ENTAKE STANDARD AND SAFETY PEG SYSTEM by CONMED CORP.

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.

AI/ML Overview

The provided text describes a 510(k) submission for the "EnTake™ PEG Standard and Safety System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independent performance studies with detailed acceptance criteria and expert reviews often seen for AI/ML devices.

Therefore, much of the requested information regarding acceptance criteria derived from a study, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment will not be present in this document.

However, I can extract the information that is available and clarify what is missing based on the nature of this submission.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Biocompatibility: Demonstrated equivalence to predicate devices.	"All testing passed the predetermined performance specifications."
Bench Testing: Demonstrated equivalence to predicate devices.	"All testing passed the predetermined performance specifications."
Intended Use: For percutaneous placement of a long-term initial-placement feeding and/or decompression device.	The device's "Intended Use" matches this criterion.
Technological Characteristics: Substantial equivalence to predicate devices.	The EnTake™ PEG System is stated to be "substantially equivalent to the predicate devices both in intended use, technological characteristics, and materials."
Materials: Substantial equivalence to predicate devices.	The EnTake™ PEG System is stated to be "substantially equivalent to the predicate devices both in intended use, technological characteristics, and materials."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided in the document. This document describes a 510(k) submission based on substantial equivalence, which primarily relies on comparison to existing legally marketed devices, biocompatibility, and bench testing, rather than clinical efficacy studies requiring large test sets of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided in the document. Ground truth establishment by experts for a test set is not part of this 510(k) summary, as it does not involve the evaluation of an algorithm's performance on medical images or diagnostic data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided in the document. Adjudication methods are not relevant to this type of device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This is not an AI/ML device, and such a study is not required for a PEG tube system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/No. This device is a medical instrument (PEG tube system), not an algorithm, so standalone performance testing in this context is irrelevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established through biocompatibility and bench testing standards, and the characteristics of the predicate devices. The device passed predetermined performance specifications based on these tests and demonstrated substantial equivalence to the predicate devices in terms of intended use, technological characteristics, and materials.

8. The sample size for the training set

Not applicable/Not provided in the document. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided in the document. As above, this is not an AI/ML device and does not utilize a training set in the conventional sense.

Summary

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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: 978-964-4251 Contact Individual: Beth Zis Vice President of Regulatory Affairs
1. Device Name: EnTake™ PEG Standard and Safety System Trade Name: Classification Name: Gastrointestinal Tubes and Accessories
1. 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.

1. 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.
1. 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.
1. 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 (301) 594-0101

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 (240) 276-0115. 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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responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, 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

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

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Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
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).(b)
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.