K Number

Device Name

Manufacturer

GOULTER MEDICAL, INC.

Date Cleared

1997-08-11

(293 days)

Product Code

EYZ,78E

Regulation Number

876.5250

Type

Traditional

Panel

Gastroenterology/Urology

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

For Penile Attachment Only
Non-indwelling Urinary Continence Aid
Management of Urinary Incontinence
Urine Collection Device

Device Description

The ZIP™ Condom Catheter has four basic elements: 1) the condom/sheath with integral urine collection compartment; 2) the Velcro-like band and support strap; 3) the Application ring; and 4) the specially designed male underpants brief.

The condom/sheath with integral urine collection compartment forms a bulbous tube approximately 10 ½ inches long. The tube is divided into two sections, the condom/sheath and the urine collection compartment. Non-return flow valves separate the condom/sheath portion from the urine collection compartment. The distal end of the urine collection compartment is affixed with a twist-open twistclosed stop-cock drain valve. The urine collection capacity is approximately 450 ml. Typical human urine output thus yields a time related capacity of about 4 to 6 hours.

A series of 4 sizes differing in sheath diameter and length will be offered. Specific name designators for the sizes are vet to be determined.

Design: The ZIP™ Condom Catheter expands upon existing male urine continence devices by first approaching the device as a "total" or "system" concept rather than just a collection of items originally developed for other urine collection purposes.

Only the essential elements of the ideal male urine continence system were considered. First, the system had to be easy to apply and use. Second, it should allow use of traditional male urination methods, i.e., the stand-up urinals found in public restrooms. Third, the system should be small enough to go unnoticed during the typical activities of daily living. Fourth, the system should have adequate capacity so that urine disposal intervals are not unreasonably short. Lastly, the system should be reusable and easily cleaned and sanitized.

This is a natural latex containing product. The ZIP™ Condom Catheter is made from the exact same natural latex formulation as the Everyday - Self-Adhesive Urinary External Catheter made by Hollister. Inc. The use of pure latex to construct the ZIP™ Condom Catheter requires the inclusion of certain FDA required cautionary statements. Latex containing devices must legibly bear an appropriate allergic reaction statement on the device labeling. In conformance with this FDA requirement, Goulter Medical, Inc. attaches a label containing the following cautionary statement to the device. "This product is made from natural rubber latex which may cause allergic reactions in some individuals".

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ZIP™ Condom Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The submission aims to show that the new device is as safe and effective as existing ones by comparing its materials, intended use, design, and method of operation.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

Not Applicable. The 510(k) process for this device relies on demonstrating substantial equivalence to predicate devices, not on meeting specific, quantifiable performance acceptance criteria from a clinical trial in the way a novel diagnostic would. The "performance" being evaluated is primarily the functional equivalence to existing devices.

2. Sample sized used for the test set and the data provenance

Not Applicable. There is no mention of a formal "test set" or clinical study with patient data used to directly evaluate the ZIP™ Condom Catheter's performance. The comparison is against predicate devices based on their established characteristics.

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

Not Applicable. No experts were used to establish ground truth for a test set as no such study was conducted or detailed in this submission.

4. Adjudication method for the test set

Not Applicable. No test set or adjudication method is mentioned.

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 physical medical device (condom catheter), not an AI diagnostic or assistance system. Therefore, no MRMC study or AI-related effectiveness is relevant or mentioned.

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

Not Applicable / Implied Equivalence. For a 510(k) for this type of device, the "ground truth" is that the predicate devices are considered safe and effective for their intended use. The new device demonstrates substantial equivalence to these established predicate devices.

8. The sample size for the training set

Not Applicable. There is no mention of a "training set" as this is not a machine learning or AI device.

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

Not Applicable. There is no training set involved.

Summary of Device Comparison (from Section 10. Feature Comparison Table):

The submission provides a feature comparison table to demonstrate substantial equivalence to predicate devices. This table serves as the primary "proof" for the 510(k) process.

