AMSURE CLEANSING ENEMA SET

K974042 · Amsino Intl., Inc. · FCE · Dec 19, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K974042
• Device Name: AMSURE CLEANSING ENEMA SET
• Applicant: Amsino Intl., Inc.
• Product Code: FCE · Gastroenterology, Urology
• Decision Date: Dec 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5210
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

AMSure CLEANSING ENEMA SET IS A DEVICE INTENDED TO INSTILL WATER INTO COLON THROUGH A NOZZLE INSERTED INTO THE RECTUM TO PROMOTE EVACUATION OF THE CONTENTS OF THE LOWER COLON.

Device Story

AMSure Cleansing Enema Set is a manual medical device used to instill water into the colon to promote evacuation of lower colon contents. The device consists of a nozzle inserted into the rectum. It is intended for use in clinical or home settings to assist with bowel evacuation. The device functions mechanically; it does not involve electronic components, software, or automated algorithms. It is a simple, non-powered device used by clinicians or patients to facilitate colon cleansing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual, non-powered enema administration set. Consists of a nozzle for rectal insertion and tubing/bag assembly for water delivery. No electronic components, software, or energy sources. Materials are standard medical-grade plastics typical for enema kits.

Indications for Use

Indicated for patients requiring evacuation of the lower colon contents via rectal instillation of water.

Regulatory Classification

Identification

An enema kit is a device intended to instill water or other fluids into the colon through a nozzle inserted into the rectum to promote evacuation of the contents of the lower colon. The device consists of a container for fluid connected to the nozzle either directly or via tubing. This device does not include the colonic irrigation system (§ 876.5220).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 9 1997

Mr. Richard Y. Li. Ph.D. President , & CEO Amsino International, Inc. 833 Towne Center Drive Pomona, California 91767

Re: K974042

AMSure® Cleansing Enema Set Dated: October 21, 1997 Received: October 24, 1997 Regulatory Class: I 21 CFR §876.5210/Product Code: 78 FCE

Dear Mr. Li:

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. However, you are responsible to determine that the medical devices you use as components in the [it have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 the market. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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

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Page 2 - Mr. Richard Y. Li , Ph.D.

Division of Small Manufacturers Assistance at its toll free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Robert R. Satling/

\$

Lillian Yin, Ph.D. Director, Divsion 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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Enclosure #7

Page ol

K974042 510(k) Number (if known): _

AMSure Cleansing Enema Set Device Name:___

Indications For Use:

AMSure CLEANSING ENEMA SET IS A DEVICE INTENDED TO INSTILL WATER INTO COLON THROUGH A NOZZLE INSERTED INTO THE RECTUM TO PROMOTE EVACUATION OF THE CONTENTS OF THE LOWER COLON.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R Ratting/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 974042 510(k) Number .

Prescription 'Use_ (Per 21 CFR 801 109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

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