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 - < 12 years old), adolescent (12 years - < 18 years old), transitional adolescent (18 - <21 years old) and adult patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.

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.

AI/ML Overview

The provided FDA 510(k) summary for the Peristeen™ Anal Irrigation System (K112860) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device.

This document describes a medical device (a rectal catheter system) that underwent biocompatibility and mechanical testing. It does not mention any AI/ML components or algorithms, nor does it discuss performance metrics like sensitivity, specificity, or AUC, which are typically found in studies validating AI/ML devices.

Therefore, I cannot provide the requested information. The document explicitly states:

SUMMARY OF CLINICAL TESTS SUBMITTED (AS APPLICABLE): Not applicable

This means no clinical trials were conducted or submitted as part of this 510(k) to evaluate the device's performance in human subjects, let alone an AI/ML component. The "nonclinical tests" listed are bench tests related to the physical properties and biocompatibility of the catheter.

Summary

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K112860
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13 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 510(k) Summary

JUN - 8 2012

. ...

510(k)	Coloplast A/S
Owner/SUBMITTER	Holtedam 13050 Humlebaek - Denmark
CONTACT PERSON	Brian SchmidtColoplast Corp1601 West River Road NorthMinneapolis, Minnesota 55411 USA
DATE PREPARED	29 September 2011
CLASSIFICATION	Gastrointestinal tube & accessories 876.5980 Class IIEnema kit 876.5210 Class I (Exempt)
COMMON NAME	Rectal Catheter and Accessories; Enema Kit
PROPRIETARYNAME	Peristeen™ Anal Irrigation
PREDICATEDEVICE	K083770, K103254
DEVICEDESCRIPTION	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 - <12 years old), adolescent (12 years - < 18 years old), transitional adolescent (18 - <21 years old) and adult patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.Peristeen™ Anal Irrigation is a prescriptive device and should only be prescribed by a licensed physician.Peristeen™ Anal Irrigation has the same indications as the predicate device.
TESTING	The Peristeen rectal catheter has been subjected to biocompatibility and mechanical testing and is
	substantially equivalent to the predicate Peristeen device(K083770, K103254).
TECHNOLOGICALCHARACTERISTICS	The Peristeen rectal catheter has the same intended use,general design, and fundamental scientific technology asthe predicate Peristeen rectal catheter.
SUMMARY OF THENONCLINICALTESTS SUBMITTED	In vitro (bench) tests; flexibility, flow rate, ballooninflation, balloon peak pressure, burst diameter/volume,biocompatibility
SUMMARY OFCLINICAL TESTSSUBMITTED (ASAPPLICABLE)	Not applicable
CONCLUSIONSDRAWN FROM THENONCLINICAL ANDCLINICAL TESTS	Substantial equivalence of the Peristeen Rectal Catheter issupported by a comparison of the design and intended usecompared to the predicate, as well as acceptable resultsfrom functional performance and biocompatibility testing.

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K 112860
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・

And 1988 to the state of the states

the submit and the submit of the subject of the subject of

and the comments of the country of

: : : :

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an eagle-like symbol with three stylized lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Coloplast A/S % Mr. Brian Schmidt Regulatory Affairs Manager Coloplast Corp 1601 West River Rd North MINNEAPOLIS MN 55411

JUN - 8 2012

Re: K112860

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

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Page 2 -

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

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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:

Prescription Use	X
------------------	---

Over-The-Counter Use

(Part 21 CFR 80T Subpart D)

(21 CFR 801 Subpart C) AND/OR

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vorn M

510(k) Numbe

Peristeen Special 510k

Page 16 of 159

Regulation Number and Section

§ 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.