McLean-Ring Enteral Feeding Tube Set

K190084 · Cook Incorporated · KNT · Oct 11, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K190084
• Device Name: McLean-Ring Enteral Feeding Tube Set
• Applicant: Cook Incorporated
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Oct 11, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The McLean-Ring Nasojejunal Feeding Tube Set is intended for enteral feeding and medication in adult and pediatric populations. The device is intended to be used in the treatment of the following pediatric subgroups: children and adolescents.

Device Story

The McLean-Ring Nasojejunal Feeding Tube Set is a 9.5 French polyurethane feeding tube with a stainless steel distal weight and a 0.038-inch PTFE-coated stainless steel wire guide. The device is used to provide enteral nutrition and medication to the gastrointestinal tract. It is introduced either via peristalsis or by passing the tube over the wire guide through the external naris, pylorus, and duodenum. The device is intended for indwelling use for up to 30 days and is for one-time use. It is intended for use in adult and pediatric populations (children and adolescents). The device is used in clinical settings to facilitate feeding in patients who cannot orally ingest nutrition. By providing direct access to the small bowel, it ensures delivery of nutrition and medication, potentially improving patient outcomes in those with gastrointestinal or nutritional challenges.

Clinical Evidence

No clinical data was generated for this specific device. The manufacturer provided a literature review of six studies involving 6F, 8F, and 10F post-pyloric feeding tubes in pediatric patients (ages ranging from neonates to 24 years). Studies included prevalence, prospective cohorts, and retrospective case series. Reported outcomes included placement success rates (up to 99%) and adverse event profiles (e.g., accidental removal, unsuccessful placement due to anatomical factors). The literature supports the safety and performance of using such tubes in children (2 years and older) and adolescents.

Technological Characteristics

9.5 French polyurethane feeding tube; 130 cm length; 0.650-inch stainless steel distal weight covered in shrink tube; 0.038-inch PTFE-coated stainless steel wire guide; six distal sideports; rounded distal tip with endhole. Sterilization: ETO (SAL 10^-6). Packaging: Tyvek peel-open pouch. No software or electronic components.

Indications for Use

Indicated for enteral feeding and medication delivery in adult and pediatric patients, specifically children and adolescents.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube (K160509)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 11, 2019

Cook Incorporated Irasema Rivera, M.A., M.P.H Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, IN 47404

Re: K190084

> Trade/Device Name: McLean-Ring Nasojejunal Feeding Tube Set Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: September 6, 2019 Received: September 9, 2019

Dear Irasema Rivera:

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.

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for

Martha W. Betz, Ph.D. Acting 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) K190084

Device Name

McLean-Ring Nasojejunal Feeding Tube Set

Indications for Use (Describe)

The McLean-Ring Nasojejunal Feeding Tube Set is intended for enteral feeding and medication in adult and pediatric populations. The device is intended to be used in the following pediatric subgroups: children and adolescents.

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, block letters on a darker red background. The logo is simple and professional, and it is likely used to represent the company on its products and marketing materials.

#### 510(k) Summary

K190084 Page 1 of 6

## K190084 McLean-Ring Nasoiejunal Feeding Tube Set 21 CFR §876.5980 Date Prepared: 11 October 2019

#### Submitted By:

Contact:

Email:

Submission: Applicant: Applicant Address:

Secondary Contact:

Traditional 510(k) Premarket Notification Cook Incorporated Cook Incorporated 750 Daniels Way Bloomington, IN 47404 Irasema Rivera Karthik Pillai [e-mail] [phone] x105166 [phone]

#### Device Information:

Contact Fax number:

Contact Phone Number:

Trade Name: Device Common Name: Classification Regulation: Device Class: Classification Panel:

McLean-Ring Nasojejunal Feeding Tube Set Gastrointestinal tube and accessories 21 CFR §876.5980, Product Code KNT Class II. Gastroenterology/Urology

# Predicate Device:

The McLean-Ring Enteral Feeding Tube Set is substantially equivalent to the following device: Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube (K160509, Cook Incorporated) cleared on May 18, 2017.

