Medline Reusable Sterilization Wrappers are intended to be used to enclose another medical device or component that is to be sterilized by health care professionals. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The Medline Reusable Sterilization Wrap is a non-sterile, reusable device, with a wash/dry/autoclave life cycle as indicated on the Wrap.

Medline Reusable Sterilization Wrappers are available in 3 different fabrics that are either single or double ply bonded sheets of cotton and polyester blends. Model Angelstat is reusable up to 50 times; Models Resistat and Ripstop are reusable up to 75 times . The Medline Reusable Sterilization Wrappers are available in Misty Green, Jade Green or Ceil Blue with configurations 12"x12" through 72"x72" and 60"x90". The Medline Reusable Sterilization Wrappers are intended to be laundered then sterilized prior to use, and examined prior to use for defects and debris.

A prevacuum steam sterilization cycle at 270 F for 4 minutes has been validated for use on textile packs, with a minimum weight of 25 pounds and 30 minute dry time.

Medline recommends following the below standards for pack configuration and assembly in sterilization facilities. · AAMI ANSI ST79 • AAMI ANSI ST65

Device Description

The Medline Reusable Sterilization Wrappers are offered in bulk, non-sterile packaging. The Medline Reusable Sterilization Wrappers are available in 3 different fabrics that are either single or double ply bonded sheets of cotton and polyester blends. The Medline Reusable Sterilization Wrappers are available in Misty Green, Jade Green or Ceil Blue with configurations 12"x12" through 72"x72" and 60"x90". The Medline Reusable Sterilization Wrappers are intended to be sterilized and laundered per the instructions.

AI/ML Overview

The provided text describes the acceptance criteria and the results of non-clinical testing for the Medline Reusable Sterilization Wrappers.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Test Method	Acceptance Criteria	Reported Device Performance
Resistance to Water Penetration	AATCC 127-2018	Test and Report - Average hydrostatic pressure	Pass
Tensile Strength and Elongation	ASTM D5034-21	Test and Report - Average load at break and elongation at break for machine and cross direction	Pass
Particle Generation (Linting)	ISO 9073-10:2004	Test and Report - Average lint counts of particles and coefficient of linting	Pass
Cytotoxicity	ISO 10993-5	Non-Cytotoxicity - device did not show cytotoxicity potential	Pass
Sensitization	ISO 10993-10	Non-sensitizing - device showed no significant evidence of causing delayed dermal contact sensitization	Pass
Irritation	ISO 10993-10	Non-irritating - the irritation response category of the device was classified as Negligible	Pass
Acute Systemic Toxicity	ISO 10993-11	Non-systemic toxicity – device did not show systemic toxicity potential	Pass
Sterilization Validation	ST79:2017	All biological indicators shall be negative, positive controls shall be positive, chemical integrators shall demonstrate adequate steam penetration, negative and environmental controls shall be negative	Pass
Dry Time Validation	ST79:2017	Average pre and post sterilization wrought difference of less than 0.2% within 5 minutes of cycle completion, no visible moisture following 30 minute cooling period and all integrators shall demonstrate steam penetration	Pass
Cleaning Validation	AAMI TIR30:2011	Each test sample shall show a TOC level of less than 12µg/cm2 and no visible soil after cleaning	Pass

2. Sample size used for the test set and the data provenance

The document does not explicitly state the specific sample sizes for each test listed. It mentions "Each test sample" for Cleaning Validation, implying multiple samples were tested. For other tests like Resistance to Water Penetration, Tensile Strength, and Particle Generation, it refers to "Test and Report" without specifying quantity.
The data provenance is not specified. It can be inferred that these tests were conducted by the manufacturer, Medline Industries, LP, to support their 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The listed tests are non-clinical bench tests and sterilization validations, which typically rely on standardized methods and laboratory analysis rather than expert human interpretation for "ground truth" establishment in the same way, for example, medical image analysis would.

4. Adjudication method for the test set

Not applicable. The tests are objective, laboratory-based physical, chemical, and biological evaluations, not requiring human adjudication of results in the traditional sense.

