(306 days)
Not Found
No
The summary describes a physical medical device (feeding tube) and its mechanical properties, with no mention of software, algorithms, or AI/ML terms.
No.
The device is for supplying nutritional sources, not for treating a disease or condition. Supplying nutrition is a supportive function, not a therapeutic one in this context.
No
The device is described as a feeding tube used to supply nutrition, not to diagnose a condition. Its function is to deliver substances, not to detect or analyze body conditions.
No
The device description explicitly details physical components like a polyurethane tube, guide wire, and connector, and the performance studies focus on mechanical and material properties, indicating it is a hardware device.
Based on the provided information, the NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to supply nutritional sources directly into the stomach or alimentary canal. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The device is a tube designed for insertion into the body to deliver substances. It does not involve the examination of specimens derived from the human body for diagnostic purposes.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or provide information about a patient's health status or disease.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube does not fit this description. It is a medical device used for direct patient care and treatment.
N/A
Intended Use / Indications for Use
The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube device is inserted into the stomach through the nasal cavity for the purpose of supplying a nutritional source for those patients who are unable to feed themselves.
Product codes (comma separated list FDA assigned to the subject device)
PIF
Device Description
The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube is an enteral feeding tube designed for continuous or intermittent use. It comprises of radio-opaque polyurethane tube with guide wire set and ENFit connector.
The guide wire set is composed of a rigid guide wire and a male threaded connector, which is inserted into the polyurethane tube. They're depth marks printed on the tube in order to provide reference about the depth of insertion to the practitioner.
The tube is to be inserted through the nasal or oral area and feed down into the alimentary canal system (i.e. stomach area, duodenum or small intestine as intended). The guide wire with male connector is removed when the insertion is done leaving the tube and ENFit connector in situ. Only a female ENFit enteral syringe can be attached to the ENFit connector when in use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach, nasal cavity
Indicated Patient Age Range
Not Found
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 biocompatibility of the NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube has been demonstrated through appropriate in vitro tests on the device. The device has been assessed in accordance with ISO 10993 and does not introduce any additional safety risk over the predicate device.
The following testing has been performed (per AAMI/CN3:2014(PS) where applicable) to support substantial equivalence:
- Falling drop positive pressure liquid leakage pass
- . Stress Cracking - pass
- . Resistance to separation from axial load – pass
- Resistance to separation from unscrewing – pass
- . Resistance to overriding – pass
- Disconnection from unscrewing pass .
- . Tensile testing of the catheter – pass
- . Tensile testing of the connectors – pass
- . Corrosion testing of guide wire – pass
- Liquid leakage - pass
A comparative study performed demonstrates that the NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube performs as intended and is safe for its intended use when compared with the predicate device.
A Risk Analysis including analysis of the risk of misconnection has been conducted in accordance with EN ISO 14971:2012
As part of demonstrating safety and effectiveness of NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube and in showing substantial equivalence to the predicate device that are subject to this 510(k) submission, GBUK Enteral Limited completed a number of test as detailed below:
- . Flow Rate Testing in accordance with EN 1618:1997
- Mechanical Testing of the connector in accordance with AAMI/CN3:2014(PS) and AAMI/CN3:2014(PS), respectively
- Dimensional analysis in accordance with AAMI/CN3:2014(PS)
The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube passed all testing stated above as shown by the acceptable results obtained.
The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or progress.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2016
Gbuk Enteral Limited % Leeanne Baker Regulatory Consultant Advena Medical Pure Offices, Plato Close Warwick, CV34 6WE United Kingdom
Re: K151503
Trade/Device Name: NUTRICARE - ISOSAF™ Naso-Gastric Feeding Tube Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and accessories Regulatory Class: Class II Product Code: PIF Dated: February 2, 2016 Received: February 12, 2016
Dear Leeanne Baker,
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education 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.
Herbert P. Lerner -S
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
Indications for Use
510(k) Number (if known) K151503
Device Name
Nutricare ISO-SAF Naso-Gastric Feeding Tube
Indications for Use (Describe)
The NUTRICARE ISO-SAF Naso-gastric Feeding Tube device is inserted into the stomach through the nasal cavity for the purpose of supplying a nutritional source for those patients who are unable to feed themselves.
| Type of Use (Select one or both, as applicable) | ☑ Research Use (Per 21 CFR 201.66; Subject to Review) ☐ Other Commercial Use (21 CFR 201.66) | ☑ Research Use (Per 21 CFR 201.66; Subject to Review) | ☐ Other Commercial Use (21 CFR 201.66) |
|---|---|---|---|
| ☑ Research Use (Per 21 CFR 201.66; Subject to Review) | ☐ Other Commercial Use (21 CFR 201.66) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
for
NUTRICARE – ISOSAF™ NASO-GASTRIC FEEDING TUBE
1. Submission Sponsor
- GBUK Enteral Limited Blackwood Hall Business Park North Duffield Selby North Yorkshire, YO8 5DD United Kingdom Phone: +44 (0)1757 282945 Contact: Mark Thompson, Managing Director
2. Submission Correspondent
Advena Medical Pure Offices Plato Close Warwick CV34 6WE United Kingdom Cell Phone: +44 (0)7876 688344 Office Phone +44 (0)1926 800153 Contact: Leeanne Baker, Regulatory Consultant Email: Leeanne.baker@advenamedical.com
3. Date Prepared
20th May 2015
4. Device Identification
| Trade/Proprietary Name: | NUTRICARE – ISOSAFTM NASO-GASTRIC FEEDING TUBI |
|---|---|
| Common/Usual Name: | Tube, feeding |
| Classification Name: | Gastrointestinal tube and accessories |
| Classification Regulation: | 21 CFR 876.5980 |
| Product Code: | PIF |
| Device Class: | Class II |
| Classification Panel: | Gastroenterology/ Urology |
5. Legally Marketed Predicate Device(s)
K083210 – CORFLO Anti-IV Enteral Feeding Tube Model Number 20-XXX
4
6. Device Description
The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube is an enteral feeding tube designed for continuous or intermittent use. It comprises of radio-opaque polyurethane tube with guide wire set and ENFit connector.
