JEJENOSTOMY FEEDING TUBE

K971906 · Boston Scientific Corp · FPD · Aug 20, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971906
• Device Name: JEJENOSTOMY FEEDING TUBE
• Applicant: Boston Scientific Corp
• Product Code: FPD · Gastroenterology, Urology
• Decision Date: Aug 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The TTP J-Tube is a three-port jejunostomy feeding tube designed for placement through an existing gastrostomy tube. It facilitates simultaneous gastric decompression and jejunal feeding. The device features two tip configurations (pigtail or bent tip) and is compatible with tether (pull) or guidewire placement techniques. It is intended for clinical use by healthcare professionals to manage patients unable to tolerate upper GI feeding. By bypassing the upper GI tract, the device provides direct nutritional support and reduces aspiration risk, aiding recovery in post-surgical or oncology patients.

Clinical Evidence

Bench testing only. Biocompatibility assessment performed on patient- and fluid-contact materials with satisfactory results.

Technological Characteristics

Three-port jejunostomy feeding tube; shaft and Y-adapter construction; available in pigtail or bent tip configurations; compatible with tether or guidewire placement. Materials are biocompatible.

Indications for Use

Indicated for patients requiring enteral nutritional support and gastric decompression when upper GI feeding is contraindicated, including those post-upper GI surgery, undergoing radiation or chemotherapy, or suffering from reflux, nausea, vomiting, or aspiration risk.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Bard's Jejunal Feeding/Gastric Decompression Tube
• Corpak's Corflo-Ultra Jejunostomy Tube

Submission Summary (Full Text)

{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 &<br>DEVICE CLASSIFICATION: | Class II | | |
| | Name | Number | 21 CFR Ref. |
| | Tube, Feeding | 78 FPD | 876.5980 |
| > DEVICE PANEL/BRANCH: | Gastroenterology-Urology (GU)<br>Gastro-Renal (GRDB) | | |
| > OWNER/OPERATOR: | Boston Scientific Corporation<br>One Boston Scientific Place<br>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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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