ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220

K020120 · Boston Scientific Corp · KNT · Aug 2, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K020120
• Device Name: ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220
• Applicant: Boston Scientific Corp
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Aug 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endovive™ Initial Placement Direct PEJ Kit is indicated for nutritional support and decompression directly into the jejunum when feeding via the upper gastrointestinal tract is contraindicated. The Endovive™ Standard Profile Balloon Replacement Tube is indicated for use in percutaneous placement of an enteral feeding tube for feeding and/or administration of medication in conjunction with an established GI stoma tract. Typical uses include the replacement of existing gastrostomy and/or jejunostomy feeding tubes. The Standard Profile Balloon Replacement Tube may also be used for decompression.

Device Story

Endovive™ Initial Placement Direct PEJ Kit and Standard Profile Balloon Replacement Tube facilitate enteral feeding and decompression. Initial placement kit enables direct jejunal access; replacement tube maintains access via established GI stoma. Devices consist of internal bolster and feeding tube. Used in clinical settings by healthcare professionals. Provides direct route for nutrition/medication delivery; bypasses upper GI tract when contraindicated. Enables decompression of GI tract. Benefits include reliable enteral access for patients unable to tolerate oral intake.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Devices consist of an internal bolster and a feeding tube. Materials and design are equivalent to previously cleared Endovive™ gastrostomy and jejunostomy devices. Mechanical device; no energy source or software components.

Indications for Use

Indicated for patients requiring nutritional support, medication administration, or gastric/jejunal decompression when upper GI tract feeding is contraindicated. Used for initial percutaneous endoscopic jejunostomy (PEJ) placement or replacement of existing gastrostomy/jejunostomy tubes in established GI stoma tracts.

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

• Endovive™ Initial Placement Gastrostomy Kit
• Endovive™ Balloon Replacement Gastrostomy Tube
• Endovive™ Percutaneous Endoscopic Jejunostomy Device

Submission Summary (Full Text)

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KU20120 10+2

AUG 0 2 2002

#### SECTION 14 510(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: | January 11, 2002 | | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------|------------|
| Common/Usual Names: | Jejunostomy Feeding Tube | | |
| Trade/Proprietary Names: | - Endovive™ Initial Placement Direct PEJ Kit<br>- Endovive™ Standard Profile Balloon Replacement Tube | | |
| Classification Name &<br>Device Classification: | Class II | | |
| | Name | Number | 21CFR Ref. |
| | Tubes, 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 | | |
| Contact Person: | Paige Sweeney<br>Regulatory Affairs Specialist | | |

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## Description of Devices

The Endovive™ Initial Placement Direct PEJ Kit is used during initial placement for direct feeding. The Endovive™ Standard Profile Balloon Replacement Tube is used for the replacement of direct feeding tubes used for direct feeding.

## Indications for Use

The Endovive™ Initial Placement Direct PEJ Kit is indicated for nutritional support and decompression directly into the jejunum when feeding via the upper gastrointestinal tract is contraindicated.

The Endovive™ Standard Profile Balloon Replacement Tube is indicated for use in percutaneous placement of an enteral feeding tube for feeding and/or administration of medication in conjunction with an established GI stoma tract. Typical uses include the replacement of existing gastrostomy and/or jejunostomy feeding tubes when feeding via the upper gastrointestinal tract in contraindicated. The Standard Profile Balloon Replacement Tube may be placed percutaneously as described herein or by using a Stamm surgical procedure (not described). The Standard Profile Balloon Replacement Tube may also be used for decompression.

## Descriptive and Technological Characteristics of Proposed and Predicate Devices

Boston Scientific Corporation believes that the Endovive™ Initial Placement Direct PEJ Kit, and the Endovive™ Standard Profile Balloon Replacement Tube, with the additional direct percutaneous endoscopic jejunostomy indication are substantially equivalent to the currently marketed Endovive™ Initial Placement Gastrostomy Kit, the Endovive™ Balloon Replacement Gastrostomy Tube, and the Endovive™ Percutaneous Endoscopic Jejunostomy Device. The major components of these devices are the internal bolster and the feeding tube. A thorough comparison of the descriptive characteristics between the proposed iejunostomy devices and the predicate devices show equivalence.

# Conclusion

Boston Scientific Corporation has demonstrated that the Endovive™ Initial Placement Direct PEJ Kit, and the Endovive™ Standard Profile Balloon Replacement Tube, are substantially equivalent to the currently marketed Endovive™ Initial Placement Gastrostomy Kit, the Endovive™ Balloon Replacement Gastrostomy Tube, and the Endovive™ Percutaneous Endoscopic Jejunostomy Device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 2 2002

Ms. Paige Sweeney Regulatory Affairs Specialist Microvasive Endoscopy Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537

Re: K020120

Trade/Device Name: EndoVive™ Initial Placement Direct PEJ Kit and EndoVive™ Standard Profile Balloon Replacement Tube Regulation Number: 21 CFR \$876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: May 8, 2002 Received: May 9, 2002

Dear Ms. Sweeney:

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 (the Act). You may, therefore, market the device, subject to the general controls provisions of 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 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, 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.

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);

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Page 2 - Ms. Paige Sweeney

labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

In addition, we have determined that your device kit contains Iodine swabs, 1% Xylocaine, lubricating jelly, and antibiotic ointment, which are subject to regulation as drugs.

Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 [phone]

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 our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact 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 Part 807.97). Other general information on your responsibilities under the Act, may be obtained 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/dsma/dsmamain.html

Sincerely yours,

David A. Leggett

for

Nancy C. Brogdon Director, Division of Reproductive, -Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 3 INDICATIONS FOR USE

| 510(k) Number: | To Be Determined K020120 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Names: | - Endovive™ Initial Placement Direct PEJ Kit<br>- Endovive™ Standard Profile Balloon Replacement Tube |
| Indications for Use: | The Endovive™ Initial Placement Direct PEJ Kit is indicated for nutritional support and decompression directly into the jejunum when feeding via the upper gastrointestinal tract is contraindicated.<br><br>The Endovive™ Standard Profile Balloon Replacement Tube is indicated for use in percutaneous placement of an enteral feeding tube for feeding and/or administration of medication in conjunction with an established GI stoma tract. Typical uses include the replacement of existing gastrostomy and/or jejunostomy feeding tubes. The Standard Profile Balloon Replacement Tube may also be used for decompression. |

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-----------------------|--------------------------------------------------------|--------------------------|
| Prescription Use | OR | Over-The-Counter Use |
| (Per 21 CFR 801.1091) | | (Optional Format 1-2-96) |

David A. Sagnon

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K020120 |

Proprietary and Confidential Information of Boston Scientific Corporation