(167 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
This device is intended to provide enteral access for decompression and delivery of nutrition and/or medication, which are therapeutic interventions.
No
Explanation: The device is intended for enteral access for decompression and delivery of nutrition and/or medication, which are therapeutic and supportive functions, not diagnostic.
No
The device description clearly outlines physical components like tubes, cannulas, guidewires, and other accessories, indicating it is a hardware-based medical device kit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide enteral access for decompression and delivery of nutrition and/or medication. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The device is a tube designed for placement within the body to deliver substances or remove contents. This is a medical device used for treatment or support, not for analyzing samples from the body to diagnose conditions.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The 2-Port TTP Jejunostomy Tube Kit is intended to provide enteral access for decompression and delivery of nutrition and/or medication.
The EndoVive Two-Port Through The PEG (TTP) Jejunal Feeding Tube (J-Tube) Kit is intended to provide enteral access for decompression and delivery of nutrition and/or medication.
Product codes (comma separated list FDA assigned to the subject device)
KNT
Device Description
The 2-Port TTP Jejunostomy Tube consists of a two-port device designed to be placed through a Boston Scientific gastrostomy tube to provide enteral access for decompression and delivery of nutrition and/or medication. The 2-Port TTP Jejunostomy Tube is available with a pigtail tip and in two lengths, 80cm and 105cm. It may be placed by either a pullwire (pull) or guidewire (push) The proposed device is available within a kit which contains the following: a technique. stiffening cannula with female luer fitting, a guidewire, lubricating jelly, gauze, a female-to-female luer adapter, port caps, and a retention ring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
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
DEC 0 3 2008
SECTION 5 510(k) SUMMARY
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4454 Fax: 508-683-5939
Contact: Marybeth Gamber Regulatory Affairs Manager Date Prepared: June 18, 2008
2. Device:
Trade Name: 2-Port Through-The-PEG (TTP) Jejunostomy Tube Kit Classification Name: Tube, Gastrointestinal (and Accessories) Regulation Number: 876.5980 Product Code: KNT Classification: Class II
3. Predicate Device:
K072476 Through-The-PEG (TTP) Jejunostomy Tube Kit Manufactured by Boston Scientific, Inc.
4. Device Description:
The 2-Port TTP Jejunostomy Tube consists of a two-port device designed to be placed through a Boston Scientific gastrostomy tube to provide enteral access for decompression and delivery of nutrition and/or medication. The 2-Port TTP Jejunostomy Tube is available with a pigtail tip and in two lengths, 80cm and 105cm. It may be placed by either a pullwire (pull) or guidewire (push) The proposed device is available within a kit which contains the following: a technique. stiffening cannula with female luer fitting, a guidewire, lubricating jelly, gauze, a female-to-female luer adapter, port caps, and a retention ring.
5. Intended Use:
The 2-Port TTP Jejunostomy Tube Kit is intended to provide enteral access for decompression and delivery of nutrition and/or medication.
6. Technological Characteristics:
The proposed 2-Port TTP Jejunostomy Tube Kit is similar in design, materials, and manufacturing processes to the predicate 3-Port TTP Jejunostomy Tube Kit (K072476).
7. Performance Data:
In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
Premarket Notification, 2-Port Through-The-PEG Jejunostomy Tube Kit
000011
1
8. Conclusion:
:
i
. .
.....
.
Boston Scientific Corporation has demonstrated that the proposed 2-Port Through-The-PFG (TTP) Jejunostomy Tube Kit is substantially equivalent to Boston Scientific Corporation's currently marketed 3-Port Through-The-PEG (TTP) Jejunostomy Tube Kit (K072476).
:
000012
.
Premarket Notification, 2-Port Through-The-PEG Jejunostomy Tube Kit
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a 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" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a person embracing or supporting another, rendered in a simple, abstract design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marybeth Gamber Manager. Regulatory Affairs Boston Scientific Corporation 100 Boston Scientific Way Endoscopy Division, M11 MARLBOROUGH MA 01752
Re: K081739
Trade/Device Name: EndoVive Two-Port Through The PEG (TTP) Jejunal Feeding Tube (J-Tube) Kit Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT
DEC 0 3 2008
Dated: November 25, 2008 Received: November 26, 2008
Dear Ms. Gamber:
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 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). 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.
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.
3
Page 2 - Ms. Gamber
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on the labeling regulation, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by . reference to premarket notification" (21 CFR Part 807.97). 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 (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh.dsmamain.html.
Sincerely yours,
Helen Remer
Joyce M. Whang, Ph.D.
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
SECTION 4 INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Indications for Use:
K081739
EndoVive Two-Port Through The PEG (TTP) Jejunal Feeding Tube (J-Tube) Kit
The EndoVive Two-Port Through The PEG (TTP) Jejunal Feeding Tube (J-Tube) Kit is intended to provide enteral access for decompression and delivery of nutrition and/or medication.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jom M. Whm
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number