(252 days)
The Nasogastric Feeding Tubes – ENFit Port - PVC are intended for hydration, feeding and administration of oral medications for patients who require enteral feeding. This product is single use for no longer than 24 hours.
The Nasogastric Feeding Tubes – ENFit Port - PVC are sterile, single use devices. The feeding tubes consist of a graduated polyvinyl chloride tube, with radiopaque edge. The tubes have a closed tip and two lateral eyes for Fr sizes 5 to 10 and three lateral eyes for Fr sizes 12 to 16. The tubes have at the other end an ENFit male connector in ABS with its Polypropylene cap. A tether in thermoplastic polyurethane connects the ENFit connector to its cap. The ENFit connector allows the device to be connected to female enteral devices that have an ISO 80369-3 compliant connector. The feeding tubes are available in 50cm and 90cm lengths and in French sizes from 5 to 16.
The provided text describes the regulatory clearance of a medical device, the "Nasogastric Feeding Tubes - ENFit Port - PVC," through a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's de novo clinical efficacy through comparative studies. As such, the information you've requested regarding AI device performance metrics, expert adjudication, and training/test set specifics for an AI algorithm is largely not applicable to this document.
The document discusses non-clinical performance testing to demonstrate that the new device meets established standards and performs comparably to the predicate device.
Here's an analysis based on the provided text, where applicable:
1. A table of acceptance criteria and the reported device performance
The document refers to a "Substantial Equivalence Discussion" (Table 5-2) comparing the new device to a predicate. The "acceptance criteria" are effectively the performance characteristics and safety profiles of the predicate device, and the "reported device performance" is the new device's compliance with these or relevant standards.
| Acceptance Criteria (Based on Predicate Device & Standards) | Reported Device Performance (New Device) |
|---|---|
| Indications for Use: Enteral feeding to deliver nutrition, fluids, medications from ENFit compatible syringe/set. | Equivalent: Intended for enteral feeding to deliver nutrition, fluids, and medications from an ENFit compatible syringe or feeding set. Single use for no longer than 24 hours. |
| Intended Use: For pediatric patients requiring enteral feeding. (Predicate warning: not beyond 3-5 days) | Similar: Intended for hydration, feeding, and administration of oral medications for pediatric and adult patients requiring enteral feeding. Single use for no longer than 24 hours. |
| Environment of Use: Unspecified - Prescription Only | Equivalent: Hospital or medical home environment - Prescription Only |
| Intended Users: Trained professional clinicians or trained pediatric caregivers. | Equivalent: Physicians, nurses, and trained clinicians. |
| Patient Population: Pediatric patients | Similar: Pediatric and Adult patients. |
| Single Use: Yes | Yes |
| Sterility Condition: Sterile | Sterile |
| ENFit Connector: Yes; compliant with ISO 80369-3 | Yes; compliant with ISO 80369-3 |
| Radiopacity Verification: Yes | Yes; compliant with ISO 20695:2020 |
| Tube Markings: Yes | Yes; compliant with ISO 20695:2020 |
| French Sizes: 3.5, 5, 6.5, 8, 10 | Similar: 5, 6, 8, 10, 12, 14, 16 |
| Lengths: 41cm, 91cm, 107cm | Similar: 50cm, 90cm |
| Biocompatibility: Compliant with ISO 10993-1 | Compliant with ISO 10993-1. Specific tests: Cytotoxicity (ISO 10993-5:2009), Guinea Pig Maximization Sensitization (ISO 10993-10:2010), Irritation (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2017), Material-Mediated Pyrogenicity (ISO 10993-11:2017). |
| Liquid Leakage Testing: Completed (e.g. EN 1615:2000) | Tested and met updated standard ISO 20695:2020 |
| Tensile Testing: Completed (e.g. EN 1615:2000) | Tested and met updated standard ISO 20695:2020 |
| Flow Rate Testing: Completed per substantial equivalence | Tested per ISO 20695:2020 |
| Fluid Leakage (Connector): Tested per ISO 80369-20 and met 80369-3 standards. | Tested per ISO 80369-20 and met 80369-3 standards. |
