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.

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.

AI/ML Overview

The provided text is a 510(k) premarket notification for the PercuVision DirectVision® Catheter, Uncoated. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive de novo clinical study data with detailed acceptance criteria and performance metrics.

Therefore, the document does not contain the requested information regarding:

A table of acceptance criteria and reported device performance.
Sample size and data provenance for a test set.
Number and qualifications of experts for ground truth establishment.
Adjudication method for a test set.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
Standalone algorithm performance data.
Type of ground truth used (e.g., pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

Instead, the document highlights the device's substantial equivalence to predicate devices, focusing on design, intended use, and materials.

Here's what can be extracted from the document:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't define specific quantitative performance acceptance criteria in the context of a clinical study. Instead, the "acceptance" for this 510(k) relies on demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" is implicitly that it functions similarly to the predicate devices and does not raise new questions of safety or effectiveness.

The core of the "study" is a comparison to predicate devices as detailed in the "Comparison to Predicate Device(s)" table and the "Substantial Equivalence Discussion."

Feature/Criterion	DirectVision® Catheter, Uncoated (Proposed Device)	PercuCath™ Urinary Catheter (Predicate 1)	Dover Foley Catheter (Predicate 2)	Substantial Equivalence Claim
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.	Identical to Predicate 1, Identical to Predicate 2.
Intended Use	Urological catheter inserted through the urethra for draining urine and other fluids (also suprapubic/nephrostomy tract placement).	Urological catheter inserted through the urethra for draining urine and other fluids (also suprapubic/nephrostomy tract placement).	Not available (but implicit in "Indication for Use")	Identical to Predicate 1.
Design: Coating	Uncoated	Coated	Uncoated	Different from Predicate 1 (uncoated vs. coated), Similar to Predicate 2 (both uncoated). The submission argues this difference does not raise new safety/effectiveness issues.
Sterility	Supplied sterile	Supplied sterile	Supplied sterile	Identical to both predicates.
Biocompatible	Yes	Yes	Yes	Identical to both predicates.
Basic Design Concept	Same as predicates	Same as predicates	Same as predicates	Substantially equivalent.
Biomechanical Properties	Same as predicates	Same as predicates	Same as predicates	Substantially equivalent.
Materials	Silicone (100% silicone, latex-free)	Not explicitly detailed in the table but indicated as similar in the discussion.	Not explicitly detailed in the table but indicated as similar in the discussion.	Substantially equivalent to predicates.

2. Sample size used for the test set and the data provenance:

Not applicable. This submission does not describe a clinical "test set" in the context of device performance evaluation with a ground truth, as it is a special 510(k) based on substantial equivalence. It likely relies on non-clinical (e.g., bench) testing to demonstrate material properties and functionality are comparable to the uncoated predicate, but this is not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical test set with expert-established ground truth is described.

4. Adjudication method for the test set:

Not applicable. No clinical test set demanding adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a urological catheter, not an AI-driven diagnostic system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this 510(k) is the established safety and effectiveness profile of the predicate devices. The applicant is demonstrating that the new device, despite being uncoated (unlike one predicate), is fundamentally similar enough not to introduce new safety or effectiveness concerns. This is based on the history of the predicate devices and any non-clinical testing performed (which details are not provided in this summary).

8. The sample size for the training set:

Not applicable. This submission does not involve an algorithm with a training set.

9. How the ground truth for the training set was established:

Not applicable. This submission does not involve an algorithm with a training set.

Summary

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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:

్

January 24, 2011

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PercuVision DirectVision® Catheter, Uncoated Special 510(k) Premarket-Notification Submission

E) Intended Use:

(

F) Comparison to Predicate Device(s):

	DirectVision®Catheter,Uncoated	PercuCath™Urinary Catheter(with lubriciouscoating)	Dover FoleyCatheter
510K Number		K090262	K860484
Product code	EZL	EZL	KOD
Indication forUse	For use in thedrainage and/orcollection and/ormeasurement ofurine.	For use in thedrainage and/orcollection and/ormeasurement ofurine.	For use in thedrainage and/orcollection and/ormeasurement ofurine.
Intended Use	It is intended to beused as aurological catheterinserted throughthe urethra for thepurpose ofdraining urine andother fluids fromthe urinary tract.However, drainageis sometimesaccomplished bysuprapubic orother placement ofthe catheter, suchas thenephrostomy tract.	It is intended to beused as aurological catheterinserted throughthe urethra for thepurpose ofdraining urine andother fluids fromthe urinary tract.However, drainageis sometimesaccomplished bysuprapubic orother placement ofthe catheter, suchas thenephrostomy tract.	Not available
DesignCoating	Uncoated	Coated	Uncoated
Sterility	Supplied sterile	Supplied sterile	Supplied sterile
Biocompatible	Yes	Yes	Yes

January 24, 2011

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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.

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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

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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

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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

Regulation Number and Section

§ 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.