Medline Quick-Clear Wand is intended to be used by health care providers to restore and maintain patency of gastrostomy tubes (G-Tubes), jejunostomy tubes (J-Tubes), and percutaneous endoscopic (PEG) tubes that may be used in infant patients over 10kg, children, adolescents, and adults.

Device Description

The Medline Quick-Clear Wand is a single use device intended for use in clearing occlusions/clogs from gastrostomy tubes (G-Tubes) and Percutaneous Endoscopic Gastrostomy tubes (PEG tubes) – tubes that are placed through the abdomen wall and rest in the stomach of the patient, and jejunostomy tubes (J-Tubes) - tubes that are placed through the abdomen wall and rest in the jejunum of the patient. The proposed device is manually inserted into the feeding tube, directed along the inside of the tube to reach the blockage, and a rotating motion of the device (manually generated by the operator) mechanically acts on the occlusion to restore the tube patency. All Medline Quick-Clear Wand are offered non-sterile and are prescription only.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Medline Quick-Clear Wand, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance values for the Medline Quick-Clear Wand. Instead, it states that "the results demonstrate that all acceptance criteria were met" for various performance tests without specifying the exact criteria or quantitative results.

However, based on the "Performance Testing (Bench)" section, we can infer the aspects that were evaluated and for which acceptance criteria were implicitly met:

Performance Characteristic	Reported Device Performance
Flexural strength	Acceptance criteria met
Seal strength	Acceptance criteria met
Marking accuracy	Acceptance criteria met
Stem tensile strength	Acceptance criteria met
Handle connection strength	Acceptance criteria met
Metrology	Acceptance criteria met
Simulated use testing	Acceptance criteria met

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

The document does not specify the sample sizes used for the non-clinical performance and biocompatibility tests. It also does not provide information on data provenance (e.g., country of origin) or whether the tests were retrospective or prospective.

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

This information is not provided in the document. The non-clinical testing appears to be primarily bench testing and simulated use, which would typically rely on engineering and laboratory standards rather than expert clinical consensus for "ground truth."

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document, as the testing described focuses on objective measurements and established standards rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted or reported. The device is a physical tool for clearing occlusions, not an AI or imaging diagnostic tool that would typically involve human readers interpreting cases.

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

This question is not applicable. The device is a physical, manually operated tool, not an algorithm.

7. The Type of Ground Truth Used

For the performance testing, the ground truth was based on established engineering and material standards (e.g., ASTM D790-17 for flexural testing, ASTM F88/F88M-15 for seal strength testing). For biocompatibility, the ground truth was based on international standards such as ISO 10993-5 and ISO 10993-10.

8. The Sample Size for the Training Set

This information is not applicable. The Medline Quick-Clear Wand is a mechanical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable, as there is no training set for a mechanical device.

Summary

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

May 4, 2019

Medline Industries, Inc. Dinah Rincones Regulatory Affairs Specialist Three Lakes Drive Northfield, IL 60093

Re: K183577

Trade/Device Name: Medline Quick-Clear Wand Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: March 29, 2019 Received: April 1, 2019

Dear Dinah Rincones:

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 (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 located 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.

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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shanil P. Haugen, Ph.D. Acting, Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K183577

Device Name Medline Quick-Clear Wand

Indications for Use (Describe)

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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K183577 Page 1 of 6

Image /page/3/Picture/1 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a white, stylized starburst symbol. The starburst has four points, with the top and bottom points being longer than the side points, creating a dynamic and eye-catching design.

Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093

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

Submitter / 510(k) Sponsor

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592

Contact Person

Dinah Rincones Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Phone: 847-949-2687 Fax: 224-931-1271 Email: DRincones@medline.com

Summary Preparation Date May 1st, 2019

Type of 510(k) Submission Traditional

Device Name / Classification

Device Common Name: Feeding tube de-clogger Trade Name: Medline Quick-Clear Wand Regulation Name: Gastrointestinal Tube and Accessories Regulation Number: 21 CFR §876.5980 Class: Class II Panel: Gastroenterology/Urology Product Code: KNT

Predicate Device

Tube DeClogger K905164

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Image /page/4/Picture/1 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, set against a blue square background. A white star-like symbol is behind the text, with the text centered on the symbol. There is a gray bar on the right side of the image.

Aedline Industries, Inc. Three Lakes Drive Northfield. IL 60093

Device Description

Indications for Use

Summary of Technological Characteristics Compared to those of the Predicate Device

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Image /page/5/Picture/1 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in white, block letters, and a white star-like symbol is placed behind the text. The symbol has four points, resembling a compass rose.

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093

DeviceCharacteristic	Proposed Device	Predicate Device(K905164)	ComparisonAnalysis
Product Name	Medline Quick-Clear Wand	Tube DeClogger	N/A
Intended Use	Intended for use in restoring andmaintaining patency of feedingtubes.	Intended for use in restoring andmaintaining patency of feedingtubes.	Same
Indications for Use	Medline Quick-Clear Wand isintended to be used by healthcare providers to restore andmaintain patency of gastrostomytubes (G-Tubes), jejunostomytubes (J-Tubes), andpercutaneous endoscopic (PEG)tubes that may be used in infantpatients over 10kg, children,adolescents, and adults.	It is intended to be used by heathcare providers to restore andmaintain patency of gastrostmytubes (G-Tubes), jejunostomytubes (J-Tubes), andpercutaneous endoscopicgastrostomy (PEG) tubes.	Same
RegulationName/Number	21 CFR §876.5980Gastrointestinal tube andaccessories	21 CFR §876.5980Gastrointestinal tube andaccessories	Same
Product Code	KNT	KNT	Same
Materials	Medical grade polypropylene	Not found	N/A
Design Features	Two-piece design.Color coded only in handle.Made with flexible plastic.Markings in centimeters.Compatible with ENFit devices.Two (2) length sizes.Five (5) French sizes.Disc to prevent over-insertion.Rounded tip.Description, SKU, and ENFitcompatibility are printed onhandle.	One-piece design.Color coded on the completeassembly.Made with flexible plastic.Markings in centimeters.Two (2) length sizes.Five (5) French sizes.Disc to prevent over-insertion.Rounded end.	Similar

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Image /page/6/Picture/1 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in white, block letters on the left side of the square. To the right of the word is a white, stylized star shape with a long tail pointing downwards.

