HALYARD SMART-FOLD Sterilization Wrap (H450 and H650) is intended to enclose another medical device that is to be sterilized by a healthcare provider using the Advanced Sterilization Products STERRAD 100NX Sterilizer ULTRA GI Cycle.

The H450 and H650 models of the HALYARD SMART-FOLD Sterilization Wrap have been validated for use with the STERRAD 100NX ULTRA GI Cycle as follows:
• Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no more than 4 channels, with lumen dimensions of ≥1mm inner diameter x ≤1500mm in length, or ≥2mm inner diameter x ≤1630mm in length.
• One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle

Note 1: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf.
Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable. Check STERRAD Sterilizer Cycle Selection table for ULTRA GI Cycle compatible duodenoscopes

The HALYARD SMART-FOLD Sterilization Wrap (H450, H650) is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used.

Device Description

Halyard Sterilization Wrap is supplied to the customer as bulk packages of single sheets, where in accordance with standard hospital practices, two sheets are then used to wrap a medical device or a collection of medical devices for sterilization. HALYARD SMART-FOLD Sterilization Wraps are comprised of two sheets of HALYARD* Sequential Sterilization Wrap. This allows for convenient wrapping with two sheets simultaneously. The HALYARD SMART-FOLD Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using the Advanced Sterilization Products, Inc. (ASP) STERRAD 100NX Sterilizer ULTRA™ GI Cycle.

AI/ML Overview

The provided text describes the performance testing for the HALYARD* SMART-FOLD* Sterilization Wrap (H450 and H650).

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Purpose	Test	Acceptance Criteria	Result
Sterilant Penetration/Efficacy	ISO 14937AAMI TIR No 12-2010	Achieving a 10$^{-6}$ sterility assurance level following processing in a worst-case half-cycle	Pass
Performance Testing (Pre-Sterilization and Post-Sterilization)	ANSI/AAMI/ISO 11607-1 Annex BISO 13938-2ASTM D4966-12CPSC 1610	Complies with the selected physical properties	Pass
Maintenance of Package Integrity	ANSI/AAMI/ISO 11607-1ANSI/AAMI ST79AAMI TIR No 12-2010ANSI/AAMI/ISO 14937	Maintain sterility for up to 90 days	Pass
Biocompatibility	ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-12ISO 14937	Non-cytotoxicNon-irritatingResidual level ≤ 9100 µg/cm$^2$	Pass

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

The document does not specify the sample size used for each test. The data provenance is not explicitly mentioned as a country of origin, nor is it stated whether the data is retrospective or prospective. These are non-clinical (laboratory) tests by their nature.

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

This section is not applicable as the tests performed are non-clinical, performance-based, and biocompatibility assessments, which rely on defined technical standards and measurements rather than expert human interpretation of complex data (like image analysis).

4. Adjudication Method

This section is not applicable for the same reasons as point 3.

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

This section is not applicable. This submission is for a medical device (sterilization wrap), not an AI/software as a medical device (SaMD). Therefore, no MRMC study or AI-related effectiveness assessment was conducted.

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

This section is not applicable for the same reasons as point 5.

7. The Type of Ground Truth Used

For the tests conducted, the "ground truth" is defined by the technical standards and specifications outlined in the referenced ISO, AAMI, ASTM, and CPSC documents. For instance:

Sterilant Penetration/Efficacy: The ground truth is a sterility assurance level (SAL) of 10$^{-6}$. This is an objective measurement based on microbiological testing.
Performance Testing: The ground truth is compliance with specified physical properties (e.g., tensile strength, tear resistance as defined by the standards).
Maintenance of Package Integrity: The ground truth is the ability to maintain sterility for up to 90 days, which is determined through microbial barrier testing and accelerated aging studies.
Biocompatibility: The ground truth is material properties meeting non-cytotoxic, non-irritating, and specific residual level criteria, evaluated through chemical extractions and biological assays.

