimilarThedifference isthe addedclaim tosterilize'IntuitiveEndowristRoboticInstruments'	To serve as an enclosure for medicaldevices during steam sterilization thatmaintains the sterility of the encloseddevice until used.
Design	• Pouches• plastic film triple heat sealed to paperbacking• thumb notches• chevron-type seal at end foropening• adhesive strip (self seal pouches only)	Same	• Pouches• plastic film triple heat sealed to paperbacking• thumb notches• chevron-type seal at end for opening• adhesive strip
Principle of Operation	Intuitive Endowrist RoboticInstrument to be sterilized is putinto pouch and the open parts ofthe pouches are closed by heatsealing or self-sealing. Sterilizationpackages then are subjected tovalidated sterilization operation ofsteam. Sterilant penetration iscarried out through the medicalgrade paper into the package andmicroorganisms on the surface ofthe medical device are destroyedwith the effect of the sterilantprocess.Other parameters of the sterilizationprocess are temperature, pressure,humidity, time and are determinedaccording to the sterilization type.	SimilarThedifference isthe addedclaim tosterilize'IntuitiveEndowristRoboticInstruments'	Medical device to be sterilized is put intopouch and the open parts of the pouchesare closed by self-sealing. Sterilizationpackages then are subjected to validatedsterilization operation of steam. Sterilantpenetration is carried out through themedical grade paper into the package andmicroorganisms on the surface of themedical device are destroyed with theeffect of the sterilant process. Otherparameters of the sterilization process aretemperature, pressure, humidity, time andare determined according to thesterilization type.After the sterilization is completed, thesterility of the enclosed medical device ismaintained 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 StrengthMD-kNm0	>66 N/15mm	Same	>66 N/15mm
Tensile StrengthCD- 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
PorosityISO 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 atotal grammage of 55 g/m2. One sheet oforiented polyester 12 microns thick. Onesheet of coextruded polypropylene 40microns thick.	Same	Two sheets of laminated plastic with a totalgrammage of 55 g/m2. One sheet oforiented polyester 12 microns thick. Onesheet of coextruded polypropylene 40microns thick.
SterilizationProperties	Steam sterilization conditions are 4minutes at 132° C or 3 minutes at 135° C	Same	Steam sterilization conditions are 4 minutesat 132° C or 3 minutes at 135° C
Sterilant Penetration	Full-cycle steam sterilization process willproduce sufficient lethality to achieve a12- log reduction, thus providing a 10-6Sterility Assurance Level (SAL).	Same	Full-cycle steam sterilization process willproduce sufficient lethality to achieve a 12-log reduction, thus providing a 10-6 SterilityAssurance Level (SAL).
MaterialCompatibility	Compatible with Steam Sterilization	Same	Compatible with Steam Sterilization
Package IntegrityTest	Closure integrity maintained beforeand after steam sterilization	Same	Closure integrity maintained beforeand after steam sterilization
Maintenance ofSterility — Shelf lifepost sterilization	1 year	Same	1 year
Shelf Life - Pre-sterilization	3 years	Same	3 years
Drying Time	20 minutes for 132° C/4 minutes condition16 minutes for 135° C/3 minutes condition	Same	20 minutes for 132° C/4 minutes condition16 minutes for 135° C/3 minutes condition
Microbial BarrierProperties	The paper of the sterile barrier systemwas examined on the packaging outer sidefor its germ proofness with air permeanceafter steam sterilization and is evaluatedas "sufficiently germ-proof"	Same	The paper of the sterile barrier system wasexamined on the packaging outer side for itgerm proofness with air permeance aftersteam sterilization and is evaluated as"sufficiently germ-proof"
Biocompatibility	Non-Cytotoxic	Same	Non-Cytotoxic
Technological Characteristics Comparison Table
Comparison Element	Submission Device K232625Steriking® Pouch for Intuitive EndowristRobotic Instruments	Comparison	Predicate Device K210810Steriking® Packaging forMedical 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 IntuitiveEndowrist Robotic Instruments ormedical devices during steam sterilizationthat maintains the sterility of theenclosed device until used.	SimilarThedifference isthe addedclaim tosterilize'IntuitiveEndowristRoboticInstruments'	To serve as an enclosure for medicaldevices during steam sterilization thatmaintains the sterility of the encloseddevice until used.
Design	• Pouches• plastic film triple heat sealed to paperbacking• thumb notches• chevron-type seal at end for opening	Same	• Pouches• plastic film triple heat sealed to paperbacking• thumb notches• chevron-type seal at end for opening
Principle ofOperation	Intuitive Endowrist RoboticInstrument to be sterilized is putinto pouch and the open parts ofthe pouches are closed by heatsealing or self-sealing. Sterilizationpackages then are subjected tovalidated sterilization operation ofsteam. Sterilant penetration iscarried out through the medicalgrade paper into the package andmicroorganisms on the surface ofthe medical device are destroyedwith the effect of the sterilantprocess.Other parameters of thesterilization process aretemperature, pressure, humidity,time and are determined accordingto the sterilization type.	Similar	Medical device to be sterilized is put intopouch and the open parts of the pouchesare closed by heat sealing. Sterilizationpackages then are subjected to validatedsterilization operation of steam. Sterilantpenetration is carried out through themedical grade paper into the package andmicroorganisms on the surface of themedical device are destroyed with theeffect of the sterilant process.Other parameters of the sterilizationprocess are temperature, pressure,humidity, time and are determinedaccording to the sterilization type.Chemical process indicator is printedexterior on the pouch (printed onmedical grade paper) changes color whenexposed to sterilant vapor duringprocessing. After the sterilization iscompleted, the sterility of the enclosedmedical device is maintained for 12monthsThe difference isthe addedclaim tosterilize'IntuitiveEndowristRoboticInstruments'
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 StrengthMD-kNm0	>66 N/15mm	Same	>66 N/15mm
Tensile StrengthCD- 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
PorosityISO 5636-3ISO 5636-5	3.9 – 5.7 µm/Pa·s24-34 s	Same	3.9 – 5.7 µm/Pa·s24-34 s
Seal Strength –N/mm	Peel ≥ 1.5 N/15mm	Same	Peel ≥ 1.5 N/15mm
Transparent Film	Two sheets of laminated plastic with atotal grammage of 55 g/m2. One sheet oforiented polyester 12 microns thick. Onesheet of coextruded polypropylene 40microns thick.	Same	Two sheets of laminated plastic with a totalgrammage of 55 g/m2. One sheet oforiented polyester 12 microns thick. Onesheet of coextruded polypropylene 40microns thick.
SterilizationProperties	Steam sterilization conditions are 4minutes at 132° C or 3 minutes at 135° C	Same	Steam sterilization conditions are 4 minutesat 132° C or 3 minutes at 135°C
Sterilant Penetration	Full-cycle steam sterilization process willproduce sufficient lethality to achieve a12- log reduction, thus providing a 10-6Sterility Assurance Level (SAL).	Same	Full-cycle steam sterilization process willproduce sufficient lethality to achieve a 12-log reduction, thus providing a 10-6 SterilityAssurance Level (SAL).
MaterialCompatibility	Compatible with Steam Sterilization	Same	Compatible with Steam Sterilization
Package IntegrityTest	Closure integrity maintained beforeand after steam sterilization	Same	Closure integrity maintained beforeand after steam sterilization
Maintenance ofSterility — Shelf lifepost sterilization	1 year	Same	1 year
Shelf Life - Pre-sterilization	5 years	Same	5 years
Drying Time	20 minutes for 132° C/4 minutes condition16 minutes for 135° C/3 minutes condition	Same	20 minutes for 132° C/4 minutes condition16 minutes for 135° C/3 minutes condition
Microbial BarrierProperties	The paper of the sterile barrier systemwas examined on the packaging outer sidefor its germ proofness with air permeanceafter steam sterilization and is evaluatedas "sufficiently germ-proof"	Same	The paper of the sterile barrier system wasexamined on the packaging outer side for itsgerm proofness with air permeance aftersteam sterilization and is evaluated as"sufficiently germ-proof"
Biocompatibility	Non-Cytotoxic	Same	Non-Cytotoxic