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 device is a medical accessory (sterilization wrapper) and does not involve AI or human "readers" for interpretation. Therefore, an MRMC study is not relevant.

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

Not applicable, as this device does not involve an algorithm or AI component.

7. The type of ground truth used

The ground truth for these tests is established by:

Standardized Test Methods and Criteria: For physical and material properties (e.g., AATCC 127-2018 for water penetration, ASTM D5034-21 for tensile strength, ISO 9073-10:2004 for particle generation).
Biological Test Outcomes: For biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity), the "ground truth" is determined by the biological response observed according to the protocols of ISO 10993 series.
Sterilization Efficacy Indicators: For Sterilization Validation and Dry Time Validation, the "ground truth" is determined by the results of biological indicators, chemical integrators, and physical observations (e.g., moisture, weight difference) as per ST79:2017.
Chemical Analysis: For Cleaning Validation, the "ground truth" is based on measurable chemical residuals (TOC level) and visual inspection for soil, guided by AAMI TIR30:2011.

8. The sample size for the training set

Not applicable. This device does not use an AI/ML component, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

{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 and Human Services logo. To the right of that 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.

September 17, 2024

Medline Industries, LP Kelsey Closen Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093, USA

Re: K234132

Trade/Device Name: Medline Reusable Sterilization Wrappers Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: December 28, 2023 Received: December 28, 2023

Dear Kelsey Closen:

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: 2024.09.17 11:49:46 -04'00'

for: Christopher Dugard Assistant Director DHT4C: Division of Infection Control 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) K234132

Device Name Medline Reusable Sterilization Wrappers

Indications for Use (Describe)

A prevacuum steam sterilization cycle at 270 F for 4 minutes has been validated for use on textile packs, with a minimum weight of 25 pounds and 30 minute dry time.

Medline recommends following the below standards for pack configuration and assembly in sterilization facilities. · AAMI ANSI ST79

• AAMI ANSI ST65

Insert model and sizes Item Resistat (1-ply) Size Description Color Pkg. MDT01302012 ResiStat Reusable Sterilization Wrap Ceil Blue 12" x 12" 5 dz/cs MDT01302018 ResiStat Reusable Sterilization Wrap Ceil Blue 18" x 18" 5 dz/cs MDT01302024 ResiStat Reusable Sterilization Wrap Ceil Blue 24" x 24" 5 dz/cs MDT01302030 ResiStat Reusable Sterilization Wrap Ceil Blue 30" x 30" 5 dz/cs MDT01302036 ResiStat Reusable Sterilization Wrap Ceil Blue 36" x 36" 5 dz/cs MDT01302045 ResiStat Reusable Sterilization Wrap Ceil Blue 45" x 45" 2 dz/cs MDT01302054 ResiStat Reusable Sterilization Wrap Ceil Blue 54" x 54" 1 dz/cs MDT013020547ResiStat Reusable Sterilization Wrap Ceil Blue 54" x 72" 2 dz/cs Rip-stop (1-ply) MDT01302124 Rip-Stop Reusable Sterilization Wrap Ceil Blue 24" x 24" 5 dz/cs MDT01302130 Rip-Stop Reusable Sterilization Wrap Ceil Blue 30" x 30" 5 dz/cs MDT01302136 Rip-Stop Reusable Sterilization Wrap Ceil Blue 36" x 36" 5 dz/cs MDT01302145 Rip-Stop Reusable Sterilization Wrap Ceil Blue 45" x 45" 2 dz/cs MDT01302154 Rip-Stop Reusable Sterilization Wrap Ceil Blue 54" x 54" 1 dz/cs MDT013021607 Rip-Stop Reusable Sterilization Wrap Ceil Blue 60" x 76" 1 dz/cs MDT013021609 Rip-Stop Reusable Sterilization Wrap Ceil Blue 60" x 90" 1 dz/cs Angelstat Bias (2-ply) MDT01320018 Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 18" x 18" 5 dz/cs MDT01320024 Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 24" x 24" 5 dz/cs MDT01320030 Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 30" x 30" 5 dz/cs MDT01320036 Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 36" x 36" 5 dz/cs

