The Medline ENFit Transition Connecting an enteral feeding set with an ENFit connector to a gastronomy tube with funnel.
The Medline ENFit G-Tube Connector is intended for connecting an enteral feeding set equipped with a stepped enteral distal end to a gastronomy tube equipped with an ENFit connector.

Device Description

In an effort to mitigate the risk of misconnections associated with enteral feeding devices, manufacturers have recently began to adopt a uniform connector for enteral devices, called an ENFit connector, which is based upon the ISO 80369 series of standards and is in accordance with FDA Final Guidance for Industry: Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications (February 11, 2015). This uniform ENFit connector provides a locking feature that signals the appropriate connection to stay in place. In addition, the ENFit connector features a female mating component end for enteral feeding sets and a male mating component end for gastronomy feeding tubes, which allows for the interconnection of these devices.

However, it will take time for enteral devices with this uniform ENFit connector to become widely available and fully adopted across healthcare settings, as existing enteral devices with previouslydesigned "legacy" connectors, which are not compliant with ISO 80369-1, still remain in inventory. Therefore, to prevent an interruption or delay in patient care when an enteral device with an AAMI/CN3:2014 (PS) compliant ENFit connector must be connected to an existing enteral device with a non-AAMI/ANSI/ISO 80369-1 compliant connector, a temporary need has emerged for an adapter that can facilitate connection between enteral devices with these incompatible end connectors.

The Medline ENFit Transition Connector and the Medline ENFit G-Tube Connector address this temporary need and facilitate enteral-specific connections between AAMI/CN3:2014 (PS) compliant enteral connectors and non-AAMI/ANSI/ISO 80369-1 compliant connectors to ensure that patient enteral feeding is not impeded when an enteral feeding device with an AAMI/CN3:2014 (PS) compliant ENFit connector must be connected to a previously-designed, existing enteral feeding device with a non-AAMI/ANSI/ISO 80369-1 compliant end connector.

The Medline ENFit Transition Connector and the Medline ENFit G-Tube Connector, which are described in further detail below, allow specific connections between enteral feeding devices with AAMI/CN3:2014 (PS) compliant ENFit connectors (also known as "PGLock" connectors) and enteral feeding devices with non-AAMI/ANSI/ISO 80369-1 compliant, legacy connectors that are still available for use in healthcare settings. To facilitate this connection, the Medline ENFit Transition Connector and the Medline ENFit G-Tube Connector are both designed with the mating component of an AAMI/CN3:2014 (PS)-compliant ENFit connector at one end and the mating component of a previously-used, legacy connector at its other end.

Specifically, the two designs of ENFit transition adapters that are within the scope of this 510(k) Premarket Notification submission are:

1.) The Medline ENFit Transition Connector
The Medline ENFit Transition Connector allows fitment of newly-released enteral feeding sets with AAMI/ CN3:2014 (PS) compliant ENFit connectors to existing gastronomy tubes with non-AAMI/ ANSI/ISO 80369-1 compliant end connectors, referred to as "funnel feeding ports," which are still available for use in healthcare settings. Specifically, to facilitate the interconnection between newlyreleased feeding sets, which are equipped with female ENFit connectors, and the funnel feeding ports of previously-designed gastronomy tubes, this adapter provides the mating component of an ENFit female connector, designed and tested in accordance with AAMI/ CN3:2014 (PS) and AAMI/CN20:2014 (PS), at one of its ends, and the mating component of a non-AAMI/ANSV/ISO 80369-1 compliant funnel feeding port, a stepped Distal Tip connector, at its other end.

2.) The Medline ENFit G-Tube Connector
The Medline ENFit G-Tube Connector allows fitment of newly-released gastronomy tubes (or "Gtubes") with AAMI/CN3:2014 (PS) compliant ENFit connectors to previously-designed enteral feeding sets with non-AAMI/ANSI/ISO 80369-1 compliant connectors, which still may be available for use in healthcare settings. To facilitate the compatibility between gastronomy tubes with ENFit male connectors and the stepped Distal Tip connector of existing enteral feeding sets, the Medline ENFit G-Tube Connector provides the mating component of an ENFit male connector, designed and tested based upon AAMI/ CN3:2014 (PS) and AAMI/CN20:2014 (PS), at one of its ends, and the mating component of a stepped Distal Tip connector, a funnel feeding port, at its other end.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Medline ENFit G-Tube Connector and Medline ENFit Transition Connector, based on the provided FDA 510(k) summary:

This device is not an AI/ML powered device, so many of the requested fields are not applicable. The device is a physical medical connector.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details the testing performed to demonstrate substantial equivalence, focusing on the physical and functional properties of the connectors. The acceptance criteria are implicitly met by successful completion of these tests in accordance with relevant standards.

