Hydrophilic-Antibacterial Intermittent Catheter is intended for urological use only. The Hydrophilic-Antibacterial Intermittent Catheter is intended for urinary bladder drainage in the management of incontinence, neurogenic bladder dysfunction, and surgical procedures in adult males and females requiring catheterization. Efficacy of the Hydrophilic-Antibacterial Intermittent Catheter in preventing urinary tract infection during intermittent use has not been shown. It is not intended as a treatment for active urinary tract infection.

Intermittent Catheter Closed System Kit is intended for use by patients for the purpose of bladder drainage.

Device Description

The Hydrophilic-Antibacterial Intermittent Catheter consists of a hydrophilic and antibacterial coated single lumen catheter with either two or four drainage eyes on the proximal tip. It is constructed from medical grade elastomers.

The Intermittent Catheter Closed System Kit consists of a single lumen urethral catheter (Hydrophilic-Antibacterial Intermittent Catheter, Hydrophilic Personal® Catheter K000723, or Antibacterial Personal® Catheter K001143) in a closed system-in-a-bag configuration with an introducer tip and insertion supplies.

AI/ML Overview

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Acceptance Criteria and Study for Rochester Medical Corporation's Urological Catheter and Accessories

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily through showing similar technological and performance characteristics, and biocompatibility testing. It doesn't present specific quantitative acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, accuracy for a diagnostic device) or provide a study demonstrating a direct comparison against such criteria for the Hydrophilic-Antibacterial Intermittent Catheter or the Intermittent Catheter Closed System Kit.

Instead, the "acceptance criteria" can be inferred from the regulatory pathway: proving substantial equivalence through comparison with existing legally marketed devices and demonstrating that the new device does not raise new questions of safety or effectiveness. The "study" in this context refers to the biocompatibility testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from 510(k) Process)	Reported Device Performance (Summary of Biocompatibility Testing)
Biocompatibility: Device materials must not cause adverse biological reactions. This broadly includes:	Cytotoxicity Study (ISO Elution Method): Test extracts showed a cytotoxic effect. Conclusion: Acceptable because the antibacterial agent is topically applied, acts locally, and is exposed to the bladder's mucous membrane in small doses.
- Lack of significant cytotoxicity	ISO Intracutaneous Study (Saline and Sesame Oil Extracts): No evidence of significant irritation.
- Lack of significant irritation (skin/tissue)	USP and ISO Systemic Toxicity Study (Saline and Sesame Oil Extracts): No mortality or evidence of systemic toxicity.
- Lack of systemic toxicity	ISO Sensitization Test (Guinea Pigs - Maximization Method): No evidence of delayed dermal contact sensitization.
- Lack of sensitization	Urinary Bladder Irritation Study with Histopathology: Considered to be a non-irritant to the urinary bladder.
- Non-irritant to urinary bladder	ISO Muscle Implantation Study - 4 Week with Histopathology: Macroscopic reaction not significant compared to negative control. Microscopically classified as a slight irritant compared to negative control.
Technological and Performance Equivalence: Device should have similar characteristics to predicate devices.	The catheters described in the 510(k) have similar technological and performance characteristics to many predicate devices. They are constructed from the same materials as the predicate devices, use similar manufacturing methods, and have a hydrophilic and antibacterial coating. Supplied in the same sizes (12 to 18 French, male and female lengths) as the Antibacterial Personal® Catheter. The Closed System Kit is substantially equivalent to specified predicate kits.

2. Sample Size Used for the Test Set and Data Provenance

Biocompatibility Testing: The document provides details on the methods used for biocompatibility testing but does not specify the sample sizes for each test (e.g., how many cells for cytotoxicity, how many animals for in-vivo tests).
Data Provenance: The biocompatibility tests are laboratory-based, performed by Rochester Medical Corporation. The document does not indicate country of origin for patients or animals, nor does it classify the data as retrospective or prospective clinical data, as this is pre-market testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this 510(k) submission. Biocompatibility testing relies on standardized laboratory protocols (e.g., ISO and USP standards) rather than expert interpretation of clinical ground truth in the way a diagnostic device might require. The "ground truth" for these tests is the outcome of the biological assay itself based on predefined criteria (e.g., cell viability, presence of irritation, mortality).

4. Adjudication Method for the Test Set

This is not applicable. The biocompatibility tests follow standardized, objective laboratory methods. There is no mention of a human adjudication process for interpreting these test outcomes beyond the standard analysis and reporting by the testing personnel.

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

No, an MRMC comparative effectiveness study was not done. This device is a urological catheter, not a diagnostic imaging device typically associated with AI assistance or human reader studies.

