(86 days)
The ConMed Irrigation Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
The device is sterile, for single-use and is intended for use as an accessory with The device is stome, for clingie nomercial distribution and acts as a nozzle when inserted into a patient's recturn to direct water into and cleanse the lower colon when medically indicated, such as before radiological or endoscopic examination. The nozzle is designed as a one-piece, injection molded plastic handpiece having a slight curvature at the end intended for insertion into the rectum. At the opposite end the device has a barbed fitting for attachment to the tubing from the colonic irrigation system. Several tip configurations are made available to provide options for the clinician.
The provided text is a 510(k) Premarket Notification for a non-AI medical device (ConMed Irrigation Nozzle). As such, it does not contain information typically found in submissions for AI/ML-powered medical devices regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
Therefore, I cannot extract the requested information.
The document discusses the device's substantial equivalence to predicate devices (Jimmy John III Rectal Nozzle and GC Irrigator) for its intended use in colon cleansing. It mentions that all devices are for similar use, made of similar materials, and have a similar design. This is a common approach for non-AI devices to demonstrate safety and effectiveness without needing extensive clinical trials in the same way an AI-powered device would.
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Image /page/0/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of a stylized black and white graphic to the left of the text "CONMED". Below the text is the word "CORPORATION" in a smaller font. There is a registered trademark symbol to the right of the word "CONMED".
ConMed Corporation
JUL 1 4 2005
page loft
510(k) Premarket Notification
510(k) Summary
| Submitter's Name:Address: | ConMed Corporation525 French RoadUtica, New York 13502 |
|---|---|
| Phone:Facsimile: | 315-797-8375315-624-3089 |
| Contact Person: | Ira DueslerDirector, RA/QAPhone: 315-624-3072Facsimile: 315-624-3089 |
| Date Summary Prepared: | April 18, 2005 |
| Name of Device: | Irrigation Nozzle |
| Common or Usual Name:Classification Name: | Colonic Irrigation SystemColonic Irrigation System |
| Predicate Devices: | Jimmy John III Rectal NozzleColon Therapeutics510(k) Premarket Notification K973256Approved September 29, 1997GC IrrigatorGentle Colonics, Inc.510(k) Premarket Notification K980868 |
Description of the Device:
The device is sterile, for single-use and is intended for use as an accessory with The device is stome, for clingie nomercial distribution and acts as a nozzle when inserted into a patient's recturn to direct water into and cleanse the lower colon when medically indicated, such as before radiological or endoscopic examination. The nozzle is designed as a one-piece, injection molded plastic handpiece having a slight curvature at the end intended for insertion into the rectum. At the opposite end the device has a barbed fitting for attachment to the tubing from the colonic irrigation system. Several tip configurations are made available to provide options for the clinician.
Approved August 6, 1998
Intended Use of Device:
The device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
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Summary of the technological characteristics of device compared to predicate device:
The Irrigation Nozzle is substantially equivalent in every way to the Jimmy John irrigation The Irrigation Nozzle is substantially equivalent in overy use for colon irrigation,
III Rectal Nozzle and the GC Irrigator. All devices are for use for use for use for use t Iff Rectar Nozzle and the OO imgater. All do like or similar materials, used for olmilar populy, and of a similar design.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a stylized drawing of a bird in flight. The bird is facing to the right, and its wings are spread upward. The bird's body is outlined with thick, black lines. To the left of the bird is a partial circular border with text along the edge. The text is oriented vertically and appears to be in a non-English language.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20050
JUL 1 4 2005
Mr. Ira Duesler Director, RA/QA ConMed® Corporation 525 French Road UTICA NY 13502
Re: K050992 Trade/Device Name: ConMed Irrigation Nozzle Regulation Number: 21 CFR §876.5220 Regulation Name: Colonic irrigation system Regulatory Class: II Product Code: KPL Dated: May 17, 2005 Received: May 19, 2005
Dear Mr. Duesler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave icenced your books. be one is substantially equivalent (for the indications for use stated in above and have decommised predicate devices marketed in interstate commerce prior to the cholosure) to regary mattered produced Device Amendments, or to devices that have been May 20, 1770, the chanamin auto of the Federal Food, Drug, and Cosmetic Act (Act) that recrassified in accordance maranet approval application (PMA). You may, therefore, market the do not require approvation of a premiums of the Act. The general controls provisions of the Act device, subjoc to the general 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 (Premarket If your device is classince (300 additional controls. Existing major regulations affecting your Apployal), it they of subject to accrived Regulations, Title 21, Parts 800 to 898. In addition, FDA device can be round in the sements 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 rederal statues and regulations administed to registration and listing (21 CFR Part 807); labeling Act s requirements, modulity, but not miness to reguirements as set forth in the quality systems (QS) (21 CFR Part 8017; good mandacting product radiation control product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 5 I0(k) This letter will anow you to ocgin makemily of substantial equivalence of your device to a legally premarket notification. The FDA Inding of Sabsantial of Sales 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), pleased if you desire specific advice for your device of our of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Nisotaneing on your responsibilities under the Act from the 807.97). You may obtain other general intornal 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/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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510(k) Number (if known): ___K050992
ConMed Irrigation Nozzle Device Name: _________________________________________________________________________________________________________________________________________________________________
- . . . . .
Indications For Use:
The ConMed Irrigation Nozzle is intended for colon cleansing when medically
in the contraction for and the includes only ovaminations The Conived Inigation Nozzions in international for endoscopic examinations.
indicated, such as before radiological or endoscopic examinations.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _X (Per 21 CFR 801.109) OR
Over-The-Counter ___
ﻴﺘﺴﺘﺮ ﻨﺎ :
.
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 876.5220 Colonic irrigation system.
(a)
Identification. A colonic irrigation system is a device intended to instill water into the colon through a nozzle inserted into the rectum to cleanse (evacuate) the contents of the lower colon. The system is designed to allow evacuation of the contents of the colon during the administration of the colonic irrigation. The device consists of a container for fluid connected to the nozzle via tubing and includes a system which enables the pressure, temperature, or flow of water through the nozzle to be controlled. The device may include a console-type toilet and necessary fittings to allow the device to be connected to water and sewer pipes. The device may use electrical power to heat the water. The device does not include the enema kit (§ 876.5210).(b)
Classification. (1) Class II (performance standards) when the device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.(2) Class III (premarket approval) when the device is intended for other uses, including colon cleansing routinely for general well being.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other colonic irrigation system shall have an approved PMA in effect before being placed in commercial distribution.