The ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 10 Fr and 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes.

The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags.

Device Description

The ENvizion Medical ENvue System is an electro-mechanical device with embedded software designed to aid in the placement of the ENvizion Medical Enteral Feeding Tube (with or without stylet), which is an enteral feeding tube placed into the stomach or small intestine of patients requiring enteral feeding. The ENvue System tracks the Enteral Feeding Tube (EFT) as it progresses through the oro/nasoenteric route down the esophagus, into the stomach and to the small intestine anatomy and displays the placement pathway in real time during placement. Once the placement is completed, the user disconnects the ENvue from the EFT. The EFT connects to a feeding pump using ENFit connections.

This Special 510(k) notification adds 4 new models of EFTs, that include a stainless-steel stylet.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics that would typically be evaluated in a clinical study. Instead, it focuses on demonstrating substantial equivalence to a predicate device and reference devices by ensuring that the differences do not raise new questions of safety or effectiveness. The performance data section describes tests completed to demonstrate substantial equivalence, rather than defining strict numerical acceptance criteria for a new feature's performance.

However, based on the performance data listed, we can infer some criteria and the reported outcome:

Acceptance Criteria (Inferred)	Reported Device Performance
Biocompatibility	Complies with ISO 10993-1, no new/significantly modified risks
Dimensional Inspection	Successfully passed (for stylet only)
Bond Strength	Successfully passed (Stylet to connector hub)
Tubing Stiffness Comparison	Stiffness of ENvizion EFTs with stylet is less than CORFLO reference device, resulting in no new/significantly modified risks
Simulated Use	Confirmed no impact of stylet on tracking
Shelf Life Validation	Confirmed no impact of stylet on EFT shelf-life
Conformity to Standards	Continues to conform to BS/EN 1615:2000, BS/EN 1618:1997, ANSI/AAMI/ISO 10993-1:2009(R) 2013, IEC 60601-1, IEC 60601-1-2, IEC 62366-1:2015, ISO 80369-3: 2016
Safety & Effectiveness	Differences do not raise new or different questions of safety and effectiveness; device is safe, effective, and performs as well or better than the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes non-clinical performance testing (biocompatibility, mechanical testing, simulated use, shelf life) rather than a clinical study with a "test set" of patients. Therefore, specific sample sizes for a clinical test set are not applicable here.

The data provenance is from laboratory and engineering testing conducted by the manufacturer, ENvizion Medical Ltd., to demonstrate compliance with standards and equivalence to predicate devices. No information about country of origin for data is provided beyond the manufacturer's location (Israel), as these are internal product verification and validation tests. The tests were performed to address the addition of a new feature (stylet) to an already cleared device, not for initial market clearance based on extensive clinical data.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This submission focuses on non-clinical performance data and equivalence for an incremental change to a medical device, not a diagnostic AI device requiring expert consensus for ground truth. The "ground truth" here is established by engineering and biological testing standards and comparison to a known predicate.

4. Adjudication Method for the Test Set:

Not applicable, as this was not a clinical study requiring adjudication of expert interpretations for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study was not done. The device is not an AI-assisted diagnostic tool that would typically undergo such a study to evaluate human reader improvement. The ENvizion Medical ENvue System aids in the physical placement of feeding tubes.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is an electro-mechanical system with embedded software designed to assist a qualified operator in a physical procedure (feeding tube placement), not a standalone algorithm providing diagnostic or predictive outputs without human intervention. The "performance data" presented relates to the physical and mechanical properties and safety of the device components.

7. Type of Ground Truth Used:

The "ground truth" in this context is established through:

Engineering specifications and test standards: For dimensional inspection, bond strength, tubing stiffness, and simulated use.
Biological safety standards: ISO 10993-1 for biocompatibility.
Comparison to predicate and reference devices: To demonstrate that the modified device performs "as well or better" and that differences do not raise new safety or effectiveness concerns.

8. Sample Size for the Training Set:

Not applicable. This submission is for an electro-mechanical device with embedded control software, not a machine learning or AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no "training set" in the context of this device and submission type.

Summary

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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.

