(293 days)
Not Found
Not Found
No
The device description focuses on the physical components and mechanical function of a condom catheter system. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is described as a "Non-indwelling Urinary Continence Aid" and "Urine Collection Device" used for the "Management of Urinary Incontinence," which are functional purposes rather than therapeutic in nature. It manages a condition rather than treating or curing it.
No
The device is described as a non-indwelling urinary continence aid and urine collection device, which are functions related to management and collection, not to diagnosing a medical condition.
No
The device description clearly outlines physical components made of materials like latex, including a condom/sheath, band, strap, ring, and underpants brief. There is no mention of software as a component of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are for penile attachment, urinary continence aid, management of urinary incontinence, and urine collection. These are all related to the physical collection and management of urine outside the body.
- Device Description: The description details a physical device designed to be worn externally for urine collection. It describes components like a condom/sheath, collection compartment, valves, and underpants.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing biological samples like blood, urine, or tissue in a laboratory setting.
This device is clearly an external medical device for managing urinary incontinence, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Cleared Indications for use are:
- For penile attachment only
- Non-Indwelling Urinary continence aid
- Management of Urinary Incontinence
- Urine Collection Device
Indications For Use:
-
- For Penile Attachment Only
-
- Non-indwelling Urinary Continence Aid
-
- Management of Urinary Incontinence
-
- Urine Collection Device
Product codes (comma separated list FDA assigned to the subject device)
78EXJ
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".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Penile
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Mentor Freedom Cath® Self Adhering External Male Catheter, Everyday Self Adhesive Urinary External Catheter, Uri-Drain® Male Urinary Control Device, Uri-Drain® Leg Bag Reusable Deluxe
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
| Premarket Notification
Section 510(k) | Summary of Safety and Effectiveness Information
for 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:
-
- Company Contact:
Ms. Susan Clymer One Embarcadero Center Suite 1020 San Francisco, California 94111-3600 415.217.5656 - 415.217.5655 fax
- Company Contact:
5. Special Controls:
FDA Mandated Special Controls do not apply to this device.
1
-
- Substantially Equivalent Device(s):
-
- Mentor Freedom Cath® Self Adhering External Male Catheter
-
- Everyday Self Adhesive Urinary External Catheter
-
- Uri-Drain® Male Urinary Control Device
-
- Uri-Drain® Leg Bag Reusable Deluxe
7. 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".
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.
2
Claims:
-
- Unobtrusive
- Reusable 2.
- Cost effective 3.
- Single piece system খ
-
- Enhanced self-image and esteem
- Improves social freedom 6.
-
- Lightweight
-
- Less physically restrictive
-
- 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™ Condom
Catheter | Mentor Freedom
Cath® | Everyday
External Catheter | Uri-Drain® | SE? |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------|------------------------------------------------------------|-----|
| 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 | | | 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 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 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 | |
10. Feature Comparison Table:
3
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
4
K964219 510(k) Number:
Device Name:
ZIP™ Condom Catheter
Indications For Use:
-
- For Penile Attachment Only
-
- Non-indwelling Urinary Continence Aid
-
- Management of Urinary Incontinence
-
- 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
OR
Over-The-Counter Use
(Optional format 1-2-96)
(Per 21 CFR 801.109)
Urores.doc