{4}------------------------------------------------

MDT01320045 Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 45" x 45" 2 dz/cs MDT01320045N Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 45" x 45" 2 dz/cs MDT01320054 Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 54" x 54" 1 dz/cs MDT013200547 Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 54" x 72" 1 dz/cs MDT01320072 Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 70" x 72" 1 dz/cs MDT01320512 Astat Bias Bound Reusable Sterilization Wrap Jade Green 12" x 12" 5 dz/cs MDT01320518 Astat Bias Bound Reusable Sterilization Wrap Jade Green 18" x 18" 5 dz/cs MDT01320524 Astat Bias Bound Reusable Sterilization Wrap Jade Green 24" x 24" 5 dz/cs MDT01320527 Astat Bias Bound Reusable Sterilization Wrap Jade Green 27" x 27" 5 dz/cs MDT01320530 Astat Bias Bound Reusable Sterilization Wrap Jade Green 30" x 30" 5 dz/cs MDT01320536 Astat Bias Bound Reusable Sterilization Wrap Jade Green 36" x 36" 5 dz/cs MDT01320545 Astat Bias Bound Reusable Sterilization Wrap Jade Green 45" x 45" 2 dz/cs MDT01320554 Astat Bias Bound Reusable Sterilization Wrap Jade Green 54" x 54" 1 dz/cs MDT013205547 Astat Bias Bound Reusable Sterilization Wrap Jade Green 54" x 72" 1 dz/cs MDT01321018 Astat Bias Bound Reusable Sterilization Wrap Misty 18" x 18" 5 dz/cs MDT01321030 Astat Bias Bound Reusable Sterilization Wrap Misty 30" x 30" 5 dz/cs MDT01321036 Astat Bias Bound Reusable Sterilization Wrap Misty 36" x 36" 5 dz/cs MDT01321045 Astat Bias Bound Reusable Sterilization Wrap Misty 45" x 45" 2 dz/cs MDT01321054 Astat Bias Bound Reusable Sterilization Wrap Misty 54" x 54" 1 dz/cs MDT013210547 Astat Bias Bound Reusable Sterilization Wrap Misty 54" x 72" 1 dz/cs MDT01321072 Astat Bias Bound Reusable Sterilization Wrap Misty 70" x 72" 1 dz/c

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image features the Medline logo, which is set against a blue background. The word "MEDLINE" is prominently displayed in white, sans-serif font, positioned to the left of a stylized white cross-like symbol. The cross is oriented diagonally, with its points extending towards the corners of the frame, creating a dynamic and modern look for the medical supply company.

Medline Industries, LP Three Lakes Drive Northfield. IL 60093

510(k) SUMMARY - K234132 [AS REQUIRED BY 21CFR807.92(c)]

Submitter / 510(k) Sponsor

Medline Industries, LP Three Lakes Drive Northfield, IL 60093, USA

Registration Number: 1417592

Contact Person

Contact Person: Kelsey Closen, Regulatory Affairs Specialist Phone: 847-949-2283 Email: KClosen@medline.com

Summary Preparation Date August 05, 2024

Type of 510(k) Submission Traditional

Device Name / Classification

Trade Name: Medline Reusable Sterilization Wrappers Common Name: Sterilization Wrapper Classification Name: Wrap, Sterilization Product Code: FRG Classification Panel: General Hospital Regulatory Class: II Regulation Number: 21 CFR 880.6850

Predicate Device

Standard Supreme Sterilization Wrapper K172207

Device Description

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image features the Medline logo, which is set against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized white starburst symbol. A gray bar is visible on the right side of the image, partially obscuring the blue background.

Medline Industries, LP Three Lakes Drive Northfield. IL 60093

Indications for Use

Medline Reusable Sterilization Wrappers are intended to enclose another medical device or component that is to be sterilized by health care professionals. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The Medline Reusable Sterilization Wrap is a non-sterile, reusable device, with a wash/dry/autoclave life cycle as indicated on the Wrap.

