(90 days)
This product is intended for short-term use < 30 days in neonatal and pediatric patients to provide nutrition via nasal or oral gastric placement.
The NeoMed Gastrointestinal Tube and Accessories is a PVC single lumen catheter that is used to deliver liquid nutritional media. This NeoMed PVC feeding tube is designed to connect with other NeoMed accessories such as the NeoMed Extension tubing under FDA clearance K100288 and NeoMed oral syringe under FDA clearance K092908.
The device consists of the following main components: a feeding tube single lumen catheter and a one-piece molded enteral only connector hub with integral tethered connection closure plug. The catheter tubing has an orange radiopaque stripe of barium sulfate embedded in the tubing wall which can be visualized on x-ray, for exact placement of the tip. The tip is closed. The single lumen catheter tubing has side holes for better flow and to provide multiple openings for aspiration.
The provided text describes a 510(k) submission for the NeoMed Gastrointestinal Tube and Accessories, which seeks substantial equivalence to existing predicate devices. The study conducted to demonstrate this equivalence is primarily an engineering bench test study rather than a clinical study involving human patients or complex AI algorithms.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (General Purpose of Test) | Reported Device Performance |
|---|---|
| Biocompatibility | Materials have a long history of use in feeding tube manufacturing, are biocompatible, and testing in accordance with ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing passed. |
| Tensile Strength | Design verification functional test results, including tensile strength, demonstrate that the NeoMed Gastrointestinal Tube and Accessories performs its intended use. |
| Dimensions | Design verification functional test results, including dimensions, demonstrate that the NeoMed Gastrointestinal Tube and Accessories performs its intended use. |
| Non-Interconnectability | Design verification functional test results, including non-interconnectability, demonstrate that the NeoMed Gastrointestinal Tube and Accessories performs its intended use. |
| Priming Volume | Design verification functional test results, including priming volume, demonstrate that the NeoMed Gastrointestinal Tube and Accessories performs its intended use. |
| Substantial Equivalence (Overall) | Bench testing has demonstrated that the NeoMed Gastrointestinal Tube and Accessories is functionally equivalent to the proposed predicate feeding tubes. The device is concluded to be equivalent to the Vygon Nutrisafe 2 (KQ60944) and Kendall Argyle PVC Feeding Tube (K820441) with respect to intended use, materials, design, and technological characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "bench testing" and "design verification functional test results." It does not specify a "test set" in the context of patient data or algorithm performance. The testing involved physical tubes and components. No information is provided regarding the specific number of units tested for each functional test (tensile strength, dimensions, etc.), nor is there any mention of data provenance (e.g., country of origin) as the tests are laboratory-based engineering evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study is a bench test, and there is no mention of experts establishing a "ground truth" for a test set in the context of clinical or image-based evaluations. The "ground truth" for these engineering tests would be the established engineering specifications and performance standards.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication, as this study does not involve human interpretation or subjective assessments that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This study is an engineering bench test for physical device characteristics and does not involve human readers, AI assistance, or comparative effectiveness in a clinical setting.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No. This device is a physical medical tube, not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.
7. Type of Ground Truth Used
The ground truth used for this study is based on engineering specifications, material properties, and functional performance standards derived from the intended use and comparison with predicate devices. For example, for dimensions, the ground truth would be the specified dimensions in the design; for tensile strength, it would be the minimum required strength; for biocompatibility, it would be successful compliance with ISO 10993-1.
8. Sample Size for the Training Set
Not applicable. This study does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This study does not involve a "training set" for which ground truth would need to be established.
