(306 days)
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 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.
This document describes the regulatory submission for the NUTRICARE – ISOSAF™ Naso-Gastric Feeding Tube, seeking substantial equivalence to a predicate device, rather than an AI-powered diagnostic device. Therefore, the questions related to AI-specific performance criteria (accuracy metrics, ground truth establishment, training/test sets, human reader studies, etc.) are not applicable to this submission.
The document focuses on demonstrating substantial equivalence based on:
- Intended Use: Both the new device and the predicate device are for supplying nutritional sources through a naso-gastric route.
- Technological Characteristics: Comparison of materials, design, sterilization, dimensions, and other physical properties.
- Non-Clinical Performance Data: Biocompatibility testing (in accordance with ISO 10993), mechanical testing (e.g., tensile strength, leakage, resistance to separation), and flow rate testing.
There is no mention of an AI algorithm, image analysis, or diagnostic performance evaluation with acceptance criteria related to sensitivity, specificity, or AUC.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI-powered diagnostics or answer the specific questions about sample sizes for test/training sets, expert consensus, adjudication methods, or MRMC studies, as these types of studies were not conducted or required for this device's 510(k) submission.
Summary of what can be extracted from the document regarding "acceptance criteria" (non-AI related):
The acceptance criteria for this device are demonstrated by its successful performance in a series of non-clinical tests, aligning with relevant industry standards and showing comparable performance to the predicate device. These tests are physical and material property tests, not performance metrics for an AI algorithm.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Test | Acceptance Criteria (Implied: Pass) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993) | Pass | Passed |
| Sensitization (ISO 10993) | Pass | Passed | |
| Intracutaneous Reactivity (ISO 10993) | Pass | Passed | |
| Mechanical Performance | Falling drop positive pressure liquid leakage (per AAMI/CN3:2014(PS)) | Pass | Pass |
| Stress Cracking | Pass | Pass | |
| Resistance to separation from axial load | Pass | Pass | |
| Resistance to separation from unscrewing | Pass | Pass | |
| Resistance to overriding | Pass | Pass | |
| Disconnection from unscrewing | Pass | Pass | |
| Tensile testing of the catheter | Pass | Pass | |
| Tensile testing of the connectors | Pass | Pass | |
| Corrosion testing of guide wire | Pass | Pass | |
| Liquid leakage | Pass | Pass | |
| Flow Rate Testing (EN 1618:1997) | As per standard | Passed | |
| Mechanical Testing of connector (AAMI/CN3:2014(PS)) | As per standard | Passed | |
| Dimensional analysis (AAMI/CN3:2014(PS)) | As per standard | Passed | |
| Risk Management | Risk Analysis (EN ISO 14971:2012), including misconnection risk | Identified & Mitigated | Conducted and reviewed |
| General Compliance | Compliance with applicable voluntary standards for biocompatibility & sterilization | Yes | Complies / Passed all testing |
2. Sample sized used for the test set and the data provenance: Not applicable. This is a medical tubing device, not an AI diagnostic with a "test set" of images/data for AI performance evaluation. The "tests" are laboratory-based physical and material tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI performance (e.g., confirmed disease status) is not relevant here. Decisions are based on objective physical/chemical test results against ISO/EN standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. See above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (feeding tube), not a diagnostic AI system requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for this device's acceptance is based on compliance with established international and national standards (ISO, EN, AAMI) for material properties and mechanical performance. This is not a diagnostic device where "ground truth" relates to clinical outcomes or expert labels.
8. The sample size for the training set: Not applicable. There is no AI training set.
9. How the ground truth for the training set was established: Not applicable. There is no AI training set.
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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
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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
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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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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
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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 FeedingTube |
| 510(k) Number | - | K083210 |
| Product Code | PIF | FPD |
| RegulationNumber | 21 CFR 876.5980 | 21 CFR 876.5980 |
| Regulation Name | Gastrointestinal tubes andaccessories | Gastrointestinal tubes andaccessories |
| Indications forUse | The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube device isinserted into the stomachthrough the nasal cavity for thepurpose of supplying anutritional source for thosepatients who are unable to feedthemselves. | The CORFLO® ANTI IV EnteralFeeding tube is intended for usein those patients who requireintermittent or continuous tubefeedings via the nasogastric ornasoenteric route |
| Material | Polyurethane | Polyurethane |
Table 54 - Comnarison of Characteristics
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| 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 unknownYes - 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 wireTip 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 | CytotoxicitySensitizationIntracutaneous 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 .
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- . 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
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referenced predicate devices.
§ 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.