(35 days)
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No
The summary describes a simple rectal nozzle for colon irrigation and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is intended for colon cleansing when medically indicated, which is a therapeutic purpose.
No
The device is intended for colon cleansing, which is a therapeutic or preparatory function, not a diagnostic one. It does not identify a disease, condition, or provide a clinical diagnosis.
No
The device description clearly states "JIMMY JOHN III RECTAL NOZZLE," which is a physical hardware component, not software.
Based on the information provided, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "RECTAL NOZZLE" intended for "Colon Irrigation." This is a physical device used for a procedure performed directly on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for "Colon cleansing," which is a physical process, not a diagnostic test.
Therefore, the JIMMY JOHN III RECTAL NOZZLE is a medical device, but it falls under a different category than IVDs.
N/A
Intended Use / Indications for Use
Intended for use in Colon Irrigation with any colon irrigation system.
Class II - These devices are intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
Product codes
78 KPL
Device Description
RECTAL NOZZLE
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Colon / Rectal
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 1997
Mr. Jim Girouard President Colon Therapeutics 2909 Main Avenue Groves, Texas 77619 Re: K973256
Jimmy John III Rectal Nozzle Dated: August 22, 1997 Received: August 25, 1997 Regulatory class: II 21 CFR §876.5220/Product code: 78 KPL
Dear Mr. Girouard:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
| દિશ્વિત ન | ી | |||
|---|---|---|---|---|
| the expendentials and an | p can and the same an |
| 510(k) Number (if known): | K973256 |
|---|---|
| Device Name: | JIMMY JOHN III RECTAL NOZZLE |
Indications For Use:
PACKAGE LABEL
Indications For Use
Intended for use in Colon Irrigation with any colon irrigation system.
Class II - These devices are intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
(PLEASE IN) NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACIE IF NUELEID)
Concurrence of CDRH, Ollice of Device Evaluation (ODE)
Robert Q. Rathbun
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 16473256 510(k) Number _
Prescription Use
(Per 21 CFR 801.109)
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Over-The-Counter Use
(Uplivini Forust 1-2-90)
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