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093

ProductConfigurations	Item	Size (FR)	Length(cm)	Item	Size (FR)	Length(cm)	Same
	ENT911-Blue*	14-16	39.5	911-Blue	14-16	39.5
	ENT912-Yellow	16-18	39.5	912-Yellow	16-18	39.5
	ENT913-Green	20-22	39.5	913-Green	20-22	39.5
	ENT921-Brown*	14-16	21.5	921-Brown	14-16	21.5
	ENT922-Orange	18-24	21.5	922-Orange	18-24	21.5
	*ENFit compatible
Packaging	Single paper-poly peel pouch.			Single paper-poly peel pouch.			Same
PerformanceCharacteristics	The following performancecharacteristics are equivalent tothe predicate device:• Flexural strength.• Stem tensile strength.• Dimensions.• Marking accuracy.• Ability to unclog.			The following performancecharacteristics are equivalent tothe proposed device:• Flexural strength.• Stem tensile strength.• Dimensions.• Marking accuracy.• Ability to unclog.			Same
Prescription vs.OTC	Prescription only			Prescription only			Same
Contact Durations	< 24 hours			< 24 hours			Same
Sterile vs. Non-Sterile	Non-sterile			Non-sterile			Same
Disposable vs.Non-Disposable	Disposable			Disposable			Same
Single Use vs.Reusable	Single use			Single use			Same
Shelf Life	Yes: 3 years			No			Different

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Image /page/7/Picture/1 description: The image is a logo for Medline. The logo consists of the word "MEDLINE" in a sans-serif font, with a white cross-like symbol behind the text. The background of the logo is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a medical symbol.

Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093

Variations from the predicate device design are nonsignificant.

Summary of Non-Clinical Testing

Non- clinical verification of the Medline Quick-Clear Wand has been conducted to evaluate its safety, performance and functionality. The results of these tests have demonstrated the overall safety of the proposed device and ultimately support a substantial equivalence determination to the predicate, Tube DeClogger (K905164).

A summary of the testing performed is presented below.

Biocompatibility Testing

The biological evaluation for the Medline Quick-Clear Wand 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. The proposed device is intended to restore and maintain patency of feeding tubes; as such, the Medline Quick-Clear Wand is only intended to operate inside feeding tubes. Therefore, the proposed device has been categorized as a surface device with indirect contact with mucosal membrane for a limited duration of contact (< 24 hours).

The following biocompatibility tests were performed:

. Cytotoxicity - MEM Elution Using L-929 Mouse Fibroblast Cells per ISO 10993-5: 2009 "Biological Evaluation of Medical Devices-Part 5: Tests for in vitro Cytotoxicity."
Sensitization Guinea Pig Maximization Sensitization Test per ISO 10993-10: 2010: "Biological ● Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization."
Irritation Intracutaneous Irritation Test per ISO 10993-10: 2010: "Biological Evaluation of . Medical Devices- Part 10: Tests for Irritation and Skin Sensitization."

The biocompatibility test results indicate that the Medline Quick Clear Wand is considered to be noncytotoxic, non-sensitizing, and a non-irritant. Collectively, the test results indicate that the product meets the biocompatibility requirements and is considered safe for its intended use.

Performance Testing (Bench)

To evaluate the performance of Medline Quick-Clear Wand, the proposed device was subjected to the following performance testing:

. Flexural testing per ASTM D790-17 - Standard Test Methods For Flexure Properties Of Unreinforced Plastics And Electrical Insulating Materials, *
Seal strength testing per ASTM F88/F88M-15 Standard Test Method For Seal Strength Of ● Flexible Barrier Materials,

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Image /page/8/Picture/1 description: The image features the logo for Medline, a healthcare company. The logo is set against a blue square background. The word "MEDLINE" is written in white, bold sans-serif font, stacked on top of a white abstract star-like shape. The star shape has four points, with the top and bottom points being longer than the side points.

edline Industries. Inc hree Lakes Drive Northfield, IL 60093

Marking accuracy, * ●
Stem tensile strength. * ●
Handle connection strength,
Metrology*, and

. Simulated use testing. * *Predicate device included for comparison in testing.

Functional performance testing was performed on the final finished form of the proposed devices and the results demonstrate that all acceptance criteria were met.

Other Testing

. Bioburden: Environmental controls and bioburden monitoring supports safe bioburden levels for the indications for use.
Phthalates: Phthalates testing supports that Medline Quick-Clear Wand is nor made with DEHP or BPA.
Stability: Stability testing supports a shelf life of three (3) years. ●

Conclusion

In accordance with 21 CFR Part 807, and based on a comparison of 'Indications for Use,' technological characteristics and performance data, Medline Industries, Inc. concludes that the proposed Medline Quick-Clear Wand is substantially equivalent to the predicate device, Tube DeClogger (K905164).

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.