Acceptance Criterion (Implicitly derived from tests)	Reported Device Performance (Successful completion of tests)
No misconnections with other connector types	Enteral Connector Misconnection Assessment Study (Successful)
User safety and ease of use	Human Factors Validation Study: Enteral Connectors Final Report (Successful)
Prevention of misconnections identified in FMEA	PG-Lock Misconnection Data with Failure Modes and Effects Analysis (FMEA) (Addressed)
Acceptable risk profile	Internal Risk Analysis (Acceptable)
Low microbial load	Bioburden Testing (Successful)
Conforms to dimensional specifications	Metrology Testing (Successful)
Maintains integrity over time	Stability (Shelf-Life) Testing (Successful)
Acceptable chemical leachates/extractables	Leachables and Extractables (L&E) Analysis with Toxicological Health Risk Assessment (Successful)
Biocompatible (non-toxic, non-irritating, non-sensitizing)	Biocompatibility Testing: Cytotoxicity, Irritation, Delayed-Type Hypersensitivity (Successful)
Resistance to positive pressure liquid leakage	ISO 80369-20 Testing: Positive Pressure Liquid Leakage (Successful)
Resistance to stress cracking	ISO 80369-20 Testing: Stress Cracking (Successful)
Resistance to separation from axial load	ISO 80369-20 Testing: Resistance to Separation from Axial Load (Successful)
Resistance to separation from unscrewing	ISO 80369-20 Testing: Resistance to Separation from Unscrewing (Successful)
Resistance to overriding	ISO 80369-20 Testing: Resistance to Overriding (Successful)
Prevention of inadvertent disconnection by unscrewing	ISO 80369-20 Testing: Disconnection by Unscrewing (Successful)

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

The document does not specify exact sample sizes for each test. It refers to "non-clinical verification" and successful completion of various studies and tests.

Sample Size for Test Set: Not explicitly stated for individual tests.
Data Provenance: The studies were conducted by Medline Industries, Inc. (the manufacturer). The data comes from non-clinical (laboratory/bench) testing of the devices themselves, rather than human or animal data. The country of origin of testing facilities is not specified, but the manufacturer is based in the USA. The data is prospective in the sense that the tests were conducted specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is Not Applicable (N/A) because the device is a physical connector, not an AI/ML algorithm that requires expert ground truth labeling of medical images or data. The "ground truth" for these tests refers to established engineering standards and safety requirements (e.g., ISO 80369-20, FDA guidance on misconnections). The tests themselves evaluate the device's adherence to these objective, measurable standards.

4. Adjudication Method for the Test Set

N/A. As the "truth" is based on objective engineering standards and observed performance in non-clinical tests, there's no need for expert adjudication in the context of this type of device submission. Test results are typically evaluated against predefined pass/fail criteria from the standards.

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

N/A. This device is a physical medical connector, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

N/A. This is not an algorithm or AI system. The tests performed are standalone in the sense that they evaluate the device itself (its physical properties and function) without human interaction being a variable in determining "performance" in the way an AI algorithm's standalone performance might be measured.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of these connectors is based on:

Established engineering standards: Primarily ISO 80369-20, and AAMI/CN3:2014 (PS), AAMI/CN20:2014 (PS).
FDA guidance documents: Specifically, "Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications (February 11, 2015)."
Objective physical and chemical test results: Measurements of leakage, strength, biocompatibility, dimensions, etc.

8. The Sample Size for the Training Set

N/A. This device is a physical connector, not an AI/ML algorithm that requires a training set. The "training" for the device's design is implicitly the engineering design process guided by the standards and predicate device.

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

N/A. As there is no AI/ML training set, this question is not applicable. The design "ground truth" would be established by the engineering and regulatory requirements for safe and effective medical device connectors. The predicate device (Cedic ENFit Transition Connectors for Enteral Applications, K140581) also serves as a benchmark for established safety and effectiveness.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 24, 2015

Medline Industries, Inc. Stephanie Blair Regulatory Affairs Specialist One Medline Place Mundelein, IL 60060

Re: K151628

Trade/Device Name: The Medline ENFit G-Tube Connector, Medline ENFit Transition Connector Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIO Dated: June 12, 2015 Received: June 17, 2015

Dear Stephanie Blair,

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.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -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)

K151628

Device Name The Medline ENFit Transition Connector

Indications for Use (Describe)

The Medline ENFit Transition Connecting an enteral feeding set with an ENFit connector to a gastronomy tube with funnel.

