(452 days)
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Not Found
No
The summary describes a standard enteral feeding set and makes no mention of AI or ML technology.
No
The device dispenses liquid nutrients, which is a supportive function and not a direct therapeutic treatment for a disease or condition. It's a method of feeding, a life-sustaining function, rather than a therapeutic intervention.
No
The device is described as an "enteral feeding set" used to "dispense liquid nutrients," indicating its function is for administering food, not for diagnosing medical conditions.
No
The device description clearly states "enteral feeding sets" which are physical devices used to dispense liquid nutrients. The description mentions components like bags and spikes, which are hardware. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are used to "dispense liquid nutrients (feeding solutions)" and "interface with the patient's feeding tube." This describes a device used for delivering substances into the body for nutritional purposes.
- IVD Definition: In vitro diagnostics are devices used to examine specimens from the human body (like blood, urine, tissue) to provide information about a person's health. This process happens outside the body ("in vitro").
- No Mention of Specimen Analysis: The description does not mention any analysis of bodily specimens or providing diagnostic information based on such analysis.
Therefore, the iMed Technology Enteral Feeding Set family falls under the category of devices used for patient care and treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The devices in the iMed Technology Enteral Feeding Set family are used to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense the feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a pre-filled container. These devices are food containing. These devices are to be issued by prescription only.
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
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Brandon Converse Director of Product Refinement iMed Technology, Inc. 17408 Tamaron Drive DALLAS TX 75287
DEC 1-6 2011
Re: K102712
Trade/Device Name: iMed Gravity Set, iMed Pump Set Regulation Number: 21 CFR$ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: November 3, 2011 Received: December 5, 2011
Dear Mr. Converse:
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
1
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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/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 vours.
Hubert Lenoir MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Premarket Notification 510(k) Traditional
4.0
INDICATIONS FOR USE STATMENT
The statement of Indications for Use for the Enteral Feeding Sets, in compliance with 21 CFR 807.87(e), is provided below:
Applicant: iMed Technology, Inc.
Device Name: iMed Gravity Set, iMed Pump Set
Indications For Use:
The devices in the iMed Technology Enteral Feeding Set family are used to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense the feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a pre-filled container. These devices are food containing. These devices are to be issued by prescription only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K102712
For Prescription Use
(Per 21 CFR 801.109)
iMed Technology, Inc