| Stress Cracking (Connector): Tested per ISO 80369-20 and met 80369-3 standards. | Tested per ISO 80369-20 and met 80369-3 standards. |
| Resistance to separation from axial load (Connector): Tested per ISO 80369-20 and met 80369-3 standards. | Tested per ISO 80369-20 and met 80369-3 standards. |
| Resistance to separation from unscrewing (Connector): Tested per ISO 80369-20 and met 80369-3 standards. | Tested per ISO 80369-20 and met 80369-3 standards. |
| Resistance to overriding (Connector): Tested per ISO 80369-20 and met 80369-3 standards. | Tested per ISO 80369-20 and met 80369-3 standards. |
| Disconnection by unscrewing (Connector): Tested per ISO 80369-20 and met 80369-3 standards. | Tested per ISO 80369-20 and met 80369-3 standards. |
| ENFit Dimensional Verification: Evaluated per ISO 80369-3. | Evaluated per ISO 80369-3. |
| Risk Analysis: Not specified for predicate, but generally expected. | Performed: ISO 14971:2019 (DFMEA) |
| Usability Analysis: Not specified for predicate, but generally expected. | Performed: ISO 62366-1:2015 |
2. Sample size used for the test set and the data provenance
The document does not detail specific sample sizes for each non-clinical test. The tests were conducted according to various ISO standards (e.g., ISO 10993 series for biocompatibility, ISO 20695:2020 for enteral device performance, ISO 80369-20:2019 linked to ISO 80369-3:2016 for connector performance). These standards typically specify sample sizes or methods for determining them. No information on data provenance (country of origin, retrospective/prospective) is provided, as these are physical product tests, not data-driven AI evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical medical tube, not an AI device that produces diagnostic interpretations requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI diagnostic device. The "tests" here are physical and chemical evaluations against predefined criteria in international 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
Not applicable. This is not an AI-powered device or an imaging device requiring human reader interpretation. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by the criteria defined in the referenced international standards (e.g., ISO 10993, ISO 20695, ISO 80369 series). For example, passing biocompatibility tests means the materials meet the safety requirements outlined in ISO 10993.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. No training set was used.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 9, 2022
Cair Lgl % Glenn Brunner Dir. Regulatory Affairs and Ouality Assurance Vesco Medical 1039 Kingsmill Parkway Columbus, OH 43229
Re: K213258
Trade/Device Name: Nasogastric Feeding Tubes - ENFit Port - PVC Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PIF Dated: May 11, 2022 Received: May 13, 2022
Dear Glenn Brunner:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 mediation-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,
Shanil P. Haugen, Ph.D. Assistant 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213258
Device Name
Nasogastric Feeding Tubes - ENFit Port - PVC
Indications for Use (Describe)
The Nasogastric Feeding Tubes - ENFit Port - PVC are intended for enteral feeding to deliver nutrition, fluids, and medications to the patient from an enteral feeding syringe or feeding set designed with ENFit connectors for enteral applications.
This product is single use for no longer than 24 hours.
| 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) |
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Nasogastric Feeding Tubes – ENFit Port - PVC
Tab 5A 510(k) Summary
Submitter .
| Official Contact | Name: | Glenn BrunnerTitle: Dir. Regulatory Affairs and Quality AssuranceEmail: gbrunner@vescomedical.com |
|---|---|---|
| Vesco MedicalAddress: 1039 Kingsmill ParkwayColumbus, Ohio 43229 | ||
| Phone: 614-946-4178 (mobile)Fax: 614-515-2800 | ||
| Date of Preparation | June 6, 2022 |
II. Device
| Trade Name: | Nasogastric Feeding Tubes – ENFit Port - PVC |
|---|---|
| Common Name: | Nasogastric Tubes |
| Classification Name &Number: | Gastrointestinal Tubes and Accessories21 CFR 876.5980 |
| Class II | |
| Product Code: PIF |
Legally Marketed Predicate Device III.
