(183 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, and there is no mention of AI or ML.
No.
This device is an extension set for enteral feeding; it delivers nutrition but does not treat a disease or condition.
No
The device is an extension set for enteral feeding tubes, designed to prevent misconnection with IV systems. It does not perform any diagnostic function.
No
The device description clearly outlines a physical medical device consisting of tubing, connectors, and a clamp, with performance studies focused on mechanical and material properties. There is no mention of software components.
Based on the provided information, the NeoMed Enteral Only Extension Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to connect enteral feeding tubes to delivery systems for feeding. This is a direct medical intervention on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description details a physical device for connecting tubes and delivering fluids, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to perform tests on samples (like blood, urine, tissue) outside of the body to diagnose, monitor, or screen for diseases or conditions. The NeoMed Enteral Only Extension Set is a device used for delivering nutrition directly into the patient's digestive system.
N/A
Intended Use / Indications for Use
The NeoMed Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental connection of an I.V. system to the enteral system or the enteral system to an I.V. system.
This device is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements.
Product codes
KNT
Device Description
The NeoMed Enteral Only Extension Set is a sterile disposable for single patient use only device designed to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. The device consists of flexible PVC tubing designed to connect existing feeding tubes (nasogastric, oralgastric, etc) to various delivery systems in including pumps and syringes. The set consists of tubing with an enteral connector (catheter tip) and an oral syringe connector not compatible with IV tubing or stopcocks. The NeoMed Enteral Only Extension Set provides an orange stripe for easy quick identification of enteral feeding lines as well as an "Enteral Only" tag and slide clamp to provide the additional safety assurance for connection errors.
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
neonatal and 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)
The NeoMed Enteral Only Extension Set materials have a long history of use in extension set and feeding tube manufacturing and are biocompatible. Design verification functional test results demonstrate that the NeoMed Enteral Only Extension Set performs its intended use.
The functional tests conducted were mechanical: tensile, strain, elongation and physical/properties testing comprised of dimensional verification, flow rate, and hub compatibility. Packaging challenges for package integrity and product stability were conducted with aging studies. All materials have been evaluated in accordance with ISO 10993-1: Biological Evaluation of Medical Devices – part 1: Evaluation and Testing and the three tests conducted - cytotoxicity, sensitization, and irritation pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K100288 page 1 of 2
NEOMED
incorporated
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| DATE | August 2, 2010 |
|---|---|
| APPLICANT | NeoMed |
| 100 Londonderry Ct | |
| Suite 112 | |
| Woodstock, GA 30188 | |
| Tony Lair, President | |
| Tel: 888-876-2225 | |
| e-mail: lair1@concentric.net | |
| OFFICIAL | |
| CORRESPONDENT | Penny Northcutt, RAC, CQA |
| Regulatory Consultant for NeoMed, Inc. | |
| REGSolutions, LLC | |
| Tel: 678-428-6978 | |
| Fax: 678-513-0937 | |
| e-mail: pennynorthcutt@theregsolutions.com | |
| TRADE NAME | NeoMed Enteral Only Extension Set |
| CLASSIFICATION | |
| NAME | Tubes, Gastrointestinal (and accessories) |
| DEVICE | |
| CLASSIFICATION | |
| AND PRODUCT | |
| CODE | Class II per 21 CFR §876.5980 |
| Gastroenterology/Urology | |
| Product Code: KNT | |
| PREDICATE | |
| DEVICE NAME | Respironics Enteral Only Extension Set, K082654 |
SUBSTANTIAL EQUIVALENCE:
The NeoMed Enteral Only Extension Set is substantially equivalent to the Respironics Enteral Only Extension Set cleared under K082654.
Both devices have similar indications for use, materials, product design, and method of operation. Bench testing has demonstrated that the NeoMed Enteral Only Extension Set is functionally equivalent to the proposed predicate extension set. Any minor differences have no impact affect safety or effectiveness of the NeoMed Enteral Only Extension Set.
1
K1002 88
Page 2 of 2
NEÖMED
incorporated
DESCRIPTION OF THE DEVICE:
The NeoMed Enteral Only Extension Set is a sterile disposable for single patient use only device designed to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. The device consists of flexible PVC tubing designed to connect existing feeding tubes (nasogastric, oralgastric, etc) to various delivery systems in including pumps and syringes. The set consists of tubing with an enteral connector (catheter tip) and an oral syringe connector not compatible with IV tubing or stopcocks. The NeoMed Enteral Only Extension Set provides an orange stripe for easy quick identification of enteral feeding lines as well as an "Enteral Only" tag and slide clamp to provide the additional safety assurance for connection errors.
INTENDED USE/INDICATIONS FOR USE:
The NeoMed Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental connection of an I.V. system to the enteral system or the enteral system to an I.V. system.
This device is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements.
PERFORMANCE DATA:
The NeoMed Enteral Only Extension Set materials have a long history of use in extension set and feeding tube manufacturing and are biocompatible. Design verification functional test results demonstrate that the NeoMed Enteral Only Extension Set performs its intended use.
The functional tests conducted were mechanical: tensile, strain, elongation and physical/properties testing comprised of dimensional verification, flow rate, and hub compatibility. Packaging challenges for package integrity and product stability were conducted with aging studies. All materials have been evaluated in accordance with ISO 10993-1: Biological Evaluation of Medical Devices – part 1: Evaluation and Testing and the three tests conducted - cytotoxicity, sensitization, and irritation pass,
CONCLUSION:
Based on the performance testing, it can be concluded that the NeoMed Enteral Only Extension Set is equivalent to the Respironics Enteral Only Extension Set predicate with respect to intended use, materials, design, and technological characteristics,
Traditional 510(k) NeoMed, Inc.
NeoMed Enteral Only Extension Set
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HU." are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002
AUG 3 -
2010
Neomed, Inc. c/o Ms. Penny Northcutt Executive Director REGSolutions, LLC 717 Lakeglen Drive SUWANEE GA 30024
· Re: K100288
Trade/Device Name: Neomed enteral only extension set Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: KNT Dated: July 28, 2010 Received: July 29, 2010
Dear Ms. Northcutt:
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 intestode 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, Drive 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, listion 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 (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.
.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Hubert Lehman MD
erbert 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
4
K100288
Indications for Use
AUG 3- 2010
K100288
Device Name: Neomed Enteral Only Extension Set
Indications For Use: The NeoMed Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental misconnection with an I.V. system to the enteral system or the enteral system to an I.V. system.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Heled Remu
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K100288