(89 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical feeding tube and does not mention any AI or ML components or functionalities.
Yes
The device is used for enteral nutritional support and decompression, addressing conditions where feeding via the upper gastrointestinal tract is contraindicated, which aligns with the definition of a therapeutic device.
No
The device is indicated for enteral nutritional support and decompression, addressing conditions like post-surgery, radiation therapy, and chemotherapy. It serves a therapeutic purpose (feeding and decompression) rather than identifying or diagnosing a medical condition.
No
The device description clearly states it is a "three port device" and mentions physical components like "tip configurations (pigtail, & bent tip)" and placement techniques involving "tether (pull), or guidewire techniques," indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "enteral nutritional support and decompression where feeding via the upper gastrointestinal tract is contraindicated." This describes a device used within the body for therapeutic purposes (feeding and decompression).
- Device Description: The description details a tube designed to be placed through a gastrostomy tube for gastric decompression and jejunal feeding. This is a medical device used for direct patient care.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens for diagnostic purposes.
Therefore, the TTP J-Tube is a medical device used for patient treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TTP J-Tube is indicated for enteral nutritional support and decompression where feeding via the upper gastrointestinal tract is contraindicated. This includes, post upper G.I. tract surgery, radiation therapy, chemotherapy, reflux and other conditions associated with nausea, vomiting and possible aspiration.
Product codes (comma separated list FDA assigned to the subject device)
78 FPD
Device Description
The Microvasive TTP J-Tube is a three port device designed to be placed through a Microvasive gastrostomy tube to provide gastric decompression and jejunal feeding. The Microvasive TTP J-Tube is available in two tip configurations (pigtail, & bent tip), and may be placed by either tether (pull), or guidewire techniques.
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)
Laboratory testing regarding characteristics was performed on the TTP J-Tube to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluidcontact materials of the TTP J-Tube with satisfactory results.
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.
Not Found
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
AUG 20 1997
SECTION 10 510(K) SUMMARY
FOI RELEASABLE
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification "...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.
| > DATE: | May 21, 1997 | ||
|---|---|---|---|
| > COMMON/USUAL NAMES: | Jejunostomy Feeding Tube | ||
| > TRADE/PROPRIETARY NAME: | Unknown this time | ||
| > CLASSIFICATION NAME & | |||
| DEVICE CLASSIFICATION: | Class II | ||
| Name | Number | 21 CFR Ref. | |
| Tube, Feeding | 78 FPD | 876.5980 | |
| > DEVICE PANEL/BRANCH: | Gastroenterology-Urology (GU) | ||
| Gastro-Renal (GRDB) | |||
| > OWNER/OPERATOR: | Boston Scientific Corporation | ||
| One Boston Scientific Place | |||
| Natick, MA 01760 |
Lisa M. Quaglia, Regulatory Affairs Manager > Contact Person:
Description of Device
The Microvasive TTP J-Tube is a three port device designed to be placed through a Microvasive gastrostomy tube to provide gastric decompression and jejunal feeding. The Microvasive TTP J-Tube is available in two tip configurations (pigtail, & bent tip), and may be placed by either tether (pull), or guidewire techniques.
INDICATIONS FOR USE
The TTP J-Tube is indicated for enteral nutritional support and decompression where feeding via the upper gastrointestinal tract is contraindicated. This includes, post upper G.I. tract surgery,
1
radiation therapy, chemotherapy, reflux and other conditions associated with nausea, vomiting and possible aspiration.
DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES
Boston Scientific Corporation believes that the TTP J-Tube is substantially equivalent to currently-marketed devices such as Bard's Jejunal Feeding/Gastric Decompression Tube and Corpak's Corflo-Ultra Jejunostomy Tube. The major components of the TTP J-Tube are the shaft and the Y-Adapter. Both predicate devices as well as the TTP J-Tube are used for the same indicated use and are constructed with similar features. A thorough comparison of the descriptive characteristics between the TTP J-Tube and the predicate devices show equivalence.
PERFORMANCE CHARACTERISTICS
Laboratory testing regarding characteristics was performed on the TTP J-Tube to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluidcontact materials of the TTP J-Tube with satisfactory results.
CONCLUSION
Boston Scientific Corporation believes that TTP J-Tube is substantially equivalent to the currently-marketed TTP J-Tube. Comparison of the descriptive characteristics of these products demonstrate the TTP J-Tube is equivalent in its indications for use, while being very similar in design and materials as the predicate devices. In addition, Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the TTP J-Tube will meet the minimum requirements that are considered acceptable for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa M. Quaglia Regulatory Affairs Manager Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537
K971906 Re: TTP Jejunostomy Feeding Tube Regulatory Class: II 21 CFR §876.5980/Product Code: 78 FPD Dated: May 21, 1997 Received: May 23, 1997
AUG 20 1997
Dear Ms. Quaglia:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 920) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
3
Page 2 - Ms. Lisa M. Quaglia
This letter will allow you to begin marketing your device as described in your 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. I E you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), pleasecontact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under the Act may 807.97) . . be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Rolar R. Satting//
fr
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Health Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
A 71706
SECTION 1 INDICATIONS FOR USE
510(k) Number:
To Be Determined
Device Name:
TTP J-Tube
Indication for Use:
The TTP J-Tube is indicated for enteral nutritional support and decompression where feeding via the upper gastrointestinal tract is contraindicated. This includes, post upper G.I. tract surgery, radiation therapy, chemotherapy, reflux and other conditions associated with nausea, vomiting and possible aspiration.
Rder Q. Sather
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1906 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter Use _
1