(262 days)
Not Found
No
The summary describes a physical medical device (a PEG tube and kit) and its performance based on industry standards and material testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
Explanation: The device is intended to provide long-term enteral access for administration of medication and nutrition, which directly involves treatment and maintenance of health, classifying it as a therapeutic device.
No
The device is described as a percutaneous endoscopic gastrostomy (PEG) tube intended for long-term enteral access for medication and nutrition administration, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components like a PEG tube, introducer device, cannula, scalpel, fixation plate, and tube clamp, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing long-term enteral access for administering medication and potentially nutrition directly to the stomach and small intestine. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The device is a physical tube and associated components for insertion into the body. IVDs typically involve reagents, instruments, or software used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on biocompatibility, conformance to standards for enteral feeding devices, and food contact testing. These are relevant to a device that is inserted into the body for delivering substances, not for analyzing biological samples.
In summary, the AbbVie PEG is a medical device used for delivering substances into the body, not for performing diagnostic tests on biological specimens.
N/A
Intended Use / Indications for Use
The AbbVie PEG is intended to provide long-term enteral access for administration of medication to the small intestine when used in conjunction with the AbbVie J, intestinal tube. As needed, enteral nutrition may be administered directly to the stomach in parallel with medication delivery to the intestine.
Product codes (comma separated list FDA assigned to the subject device)
KNT
Device Description
The AbbVie™ PEG is a percutaneous endoscopic gastrostomy (PEG or gastric) tube, either 15 FR or 20 FR and 35 cm in length. The kit includes the following: AbbVie PEG Tube (polyurethane), Reel of Thread with double thread and Introducer Device, Puncture Cannula with safety (air) valve, Disposable Scalpel, Silicone external Fixation Plate (radio-opaque) with integrated Tube Clip, and Tube Clamp.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small intestine, stomach
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: The performance characteristics of the AbbVie PEG have been verified based on the conformance to applicable industry standards. The material composition of the AbbVie PEG 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 PEG 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 PEG 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. Food contact testing was conducted on the AbbVie PEG and demonstrated that the materials that constitute the AbbVie PEG are acceptable for food contact use. The study was conducted as described in 21 CFR 177.2600 Indirect Food Additives: Polymers, Rubber articles intended for repeated use per the extractable limits.
Clinical Performance Data: No clinical evaluations were performed or relied upon for the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 9 2014
·
| AbbVie | AbbVie PEG K133087 |
|---|---|
| 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™ PEG |
| Common Name: | Gastrostomy Tube |
| Classification Name: | Tubes, Gastrointestinal and Accessories |
| 21 CFR 876.5980, Product Code KNT, Class II | |
| Predicate Device: | EndoVive™ Initial Placement PEG Kit, K030855 |
| Device Description: |
The AbbVie™ PEG is a percutaneous endoscopic gastrostomy (PEG or gastric) tube, either 15 FR or 20 FR and 35 cm in length. The kit includes the following: AbbVie PEG Tube (polyurethane), Reel of Thread with double thread and Introducer Device, Puncture
]
.
1
2
AbbVie PEG K133087 abbvie Traditional 510(k) Notification 510(k) Summary
Cannula with safety (air) valve, Disposable Scalpel, Silicone external Fixation Plate (radio-opaque) with integrated Tube Clip, and Tube Clamp.
Device Intended Use:
The AbbVie PEG is intended to provide long-term enteral access for administration of medication to the small intestine when used in conjunction with the AbbVie J, intestinal tube. As needed, enteral nutrition may be administered directly to the stomach in parallel with medication delivery to the intestine.
Comparison of Product Characteristics:
The AbbVie PEG is substantially equivalent to the currently marketed device, Endo Vive™ Initial Placement PEG Kit (K030855). Both devices are percutaneous endoscopic gastrostomy tubes. The tubes have the same fundamental structure and function. Both devices are single use, sterile and provide an opening into the stomach for feeding and insertion of an intestinal tube. Differences include tube material and indications for use (the AbbVie PEG is indicated for the administration of medication and enteral feeding, the EndoVive Initial Placement PEG Kit for enteral feeding).
Non-Clinical Performance Data:
The performance characteristics of the AbbVie PEG have been verified based on the conformance to applicable industry standards. The material composition of the AbbVie PEG 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 PEG 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 PEG 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. Food contact testing was conducted on the AbbVie PEG and demonstrated that the materials that constitute the AbbVie PEG are acceptable for food
2
AbbVie PEG K133087 abbvie Traditional 510(k) Notification 510(k) Summary
contact use. The study was conducted as described in 21 CFR 177.2600 Indirect Food Additives: Polymers, Rubber articles intended for repeated use per the extractable limits.
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 PEG has no differences that would affect the safety or effectiveness of the device as compared to the predicate device, EndoVive Initial Placement PEG Kit. The differences between the two devices do not raise new issues of safety or effectiveness. The AbbVie PEG is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its wing and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2014
AbbVie, Inc. Katherine Wortley, Ph.D., RAC Director Regulatory Affairs I N. Waukegan Road North Chicago, IL 60064
K133087 Re:
Trade/Device Name: AbbVie™ PEG 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. 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, and 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 ir your de roo is olditional 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.
4
Page 2 - Katherine Wortley, Ph.D., RAC
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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 vours.
Image /page/4/Picture/8 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The letters are black against a white background, creating a high contrast. The text appears to be a title or heading, possibly indicating a person's name and initial.
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
5
AbbVie PEG K133087 abbvie Traditional 510(k) Notification Additional Information Response
Indications for Use
510(k) Number (if known): K133087
Device Name: AbbVie™ PEG
Indications for Use:
."
The AbbVie PEG is intended to provide long-term enteral access for administration of medication to the small intestine when used in conjunction with the AbbVie J, intestinal tube. As needed, enteral nutrition may be administered directly to the stomach in parallel with medication delivery to the intestine.
Prescription Use X__________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner 2014.06.19 14:49:33
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