(172 days)
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities.
Yes.
The device is intended for "colon cleansing when medically indicated," which serves a therapeutic purpose.
No.
The device is used for colon cleansing prior to examinations but does not itself provide diagnostic information.
No
The device description clearly states it is a physical, plastic product intended for insertion into the rectum, making it a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "colon 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 to diagnose a condition.
- Device Description: The device is a physical nozzle inserted into the rectum to instill water. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of samples, reagents, or diagnostic information derived from the device's use.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
"The Libbe Colonic Nozzle is to be used as the Device/Nozzle inserted into the rectum when used with the LIBBE Lower Bowel Evacuation System. The Device/Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examination."
Product codes
KPL
Device Description
The LIBBE Colonic Nozzle device is a plastic, non-sterile, single use product for use as an accessory with lower bowel evacuation systems or enema kits. The Device/Nozzle is intended to be inserted two to three inches into the rectum for instilling water into the colon region.
The LIBBE Colonic Nozzle is designed as a one-piece, injection molded, medical grade plastic accessory. The nozzle has an open tip with a slight bulb shape that has two small holes in its wall. The proximal end of the nozzle has a barbed fitting for attachment to plastic tubing from the colonic irrigation, or enema, system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rectum, colon region
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)
Not Found
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
§ 876.5220 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
DCT 5 2007 Tab 5
510(k) Summary (Revised)
| Submitters Name: | Tiller MIND BODY, Inc. |
|---|---|
| Contact: | Jeri C. Tiller |
| Address: | 10911 West Ave |
| San Antonio, Texas 78213 | |
| (210) 308-8888 Office | |
| (210) 349-5679 Fax | |
| Date Prepared: | April 12, 2007 |
| Trade Name: | LIBBE Colonic Nozzle |
|---|---|
| Common Name: | LIBBE Colonic Nozzle |
| Classification Name: | Colonic Irrigation System |
The legally marketed device to which we are claiming equivalence [(807.92(a) (3)]:
The Libbe Colonic Nozzle is equivalent to the Libbe Rectal Tube (K962259), which was granted approval on August 29, 1996 (Tab 5 - Attachment A.)
Description of the Device:
The LIBBE Colonic Nozzle device is a plastic, non-sterile, single use product for use as an accessory with lower bowel evacuation systems or enema kits. The Device/Nozzle is intended to be inserted two to three inches into the rectum for instilling water into the colon region.
The LIBBE Colonic Nozzle is designed as a one-piece, injection molded, medical grade plastic accessory. The nozzle has an open tip with a slight bulb shape that has two small holes in its wall. The proximal end of the nozzle has a barbed fitting for attachment to plastic tubing from the colonic irrigation, or enema, system.
Indications:
The Libbe Colonic Nozzle is to be used as the Device/Nozzle inserted into the rectum when used with the LIBBE Lower Bowel Evacuation System. The Device/Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examination.
1
Technical Characteristics:
Technological characteristics of our LIBBE Colonic Nozzle compared to the predicate device, the Libbe Rectal Tube (K962259), are the same except for the length, material used, and the addition of a bulb shape at the tip. The bulb tip of our new nozzle has two holes in its wall and is open. The predicate device has a smooth tip that is open and has two small holes. The predicate device is narrower than the LIBBE Colonic Nozzle and is rigid plastic, while our Libbe Rectal nozzle is semi-rigid plastic.
In addition, the proximal end of the LIBBE Colonic Nozzle has a barbed fitting for attachment to plastic tubing from the LIBBE colonic system. The predicate device is a continuous, straight tube with a smooth wall at the equipment connection point.
Biocompatibility:
The LIBBE Colonic Nozzle meets biocompatibility requirements as specified in FDA Guidance G95-1, and has been tested in accordance with ISO 10993. (See Letter of Authorization from Kraton Polymers LLC, Tab 15.)
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle.
Tab 5 - Attachment A DEPARTMENT OF HEALTH & HUMAN SERVICES
1071057
Page 3 of 3
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 29 1996
Re: K962259
Ms. Jeri C. Tiller President Tiller MIND BODY, Inc. 2204 N.W. Loop 410, #2C San Antonio, Texas 78230-5352
LIBBE Rectal Tube Dated: June 6, 1996 Received: June 12, 1996 Regulatory class: II 21 CFR §876.5220/Product code: 78 KPL
Dear Ms. Tiller:
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, 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 the Electronic Product 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 viro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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 at (301) 443-6597.
Sincerely yours,
William Uric
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
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tiller MIND BODY, Inc. c/o Mr. Harold L. Jones Consultant Quality Partners Consulting 42 East Whisters Bend Circle THE WOODLANDS TX 77384
0CT 5 2007
Re: K071057
Trade/Device Name: LIBBE Colonic Nozzle Regulation Number: 21 CFR §876.5220 Regulation Name: Colonic irrigation system Regulatory Class: II Product Code: KPL Dated: July 24, 2007 Received: July 27, 2007
Dear Mr. Jones:
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, 1796, 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 (PMA), 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.
4
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.
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 (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
5
Tab 4
Indications for Use Statement (Revised)
510(k) Number (if Known): K071057
Device Name: Libbe Colonic Nozzle
Indications for Use: "The Libbe Colonic Nozzle is to be used as the Device/Nozzle inserted into the rectum when used with the LIBBE Lower Bowel Evacuation System. The Device/Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examination."
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Herbert Heimer
Division of Reproductive, Abdomin Radiological Devices 510(k) Number