(261 days)
No
The device description and performance studies focus on the physical characteristics, materials, and conformance to standards for an enteral feeding tube, with no mention of AI or ML.
Yes
The device is intended for the administration of medication, which can be considered a therapeutic purpose.
No
The device is intended for "long-term enteral access for administration of medication," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly outlines physical components like a tube, guide wire, connectors, and a fixation screw, indicating it is a hardware medical device.
Based on the provided information, the AbbVie J is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "to provide long-term enteral access for administration of medication to the small intestine." This describes a device used in vivo (within the body) for delivering substances, not for testing samples in vitro (outside the body) to diagnose conditions.
- Device Description: The description details a tube, guide wire, connectors, and fixation components, all consistent with a device for insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, the AbbVie J is a medical device used for therapeutic purposes (medication administration), not for diagnostic testing.
N/A
Intended Use / Indications for Use
The AbbVie J is intended to provide long-term enteral access for administration of medication to the small intestine.
Product codes
KNT
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, Y-Connector, Fixation Screw (blue or violet) with Outer Ring, Click Adaptor consisting of: Click Adaptor Cap and Click Adaptor Connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small intestine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Clinical Performance Data: No clinical evaluations were performed or relied upon for the determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JUN 1 8 2014
| abbvie AbbVie J K133096 | Traditional 510(k) Notification
510(k) Summary |
| ------------------------- | --------------------------------------------------- |
|---|
| 510(k) Summary | |
|---|---|
| Sponsor: | AbbVie Inc. |
| 1 N. Waukegan Road | |
| North Chicago, IL 60064 | |
| Contact: | Katherine Wortley, Ph.D. |
| Director Regulatory Affairs | |
| AbbVie Inc.. | |
| Telephone: (847) 938-7707 | |
| Fax: (847) 775-4997 | |
| Email: Katherine.wortley@abbvie.com | |
| Date Prepared: | September 30, 2013 |
| Device: | |
| Trade Name: | AbbVie™ J |
| Common Name: | Intestinal Tube |
| Classification Name: | Tubes, Gastrointestinal and Accessories |
| 21 CFR 876.5980, Product Code KNT, Class II | |
| Predicate Device: | EndoVive™ Two-Port Through The PEG (TTP) Jejunal |
| Feeding 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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1
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.
2
3
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.
3
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.
4
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
5
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)