## Device Description:

The McLean-Ring Nasojejunal Feeding Tube Set is composed of a feeding tube and wire guide. The feeding tube is made of a 9.5 French polyurethane tube. The feeding tube is available in 130 centimeters only, measured from the distal tip to the proximal hub. The distal end of the feeding tube features six sideports. The distal tip of the feeding tube is open with a smooth round finish. A 0.650-inch long stainless steel weight is fit outside the distal end of the feeding tube and is completely covered with a shrink tube, forming 0.180-inch outer diameter over the weight. The proximal end of the feeding tube features a hub with a cap that is made of polyurethane.

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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font on a red square. Below the red square is a smaller, darker red rectangle with the word "MEDICAL" in white, sans-serif font.

The wire guide is made of stainless steel in a 0.038-inch diameter. The wire guide is 275 centimeters long. In addition, the entire length of the wire guide is coated with PTFE. The distal end of the wire guide is straight but flexible.

The subject device, McLean-Ring Nasojejunal Feeding Tube Set, may be introduced directly when there is adequate peristalsis and no gastric outlet obstruction. Alternatively, the feeding tube may be passed over a wire guide. The feeding tube is intended to be indwelling up to 30 days and is for one-time use.

# Indications for Use:

The McLean-Ring Nasojejunal Feeding Tube Set is intended for enteral feeding and medication in adult and pediatric populations. The device is intended to be used in the treatment of the following pediatric subgroups: children and adolescents.

# Comparison to Predicate Device:

The subject device, McLean-Ring Nasojejunal Feeding Tube Set, and the predicate device, the Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube (K160509), are substantially equivalent in that these devices have a similar intended use, technological characteristics, placement location, indwell time, sterilization method, and packaging. The subject device and predicate device similarly establish an enteral delivery for feeding and medication. The subject device and predicate device have identical characteristics including the number of sideports on the distal end of the catheter and rounded distal tip. The subject device and predicate device pass through the patient's oropharynx before descending the gastrointestinal track to the intended access site. The predicate device's access sites are the stomach or the small bowel; the subject device's access sites are the pylorus or the duodenum, which lie between or are part of the stomach and small bowel.

The differences between the subject and the predicate device including the materials of construction, catheter dimensions, distal tip features, mode of operation, and intended patient population do not raise any new issues of safety and/or effectiveness.

Similarities and differences in technological characteristics are captured in the substantial equivalence comparison of the subject device, McLean-Ring Nasojejunal Feeding Tube Set, and the predicate device, Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube, which is provided in Table 1.

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Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, set against a red square. Below the red square is the word "MEDICAL" in white, set against a smaller red rectangle.

#### Table 1: Substantial Equivalence

| | | Tiger 2 Self-Advancing Nasal Jejunal | McLean-Ring Nasojejunal Feeding | |
|----------------------------|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | Feeding Tube | Tube Set | |
| | | (K160509) | Subject Device | |
| | Regulation Number | 876.5980 | 876.5980 | |
| | Product Code | KNT | KNT | |
| | Classification | II | II | |
| | Intended Use | Intended to provide short-term enteral<br>access for delivery of nutrition and/or<br>medications to the small bowel in patients<br>older than 12 years old | Intended for enteral feeding and<br>medication in adult and pediatric<br>populations. The device is intended to be<br>used in the treatment of the following<br>pediatric subgroups: children and<br>adolescents | |
| Mode of Operation | | Flaps allow catheter to be pulled into the<br>stomach or small bowel by peristalsis<br>from the patient's nose or mouth | Advance the catheter through the external<br>naris through the pylorus and duodenum to<br>the level of ligament of Treitz with the aid<br>of peristalsis, or by introduction over a<br>wire guide. | |
| Device Picture | | Image: Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube | Image: McLean-Ring Nasojejunal Feeding Tube Set | |
| | Length | 153 cm | 130 cm | |
| | Outer Diameter | 14 Fr | 9.5 Fr | |
| | Shaft Material | Polyether-Urethane | Polyurethane | |
| | Hub Material | Polyvinyl chloride (PVC) | Polyurethane | |
| | Hub Inner | 0.255-inch tapers to 0.150-inch in 0.185- | 0.313-inch tapers to 0.135-inch in 0.537- | |
| Catheter | Diameters | inch length | inch length | |
| | Distal Tip | Rounded, no endhole, sideports, no<br>weight | Rounded, endhole, sideports, distal weight | |
| | Sideports | 6 | Identical | |
| | Maximum Indwell | Up to 30 days | Identical | |
| Device for One-Time<br>Use | | Yes | Identical | |
| Sterilization, SAL | | ETO, 10-6 | Identical | |
| Packaging | | Tyvek peel-open pouch | Identical | |