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

|| | Prescription Use (Part 21 CFR 801 Subpart D)

|__| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known)

K151628

Device Name The Medline ENFit G-Tube Connector

Indications for Use (Describe)

The Medline ENFit G-Tube Connector is intended for connecting an enteral feeding set equipped with a stepped enteral distal end to a gastronomy tube equipped with an ENFit connector.

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in bold, sans-serif font, and a white starburst-like symbol is above the text. The starburst has four points, with two pointing upwards and two pointing downwards.

edline Industries. Inc One Medline Place Mundelein, IL 60060

510(k) Premarket Notification Medline ENFit Transition Connector Medline ENFit G-Tube Connector

TRADITIONAL 510(k) SUMMARY [AS REQUIRED BY 21 CFR 807.92(a)]

SUMMARY PREPARATION DATE

July 21st, 2015

SUBMITTER / 510(k) SPONSOR

Medline Industries, Inc. One Medline Place Mundelein, IL 60060 Registration Number: 1417592

CONTACT PERSON

Stephanie Blair Regulatory Affairs Specialist Phone: 847-643-3690 Email: SBlair(@medline.com

TYPE OF SUBMISSION

Traditional 510(k)

DEVICE NAME / CLASSIFICATION

Trade/Proprietary Name(s):
Common Name:
. Product Code:
Classification Name:
Device Class: ●
Classification Regulation:
Classification Panel:

Medline ENFit Transition Connector Medline ENFit G-Tube Connector Transition Connectors for Enteral Applications PIO Gastrointestinal Tube and Accessories Class II 21 CFR 876.5980 Gastroenterology and Urology

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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, block letters on the left side of the logo. To the right of the word is a white, stylized cross symbol.

ledline Industries. Inc One Medline Place Mundelein, IL 60060

510(k) Premarket Notification Medline ENFit Transition Connector Medline ENFit G-Tube Connector

PREDICATE DEVICE

Cedic ENFit Transition Connectors for Enteral Applications (K140581) are identified herein as the predicate device of the Medline ENFit Transition Connector and the Medline ENFit G-Tube Connector. Please note that there are multiple design configurations of Cedic ENFit Transition Connectors for Enteral Applications cleared under K140581; therefore:

. The specific Cedic ENFit Transition Connector for Enteral Applications cleared under K140581 that is selected for comparison with the Medline ENFit Transition Connector is: The Cedic Enteral Distal End ENFit Transition Connector.
. The specific Cedic ENFit Transition Connector for Enteral Applications cleared under K140581 that is selected for comparison with the Medline ENFit G-Tube Connector is: The Cedic Enteral Funnel ENFit Transition Connector.

INDICATIONS FOR USE

The Medline ENFit Transition Connector is intended for connecting an enteral feeding set with an ENFit connector to a gastronomy tube with funnel.

The Medline ENFit G-Tube Connector is intended for connecting an enteral feeding set equipped with a stepped enteral distal end to a gastronomy tube equipped with an ENFit connector.

DEVICE DESCRIPTION

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Image /page/6/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is in bold, white font and is stacked on top of a white star-like symbol. The star symbol has four points, with the top and bottom points being longer than the side points.

ledline Industries. One Medline Place Mundelein, IL 60060

510(k) Premarket Notification Medline ENFit Transition Connector Medline ENFit G-Tube Connector

AAMI/CN3:2014 (PS) compliant ENFit connector must be connected to an existing enteral device with a non-AAMI/ANSI/ISO 80369-1 compliant connector, a temporary need has emerged for an adapter that can facilitate connection between enteral devices with these incompatible end connectors.

Specifically, the two designs of ENFit transition adapters that are within the scope of this 510(k) Premarket Notification submission are:

1.) The Medline ENFit Transition Connector

The Medline ENFit Transition Connector allows fitment of newly-released enteral feeding sets with AAMI/ CN3:2014 (PS) compliant ENFit connectors to existing gastronomy tubes with non-AAMI/ ANSI/ISO 80369-1 compliant end connectors, referred to as "funnel feeding ports," which are still available for use in healthcare settings. Specifically, to facilitate the interconnection between newlyreleased feeding sets, which are equipped with female ENFit connectors, and the funnel feeding ports of previously-designed gastronomy tubes, this adapter provides the mating component of an ENFit female connector, designed and tested in accordance with AAMI/ CN3:2014 (PS) and AAMI/CN20:2014 (PS), at one of its ends, and the mating component of a non-AAMI/ANSV/ISO 80369-1 compliant funnel feeding port, a stepped Distal Tip connector, at its other end.

