(354 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a feeding tube and extension set, with no mention of AI or ML.
No
The device is for the delivery of nutritional media, which is a supportive function, not a therapeutic treatment for a disease or condition.
No
The device is intended for the delivery of nutritional media, not for diagnosing a condition or disease.
No
The device description clearly details physical components like tubes, connectors, and a radiopaque stripe, and the performance studies focus on bench testing of these physical properties. There is no mention of software as a component or function of the device.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The VR Medical Feeding Tube and Enteral Feeding Extension Set are designed for the delivery of liquid nutritional media directly into the gastrointestinal tract. They are used for feeding, not for testing samples from the body.
- Intended Use: The intended use clearly states "nasogastric delivery of various types of liquid nutritional media" and "provide nutrition via nasal or oral gastric placements." This is a therapeutic/supportive function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and function of the tubes and extension sets for feeding.
- Performance Studies: The performance studies listed are related to the physical integrity, flow rate, and compatibility of the feeding system, not diagnostic accuracy or performance on biological samples.
Therefore, the VR Medical Feeding Tube and Enteral Feeding Extension Set fall under the category of devices used for enteral feeding, which is a form of medical nutrition delivery, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The VR Medical 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.
The Enteral Feeding Extension Set (EFES) is intended for use as an extension set for nasogastric / oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors/small bore connectors which are intended to reduce the misconnection between the following applications: I.V. system and Enteral Feeding System.
The EFES 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 (comma separated list FDA assigned to the subject device)
FPD, KNT, PIF
Device Description
Enteral Feeding Tube
The VR Medical Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the qastro intestinal tract of neonatal, pediatric and is not intended for use beyond 30 days.
They are sterile, individually packaged. The orange color coding provides easy visual recognition of the enteral connection. They are designed with a radiopague stripe for X-ray visualization to confirm proper feeding tube placement. They are marked with French size and markings to assist tube placement or check for migration. A tethered plug for connector closure is incorporated when not in use.
Enteral Feeding Extension Sets
The Enteral Feeding Extension Sets ("EFES") are intended to provide access from the feeding tube to a syringe or nutritional source accepting a connector for enteral applications. They are available in multiple configurations: with and without an in-line Y port and lengths.
The EFES are sterile disposable device for single patient use only. The EFES is designed to connect existing feeding tubes (nasogastric, gastric, etc.) to various delivery enteral syringes as well as to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. i.e., the device cannot be connected to a luer connector
The EFES consists of flexible tubing with an orange strip for easy quick identification of enteral feeding lines as well as a "For Enteral Feeding Only" tag and a 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
gastro intestinal tract (nasogastric, orogastric, gastric)
Indicated Patient Age Range
neonatal and small pediatric patients, Neonate and pediatric patients.
Intended User / Care Setting
Hospital, sub-acute care and home settings.
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)
Non-clinical Bench Testing was performed on the Enteral Feeding Tube and Extension Set using the following standards:
- ISO 80369-3. First Edition. Small-bore Connectors for Liquids and Gases in Healthcare Applications - Part 3: Connectors for Enteral Applications
- ISO 80369-20, First Edition, Small-bore Connectors for Liquids and Gases in Healthcare Applications - Part 20: Common Test Methods
- ISO 80369-1, Small-bore Connectors for Liquids and Gases in Healthcare Applications - Part 1: General requirements
- EN1615: 2000, Enteral feeding catheters and enteral giving sets for single use and their connectors-Design and testing
- ANSI/AAMI ID54:1996/(R) 2012, "Enteral feeding set adapters and connectors"
- EN1618:1997 Catheters other than intravascular catheters-Test methods for common properties
Performance testing of the Enteral Feeding Tube (EFT) was conducted for:
- Connector Compatibility Test
- Tensile Property Test of tubing
- Tensile Property Test of bonding between connectors and tubing
- Liquid Leakage Test
- Tensile Property test of Assembled connection of connectors
- Connector Performance test
- Printing Firmness Test
- Priming Volume Test
- Flow Rate Test using Enfamil solution
- Radiopaque Capacity Test
- Connector Incapability test with specific connectors
Performance testing of the Enteral Feeding Extension Sets (EFES) was conducted for:
- Connector Compatibility Test
- Connector Performance test
- Tensile Property Test of tubing
- Tensile Property Test of bonding between connectors and tubing
- Liquid Leakage Test
- Tensile Property test of Assembled connection of connectors
- Priming Volume Test
- Flow Rate Test using Enfamil solution
- Connector Incapability test with specific connectors
Biocompatibility evaluation for the Enteral Feeding Tube and Enteral Feeding Extension Set was performed in accordance with FDA Draft Guidance on the Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".
