(22 days)
Not Found
Not Found
No
The summary describes a mechanical device (guidewires for drainage catheters) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The PBN Drainage Catheter Guidewires are used for placement of drainage catheters and for fluid drainage, which are diagnostic or procedural functions, not directly treating a disease or condition in a therapeutic manner.
No
The device, PBN Drainage Catheter Guidewires, is intended for the placement of drainage catheters and for fluid drainage procedures (paracentesis, thoracentesis), which are interventional or therapeutic in nature, not diagnostic.
No
The device description is not found, but the intended use clearly describes a "PBN Drainage Catheter Guidewire," which is a physical medical device used in procedures. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's function in placing drainage catheters and performing fluid drainage procedures within the body (percutaneous).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information about a physiological state, health, or disease.
IVDs are typically used to test samples like blood, urine, or tissue in a laboratory setting. This device is used for a procedural intervention.
N/A
Intended Use / Indications for Use
The PBN Drainage Catheter Guidewires are intended for use in the placement of non-vascular percutaneous drainage catheters where a guidewire is indicated, such as in paracentesis, thoracentesis, and other fluid drainage procedures.
Product codes
KNY
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
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is black and is on a white background. The text is slightly angled.
Image /page/0/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other, with 'Public' on the top line, 'Health' on the second line, and 'Service' on the third line. The text appears to be part of a document or sign.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 1999
Mr. Karl Swartz Quality Manager Medical Device Technologies, Inc. 3600 S.W. 47th Avenue Gainesville, FL 32608
Re: K991097 PBN Drainage Catheter Guidewires Dated: March 30, 1999 Received: April 1, 1999 Regulatory Class: II 21 CFR 876.5130/Procode: 78 KNY
Dear Mr. Swartz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have have have have have have have have have be have We nave reviews your occusive ifor the indications for use stated in the endosure) to legally marketed predicate devices marketed in interstate commerce pror to May 28, 1976, the enactment date of the manced prodocto do nove hambled in motion in accordance with the provisions of the specificated to the annorgi one Medical Device Anientanie, or to neviews that had nav therefore, market the device, subject to the general controls I edelan Food, Drug, and Oosments root, "Tou may f the Act include requirements for annual registration, listing of provident of the new active, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Special Controls) or class III (Prema Ker Approval), it may if your device is classifica (GCC doove) into dimorations affecting your device can be found in the Code of be dayson to battlerity of the 11, Parts 800 to 895. A substantially equivalent determination assumes on the compliance r Goldin Regulations, This 21, Tare over equirements, as set forth in the Quality System Regulation (QS) for the Current Good Manufacturing Practicents, as detern in the becinity of Sincertions, the Food and Meanal Devices. Ocheral roguently such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Feceral regulatory action. In addition: 1971 may publicit notification submission does not affect any objection your register. Thease neces the roopense to your product to for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA This reter will and with to begin marketing your 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 labcling regulation (21 CFR Part 801 and additionally 809.10 or nin in diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionaliy 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 807.97). Other predise the regalation onlines "Misallanen" and readly of the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nosc and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Image /page/1/Picture/0 description: The image shows a logo for MDTECH MEDICAL DEVICE TECHNOLOGIES INC. The logo is black and white and features the company name in a bold, sans-serif font. The letters "MDTECH" are stacked on top of the rest of the company name. The logo is simple and modern.
3600 SW 47th Avenue Gainesville, Florida 32608 EL: 352/338-0440 FAX: 352/338-0662
Page 1_of_1_
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: PBN Guidewires
Indications for Use:
The PBN Drainage Catheter Guidewires are intended for use in the placement of non-vascular porculations The PBN Drainage Catheter Guider in use in the paccinent of Resident of Resident of Residentials and Submitted States is, the pleuracentcsis, and other fluid drainage.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_X (Per 21 CFR 801.109) OR
Over-The-Counter Use_
Signature
(Optional Format 1-2-96
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K991097
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