Medline Reusable Sterilization Wrappers are available in 3 different fabrics that are either single or double ply bonded sheets of cotton and polyester blends. Model Angelstat is reusable up to 50 times: Models Resistat and Ripstop are reusable up to 75 times . The Medline Reusable Sterilization Wrappers are available in Misty Green, Jade Green or Ceil Blue with configurations 12"x12" and 60"x90". The Medline Reusable Sterilization Wrappers are intended to be laundered then sterilized prior to use, and examined prior to use for defects and debris. A prevacuum steam sterilization cycle at 270 F for 4 minutes has been validated for use on textile packs, with a minimum weight of 25 pounds and 30 minute dry time.

Medline recommends following the below standards for pack configuration and assembly in sterilization facilities.

· AAMI ANSI ST79

AAMI ANSI ST65
Insert model and sizes Item Resistat (1-ply) Description Color Size Pkg. MDT01302012 ResiStat Reusable Sterilization Wrap Ceil Blue 12" x 12" 5 dz/cs MDT01302018 ResiStat Reusable Sterilization Wrap Ceil Blue 18" x 18" 5 dz/cs MDT01302024 ResiStat Reusable Sterilization Wrap Ceil Blue 24" x 24" 5 dz/cs MDT01302030 ResiStat Reusable Sterilization Wrap Ceil Blue 30" x 30" 5 dz/cs MDT01302036 ResiStat Reusable Sterilization Wrap Ceil Blue 36" x 36" 5 dz/cs MDT01302045 ResiStat Reusable Sterilization Wrap Ceil Blue 45" x 45" 2 dz/cs MDT01302054 ResiStat Reusable Sterilization Wrap Ceil Blue 54" x 54" 1 dz/cs MDT013020547ResiStat Reusable Sterilization Wrap Ceil Blue 54" x 72" 2 dz/cs Rip-stop (1-ply) MDT01302124 Rip-Stop Reusable Sterilization Wrap Ceil Blue 24" x 24" 5 dz/cs MDT01302130 Rip-Stop Reusable Sterilization Wrap Ceil Blue 30" x 30" 5 dz/cs MDT01302136 Rip-Stop Reusable Sterilization Wrap Ceil Blue 36" x 36" 5 dz/cs MDT01302145 Rip-Stop Reusable Sterilization Wrap Ceil Blue 45" x 45" 2 dz/cs MDT01302154 Rip-Stop Reusable Sterilization Wrap Ceil Blue 54" x 54" 1 dz/cs MDT013021607 Rip-Stop Reusable Sterilization Wrap Ceil Blue 60" x 76" 1 dz/cs MDT013021609 Rip-Stop Reusable Sterilization Wrap Ceil Blue 60" x 90" 1 dz/cs

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image features the logo of Medline, a healthcare company. The logo is set against a blue background and consists of the word "MEDLINE" in bold, sans-serif font, positioned to the left of a stylized white symbol that resembles a compass or a star. The symbol has four points, with the top and bottom points being longer than the side points. A small gray rectangle is visible in the upper right corner of the image.

Medline Industries, LF Three Lakes Drive Northfield. IL 60093

Angelstat Bias (2-ply)

