The AbbVie™ J is a 9 FR intestinal (J) tube, 120 cm in length. The kit includes: AbbVie J tube with Teflon™-coated Guide Wire and Blue Guide Wire Lock, Y-Connector, Fixation Screw (blue or violet) with Outer Ring, Click Adaptor consisting of: Click Adaptor Cap and Click Adaptor Connector.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Biocompatibility (per ISO 10993-1:2009)	Acceptable performance across all protocols tested for biocompatibility.
Material Composition	Acceptable performance across all protocols tested for biocompatibility. (Implicitly tied to biocompatibility, but explicitly mentioned).
Conformance to EN 1615:2000 (Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing)	Device assessed for conformance and shown to be acceptable.
Conformance to ISO 80369-1:2010 (Small-bore Connectors for Liquids and Gases in Healthcare Applications - Part 1: General requirements)	Assessment completed and shown to be acceptable.
Substantial Equivalence to Predicate Device (EndoVive™ Two-Port Through The PEG (TTP) Jejunal Feeding Tube (J-Tube) Kit, K081739)	Demonstrated no differences that would affect safety or effectiveness, and differences do not raise new issues of safety or effectiveness.

2. Sample Size for Test Set and Data Provenance:

The document explicitly states: "No clinical evaluations were performed or relied upon for the determination of substantial equivalence." This means there was no test set in the traditional sense of patient data or clinical trials for evaluating device performance in humans. The testing was entirely non-clinical (bench testing and material assessments). Therefore, there is no information about sample size for a test set or data provenance related to human subjects.

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

Since no clinical evaluations were performed, there was no "ground truth" derived from patient outcomes or expert consensus on clinical data. The acceptance criteria were based on adherence to international standards and non-clinical performance characteristics. The "experts" involved would likely be the engineers, toxicologists, and regulatory specialists within AbbVie who conducted and reviewed the non-clinical testing. Their specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication by experts was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The device's approval was based on non-clinical performance and substantial equivalence to a predicate device, not on human-in-the-loop performance or comparison of human readers with and without AI assistance.

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

Not applicable. This device is a physical medical device (an intestinal tube), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

The "ground truth" for the device's acceptance relied on:

Compliance with recognized international standards: ISO 10993-1:2009, EN 1615:2000, and ISO 80369-1:2010.
Bench test results: Demonstrating mechanical and material properties meet specified requirements.
Biocompatibility testing: As per ISO 10993, which provides a "ground truth" for material interaction with biological systems.
Comparison to a predicate device: Establishing substantial equivalence based on technical characteristics and intended use.

8. The Sample Size for the Training Set:

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing process would involve various prototypes and batch testing, but these are not considered a "training set" for an algorithm.

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

Not applicable, as there is no "training set" for this type of device. The design specifications and performance requirements for the device would have been established through engineering principles, prior knowledge of similar devices, and regulatory standards.

Summary

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JUN 1 8 2014

abbvie AbbVie J K133096	Traditional 510(k) Notification510(k) Summary
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510(k) Summary
Sponsor:	AbbVie Inc.1 N. Waukegan RoadNorth Chicago, IL 60064
Contact:	Katherine Wortley, Ph.D.Director Regulatory AffairsAbbVie Inc..Telephone: (847) 938-7707Fax: (847) 775-4997Email: Katherine.wortley@abbvie.com
Date Prepared:	September 30, 2013
Device:
Trade Name:	AbbVie™ J
Common Name:	Intestinal Tube
Classification Name:	Tubes, Gastrointestinal and Accessories21 CFR 876.5980, Product Code KNT, Class II
Predicate Device:	EndoVive™ Two-Port Through The PEG (TTP) JejunalFeeding Tube (J-Tube) Kit, K081739
Device Description:

The AbbVie™ J is a 9 FR intestinal (J) tube, 120 cm in length. The kit includes: AbbVie J tube with Teflon™-coated Guide Wire and Blue Guide Wire Lock,

— — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — —

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AbbVie J K 133096 abbvie Traditional 510(k) Notification 510(k) Summary

Y-Connector, Fixation Screw (blue or violet) with Outer Ring, Click Adaptor consisting of: Click Adaptor Cap and Click Adaptor Connector.

Device Intended Use:

The AbbVie J is intended to provide long-term enteral access for administration of medication to the small intestine.

Comparison of Product Characteristics:

The AbbVie J is substantially equivalent to the currently marketed device, EndoVive™ Two-Port Through The PEG (TTP) Jejunal Feeding Tube (J-Tube) Kit (K081739). Both devices are intestinal tubes have the same fundamental structure and function. Both tubes are used in conjunction with a percutaneous endoscopic gastrostomy tube. Both devices are single lumen, single use, sterile (by ethylene oxide sterilization methods), made of polyurethane, and provide access to the small intestine to administer medication. Both devices have a coiled distal region, male Luer lock connector and utilize a guide wire during installation. Differences include length and indications for use (the Abb Vie tube is indicated for the administration, the Boston Scientific tube for enteral feeding and medication administration).

Non-Clinical Performance Data:

The performance characteristics of the Abb Vie J have been verified based on the conformance to applicable industry standards. The material composition of the AbbVie J shows acceptable performance across all protocols tested for biocompatibility per ISO 10993-1:2009 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process. The AbbVie J was assessed for conformance to standard EN 1615:2000 Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing. An assessment of the AbbVie J has been completed and shown to be acceptable per ISO 80369-1:2010 Small-bore Connectors for Liquids and Gases in Healthcare Applications- Part 1: General requirements.

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AbbVie J K133096 abbvie Traditional 510(k) Notification 510(k) Summary

Clinical Performance Data:

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

Conclusion:

The information provided within this pre-market notification demonstrates that the AbbVie J has no differences that would affect the safety or effectiveness of the device as compared to the predicate device, Endo Vive Two-Port Through The PEG (TTP) Jejunal Feeding Tube (J-Tube) Kit. The differences between the two devices do not raise new issues of safety or effectiveness. The AbbVie J is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.

Public Health Service

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

June 18, 2014

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

Re: K133096

Trade/Device Name: AbbVie™ J Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: May 15, 2014 Received: May 16, 2014

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. 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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Page 2 - Katherine Wortley, Ph.D., RAC

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Image /page/4/Picture/6 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The text is black against a white background, making it highly legible. There is a decorative element between the "P." and "Lerner" which appears to be a seal or emblem, adding a touch of formality to the presentation. The overall impression is clean and professional.

for 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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AbbVie J K133096 abbvie Traditional 510(k) Notification Additional Information Response

Indications for Use

510(k) Number (if known): K133096

Device Name: AbbVie™ J

Indications for Use: .

The AbbVie J is intended to provide long-term enteral access for administration of medication to the small intestine.

Prescription Use X

(21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

Over-The-Counter Use _

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S 2014.06.19 07:00:11 -04'00'

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.