Product name: Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector
510(k) Number: K150084
Manufacturer: Covidien
Product Code: PIF
Device Class: Class II
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IV. Device Description
General Description of Nasogastric Feeding Tubes – ENFit Port - PVC
The Nasogastric Feeding Tubes – ENFit Port - PVC are sterile, single use devices. The feeding tubes consist of a graduated polyvinyl chloride tube, with radiopaque edge. The tubes have a closed tip and two lateral eyes for Fr sizes 5 to 10 and three lateral eyes for Fr sizes 12 to 16. The tubes have at the other end an ENFit male connector in ABS with its Polypropylene cap. A tether in thermoplastic polyurethane connects the ENFit connector to its cap. The ENFit connector allows the device to be connected to female enteral devices that have an ISO 80369-3 compliant connector. The feeding tubes are available in 50cm and 90cm lengths and in French sizes from 5 to 16 see Table 5-1.
| Nasogastric Feeding Tubes – ENFit Port - PVC | ||
|---|---|---|
| Model | TubeSize | Device Length |
| VED-95005EO | 5 Fr | 50 cm |
| VED-99005EO | 5 Fr | 90 cm |
| VED-95006EO | 6 Fr | 50 cm |
| VED-99006EO | 6 Fr | 90 cm |
| VED-95008EO | 8 Fr | 50 cm |
| VED-99008EO | 8 Fr | 90 cm |
| VED-95010EO | 10 Fr | 50 cm |
| VED-99010EO | 10 Fr | 90 cm |
| VED-99012EO | 12 Fr | 90 cm |
| VED-99014EO | 14 Fr | 90 cm |
| VED-99016EO | 16 Fr | 90 cm |
Table 5-1: Models of Nasogastric Feeding Tubes
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V. Intended Use
The Nasogastric Feeding Tubes – ENFit Port – PVC are intended for hydration, feeding and administration of oral medications for patients who require enteral feeding. This product is single use for no longer than 24 hours.
VI. Substantial Equivalence Discussion
The Nasogastric Feeding Tubes – ENFit Port - PVC are substantially equivalent to the currently marketed predicate Feeding Tube. Table 5-2 is a detailed comparison of the Cair feeding tubes to the predicate devices regarding substantial equivalence.
| Table 5-2: Device comparison table for Nasogastric Feeding Tubes – ENFit Port - PVC and the |
|---|
| predicate device. |
| DesignFeatures/Function | Argyle PolyvinylChloride FeedingTube, K150084(Predicate) | Nasogastric FeedingTubes -ENFit Port -PVC | SubstantiallyEquivalent? | Impact on Safetyand Performance |
|---|---|---|---|---|
| Indications for Use | The Argyle PolyvinylChloride (PVC)Neonatal andPediatric FeedingTubes with ENFitconnectors areintended for enteralfeeding to deliverenteral nutrition,liquid or medicationto patient from anenteral feedingsyringe or feedingset designed with aconnector for enteralapplications. | The NasogastricFeeding Tubes - ENFitPort - PVC areintended for enteralfeeding to delivernutrition, fluids, andmedications to thepatient from an enteralfeeding syringe orfeeding set designedwith ENFit connectorsfor enteral applications.This product is singleuse for no longer than24 hours. | Yes | Equivalent toK150084. There areno differences inindications for use thatwould impact thesafety andperformance of thedevice. |
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| Nasogastric Feeding Tubes – ENFit Port - PVC | |||||
|---|---|---|---|---|---|
| ---------------------------------------------- | -- | -- | -- | -- | -- |
| Intended Use | The Argyle PolyvinylChloride FeedingTube is intended forpediatric patientswho require enteralfeeding.(Warning: ThePolyvinyl Chloridefeeding tube is notintended for usebeyond 3-5 days) | The NasogastricFeeding Tubes – ENFitPort - PVC areintended for hydration,feeding, andadministration of oralmedications forpediatric and adultpatients who requireenteral feeding. Thisproduct is single usefor no longer than 24hours. | Yes | Equivalent toK150084. There areno differences inintended use thatwould impact thesafety andperformance of thedevice. |
