The Conveen® EasiCath Set is a single use, disposable system that consists of a sterile polyvinylchloride intermittent catheter, coated with polyvinvlovrrolidone, and a sterile saline solution ampoule all sealed in a urine collection bag. The user twists open the saline ampoule inside the bag and soaks the catheter for 30 seconds. Once wet, the polyvinylpyrrolidone layer binds water molecules to the surface of the catheter creating a smooth lubricating film. The bag is opened and the catheter is inserted into the patent's urethra. The catheter itself is the same design and materials as our current non-coated Conveen® Intermittent Catheters, K896729.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Conveen® EasiCath Set, derived from the provided 510(k) summary:

This device appears to be primarily a catheter system and the "acceptance criteria" and "studies" are focused on biocompatibility and safety of its components, rather than a performance study measuring clinical outcomes or diagnostic accuracy which would typically involve human readers or ground truth as seen in AI/imaging devices.

Therefore, many of the requested fields regarding AI/human reader performance, ground truth establishment, and sample sizes for training/test sets are not applicable to this type of device and its submission.

Acceptance Criteria and Reported Device Performance

Test/Criteria	Acceptance Criteria (Implied by USB XXII Requirements)	Reported Device Performance
Intracutaneous Test	No significant difference in skin reaction between extract and control solutions.	Conclusion: "No difference in skin reaction was observed at the injection sites of the extracts or the control solutions. Passed the Intracutaneous Test according to USP XXII requirements."
Systemic Injection Test	No signs of toxicity in treated animals compared to controls.	Conclusion: "No signs of toxicity were observed in the mice treated with the extract or the control solution. Passed the Systemic Injection Test according to USP XXII requirements."
Mutagenicity Ames Test	No increase in the number of revertants compared to controls, indicating no mutagenic activity.	Conclusion: "The extracts induced no increase in the number of revertants as compared to the controls. Thus, no detectable mutagenic activity was found of the extracts in the Ames test."
Sensitization Guinea Pig Maximization Test	No evidence of delayed contact hypersensitivity.	Conclusion: "No evidence of delayed contact hypersensitivity was seen after treatment with the extract or the control solution."
Cytotoxicity Elution Test (L 929 cells)	Cytotoxicity grade < 2.	Conclusion: "Passed the Elution Test according to USP XXII requirements (cytotoxicity grade < 2)"

Study Details

Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated in terms of number of subjects or samples. The tests described (Intracutaneous, Systemic Injection, Ames, Guinea Pig Maximization, Cytotoxicity) are laboratory-based biocompatibility tests that use standardized biological models (e.g., mice for systemic injection, guinea pigs for sensitization, L 929 cells for cytotoxicity, bacterial strains for Ames test).
- Data provenance: Not specified in terms of country of origin. The tests are laboratory studies following recognized standards (USP XXII).
- Retrospective or prospective: N/A (laboratory biocompatibility testing).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. The "ground truth" for these tests is defined by the objective results of the standardized biological assays as interpreted by the test protocols, not by expert consensus in a clinical sense.
Adjudication method for the test set: N/A. The results of these laboratory tests are typically determined by protocol-driven observations and measurements, not by expert adjudication.
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: N/A. This is not an AI/imaging device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A. This is not an AI algorithm.
The type of ground truth used: The "ground truth" here is based on the biological response observed in standardized biocompatibility assays according to USP XXII requirements (e.g., absence of toxicity, absence of mutagenicity, absence of sensitization, low cytotoxicity).
The sample size for the training set: N/A. This is not an AI device that requires a training set. The "training" for such devices involves ensuring the manufacturing process consistently produces safe materials.
How the ground truth for the training set was established: N/A.

Summary

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510(k) Summary Conveen® EasiCath Set

K973076
144

NOV - 6 1997

Coloplast Corporation 1955 West Oak Circle Marietta, Georgia 30062-2249 Date: August 15, 1997

1. Contact Person

Ms. Sydney Lilly, (770) 426-6362

2. Name of the Medical Device

Classification name: Common/usual name: Proprietary name:

Urological catheter and accessories Intermittent Catheter Conveen® EasiCath Set

3. Device Classification

The Conveen® EasiCath Set has been classified by the FDA under the heading of Urological catheter and accessories as a Class II device.

4. Statement of Substantial Equivalence

The Conveen® EasiCath Set is substantially equivalent to the O'Neil Urinary Catheterization System™ manufactured by Medical Marketing Group, Inc. K910022.

5. Intended Use

The Conveen® EasiCath Set is indicated for use by patients for intermittent catheterization for the purpose of bladder drainage.

6. Description of Device

The Conveen® EasiCath Set is a single use, disposable system that consists of a sterile polyviny|chloride intermittent catheter, coated with polyvinvlovrrolidone, and a sterile saline solution ampoule all sealed in a urine collection bag. The user twists open the saline ampoule inside the bag and soaks the catheter for 30 seconds. Once wet, the polyvinylpyrrolidone layer binds water molecules to the surface of the catheter creating a smooth lubricating film. The bag is opened and the catheter is inserted into the patent's urethra. The catheter itself is the same design and materials as our current non-coated Conveen® Intermittent Catheters, K896729.

