The Irrigation Set is a Class II device, consisting of a single-use sleeve; a water bag (500-2000 ml) to hold water, a regulator where the paddle wheel that is integrated in the regulator gives visual assurance that water is entering the colon, a tube with a cone-shaped tip, a press plate and belt which are reusable devices. The Irrigation Set is provided with a nylon storage case.

AI/ML Overview

The provided text describes the 510(k) summary for the Irrigation Set, a Class II medical device. It focuses on demonstrating substantial equivalence to a predicate device (K840268) based on design, intended use, and functional performance.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the acceptance criteria and performance are listed as "functional performance and biocompatibility testing" with "acceptable results". More specific details are provided for the bench tests.

Acceptance Criteria Category	Specific Test / Performance Metric	Reported Device Performance
Functional Performance	Accuracy of Volume Indicator	Acceptable results
	Freedom from Leakage	Acceptable results
	Flow Controller	Acceptable results
	Hanging Strength	Acceptable results
Biocompatibility	Biocompatibility testing	Acceptable results

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the test set (bench tests). It also does not mention the country of origin of the data or whether the tests were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The testing involved in-vitro (bench) tests, not clinical evaluations that would require expert ground truth assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving interpretation by multiple experts, which is not the case for these bench tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study, AI, or human readers in the provided text. The device is an "Irrigation Set" and the tests are non-clinical in nature.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

There is no mention of any algorithm or AI in the provided text. The device is a physical medical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The concept of "ground truth" as typically used in AI/diagnostic studies is not applicable here. The "ground truth" for these non-clinical tests would be the established engineering specifications and scientific principles governing the performance of the device's components (e.g., a volume indicator's accuracy is measured against a known standard, leakage is determined by the absence of fluid escape, etc.). The study relies on objective physical measurements and established biocompatibility testing protocols.

8. The sample size for the training set

There is no mention of a "training set" in the provided text. This concept is relevant to machine learning or AI device development, which is not described here.

9. How the ground truth for the training set was established

Not applicable, as no training set is mentioned or relevant to the described device and testing.

Summary

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K121833 Page I of I

510(k) Summary 4

JUL 16 2012

510(k)Owner/SUBMITTER	Coloplast A/SHoltedam 13050 Humlebaek - Denmark
CONTACT PERSON	Tim CrabtreeColoplast Corp1601 West River Road NorthMinneapolis, Minnesota 55411 USATelephone:
DATE PREPARED	21 June 2012
CLASSIFICATION	Ostomy irrigator 876.5895 Class II
COMMON NAME	Irrigator, ostomy
PROPRIETARYNAME	Irrigation Set
PREDICATEDEVICE	K840268
DEVICEDESCRIPTION	The Irrigation Set is a Class II device, consisting of asingle-use sleeve; a water bag (500-2000 ml) to hold water, aregulator where the paddle wheel that is integrated in theregulator gives visual assurance that water is entering the colon,a tube with a cone-shaped tip, a press plate and belt which arereusable devices. The Irrigation Set is provided with a nylonstorage case.
INDICATIONS	The Irrigation Set is indicated for people with a stomawho want to irrigate.
	Irrigation Set has the same indications as the predicatedevice.
TESTING	The Irrigation Set water bag has been subjected tobiocompatibility and mechanical testing and issubstantially equivalent to the predicate Irrigation Set(K840268).
TECHNOLOGICALCHARACTERISTICS	The Irrigation Set has the same intended use, generaldesign, and fundamental scientific technology as thepredicate Irrigation Set.
SUMMARY OF THENONCLINICALTESTS SUBMITTED	In vitro (bench) tests; accuracy of volume indicator,freedom from leakage, flow controller, hanging strength,biocompatibility.
SUMMARY OFCLINICAL TESTSSUBMITTED (ASAPPLICABLE)	Not applicable
CONCLUSIONSDRAWN FROM THENONCLINICAL ANDCLINICAL TESTS	Substantial equivalence of the Irrigation Set is supportedby a comparison of the design and intended use comparedto the predicate, as well as acceptable results fromfunctional performance and biocompatibility testing.

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Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is black and the background is white.

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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. Tim Crabtree Regulatory Affairs Manager Coloplast Corp. 1601 West River Road North MINNEAPOLIS MN 55411

Re: K121833

Trade/Device Name: Irrigation Set Regulation Number: 21 CFR§ 876.5895 Regulation Name: Ostomy irrigator Regulatory Class: II Product Code: EXD Dated: June 21, 2012 Received: June 22, 2012

Dear Mr. Crabtree:

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

JUL 16 2012

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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.

Sincerély vours,

Sincerely yours,

Benjamin K. Kirk

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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3 Statement of Indications for Use

Indications for Use

K121833 510(k) Number (if known): _

Irrigation Set Device Name:

Indications for Use:

The Irrigation Set is indicated for people with a stoma who want to irrigate.

Prescription Use

(Part 21 CFR 80T Subpart D)

Over-The-Counter Use

(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)

Kulin Reuss

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K121833

Page 7 of 20

Regulation Number and Section

§ 876.5895 Ostomy irrigator.

(a)
Identification. An ostomy irrigator is a device that consists of a container for fluid, tubing with a cone-shaped tip or a soft and flexible catheter with a retention shield and that is used to wash out the colon through a colostomy, a surgically created opening of the colon on the surface of the body.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.