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Image /page/6/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, sans-serif font, stacked on top of the word "MEDICAL" in white, sans-serif font. The words are set against a red background. The word "COOK" is in a larger font size than the word "MEDICAL".

## Technological Characteristics:

The subject device, McLean-Ring Nasojejunal Feeding Tube Set, was subjected to the following applicable testing to assure reliable design and performance under the specified testing parameters:

## Bench Testing

- . Dimensional, Compatibility and Visual Analysis (Zero Time and Accelerated Aged)
- . Flow Rate Testing (Zero Time and Accelerated Aged)
- Resistance to Liquid Leakage Under Positive Pressure (Zero Time and Accelerated Aged) .
- Kink Resistance (Zero Time and Accelerated Aged) ●
- Corrosion Testing (Zero Time and Accelerated Aged)
- Tensile Testing (Zero Time and Accelerated Aged)
- . MRI Testing (Magnetically Induced Displacement Force, Magnetically Induced Torque, RF-Induced Heating, Image Artifact) (Zero Time)
- Radiopacity Testing (Zero Time) ●
- ISO 80369-1: Non-Interconnectability Testing (Zero Time)
- . Wire Guide Puncture Evaluation (Zero Time and Accelerated Aged)

# Biocompatibility Testing:

Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, subchronic toxicity, implantation, and material-mediated pyrogenicity were performed to ensure the biocompatibility of the subject device.

# Clinical Evidence:

Published literature was evaluated as supporting evidence that the subject device is appropriate for use in children (2 years and older) and adolescents. Six articles provided clinical evidence on safety and performance of using 6 French, 8 French, or 10 French post-pyloric feeding tubes in pediatric patients. The studies, number of patients, description of the patients/subjects, and a summary of the safety and/or effectiveness data as it pertains to adverse effects and complications reported in the studies is summarized in Table 2.

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Image /page/7/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in white, bold letters on a red background. Below that, the word "MEDICAL" is in white, smaller letters on a darker red background.

COOK INCORPORATED 750 Daniels Way BLOOMINGTON, IN 47404 USA PHONE: [phone] TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

