(15 days)
No
The summary describes a mechanical device for feeding tube placement and does not mention any software, algorithms, or AI/ML components.
Yes.
The device is a gastrostomy feeding tube system intended for long-term feeding, which is a therapeutic purpose.
No
Explanation: The device description clearly states its purpose is for "percutaneous placement of a long-term initial-placement feeding and/or decompression device" and it involves a "gastrostomy feeding tube." This indicates a therapeutic or interventional function, not a diagnostic one (identifying or characterizing a disease or condition).
No
The device description explicitly lists physical components such as a gastrostomy feeding tube, external retention bolster, feeding adapter, and clamp, indicating it is a hardware-based medical device kit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For percutaneous placement of a long-term initial-placement feeding and/or decompression device." This describes a surgical or procedural device used to deliver substances into the body or remove substances from the body.
- Device Description: The device is a gastrostomy feeding tube and associated components used for placement. This is a medical device used for direct patient care and intervention.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of samples or diagnostic purposes.
Therefore, the EnTake PEG System is a medical device used for a therapeutic or supportive purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For percutaneous placement of a long-term initial-placement feeding and/or decompression device.
Product codes
KNT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility and bench testing have been performed to demonstrate equivalence of the device to its predicates. All testing passed the predetermined performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
-
- Device Name: EnTake™ PEG Standard and Safety System Trade Name: Classification Name: Gastrointestinal Tubes and Accessories
-
- 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.
-
- 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.
- Device Description
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. -
- 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.
-
- 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.
1
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.
2
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
3
Page 3 - Mr. Lehtonen
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
4
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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