The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to enclose other medical devices that are to be sterilized by a health care provider. The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to allow sterilization of the enclosed medical devices.

The NUVENTUS NV.C™ Surgical Cassette and Tray requires the use of an FDA cleared wrap to maintain the sterility of the enclosed devices. The NUVENTUS NV.C™ Surgical Cassette and Tray should be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle: Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time.

The NUVENTUS NV.C™ Surgical Cassette and Tray is intended for sterilization of non-porous loads.

The NUVENTUS NV.C™ Surgical Cassette and Tray is recommended not to be stacked during sterilization. The combined weight of the NUVENTUS NV.C™ Surgical Cassette and Tray and the associated instruments is 220 grams. The weight of the empty NUVENTUS NV.C™ Surgical Cassette and Tray is 200 grams.

Device Description

The subject device is a reusable rigid container, comprising a base (bottom), a removable inner tray, and a lid (cover). It is designed to organize and protect NUVENTUS NV.CTM instruments that fall within the cleaning and sterilization validation scope and are sterilized in the tray by a healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior contents during sterilization. The tray is perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polyphenylsulfone (PPSU), and holders of various geometries to position instruments in the trays are manufactured from silicone.

AI/ML Overview

This document is a 510(k) summary for the NUVENTUS NV.C™ Surgical Cassette and Tray, a rigid sterilization container. The information provided heavily focuses on non-clinical testing for substantial equivalence, rather than a clinical study involving human readers and AI for diagnostic improvement. Therefore, many of the requested elements for an AI-assisted diagnostic device study (like MRMC, human-in-the-loop, expert consensus for ground truth on a test set, etc.) are not applicable to this document.

However, I can extract the acceptance criteria and performance data for the device's functional validation as presented in the non-clinical testing summary.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
Validation of the Manual Cleaning Process According to the ISO 17664 and the AAMI ST98 Standards	Evaluate and validate the manual cleaning of the subject devices	Extraction Recovery: The extraction efficiency for each marker should be no less than 70%. The amounts of each marker residual detected in the fourth extract should be less than 10% of that detected in the first extraction.Residual marker testing (Protein Assay): less than 6.4 µg/cm² (Assay quantitation limits: 2.5 µg/mL)Residual marker testing (Hemoglobin assay): less than 2.2 µg/cm² (Assay quantitation limits: 10.0 µg/mL)	Pass
Validation of the Automated Cleaning Process According to the ISO 17664 and the AAMI ST98 Standards	Evaluate and validate the automated cleaning of the subject devices	Extraction Recovery: The extraction efficiency for each marker should be no less than 70%. The amounts of each marker residual detected in the fourth extract should be less than 10% of that detected in the first extraction.Residual marker testing (Protein Assay): less than 6.4 µg/cm² (Assay quantitation limits: 2.5 µg/mL)Residual marker testing (Hemoglobin assay): less than 2.2 µg/cm² (Assay quantitation limits: 10.0 µg/mL)	Pass
Sterilization Validation According to the ISO 17664 - ISO 17665 Standards and the AAMI TIR 12 Technical Report	Validate a sterilization cycle and drying time of the subject devices	Sterilization Effectiveness: 3 consecutive half-cycles will demonstrate complete inactivation of all biologic indicators; A minimum SAL of 10⁻⁶ is achieved if the Instructions for Use are followed.Drying Time: Using pre-cycle and post-cycle weights, the weight gain after drying will not exceed +3%	Pass
Use Life Testing (FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling and ISO 13402:1995)	Life Cycle (simulated use) testing after 225 cleaning, disinfection and sterilization cycles	Durability/Functionality: Visual inspection, functional verification for 225 use cycles.	Pass
Biocompatibility of Subject Device (by cytotoxicity testing) ISO 10993-5, ISO 10993-12	Evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay	Cytotoxicity: ≤ 2 reactivity grade after exposure to extract of the device	Pass