|---|---|---|---|---|
| Environment of Use | Unspecified -Prescription Only | Hospital or medicalhome environment -Prescription Only | Yes | Equivalent toK150084. There areno differences inenvironment of usethat would impact thesafety andperformance of thedevice. |
| Intended Users | Trained professionalclinicians or trainedpediatric caregivers. | Physicians, nurses,and trained clinicians(by facility policy) | Yes | Equivalent toK150084. There areno differences inintended users thatwould impact thesafety andperformance of thedevice |
| Patient Population | Pediatric patients | Pediatric and Adultpatients | Yes | Similar to K150084.There are nodifferences in patientpopulation that wouldimpact the safety andperformance of thedevice |
| Single Use | Yes | Yes | Yes | Equivalent toK150084. No impacton safety orperformance |
| Sterility Condition | Sterile | Sterile | Yes | Equivalent toK150084. No impacton safety orperformance |
| ENFit Connector | Yes; compliant withISO 80369-3 | Yes; compliant withISO 80369-3 | Yes | Equivalent toK150084. No impacton safety orperformance |
| RadiopacityVerification | Yes | Yes; compliant withISO 20695:2020 | Yes | Equivalent toK150084. No impacton safety orperformance |
| Tube Markings | Yes | Yes; compliant withISO 20695:2020 | Yes | Equivalent toK150084. No impacton safety orperformance |
| French Sizes | 3.5, 5, 6.5, 8, 10 | 5, 6, 8, 10, 12, 14, 16 | Yes | Similar to K150084.No impact on safety orproper performance |
| Lengths | 41cm, 91cm, 107cm | 50cm, 90cm | Yes | Similar to K150084.No impact on safety orproper performance |
| Biocompatibility | Compliant with Useof InternationalStandard ISO10993-1, "Biologicalevaluation ofmedical devices -Part 1: Evaluationand testing within arisk managementprocess" | Compliant with Use ofInternational StandardISO 10993-1,"Biological evaluationof medical devices -Part 1: Evaluation andtesting within a riskmanagement process" | Yes | Equivalent toK150084. No impacton safety orperformance |
| Liquid LeakageTesting | Liquid LeakageTesting Completed(e.g. EN 1615:2000) | Tested and metupdated standard ISO20695:2020 EnteralFeeding Systems -Design and Testing | Yes | Equivalent toK150084. No impacton safety orperformance |
| Tensile Testing | Tensile TestingCompleted (e.g. EN1615:2000) | Tested and metupdated standard ISO20695:2020 EnteralFeeding Systems –Design and Testing | Yes | Equivalent toK150084. No impacton safety orperformance |
| Flow Rate Testing | Flow Rate TestingCompleted persubstantialequivalence topredicate device | Tested per ISO20695:2020 EnteralFeeding Systems –Design and Testing | Yes | Equivalent toK150084. No impacton safety orperformance |
| Fluid Leakage:Connector | Tested per ISO80369-20 and metthe standards of80369-3 for fluidleakage. | Tested per ISO 80369-20 and met thestandards of 80369-3for fluid leakage. | Yes | Equivalent toK150084. No impacton safety orperformance |
| Stress Cracking:Connector | Tested per ISO80369-20 and metthe standards of80369-3 for stresscracking. | Tested per ISO 80369-20 and met thestandards of ISO80369-3 for stresscracking. | Yes | Equivalent toK150084. No impacton safety orperformance |
| Resistance toseparation fromaxial load:connector | Tested per ISO80369-20 and metthe standards of80369-3 forresistance toseparation fromaxial load. | Tested per ISO 80369-20 and met thestandards of ISO80369-3 for resistanceto separation from axialload. | Yes | Equivalent toK150084. No impacton safety orperformance |