June 14, 2019

Envizion Medical Ltd. % Clay Anselmo Principal Consultant Shriner & Associates 429 Whitepine Creek Road Trout Creek, Montana 59872

Re: K191387

Trade/Device Name: ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube And Accessories Regulatory Class: Class II Product Code: KNT, PIF Dated: May 24, 2019 Received: May 24, 2019

Dear Clay Anselmo:

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. Although this letter refers to your product as a device, please be aware 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

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Shani P. Haugen, Ph.D. Acting, Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K191387

Device Name

ENvizion Medical ENvue System ENvizion Medical Enteral Feeding Tube

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Introduction:

This document contains the 510(k) Summary for the ENvizion Medical ENvue and ENvizion Medical Enteral Feeding Tube. The content of this summary is based on the requirements set forth in 21 CFR 807.92(c).

SUBMITTER INFORMATION

Applicant / ManufacturerName and Address	ENvizion Medical Ltd.7 Haarad StreetTel Aviv, 6971060IsraelPhone +972 72-2288240
510(k) contact person	Clay AnselmoPrincipal Quality and Regulatory ConsultantShriner & Associates429 Whitepine Creek RoadTrout Creek, MT 59874Clay.anselmo@shrinerandassociates.com(303) 907-2955
Date prepared	May 24, 2019
DEVICE IDENTIFICATION
Trade names	ENvizion Medical ENvue SYSTEMENvizion Medical Enteral Feeding Tube
Common name	Gastrointestinal tube and accessories
Classification name	Gastrointestinal Tubes And Accessories
Regulation Number	21 CFR Part 876.5980
Classification	Class II

PREDICATE DEVICE

Trade names	ENvizion Medical ENvueENvizion Medical Enteral Feeding Tube
510(k) number	K182915

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DEVICE DESCRIPTION

This Special 510(k) notification adds 4 new models of EFTs, that include a stainless-steel stylet.

INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERISTICS COMPARISON

Substantial Equivalence: The modified version of the ENvizion Medical ENvue with ENvizion Medical Enteral Feeding Tubes is substantially equivalent to the unmodified version of the device (ENvizion Medical ENvue with ENvizion Medical Enteral Feeding Tubes).

The 510(k) Substantial Equivalence Decision-making Process (detailed) from the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] was followed as described below:

The ENvue device has the same intended use and the same indications for use as the Predicate device.
The ENvue device uses the same fundamental technology as the Predicate device and very similar detailed technological characteristics. The only difference between the devices is the addition of 4 new EFT models incorporating a stainless-steel stylet to address some customer's preference for a stiffer tube during insertion. The stylet being added to these 4 new models is identical in technology, materials, manufacturing methods, and specifications, with the exception of length, to the stylet used in the Cediflo device cleared in K181787.
The small differences between the ENvue device and the Predicate do not raise new types of questions of safety or effectiveness
- The biocompatibility of both products' patient contact materials complies with ISO O 10993-1 in accordance with FDA guidance related to the application of this standard.
- The stylet being added to the EFTs is equivalent to the stylet being used in the cited O reference devices and the stiffness of the ENvizion EFTs with the stylet is less than

CONFIDENTIAL

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the CORFLO reference device, resulting in no new / significantly modified risks as a result of the modification.

PERFORMANCE DATA

There are no known performance standards for this device.

The Enteral Feeding Tube were verified and validated in accordance with 820.30. The following tests were completed to demonstrate substantial equivalence and that any technological differences do not raise new or different questions of safety and effectiveness. The device successfully passed all of the testing and the results demonstrate the device is safe, effective, and performs as well or better than the predicate device.

Biocompatibility – Stylet and connector hub only
Dimensional Inspection Stylet only .
Bond strength – Stylet to connector hub
Tubing Stiffness Comparison - Impact of Stylet on tubing stiffness
Simulated Use - Confirm no impact of stylet on tracking
. Shelf Life Validation – Impact of stylet on EFT shelf-life

The device continues to conform to the following voluntary recognized consensus standards:

BS/EN 1615:2000 – Enteral feeding catheters and enteral giving sets for single use and their connectors. Design and testing.
BS/EN 1618:1997 – Catheters other than intravascular catheters. Test methods for common properties.
ANSI/AAMI/ISO 10993-1:2009(R) 2013 Biological evaluation of medical devices Part 1: ● Evaluation and testing within a risk management process
IEC 60601-1, Ed. 3: Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance; Corrigendum 1(2006): Corrigendum 2 (2007)
IEC 60601-1-2 Ed 4.0: Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
IEC 62366-1:2015: Medical devices -- Part 1: Application of usability engineering to medical devices
. ISO 80369-3: 2016: Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications