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a "sample size" in terms of number of surgical cassettes tested, but rather the number of cycles or repetitions for certain tests.
- Cleaning Validation: Not explicitly stated as a number of devices, but implies multiple tests to meet extraction efficiency and residual marker criteria.
- Sterilization Validation: "3 consecutive half-cycles" implies a specific test setup for validation, not a large sample of devices.
- Use Life Testing: The device was tested for "225 cleaning, disinfection and sterilization cycles." This refers to repeated cycles on a single or limited number of test units to simulate usage over time.
- Biocompatibility: Not specified as a number of devices.
Data Provenance: Not specified in terms of country of origin. The study appears to be entirely non-clinical bench testing, conducted to demonstrate the device's functional performance and safety (e.g., ability to be cleaned and sterilized, durability, biocompatibility), rather than a clinical study on patient data. It is therefore retrospective in the sense that prototypes were subjected to rigorous testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This is non-clinical bench testing. There is no "ground truth" derived from expert interpretation of medical images or patient data. The "ground truth" here is the objective measurement of chemical residuals, biological indicator inactivation, weight change, and visual/functional inspection against defined engineering and regulatory standards.

4. Adjudication Method for the Test Set

Not Applicable. As there are no human readers or interpretations involved in establishing ground truth for this type of test, no adjudication method is needed or mentioned.

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 not an AI-assisted diagnostic device. It's a medical device (surgical cassette and tray) intended for sterilization. No MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. There is no algorithm for diagnostic purposes. The device is a physical object.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" is established by objective physical and chemical measurements against pre-defined performance standards based on recognized test methodologies (ISO, AAMI standards). This includes:
- Quantitative measurements of protein and hemoglobin residuals after cleaning.
- Verification of biological indicator inactivation for sterilization efficacy.
- Weight measurements to assess drying.
- Visual inspection and functional verification against product specifications for use life.
- Cytotoxicity assays for biocompatibility.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set.

In summary, the provided document details the non-clinical performance validation of a reusable surgical cassette and tray to demonstrate its substantial equivalence to a predicate device, focusing on its ability to be cleaned, sterilized, its durability, and biocompatibility. It is not an AI/ML-enabled diagnostic device, so many of the requested elements for such a study are irrelevant to this submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

February 11, 2025

Infinitum Eta Ltd. Avital Barlev Vice President QA&RA Hatnufa St. 6 Petach Tikva, 4951024 Israel

Re: K243317

Trade/Device Name: NUVENTUS NV.CTM Surgical Cassette and Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: October 22, 2024 Received: October 22, 2024

Dear Avital Barlev:

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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).

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Sincerely,

Image /page/2/Picture/3 description: The image contains the text "Stephen A. Anisko -S". The text is arranged in a vertical format, with "Stephen A." on the first line, "Anisko" on the second line, and "-S" on the third line. The text is in a simple, sans-serif font and is black in color. The background of the image is white.

Digitally signed by Stephen A. Anisko -S Date: 2025.02.11 11:03:44 -05'00'

for: Christopher K. Dugard Division Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices 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) K243317

Device Name

NUVENTUS NV.CTM Surgical Cassette and Tray

Indications for Use (Describe)

The NUVENTUS NV.C™ Surgical Cassette and Tray requires the use of an FDA cleared wrap to maintain the sterility of the enclosed devices. The NUVENTUS NV.C™ Surgical Cassette and Tray should be enclosed in a sterlization wrap that is FDA cleared for the indicated cvcle, and moist heat (steam) sterilized using the following cvcle: Pre-vacum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time.

The NUVENTUS NV.CTM Surgical Cassette and Tray is intended for sterilization of non-porous loads.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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INFIN

510(K) Summary (K243317) for Infineta's NUVENTUS NV.CTM Surgical Cassette and Tray

Date Prepared:	11 February 2025
1. Submitter
Company Name:	Infinitum Eta Ltd
Address:	Hatnufa St. 6, Petach Tikva, 4951024, Israel
Phone and E-mail:	avitalb@infinetamed.com; +972-54-2272773
Contact Person:	Avital Barlev, Vice President QA&RA
2. Device:
Proprietary/Trade Name:	NUVENTUS NV.CTM Surgical Cassette and Tray
Common Name:	Instrument Sterilization Trays
Regulation Number:	21 CFR 880.6850
Regulation Name:	Containers, Trays, Surgical Cassettes & Other Accessories
Regulatory Class:	Class II
Product Code:	KCT

Predicate Device: Z-Systems AG's ST-Z5, cleared under K201878.

4. Device Description

5. Indications for Use

The NUVENTUS NV.C™ Surgical Cassette and Tray is intended for sterilization of non-porous loads.

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INFINETA

Comparison of Technological Characteristics 6.

