(122 days)
No
The device description details a standard Foley catheter with multiple lumens and a council tip, designed for urine drainage and irrigation. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The device is described as a flexible tubular device and its function is purely mechanical for fluid management.
No.
The device is a Foley catheter used for drainage and collection of urine, and for irrigation, which are not considered therapeutic actions.
No
The device is indicated for drainage, collection, and measurement of urine, and for irrigation of the bladder. There is no mention of it being used to diagnose conditions or obtain diagnostic information.
No
The device description clearly describes a physical, tubular device made of silicone with lumens, a balloon, and a valve, which are all hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the drainage, collection, and measurement of urine, and for irrigation of the bladder. These are all physical actions performed on the body or with bodily fluids outside of the body for collection or removal.
- Device Description: The device is a physical catheter designed for insertion into the urinary tract. It facilitates the movement of fluids.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside of the living body) to provide information for the diagnosis, prevention, or treatment of a disease or condition. It doesn't perform tests on the urine itself to analyze its composition or detect markers.
IVDs are typically devices like test strips, analyzers, or kits used to perform tests on samples like blood, urine, or tissue to gain diagnostic information. This catheter is a tool for managing bodily fluids, not for analyzing them for diagnostic purposes.
N/A
Intended Use / Indications for Use
The DirectVision® Catheter, Uncoated is indicated for use in the drainage and/or collection and/or measurement of urine. It is intended to be used as a urological catheter inserted through the urethra for the purpose of draining urine and other fluids from the urinary tract. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as the nephrostomy tract.
Product codes
EZL
Device Description
The DirectVision® Catheter,-Uncoated is a flexible tubular device that is inserted through the urethra and used to pass fluids to and from the urinary tract. It is a 100% silicone, latex-free, triple lumen (3-Way) Foley catheter with a straight or angled council tip to facilitate insertion. The DirectVision® Catheter, Uncoated is composed of a silicone tube that trifurcates into three (3) lumens, a silicone balloon, and a two-way valve. Of the three lumens, one lumen is used for urinary drainage and can be connected to a urine collection container (drainage bag or urine meter); one lumen has a two-way valve for inflation/deflation of the Foley balloon; and the third lumen can be used for irrigation of the bladder. The council tip has an opening (eyelet) in the tip that can be used to pass a guidewire or similar device to facilitate catheter insertion. This catheter device will be available with a single or double drainage eyelet, 14 through 24 French shafts, and either a 10 cc or 30 cc balloon. The DirectVision® Catheter, Uncoated is designed to be usable with the PercuVision DirectVision™ Guide System (K091600). In the DirectVision™ Guide System, the DirectVision® Catheter, Uncoated provides a sheath around the microendoscope to facilitate its use. The catheter also incorporates a channel to be used for supplying irrigation to the microendoscope tip for clearing away debris from the field of view during use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract, urethra, bladder
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
K110214
(pg 1 of 3)
Percu Vision DirectVision® Catheter, Uncoated Special 510(k) Premarket-Notification Submission
| Special 510(k) Summary | |
|---|---|
| MAY 27 2011 | |
| A) Submitted by: | PercuVision |
| 6264 S. Sunbury Rd. | |
| Westerville, Ohio 43081 | |
| Phone number is 614-891-4800 | |
| Toll Free 1-877-913-6333 | |
| Fax 614-891-3500 | |
| Contact: | MEDIcept |
| 200 Homer Ave | |
| Ashland, MA 01721 | |
| F. David Rothkopf | |
| 508-231-8842 Tel | |
| 508-231-8861 Fax | |
| B) Device Name: | |
| Common Name: | Urologic Catheter |
| Proprietary Name: | DirectVision® Catheter, Uncoated |
| Device Class: | 21 CFR 876.5130 Urological Catheter and Accessories, Class II |
| Product Code | EZL (Catheter, Retention Type, Balloon) |
| C) Predicate: | K090262 PercuCath™ Urinary Catheter (with lubricious coating) |
| K860484 Dover Foley Catheter |
D) Device Description:
్
The DirectVision® Catheter,-Uncoated is a flexible tubular device that is inserted through the urethra and used to pass fluids to and from the urinary tract. It is a 100% silicone, latex-free, triple lumen (3-Way) Foley catheter with a straight or angled council tip to facilitate insertion. The DirectVision® Catheter, Uncoated is composed of a silicone tube that trifurcates into three (3) lumens, a silicone balloon, and a two-way valve. Of the three lumens, one lumen is used for urinary drainage and can be connected to a urine collection container (drainage bag or urine meter); one lumen has a two-way valve for inflation/deflation of the Foley balloon; and the third lumen can be used for irrigation of the bladder. The council tip has an opening (eyelet) in the tip that can be used to pass a guidewire or similar device to facilitate catheter insertion. This catheter device will be available with a single or double drainage eyelet, 14 through 24 French shafts, and either a 10 cc or 30 cc balloon. The DirectVision® Catheter, Uncoated is designed to be usable with the PercuVision DirectVision™ Guide System (K091600). In the DirectVision™ Guide System, the DirectVision® Catheter, Uncoated provides a sheath around the microendoscope to facilitate its use. The catheter also incorporates a channel to be used for supplying irrigation to the microendoscope tip for clearing away debris from the field of view during use.