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

No, a standalone algorithm performance study was not done. This device is a medical product (catheter), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's safety (biocompatibility) and performance (similarity to predicates) relies on:

Standardized Laboratory Protocols and Results: For biocompatibility, the truth is established by the factual biological outcomes of in-vitro and in-vivo tests as per ISO and USP standards.
Engineering and Material Specifications: For technological equivalence, the ground truth is established by comparing the physical, material, and design specifications of the new device against those of legally marketed predicate devices.

8. The Sample Size for the Training Set

There is no mention of a training set in this context. Training sets are relevant for machine learning algorithms or complex diagnostics, not for the submission of a physical medical device like a catheter seeking 510(k) clearance based on substantial equivalence and biocompatibility.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set mentioned or implied in the provided document.

Summary

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JUN 1 0 2004

Image /page/0/Picture/1 description: The image shows the logo for Rochester Medical. The logo features a stylized checkmark above the word "Rochester" in a bold, italicized font. Below "Rochester" is the word "MEDICAL" in smaller, block letters. The logo is black and white.

14.0 510(k) SUMMARY

This summary of safety and effectiveness information is being submitted in accordance with the f
or and effective and as a CDP 907 02 I ills summary of carses of SMDA 1990 and 21 CFR 807.92.

Submitter and Contact Person:	Robert AnglinRochester Medical Corporation
Name of the Device:	Urological Catheter and Accessories
Classification Name:	Hydrophilic-Antibacterial Intermittent Cathete
Proprietary Name:	Intermittent Catheter Closed System Kit

Predicate Devices:

Predicate Devices.
Rochester Medical Antibacterial Personal®Catheter K001143
143 Rochester Medical Antibacterial Personal® Catheter K000722 Rochester Medical Hydrophilic Personal® Catheter K000723 Mentor Self-Cath Closed System K003873 Hollister InCare Advance Plus Kit K013483 Rusch MMG/O'Neil Catheter K010420

Intended Use of the Device

Hydrophilic-Antibacterial Intermittent Catheter

Hydrophilic-Antibacterial Intermittent Catheter is internittent Catheter is intended for actual For urological use only. The Hydrophility of increations and increating overlung dysfunction males and temales requiring cannelerization for maining militarerial Intermittent Catheter in and surgical procedures. Efficacy of the Trydropinne Printent use has not been shown. It is not intended as a treatment for active urinary tract infection.

Intermittent Catheter Closed System Kit

Intermittent Closed System Kit is intended for use by patients for use by patients for the purpose of bladder drainage.

Device Description

The Hydrophilic-Antibacterial Intermittent Catheter consists of a hydrophilic and antibacterial I he Hydrophilic-Antibacterial internities canfour drainage eyes on the proximal tip. It is
coated single lumen catheter with either two or four drainers of 8 coated single fumen cathers.

The Intermittent Catheter Closed System Kit consists of a single lumen urethral catheter I he intermittent Catherer Closed Dystem ren contral® Catheter K000723, Hydrophilic
(Hydrophilic-Antibacterial Intermittent catheter, Personal)® Catheter K001142) in a closed (Hydrophilic-Antibacterial internation catherer (1 Catheter K001 143) in a closed system Personal® Catheter K000723, of Antibacterial Fersonal - Gatherer-in-a-bag configuration with an introducer tip and insertion supplies.

Rochester Medical Corporation Rochester Medical Corporation
Hydrophilic-Antibacterial Intermittent Catheter and Intermittent Catheter Closed System Kit 510 (k) Notification

Page 11 of 12

Rochester Medical Drive

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Image /page/1/Picture/0 description: The image shows the logo for Rochester Medical. The logo is black and white and features the word "Rochester" in a bold, sans-serif font. Below the word "Rochester" is the word "MEDICAL" in a smaller, sans-serif font. Above the word "Rochester" is a curved line.

The catheters described in the 510(k) have similar technological and performance characteristics to
ries of the many of the collection (Artibostorial Personal) Catheter K0011 The cathers described in the STORT have simmal teesonal" Catheter K001143 and the Rochester Medical orand devices are need in the catheres are manufactured using similar.
Hydrophilic Personal® Catheter K000723). All of the catatomers and have a hydrop Hydrophilic Personal " Catheter K00072-3). An other elastomers and have a hydrophilie and processes. The cathere's are constructed from smeene same materials as the predicate antibacterial coating. The device are thanhactures as the Antibaterial Personal® Catheter, 12 to
devices. The catheters are supplied in the same sizes as the Antibation of Ca devices. The catheters are supplied in the same in the Prosed System Kit is substantially
18 French male and female lengths. The International Closed System Kit 18 French male and female lengths. The Intentified Costem, Hollister InCare Advance Plus Kit,
equivalent to the predicate Mentor Self-Cli-Characa are appliae sterile for sing equivalent to the predicate Mentor Sell-Cather, Second, Section, Section of Single use.
and the Rusch MMG/O'Neil Catheter. All of the devices are supplied sterile for single

