(110 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical characteristics, biocompatibility, and compatibility with the medication, with no mention of AI or ML.
No.
The device is intended for administration of medication, not for treating a disease or condition itself.
No
The device is described as a naso-jejunal tube intended for the administration of medication, not for diagnosing conditions.
No
The device description clearly states it is a physical naso-jejunal tube made of polyurethane with a stainless steel stylet, indicating it is a hardware medical device.
Based on the provided information, the AbbVie NJ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing "short-term enteral access for administration of medication to the small intestine." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a tube designed for delivering medication, not for analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples, measure biomarkers, or provide any kind of diagnostic result.
- Performance Studies: The performance studies focus on biocompatibility and physical performance (conformance to standards, compatibility with the medication), which are relevant for a medical device used for drug delivery, not for an IVD.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The AbbVie NJ does not fit this description.
N/A
Intended Use / Indications for Use
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).
Product codes
KNT
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.
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
Home and/or healthcare facility environment.
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
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 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 (
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
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.
1
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
2
Indications for Use
510(k) Number (if known): K142792
Device Name: AbbVie NJ
Indications for Use:
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).
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 Usual | |
| Name: | 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.
4
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.
INDICATIONS FOR USE
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).
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
5
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 (