2.) The Medline ENFit G-Tube Connector

The Medline ENFit G-Tube Connector allows fitment of newly-released gastronomy tubes (or "Gtubes") with AAMI/CN3:2014 (PS) compliant ENFit connectors to previously-designed enteral feeding sets with non-AAMI/ANSI/ISO 80369-1 compliant connectors, which still may be available for use in healthcare settings. To facilitate the compatibility between gastronomy tubes with ENFit male

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Image /page/7/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, bold, sans-serif font, stacked on top of a white, stylized starburst shape. The background is a solid dark blue color. The logo is simple and modern, and the colors are clean and professional.

ledline Industries. In One Medline Place Mundelein, IL 60060

510(k) Premarket Notification Medline ENFit Transition Connector Medline ENFit G-Tube Connector

connectors and the stepped Distal Tip connector of existing enteral feeding sets, the Medline ENFit G-Tube Connector provides the mating component of an ENFit male connector, designed and tested based upon AAMI/ CN3:2014 (PS) and AAMI/CN20:2014 (PS), at one of its ends, and the mating component of a stepped Distal Tip connector, a funnel feeding port, at its other end.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The Medline ENFit Transition Connector and the Medline ENFit G-Tube Connector are made of non-DEHP PVC and are both non-sterile, single-use devices. In addition, the ENFit connector featured on both configurations of the proposed device is made of rigid materials to reduce the likelihood of forced fits between flexible connectors that are not intended to connect with each other, as recommended in FDA Final Guidance for Industry: Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications (February 11, 2015).

Additionally, the Medline ENFit Transition Connector and the Medline ENFit G-Tube Connector are similar in design, intended use, function and internal and external characteristics to the predicate device cleared under K140581. Cedic ENFit Transition Connectors for Enteral Applications. Both the proposed and predicate devices operate by providing a means of interconnecting incompatible enteral feeding device end-fittings together, so that patient enteral feeding can take place when enteral feeding devices with AAMI/CN3:2014 (PS) compliant ENFit connectors must be connected to enteral feeding devices with previously-designed, non-AAMI/ANSI/ISO 80369-1 compliant enteral connectors. To facilitate this connection, both the proposed and predicate devices act as an adapter by providing the mating component of an AAMI/CN3:2014 (PS) compliant ENFit connector at one end and the mating component of a previously-used, legacy connector at its other end.

SUMMARY OF PERFORMANCE TESTING

Non-clinical verification of the Medline ENFit Transition Connector and the Medline ENFit G-Tube Connector has been conducted to evaluate the safety, performance and functionality of these devices. The results of all testing were ultimately found to support a substantial equivalence determination.

Specifically, the proposed Medline ENFit Transition Connector and Medline ENFit G-Tube Connector were evaluated through the following tests:

Enteral Connector Misconnection Assessment Study
Human Factors Validation Study: Enteral Connectors Final Report ●
PG-Lock Misconnection Data with Failure Modes and Effects Analysis (FMEA) ●
Internal Risk Analysis

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Image /page/8/Picture/0 description: The image shows the logo for Medline. The logo is set against a blue square background. The word "MEDLINE" is written in white, block letters, stacked on top of a white starburst symbol. The starburst has four points, two pointing horizontally and two pointing vertically.

edline Industries. Inc One Medline Place Mundelein, IL 60060

510(k) Premarket Notification Medline ENFit Transition Connector Medline ENFit G-Tube Connector

Bioburden Testing ●
Metrology Testing
Stability (Shelf-Life) Testing
Leachables and Extractables (L&E) Analysis with Toxicological Health Risk Assessment
Biocompatibility Testing:
- Cytotoxicity MEM elution per ISO 10993-5 O
- Irritation Intracutaneous reactivity per ISO 10993-10 O
- Delayed-Type Hypersensitivity (Sensitization) Guinea Pig Maximization Test per о ISO 10993-10
ISO 80369-20 Testing: ●
- Positive Pressure Liquid Leakage O
- Stress Cracking O
- Resistance to Separation from Axial Load O
- Resistance to Separation from Unscrewing O
- Resistance to Overriding O
- Disconnection by Unscrewing O

SUMMARY OF CLINICAL TESTING

Not applicable.

SUMMARY OF ANIMAL TESTING

Not applicable.

CONCLUSION

In accordance with 21 CFR Part 807, and based on a comparison of 'Indications for Use,' technological characteristics and performance data. Medline Industries, Inc. concludes that the proposed Medline ENFit Transition Connector and Medline ENFit G-Tube Connector are substantially equivalent to the predicate device.

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.