(77 days)
The UrAssist system is intended for the non-invasive, non-sterile collection of urine.
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.
The provided text describes the UrAssist system, a urine collection unit. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way one might expect for a typical medical device with quantitative performance metrics.
Instead, the document is a 510(k) summary for a Class I device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than rigorous performance goal attainment through clinical studies with defined endpoints.
Here's a breakdown of what is and is not in the document, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided in the document as quantitative acceptance criteria with corresponding performance metrics. The document states compliance with general safety and electrical standards and non-clinical testing.
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied/stated) | Reported Device Performance (as implied/stated) |
|---|---|---|
| Safety | Compliance with IEC 60601-1 (electrical safety) | "in-house testing verify or will verify that UrAssist meets the requirements specified for a urine collection unit", "safe, clean, concealed method to store" |
| EMC | Compliance with IEC 60601-1-2 (EMC) | "in-house testing verify or will verify that UrAssist meets the requirements specified for a urine collection unit" |
| Biocompatibility | Biocompatibility requirements for urine collection unit | "Biocompatibility...testing verify or will verify that UrAssist meets the requirements specified for a urine collection unit" |
| Functionality | Urine collection ability | "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" |
2. Sample Size Used for the Test Set and Data Provenance
- Not specified. The document mentions "in-house testing" and non-clinical studies (biocompatibility, EMC, electrical safety) but does not provide details on sample sizes, methodologies, or data provenance for any specific test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable/Not specified. This document describes a 510(k) submission for a urine collection device, not an imaging or diagnostic AI device where expert ground truth for test sets is typically established. The "testing" referred to is about engineering and material safety, not diagnostic accuracy.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not mentioned as this device is a physical urine collection unit, not a diagnostic imaging or AI-assisted interpretation tool where reader performance is evaluated.
6. Standalone (Algorithm Only) Performance Study
- No. This is not an algorithm-based device.
7. Type of Ground Truth Used
- Given the nature of the device (a urine collector), the "ground truth" for the tests mentioned (biocompatibility, EMC, electrical safety) would likely be engineering specifications, material standards, and regulatory compliance requirements rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. Sample Size for the Training Set
- Not applicable/Not specified. This is not an AI or machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
In summary: The provided document is a 510(k) summary for a Class I medical device (urine collector). Its purpose is to demonstrate substantial equivalence to a predicate device, primarily through non-clinical testing for safety, EMC, and biocompatibility, as well as describing its functional characteristics. It does not include the detailed performance study information with explicit acceptance criteria, sample sizes, and expert review often associated with more complex medical devices, especially those incorporating AI or diagnostic functions.
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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.
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- Name of Submitter, Contact Person and Date Summary Prepared:
OCT = 5 2006
- Name of Submitter, Contact Person and Date Summary Prepared:
| Applicant: | Edgar OttoChairman of the BoardPreferred Medical Devices, Inc.6400 Congress Avenue, Suite 1700Boca Raton, FL 33487 |
|---|---|
| Phone:Fax: | 561.417.3595561.417.4857 |
| Contact: | Penelope GrecoMedApprove, Inc. |
| Phone:Fax: | 508.843.0282207.439.0781 |
| Date of Preparation: | September 25, 2006 |
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- 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 DrainageCollectorsHollister 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.
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- 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.
-
- Intended Use of the Device: The UrAssist system is intended for the non-invasive, non-sterile collection of urine.
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- 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.
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- 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.
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- 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 (800) 638-2041 or (240) 276-3150
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
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
§ 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.