8. The Sample Size for the Training Set

This section is not applicable as the device is a physical sterilization wrap and does not involve machine learning or AI models with training sets.

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

This section is not applicable for the same reasons as point 8.

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.

August 7, 2024

O&M Halyard, Inc. Anureet Singh Regulatory Affairs Manager 9120 Lockwood Blvd Mechanicsville, Virginia 23116

Re: K240330

Trade/Device Name: HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: February 2, 2024 Received: February 5, 2024

Dear Anureet Singh:

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" (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).

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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 QS 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,

Image /page/1/Picture/6 description: The image shows a digital signature. The signature includes the name "Stephen A. Anisko -S" on two lines on the left side of the image. On the right side of the image, the text "Digitally signed by Stephen A. Anisko -S" is present, along with the date "2024.08.07" and the time "16:07:04 -04'00'".

for: Christopher Dugard Assistant Director DHT4C: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Enclosure

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Indications for Use

510(k) Number (if known) K240330

Device Name

HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)

Indications for Use (Describe)

The H450 and H650 models of the HALY ARD SMART-FOLD Sterilization Wrap have been validated for use with the STERRAD 100NX ULTRA GI Cycle as follows:

• Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no more than 4 channels, with lumen dimensions of ≥1mm inner diameter x ≤1500mm in length, or ≥2mm inner diameter x ≤1630mm in length.

· One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle

Note 1: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf.

Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable. Check STERRAD Sterilizer Cycle Selection table for ULTRA GI Cycle compatible duodenoscopes

The HALYARD SMART-FOLD Sterilization Wrap (H450, H650) is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K240330

Submitter:	O&M Halyard, Inc.9120 Lockwood BoulevardMechanicsville, VA 23116Phone: 804-723-7000/800-488-8850Fax: 804-723-7100
Regulatory Contact:	Anureet SinghRegulatory Affairs Manager
Date of Summary:	05 August 2024
Device Trade Name:	HALYARD* SMART-FOLD* Sterilization Wrap (H450);HALYARD* SMART-FOLD* Sterilization Wrap (H650)
Common Name:	Sterilization Wrap
Classification Name:	Sterilization wrap (21 CFR 880.6850, Product Code FRG)
Predicate Device:Reference Device:	K181959 (SMART-FOLD Sterilization Wrap)K140963 (SMART-FOLD Sterilization Wrap)
Device Description:	Halyard Sterilization Wrap is supplied to the customer as bulk packages of singlesheets, where in accordance with standard hospital practices, two sheets are thenused to wrap a medical device or a collection of medical devices for sterilization.HALYARD SMART-FOLD Sterilization Wraps are comprised of two sheets ofHALYARD* Sequential Sterilization Wrap. This allows for convenient wrappingwith two sheets simultaneously.The HALYARD SMART-FOLD Sterilization Wraps are intended to encloseanother medical device that is to be sterilized by a healthcare provider using theAdvanced Sterilization Products, Inc. (ASP) STERRAD 100NX SterilizerULTRA™ GI Cycle.
Indications for Use:	HALYARD SMART-FOLD Sterilization Wrap (H450 and H650) is intended toenclose another medical device that is to be sterilized by a healthcare providerusing the Advanced Sterilization Products STERRAD 100NX Sterilizer ULTRAGI Cycle.The H450 and H650 models of the HALYARD SMART-FOLD SterilizationWrap have been validated for use with the STERRAD 100NX ULTRA GI Cycleas follows:• Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with nomore than 4 channels, with lumen dimensions of ≥1mm inner diameter x≤1500mm in length, or ≥2mm inner diameter x ≤1630mm in length.• One flexible duodenoscope per tray, and no more than two flexibleduodenoscope per cycle

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Note 1: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf.

The HALYARD SMART-FOLD Sterilization Wrap (H450, H650) is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used.

