(56 days)
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.
AMSure® Cleansing Enema Set
This document, K974042, is a 510(k) premarket notification decision letter for the AMSure® Cleansing Enema Set. It declares the device substantially equivalent to legally marketed predicate devices.
The information provided does not contain the details typically sought when describing acceptance criteria and a study to prove a device meets those criteria in the context of a new, potentially AI-driven, medical device. This is largely because the document pertains to a Class I medical device (a cleansing enema set) cleared in 1997, which would not involve the complex performance studies, statistical analysis, or AI-specific criteria requested in the prompt.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria development, study design, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth establishment, or sample sizes related to a performance study for this device based on the given text.
The closest information provided is:
- Device Name: AMSure® Cleansing Enema Set
- 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."
- Regulatory Class: I (21 CFR §876.5210/Product Code: 78 FCE)
For Class I devices like this, substantial equivalence is often based on fundamental design, materials, and intended use being similar to existing legally marketed devices, rather than extensive clinical performance studies as would be required for higher-risk devices or novel AI/software as a medical device. The "acceptance criteria" here implicitly refer to meeting the general controls provisions of the Act and demonstrating substantial equivalence to a predicate device, which would involve showing that the device is as safe and effective as the predicate.
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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 (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
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Page 2 - Mr. Richard Y. Li , Ph.D.
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,
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)
. "
§ 876.5210 Enema kit.
(a)
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).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9. The device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.