Characteristic	ENvizion Medical™ENvue(Predicate Device)	CORPAK CORFLONasoentericFeeding Tubes(Reference Device)	Cediflo EnteralFeeding Tubes(Reference Device)	Modified ENvizionMedical™ ENvue(Subject Device)	Comparisonto Predicate/ ReferenceDevice
510(k) Number	K182915	K821906	K181787	N/A	N/A
RegulationNumber	21 CFR 876.5980	21 CFR 876.5980	21 CFR 876.5980	21 CFR 876.5980	Identical
Characteristic	ENvizion Medical™ENvue(Predicate Device)	CORPAK CORFLONasoentericFeeding Tubes(Reference Device)	Cediflo EnteralFeeding Tubes(Reference Device)	Modified ENvizionMedical™ ENvue(Subject Device)	Comparisonto Predicate/ ReferenceDevice
ClassificationName	GastrointestinalTube andAccessories.	GastrointestinalTube andAccessories.	GastrointestinalTube andAccessories.	GastrointestinalTube andAccessories.	Identical
ProductClassificationCode	KNT, PIF	KNT	PIF	KNT	Identical toPredicate
Regulatory Class	Class II	Class II	Class II	Class II	Identical
Intended Use	Aids qualifiedoperators in theplacement of the ofnasoenteralfeeding tubes intothe stomach orsmall intestine ofpatients requiringenteral feeding.	Delivery ofnutrition, fluids,and medications tothe stomach orbowel	Delivery of nutrition,fluids, andmedications to thestomach or bowel	Aids qualifiedoperators in theplacement of the ofenteral feedingtubes into thestomach or smallintestine ofpatients requiringenteral feeding.	Identical toPredicate
Indications forUse	The ENvizion MedicalENvue System is designedto aid qualified operatorsin the placement of theENvizion Medical EnteralFeeding Tube of 10 Fr and12 Fr into the stomach orsmall intestine of adultpatients requiring enteralfeeding. The ENvizionMedical ENvue System isintended as an adjunct tocurrent placementpractices for assistingclinical practitioners whoplace feeding tubes.The ENVIZION MEDICALEnteral Feeding Tube (EFT)has been specificallydesigned for use with theENvue System and isintended for placement inthe stomach or smallintestine. It is intended foruse in adult patients whorequire intermittent orcontinuous feeding via theoro/nasoenteric route.The EFT is intended only tobe used with a feedingpump and is notcompatible with gravity-based feeding bags	The CORFLO NasoentericFeeding Tube is intendedfor use in those patientswho require intermittentor continuous tubefeedings via thenasogastric or nasoentericfeeding route.	The Cediflo Enteral FeedingTubes are intended for theadministration of enteralnutrition, fluids, and/ormedications by thenasoenteric route into thestomach or small intestine.Indicated for patients 2 yearsand above which requirenutritional support, are notable to meet their nutritionalrequirements by oral intakeand have functioning andaccessible gastrointestinaltract. Maximum duration ofuse: 42 days.	The ENvizion MedicalENvue System is designedto aid qualified operatorsin the placement of theENvizion Medical EnteralFeeding Tube of 10 Fr and12 Fr into the stomach orsmall intestine of adultpatients requiring enteralfeeding. The ENvizionMedical ENvue System isintended as an adjunct tocurrent placementpractices for assistingclinical practitioners whoplace feeding tubes.The ENVIZION MEDICALEnteral Feeding Tube (EFT)has been specificallydesigned for use with theENvue System and isintended for placement inthe stomach or smallintestine. It is intended foruse in adult patients whorequire intermittent orcontinuous feeding via theoro/nasoenteric route.The EFT is intended only tobe used with a feedingpump and is notcompatible with gravity-based feeding bags	Identical toPredicate
Characteristic	ENvizion Medical™ENvue(Predicate Device)	CORPAK CORFLONasoentericFeeding Tubes(Reference Device)	Cediflo EnteralFeeding Tubes(Reference Device)	Modified ENvizionMedical™ ENvue(Subject Device)	Comparisonto Predicate/ ReferenceDevice