Technological Characteristics Comparison Table:

	ProposedHALYARD SMART-FOLD Sterilization Wrap	PredicateHALYARD SMART-FOLD Sterilization Wrap(K181959)	ReferenceKIMGUARD Smart-FoldSterilization Wrap(K140963)	Comparison
Manufacturer	O&M Halyard, Inc.	Halyard Health, Inc.	Kimberly-Clark Health Care	Different
DeviceModelNumbers	H450H650	H450H650	KC450KC650	Same
Common orUsual Name	Sterilization Wrap	Sterilization Wrap	Sterilization Wrap	Same
Classification	21 CFR 880.6850	21 CFR 880.6850	21 CFR 880.6850	Same
Class	II	II	II	Same
Product Code	FRG	FRG	FRG	Same
Intended Use	Intended to allow sterilizationof the enclosed medicaldevice(s) and also maintainsterility of the encloseddevice(s) until used.	Intended to allow sterilizationof the enclosed medicaldevice(s) and also maintainsterility of the encloseddevice(s) until used.	Intended to allow sterilizationof the enclosed medicaldevice(s) and also maintainsterility of the encloseddevice(s) until used.	Same
Indicationsfor Use	HALYARD SMART-FOLDSterilization Wrap (H450 andH650) is intended to encloseanother medical device that isto be sterilized by a healthcareprovider using the AdvancedSterilization ProductsSTERRAD 100NX SterilizerULTRA GI Cycle.The H450 and H650 models ofthe HALYARD SMART-FOLD Sterilization Wrap havebeen validated for use with theSTERRAD 100NX ULTRAGI Cycle as follows:• Hydrogen peroxidecompatible flexible multi-channel duodenoscopes, withno more than 4 channels, withlumen dimensions of ≥1mminner diameter x ≤1500mm in	HALYARD SMART-FOLDSterilization Wrap (H450,H650) is intended to encloseanother medical device that isto be sterilized by a healthcareprovider using Steris V-PROLow Temperature Sterilizationsystem that includes:• V-PRO 1 (Lumen Cycle)• V- PRO 1 Plus (Lumen andNon-Lumen Cycle)• V-PRO maX, V-PRO maX 2and V-PRO 60 (Lumen, Non-Lumen, and Flexible Cycle)The HALYARD SMART-FOLD Sterilization Wrap(H450, H650) is intended toallow sterilization of theenclosed medical device(s) and	KIMGUARD* Smart FoldSterilization Wrap (KC450 andKC650) is intended to be usedto enclose another medicaldevice that is to be sterilizedby a healthcare provider using:Advanced SterilizationProducts' STERRADSterilization Systems thatinclude:o STERRAD 100So STERRAD NX [StandardCycle, Advanced Cycle]o STERRAD 100NX).[Standard Cycle, Flex Cycle,EXPRESS cycle, DUO Cycle]KIMGUARD Smart Fold*Sterilization Wraps (KC450and KC650) are intended toallow sterilization of theenclosed medical device(s) and	Different,includesadditionalindications forUse for ULTRAGI cycle.
	length, or ≥2mm innerdiameter x ≤1630mm inlength.• One flexible duodenoscopeper tray, and no more than twoflexible duodenoscope percycleNote 1: The STERRAD100NX Sterilizer ULTRA GICycle was validated using aload weight of 15.4 lbs (2 x 7.7lbs), one endoscope per shelf.Note 2: Only duodenoscopesthat have been cleared ascompatible with vaporizedhydrogen peroxide areacceptable. Check STERRADSterilizer Cycle Selection tablefor ULTRA GI Cyclecompatible duodenoscopesThe HALYARD SMART-FOLD Sterilization Wrap(H450, H650) is intended toallow sterilization of theenclosed medical device(s) andto maintain sterility of theenclosed device(s) until used.	to maintain sterility of theenclosed device(s) until used.	also maintain sterility of theenclosed device(s) until used.
DeviceDesign	Two pre-shaped sheets ofHalyard Sterilization Wrap,which include reinforcementzones, medical deviceplacement reference line, awhite inner layer, side-tabswith closure strips and pull-tabs to allow convenientwrapping with two sheetssimultaneously	Two pre-shaped sheets ofHalyard Sterilization Wrap,which include reinforcementzones, medical deviceplacement reference line, awhite inner layer, side-tabswith closure strips and pull-tabs to allow convenientwrapping with two sheetssimultaneously	Two pre-shaped sheets ofHalyard Sterilization Wrap,which include reinforcementzones, medical deviceplacement reference line, awhite inner layer, side-tabswith closure strips and pull-tabs to allow convenientwrapping with two sheetssimultaneously	Same
Sterilant	Hydrogen Peroxide	Hydrogen Peroxide	Hydrogen Peroxide	Same
Technology	Polypropylene SMS materialthat allows sterilant topenetrate and maintain sterilebarrier	Polypropylene SMS materialthat allows sterilant topenetrate and maintain sterilebarrier	Polypropylene SMS materialthat allows sterilant topenetrate and maintain sterilebarrier	Same
Materials	Each sheet is composed of athree-layer SMS(spunbond-meltblown-spunbond) polypropylenefabric treated with an antistatictreatment.	Each sheet is composed of athree-layer SMS(spunbond-meltblown-spunbond) polypropylenefabric treated with an antistatictreatment.	Each sheet is composed of athree-layer SMS(spunbond-meltblown-spunbond) polypropylenefabric treated with an antistatictreatment.	Same
Distribution	Non-SterileOver-the-Counter	Non-SterileOver-the-Counter	Non-SterileOver-the-Counter	Same
Single UseDevice	Yes	Yes	Yes	Same