The guide wire set is composed of a rigid guide wire and a male threaded connector, which is inserted into the polyurethane tube. They're depth marks printed on the tube in order to provide reference about the depth of insertion to the practitioner.
The tube is to be inserted through the nasal or oral area and feed down into the alimentary canal system (i.e. stomach area, duodenum or small intestine as intended). The guide wire with male connector is removed when the insertion is done leaving the tube and ENFit connector in situ. Only a female ENFit enteral syringe can be attached to the ENFit connector when in use.
7. Indication for Use Statement
The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube device is inserted into the stomach through the nasal cavity for the purpose of supplying a nutritional source for those patients who are unable to feed themselves.
8. Substantial Equivalence Discussion
The following table compares the NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Table 5A - Comparison of Characteristics | ||
|---|---|---|
| Manufacturer | GBUK ENTERAL LTD | CORPAC INC. |
| Trade Name | NUTRICARE ISO-SAF™ Naso- | |
| gastric Feeding Tube | Corflo Anti IV Enteral Feeding | |
| Tube | ||
| 510(k) Number | - | K083210 |
| Product Code | PIF | FPD |
| Regulation | ||
| Number | 21 CFR 876.5980 | 21 CFR 876.5980 |
| Regulation Name | Gastrointestinal tubes and | |
| accessories | Gastrointestinal tubes and | |
| accessories | ||
| Indications for | ||
| Use | The NUTRICARE ISO-SAF™ Naso- | |
| gastric Feeding Tube device is | ||
| inserted into the stomach | ||
| through the nasal cavity for the | ||
| purpose of supplying a | ||
| nutritional source for those | ||
| patients who are unable to feed | ||
| themselves. | The CORFLO® ANTI IV Enteral | |
| Feeding tube is intended for use | ||
| in those patients who require | ||
| intermittent or continuous tube | ||
| feedings via the nasogastric or | ||
| nasoenteric route | ||
| Material | Polyurethane | Polyurethane |
Table 54 - Comnarison of Characteristics
5
| Manufacturer | GBUK ENTERAL LTD | CORPAC INC. |
|---|---|---|
| Trade Name | NUTRICARE ISO-SAFT™ Naso-gastric Feeding Tube | Corflo Anti IV Enteral Feeding Tube |
| Sterile | Yes - Ethylene Oxide | Rest unknown |
| Yes - Ethylene Oxide | ||
| Overall Design | ||
| Proximal Connector | Single connector ENFit/ISO 80369-1 compliant | Luer slip two (2) ports |
| Distal feeding port | Dual openings on opposite sides of tube at offset levels | Single opening |
| Distal Tip | Continuous with diameter of rest of tube. Extra radiopaque tip | Contoured larger than diameter of rest of tube |
| Fully Radiopaque throughout length | Yes | Yes |
| Cm Markings | Numbered markings throughout the length of the tube | Markings through the length of the tube |
| Overall length | 50cm - 120cm | 55cm - 140cm |
| Guidewire | Twisted metal wire with sealed tip ends prior to the feeding port to prevent accidental emergence | Braided metal wire |
| Tip ends prior to the feeding port to prevent accidental emergence | ||
| Diameter | 6Fr to 12Fr | 5Fr to 12Fr |
| Duration of Use | Short term (up to 30 days) | Short term |
| Single-Use | Yes | Yes |
| Shelf Life | 3 years | 5 years |
| Latex Free | Yes | Yes |
| Complies with ISO 10993-1 | Cytotoxicity | |
| Sensitization | ||
| Intracutaneous Reactivity | Unknown but assumed to comply as has 510k | |
| ISO 80369-1 ENFIT compliant | Yes | Current product has luer slip connector |
9. Non-Clinical Performance Data
The biocompatibility of the NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube has been demonstrated through appropriate in vitro tests on the device. The device has been assessed in accordance with ISO 10993 and does not introduce any additional safety risk over the predicate device.
The following testing has been performed (per AAMI/CN3:2014(PS) where applicable) to support substantial equivalence:
- Falling drop positive pressure liquid leakage pass ●
- . Stress Cracking - pass
- . Resistance to separation from axial load – pass
- Resistance to separation from unscrewing – pass
- . Resistance to overriding – pass
- Disconnection from unscrewing pass .
6
- . Tensile testing of the catheter – pass
- . Tensile testing of the connectors – pass
- . Corrosion testing of guide wire – pass
- Liquid leakage - pass
A comparative study performed demonstrates that the NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube performs as intended and is safe for its intended use when compared with the predicate device.
A Risk Analysis including analysis of the risk of misconnection has been conducted in accordance with EN ISO 14971:2012
As part of demonstrating safety and effectiveness of NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube and in showing substantial equivalence to the predicate device that are subject to this 510(k) submission, GBUK Enteral Limited completed a number of test as detailed below:
- . Flow Rate Testing in accordance with EN 1618:1997
- Mechanical Testing of the connector in accordance with AAMI/CN3:2014(PS) and AAMI/CN3:2014(PS), respectively
- Dimensional analysis in accordance with AAMI/CN3:2014(PS)
The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube passed all testing stated above as shown by the acceptable results obtained.
The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.
10. Clinical Performance Data
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the difference between the NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube and the predicate devices do not raise any questions regarding its safety and effectiveness. The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube, as designed and manufactured, is determined to be substantially equivalent to the
7
referenced predicate devices.