(120 days)
The GRIOUFS is intended to be used to measure urinary flow rates.
Urine flowrate meter used for determining urine flow rate from patients performing normal micturition. The device functions by weighing the voided urine, the weight in grans approximates to the volume in ml the specific gravity of urine varies between 1.002 and 1.006 in infants and 1.025 in adults (95% ranges) and any inaccuracy is therefore no more than 2.5%. The urine is weighed as the urine flows using a straingauged load cell, the signal nutput from which is digitised. The flow volume is differentiated digitally to give the flow rate, which is printed on a paper chart recorder. The flowmeter uses algorithms to calculate the following parameters.
- Total voided volume Volume at maximum flow Maximum Now rate Mcan flow rate Flow time Time of maximum flow
The recorder is a table-top device connected to the load coll which supports a jug and which fits under either a commode chair or stand.
This document is a 510(k) summary for the Albyn Medical Ltd. GR100F Urine Flowmeter, dated September 19, 1997. It describes the device, its intended use, and claims substantial equivalence to a predicate device, the Browne Medical Systems Inc. "UroFlo".
However, the provided text does not contain any information regarding acceptance criteria, study details, or performance results of the GR100F Urine Flowmeter. The document is a regulatory submission for premarket notification, outlining the device's characteristics and its equivalence claim, but it does not include the results of a study to prove it meets specific performance criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence to a predicate device, not on a detailed performance study with acceptance criteria.
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ULDYN MEDICUL LTD
Image /page/0/Picture/2 description: The image shows the logo for Albyn Medical. The logo is in black and white and features the company name in a bold, sans-serif font. Above the word "MEDICAL" is a symbol that looks like a stylized tree. To the right of the logo are the words "Plot 2" and "K971913" written in a handwritten font.
19 September 1997
SEP 1 9 1997
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ 401) 9200 Corporate Boulevard Rockville Maryland 20850 USA
Bridgend Road Industrial Estate Dinuwall. Ross-shire IV15 9QF. colland 16 Juliums. (01349) 862386 ax: (01349) 864146 Mall: info@ albyn.com
Attn: Ms Nicole I. Wolanski
Dear Ms Wolanski
- 510(k) numher K971913 Re: GR100F Urine Flowmeter Dated: May 14, 1997 Received: May 22, 1997
The Safe Medical Devices Act of 1990 - 510(k) Summary
| (1) | Submitter's name: | Albyn Medical Ltd |
|---|---|---|
| Submitter's address: | Bridgend Road Industrial EstateDingwallIV15 9QFScotlandUK | |
| Submitter's tel. no: | 011 44 134 986 2388 | |
| Contact person: | Ross K. Maxwell | |
| Date Summary Prepared: | 19 September 1997 |
- GR100FS Urine Flowmeter (2) Name of device
- (3) Identification of legally marketed device to which equivalence is claimed Browne Medical Systems Inc "I IroFlo"
- (4) Description of the device.
Urine flowrate meter used for determining urine flow rate from patients performing normal micturition. The device functions by weighing the voided urine, the weight in grans approximates to the volume in ml the specific gravity of urine varies between 1.002 and 1.006 in infants and 1.025 in adults (95% ranges) and any inaccuracy is therefore no more than 2.5%. The urine is weighed as the urine flows using a straingauged load cell, the signal nutput from which is digitised. The flow volume is
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K971913
differentiated digitally to give the flow rate, which is printed on a paper chart recorder. The flowmeter uses algorithms to calculate the following parameters.
-
Total voided volume Volume at maximum flow Maximum Now rate Mcan flow rate Flow time Time of maximum flow
The recorder is a table-top device connected to the load coll which supports a jug and which fits under either a commode chair or stand. -
(5) Intended use for the device
The device is intended to be used to measure urinary flow rates -
The device has the same technolgical characteristics as the predicate device identified in (6) paragraph (3)
Prepared by:
R. An
Ross K. Maxwell 19 September 1997
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 1997
Ross K. Maxwell, Ph.D. Director Responsible for Regulatory Affairs Albyn Medical Ltd. Bridgend Road Industrial Estate, Dingwall. Ross-shire 1V15 9OF. SCOTLAND
Re: K971913 GR100F Urine Flowmeter Dated: June 27, 1997 Received: July 1, 1997 Regulatory class: II 21 CFR §876.1800/Product code: 78 EXY & EXS
Dear Dr. Maxwell:
We have reviewed your Section 510(k) notification of intent to market the device 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, 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 QS 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 question 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.
hĩiau Yu
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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510(k) Number (if Known): K971913 Device Name: GRIO OFS URINE FLOWITE TER Indications For Use:
The GRIOUFS is intended to be used to measure
urinary flow rates.
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Robert R Sathy | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | 971913 |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
..............................................................................................................................................................................
§ 876.1800 Urine flow or volume measuring system.
(a)
Identification. A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder and a transducer and electrical signal conditioning and display equipment. This generic type of device includes the electrical urinometer, mechanical urinometer, nonelectric urinometer, disposable nonelectric urine flow rate measuring device, and uroflowmeter.(b)
Classification. (1) Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.