(57 days)
Not Found
No
The summary describes a physical feeding tube and its components, with no mention of software, algorithms, or AI/ML capabilities.
No.
A therapeutic device is one that treats or cures a disease or condition. This device is a feeding tube used to deliver nutrition, which is supportive care rather than therapeutic.
No
The device is a feeding tube designed for delivering nutritional media and medication, and its Radiopaque stripe is for confirming placement, not for diagnosing conditions.
No
The device description clearly outlines physical components made of polyurethane and silicone, including a catheter, connector, and plug. It is a hardware device for delivering fluids.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of liquid nutritional media and medication directly into the gastrointestinal tract. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device is a feeding tube, a physical conduit for delivering substances into the body. It does not perform any tests on samples taken from the body to diagnose a condition.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze blood, urine, tissue, or any other biological sample to provide information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This feeding tube does not fit that description.
N/A
Intended Use / Indications for Use
The Amertius Entral™ Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.
Product codes
FPD
Device Description
The Ameritus Entral™ Feeding Tubes are composed of two families of Feeding Tubes each made with different materials: polyurethane and silicone. The two families of Feeding Tubes are all made with a single lumen catheter that is used to deliver fluids as prescribed by the physician including liquid nutritional media and/or medication.
The Ameritus Entral " Feeding Tubes are sterile, individually packaged, Latex Free and DEHP Free. The orange color coding provides easy visual recognition of the enteral connection. The Ameritus Entral "" Feeding Tubes are designed with a Radiopaque stripe for X-ray visualization to confirm proper feeding tube placement. French size and length clearly printed on the feeding tube as well as centimeter markings (approx.) to assist tube placement or check for migration. A Tethered plug for connector closure is incorporated to prevent air and fluid ingress when not in use.
The device consists of the following main components: A feeding tube single lumen catheter and a connector with molded closure plug.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastro intestinal tract
Indicated Patient Age Range
neonatal and small 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
Both design verification and performance test results demonstrated that Ameritus Entral™ Feeding Tube two families made of either Polyurethane or Silicone performed as per their intended use and are equivalent to their respective predicate devices.
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
Premarket Notification - Ameri
Image /page/0/Picture/1 description: The image shows the logo for KENTEC MEDICAL, INC. The logo features a stylized letter "A" on the left, with the company name "KENTEC" in bold, sans-serif font to the right. Below "KENTEC" is the text "MEDICAL, INC." in a smaller font size.
APR 2 2 2010
SUMMARY OF SAFETY & EFFECTIVENESS
This 510k summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| APPLICANT | Kentec Medical, Inc.
17871 Fitch
Irvine, CA 92614
Tel: 949-863-0810
Fax: 949-833-9730 |
|---------------|---------------------------------------------------------------------------------------------------|
| OFFICIAL | Keith Books |
| OFFICIAL | Keith Rooks |
| CORRESPONDENT | QA/RA Manager |
| | Tel: 949-863-0810 |
| | Fax: 949-833-9730 |
| | Kjrooks@kentecmedical.com |
| TRADE NAME | Ameritus® Entral™ Polyurethane Feeding Tube |
|---|---|
| . Ameritus® Entral™ Silicone Feeding Tube |
| COMMON OR USUAL NAME | Feeding Tube |
|---|---|
| CLASSIFICATION NAME | Gastrointestinal Tubes and accessories |
| DEVICE CLASSIFICATION | Class II per 21CFR §876.5980 |
| PRODUCT CODE | FPD |
| PREDICATE DEVICE | |
| NAMES | NeoMed Polyurethane Enteral Feeding Tube (K082238) |
| NeoMed Silicone Enteral Feeding Tube (K072881) |
SUBSTANTIAL EQUIVALENCE
The Ameritus Entral™ Feeding Tubes made of either Polyurethane or Silicone are substantially equivalent to the Neomed Polyurethane and Silicone Enteral Feeding Tubes.
The devices have the same method of operation, delivery of fluids including liquid nutrition media and medication through single lumen catheter. Bench testing demonstrated that Ameritus Entral™ Feeding Tubes made of either Polyurethane or Silicone are functionally equivalent to the predicate devices and that any minor differences do not affect safety or effectiveness.
DESCRIPTION OF DEVICE
The Ameritus Entral™ Feeding Tubes are composed of two families of Feeding Tubes each made with different materials: polyurethane and silicone. The two families of Feeding Tubes are all made with a single lumen catheter that is used to deliver fluids as prescribed by the physician including liquid nutritional media and/or medication.
The Ameritus Entral " Feeding Tubes are sterile, individually packaged, Latex Free and DEHP Free. The orange color coding provides easy visual recognition of the enteral connection. The Ameritus Entral "" Feeding
1
Premarket Notification - Ameritu
Tubes are designed with a Radiopaque stripe for X-ray visualization to confirm proper feeding tube placement. French size and length clearly printed on the feeding tube as well as centimeter markings (approx.) to assist tube placement or check for migration. A Tethered plug for connector closure is incorporated to prevent air and fluid ingress when not in use.
The device consists of the following main components: A feeding tube single lumen catheter and a connector with molded closure plug.
INDICATIONS FOR USE
The Amerius Entral™ Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.
PERFORMANCE DATA
Both design verification and performance test results demonstrated that Ameritus Entral™ Feeding Tube two families made of either Polyurethane or Silicone performed as per their intended use and are equivalent to their respective predicate devices.
CONCLUSION
Based on performance testing test results, Kentec Medical can conclude that the Ameritus Entral™ Feeding tube two families made of either Polyurethane or Silicone are equivalent to their respective predicate device with respect to intended use and technological characteristics.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a stamp or seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6( Silver Spring, MD 20993-0002
Mr. Keith Rooks RA/QA Manager Kentec Medical, Inc. 17871 Fitch IRVINE CA 92614
APR 2 2 2010
· Re: K100526 Trade/Device Name: Ameritus Entral" Feeding Tubes Regulation Number: 21 CFR §876.5980 · Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FPD Dated: April 13, 2010
Received: April 13, 2010
Dear Mr. Rooks:
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
3
Page 2 -
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
4
K100526 510(k) Number (if known):
Device Name: Ameritus Entral™ Feeding Tubes
Indications For Use:
The Amertius Entral™ Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.
Prescription Use (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)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Device 510(k) Number
Kentec Medical, Inc.
CONFIDENTIAL
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