FEMALE EXTERNAL URINARY COLLECTION POUCH

K971499 · Mediquest, Inc. · EXI · Aug 28, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971499
• Device Name: FEMALE EXTERNAL URINARY COLLECTION POUCH
• Applicant: Mediquest, Inc.
• Product Code: EXI · Gastroenterology, Urology
• Decision Date: Aug 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5250
• Device Class: Class 1

Intended Use

As a disposable, single use Female External Urinary Collection Pouch, it is intended to collect urine and assist in directing it away from the body.

Device Story

Disposable, single-use female external urinary collection pouch; collects urine and directs flow away from body. Used in clinical or home settings to manage incontinence or assist patients with limited mobility. Device functions as passive collection system; no active components or sensors. Healthcare providers or caregivers apply pouch to patient; output is urine collection for disposal. Benefits include skin protection and hygiene maintenance by diverting urine away from body.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use comparison to legally marketed predicate devices.

Technological Characteristics

Disposable pouch design; materials unspecified. Passive collection mechanism; no energy source or electronic components. Non-sterile or sterile (not specified). Standalone device.

Indications for Use

Indicated for female patients requiring external urine collection and diversion.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mediquest, Inc. c/o Holland & Associates Mr. Greg Holland 3722 Avenue Sausalito Irvine, California 92606

Re: K971499 Female External Urinary Collection Pouch Dated: July 11, 1997 Received: July 14, 1997 Regulatory Class: I 21 CFR §876.5250/Product Code: 78 EXI and EYZ

Dear Mr. Holland:

AUG 28 1997

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 Amendments, or to 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 Act. 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 (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 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 [phone]. Additionally, for question 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,

h7 liau Yu

Lilian 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

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510(k) Number (if known):

Device Name: Mediquest, Inc.'s Female External Urinary Collection Pouch

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Indications For Use:

As a disposable, single use Female External Urinary Collection Pouch, it is intended to collect urine and assist in directing it away from the body.

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