(250 days)
Not Found
No
The summary describes a feeding tube with a safety connector and a different silicone formulation. There is no mention of AI, ML, image processing, or any data-driven algorithms.
No.
The device is used for enteral feeding, which is a supportive rather than a therapeutic function. It administers nutrients but does not treat a disease or condition.
No
The device description and intended use clearly state that it is for "nasogastric/oralgastric enteral feeding," which is a therapeutic function, not a diagnostic one. Its purpose is to deliver nutrients, not to identify a medical condition or disease.
No
The device description clearly describes physical feeding tubes made of silicone material, which are hardware components. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "nasogastric/oralgastric enteral feeding." This is a direct medical intervention for delivering nutrition, not for examining specimens from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description details a feeding tube and its connection system. It explicitly states that the connection "does not incorporate a luer, reducing the risk of inadvertent connection with an IV administration set or other medical delivery systems." This further reinforces its purpose as a feeding device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a medical device used for therapeutic purposes (feeding), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For nasogastric/oralgastric enteral feeding, incorporating safety connectors which reduce the risk of misconnections between feeding tubes and intravenous connectors.
Product codes
FPD
Device Description
The Nutrisafe 2 silicone feeding tubes are utilizing a different formulation of silicone material I he Nutrisate 2 silicone feeding tubes. The feeding tubes. The feeding tubes are available in several than the catisting Nutrioure is a unique connection does not incorporate a luer, reducing SIZCS, and the leveling system connains an IV administration set or other medical delivery the fisk of madvertenity connection reduces the risk of involuntary disconnection; voluntary systems: "The is achieved by simply unscrewing the hub connections.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
Non-Clinical verification of Nutrisafe 2 Feeding Tubes was conducted through in-vitro bench testing. Results of this testing indicate that the Nutrisafe 2 Feeding Tube material change meets all specifications and intended use.
Key Metrics
Not Found
Predicate Device(s)
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
Nutrisafe 2 Feeding Tubes Premarket Notification 510(k) Submission
510(k) SUMMARY DEC 1 8 2012 (As Required By 21 CFR §807.92) -K121105 510k number: Vygon Applicant: 103A Park Dr Montgomeryville, PA 18936 Jillian Mikovich Contact Name: Regulatory Affairs Specialist Phone: 800-473-5414 Fax: 215-672-6740 Nutrisafe 2 Feeding Tube Trade Name: Tubes, Feeding Common Name: 876.5980 Regulation Number: FPD Product Code: Gastrointestinal tube and accessories devices, 21 CFR §876.5980 Classification Name: Class II Regulatory Class: Nutrisafe 2 Feeding Tubes, K060944 Predicate Devices: Nutrisafe 2 Feeding Tubes, K100163 June 14, 2012 Date Prepared:
Device Description:
Device Description.
The Nutrisafe 2 silicone feeding tubes are utilizing a different formulation of silicone material I he Nutrisate 2 silicone feeding tubes. The feeding tubes. The feeding tubes are available in several than the catisting Nutrioure is a unique connection does not incorporate a luer, reducing SIZCS, and the leveling system connains an IV administration set or other medical delivery the fisk of madvertenity connection reduces the risk of involuntary disconnection; voluntary systems: "The is achieved by simply unscrewing the hub connections.
Intended Use:
For nasogastric oralgastric enteral feeding, incorporating safety connectors which reduce the risk of misconnections between feeding tubes and intravenous connectors.
Technology Characteristics:
The subject Nutrisafe 2 feeding tubes have the same technological characteristics of the predicate I he subject Natible = 100cmg asteristics are substantially equivalent to the predicate devices.
Non-Clinical Summary:
Non-Clinical verification of Nutrisafe 2 Feeding Tubes was conducted through in-vitro bench testing. Results of this testing indicate that the Nutrisafe 2 Feeding Tube material change meets all specifications and intended use.
14 June 2012
PREMARKET NOTIFICATION
14 June 201
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with healthcare and medicine.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2012
Vygon Corp. % Ms. Jillian Mikovich Regulatory Affairs Specialist . 103A Park Drive MONTGOMERYVILLE PA 18936
Re: K121105
Trade/Device Name: Nurisafe 2 Feeding Tube Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FPD Dated: December 12, 2012 Received: December 13, 2012
Dear Ms. Mikovich:
We have reviewed vour 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.
2
Page 2 - Ms. Jillian Mikovich
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 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/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,
Benjamin R. Fisher -S
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
3
Nutrisafe 2 Feeding Tubes Premarket Notification 510(k) Submission 14 June 2012
Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
Nutrisafe 2 Feeding Tube
For nasogastric/oralgastric enteral feeding, incorporating safety connectors which reduce the risk of misconnections between feeding tubes and intravenous connectors.
Prescription Use _ X
AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)
Benjamin R. Fjisher -S 2012.12.18 1/3:56:49 -05'00'
Division Sign-Off) Division of Reproductive, Gastro-Renal, a urological Devices 510(k) Number
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