ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521

K022648 · Boston Scientific Corp · KNT · Sep 5, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K022648
• Device Name: ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
• Applicant: Boston Scientific Corp
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Sep 5, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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.

Device Story

EndoVive™ Initial Placement Direct PEJ Kit facilitates direct jejunal feeding and decompression. Kit includes jejunostomy tube and various components; used by clinicians in clinical settings. Device provides enteral access when upper GI tract feeding is contraindicated. Substantially equivalent to previous EndoVive™ kit (K020120) with minor component modification. Kit contains drug components (iodine swabs, lubricating jelly, antibiotic ointment, 1% Xylocaine®) subject to separate regulatory oversight.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence based on performance characteristics and biocompatibility testing.

Technological Characteristics

Jejunostomy feeding tube kit. Includes medical device components and drug components (iodine swabs, lubricating jelly, antibiotic ointment, 1% Xylocaine®). Mechanical device; no software or electronic components.

Indications for Use

Indicated for patients requiring enteral nutritional support or decompression directly into the jejunum when upper gastrointestinal tract feeding is contraindicated.

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 Direct PEJ Kit (K020120)

Submission Summary (Full Text)

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## Section 10 510(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>Regulatory Affairs Specialist |
| DATE OF SUBMISSION: | August 8, 2002 |
| DEVICE: | EndoVive ^™ Initial Placement Direct PEJ Kit |
| 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. |
| PREDICATE DEVICE: | EndoVive ^™ Initial Placement Direct PEJ Kit<br>(K020120) |
| DEVICE DESCRIPTION: | The proposed EndoVive ^™ Initial Placement Direct PEJ<br>Kit is used during initial placement for direct<br>feeding. |
| INTENDED USE: | The EndoVive ^™ Initial Placement Direct PEJ Kit is<br>indicated for use for enteral nutritional support and<br>decompression directly into the jejunum when feeding<br>via the upper gastrointestinal tract is contraindicated. |
| COMPARISON OF<br>CHARACTERISTICS: | The proposed device is substantially equivalent to<br>currently marketed devices, as they are identical with the<br>exception of a modified kit component. |
| PERFORMANCE DATA: | The proposed device is substantially equivalent to<br>currently marketed device in terms of performance<br>characteristics tested and biocompatibility. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is a stylized image of an eagle with its wings spread, with three lines representing the feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 2002

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

Re: K022648

Trade/Device Name: EndoVive™ Initial Placement Direct PEJ Kit Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: August 8, 2002 Received: August 9, 2002

Dear Ms. Sweeney:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 vour 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); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality

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Page 2 - Ms. Paige Sweeney

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 component[s]. For information on applicable Agency requirements for marketing this [these] drug[s], 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,

Nancy C Brogdon

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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## Indications for Use Statement

| 510(k) Number (if known) | K022648 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | EndoVive™ Initial Placement Direct PEJ Kit |
| Indications for Use | 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. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) /

OR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

Nancy Crozdon

(Division Sign Off) Division of Reproductive, Abdom and HadioIngical Devices 510(k) Number