(573 days)
No
The summary describes a mechanical device for anal irrigation and does not mention any AI or ML components or functionalities.
Yes
The device is intended to treat or alleviate the symptoms of neurogenic bowel dysfunction, specifically fecal incontinence, chronic constipation, and time-consuming bowel management procedures. This aligns with the definition of a therapeutic device.
No
The device is an anal irrigation system used to facilitate emptying of the colon/bowel, not to diagnose a medical condition. Its intended use is therapeutic, not diagnostic.
No
The device description explicitly states the system consists of a single-use irrigation catheter with an inflatable balloon and other components, indicating it is a hardware-based medical 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 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 anal irrigation, involving a catheter and water. It does not involve analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, or analysis of biological 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 definition.
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.
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Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3, 2015
Coloplast A/S % Brian Schmidt Regulatory Affairs Manager Coloplast Corp. 1601 West River Road North Minneapolis, MN 55411
Re: K140310
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. FCE Dated: July 23, 2015 Received: July 27, 2015
Dear Brian 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.
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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 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for 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
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Indications for Use
510(k) Number (if known) K140310
Device Name Peristeen™ Anal Irrigation System
Indications for Use (Describe)
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 - Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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1. 510(K) SUMMARY OR 510(K) SUMMARY STATEMENT
| 510(k) Summary | |||
|---|---|---|---|
| 510(K) Owner's Name: | Coloplast A/S | ||
| Address: | Holtedam 1 | ||
| 3050 Humlebaek, Denmark | |||
| Establishment Registration: 9610694 | |||
| Owner/Operator: 8010144 | |||
| Name of Contact Person: | Brian Schmidt | ||
| Regulatory Affairs Manager | |||
| Address/Contact: | 1601 West River Road | ||
| Minneapolis, MN 55411 | |||
| Phone/Fax/Email: | Office: | ||
| Mobile: | |||
| Fax: | |||
| email: | (612) 302-4987 | ||
| (612) 968-9567 | |||
| (612) 287-4138 | |||
| usbes@coloplast.com | |||
| Date Prepared: | February 4, 2014 | ||
| Trade Name: | Peristeen™ Anal Irrigation System | ||
| Common Name: | Rectal Catheter and accessories and | ||
| Enema kit | |||
| Classification Name: | 876.5980 Gastrointestinal tube & accessories | ||
| Class II and | |||
| 876.5210 Enema kit | |||
| Class I (Exempt) | |||
| Product Code: | KNT and FCE |
Legally Marketed Devices To Which Your Firm Is Claiming Equivalence:
The Peristeen™ Anal Irrigation System is substantially equivalent in performance, indications, design and materials to the Peristeen™ Anal Irrigation System cleared on June 8, 2012 under premarket notification 510(k) number K112860.
Indications for Use
The Peristeen™ Anal Irrigation (PAI) 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 PAI System is indicated for use by Children (2 years -