A tabular comparison of technological characteristics is presented herein:

Table 1: Indications for Use Comparison

Device Name	Indications for Use
SubjectDevice	NUVENTUSNV.CTM SurgicalCassette andTray(K243317)	The NUVENTUS NV.CTM Surgical Cassette and Tray is intended to enclose other medicaldevices that are to be sterilized by a health care provider. The NUVENTUS NV.CTM SurgicalCassette and Tray is intended to allow sterilization of the enclosed medical devices.The NUVENTUS NV.CTM Surgical Cassette and Tray requires the use of an FDA cleared wrapto maintain the sterility of the enclosed devices. The NUVENTUS NV.CTM Surgical Cassetteand Tray should be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle,and moist heat (steam) sterilized using the following cycle: Pre-vacuum steam: 132°C (270°F)for 4 minutes with 30 minutes drying time.The NUVENTUS NV.CTM Surgical Cassette and Tray is intended for sterilization of non-porous loads.The NUVENTUS NV.CTM Surgical Cassette and Tray is recommended not to be stackedduring sterilization. The combined weight of the NUVENTUS NV.CTM Surgical Cassette andTray and the associated instruments is 220 grams. The weight of the empty NUVENTUSNV.CTM Surgical Cassette and Tray is 200 grams.
PrimaryPredicateDevice	ST-Z5(K201878)	ST-Z5 surgical trays are intended to be used to enclose other medical devices that are to besterilized by a health care provider. ST-Z5 surgical trays are intended to allow sterilization ofthe enclosed medical devices. ST-Z5 surgical trays require the use of an FDA cleared wrap tomaintain the sterility of the enclosed devices. The trays are to be enclosed in a sterilizationwrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using thefollowing cycle: Pre-vacuum steam: 132 °C (270 °F) for 4 minutes with 20 minutes dryingtime. ST-Z5 surgical trays are intended for sterilization of non-porous loads. ST-Z5 surgicaltrays are recommended not to be stacked during sterilization. The combined weight of the ST-Z5_c_m_c(t)_m(t) tray and the associated instruments is 441 grams. The weight of the emptyST-Z5_c_m_c(t)_m(t) tray is 361 grams. The combined weight of the Z5-BL/TL tray and theassociated instruments is 427 grams. The weight of the empty Z5-BL/TL tray is 363 grams.

Table 2: Technological Characteristics Comparison

Feature	Subject Device	Primary Predicate Device	TechnologicalCharacteristicsComparison
	NUVENTUS NV.CTM SurgicalCassette and Tray (K243317)	ST-Z5 (K201878)
Product Code	KCT	KCT	Identical
Design	Rigid polymer base, lid, and removableinner tray	Rigid polymer base, lid, and removableinner tray	Identical
Materials	Polyphenylsulfone [lid, base, tray]	Polyphenylsulfone [lid, base, tray]	Identical

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INFINETA

	Subject Device	Primary Predicate Device	TechnologicalCharacteristicsComparison
Feature	NUVENTUS NV.CTM SurgicalCassette and Tray (K243317)	ST-Z5 (K201878)
	Medical grade silicone[grommets/holders]	Medical grade silicone[grommets/holders]
MaterialscompatiblewithSterilizationMethod	Yes	Yes	Identical
Perforated	Yes; allows moist heat (steam)penetration to achieve sterilization	Yes; allows moist heat (steam)penetration to achieve sterilization	Identical
Number ofOverall Sizes	1	1	Identical
Number ofConfigurations	1	2	Similar
OverallDimensions	138L x 98W x 62H [mm]	185.1L x 133.6W x 61.5H [mm]	Similar
Vent toVolume Ratio	0.0172 cm2 / cm3	0.01596 cm2 / cm3	Similar
Reusable	Yes	Yes	Identical
Number ofUses	225	101	Similar
Use LifeTesting	Reusable up to 225 cyclesAssembled, cleaned, disinfected andsterilizedVisual inspectionDefect and deformationFunctional performance (Cassette andTray)	Reusable up to 101 cyclesAssembled and sterilizedVisual inspectionComponent dimensional fit verificationFunctional closure (lid-base latch)verification	Similar
SterilizationMethod	Moist Heat	Moist Heat	Identical
SterilizationCycles	Fractionated vacuum (pre-vacuum)Exposure at 132 °C (270 °F) for 4minutes with 30 minutes drying time	Fractionated vacuum (pre-vacuum)Exposure at 132 °C (270 °F) for 4minutes with 20 minutes drying time	Similar
SterileBarrier	Sterilization wrap, FDA cleared forindicated method and cycle	Sterilization wrap, FDA cleared forindicated method and cycle	Identical

7. Technological Comparison Discussion:

The subject device is similar in indications and design principles to the predicate device.