K190084 Page 5 of 6

#### Table 2: Clinical literature

| Study<br>(Study type) | Number of<br>pediatric<br>patients | Patient Age | | Tube Size | Safety Data<br>Associated with<br>Use of Feeding<br>Tube | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------------------|----------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| | | Weight<br>(kg) | Estimated<br>age<br>(months)* | | | |
| Lyman B., Kemper C.,<br>Northington L., Yaworski J.A.,<br>Wilder K., Moore C., Duesing<br>L.A., Irving S. Use of Temporary<br>Enteral Access Devices in<br>Hospitalized Neonatal and<br>Pediatric Patients in the United<br>States. Journal of Parenteral and<br>Enteral Nutrition. 2014, 40:4 (574-<br>580). (Prevalence study) | 1435<br>233<br>120<br>132 | <5<br>5 to < 10<br>10 to < 20<br>>20 | <4<br>4 to < 22<br>22 to < 96<br>> 96 (8<br>years) | Average<br>Tube<br>Size<br>(Fr)<br>6<br>7<br>8<br>9 | Smallest<br>Tube<br>Size<br>(Fr)<br>4<br>5<br>5<br>5 | No adverse<br>events due to<br>procedure or<br>devices were<br>reported in this<br>study |
| Clifford P., Ely E., Heimall L.<br>Bedside Placement of the<br>Postpyloric Tube in Infants.<br>Advances in Neonatal Care. 2017,<br>17:1 (19-26). (Prospective cohort) | 1435 | Mean 40.5 weeks/ | | 6 French | Lower success<br>rate of placement<br>in infants with<br>congenital<br>diaphragmatic<br>hernia (CDH) | |
| Koot et al. Electromagnetic-guided<br>postpyloric tube placement in<br>children: pilot study of its use as a<br>rescue therapy. European e-Journal<br>of Clinical Nutrition and<br>Metabolism 2011, 6:2 (e74-e76).<br>(Retrospective case series) | 233 | Median 7.5 years<br>(range: 1-month to 14<br>year) | | 8, 10 French | No adverse<br>events occurred,<br>and the tubes<br>were well<br>tolerated. | |
| October and Hardart. Successful<br>placement of postpyloric enteral<br>tubes using electromagnetic<br>guidance in critically ill children.<br>Pediatric Critical Care Medicine<br>2009, 10:2 (196-200). (Prospective<br>cohort) | 120 | Median 3.2 years<br>(range: 2-month to 24<br>years) | | 8, 10 French | No acute<br>complications<br>observed during<br>the trial period | |
| Iglesias et al. Enteral nutrition in<br>critically ill children: are<br>prescription and delivery according<br>to their energy requirements?<br>Nutrition in Clinical Practice 2007,<br>22:2 (233-239). (Prospective<br>cohort) | 132 | Mean 8.2 month<br>(range: 0 to 13.5 years) | | Article does not<br>mention the size of<br>feeding tube being<br>used in patients. | Accidental<br>feeding tube<br>removal (27%). | |

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Image /page/8/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, uppercase letters in the top portion of the logo. Below the word "COOK" is the word "MEDICAL" in white, uppercase letters.

COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: [phone] TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

#### Table 2: Clinical literature (continued)

| Study<br>(Study type) | Number of<br>pediatric<br>patients | Patient Age | Tube Size | Safety Data<br>Associated with<br>Use of Feeding<br>Tube |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------|-----------------------------------------------------------------------------------------------------------------|
| Pobiel, R. S., Bisset 3rd, G. S., &<br>Pobiel, M. S. Nasojejunal feeding<br>tube placement in children: four-<br>year cumulative experience.<br>Radiology, 1994, 190:1 (127-129). | 232 | Mean 3.5 years (range:<br>1 week to 24 years) | 8 French | 3% unsuccessful<br>due to<br>malrotation,<br>CDH, gaseous<br>distension, or<br>hypertrophic<br>pyloric stenosis |
| Cone L.C., Gilligan M.F., Kagan<br>R.J., Mayes T., Gottschlich M.M.<br>Enhancing patient safety: The<br>effect of process improvement on<br>bedside fluoroscopy time related to<br>nasoduodenal feeding tube<br>placement in pediatric burn<br>patients. Journal of Burn Care and<br>Research 2009, 30:4 (606-611). | 2161<br>fluoroscopic<br>assisted tube<br>placements.<br>Number. Total<br>number<br>patients not<br>reported. | Age range not reported,<br>although the study was<br>conducted on pediatric<br>burn patients. | 8 French | 99 % success<br>rate. No adverse<br>events reported |

* Age estimated based on CDC weight chart for girls at the 5th percentile.

These data do not identify additional potential adverse events that are not covered in the proposed IFU of the subject device. The clinical literature summarized in Table 2 provides supporting evidence that the subject device is appropriate for use in children (2 years and older) and adolescents and raises no new question of safety and/or effectiveness.

#### Conclusion:

The results of these tests confirm that the McLean-Ring Nasojejunal Feeding Tube Set meets the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety and/or effectiveness and is substantially equivalent to the predicate device, the Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube (K160509, Cook Incorporated).