| Resistance toseparation fromunscrewing:connector | Tested per ISO80369-20 and metthe standards of80369-3 forseparation fromunscrewing. | Tested per ISO 80369-20 and met thestandards of ISO80369-3 for separationfrom unscrewing. | Yes | Equivalent toK150084. No impacton safety orperformance |
| Resistance tooverriding:connector | Tested per ISO80369-20 and metthe standards of80369-3 forresistance tooverriding. | Tested per ISO 80369-20 and met thestandards of ISO80369-3 for resistanceto overriding. | Yes | Equivalent toK150084. No impacton safety orperformance |
| Disconnection byunscrewing:connector | Tested per ISO80369-20 and metthe standards of80369-3 fordisconnection byunscrewing. | Tested per ISO 80369-20 and met thestandards of ISO80369-3 fordisconnection byunscrewing. | Yes | Equivalent toK150084. No impacton safety orperformance |
| ENFit DimensionalVerification | Evaluated per ISO80369-3 for ENFitdimensionalverification. | Evaluated per ISO80369-3 for ENFitdimensionalverification. | Yes | Equivalent toK150084. No impacton safety orperformance |
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VII. Discussion of Differences
There are no substantial differences between the indications for use, use conditions, and use environment of the predicate devices and the Nasogastric Feeding Tubes – ENFit Port - PVC.
VIII. Performance Testing
Non-Clinical Tests
Verification and validation testing was performed with the Nasogastric Feeding Tubes – ENFit Port - PVC. It was found that feeding tubes are in compliance with the design and performance requirements when tested per the standards listed below.
-
- Biocompatibility:
- a. Cytotoxicity per ISO 10993-5:2009
- b. Guinea Pig Maximization Sensitization per ISO 10993-10:2010
- c. Irritation per ISO 10993-10:2010
- d. Acute Systemic Toxicity per ISO 10993-11:2017
- e. Material-Mediated Pyrogenicity per 10993-11:2017
-
- Visual Inspections
- a. Visual inspection for verification of bonding
-
- Enteral Device Performance test
- a. Pressure leak testing in accordance with ISO 20695:2020
- b. Tensile testing in accordance with ISO 20695:2020
- c. Resistance of the tube marking to acid in accordance with internal protocol
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- d. Resistance of the tube marking to disinfectants in accordance with ISO 20695:2020
- e. Visibility of enteral tube under x-ray in accordance with internal protocol based on ASTM F640-12
- Flow rate testing in accordance with ISO 20695:2020 f.
-
- Enteral Connector Performance Tests
- a. Fluid leakage per ISO 80369-20:2019
- b. Stress cracking per ISO 80369-20:2019
- C. Resistance to separation from axial load per ISO 80369-20:2019
- d. Resistance to separation from unscrewing per ISO 80369-20:2019
- e. Resistance to overriding per ISO 80369-20:2019
- Disconnection by unscrewing per ISO 80369-20:2019 f.
- g. ENFit dimensional verification per ISO 80369-3:2016
-
- Risk Analysis per ISO 14971:2019.
- a. Design Failure Modes and Effects Analysis (DFMEA).
-
- Usability Analysis per ISO 62366-1:2015.
Clinical Tests
Clinical tests were not required to demonstrate the safety and performance of the Nasogastric Feeding Tubes – ENFit Port - PVC. Product functionality has been adequately assessed by non-clinical tests.
Animal Tests
Animal tests were not required to demonstrate the safety and performance the Nasogastric Feeding Tubes – ENFit Port - PVC. Product functionality has been adequately assessed by non-animal tests.
IX. Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the Nasogastric Feeding Tubes – ENFit Port - PVC are substantially equivalent in safety and effectiveness to the legally marketed devices identified in part III, "Legally Marketed Predicate Devices" of this section.
(End of 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.