The COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube Kit is intended for use as a surgically place gastrostomy tube intended to deliver enteral feeding formulas directly into the small bowel (jejunum). The COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube is intended for use with patients who require enteral feeding. Indications for such medical and post-surgical treatments may include surgical problems, prolonged artificial ventilation, central nervous system trauma, and others. The placement of the device in patients is accomplished surgically using standard surgical techniques. This method is used to enhance the absorption of nutrients and minimize the risks of gastric feeding including gastric reflux and aspiration.

The COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube also provides for the evacuation of gastric contents through the gastrostomy tube while simultaneously feeding directly into the small bowel with the jejunal feeding tube. This device is for use under medical supervision only.

The COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube Kit provides for the delivery of enteral formula through a surgically placed Gastrostomy/Jejunostomy feeding tube. Jejunal feeding is used when patients require feeding past the stomach directly into the jejunum. This method is used to enhance the absorption of nutrients and minimize the risks of gastric feeding including gastric reflux and aspiration.

Device Description

The Novartis Nutrition COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube is packaged in a sterile kit. It is designed for easy intra-operative placement and facilitates immediate postoperative feeding into the jejunum. The two-tube system allows for easy placement and replacement in the event of a jejunal tube clog. The large gastrostomy tube provides access to the stomach for decompression and drainage. The system's jejunal feeding tube is easy to place intra-operatively through the gastrostomy tube into the small bowel using the innovative balloon tipped stylet provided in the kit.

The major components of the kit include:

. 28 FR Silicone Gastrostomy Tube
12 FR Polyurethane Jejunal Feeding Tube with Double Lumen FEED/DRAIN . adapter and radiopaque, flow-through tip
Preassembled disposable balloon tipped stylet

The COMPAT administration set contains or attaches to the formula reservoir/container and provides the conduit to deliver the feeding solution to the patient's feeding tube via a feeding pump. The patient's feeding tube may be a variety of tubes including, but not limited to, a nasogastic tube, a gastrostomy tube, or a jejunostomy tube. The administration set attaches to the patient's feeding tube to provide the formula or feeding solution required.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data to prove novel performance criteria. Therefore, the typical structure of an acceptance criteria table and a study proving those criteria is not directly applicable in this context.

Instead, the document asserts substantial equivalence based on technological characteristics and the absence of additional non-clinical or clinical testing for this specific use.

Here's an analysis of the provided information in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission primarily based on substantial equivalence, there isn't a table of new acceptance criteria that the device had to meet through a specific study. The "acceptance criteria" here are implicitly that the modified device performs similarly to the predicate device and does not raise new questions of safety or effectiveness.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance
Intended Use: Delivery of enteral feeding formula directly into the small bowel, minimization of gastric reflux and aspiration, and evacuation of gastric contents.	Met: "The COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube Kit provides the same ability as the comparative substantially equivalent device for delivery of formula and medications to the small intestine... while allowing simultaneous gastric drainage." The Statement of Intended Use and Indications for Use are identical to the predicate device.
Placement Techniques & Confirmation: Surgical placement, manipulation into jejunum, and confirmation via X-ray/fluoroscopy.	Met: "Initial placement... may be accomplished surgically, as with the predicate substantially equivalent device." "The jejunal feeding tube can be placed in a similar fashion to that of the substantially equivalent device." "Confirmation of placement... may be accomplished using x-ray or fluoroscopic techniques."
Materials of Construction: Gastrostomy and Jejunostomy tube materials.	Met: "The materials of construction of the Gastrostomy and Jejunostomy tubes are identical to that of the substantially equivalent device."
Radiopacity of Jejunal Tubing: Visibility under imaging.	Met/Equivalent: The only difference is the orientation of the radiopaque material (solid filled vs. stripe), but the content (20% barium sulfate) is unchanged. This change is not considered to alter performance.

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

Sample Size: Not applicable. No clinical or non-clinical studies with a "test set" were conducted beyond the comparison of technological characteristics to the predicate device.
Data Provenance: Not applicable.

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

Not applicable. No new ground truth was established as no new studies were conducted. The ground truth relies on the established safety and effectiveness of the predicate device.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC comparative effectiveness study was not done. This device is a component for enteral feeding, not an AI-assisted diagnostic or therapeutic tool that would typically involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No. This is a medical device (feeding tube kit), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The implicit "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate device (Sandoz Nutrition COMPAT® Surgical Gastro/Jejunostomy Feeding Tube Kit, K965087). The documentation focuses on demonstrating that the modified device is substantially equivalent and does not introduce new questions of safety or effectiveness compared to this predicate.

8. The Sample Size for the Training Set:

Not applicable. No "training set" was used as this is not an AI/machine learning device.

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

Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" in this context is the 510(k) Premarket Notification process itself, which concluded that the modified Novartis Nutrition Corporation COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube Kit (item number 088000) is substantially equivalent to its predicate device (Sandoz Nutrition COMPAT® Surgical Gastro/Jejunostomy Feeding Tube Kit, K965087).

The document explicitly states:

"No additional non-clinical testing of this product for this use was conducted."
"No additional clinical evaluations of this product for this use have been conducted."

The justification for substantial equivalence relies on comparing the technological characteristics of the modified device to the predicate device, specifically highlighting:

Identical intended use and indications for use.
Similar functionality (intestinal feeding, gastric drainage).
Similar placement techniques and confirmation methods.
Identical materials of construction for the tubes, with a minor, non-performance-altering change in the radiopaque material's orientation within the jejunal tubing.

The FDA's decision to clear the device (K071191) indicates their agreement with the manufacturer's assertion of substantial equivalence based on this comparison of technological characteristics and the absence of new safety or effectiveness concerns.

