(120 days)
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Not Found
No
The description details standard digital signal processing and calculation of parameters using algorithms, but does not mention AI or ML.
No.
The device measures urinary flow rates, which is a diagnostic function, not a therapeutic intervention.
Yes
The device measures urinary flow rates and calculates parameters like voided volume, maximum flow rate, and mean flow rate. These measurements provide insights into a patient's physiological state related to urination, which can be used by healthcare professionals to diagnose conditions affecting urinary function.
No
The device description explicitly mentions hardware components such as a strain-gauged load cell, a digital signal output, a paper chart recorder, and a table-top device connected to the load cell.
Based on the provided information, the GR100FS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or screening purposes.
- GR100FS Function: The GR100FS measures the flow rate and volume of urine as it is being voided from the body. It is a measurement of a physiological process happening in vivo (within the body), even though the urine is collected in a jug.
- Lack of Specimen Analysis: The device does not analyze the chemical composition, cellular content, or any other properties of the urine itself. It simply measures the physical characteristics of the flow and volume.
The device is a urological measurement tool used to assess bladder function during micturition, which is a physiological process.
N/A
Intended Use / Indications for Use
The GRIOUFS is intended to be used to measure urinary flow rates.
Product codes (comma separated list FDA assigned to the subject device)
78 EXY, EXS
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
The specific gravity of urine varies between 1.002 and 1.006 in infants and 1.025 in adults (95% ranges)
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Browne Medical Systems Inc "I IroFlo"
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.
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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
§ 876.1800 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.
0
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 Estate | |
| Dingwall | ||
| IV15 9QF | ||
| Scotland | ||
| UK | ||
| 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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P 2 of 2
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
2
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) |
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