- The VR Medical Enteral Feeding Tubes are a Surface Contacting, mucosal membrane, prolonged duration (> 24 hours,
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 18, 2019
VR Medical Technology Co., Ltd % Paul E. Dryden Consultant VR Medical c/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704
Re: K180236
Trade/Device Name: VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: FPD, KNT, PIF Dated: December 7, 2018 Received: December 10, 2018
Dear Paul E. Dryden:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel G. Walter Jr -S
for
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180236
Device Name
VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
Indications for Use (Describe)
The VR Medical 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 bevond 30 days.
The Enteral Feeding Extension Set (EFES) is intended for use as an extension set for nasogastric / oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors/small bore connectors which are intended to reduce the misconnection between the following applications: I.V. system and Enteral Feeding System.
The EFES 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.
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (7/17)
3
Image /page/3/Picture/1 description: The image shows a logo for VR Medical. The logo features the letters "VR" in a stylized font, with a green plus sign above the "R". Below the letters, the words "VR Medical" are written in a simple font. A curved green line is below the letters.
| Date Prepared: | 11-Jan-2019 |
|---|---|
| Submitter: | VR Medical Technology Company, Ltd. |
| 90 Gao Xin Road | |
| ZhouZhuang | |
| Kunshan Jiangsu, China 215325 | |
| T - +86 512 5720 0500 | |
| Official Contact: | Lee Pan, Ph.D., CEO |
| Proprietary or Trade Name: | VR Medical Feeding Tube and |
| Enteral Feeding Extension Set (EFES) | |
| Common/Usual Name: | Tubes, Gastrointestinal (And Accessories) |
| Classification Name: | Gastrointestinal Tube and Accessories |
| Classification Details: | 21CFR 876.5980 |
| FPD, KNT, PIF | |
| Class II | |
| Predicate Devices: | K100526 - Kentec Enteral Feeding Tube |
| K150084 – Covidien Argyle PVC Enteral Feeding Tubes | |
| K120272 - Kentec Enteral Feeding Tube Extension Set |
Device Description:
Enteral Feeding Tube
The VR Medical Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the qastro intestinal tract of neonatal, pediatric and is not intended for use beyond 30 days.
They are sterile, individually packaged. The orange color coding provides easy visual recognition of the enteral connection. They are designed with a radiopague stripe for X-ray visualization to confirm proper feeding tube placement. They are marked with French size and markings to assist tube placement or check for migration. A tethered plug for connector closure is incorporated when not in use.
Enteral Feeding Extension Sets
The Enteral Feeding Extension Sets ("EFES") are intended to provide access from the feeding tube to a syringe or nutritional source accepting a connector for enteral applications. They are available in multiple configurations: with and without an in-line Y port and lengths.
The EFES are sterile disposable device for single patient use only. The EFES is designed to connect existing feeding tubes (nasogastric, gastric, etc.) to various delivery enteral syringes as well as to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. i.e., the device cannot be connected to a luer connector
The EFES consists of flexible tubing with an orange strip for easy quick identification of enteral feeding lines as well as a "For Enteral Feeding Only" tag and a slide clamp to provide the additional safety assurance for connection errors.
Indications for Use:
The VR Medical Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the qastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.
4
Image /page/4/Picture/2 description: The image shows a logo for VR Medical. The logo features the letters "V" and "R" in a stylized, interconnected design, with a green medical cross positioned above the "V". A curved, green line underlines the letters, adding a sense of motion or support. Below the logo, the words "VR Medical" are written in a simple, sans-serif font.
The Enteral Feeding Extension Set (EFES) is intended for use as an extension set for nasogastric / oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors/small bore connectors which are intended to reduce the misconnection between the following applications: I.V. system and Enteral Feeding System.
The EFES 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.
Patient Population:
Neonate and pediatric patients.
Environments of use:
Hospital, sub-acute care and home settings.
Comparison to Predicates
Enteral Feeding Tube Comparison
The VR Medical Feeding Tube and Enteral Feeding Extension Set are substantially equivalent to the predicate devices, based upon the similar indications for use and similar technological characteristics.
Table 1 - Substantial Equivalence Comparison Table - VR Medical Feeding Tube and Enteral Feeding Extension Set to the predicate devices summarizes the comparison of the VR Medical subject devices to the predicate devices.
