CONVEEN EASICATH SET

K973070 · Coloplast Corp. · EZD · Nov 6, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K973070
• Device Name: CONVEEN EASICATH SET
• Applicant: Coloplast Corp.
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Nov 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

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

Device Story

Conveen® EasiCath Set is a single-use, disposable intermittent catheter system. Input: sterile saline solution ampoule and polyvinylchloride (PVC) catheter coated with polyvinylpyrrolidone (PVP), all contained within a urine collection bag. Operation: user activates saline ampoule to soak catheter for 30 seconds; PVP coating binds water to create a lubricating film; catheter is inserted into the urethra to reach the bladder for urine drainage. Used in clinical or home settings by patients or caregivers. Output: bladder drainage into the collection bag. Benefits: provides a pre-lubricated, sterile system for intermittent catheterization, reducing friction during insertion.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per USP XXII requirements: Intracutaneous test, Systemic Injection test, Mutagenicity Ames test, Sensitization Guinea Pig Maximization test, and Cytotoxicity elution test (L 929 cells). All tests passed with no evidence of toxicity, mutagenicity, sensitization, or skin reaction.

Technological Characteristics

Polyvinylchloride (PVC) catheter coated with polyvinylpyrrolidone (PVP); sterile saline ampoule; urine collection bag. Dimensions vary by size (Female, Nelaton, Pediatric). Sterilization: Sterile. No software or electronic components.

Indications for Use

Indicated for patients requiring intermittent catheterization for bladder drainage.

Regulatory Classification

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).

Predicate Devices

• O'Neil Urinary Catheterization System™ (K910022)

Reference Devices

• Conveen® Intermittent Catheters (K896729)

Submission Summary (Full Text)

{0}------------------------------------------------

# 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, [phone]

## 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.

{1}------------------------------------------------

.
1-

:

# 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.<br>O'Neil Urinary Catheterization<br>System™ |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K910022 |
| Device<br>composition | Polyvinylchloride catheter<br>coated with<br>polyvinylpyrrolidone, and<br>sterile saline solution<br>sealed in a urine collection<br>bag. | Polyvinylchloride catheter<br>coated with silicone sealed in<br>a urine collection bag. |
| Sizes | Female Straight Ch. 8, 10,<br>12, & 14.<br>Nelaton Ch. 8,10, 12, 14,<br>16, & 18.<br>Pediatric Ch. 6, 8, & 10. | Female Straight - Sizes 6,<br>8,10, 12, 14, & 16 FR. |
| Function of<br>device | Inserted into urethra<br>through urinary tract till<br>catheter reaches bladder<br>and allows urine to drain. | Inserted into urethra through<br>urinary tract till catheter<br>reaches bladder and allows<br>urine to drain. |
| Indication for<br>use | For intermittent<br>catheterization for the<br>purpose of bladder<br>drainage. | For intermittent catheterization<br>for the purpose of bladder<br>drainage. |
| Features of<br>device | Coated catheter and<br>saline ampoule sealed in<br>urine collection bag. | Silicone coated catheter<br>sealed in urine collection bag<br>with silicone applicator tip. Kit<br>includes povidone iodine<br>swabs, gloves, underpad and<br>tissue. |
| Sterilization | Sterile | Sterile |
| Packaging | Peel Pack | Peel Pack |

・

・.

{2}------------------------------------------------

## 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 |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intracutaneous<br>Test | No difference in skin reaction was observed at the<br>injection sites of the extracts or the control solutions.<br>Passed the Intracutaneous Test according to USP XXII<br>requirements. |
| Systemic Injection<br>Test | No signs of toxicity were observed in the mice treated<br>with the extract or the control solution. Passed the<br>Systemic Injection Test according to USP XXII<br>requirements |
| Mutagenicity Ames<br>Test | The extracts induced no increase in the number of<br>revertants as compared to the controls. Thus, no<br>detectable mutagenic activity was found of the extracts<br>in the Ames test. |
| Sensitization<br>Guinea Pig<br>Maximization Test | No evidence of delayed contact hypersensitivity was<br>seen after treatment with the extract or the control<br>solution. |
| Cytotoxicity elution<br>Test (L 929 cells) | Passed the Elution Test according to USP XXII<br>requirements (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.

।

: 上

and the comments of the comments of the count

이 그 사용 사용 등 100

:

: :

......

::

.

1 1 : 1 :

1. 4. 11. 11. 11.

: '

: :

{3}------------------------------------------------

# 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.

.

:

2

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.

4

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.

{4}------------------------------------------------

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

{5}------------------------------------------------

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.

.....

(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

OR

**Prescription Use**
(Per 21 CFR 801.109) ✓

Over-The-Counter Use

(Optional Format 1-2-96)