(55 days)
Not Found
Not Found
No
The summary describes a mechanical valve for a gastric tube and contains no mention of AI, ML, or related concepts.
No
The device prevents stomach contents from exiting the vent lumen of a gastric sump tube, reducing exposure to healthcare workers and preventing bedding and gown changes. It does not treat or diagnose a medical condition.
No
The device's function is to prevent stomach contents from exiting the vent lumen of a gastric sump tube, thereby reducing exposure to gastric fluids. This is a protective/preventative function, not a diagnostic one.
No
The description clearly describes a physical valve intended to be attached to a gastric sump tube, which is a hardware device. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that manages the flow of gastric contents and prevents exposure to healthcare workers. This is a mechanical function related to patient care and safety, not a diagnostic test performed on samples outside the body.
- Device Description: While the description is "Not Found," the intended use clearly indicates a physical device interacting with a gastric tube.
- No mention of diagnostic testing: There is no mention of analyzing samples, detecting substances, or providing diagnostic information about a patient's health status.
- Anatomical Site: The device interacts with the stomach, which is a physical location within the body, not a sample being tested.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Medline Anti-Reflux Valve allows the vent lumen of the gastric sump tube to neutralize the vacuum pressure in the stomach when the contents are fully evacuated, but prevents stomach contents from exiting the vent lumen. This reduces the risk that healthcare workers will be exposed to potentially infectious gastric fluids and also prevents unnecessary patient bedding and gown changes.
Product codes
FEG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare workers
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the branches of government.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2013
Medline Industries, Inc. % Matt Clausen Sr. Regulatory Affairs Specialist One Medline Place Mundelein, IL 60060
Re: K132314
Trade/Device Name: Medline Anti-Reflux Valve Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FEG Dated: July 22, 2013 Received: July 25, 2013
Dear Matt Clausen,
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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. 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 (reporting of
1
medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/1/Figure/6 description: The image shows the name "Herbert P. Lerner-S" in a stylized font. The name is written in black ink on a white background. The letters "P" and "L" are stylized with a decorative pattern.
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in bold, italicized letters. Above the word is a symbol that resembles a compass rose or a stylized star. The symbol has four points, with the bottom point extending further down than the others.
Medine Industries Inc. Medline Place ndelein, II 60060
Indications for Use
510(k) Number (if known):
Device Name: Medline Anti-Reflux Valve
Indications for Use:
The Medline Anti-Reflux Valve allows the vent lumen of the gastric sump tube to neutralize the vacuum pressure in the stomach when the contents are fully evacuated, but prevents stomach contents from exiting the vent lumen. This reduces the risk that healthcare workers will be exposed to potentially infectious gastric fluids and also prevents unnecessary patient bedding and gown changes.
Prescription Use X - -(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert Lerner -S