January 24, 2011
1
PercuVision DirectVision® Catheter, Uncoated Special 510(k) Premarket-Notification Submission
E) Intended Use:
- (
The DirectVision® Catheter, Uncoated is indicated for use in the drainage and/or collection and/or measurement of urine. It is intended to be used as a urological catheter inserted through the urethra for the purpose of draining urine and other fluids from the urinary tract. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as the nephrostomy tract.
F) Comparison to Predicate Device(s):
| | DirectVision®
Catheter,
Uncoated | PercuCath™
Urinary Catheter
(with lubricious
coating) | Dover Foley
Catheter |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| 510K Number | | K090262 | K860484 |
| Product code | EZL | EZL | KOD |
| Indication for
Use | For use in the
drainage and/or
collection and/or
measurement of
urine. | For use in the
drainage and/or
collection and/or
measurement of
urine. | For use in the
drainage and/or
collection and/or
measurement of
urine. |
| Intended Use | It is intended to be
used as a
urological catheter
inserted through
the urethra for the
purpose of
draining urine and
other fluids from
the urinary tract.
However, drainage
is sometimes
accomplished by
suprapubic or
other placement of
the catheter, such
as the
nephrostomy tract. | It is intended to be
used as a
urological catheter
inserted through
the urethra for the
purpose of
draining urine and
other fluids from
the urinary tract.
However, drainage
is sometimes
accomplished by
suprapubic or
other placement of
the catheter, such
as the
nephrostomy tract. | Not available |
| Design
Coating | Uncoated | Coated | Uncoated |
| Sterility | Supplied sterile | Supplied sterile | Supplied sterile |
| Biocompatible | Yes | Yes | Yes |
January 24, 2011
2
PercuVision DirectVision® Catheter, Uncoated Special 510(k) Premarket-Notification Submission
Substantial Equivalence Discussion
There is no change in Indication for Use or Intended use of the DirectVision® Catheter, Uncoated. The Direct Vision® Catheter, Uncoated is identical in all aspects to the Percu Vision PercuCath™ Catheter Urinary Catheter with lubricious coating, except for being uncoated. The DirectVision® Catheter, Uncoated is similar to the Dover Foley catheter, which also does not have a lubricious coating. Percu Vision does not believe that removal of the coating raises new issues of safety or effectiveness, and that the DirectVision® Catheter, Uncoated is substantially equivalent to the predicates in terms of materials, intended use, basic design concept and biomechanical properties.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming a wing-like shape above a staff with a snake coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60! Silver Spring, MD 20993-0002
PercuVision, LLC c/o F. David Rothkopf President MEDIcept, Inc. 200 Homer Avenue ASHLAND MA 01721
MAY 2 7 2011
Re: K110214
Trade/Device Name: DirectVision® Catheter, Uncoated Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: May 3, 2011 Received: May 4, 2011
Dear Mr. Rothkopf:
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 of medical device-related
4
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.
Sincerely yours,
Hubert Lehman MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
PercuVision DirectVision® Catheter; Uncoated Special 510(k) Premarket-Notification Submission
Indications for Use
14110214 510(k) Number (if known):
Device Name: DirectVision® Catheter, Uncoated
Indications for Use:
The DirectVision® Catheter, Uncoated is indicated for use in the drainage and/or collection and/or measurement of urine. :
Prescription Use _ 21CFR 801, Subpart D OR Over-the-Counter Use _ 21 CFR 876.1500
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
Hula Rume
ivision /Silan-Off n of Reproductive, Gastro-Renal, and logical Devices 10(k) Number