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Summary of Performance Tests:

Element	Standard reference	Acceptance Criteria	Results
SterilantPenetration	AAMI TIR 12:2020,Designing, testing, andlabeling medical devicesintended for processing byhealth care facilities	Demonstrates that a minimum of 1.0x10^6Geobacilus stearothermophilus spores werekilled in a half-cycle (6-log reduction)	Pass
Drying Time	ISO 17665-1: 2006/2016 -Sterilization of health careproducts - Moist Heat- Part1: Requirements for thedevelopment, validation,and routine control of asterilization process formedical devices	Test samples do not exceed a 3% weight gain	Pass
MaterialCompatibility	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
PunctureResistance	ISO 14477 - Packaging.Flexible packaging material.Determination of punctureresistance.	Internal protocol, Accepted by Sponsor	Pass
PackageIntegrity	ASTM F1929 - StandardTest Method for DetectingSeal Leaks in PorousMedical Packaging by DyePenetration	No leaks detected after dye migration	Pass
MicrobialBarrierProperties	DIN EN ISO -11607-1:2017-10 Section 5.1.6. a)microbial barrierDIN 953-6, section 4.8.6.	Evaluated as "sufficiently germ-proof"	Pass
Shelf Life Priorto Sterilization	ASTM F1929-15 "StandardTest Method for DetectingSeal Leaks in PorousMedical Packaging by DyePenetration	No leaks detected after dye migration
	EN 868-5 Packaging forterminally sterilizedmedical devices — Part 5:Sealable pouches and reelsof porous materials andplastic film construction -Requirements and testmethods	>= 1.5 N/15 mm	Pass
	ISO 5636-3 Paper and board— Determination of airpermeance	>=3.4 $\mu$ m/Pa •s
	ASTM F1980 - 16 StandardGuide for Accelerated Agingof Sterile Barrier Systemsfor Medical Devices	Executed as per standard, No Acceptance Criteria
Shelf Life Poststerilization	ASTM F1929-15 "StandardTest Method for DetectingSeal Leaks in PorousMedical Packaging by DyePenetration	No leaks detected after dye migration	Pass
	ASTM F88/F88M-15:Standard Test Method forSeal Strength of FlexibleBarrier Materials	>= 1.5 N/15 mm
Biocompatibility	ISO 10993-5, Biologicalevaluation of medicaldevices — Part 5: Tests forin vitro cytotoxicity	Not greater than Grade 2 reactivity (mildlyreactive)	Pass
Evidence thatprinting ink onpaper materialdoes not leachinto the interiorof 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.

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).