(134 days)
Not Found
No
The device description and performance studies focus on mechanical action and material properties, with no mention of AI or ML.
No.
The device is intended to clear occlusions in feeding tubes, which is a maintenance function for the tubes, not a direct therapeutic application for the patient's health condition.
No
The device is intended to clear occlusions/clogs from feeding tubes, which is a therapeutic action, not a diagnostic one. It restores the patency of the tube, it does not identify or analyze a condition.
No
The device description clearly states it is a "single use device" that is "manually inserted into the feeding tube" and uses a "rotating motion of the device (manually generated by the operator)" to mechanically act on the occlusion. This describes a physical, mechanical device, not software.
Based on the provided information, the Medline Quick-Clear Wand is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Medline Quick-Clear Wand Function: The Medline Quick-Clear Wand is a mechanical device used to physically clear blockages within feeding tubes that are already inserted into a patient's body. It does not analyze any biological specimens or provide diagnostic information about the patient's health. Its function is purely mechanical and therapeutic (restoring patency).
The description clearly states its purpose is to "restore and maintain patency of gastrostomy tubes (G-Tubes), jejunostomy tubes (J-Tubes), and percutaneous endoscopic (PEG) tubes" by mechanically acting on occlusions. This is a physical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KNT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrostomy tubes (G-Tubes), jejunostomy tubes (J-Tubes), and percutaneous endoscopic (PEG) tubes
Indicated Patient Age Range
infant patients over 10kg, children, adolescents, and adults.
Intended User / Care Setting
health care providers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (
§ 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.
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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.
1
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)
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.
| 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
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.
Indications for Use
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.
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
| Device
Characteristic | Proposed Device | Predicate Device
(K905164) | Comparison
Analysis |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Medline Quick-Clear Wand | Tube DeClogger | N/A |
| Intended Use | Intended for use in restoring and
maintaining patency of feeding
tubes. | Intended for use in restoring and
maintaining patency of feeding
tubes. | Same |
| Indications for Use | 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. | It is intended to be used by heath
care providers to restore and
maintain patency of gastrostmy
tubes (G-Tubes), jejunostomy
tubes (J-Tubes), and
percutaneous endoscopic
gastrostomy (PEG) tubes. | Same |
| Regulation
Name/Number | 21 CFR §876.5980
Gastrointestinal tube and
accessories | 21 CFR §876.5980
Gastrointestinal tube and
accessories | 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 ENFit
compatibility are printed on
handle. | One-piece design.
Color coded on the complete
assembly.
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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Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
| Product
Configurations | 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 |
| Performance
Characteristics | The following performance
characteristics are equivalent to
the predicate device:
• Flexural strength.
• Stem tensile strength.
• Dimensions.
• Marking accuracy.
• Ability to unclog. | | | | The following performance
characteristics are equivalent to
the proposed device:
• Flexural strength.
• Stem tensile strength.
• Dimensions.
• Marking accuracy.
• Ability to unclog. | | | Same |
| Prescription vs.
OTC | Prescription only | | | | Prescription only | | | Same |
| Contact Durations |