(80 days)
Not Found
Not Found
No
The summary describes a mechanical device for dilation and sheath placement, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is used for "dilation of the musculofascial nephrostomy tract," which is a medical procedure intended to treat or manage a condition, thus making it a therapeutic device.
No.
Explanation: The device is a tool for dilation of a musculofascial nephrostomy tract and placement of a working sheath, which are interventional procedures, not diagnostic ones. It does not gather information about a patient's condition for the purpose of diagnosis.
No
The device description clearly outlines physical components made of materials like Nylon, Polyethylene, Vinyl, and TFE, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the dilation of a physical tract within the body (musculofascial nephrostomy tract) and placement of a sheath. This is a surgical/interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a catheter, balloon, sheath, and inflation gauge – all components used for a physical intervention.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside that definition.
N/A
Intended Use / Indications for Use
The Cook Nephrostomy Tract Balloon Dilation Catheter Set is used for one step, dilation of the musculofascial nephrostomy tract and placement of the working sheath.
Product codes
78LJE
Device Description
The materials used to construct the balloon are Nylon and Polyethylene. The Nephrostomy Balloon Catheter Set will be offered with a 7.3 Fr. diameter, 55cm long catheter, a 32 Fr. diameter, 16cm long sheath Vinyl or TFE and an inflation gauge.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
musculofascial nephrostomy tract
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) Premarket Notification Cook Nephrostomy Balloon Dilation Catheter Set Cook Urological, Inc.
Ko 2 4050
8
FEB 2 7 2003
510(k) SUMMARY I.
Submitted By:
Debbie Schmitt Cook Urological 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891
December 6, 2002
Device
Nephrostomy Tract Dilation Balloon
Cook Nephrostomy Balloon Dilation Catheter Set
Trade Name:
Proposed Classification Name:
Class II Catheter, Nephrostomy 78LJE
Predicate Devices:
The Cook Nephrostomy Balloon Dilation Catheter Set is substantially equivalent to predicate devices in terms of indication for use and design. Predicate devices include other Nephrostomy Dilation Balloons manufactured and marketed by Cook Urological and The NephroMax Balloon Dilatation Catheter Sets marketed by Boston Scientific/Microvasive.
Device Description:
The materials used to construct the balloon are Nylon and Polyethylene. The Nephrostomy Balloon Catheter Set will be offered with a 7.3 Fr. diameter, 55cm long catheter, a 32 Fr. diameter, 16cm long sheath Vinyl or TFE and an inflation gauge.
Substantial Equivalence:
The device will manufactured according to specified process controls and a Quality Assurance Program. The device will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Urological, Inc. The materials used to produce the devices are currently marketed by Cook Urological, Inc. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a simple, flowing line style. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2003
Ms. Debbie Schmitt Regulatory Affairs Manager Cook® Urological 1100 W. Morgan Street SPENCER IN 47460
Re: K024050
Trade/Device Name: Cook® Nephrostomy Dilation Balloon Catheter Set Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LJE Dated: December 6, 2002 Received: December 9, 2002
Dear Ms. Schmitt:
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.
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); 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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/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
3
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
1024050 510(k) Number (if known): Not yet assigned
Device Name:
Cook Nephrostomy Balloon Dilation Catheter Set
The Cook Nephrostomy Tract Balloon Dilation Catheter Set is used for one step, dilation of the musculofascial nephrostomy tract and placement of the working sheath.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use J/ (Per 21 CFR 801.109) OR
Over-The-Counter Use
David A. Symm
(Division Sign-Off) Division of Reproductive. Ab and Radiological Devices 510(k) Number