Table 1 - Substantial Equivalence Comparison Table – VR Medical Feeding Tube to the Predicate Enteral Feeding Tube Devices
| Characteristics | VR Medical Feeding Tube | Kentec Enteral PU Feeding Tube (K100526) | Arygle PVC Feeding Tube (K150084) |
|---|---|---|---|
| Indications for Use | The device 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 | The device 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 | The device is intended for enteral feeding to deliver enteral nutrition, liquid or medication to patient from an enteral feeding syringe or feeding set designed with a connector for enteral application. The device is intended for pediatric patients who require enteral feeding. |
| Regulation | 21CFR 876.5980 | 21CFR 876.5980 | 21CFR 876.5980 |
| Number and Product Code | Product Code: FPD | Product Code: FPD | Product Code: PIF |
| Single-Patient Use | Yes | Yes | Yes |
| Disposable | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes |
| Use Environment | Hospital or environments where placement of a feeding tube is required. | Hospital or environments where placement of a feeding tube is required. | Hospital or environments where placement of a feeding tube is required. |
| Patient Population | Neonatal and pediatric patients | Neonatal and pediatric patients | Neonatal and pediatric patients |
| Feeding Tube | Polyurethane (PU) | Polyurethane (PU) | NA |
| Polyvinyl Chloride (PVC) | No | Polyvinyl Chloride (PVC) | |
| Small Bore (ENFit) Connector, Cap and Y Connector Base | Yes | Yes | |
| ENFit not part of submission | Yes |
INDICATIONS FOR USE SUBSTANTIAL EQUIVALENCY COMPARISON
5
Image /page/5/Picture/0 description: The image shows a logo for VR Medical. The logo features a stylized blue "VR" with a green medical cross above the "V". Below the "VR" is the text "VR Medical" in a smaller font size. The bottom of the logo has a green curved line.
| TECHNICAL CHARACTERISTICS FOR SUBSTANTIAL EQUIVALENCY COMPARISON | |||
|---|---|---|---|
| A single lumen catheter | |||
| Sizes | French sizes - (4 – 12 Fr) | ||
| Lengths - (40 - 110 cm) | French sizes – (4 - 12 Fr) | ||
| Lengths - (40 - 110 cm) | French sizes - (3.5- 10 Fr) | ||
| Lengths - (31 to 107 cm) | |||
| Oral Connector | Yes | Yes | Yes |
| ENFit Connector | Yes | Not in the original file | Yes |
| Cap | Yes | Yes | Yes |
| Provided Sterile | Yes (ETO Sterilization) | Yes (ETO Sterilization) | Yes |
| Connector Design | |||
| Compliant to ISO | |||
| 80369-3 | ENFIT Connector | ENFIT Connector | ENFIT Connector |
| Performance | |||
| Testing per ISO | |||
| 80369-3 | Connector performance | Connector performance | Yes |
| Performance | |||
| Testing Per | |||
| EN1615 | Yes | ||
| Biocompatibility ISO | |||
| 10993-1 | Surface Contacting. Mucosal | ||
| membrane, Prolonged duration | |||
| Cytotoxicity, Sensitization, Irritation. | |||
| Acute systemic and Sub-acute | |||
| toxicity, Implantation (14 day) and | |||
| Pyrogenicity | Surface Contacting. Mucosal | ||
| membrane, Prolonged duration | |||
| Cytotoxicity, Sensitization, Irritation | Surface Contacting, Mucosal | ||
| membrane, Prolonged duration |
Substantial Equivalence Discussion for Enteral Feeding Tubes
The VR Medical Feeding Tube and the predicate devices have similar indications for use.
Both the subject and predicate devices are prescription, sterile, disposable and single use devices intended for enteral use to provide nutrition/liquids via nasal or oral gastric placement.
Both the subject and predicate devices have similar use environment and patient populations. Both are intended to be used at Hospital or environments where placement of a feeding tube is required for neonatal and pediatric patients.
Comparison of the Enteral Feeding Tube to the Predicate Device for Component and Materials
The subject devices have similar materials and components and construction.
Comparison of the Enteral Feeding Tube to the Predicate Device for Technological Characteristics
Both the VR Medical Enteral Feeding Tube and Predicate Feeding Tube devices have a single lumen catheter with connector that is designed to be compatible only with enteral access devices or accessories. Both the subject and predicate devices are sterile, individual packaged, and available in various sizes.
