ENTAKE STANDARD AND SAFETY PEG SYSTEM

K061021 · Conmedcorp · KNT · Apr 28, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K061021
• Device Name: ENTAKE STANDARD AND SAFETY PEG SYSTEM
• Applicant: Conmedcorp
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Apr 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

For percutaneous placement of a long-term initial-placement feeding and/or decompression device.

Device Story

EnTake PEG Standard and Safety System is a kit for percutaneous endoscopic gastrostomy (PEG) placement. Components include a gastrostomy feeding tube, external retention bolster, two-port feeding adapter, and feeding tube clamp. Kits are available in standard and safety configurations, with safety versions including alternative scalpel, needle introducer, and 5 cc syringe. System supports installation via guidewire (push) or pull wire methods for new gastrostomy placement. Used by clinicians in clinical settings to establish long-term enteral access; facilitates patient nutrition and gastric decompression. Device is provided sterile.

Clinical Evidence

Bench testing only. Biocompatibility and performance testing were conducted to demonstrate equivalence to predicate devices; all testing passed predetermined specifications.

Technological Characteristics

Kit-based gastrostomy system. Components include feeding tube, bolster, adapter, clamp, and procedural accessories (scalpel, needle, syringe). Available in push (guidewire) and pull wire configurations. Sterile packaging. Materials and design are equivalent to predicate PEG kits.

Indications for Use

Indicated for percutaneous placement of long-term initial-placement feeding and/or decompression devices in patients requiring enteral nutrition or gastric decompression.

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

• Kimberly-Clark MIC™ PEG Standard and Safety Kit (K924065)
• Boston Scientific EndoVive™ PEG Standard and Safety Kit (K031538)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Conmed Endoscopic Technologies. The logo features a stylized black and white graphic to the left of the word "CONMED" in large, bold, black letters. Below the word "CONMED" are the words "ENDOSCOPIC TECHNOLOGIES" in smaller, black letters. The letters are all capitalized.

2 8 2006

## 510(K) Summary of Safety and Effectiveness

- ا . Sponsor Name: ConMed Endoscopic Technologies, Inc. 129 Concord Rd. Billerica, MA 01821 Telephone: [phone] Contact Individual: Beth Zis Vice President of Regulatory Affairs
- 2. Device Name: EnTake™ PEG Standard and Safety System Trade Name: Classification Name: Gastrointestinal Tubes and Accessories
- 3. Identification of Predicate or Legally Marketed Device:

Kimberly-Clark MICTM PEG Standard and Safety Kit, cleared under K924065. Boston Scientific EndoVive™ PEG Standard and Safety Kit, cleared under K031538.

- 4. Device Description
The EnTake PEG Standard and Safety System contains a gastrostomy feeding tube, external retention bolster, two-port feeding adapter, feeding tube clamp packaged sterile in a kit containing procedural aides. The EnTake PEG System consist of both standard and safety kits in both push and pull versions. Standard kits contain the components that are typically used in the procedure. Safety kits contain alternative safety versions of the scalpel, the needle introducer and the 5 cc syringe.

The EnTake PEG System will be offered in a variety of sizes and variations that allow for installation via guidewire (push) or pull wire, placement in a new gastrostomy.

- న. Intended Use
For percutaneous placement of a long-term initial-placement feeding and/or decompression device.

- 6. Comparison of Technological Characteristics The EnTake TM PEG Standard and Safety System is substantially equivalent to the predicate devices both in intended use, technological characteristics, and materials.
- 7. Performance Testing Biocompatibility and bench testing have been performed to demonstrate equivalence of the device to its predicates. All testing passed the predetermined performance specifications.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2006

ConMed Corporation c/o Intertek Testing Services NA, Inc. Mr. Daniel W. Lehtonen 2307 East Aurora Road Unit B7 TWINSBURG OH 44087

Re: K061021

.

Trade Name: EnTake Standard and Safety PEG System Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tubes and Accessories Regulatory Class: II Product Code: KNT Dated: April 12, 2006 Received: April 13, 2006

Dear Mr. Lehtonen:

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 (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 vou 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/tray. 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.

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## Page 2 - Mr. Lehtonen

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); 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 povidone-iodine swabs, povidone-iodine ointment, and lidocaine 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, 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). You may obtain other general information on your

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Page 3 - Mr. Lehtonen

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.dsma/dsmamain.html.

Sincerely yours,

David A. Leyson

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

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K061021

## INDICATIONS FOR USE KO661021 C.

510(k) Number (if known):

Device Name: EnTake TM PEG Standard and Safety System

Indications For Use:

For percutaneous placement of a long-term initial-placement feeding and/or decompression device.

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)

Daniela. borgeson

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sion of Reproductive. Abdomina and Radiological Devic 510(k) Number

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