(24 days)
Not Found
No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI/ML terms or functionalities.
Yes
The device is used for irrigation by people with a stoma, which is a medical procedure to manage bodily waste, indicating a therapeutic purpose.
No.
The "Intended Use / Indications for Use" states that the device is "indicated for people with a stoma who want to irrigate," which describes a therapeutic or maintenance function, not a diagnostic one. The device description and performance studies do not mention any diagnostic capabilities.
No
The device description explicitly lists multiple hardware components: a single-use sleeve, a water bag, a regulator with a paddle wheel, a tube with a cone-shaped tip, a press plate, a belt, and a nylon storage case.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "people with a stoma who want to irrigate." This describes a procedure performed on the body (in vivo), not a test performed on a sample taken from the body (in vitro).
- Device Description: The components described (sleeve, water bag, regulator, tube, cone-shaped tip, press plate, belt) are all designed for delivering fluid into the colon via a stoma. This is a physical intervention, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition. The "visual assurance that water is entering the colon" is a functional indicator of the device's operation, not a diagnostic result.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Irrigation Set is indicated for people with a stoma who want to irrigate.
Product codes
EXD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro (bench) tests; accuracy of volume indicator, freedom from leakage, flow controller, hanging strength, biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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K121833 Page I of I
510(k) Summary 4
JUL 16 2012
| 510(k)
Owner/SUBMITTER | Coloplast A/S
Holtedam 1
3050 Humlebaek - Denmark |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON | Tim Crabtree
Coloplast Corp
1601 West River Road North
Minneapolis, Minnesota 55411 USA
Telephone: |
| DATE PREPARED | 21 June 2012 |
| CLASSIFICATION | Ostomy irrigator 876.5895 Class II |
| COMMON NAME | Irrigator, ostomy |
| PROPRIETARY
NAME | Irrigation Set |
| PREDICATE
DEVICE | K840268 |
| DEVICE
DESCRIPTION | 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. |
| INDICATIONS | The Irrigation Set is indicated for people with a stoma
who want to irrigate. |
| | Irrigation Set has the same indications as the predicate
device. |
| TESTING | The Irrigation Set water bag has been subjected to
biocompatibility and mechanical testing and is
substantially equivalent to the predicate Irrigation Set
(K840268). |
| TECHNOLOGICAL
CHARACTERISTICS | The Irrigation Set has the same intended use, general
design, and fundamental scientific technology as the
predicate Irrigation Set. |
| SUMMARY OF THE
NONCLINICAL
TESTS SUBMITTED | In vitro (bench) tests; accuracy of volume indicator,
freedom from leakage, flow controller, hanging strength,
biocompatibility. |
| SUMMARY OF
CLINICAL TESTS
SUBMITTED (AS
APPLICABLE) | Not applicable |
| CONCLUSIONS
DRAWN FROM THE
NONCLINICAL AND
CLINICAL TESTS | Substantial equivalence of the Irrigation Set is supported
by a comparison of the design and intended use compared
to the predicate, as well as acceptable results from
functional performance and biocompatibility testing. |
1
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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
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.
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
3
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
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