(97 days)
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Not Found
No
The summary describes a mechanical reservoir system for managing gastric distention and enteral feeding, with no mention of AI, ML, or related concepts.
Yes
Explanation: The device is intended to treat gastric distention/bloating by evacuating excess gas and enteral feeding formula from the stomach, which constitutes a therapeutic action.
No
The device is described as a reservoir system for evacuating gas and feeding formula from the stomach, which is a therapeutic rather than a diagnostic function.
No
The device description clearly indicates a "reservoir system" and "connectors," which are physical components, not software.
Based on the provided information, the Farrell Valve is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for evacuating gas and feeding formula from the stomach of patients receiving enteral feeding. This is a direct interaction with the patient's body and their internal contents, not an analysis of samples taken from the body.
- Anatomical Site: The device operates within the stomach, which is an in-vivo (within the living body) application.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic testing, or the use of reagents, which are typical characteristics of IVDs.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Farrell Valve's function is purely mechanical and related to managing gastric contents.
N/A
Intended Use / Indications for Use
The Farrell Valve is a reservoir system intended to allow the evacuation of excess gas(gastric distention/bloating) and enteral feeding formula from the stomach of patients receiving enteral formula via feeding tubes and sets. Farrell Valve with CORFLO ANTI IV Connectors is for use with pediatric patients.
Product codes
KNT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Pediatric patients
Intended User / Care Setting
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6( Silver Spring, MD 20993-0002
Ms. Stephanie Wasielewski VP. Regulatory Affairs/Quality CORPAK MedSystems 100 Chaddick Drive WHEELING IL 60090
MAY 2 0 2010
Re: K100365
Trade/Device Name: FARRELL VALVE with CORFLO® ANTI IV Connectors Regulation Number: 21 CFR 8876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: May 7, 2010 Received: May 10, 2010
Dear Ms. Wasielewski:
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, 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. 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
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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/ReportaProblem/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,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
510(k): K100365
Device Name: FARRELL VALVE with CORFLO® ANTI IV Connectors
Indications for use:
The Farrell Valve is a reservoir system intended to allow the evacuation of excess gas(gastric distention/bloating) and enteral feeding formula from the stomach of patients receiving enteral formula via feeding tubes and sets. Farrell Valve with CORFLO ANTI IV Connectors is for use with pediatric patients.
Prescription Use ﺎ (Per 21 CFR 801.109)
or Over-the-counter use
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulu Lemun
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number