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K120/82
Page 1 of 3
APR 1 9 2012
NeoMe
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:
April 11, 2012
APPLICANT:
NeoMed, Inc. 100 Londonderry Ct Suite 112 Woodstock, GA 30188 Tony Lair, President Tel: 770-516-2225 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 Gastrointestinal Tube and Accessories
Classification Tubes, Gastrointestinal (and accessories) Name:
| DEVICE | Class II per 21 CFR §876.5980 |
|---|---|
| CLASSIFICATION AND | Gastroenterology/Urology |
| PRODUCT CODE: | Product Code: KNT |
| PREDICATE DEVICE | Vygon Nutrisafe 2, KO60944 |
|---|---|
| NAME: | Kendall Argyle PVC Feeding Tube, K820441 (Sherwood) |
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K12 0182
Page 2 of 3
SUBSTANTIAL EQUIVALENCE:
The NeoMed Gastrointestinal Tube and Accessories is substantially equivalent to the legally marketed Vygon Nutrisafe 2 (K060944) and Kendall Argyle PVC Feeding Tube (K820441). In addition, the NeoMed PVC feeding tube device design is the same as previously cleared NeoMed Silicone (K072881) and Polyurethane (K082238) Feeding Tubes.
TECNOLOGICAL CHARACTERISTICS:
The NeoMed Gastrointestinal Tube and Accessories have similar technological characteristics when compared to the predicate devices. They have similar indications for use, materials, product design, and principles of operation. Bench testing has demonstrated that the NeoMed Gastrointestinal Tube and Accessories is functionally equivalent to the proposed predicate feeding tubes. Any minor differences do not affect safety or effectiveness of the NeoMed Gastrointestinal Tube and Accessories.
DESCRIPTION OF THE DEVICE:
The NeoMed Gastrointestinal Tube and Accessories is a PVC single lumen catheter that is used to deliver liquid nutritional media. This NeoMed PVC feeding tube is designed to connect with other NeoMed accessories such as the NeoMed Extension tubing under FDA clearance K100288 and NeoMed oral syringe under FDA clearance K092908.
The device consists of the following main components: a feeding tube single lumen catheter and a one-piece molded enteral only connector hub with integral tethered connection closure plug. The catheter tubing has an orange radiopaque stripe of barium sulfate embedded in the tubing wall which can be visualized on x-ray, for exact placement of the tip. The tip is closed. The single lumen catheter tubing has side holes for better flow and to provide multiple openings for aspiration.
INTENDED USE/INDICATIONS FOR USE:
The NeoMed Gastrointestinal Tube and Accessories is intended for short-term use < 30 days in neonatal and pediatric patients to provide nutrition via nasal or oral gastric placement.
PERFORMANCE DATA:
The NeoMed Gastrointestinal Tube and Accessories materials have a long history of use in feeding tube manufacturing and are biocompatible and have been evaluated in accordance with ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing and these tests pass.
Design verification functional test results including tensile strength, dimensions, noninterconnectability, and priming volume demonstrate that the NeoMed Gastrointestinal Tube and Accessories performs its intended use and is substantially equivalent to the predicate devices by Kendall and Vygon.
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CONCLUSION:
Based on the performance testing, it can be concluded that the NeoMed Gastrointestinal Tube and Accessories is equivalent to the Vygon Nutrisafe 2 (KQ60944) and Kendall Argyle PVC Feeding Tube (K820441) predicts with respect to intended use, materials, design, and technological characteristics.
ly
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NeoMed, Inc. % Ms. Penny Northcutt President/CEO REGSolutions, LLC 717 Lakeglen Drive SUWANNEE GA 30024
APR 1 9 2012
Re: K120182
Trade/Device Name: NeoMed Gastrointestinal Tube and Accessories Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: January 19, 2012 Received: January 20, 2012
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 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 (reporting of medical
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Page 2-
device-related 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 1 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,
Sincerely yours,
Benjamin R. Fisher, Ph.D.
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
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Indications for Use
510(k) Number (if known):
Device Name: NeoMed Gastrointestinal Tube and Accessories
Indications For Use:
This product is intended for short-term use (< 30 days) in neonatal and pediatric patients to provide nutrition via nasal or oral gastric placement.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
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)
Huld Reimer
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K120182
Page 1 of _ 1_____________________________________________________________________________________________________________________________________________________________________________
Traditional 510(k) NeoMed, Inc. 1
NeoMed Gastrointestinal Tube and Accessories
§ 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.