The subject device and the predicate device have the same intended use, the same product classification and product code (KCT), and have similar Indications for Use statements.

Except for the details concerning the weights of the empty and loaded trays, the indications for use statement for the subject device is identical to that of the predicate device K201878.

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INFINETA

The subject device and the predicate device are reusable rigid sterilization trays intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Components of the subject device and the predicate device are perforated to allow for penetration of the sterilant, are to be used with the same moist heat (steam) sterilization cycle and require the use of an FDA-cleared wrap to maintain sterility.

The subject device and the predicate device include components manufactured from polyphenylsulfone (PPSU) and silicone, and both devices are provided in one overall size. While the predicate device is provided in two configurations, the subject device is provided in one configuration. The overall dimensions of the subject device are smaller than the overall dimensions for the predicate device and the vent to volume ratio of the subject device is larger than the vent to volume ratio of the predicate device.

There are minor differences in the configurations, sizes, or designs between the subject device and the predicate device. The differences are related to the specific design features and system components and are supported by the cleaning and sterilization validation and use life testing performed.

The subject device and the predicate device have different use life, 225 compared to 101, respectively.

8. Non-clinical Testing Summary

Provided below is a summary of the non-clinical performance testing included in this submission, including the test methods, purpose, acceptance criteria, and results.

Test Methodology	Purpose	Acceptance Criteria	Results
Validation of the ManualCleaning ProcessAccording to the ISO17664 and the AAMIST98 Standards	Evaluate and validate themanual cleaning of thesubject devices	Extraction Recovery - The extraction efficiency foreach marker should be no less than 70%. The amountsof each marker residual detected in the fourth extractshould be less than 10% of that detected in the firstextraction.Residual marker testing - Protein Assay Acceptancecriterion: less than 6.4 µg/cm2 Assay quantitationlimits: 2.5 µg/mL Hemoglobin assay Acceptancecriterion: less than 2.2 µg/cm2 Assay quantitationlimits: 10.0 µg/mL	Pass
Validation of theAutomated CleaningProcess According to theISO 17664 and the AAMIST98 Standards	Evaluate and validate theautomated cleaning ofthe subject devices	Extraction Recovery - The extraction efficiency foreach marker should be no less than 70%. The amountsof each marker residual detected in the fourth extractshould be less than 10% of that detected in the firstextraction.Residual marker testing - Protein Assay Acceptancecriterion: less than 6.4 µg/cm2 Assay quantitationlimits: 2.5 µg/mL Hemoglobin assay Acceptancecriterion: less than 2.2 µg/cm2 Assay quantitationlimits: 10.0 µg/mL	Pass
Sterilization ValidationAccording to the ISO17664 - ISO 17665Standards and the AAMITIR 12 Technical Report	Validate a sterilizationcycle and drying time ofthe subject devices	Acceptance criterion: 3 consecutive half-cycles willdemonstrate complete inactivation of all biologicindicators; A minimum SAL of 10-6 is achieved if theInstructions for Use are followed	Pass

Table 3: Non-Clinical Testing Summary

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I N

Test Methodology	Purpose	Acceptance Criteria	Results
		Acceptance criterion: Using pre-cycle and post-cycleweights, the weight gain after drying will not exceed+3%
Use Life TestingFDA GuidanceReprocessing MedicalDevices in Health CareSettings: ValidationMethods and Labeling andISO 13402:1995	Life Cycle (simulateduse) testing after 225cleaning, disinfectionand sterilization cycles	Acceptance criteria: Visual inspection, functionalverification for 225 use cycles	Pass
Biocompatibility ofSubject Device (bycytotoxicity testing)ISO 10993-5ISO 10993-12	The purpose of this testis to evaluate thecytotoxicity potential ofthe test article using an invitro cell culture assay.	Acceptance criterion: ≤ 2 reactivity grade afterexposure to extract of the device	Pass

In summary, the nonclinical testing provided for these devices met the acceptance criteria for each standard and test methodology used to evaluate the devices as shown in the table above.

No clinical data were included in this submission.

9. Conclusion

To conclude, the conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K201878.

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).