FEATURE	ZIP™ Condom Catheter	Mentor Freedom Cath®	Everyday External Catheter	Uri-Drain®	Substantially Equivalent?
Materials:	Medical Grade Latex	Latex	Identical Latex Formulation	Latex	Yes
Intended Use(s):	Non-Indwelling Male Urinary Continence Aid Management of Male Urinary Incontinence Male Bladder Training Aid to Improve Urinary Continence	Same	(Not explicitly stated for predicate in table, but implied by "Same" for Mentor)	(Not explicitly stated for predicate in table, but implied by "Same" for Mentor)	Yes
Design:	Single Piece Unit	Condom Only	Condom Only	Condom Only	Yes
Method of Operation:	One Way Flow to Collection Bag	Same	Same	Same	Yes
Bag:	Integral to Condom Sheath	Requires Secondary Leg Bag	Requires Secondary Leg Bag	Requires Secondary Leg Bag	Yes
Bag Capacity:	Approx. 450 ml	About 1 Liter	About 1 Liter	About 1 Liter	Yes
Underpant:	Male Brief W/ Pouch	NA	NA	NA	No
How Secured:	Velcro Band & Strap	Adhesive Sheath	Spiral Foam Band	Spiral Foam Band	Yes
Sizes:	4	4	3	3	Yes
Additional Items Needed to Use the Device:	None - Sold Complete	Leg Bag Connectors Tubing Adhesive tube Holder	Leg Bag Connectors Tubing Tube clamp	Leg Bag Connectors Tubing Adhesive tube Holder	No
Manufacturer:	Goulter Medical	Mentor	Hollister	Sherwood Medical	Yes
Product Code:	78EXJ	78EXJ	78EXJ	78EXJ	Yes
K - Number	K964219	Preamendment	Preamendment	Preamendment

The "Yes" in the "SE?" column (which stands for Substantially Equivalent) indicates that, for that specific feature, the ZIP™ Condom Catheter is considered substantially equivalent to the predicate devices. The two "No" entries highlight differences (Underpant, Additional Items Needed to Use the Device) which the FDA presumably deemed not significant enough to prevent a finding of substantial equivalence overall, especially since the ZIP™ device offers a more integrated solution (integral bag, complete kit) which could be seen as an improvement in convenience rather than a safety/effectiveness concern.

Summary

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Premarket NotificationSection 510(k)	Summary of Safety and Effectiveness Informationfor the ZIP™ Condom Catheter
------------------------------------------	---------------------------------------------------------------------------------

Regulatory Authority:	Safe Medical Devices Act of 1990, 21 CFR 807.92
1. Device Trade Name:	ZIP™ Condom Catheter
Common Name:	External male urine collection device
Classification Name:	Device, Incontinence, Urosheath Type, Urine Collector and Accessories

AUG 11 1997### Establishment Name & Registration Number: 2.

Goulter Medical, Inc. Name:

Number: Pending

3. Classification:

§ 876.5250 Urine collector and accessories. (a) Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the back-flow of urine or ascent of infection. The two kinds of urine collectors are: (1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and (2) a urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the pasteon device for incontinence. (b) Classification. (1) Class II (performance standards) for a urine collector and accessories intended to be connected to an indwelling catheter. (2) Class I (general controls) for a urine collector and accessories not intended to be connected to an indwelling catheter. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requlations in Part 820, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

UNDERLINE ADDED

Class I for the proposed indications. Device Class:

Classification Panel: Urology

Product Code: 78EXJ

Tier I Device Tier Class:

1. Company Contact:
  Ms. Susan Clymer One Embarcadero Center Suite 1020 San Francisco, California 94111-3600 415.217.5656 - 415.217.5655 fax

5. Special Controls:

FDA Mandated Special Controls do not apply to this device.

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1. Substantially Equivalent Device(s):
- 1. Mentor Freedom Cath® Self Adhering External Male Catheter
- 1. Everyday Self Adhesive Urinary External Catheter
- 1. Uri-Drain® Male Urinary Control Device
- 1. Uri-Drain® Leg Bag Reusable Deluxe

7. Device Description:

A series of 4 sizes differing in sheath diameter and length will be offered. Specific name designators for the sizes are vet to be determined.