Summary

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Kozy 91 1044

510(k) Summary (per 21 CFR 807.87(h))

JUL 2 3 2007

Common/Usual Name:	Gastrostomy/Jejunostomy Feeding Tube Kit
Product Trade Name:	COMPAT® Surgical Gastrostomy/JejunostomyFeeding Tube Kit, Model #088000
Classification Name:	Tubes, Gastrointestinal (and Accessories)Class II per 21 CFR §876.5980Product Code KNT
Predicate Device:	Novartis Item 088000, COMPAT® SurgicalGastrojejunostomy Feeding Tube Kit, (K965087)
Manufacturer:	Novartis Nutrition Corporation1541 Park Place BlvdSt. Louis Park, MN 55416
Establishment Registration:	2110851
Contact:	Sue Fidler,Manager, Regulatory Affairs NATelephone: 952-848-6328 / Fax: 952-848-6319Email: susan.fidler@novartis.com
Performance Standards:	No performance standards have been developedunder section 514 for this device.
Date Prepared:	April 21, 2006

Device Description:

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drainage. The system's jejunal feeding tube is easy to place intra-operatively through the gastrostomy tube into the small bowel using the innovative balloon tipped stylet provided in the kit.

The major components of the kit include:

. 28 FR Silicone Gastrostomy Tube
12 FR Polyurethane Jejunal Feeding Tube with Double Lumen FEED/DRAIN . adapter and radiopaque, flow-through tip
Preassembled disposable balloon tipped stylet1 .

Statement of Intended Use:

Indications for Use:

1 The balloon on the disposable stylet is made from natural rubber latex. The stylet is removed after placement.

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into the jejunum. This method is used to enhance the absorption of nutrients and minimize the risks of gastric feeding including gastric reflux and aspiration.

Summary of technological characteristics in comparison to those of the predicate device.

1. Intestinal feeding and gastric drainage.

The COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube Kit provides the same ability as the comparative substantially equivalent device for delivery of formula and medications to the small intestine (through "FEED" port) while allowing simultaneous gastric drainage (through "DRAIN" port) via the gastrostomy tube. The COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube also provides for the evacuation of gastric contents through the gastrostomy tube while simultaneously feeding directly into the small bowel with the jejunal feeding tube.

Placement techniques and confirmation methods. 2.

Initial placement of the COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube may be accomplished surgically, as with the predicate substantially equivalent device through a faparotomy midline incision and Stamm (gastrostomy) technique. The jejunal feeding tube can be placed in a similar fashion to that of the substantially equivalent device in that the tube is led through the lumen of the gastrostomy tube into the stomach, then grasped at its tip and manipulated through the gastric pylorus into the small intestine.

This manual manipulation into the bowel is assisted by the presence of the bolus tip on the jejunal tube and by a removable stylet. The inflation of the cuff provides an additional (temporary) feature for grasping and directing the jejunal tube tip.

Both the substantially equivalent and this device contain a Y-port at the connector end of the Jejunal Feeding tube, which may be pressed into the lumen of the Gastrostomy tube to complete the placement and allow for gastric drainage through the gastrostomy tube. The Gastrostomy/Jejunostomy tube combination may be immobilized using the external retainer and the abdomen may be closed in the standard fashion.

Confirmation of placement of both tubes may be accomplished using x-ray or fluoroscopic techniques.

3. Tube and Stylet Construction.

The materials of construction of the Gastrostomy and Jejunostomy tubes are identical to that of the substantially equivalent device. The only difference is the orientation of the radiopaque material in the jejunal tubing. The tubing of the

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substantially equivalent device contained 20% barium sulfate in a stripe configuration, whereas the modified tubing is solid filled 20% barium sulfate. The content of the barium sulfate contained in the tube has not changed from that of the substantially equivalent device.

Summary of Non-Clinical Testing:

No additional non-clinical testing of this product for this use was conducted.

Summary of Clinical Testing:

No additional clinical evaluations of this product for this use have been conducted.

Predicate Devices:

The predicate device of the Novartis Nutrition Corporation COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube Kit item number 088000, as modified, is the Sandoz Nutrition COMPAT® Surgical Gastro/Jejunostomy Feeding Tube Kit, (K965087). The company name has been changed from Sandoz Nutrition to Novartis Nutrition Corporation.

Conclusions:

Novartis Nutrition Corporation COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube Kit item number 088000, as modified, is substantially equivalent to Sandoz Nutrition COMPAT® Surgical Gastro/Jejunostomy Feeding Tube Kit, (K965087).

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Novartis Nutrition Corporation c/o Ms. Laura Danielson Program Manager TÜV SÜD America, Inc. 1775 Old Highway 8 NW, Ste. 104 NEW BRIGHTON MN 55112-1891

Re: K071191

Trade/Device Name: COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube Kit Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FPD Dated: July 9, 2007 Received: July 10, 2007

2 3 2007

Dear Ms. Danielson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/4/Picture/9 description: The image is a black and white circular logo. The logo has the text "1906-2006 FDA Centennial" in the center. The text is surrounded by a circle of stars. The logo is likely for the 100th anniversary of the Food and Drug Administration.

Protecting and Promoting Public Health

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx 21 CFR 884.xxxx 21 CFR 892 xxxxx Other

(Gastroenterology/Renal/Urology) 240-276-0115 (Obstetrics/Gynecology) 240-276-0115 (Radiology) 240-276-0120 240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

Ko71191 Current 510(k) Number:

Device Name: COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube Kit

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

oductive. Abdominal. Radiological Device

510(k) Number K871191

Page 1 of 1

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.