O&M Halyard, Inc.

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Summary of Non-Clinical Performance Testing:

Performance testing of HALYARD SMART-FOLD Sterilization Wrap was evaluated and the results showed that acceptance criteria were met demonstrating that the HALYARD SMART-FOLD Sterilization Wrap allows sterilization of its contents using the STERRAD 100NX Sterilizer ULTRA GI Cycle and that sterility is maintained for the testing period of 90 days.

Purpose	Test	Acceptance Criteria	Result
SterilantPenetration/Efficacy	ISO 14937AAMI TIR No 12-2010	Achieving a 10-6 sterility assurance levelfollowing processing in a worst-casehalf-cycle	Pass
Performance Testing(Pre-Sterilizationand Post-Sterilization)	ANSI/AAMI/ISO 11607-1 Annex BISO 13938-2ASTM D4966-12CPSC 1610	Complies with the selected physicalproperties	Pass
Maintenance ofPackage Integrity	ANSI/AAMI/ISO 11607-1ANSI/AAMI ST79AAMI TIR No 12-2010ANSI/AAMI/ISO 14937	Maintain sterility for up to 90 days	Pass
Biocompatibility	ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-12ISO 14937	Non-cytotoxicNon-irritatingResidual level ≤ 9100 µg/cm2	Pass

Summary of Non-Clinical Testing Performed

Summary of Clinical Performance Testing:

Clinical evaluations were not required and therefore are not submitted with this 510(k).

Discussion:

The HALY ARD SMART-FOLD Sterilization Wrap in this submission and the predicate device submission are intended to enclose another medical device that is to be sterilized by a healthcare provider, to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s). The SMART-FOLD Sterilization Wrap in this submission and the predicate device submission have identical intended use, design, materials, specifications, and composition, and are manufactured using identical production methods. The different technological characteristics, that is, the Indications for Use, do not affect the safety and effectiveness of the device as evidenced by the results of the nonclinical testing.

Conclusion:

The conclusions drawn from the non-clinical tests demonstrate that the HALYARD SMART-FOLD Sterilization Wrap (K240330) is as safe, as effective, and performs as well as or better than the legally marketed device, the HALYARD SMART-FOLD Sterilization Wrap (K181959).

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).