(133 days)
The Dfiner is indicated for catheterization of the male urethra for the introduction of contrast materials.
The Dfiner Urological Catheter is a dual lumen flexible co-axial catheter. The main lumen contains a flexable sheath which houses is a solid flexible rod. Attached to the distal end of the rod is an array of wires. The wire bundle can be advanced and deployed in the bladder to assist with anatomical imaging. Contrast material is introduced through the main lumen. The catheter has a rigid "Y" connector at the proximal end that allows the wire bundle/sheath to be deployed/retracted and access to the main lumen.
The provided text is a 510(k) Summary for the Dfiner Urological Catheter. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with AI/ML medical devices.
The document describes a traditional medical device (a catheter) and references a "comparison of technological characteristics" to predicate devices, rather than a clinical performance study with acceptance criteria, sample sizes, ground truth, or expert involvement.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to already legally marketed devices based on design, intended use, and materials of manufacture, not on the performance of an AI algorithm.
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FEB 2 0 2002
510(k) Summary Dfiner Urological Catheter Date Prepared: 5 October 2001
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92.
A. Submitter
NeoSeed Technology, L.L.C. The Presidio-Old Army Headquarters Building 220, Suite 120 San Francisco, CA 94129
Company Contact B.
Mark Kieras Director, Regulatory Affairs
Device Name ﺰ
| Trade Name: | Dfiner Urological Catheter |
|---|---|
| Common Name: | Male Urethrographic Catheter |
| Classification Name: | Urological Catheter and Accessories |
Predicate Devices D.
Imager Torque Catheter, K965229 Imager II Torque Catheter, K011965
E. Description of Device
The Dfiner Urological Catheter is a dual lumen flexible co-axial catheter. The main lumen contains a flexable sheath which houses is a solid flexible rod. Attached to the distal end of the rod is an array of wires. The wire bundle can be advanced and deployed in the bladder to assist with anatomical imaging. Contrast material is introduced through the main lumen. The catheter has a rigid "Y" connector at the proximal end that allows the wire bundle/sheath to be deployed/retracted and access to the main lumen.
D. Intended Use
The Dfiner is indicated for catheterization of the male urethra for the introduction of contrast materials.
E. Comparison of Technological Characteristics
The proposed device is substantially equivalent to the legally marketed predicate devices in design, intended use and materials of manufacture.
Mark Kiss
Mark Kieras
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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 eagle with three wavy lines representing the department's mission to promote health, well-being, and human services. The department's name is written in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2002
Mr. Mark Kieras Director. Regulatory Affairs NEOSeed Technology, L.L.C. 22 Hill Street NEWBURYPORT MA 01950 Re: K013360
Trade/Device Name: NeoSeed Dfiner Urological Catheter Male Urethrographic Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 FGI and KOD Dated: January 18, 2002 Received: January 22, 2002
Dear Mr. Kieras:
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.
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This letter will allow you to begin marketing your device as described in your 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 this 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" (21 CFR Part 807.97). 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
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510(k) Number : K013360
Device Name : Dfiner Urological Catheter
Indications for Use: The Dfiner is indicated for catheterization of the male urethra for the introduction of contrast materials.
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109) (Optional Format 1-2-96)
OR
Over-the-Counter _____________________________________________________________________________________________________________________________________________________________
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013360
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.