The proposed device is intended for use in the drainage of urine from the urinary bladder. The proposed as intended for intermittent catheterization on patients who are not capable of rne product is intonetion. This product is not designed for use as an indwelling catheter.

Device Description

The Tyco Healthcare/Kendall DOVER® RED RUBBER ROBINSON Catheter is a sterile, single use, intermittent urinary drainage catheter made from latex using dipping technology.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This 510(k) submission for the Tyco Healthcare/Kendall DOVER® RED RUBBER ROBINSON Catheter does not contain the kind of detailed information typically found in acceptance criteria and efficacy studies for more complex medical devices. This is a pre-amendment device, meaning it was legally marketed before May 28, 1976. This typically implies a different, less stringent review pathway focusing primarily on substantial equivalence to a predicate device rather than novel performance claims and extensive clinical studies.

Therefore, many of the requested categories will be "Not Applicable" or "Not Provided" based on the nature of this submission.

Acceptance Criteria and Device Performance

Based on the provided document, the "acceptance criteria" for this device are primarily tied to its substantial equivalence to an existing, legally marketed predicate device, and biocompatibility. There are no explicit performance metrics (e.g., success rate of urine drainage, specific flow rates, or duration of function) outlined as acceptance criteria with corresponding performance results.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Substantial Equivalence	Same intended use, function, and mode of operation as predicate device.	"The proposed DOVER® RED RUBBER ROBINSON Catheter is substantially equivalent to the predicate device in that each product has the same intended use and same physical, functional and performance characteristics. The proposed and predicate devices are made from the same materials and have the same design."
Biocompatibility	Meets requirements of ISO 10993-1 (with G95-1 modifications).	"Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1."
Sterility	Sterile (implied by "sterile, single use").	Stated as "sterile, single use". Specific sterility assurance levels or tests are not detailed in this summary.
Materials	Made from latex using dipping technology (same as predicate).	Stated as "made from latex using dipping technology" and "made from the same materials [as predicate]".
Design	Same design as predicate device.	"have the same design [as predicate device]".

Study Details (Based on available information)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided/Applicable. The submission focuses on substantial equivalence and non-clinical biocompatibility testing. There is no mention of a "test set" from a human factors or clinical performance perspective for this type of device. Biocompatibility testing involves material samples, not a patient test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No clinical "ground truth" or expert review of device performance on patients is described in this 510(k) summary for establishing a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As no clinical test set for performance is described, no adjudication method is relevant.

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-powered diagnostic tool. MRMC studies are not relevant here.

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)

For Substantial Equivalence: The "ground truth" is the predicate device itself, meaning its established characteristics, materials, and intended use as a legally marketed product.
For Biocompatibility: The "ground truth" is adherence to the ISO 10993-1 standard and FDA modifications, demonstrated through laboratory testing on materials.

8. The sample size for the training set

Not Applicable. No "training set" in the context of machine learning or clinical validation is described.

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

Not Applicable. As no training set is described, this question is not relevant.

Summary of Approach in the 510(k):

This 510(k) submission relies on demonstrating substantial equivalence to a previously legally marketed predicate device (the Tyco Healthcare/Kendall DOVER® RED RUBBER ROBINSON Catheter, which was marketed pre-1976). This means the core "study" is a comparison:

Intended Use: Identical.
Technological Characteristics: Identical (materials, design, function, mode of operation).

The only specific "testing" mentioned is biocompatibility testing to confirm the safety of the materials in contact with the body, aligning with recognized international standards (ISO 10993-1) as modified by FDA guidance (G95-1).

There are no performance studies against specific clinical endpoints or comparison against human performance because the device is a simple, well-understood urological catheter and the regulatory pathway allows for reliance on substantial equivalence to a pre-amendment device.

Summary

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K0412B

Kuy Lopez

JUL - 7 2004 510(k) Summary

In accordance with section 513(I) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:

Tyco Healthcare/Kendall 15 Hampshire Street Mansfield, MA 02048 Date Prepared: May 6, 2004

1. Contact Person

Wei Zhao Senior Specialist, Regulatory Affairs Tvco Healthcare/Kendall Telephone: (508) 261-8404 Fax: (508)261-8461

2. Name of Medical Device

Classification Name: Common or Usual Name: Urological catheter and accessories Urinary Drainage Catheter

3. Identification of Legally Marketed Device

The proposed Tyco Healthcare/Kendall DOVER® RED RUBBER ROBINSON Catheter is substantially equivalent in intended use, function and mode of operation to the Tyco Healthcare/Kendall DOVER® RED RUBBER ROBINSON Catheter, which is legally marketed prior to May 28, 1976.

4. Device Description

The Tyco Healthcare/Kendall DOVER® RED RUBBER ROBINSON Catheter is a sterile, single use, intermittent urinary drainage catheter made from latex using dipping technology.

5. Device Intended Use

The product is intended for intermittent catheterization to drain urine from the urinary bladder. The product is intended for use on patients who are not capable of voluntary urination.

6. Product Comparison

The proposed DOVER® RED RUBBER ROBINSON Catheter is substantially equivalent to the predicate device in that each product has the same intended use and same physical,

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functional and performance characteristics. The proposed and predicate devices are made from the same materials and have the same design.

7. Nonclinical Testing

Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.

End of Document

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing-like shapes and a wavy line at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2004

Ms. Wei Zhao Senior Specialist, Regulatory Affairs Tyco Healthcare The Kendall Company 15 Hampshire Street MANSFIELD MA 02048

Re: K041243

K041243
Trade/Device Name: Tyco Healthcare/Kendall DOVER® RED RUBBER ROBINSON Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 KOD Dated: June 22, 2004 Received: June 23, 2004

Dear Ms. Zhao:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaon 9 ro(t) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard) names the Medical Device Amendments, or to connieres prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been rockssined in avere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mance af the Act include requirements for annual registration, listing of general Controls provisions of the rest 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 your device is classified (500 a0070) ... Existing major regulations affecting your device can be it may be subjoct to adultions, 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 I Toase of actived that I Dr o assumithat your device complies with other requirements of the Act that I Dri has made a asid regulations administered by other Federal agencies. You must of any I ederal blatates and registements, including, but not limited to: registration and listing comply with an the rior requirements, a 801); good manufacturing practice requirements as set (21 CFR Part 007), laboring (27 cegulation (21 CFR Part 820); and if applicable, the clectronic forth in the quality byticles (QS) regions 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to ocgli marketing of substantial equivalence of your device to a legally premarket nothication. The PDA hidding of backlined 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 Park 801), please If you desire specific advice for your device on our car and of 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, 101 questions on the promote on a ...
Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Othice of Compliance at (501) 597-10597. The Part 807.97) you may obtain. Other general by reference to premation (21 or extrained the Act may be obtained from the Division of Strall information on your responsionalities and Consumer Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-frien Manufacturers, International and Consumior Passession of Schoolson of Schildsmaldsmamain.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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Indication for Use Statement

Ko41243 510(k) Number (if known):

Device Name:

Tyco Healthcare/Kendall DOVER® RED RUBBER ROBINSON Catheter

Indications for Use:

Please DO NOT Write Below This Line – Continue On Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ X ___ OR OVER-The -Counter Use _____ (Per 21 CFR 801.109)

Nancy C Brogdon

(Division Sign Division of Reproducti va Akda and Radiological I 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.