OperatingPrinciple anddesign	Rechargeable batterypoweredelectromagnetic (EM)system sensingtechnology to track anddisplay path of feedingtube using an EMTracking System,Computer and Display.The EM Transmitter isthe Field Generator andthe system usesmultiple EM Receiversincluding oneintegrated in the tubedistal tip.A single-use	A single-usepolyurethaneradiopaque tube andtip (for X-rayvisualization).Nutrition isadministered with thepolymeric tubingproviding a fluid pathbetween the nutritionalsupplement source (e.g.feeding bag or feedingpump) and the stomachor small intestine of thepatient.	The Cediflo EnteralFeeding Tubes are sterile,single use devicesintended for use in acutecare facilities, long-termcare facilities, and home.They are made fromradiopaque polyurethanetubing printed withcentimeter markings andbonded at the proximalend to a rigid male ENFitconnector with a tetheredcap. These tubes aresupplied with or without aguidewire.	Rechargeable batterypoweredelectromagnetic (EM)system sensingtechnology to track anddisplay path of feedingtube using an EMTracking System,Computer and Display.The EM Transmitter isthe Field Generator andthe system usesmultiple EM Receiversincluding oneintegrated in the tubedistal tip.A single-use	SubstantiallyEquivalent.EFT's withstylet areequivalent toReferenceDevicesDifferencesdo not raisenew ordifferentquestionsregardingsafety or
	polyurethaneradiopaque tube andtip (for X-rayvisualization). Nutritionis administered withthe polymeric tubingproviding a fluid pathbetween the nutritionalsupplement source (i.e.feeding pump) and thestomach or smallintestine of the patient.			polyurethaneradiopaque tube andtip (for X-rayvisualization) availablewith and without stylet.Nutrition isadministered with thepolymeric tubingproviding a fluid pathbetween the nutritionalsupplement source (i.e.feeding pump) and thestomach or smallintestine of the patient.	effectiveness
Tube Type	Multi Lumenwithout stylet	Single lumen withstylet	Single lumen withand without stylet	Multi Lumen withand withoutoptional stylet	Equivalent toReferenceDevices
Tube OuterDiameter	10 and 12Fr	8 to 12 Fr	5 to 16Fr	10 and 12Fr	Identical toPredicate
Tube UsableLength	36 to 55 in91 to 140 cm	36 to 55 in91 to 140 cm	20 to 47in50cm to 120cm	36 to 55 in91 to 140 cm	Identical toPredicate
Patientcontacting tubingmaterial	Polyurethane	Polyurethane	Polyurethane	Polyurethane	Identical
Biocompatibility	FDA application ofISO 10993	ISO 10993	FDA application ofISO 10993	FDA application ofISO 10993	Identical toPredicate
FeedingConnector	80369-3 Connector- ENFit	80369-3 Connector- ENFit	80369-3 Connector- ENFit	80369-3 Connector- ENFit	Identical
Sterilization	Non-sterile	Non-sterile	Sterile	Non-sterile	Identical toPredicate
Target User	Intended for use byphysicians	Intended for use byphysicians	Intended for use byphysicians	Intended for use byphysicians	Identical
Characteristic	ENvizion Medical™ENvue(Predicate Device)	CORPAK CORFLONasoentericFeeding Tubes(Reference Device)	Cediflo EnteralFeeding Tubes(Reference Device)	Modified ENvizionMedical™ ENvue(Subject Device)	Comparisonto Predicate/ ReferenceDevice
technicians andnutritionists.	technicians andnutritionists.	technicians andnutritionists.	technicians andnutritionists.	technicians andnutritionists.
Use Environment	Hospitals and otherhealthcare facilities	Hospitals and otherhealthcare facilities	Hospitals and otherhealthcare facilities	Hospitals and otherhealthcare facilities	Identical
Access /Anatomical Site	Oro / Nasoenteric	Nasoenteric	Oro / Nasoenteric	Oro / Nasoenteric	Identical toPredicate
Energy Type –For EFT Tracking	ElectromagneticField	ElectromagneticField	N/A	ElectromagneticField	Identical toPredicate
PatientPopulation	Adults	Adults	Adults	Adults	Identical

SUBSTANTIAL EQUIVALENCE COMPARISON

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The modified ENvizion Medical ENvue System and Enteral Feeding Tube is substantially equivalent with respect to the indication for use, technological characteristics, target user, and use environment to the following legally marked Predicate devices. The addition of the stylet is addressed from a technological perspective by the specified reference device:

Predicate: ENvizion Medical ENvue System and Enteral Feeding Tube (unmodified version)
Reference Device: CORPAK CORFLO Nasoenteric Feeding Tubes, K821906 ●
. Reference Device: CEDIFLO Enteral Feeding Tubes, K181787

CONCLUSION

The modified ENvizion Medical ENvue and Enteral Feeding Tube are substantially equivalent to the unmodified version of the ENvizion Medical ENvue System and Enteral Feeding Tube

Regulation Number and Section

§ 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.