THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350

K091340 · Boston Scientific Corp · FPD · Jun 9, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K091340
• Device Name: THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
• Applicant: Boston Scientific Corp
• Product Code: FPD · Gastroenterology, Urology
• Decision Date: Jun 9, 2009
• Decision: SESK
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Through-the PEG (TTP) Jejunal Feeding Tube Kit is intended to provide enteral access for decompression and delivery of nutrition and/or medication.

Device Story

The TTP Jejunal Feeding Tube is a three-port device designed for placement through an existing gastrostomy tube. It provides enteral access for gastric/jejunal decompression and the administration of nutrition or medication. The kit includes options for pigtail or bent tip configurations and supports placement via tether or guidewire techniques. It is used in clinical settings by healthcare professionals to manage patient enteral feeding needs.

Clinical Evidence

Bench testing only. In-vitro testing performed on all components and subassemblies confirmed compliance with required specifications.

Technological Characteristics

Three-port gastrointestinal feeding tube; available in pigtail or bent tip configurations; compatible with tether or guidewire placement techniques. Materials and design are identical to the predicate device (K072476).

Indications for Use

Indicated for patients requiring enteral access for decompression and delivery of nutrition and/or medication.

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

• Through-The-PEG (TTP) Jejunostomy Tube Kit (K072476)

Submission Summary (Full Text)

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K09/340
181

SECTION 5 510(k) SUMMARY

JUN - 9 2009

## 510(k) SUMMARY

#### 1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: [phone] Fax: [phone]

Contact: Marybeth Gamber Regulatory Affairs Manager Date Prepared: May 5, 2009

#### 2. Device:

Trade Name: EndoVive™ Through-The-PEG (TTP) Jejunal Feeding Tube Kit Classification Name: Tube, Gastrointestinal (and Accessories) Regulation Number: 876.5980 Product Code: KNT Classification: Class II

## 3. Predicate Device:

Through-The-PEG (TTP) Jejunostomy Tube Kit Manufactured by Boston Scientific, Inc.

K072476

## 4. Device Description:

The TTP Jejunal Feeding Tube consists of a three-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 TTP Jejunal Feeding Tube Kit is available in two tip configurations, a pigtail tip and a bent tip. It may be placed by either the tether or guidewire techniques.

#### 5. Intended Use:

The Through-the PEG (TTP) Jejunal Feeding Tube Kit is intended to provide enteral access for decompression and delivery of nutrition and/or medication.

#### 6. Technological Characteristics:

The proposed TTP Jejunal Feeding Tube Kit is similar in design, materials, and manufacturing processes to the predicate 3-Port TTP Jejunal Feeding 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.

## 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed Through-The-PEG (TTP) Jejunal Feeding Tube Kit is substantially equivalent to Boston Scientific Corporation's currently marketed Through-The-PEG (TTP) Jejunostomy Tube Kit (K072476).

000010

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN - 9 2009

Ms. Marybeth Gamber Manager Regulatory Affairs Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way MALBOROUGH MA 01752

Re: K091340

Trade/Device Name: Through-The-Peg (TTP) Jejunal Feeding Tube Kit Regulation Number: 21 CFR 876.5980, Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT and FPD Dated: May 5, 2009 Received: May 12, 2009

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/tray] 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/tray. 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.

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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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Herbert Lenin

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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K091340
181

SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

This application

Device Name:

Through-The-PEG (TTP) Jejunal Feeding Tube Kit

Indications for Use:

The Through-The-PEG (TTP) Jejunal Feeding 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) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hebert Penn

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

00009

Spccial 510(k) Premarket Notification, Through-The-PEG (TTP) Jejunal Feeding Tube Kit