JIMMY JOHN III RECTAL NOZZLE by COLON THERAPEUTICS

The provided documents are a 510(k) clearance letter and an "Indications For Use" form for the "JIMMY JOHN III RECTAL NOZZLE". These documents are from 1997 and pertain to a medical device for colon irrigation.

Based on the content of these documents, it is not possible to provide the requested information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

Here's why:

Age of Documents: These documents are from 1997, which predates the common practices and requirements for detailed performance study reporting as outlined in your request.
Type of Device: A "rectal nozzle" for colon irrigation is a relatively simple device compared to complex algorithms or imaging devices that would typically undergo rigorous performance studies with specific statistical metrics.
"Substantially Equivalent" Clearance: The 510(k) clearance process, especially in 1997, largely relied on demonstrating "substantial equivalence" to a predicate device already on the market, rather than requiring extensive de novo clinical performance studies with specific acceptance criteria as would be expected for novel or high-risk devices.
"Indications For Use" Form: This form only defines the intended use of the device, not its performance metrics or how those metrics were validated.

Specifically addressing your points, based only on the provided text:

A table of acceptance criteria and the reported device performance: Not available. The documents do not contain any performance metrics or acceptance criteria for the device beyond its intended use for colon cleansing.
Sample sized used for the test set and the data provenance: Not available. No a clinical study is described that would have a test set and associated data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. No ground truth establishment is mentioned.
Adjudication method for the test set: Not available. No adjudication method is mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is not mentioned as it's typically for diagnostic or imaging devices, not a physical medical device for irrigation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This device is a physical nozzle, not an algorithm.
The type of ground truth used: Not applicable/Not available. For a device like this, the "ground truth" would likely relate to the effectiveness of colon cleansing, which would be evaluated clinically, but no such study is described.
The sample size for the training set: Not applicable/Not available. There is no "training set" for this type of device.
How the ground truth for the training set was established: Not applicable/Not available.

In summary, the provided documents are regulatory clearance papers for a physical medical device from 1997. They do not contain the type of detailed performance study information, acceptance criteria, or statistical results that you are asking for, which are more commonly associated with modern submissions for diagnostic algorithms, imaging devices, or novel therapeutic devices.

Summary

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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

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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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Regulation Number and Section

§ 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.