(252 days)
Not Found
No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI or ML.
Yes
The device is intended to promote evacuation of colon contents for patients suffering from fecal incontinence and chronic constipation, which are therapeutic actions.
No
The device is an anal irrigation system intended to instill water into the colon to promote evacuation, which is a therapeutic function, not a diagnostic one. It is used to manage symptoms like fecal incontinence and chronic constipation.
No
The device description clearly lists multiple hardware components including a catheter, control unit, water bag, leg straps, tubes, and a storage case. It is a physical system for anal irrigation, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to instill water into the colon to promote evacuation. This is a physical intervention 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 system for delivering water and managing a balloon within the rectum. It does not involve analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no references to diagnostic tests, assays, or the detection of specific substances or markers.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Peristeen™ Anal Irrigation System does not fit this description.
N/A
Intended Use / Indications for Use
The Peristeen™ Anal Irrigation System is intended to instill water into the colon through a rectal catheter-which incorporates an inflatable balloon-inserted into the rectum to promote evacuation of the contents of the lower colon. The Peristeen™ Anal Irrigation System is indicated for use by children (2 years -
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
K112860
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JUN - 8 2012
. ...
| 510(k) | Coloplast A/S |
|---|---|
| Owner/SUBMITTER | Holtedam 1 |
| 3050 Humlebaek - Denmark | |
| CONTACT PERSON | Brian Schmidt |
| Coloplast Corp | |
| 1601 West River Road North | |
| Minneapolis, Minnesota 55411 USA | |
| DATE PREPARED | 29 September 2011 |
| CLASSIFICATION | Gastrointestinal tube & accessories 876.5980 Class II |
| Enema kit 876.5210 Class I (Exempt) | |
| COMMON NAME | Rectal Catheter and Accessories; Enema Kit |
| PROPRIETARY | |
| NAME | Peristeen™ Anal Irrigation |
| PREDICATE | |
| DEVICE | K083770, K103254 |
| DEVICE | |
| DESCRIPTION | The Peristeen™ Anal Irrigation system is a Class II device, consisting of a single-use irrigation catheter with balloon for retention; a control unit with a manual switch that allows for addition of pressure to the water bag, and inflation and deflation of the balloon on the catheter; a bag with a lid to hold water, leg straps that may be used to fasten the control unit and tubing to the thigh, and tubes with connectors. The system is provided with a nylon storage case. The rectal catheter is single-use, but the other components may be used multiple times. |
| INDICATIONS | The Peristeen™ Anal Irrigation System is intended to instill water into the colon through a rectal catheter-which incorporates an inflatable balloon-inserted into the rectum to promote evacuation of the contents of the lower colon. The Peristeen™ Anal Irrigation System is indicated for use by children (2 years - Trade/Device Name: Peristeen™ Anal Irrigation System Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: May 24, 2012 Received: May 25, 2012 |
Dear Mr. Schmidt:
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, 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) 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical
3
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin K. Tachi
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2 Statement of Indications for Use
Indications for Use
510(k) Number (if known): K1/2860
Device Name:
Peristeen™ Anal Irrigation System
Indications for Use:
The Peristeen™ Anal Irrigation System is intended to instill water into the colon through a rectal catheter-which incorporates an inflatable balloon-inserted into the rectum to promote evacuation of the contents of the lower colon. The Peristeen™ Anal Irrigation System is indicated for use by children (2 years -