MDT01320018 Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 18" x 18" 5 dz/cs MDT01320024 Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 24" x 24" 5 dz/cs MDT01320030 Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 30" x 30" 5 dz/cs MDT01320036 Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 36" x 36" 5 dz/cs MDT01320045 Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 45" x 45" 2 dz/cs MDT01320045N Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 45" x 45" 2 dz/cs MDT01320054 Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 54" x 54" 1 dz/cs MDT013200547 Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 54" x 72" 1 dz/cs MDT01320072 Astat Bias Bound Reusable Sterilization Wrap Ceil Blue 70" x 72" 1 dz/cs MDT01320512 Astat Bias Bound Reusable Sterilization Wrap Jade Green 12" x 12" 5 dz/cs MDT01320518 Astat Bias Bound Reusable Sterilization Wrap Jade Green 18" x 18" 5 dz/cs MDT01320524 Astat Bias Bound Reusable Sterilization Wrap Jade Green 24" x 24" 5 dz/cs MDT01320527 Astat Bias Bound Reusable Sterilization Wrap Jade Green 27" x 27" 5 dz/cs MDT01320530 Astat Bias Bound Reusable Sterilization Wrap Jade Green 30" x 30" 5 dz/cs MDT01320536 Astat Bias Bound Reusable Sterilization Wrap Jade Green 36" x 36" 5 dz/cs MDT01320545 Astat Bias Bound Reusable Sterilization Wrap Jade Green 45" x 45" 2 dz/cs MDT01320554 Astat Bias Bound Reusable Sterilization Wrap Jade Green 54" x 54" 1 dz/cs MDT013205547 Astat Bias Bound Reusable Sterilization Wrap Jade Green 54" x 72" 1 dz/cs MDT01321018 Astat Bias Bound Reusable Sterilization Wrap Misty 18" x 18" 5 dz/cs MDT01321030 Astat Bias Bound Reusable Sterilization Wrap Misty 30" x 30" 5 dz/cs MDT01321036 Astat Bias Bound Reusable Sterilization Wrap Misty 36" x 36" 5 dz/cs MDT01321045 Astat Bias Bound Reusable Sterilization Wrap Misty 45" x 45" 2 dz/cs MDT01321054 Astat Bias Bound Reusable Sterilization Wrap Misty 54" x 54" 1 dz/cs MDT013210547 Astat Bias Bound Reusable Sterilization Wrap Misty 54" x 72" 1 dz/cs MDT01321072 Astat Bias Bound Reusable Sterilization Wrap Misty 70" x 72" 1 dz/cs

TABLE 1: COMPARISON OF SUBJECT AND PREDICATE DEVICES
Device Characteristic	Subject Device	Predicate Device	ComparisonAnalysis
Product Name	Medline ReusableSterilization Wrappers	Standard Supreme SterilizationWrapper	N/A
510(k) Reference	K234132	K172207	N/A
Product Owner	Medline Industries, LP	Standard Textile Co., Inc.	N/A
Product Code	FRG	FRG	Same
Intended Use	Medline ReusableSterilization Wrappers areintended to be used toenclose another medical	Standard Supreme SterilizationWrappers are intended to beused to enclose another medicaldevice that is to be sterilized by	Same
	device or component that isto be sterilized by health careprofessionals. It is intendedto allow sterilization of theenclosed medical device andalso to maintain sterility ofthe enclosed device untilused. The Medline ReusableSterilization Wrap is a non-sterile, reusable device, witha wash/dry/autoclave lifecycle as indicated on theWrap.	a health care provider. They areintended to allow sterilization ofthe enclosed medical device andalso to maintain sterility of theenclosed device until used.Standard Supreme SterilizationWrappers will function as asterilization wrap whenprocessed according toinstructions. StandardSupreme Sterilization Wrappersare reusable through 75 wash,dry, and sterilization cycles.They are manufactured anddistributed as non-sterilesterilization wraps that areintended to be sterilized andprocessed by health carefacilities and/orcontract sterilization/laundrycompanies
Regulation Number	21 CFR 880.6850	21 CFR 880.6850	Same
Color Options	3 colors Misty, Ceil and Jade	3 colors Misty, Ceil and Jade	Same
Design Configurations	Sizes 12"x12"through 72"x72"and 60"x90"3 Colors: Misty,Jade and Ceil Blue3 fabric options:Cotton andpolyester blends	Sizes 12x12 - 70x703 Colors: Misty, Jadeand Ceil Blue1 fabric option: cottonand polyester blend	Similar — Medlineoffers a larger size anddifferent fabrics theseadditional sizes andfabrics do not create anyrisk or concerns based onperformance andbiocompatibility testing
Prescription vs. OTC	OTC	OTC	Same
Sterile vs. Non-Sterile	Non-sterile	Non-sterile	Same
Sterilization	Steam	Steam	Same
Disposable vs. Reusable	Reusable	Reusable	Same
Use Life	Ripstop and Resistat are 75wash, dry, autoclave	75 wash, dry, autoclave	Similar- MedlineAngelstat is different thanthe proposed device for
	Angelstate is 50 wash, dry, autoclave		use life but this differences does not create any risk or concerns based on performance testing

Summary of Technological Characteristics TABLE 1: COMPARISON OF SUBJECT AND PREDICATE DEVICES

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in white, stacked vertically, with a stylized white starburst symbol to the right of the text. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a memorable symbol.