The Cleared Indications for use are:

For penile attachment only ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Non-Indwelling Urinary continence aid 2.
Management of Urinary Incontinence ကံ
Urine Collection Device 4.

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Claims:

1. Unobtrusive
Reusable 2.
Cost effective 3.
Single piece system খ
1. Enhanced self-image and esteem
Improves social freedom 6.
1. Lightweight
1. Less physically restrictive
1. Easy to use

Cleaning/Sterilization/Re-sterilization: 8.

The device may not be sterilized or re-sterilized. Cleaning and washing using soap/detergent/water followed by surface disinfection may be employed using commercially available liquid germicidal agents. The device is reusable for a limited period of time. Generally, with reasonable care, the device may be used for about a week. Though in individual cases this period may be shorter or longer. Most often the limiting factor is the performance of the anti-reverse flow valves which tend to be performance affected by accumulating urine sediments and crystals. It is recommended that the device not be reused for more than a week and it should be replaced at once if the valves fail to operated properly.

9. Equivalence:

Based on the materials, intended uses, design and clinical effectiveness, the ZIP™ Condom Catheter is substantially equivalent to the previously referenced legally marketed male external urinary collection devices.

The feature comparison chart on the following page graphically demonstrates equivalence.

FEATURE	ZIP™ CondomCatheter	Mentor FreedomCath®	EverydayExternal Catheter	Uri-Drain®	SE?
Materials:	Medical Grade Latex	Latex	Identical LatexFormulation	Latex	Yes
Intended Use(s):	Non-Indwelling MaleUrinary Continence AidManagement of MaleUrinary IncontinenceMale Bladder TrainingAid to Improve UrinaryContinence	Same			Yes
Design:	Single Piece Unit	Condom Only	Condom Only	Condom Only	Yes
Method ofOperation:	One Way Flow toCollection Bag	Same	Same	Same	Yes
Bag:	Integral to CondomSheath	Requires SecondaryLeg Bag	Requires SecondaryLeg Bag	RequiresSecondary LegBag	Yes
Bag Capacity:	Approx. 450 m/L	About 1 Liter	About 1 Liter	About 1 Liter	Yes
Underpant:	Male Brief W/ Pouch	NA	NA	NA	No
How Secured:	Velcro Band & Strap	Adhesive Sheath	Spiral Foam Band	Spiral Foam Band	Yes
Sizes:	4	4	3	3	Yes
Additional ItemsNeeded to Use theDevice:	None - Sold Complete	Leg BagConnectorsTubingAdhesive tube Holder	Leg BagConnectorsTubingTube clamp	Leg BagConnectorsTubingAdhesive tubeHolder	No
Manufacturer:	Goulter Medical	Mentor	Hollister	Sherwood Medical	Yes
Product Code:	78EXJ	78EXJ	78EXJ	78EXJ	Yes
K - Number	K964219	Preamendment	Preamendment	Preamendment

10. Feature Comparison Table:

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 11 1997

Re:

Goulter Medical, Inc. c/o Buckman Company, Inc. Mr. David W. Schlerf 1000 Burnett Avenue, Suite 450 Concord, California 94520

K964219 Zip™ Condom Catheter Dated: July 12, 1997 Received: July 21, 1997 Regulatory Class: T 21 CFR §876.5250/Product Code: 78 EXJ & EYZ

Dear Mr. Schlerf:

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 Device 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 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.

If your device is classified (see above) into either class III (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 (OS) 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 submission 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 device as described in your 510(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 vours.

Sincerery yours,

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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K964219 510(k) Number:

Device Name:

ZIP™ Condom Catheter

Indications For Use:

1. For Penile Attachment Only
1. Non-indwelling Urinary Continence Aid
1. Management of Urinary Incontinence
1. Urine Collection Device

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

Colin m. Pollard

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

Prescription Use

Over-The-Counter Use

(Optional format 1-2-96)

(Per 21 CFR 801.109)

Urores.doc

Regulation Number and Section

§ 876.5250 Urine collector and accessories.

(a)
Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and
(2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
(b)
Classification —(1)Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2)
Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.