The performance of the subject device has been established in performance testing conducted in accordance with ISO 80369-3 and EN1615.
6
Image /page/6/Picture/2 description: The image shows the logo for VR Medical. The logo features the letters "VR" in a stylized, interconnected design, with the "V" and "R" in a dark blue color. Above the "VR" is a green medical cross symbol, and below the letters is the text "VR Medical" in a smaller font size.
Enteral Feeding Extension Set Substantial Equivalence Comparison
The Enteral Feeding Extension Sets are substantially equivalent to the predicate device, based upon the same intended use and indications for use, and similar technological characteristics.
Table 2 summarizes the comparison of the VR Medical subject devices to the predicate device in terms of intended use and technological characteristics.
Table 2 - Substantial Equivalence Comparison Table -Enteral Feeding Extension Sets to the Predicate
| Comparison Table - VR Medical Enteral Feeding Extension Sets to the Predicate | ||
|---|---|---|
| Characteristics | VR Medical Enteral Feeding Tube Extension Set | Kentec Enteral Feeding Tube Extension Set (K120272) |
| Indications for Use | The Enteral Feeding Extension Set (EFES) is intended for use as an extension set for nasogastric / oral gastric or gastric tube enteral feeding tubes, incorporating safety connectors/small bore connectors which are intended to reduce the misconnection between the following applications: I.V. system and Enteral Feeding System. | |
| The EFES is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oralgastric placements. | The Ameritus® Enteral Feeding 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 IV system to the enteral system or the enteral system to an IV system. | |
| Single-Patient Use | Yes | Yes |
| Disposable | Yes | Yes |
| Sterile | Yes | Yes |
| Use Environment | Hospital or environments where placement of a feeding tube is required. | Hospital or environments where placement of a feeding tube is required. |
| Patient Population | Neonatal and pediatric patients | Neonatal and pediatric patients |
| COMPONENT AND MATERIALS FOR SUBSTANTIAL EQUIVALENCY COMPARISON | ||
| Characteristics | VR Medical Enteral Feeding Tube Extension Set | Kentec Enteral Feeding Tube Extension Set (K120272) |
| Tubing | Polyvinyl Chloride (PVC) | Polyvinyl Chloride (PVC) |
| Lengths | 22" to 60" | 22" to 60" |
| Connectors | Male / Female | Male / Female |
| Slides | Yes | Yes |
| Performance | ||
| Testing per ISO | ||
| 80369-3 | Connector Compatibility | |
| Connector Performance | Yes | |
| Performance | ||
| Testing Per | ||
| EN1615 | Tensile Property Test of tubing | |
| Tensile Property Test of bonding | ||
| Liquid Leakage Test | ||
| Internal Capacity Test | ||
| Flow Rate Test | EN 1615 | |
| Biocompatibility ISO | ||
| 10993-1 | Surface Contacting. Mucosal membrane, Prolonged duration | |
| Cytotoxicity, Sensitization, Irritation. Acute systemic and Sub-acute toxicity, Implantation (14 day) and | Externally Communicating, Mucosal membrane, | |
| Prolonged duration | ||
| Cytotoxicity ,Sensitization, Irritation |
7
Image /page/7/Picture/2 description: The image shows a logo for VR Medical. The logo features the letters "V" and "R" in a stylized, connected design, with a green medical cross positioned above the "R". A curved green line appears beneath the letters, giving the impression of an arc or a base. Below the logo, the words "VR Medical" are written in a smaller, sans-serif font.
The VR Medical Enteral Feeding Tube Extension Sets and the predicate devices both have similar indications for use.
Both the subject and predicate devices have similar use environment and patient populations. Both are intended to be used at Hospital or environments where placement of a feeding tube is required for neonatal and pediatric patients.
Comparison of the Enteral Feeding Extension Set to the Predicate Device for Component and Materials
The subject devices have similar materials and components and construction.
Comparison of the Enteral Feeding Extension Set to the Predicate Device for Technological Characteristics
Both the Enteral Feeding Tube Extension Sets and Predicate are tubing with connectors that allow connection between the solutions and the Feeding Tube. Both the subject and predicate devices are supplied sterile, individual packaged, and available in various lengths and configurations.
The performance of the subject device has been established in performance testing conducted in accordance with ISO 80369-3 and EN 1615.