Medline Industries, LP Three Lakes Drive Northfield, IL 60093

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image features the logo for Medline, a healthcare company. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized, white cross-like symbol. The background is a solid dark blue color, and there is a gray bar at the top of the image.

Medline Industries, LP Three Lakes Drive
Northfield, IL 60093

Summary of Non-Clinical Testing

Test Performed	Test Method	Acceptance Criteria	Result
Resistance to WaterPenetration	AATCC 127-2018	Test and Report -Average hydrostaticpressure	Pass
Tensile Strength andElongation	ASTM D5034-21	Test and Report -Average load at break andelongation at break formachine and crossdirection	Pass
Particle Generation	ISO 9073-10:2004	Test and Report -Average lint counts ofparticles and coeffect oflinting	Pass
Cytotoxicity	ISO 10993-5	Non-Cytotoxicity - devicedid not show cytotoxicitypotential	Pass
Sensitization	ISO 10993-10	Non-sensitizing - deviceshowed no significantevidence of causingdelayed dermal contactsensitization	Pass
Irritation	ISO 10993-10	Non-irritating - theirritation response categoryof the device was classifiedas Negligible	Pass
Acute Systemic Toxicity	ISO 10993-11	Non-systemic toxicity –device did not showsystemic toxicity potential	Pass
Sterilization Validation	ST79:2017	All biological indicatorsshall be negative, positivecontrols shall be positive,chemical integrators shalldemonstrate adequatesteam penetration, negative	Pass

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image is a logo for Medline. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with a stylized starburst symbol to the right of the word. The background is a solid dark blue color. The starburst symbol is white, and the word "MEDLINE" is in a lighter color, possibly white or a light shade of blue.

Medline Industries, LP Three Lakes Drive Northfield. IL 60093

		and environmental controls
		shall be negative
Dry Time Validation	ST79:2017	Average pre and poststerilization wroughtdifference of less than0.2% within 5 minutes ofcycle completion, novisible moisture following30 minute colling periodand all integrators shalldemonstrate steampenetration	Pass
Cleaning Validation	AAMI TIR30:2011	Each test sample shallshow a TOC level of lessthan 12µg/cm2 and novisible soil after cleaning	Pass

Biocompatibility Testing

The biological evaluation for the Medline Reusable Sterilization Wrappers was conducted in accordance with FDA guidance document, "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and "ISO 10993-1 Biological Evaluation of the Medical Devices -Part 1: Evaluation of Testing within a Risk Management Process."

Performance Testing (Bench)

The following performance testing was conducted on the Medline Reusable Sterilization Wrappers:

ASTM D5034: Tensile Strength ●
ISO 9073-10: Linting
AATCC 127: Water Resistance (Rip-stop/Resistat only based on claim) ●

Other Testing

Sterilization Validation ●
Dry Time Validation ●
Cleaning Validation

Conclusion

In accordance with 21 CFR Part 807, the conclusions drawn from the non-clinical tests in this premarket notification demonstrates that the Reusable Sterilization Wrappers are as safe and as effective,

{11}------------------------------------------------

Image /page/11/Picture/1 description: The image features the logo of Medline, a healthcare company. The logo is set against a blue background and consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized star or cross-like symbol. The symbol is white, contrasting with the blue background, and has a modern, geometric design.

Medline Industries, LP Three Lakes Drive Northfield, IL 60093

and perform as well as or better then the legally marketed predicate device, Standard Supreme Sterilization Wrappers (K172207).

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).