(27 days)
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No
The summary provides no information suggesting the use of AI or ML. The intended use and lack of mentions of AI/ML, image processing, or performance studies related to algorithmic analysis indicate a standard drainage catheter.
Yes
The device is used for percutaneous drainage of abscesses, nephrostomies, and other fluids, which is a therapeutic intervention.
No
The device, a drainage catheter, is used for percutaneous drainage of fluids, which is a therapeutic intervention, not a diagnostic one. It is used to remove substances from the body rather than to identify a medical condition.
No
The intended use describes "Drainage Catheters," which are physical medical devices, not software. The summary provides no information about any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "percutaneous drainage of abscesses, nephrostomies, and other fluids." This describes a procedure performed on the patient's body to remove fluids.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
The description of the device's use clearly falls outside the scope of examining specimens in vitro (outside the body). It's a device used in vivo (within the body) for a therapeutic or procedural purpose.
N/A
Intended Use / Indications for Use
The Drainage Catheters are to be used for percutaneous drainage of abscesses, nephrostomies, and other fluids.
Product codes
78 FGE, 78 LJE, 79 GBO, 79 GBX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 878.4200 Introduction/drainage catheter and accessories.
(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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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 is circular in shape and features an abstract image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2004
Mr. Matthew Mahon RA/QA Manager UreSil, LLC 5418 W. Touhy Ave. SKOKIE IL 60077
Re: K041995
Trade/Device Name: General purpose drainage catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheters and accessories Product Code: 78 FGE and LJE; 79 GBO and GBX Regulatory Class: II Dated: July 21, 2004 Received: July 26, 2004
Dear Mr. Mahon:
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 rommerce 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 r ou may) ateror of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 or any I castin bathates including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) I his lefter will anow you to begin marketing, your antial equivalence of your device to a legally premarket nothleation - The FIPA momys. Easy in the your device and thus, permits your device to proceed to the market.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice tor your do too ...
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter.
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions of the promotive of the regulation entitled, "Misbranding Other of Compliance at (301) 57 + 102 (21CFR Part 807.97) you may obtain. Other general by relected to premarks notification (2) Or Act may be obtained from the Division of Small Information on your responsionalism and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdch/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) #: K041995
Device Name : General Purpose Drainage Catheter
Indications for Use:
The Drainage Catheters are to be used for percutaneous drainage of abscesses, nephrostomies, and other fluids.
Prescription Use
(Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number .