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510(k) Summary Conveen® EasiCath Set

A comparison Matrix for the EasiCath Set versus the Medical Marketing Group, Inc. O'Neil Urinary Catheterization System™ is presented below.

	Conveen® EasiCath Set	Medical Marketing Group, Inc.O'Neil Urinary CatheterizationSystem™
510(k) Number		K910022
Devicecomposition	Polyvinylchloride cathetercoated withpolyvinylpyrrolidone, andsterile saline solutionsealed in a urine collectionbag.	Polyvinylchloride cathetercoated with silicone sealed ina urine collection bag.
Sizes	Female Straight Ch. 8, 10,12, & 14.Nelaton Ch. 8,10, 12, 14,16, & 18.Pediatric Ch. 6, 8, & 10.	Female Straight - Sizes 6,8,10, 12, 14, & 16 FR.
Function ofdevice	Inserted into urethrathrough urinary tract tillcatheter reaches bladderand allows urine to drain.	Inserted into urethra throughurinary tract till catheterreaches bladder and allowsurine to drain.
Indication foruse	For intermittentcatheterization for thepurpose of bladderdrainage.	For intermittent catheterizationfor the purpose of bladderdrainage.
Features ofdevice	Coated catheter andsaline ampoule sealed inurine collection bag.	Silicone coated cathetersealed in urine collection bagwith silicone applicator tip. Kitincludes povidone iodineswabs, gloves, underpad andtissue.
Sterilization	Sterile	Sterile
Packaging	Peel Pack	Peel Pack

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510(k) Summary Conveen® EasiCath Set

Summary of Safety Testing 7.

A summary of the safety testing performed on the final sterile PVP coated catheter is listed below:

Test	Conclusion
IntracutaneousTest	No difference in skin reaction was observed at theinjection sites of the extracts or the control solutions.Passed the Intracutaneous Test according to USP XXIIrequirements.
Systemic InjectionTest	No signs of toxicity were observed in the mice treatedwith the extract or the control solution. Passed theSystemic Injection Test according to USP XXIIrequirements
Mutagenicity AmesTest	The extracts induced no increase in the number ofrevertants as compared to the controls. Thus, nodetectable mutagenic activity was found of the extractsin the Ames test.
SensitizationGuinea PigMaximization Test	No evidence of delayed contact hypersensitivity wasseen after treatment with the extract or the controlsolution.
Cytotoxicity elutionTest (L 929 cells)	Passed the Elution Test according to USP XXIIrequirements (cytotoxicity grade < 2)

Polyvinylpyrrolidone is used in a number of medical devices that are commercially available in the U.S. Including Neurointerventional and Gastro-enteral Guidewires, Enteral Feeding Tubes, Urinary Stents, and Cannula for port access heart procedures.

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510(k) Summary

Conveen® EasiCath Set

Elgure T

EasiCath Set Descriptive Drawings:

Conveen EasiCath Sol

Image /page/3/Picture/4 description: The image shows a drawing of a device that appears to be a type of scientific instrument or tool. It has a long, slender neck with a loop at the top, which widens into a bulbous body. Inside the body, there is a small bottle-like object, and the device is supported by a circular base with small rollers or supports at the bottom.

Image /page/3/Picture/8 description: This image shows a diagram of a person using a dropper to put liquid into a tube. The tube is inside of a larger container. The number 2 is in the upper left corner of the image. The text "MIN. 30 SEC." is in the lower right corner of the image.

・・

Image /page/3/Picture/9 description: This image is a black and white drawing of a hand pruning a plant. The hand is holding a pair of pruning shears and is cutting a stem off of the plant. The plant has several leaves and stems. The number 3 is in the upper left corner of the image.

Image /page/3/Picture/10 description: This image contains two separate figures. The figure on the left shows a pair of hands holding a group of sticks over a triangular object. The figure on the right has the number 5 in the upper left corner and a curved line in the center.

Image /page/3/Picture/11 description: In this image, a hand is shown tying a knot in a bag. The bag appears to be filled with a dark liquid. The number 5 is in the upper left corner of the image. The image is a black and white drawing.

Image /page/3/Picture/12 description: This image shows a black and white drawing of two hands squeezing a dark, undefined substance. The substance is dripping from the hands into a container below. The number 6 is in the upper left corner of the image.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 6 1997

Ms. Sydney Lilly Quality Assurance & Regulatory Affairs Manager Coloplast Corporation 1955 West Oak Circle Marietta, Georgia 30062-2249

Re: K973070 Conveen® EasiCath Set Dated: August 15, 1997 Received: August 18, 1997 Regulatory class: II 21 CFR 8876.5130/Product code: 78 EZD 21 CFR §876.5250/Product code: 78 KNX

Dear Ms. Lilly:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranion.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify 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 Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your 100(k) premarket notification. The FDA finding of substantial equivalence of your device 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 labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, 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 general information on your responsibilities under the Act may be obtained from 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/dsmamain.html".

Sincerely yours.

William Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_K973070

Device Name: Conveen® EasiCath Set

Indications For Use:

The Conveen® EasiCath Set is indicated for use by patients for intermittent catheterization for the purpose of bladder drainage.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert P. Sithong

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1973070 510(k) Number J

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter Use

(Optional Format 1-2-96)

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.