Testing and Results

The following is a summary of biocompatibility testing that Rochester Medical Corporation has The following is a summary of blocompatibility testing that seems on the Intermittent Catheter Closed System Kit:

Test	Conclusion
Cytotoxicity Study using the ISO ElutionMethod	*Test extracts showed a cytotoxic effect. Theantibacterial agent is a known mutagen and isknown to be cytotoxic.
ISO Intracutaneous Study (Saline and SesameOil Extracts)	No evidence of significant irritation.
USP and ISO Systemic Toxicity Study (Salineand Sesame Oil Extracts)	No mortality or evidence of systemic toxicity.
ISO Sensitization Test in Fifteen Guinea Pigs –Maximization Method (Saline and Sesame OilExtract)	No evidence of delayed dermal contactsensitization.
Urinary Bladder Irritation Study withHistopathology	Considered to be a non irritant to the urinarybladder.
ISO Muscle Implantation Study -4 Week withHistopathology	The macroscopic reaction was not significantas compared to the negative control material.Microscopically classified as a slight irritant ascompared to the negative control article.

We conclude that this result is acceptable in the intended clinical application because the drug
e *We conclude that this result is acceptable in the meet o intract upply an in small doses (total of
substance is topically applied and acts local complements be grown of the substance is topically applied and acts locally, is exposed to mast and and and and through the mucous membrane of the urethra.

Rochester Medical Corporation Rochester Medical Corporation
Hydrophilic-Antibacterial Intermittent Catheter and Intermittent Catheter Closed System Kit 510 (k) Notification

Page 12 of 12

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JUN 1 0 2004

Mr. Richard Fryar VP, Research & Development Rochester® Medical One Rochester Medical Drive STEWARTVILLE MN 55976

Re: K033477

Rosser /
Trade/Device Name: Hydrophilic-Antibacterial Intermittent Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 MJC Dated: May 20, 2004 Received: May 24, 2004

Dear Mr. Fryar:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) the acted predicate devices marketed in interstate for use stated in the encrosule, to regally manated problem to the Medical Device Ameralments, or to commerce prior to May 28, 1976, and enacting with the provisions of the Federal Food, Drug, devices that have been recassince in accordance what a premarket approval application (PMA).).). and Cosment Act (Act) that to not require sppro the general controls provisions of the Act. The You may, therefore, market me devices, saojeen to the more of registration, listing of general controls provisions of the free here and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classifica (sec above) into etime major regulations affecting your device can be it may be subject to adultional controls. Entraling may of the 21, Parts 800 to 898. In addition, FDA may found in the Code of reactar regularing your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuates of a subscribes with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA has made a decemmanon and Journer Federal agencies. You must of any Federal Statues and regulations amminents, but not limited to: registration and listing comply with an the Act STequilements, metading on manufacturing practice requirements as set (21 CFR Part 807), fabening (21 CFR Part 820); and 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 81 CFR 1980 1960 forth in the quality systems (QS) regulation (ST-542 of the Act); 21 CFR 1000-1050.
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 Section 510(k) This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA inding of substantial oquivalence and th premarket notification. The FDA inding of substantial of the more of this, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (2) CFR Part 801), please
r in the regulation of the following suggest of a following suggless, based If you desire specific advice for your device on our labouring organized 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 Additionally, for questions on the promotion and and the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, please note obtain. Other general Office of Compliance at (301) 594-4057. Associated on any obtain. Other general
by reference to premarket notification" (21CFR Part 807.97) you may obtain of Sma by reference to premarket notification (21C) 1 Friend 60 mg good from the Division of Small
information on your responsibilities under the Act its toll from the United (800) information on your responsibilities much as its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free number (800). Manufacturers, International and Collsumer Assistance a to too.
(301) 443-6597 or at its Internet address http://www.fda.gov/odch/dsmaldsmamain.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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K033477 510(k) NUMBER (if Known):

Hydrophilic-Antibacterial Intermittent Catheter DEVICE NAME:

INDICATIONS FOR USE:

Urethral catheter for urological use only. The Rochester Medical Corporation Urentral calleter for urbrogream aso only. This as intended for urinary bladder drainage Hydropmit-Antibacterial internation on their in the management of incontinence, in adult males and remails requiring cather.com.com of the Hydrophilic-Antibacterial volume dystunction, and surgear prooocal to: 1 infection during intermittent use has not Intermittent Catherer in prevening armaly traot micented as a treatment for active urinary tract infection.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) ( . . . . . . Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________ Prescription Use _ X OR

(Per 21 CFR 801.109)

David br. hegeman
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number

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K033477 510(k) NUMBER (if Known):

Intermittent Catheter Closed System Kit DEVICE NAME:

INDICATIONS FOR USE:

For urological use only. The Intermittent Catheter Closed System Kit is intended for use by patients for the purpose of bladder drainage.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

Daniel R. Lagemann

(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(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.