(87 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No.
The intended use describes cleansing prior to medical examinations, which is a preparation step rather than a direct therapeutic intervention for a disease or condition.
No
The device description and intended use indicate it is an attachment for cleansing, not for diagnosing medical conditions.
No
The device description clearly states it is made of "medical grade tubing" and has physical features like "an opening on one end" and "holes on the sides," indicating it is a physical hardware device, not software.
Based on the provided information, the Colonic Nozzle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cleansing when medically indicated such as before radiological or endoscopic examination." This is a physical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical attachment for a colonic system, not a reagent, instrument, or kit used to analyze biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases based on sample analysis
IVDs are devices used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Colonic Nozzle does not fit this definition.
N/A
Intended Use / Indications for Use
The Colonic Nozzle is to be used as an attachment to gravity fed colonic systems for cleansing when medically indicated such as before radiological or endoscopic examination.
Product codes
KPL
Device Description
This Colonic nozzle is made of medical grade tubing, has an opening on one end. The other end is sealed with a small hole in the middle and has two holes on the sides at the same end.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
ATTACHMENT B Ultimate Concepts Inc.
Ko 51344
5056 Crimson Patch Way Riverton, Utah 84065 Phone 800-682-3241 or 801-566-3214 SUMMARY
AUG 1 8 2005
Submitter's name: Address:
Phone:
Fax number:
Ultimate Concepts, Inc. 5056 Crimson Patch Way Riverton, Utah 84065 800-632-3241 801-566-7152
Name of contact person:
Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 fax: 949-552-2821
Date the summary was prepared: July 18, 2005
| Trade Name: | Colonic and Enema Nozzle |
|---|---|
| Common/Usual Name: | Colonic and Enema Nozzle |
| Classification Name: | Colonic Irrigation System, Enema Kit |
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
This Colonic Nozzle is equivalent to Ultimate Professional Continuous Flow colonic System, K033149.
Description of the device:
This Colonic nozzle is made of medical grade tubing, has an opening on one end. The other end is sealed with a small hole in the middle and has two holes on the sides at the same end.
Indications:
The Colonic Nozzle is an attachment to colon cleansing systems.
Technological characteristics of our device compared to the predicate device, Ultimate Professional Continuous Flow colonic System, K033149, are exactly the same except for material used and the addition of a hole at one end. The new material is still medical grade and therefore equivalent. The hole at the end is equivalent to the design of the Jimmy John nozzle, K973256.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20050
AUG 1 8 2005
Ultimate Concepts, Inc. c/o Ms. Grace Holland Regulatory Consultant Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606
Re: K051344
Trade/Device Name: Colonic Nozzle Regulation Number: 21 CFR §876.5220 Regulation Name: Colonic irrigation system Regulatory Class: II Product Code: KPL Dated: July 18, 2005 Received: July 21, 2005
Dear Ms. Holland:
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 (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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 (Premarket Approval), it may be subject to such 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 (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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting your and equivalence of your device to a legally premarket nothleation. The I DA Intentig of bassification 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), please If you desire specific advice for your device on our be of the regulation 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, prease note the regulation other general information on your responsibilities under the Act from the 807.97). I ou may outlin other general missance 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
ATTACHMENT A
Indications for Use Statement
Page 1 of of lof
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K051344
Device Name: Colonic Nozzle
Indications For Use:
The Colonic Nozzle is to be used as an attachment to gravity fed colonic systems for cleansing when medically indicated such as before radiological or endoscopic examination.
Prescription Use (Part 21 CFR 801Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Croydon
(Division S Division of Reproduc ve, Abdominal. and Radiological Devices 510(k) Number