Summary of Performance Testing
Non-clinical Bench Testing
Enteral Feeding Tube and Extension Set have been tested using the following standards:
ISO 80369-3. First Edition. Small-bore Connectors for Liquids and Gases in Healthcare Applications - Part 3: Connectors for Enteral Applications
ISO 80369-20, First Edition, Small-bore Connectors for Liquids and Gases in Healthcare Applications - Part 20: Common Test Methods
ISO 80369-1, Small-bore Connectors for Liquids and Gases in Healthcare Applications - Part 1: General requirements
EN1615: 2000, Enteral feeding catheters and enteral giving sets for single use and their connectors-Design and testing
ANSI/AAMI ID54:1996/(R) 2012, "Enteral feeding set adapters and connectors"
EN1618:1997 Catheters other than intravascular catheters-Test methods for common properties
The following performance testing of the Enteral Feeding Tube (EFT) was conducted.
- a. Connector Compatibility Test in accordance with section 4.2.1 of EN1615: 2000 Enteral feeding catheters and enteral giving sets for single use and their connectors-Design and Testing and ANSI/AAMI ID54: 1996/(R) 2012 Enteral feeding set adapters and connectors.
- b. Tensile Property Test of tubing in accordance with section 4.2.2.1 of EN1615: 2000 Enteral feeding catheters and enteral giving sets for single use and their connectors-Design and testing.
- ﻥ Tensile Property Test of bonding between connectors and tubing in accordance with section 4.2.2.1 of EN1615: 2000 Enteral feeding catheters and enteral giving sets for single use and their connectors-Design and testing.
8
Image /page/8/Picture/2 description: The image shows a logo for VR Medical. The logo features a stylized letter "R" in blue, with a green medical cross positioned above and to the left of the "R". Below the "R", the text "VR Medical" is written in a smaller font size, also in blue. The logo has a modern and professional look, likely representing a healthcare or medical-related company.
- d. Liquid Leakage Test in accordance with section 4.3.2 of EN1615: 2000 Enteral feeding catheters and enteral giving sets for single use and their connectors-Design and testing.
- e. Tensile Property test of Assembled connection of connectors in accordance with section 4.3.1 of EN1615: 2000 Enteral feeding catheters and enteral giving sets for single use and their connectors-Design and testing.
- Connector Performance test in accordance with ISO 80369-3: 2016 Small-bore f. connectors for liguids and gases in healthcare applications- Part3: Connectors for enteral applications.
- Printing Firmness Test in accordance with ASTM D3359-09 Standard Test Methods g. for Measuring Adhesion by Tape Test.
- Priming Volume Test h.
- Flow Rate Test using Enfamil solution i.
- Radiopaque Capacity Test j.
- k. Connector Incapability test with specific connectors which defined in ISO 80369-1: 2010 Section 5.1 & Annex B.
The following performance testing of the Enteral Feeding Extension Sets (EFES) was conducted.
- Connector Compatibility Test in accordance with section 4.1.2 of EN1615: 2000 a. Enteral feeding catheters and enteral giving sets for single use and their connectors-Design and testing and ANSI/AAMI ID54: 1996/(R) 2012 Enteral feeding set adapters and connectors.
- Connector Performance test in accordance with ISO 80369-3: 2016 Small-bore ﻒ connectors for liquids and gases in healthcare applications- Part3: Connectors for enteral applications.
- Tensile Property Test of tubing in accordance with section 4.1.1 of EN1615: 2000 C. Enteral feeding catheters and enteral giving sets for single use and their connectors-Design and testing.
- ರ. Tensile Property Test of bonding between connectors and tubing in accordance with section 4.1.1 of EN1615: 2000 Enteral feeding catheters and enteral giving sets for single use and their connectors-Design and testing.
- Liquid Leakage Test in accordance with section 4.1.3 & 4.3.2 of EN1615: 2000 e. Enteral feeding catheters and enteral giving sets for single use and their connectors-Design and testing.
- Tensile Property test of Assembled connection of connectors in accordance with f. section 4.3.1 of EN1615: 2000 Enteral feeding catheters and enteral giving sets for single use and their connectors-Design and testing.
- Priming Volume Test g.
- Flow Rate Test using Enfamil solution h.
- Connector Incapability test with specific connectors which defined in ISO 80369-1: i. 2010 Section 5.1 & Annex B.
Biocompatibility
The biocompatibility evaluation for the Enteral Feeding Tube and Enteral Feeding Extension Set was conducted in accordance with the FDA Draft Guidance on the Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".
The VR Medical Enteral Feeding Tubes are a
- Surface Contacting, mucosal membrane, prolonged duration (> 24 hours,