MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT

K030855 · Boston Scientific Corp · KNT · Apr 17, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K030855
• Device Name: MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT
• Applicant: Boston Scientific Corp
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Apr 17, 2003
• Decision: SESK
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

EndoVive™ Initial Placement PEG Kit is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. The EndoVive™ Initial Placement Direct PEJ Kit is indicated for use for enteral nutritional support and decompression directly into the jejunum when feeding via the upper gastrointestinal tract is contraindicated. The EndoVive™ Initial Placement PEG Safety Kit is indicated for providing nutrition directly into the stomach in patients who are unable to consume nutrition by conventional means. The safety components of the kit are designed to reduce the potential for inadvertent sharps injury to medical personnel during and after the procedure.

Device Story

EndoVive kits facilitate initial placement of gastrostomy (PEG) or jejunostomy (PEJ) tubes for enteral feeding or decompression. Devices are used in clinical settings by medical professionals. The primary modification in this submission is the use of a new material for the domed portion of the PEG/PEJ tubes. The kits include various components for tube placement, including sharps for the safety kit version. Healthcare providers use these tubes to provide direct nutritional access to the stomach or jejunum, bypassing the upper GI tract when necessary. The safety kit specifically aims to mitigate sharps injury risks during the procedure. The device functions as a conduit for nutrition and decompression, directly impacting patient nutritional status.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and biocompatibility evaluation of the new domed material.

Technological Characteristics

Gastrointestinal feeding/decompression tubes. Modification involves a new material for the domed component. Biocompatibility testing conducted. Class II device under 21 CFR 876.5980.

Indications for Use

Indicated for enteral nutrition/decompression in pediatric and adult patients unable to consume nutrition conventionally or where upper GI feeding is contraindicated. Safety kit version includes features to reduce sharps injury risk to medical personnel.

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 PEG Kit (K014297)
• EndoVive™ Initial Placement Direct PEJ Kit (K020120)
• EndoVive™ Initial Placement PEG Safety Kit (K014297)

Submission Summary (Full Text)

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K030855
1 of 2

Special 510(k) Premarket Notification New Material for Domed PEG/PEJ

Boston Scientific Corporation March 17, 2003

# APR 1 7 2003

## 510(K) SUMMARY

| SPONSOR: | Boston Scientific Corporation (BSC)<br>Microvasive Endoscopy Division<br>One Boston Scientific Place<br>Natick, MA 01760 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Paige Sweeney<br>Senior Regulatory Affairs Specialist |
| DATE OF SUBMISSION: | March 17, 2003 |
| DEVICES: | EndoVive ^™ Initial Placement PEG Kit EndoVive ^™<br>Initial Placement Direct PEJ Kit<br>EndoVive ^™ Initial Placement PEG Safety Kit |
| TRADE NAME: | EndoVive ^™ Initial Placement PEG Kit |
| COMMON NAME: | Gastrostomy Tube |
| CLASSIFICATION: | Tubes, Gastrointestinal & Accessories<br>Tube, Gastro-Enterostomy<br>Classified Under 21 CFR Part 876, §5980.<br>Classified as a Class II Device |
| TRADE NAME: | EndoVive ^™ Initial Placement Direct PEJ Kit |
| COMMON NAME: | Jejunostomy Tube |
| CLASSIFICATION: | Tube, Feeding<br>Classified Under 21 CFR Part 876, §5980.<br>Classified as a Class II Device |
| TRADE NAME: | EndoVive ^™ Initial Placement PEG Safety Kit |
| COMMON NAME: | Gastrostomy Tube |
| CLASSIFICATION: | Tubes, Gastrointestinal & Accessories<br>Tube, Gastro-Enterostomy<br>Classified Under 21 CFR Part 876, §5980.<br>Classified as a Class II Device |
| PREDICATE DEVICES: | EndoVive ^™ Initial Placement PEG Kit<br>(K014297)<br>EndoVive ^™ Initial Placement Direct PEJ Kit<br>(K020120)<br>EndoVive ^™ Initial Placement PEG Safety Kit<br>(K014297) |
| DEVICE DESCRIPTIONS: | The proposed EndoVive ^™ Initial Placement PEG<br>Kit, the proposed EndoVive ^™ Initial Placement<br>Direct PEJ Kit, and the EndoVive ^™ Initial Placement |

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K030855
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#### INTENDED USES:

COMPARISON OF

CHARACTERISTICS:

Boston Scientific Corporation March 17, 2003

PEG Safety Kit are used during initial placement for direct feeding.

EndoVive™ Initial Placement PEG Kit is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means.

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

The EndoVive™ Initial Placement PEG Safety Kit is indicated for providing nutrition directly into the stomach in patients who are unable to consume nutrition by conventional means. The safety components of the kit are designed to reduce the potential for inadvertent sharps injury to medical personnel during and after the procedure.

The proposed devices are substantially equivalent to currently marketed devices, as they are identical with the exception of the proposed domed PEG/PEJ material.

The proposed devices are substantially equivalent to PERFORMANCE DATA: currently marketed devices in terms of performance characteristics and were tested for biocompatibility.

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Image /page/2/Picture/12 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles a human figure or a bird in flight, composed of several curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2003

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

Re: K030855

Trade/Device Name: EndoVive™ Initial Placement PEG Kit EndoVive™ Initial Placement Direct PEJ Kit EndoVive™ Initial Placement PEG Safety Kit Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: March 17, 2003 Received: March 18, 2003

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

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Page 2 - Ms. Paige Sweeney

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.

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

Our substantially equivalent determination does not apply to the drug component[s] 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, please contact the Office of Compliance at (301) 594- . 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 [phone] or [phone], or at its Internet address http://www.fda.gov/dsma/dsmamain.html.

Sincerely yours.

David A. Segner

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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KO 30855

Special 510(k) Premarket Notification New Material for Domed PEG/PEJ

Boston Scientific Corporation March 17, 2003

### INDICATIONS FOR USE STATEMENTS

| 510(k) Number<br>(if known) | To be determined | Page 1 of 1 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device Names | EndoVive™ Initial Placement PEG Kit<br>EndoVive™ Initial Placement Direct PEJ Kit<br>EndoVive™ Initial Placement PEG Safety Kit | |
| Indications for Use | EndoVive™ Initial Placement PEG Kit is indicated for enteral<br>nutrition directly into the stomach in both pediatric and adult patients<br>who are unable to consume nutrition by conventional means. | |
| | The EndoVive™ Initial Placement Direct PEJ Kit is indicated for<br>nutritional support and decompression directly into the jejunum when<br>feeding via the upper gastrointestinal tract is contraindicated. | |
| | The EndoVive™ Initial Placement PEG Safety Kit is indicated for<br>providing nutrition directly into the stomach in patients who are<br>unable to consume nutrition by conventional means. The safety<br>components of the kit are designed to reduce the potential for<br>inadvertent sharps injury to medical personnel during and after the<br>procedure. | |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

David R. Lehman

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

000101

Proprietary and Confidential Information of Boston Scientific Corporation