The AbbVie NJ is intended to provide short-term enteral access for administration of medication to the small intestine. The AbbVie NJ is indicated for the administration of the medication DUOPA (carbidopa and levodopa enteral suspension).

Device Description

The AbbVie NJ (List Number 62903) is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaque polyurethane. The distal coiled end region and bolus tip are coated with a water activated lubricant. The AbbVie NJ includes a silicone coated stainless steel Stylet. The kit is supplied sterile (ethylene oxide). The AbbVie NJ is inserted through the nose and advanced into the small intestine for administration of medication in a home and/or healthcare facility environment. The Stylet is used to aid insertion and is removed once the tube is in place.

AI/ML Overview

The provided text describes a 510(k) submission for the AbbVie NJ device, a naso-jejunal tube. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria for a novel device. Therefore, much of the requested information about device performance, study design, and ground truth establishment is not available in the provided text.

Based on the information given:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as numerical performance criteria for the device itself. Instead, the focus is on demonstrating conformance to standards and biocompatibility.	Biocompatibility: Passed Cytotoxicity, Sensitization, Irritation (intracutaneous reactivity), Systemic toxicity (acute), Pyrogen Testing, and Implantation tests.
Product Specific Performance: Conformance to BS EN 1615:2000 for enteral feeding catheters and enteral giving sets.	Found to be acceptable per ISO 80369-1:2010.
Material Compatibility: Compatibility with DUOPA medication.	Passed compatibility testing with the medication DUOPA.
Substantial Equivalence: Device is identical to the predicate device (AbbVie NJ, K133129) and the new indication does not alter intended use or impact safety/effectiveness.	Demonstrated by stating identity to predicate device and no change in intended use or safety/effectiveness due to the new indication.

2. Sample size used for the test set and the data provenance:

The document states, "No animal or clinical evaluations were performed or relied upon for the determination of substantial equivalence." This implies that there was no specific test set or clinical data of human subjects to evaluate the device's performance in a clinical setting against acceptance criteria.
The "test set" for performance evaluation consisted of the physical device undergoing various laboratory tests (biocompatibility, product-specific performance, material compatibility). The sample size for these laboratory tests is not specified in the provided text, nor is the data provenance in terms of country of origin or retrospective/prospective nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. As no clinical or animal studies were conducted, there were no human subjects or cases requiring expert consensus for ground truth. The "ground truth" for the laboratory tests would be the accepted standards and methods for those tests.

4. Adjudication method for the test set:

Not applicable. No clinical data requiring adjudication was generated or relied upon.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

No. The document explicitly states, "No animal or clinical evaluations were performed or relied upon for the determination of substantial equivalence." Therefore, no MRMC study was conducted.

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

Not applicable. This device is a physical medical device (naso-jejunal tube), not a software algorithm or AI model.

7. The type of ground truth used:

The "ground truth" implicitly used for this submission is based on established international and FDA-recognized standards and test methods for biocompatibility (ISO 10993 series), product-specific performance (BS EN 1615:2000, ISO 80369-1:2010), and material compatibility. The successful completion of these tests serves as the "ground truth" for meeting the regulatory requirements for substantial equivalence.

8. The sample size for the training set:

Not applicable. This device is a physical medical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. (See point 8).

Summary

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

January 14, 2015

AbbVie, Inc. Katherine Wortley Director Regulatory Affairs 1 N. Waukegan Road North Chicago, IL 60064

Re: K142792 Trade/Device Name: AbbVie NJ Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: Class II Product Code: KNT Dated: January 9, 2015 Received: January 12, 2015

Dear Katherine Wortley,

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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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 (reporting of medical devicerelated 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 -A

Benjamin 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): K142792

Device Name: AbbVie NJ

Indications for Use:

Prescription Use _X __________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(21 CFR 801 Subpart D)

(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)

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510(k) Summary

SUBMITTER

AbbVie Inc. 1 N. Waukegan Road North Chicago, IL 60064

Phone: (847) 938-7707 Fax: (847) 775-4997

Contact Person: Katherine Wortley, Ph.D., Director Regulatory Affairs Email: Katherine.wortley@abbvie.com

Date Prepared: September 25, 2014

DEVICE

Name of Device:	AbbVie NJ
Common or UsualName:	Naso-Jejunal Tube
Classification Name:	Tubes, Gastrointestinal and Accessories(21 CFR 876.5980)
Regulatory Class:	II
Product Code:	KNT

PREDICATE DEVICE

AbbVie NJ, K133129 No reference devices were used in this submission.

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DEVICE DESCRIPTION

The kit is supplied sterile (ethylene oxide).

The AbbVie NJ is inserted through the nose and advanced into the small intestine for administration of medication in a home and/or healthcare facility environment. The Stylet is used to aid insertion and is removed once the tube is in place.

INDICATIONS FOR USE

COMPARISON OF TECHNILOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The proposed device is identical to the predicate device (AbbVie NJ, K133129) with the exception of the proposed indication for use with DUOPA.

PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the AbbVie NJ was conducted in accordance with the FDA Blue Book Memorandum #G95-1 Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,' published May 1, 1995, FDA Draft Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" published April 23, 2013 and International Standard

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ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. A naso-jejunal tube is characterized as a "surface device" through contact with mucosal membrane. Per the standard, the contact duration can be defined as "prolonged, > 24 hours to 30 days." The stylet is used only during the tube placement procedure and contact was defined as "Limited (< 24 hours)." The battery of testing included the following:

Cytotoxicity .
. Sensitization
Irritation (intracutaneous reactivity) ●
Systemic toxicity (acute) ●
Pyrogen Testing and ●
Implantation. ●

Product Specific Performance Testing

The AbbVie NJ was assessed for conformance to standard BS EN 1615:2000 Enteral feeding catheters and enteral giving sets for single use and their connectors – Design and testing. An assessment of the AbbVie NJ has been completed and shown to be acceptable per ISO 80369-1:2010 Small-bore Connectors for Liguids and Gases in Healthcare Applications- Part 1: General requirements. AbbVie NJ has passed compatibility testing with the medication DUOPA.

Animal and Clinical Studies

No animal or clinical evaluations were performed or relied upon for the determination of substantial equivalence.

CONCLUSIONS

The proposed device, AbbVie NJ, is substantially equivalent to the predicate device as it is identical to the previously cleared predicate device (AbbVie NJ, K133129). The indication for use with DUOPA does not alter the intended use (enteral delivery of fluids) or introduce a difference that impacts safety or effectiveness of the 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.