(55 days)
Not Found
No
The summary describes a physical feeding tube and does not mention any software, algorithms, or AI/ML related terms.
No.
The device is described as a feeding tube used for delivery of liquid nutritional media, which is a supportive rather than a therapeutic function.
No
The device is a feeding tube designed for delivering nutritional media, not for diagnosing medical conditions.
No
The device description clearly states it is a physical catheter made of polyurethane with a lumen, hub, and connector, indicating it is a hardware 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 the delivery of liquid nutritional media through the gastrointestinal tract. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device is a catheter for delivering substances, not for analyzing samples from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This feeding tube does not fit that description.
N/A
Intended Use / Indications for Use
The NeoMed Polyurethane Feeding Tube is intended for nasogastric or orogastric 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 (comma separated list FDA assigned to the subject device)
FPD, BSS
Device Description
The NeoMed Polyurethane Feeding Tube is a polyurethane single lumen catheter that is used to deliver liquid nutritional media. The device consists of the following main components: a feeding tube single lumen catheter, a hub with tethered connection closure plug, and a connector.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing has demonstrated that the NeoMed Polyurethane Feeding Tube is functionally equivalent to predicate NeoMed Silicone Enteral Feeding Tube, and that any minor differences do not affect safety or effectiveness.
Design verification performance test results demonstrate that the NeoMed Polyurethane Feeding Tube performs its intended use and is equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SUMMARY OF SAFETY & EFFECTIVENESS
Image /page/0/Picture/3 description: The image shows the logo for "NEOMED incorporated". The word "NEOMED" is in a sans-serif font, with a stylized "O" that has a small swirl above it. Below "NEOMED" is the word "incorporated" in a smaller, cursive font.
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.
| APPLICANT | NeoMed
FDA Owner/Operator #10022926
507 Hickory Ridge Trail
Suite 120
Woodstock, GA 30188
Tony Lair, President
Tel: 770-516-2225
Fax: 770-516-2448
Email: lair1@concentric.net |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL CORRESPONDENT | Penny Northcutt, RAC, CQA
Regulatory Consultant for NeoMed, Inc.
REGSolutions, LLC
Tel: 678-428-6978
Fax: 678-513-0937
Email: pennynorthcutt@theregsolutions.com |
| TRADE NAME: | NeoMed Polyurethane Feeding Tube |
| CLASSIFICATION NAME: | Gastrointestinal Tube and Accessories |
| DEVICE CLASSIFICATION
AND PRODUCT CODE | Class II per 21 CFR §876.5980
Product Code: 78 FPD |
| PREDICATE DEVICE NAME | NeoMed Silicone Enteral Feeding Tube (K072881)
Cleared January 8, 2008 |
SUBSTANTIAL EQUIVALENCE:
The NeoMed Polyurethane Feeding Tube is substantially equivalent to the NeoMed Silicone Enteral Feeding Tube cleared under K072881.
Both devices have the same method of operation, delivery of liquid nutrition media through a single lumen catheter. Bench testing has demonstrated that the NeoMed Polyurethane Feeding Tube is functionally equivalent to predicate NeoMed Silicone Enteral Feeding Tube, and that any minor differences do not affect safety or effectiveness.
$$\mathbf{s}$$
.
1
K082238
292
DESCRIPTION OF THE DEVICE:
The NeoMed Polyurethane Feeding Tube is a polyurethane single lumen catheter that is used to deliver liquid nutritional media.
The device consists of the following main components: a feeding tube single lumen catheter, a hub with tethered connection closure plug, and a connector.
INDICATIONS FOR USE:
The NeoMed Polyurethane Feeding Tube is intended for nasogastric or orogastric 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:
The NeoMed Polyurethane Feeding Tube materials that come in direct contact with the patient have a long history of use in catheter and feeding tube manufacture and are biocompatible according to ISO 10993. Design verification performance test results demonstrate that the NeoMed Polyurethane Feeding Tube performs its intended use and is equivalent to the predicate device.
CONCLUSION:
Based on the performance testing, it can be concluded that the NeoMed Polyurethane Feeding Tube is equivalent to the predicate NeoMed Silicone Enteral Feeding Tube with respect to intended use and technological characteristics.
NeoMed Polyurethane Feeding Tube Confidential
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
OCT 01 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NeoMed, Inc. c/o Ms. Penny Northcutt, RAC Official Correspondent Regsolutions, LLC 717 Lakeglen Drive SUWANEE GA 30024
K082238 Re:
Trade/Device Name: NeoMed Polyurethane Feeding Tube Regulation Number: 21 CFR $876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FPD, BSS Dated: September 17, 2008 Received: September 19, 2008
Dear Ms. Northcutt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/odrh/industry/support/index.html.
Sincerely yours,
Joppu M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: NeoMed Polyurethane Feeding Tube
Indications For Use:
The NeoMed Polyurethane Feeding Tube is intended for nasogastric or orogastric 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 _ X (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)
Hulsen
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 1 of
Special 510(k): Design Modification NeoMed, Inc.
NeoMed Polyurethane Feeding Tube Confidential
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