URASSIST

K062061 · Preferred Medical Devices, Inc. · NZU · Oct 5, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K062061
• Device Name: URASSIST
• Applicant: Preferred Medical Devices, Inc.
• Product Code: NZU · Gastroenterology, Urology
• Decision Date: Oct 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5250
• Device Class: Class 1

Indications for Use

The UrAssist system is intended for the non-invasive, non-sterile collection of urine.

Device Story

UrAssist is a portable urine collection system; utilizes battery-operated pump to actively drain urine from collection cup through plastic tubing into storage bag. Unlike gravity-dependent predicate devices, pump-assisted mechanism facilitates drainage. Designed for patient use to provide a concealed, clean method for storing a day's worth of urine. System components include collection cup, pump, tubing, and collection bag.

Clinical Evidence

Bench testing only. Includes biocompatibility, EMC, and electrical safety testing to verify compliance with requirements for urine collection units.

Technological Characteristics

Portable urine collection unit; battery-operated pump-assisted drainage; plastic tubing; collection bag. Compliance with IEC 60601-1 and IEC 60601-1-2 standards. Class I device.

Indications for Use

Indicated for individuals requiring non-invasive, non-sterile urine collection for storage of up to a day's volume.

Regulatory Classification

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.

Special Controls

*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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

Predicate Devices

• Hollister Urinary Drainage Collectors
• Hollister Urinary Leg Bag

Submission Summary (Full Text)

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Kob2061
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## 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, 21 CFR 807.87, 21 CFR 807.92, Format for Traditional and Abbreviated 510(k)s.

- 1. Name of Submitter, Contact Person and Date Summary Prepared:
OCT = 5 2006

| Applicant: | Edgar Otto<br>Chairman of the Board<br>Preferred Medical Devices, Inc.<br>6400 Congress Avenue, Suite 1700<br>Boca Raton, FL 33487 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Phone:<br>Fax: | 561.417.3595<br>561.417.4857 |
| Contact: | Penelope Greco<br>MedApprove, Inc. |
| Phone:<br>Fax: | 508.843.0282<br>207.439.0781 |
| Date of Preparation: | September 25, 2006 |

- 2. Device Trade Name and Common Name:

| | Trade Name: | UrAssist |
|----|-------------------------------------------|-----------------------------------------------------------------------|
| | Common/Usual Name: | Urine Collector and accessories |
| | Regulation Number: | 21 CFR 876.5250 |
| 3. | Device Class: | Class 1 |
| 4. | Legally Marketed Equivalent Device Names: | Hollister Urinary Drainage<br>Collectors<br>Hollister Urinary Leg Bag |

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Preferred Medical Devices 6400 Congress Avenue, Suite 1700 Boca Raton, FL 33487

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- Performance Standards: న్. UrAssist will comply with applicable parts of IEC 60601-1 and IEC 60601-1-2 Prior to release in the US market.
- 6. Description of the Device: UrAssist is a portable urine collection unit which utilizes a battery-operated pump-assisted technology to drain the urine from a collection cup through a plastic tube and into a collection bag that stores a day's amount of urine.
- 7. Intended Use of the Device: The UrAssist system is intended for the non-invasive, non-sterile collection of urine.
- 8. Comparison of technological characteristics with Predicate Device: The primary difference between Urassist and urine collections units already legally marketed as Class 1 devices is that the Urassist system includes a batteryoperated pump that drains urine from a collection cup through a tube and into a receptacle (collection bag). Legally marketed urine collection systems rely on gravity for drainage through tubing and into a collection bag.
- 9. Discussion of Non-clinical Studies: Biocompatibility, EMC and electrical safety testing, as well as in-house testing verify or will verify that UrAssist meets the requirements specified for a urine collection unit.
- 10. Conclusion: The UrAssist System is safe and effective and affords individuals who rely on urine collection systems, a safe, clean, concealed method to store a day's worth of urine.

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Preferred Medical Devices 6400 Congress Avenue, Suite 1700 Boca Raton, FL 33487

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Image /page/2/Picture/1 description: The image shows a logo with a stylized bird-like symbol consisting of three curved lines, resembling wings or feathers. The logo is encircled by text that reads "HUMAN SERVICES USA DEPARTMENT OF HEALTH". The text is arranged in a circular fashion around the bird symbol, with the words "HUMAN SERVICES USA" at the top and "DEPARTMENT OF HEALTH" at the bottom.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

OCT -5 2006

Preferred Medical Devices, Inc. c/o Ms. Penelope H. Greco MedApprove 8 Gray Lodge Road KITTERY ME 03904

Re: K062061

> Trade/Device Name: UrAssist Regulation Number: 21 CFR §876.5250 Regulation Name: Urine collector and accessories Regulatory Class: I Product Code: NZU Dated: August 30, 2006 Received: August 31, 2006

Dear Ms. Greco:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1926-2006" is at the top of the logo. Below that is the text "PA Centennial" in a stylized font. There are three stars at the bottom of the logo.

Protecting and Promoting Public Health

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'Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrlvindustry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. B rogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ur Assist

K062061

510(k) Number (if known): K062061

Device Name:

Indications for Use:

The UrAssist system is intended for the non-invasive, non-sterile collection of urine.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use V

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniela Bergman

Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number

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Preferred Medical Devices 6400 Congress Avenue, Suite 1700 Boca Raton, FL 33487