(248 days)
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No
The device description and performance studies focus on a physical method for culturing bacteria and do not mention any computational analysis or algorithms.
No
The device is used for the isolation and enumeration of bacteria in urine, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is used for the isolation and enumeration of bacteria in urine, which is a diagnostic process to identify the presence and quantity of microorganisms. The performance studies also mention sensitivity and specificity, which are metrics commonly associated with diagnostic devices.
No
The device description clearly outlines a physical device consisting of a plastic paddle, agar surfaces, plastic prongs, and a plastic tube. This is a hardware-based medical device for culturing urine samples.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "used for the isolation and enumeration of bacteria in urine." This is a diagnostic purpose, specifically identifying and quantifying microorganisms in a biological sample (urine).
- Device Description: The device is designed to interact directly with a biological sample (urine) to perform a test (culturing bacteria on agar).
- Performance Studies: The performance studies compare the device to a predicate device and traditional petri dish culture, evaluating its accuracy in detecting and quantifying bacteria in urine samples. This is typical for IVD devices demonstrating their clinical performance.
The core function of the device is to perform a test on a biological sample in vitro (outside the body) to provide diagnostic information about the presence and quantity of bacteria. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Novamed, Ltd. DipStreak Urine Culture Device is used for the isolation and enumeration of bacteria in urine. A set of plastic prongs on the end of the device are dipped into the urine sample. The drops of urine which adhere to the prongs are then streaked across two different agar surfaces (CLED agar on one side, MacConkey agar on the other). A dilution effect takes place which allows the isolation of single colonies.
Product codes (comma separated list FDA assigned to the subject device)
JSI
Device Description
DipStreak comprises a plastic paddle with two types of agar attached back-to-back, housed in a closed transparent plastic tube. A ring with elongated prongs is attached to the end of the paddle so that there are prongs on each side of the slide. The ends of the prongs are dipped into the urine sample. Upon re-insertion into the plastic tube, the prongs are prevented from moving and the agar surfaces are inoculated with bacteria from the urine sample as the agar-coated paddle passes over the prongs. The result is a series of streaks of decreasing bacterial concentration which permits isolation of single colonies even when the original bacterial population of the sample was as high as 10' organisms per milliliter.
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
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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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
when compared to the predicate device in two studies comprising 522 clinical samples, the DipStreak Urine Culture Device demonstrated overall agreement of 96.4% at the cutoff level of 10° CFU/ml and 96.9% at the cutoff level of 10° CFU/ml. The DipStreak Urine Culture Device was also compared to traditional petri dish culture in a study of 1000 clinical samples. Sensitivity and specificity values for cutoff levels of 10° and 10° CFU/ml were all above 98.6%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity and specificity values for cutoff levels of 10° and 10° CFU/ml were all above 98.6%
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.
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.
Not Found
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
§ 866.2360 Selective culture medium.
(a)
Identification. A selective culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify certain pathogenic microorganisms. The device contains one or more components that suppress the growth of certain microorganisms while either promoting or not affecting the growth of other microorganisms. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
0
Jul 3 0 1998
1697-4428
Name of device: DipStreak Urine Culture Device (K974428) 1.
- Identification of the predicate device: the Savyon Diaslide Urine Culturing Device 2. (510(k) no. K921045).
- Description of the device: DipStreak comprises a plastic paddle with two types of agar 3. attached back-to-back, housed in a closed transparent plastic tube. A ring with elongated prongs is attached to the end of the paddle so that there are prongs on each side of the slide. The ends of the prongs are dipped into the urine sample. Upon re-insertion into the plastic tube, the prongs are prevented from moving and the agar surfaces are inoculated with bacteria from the urine sample as the agar-coated paddle passes over the prongs. The result is a series of streaks of decreasing bacterial concentration which permits isolation of single colonies even when the original bacterial population of the sample was as high as 10' organisms per milliliter.
- Intended use: the Novamed, Ltd. DipStreak Urine Culture Device is used for the isolation 4. and enumeration of bacteria in urine.
- Performance and design specifications: pathogenic bacteria found in urine samples at levels 5. from 103 to 10' CFU/ml are detected accurately and consistently when using the DipStreak Urine Culture Device. Experimental evidence to support this claim is given in the application in the Precision Study.
- Performance data: when compared to the predicate device in two studies comprising 522 6. clinical samples, the DipStreak Urine Culture Device demonstrated overall agreement of 96.4% at the cutoff level of 10° CFU/ml and 96.9% at the cutoff level of 10° CFU/ml. The DipStreak Urine Culture Device was also compared to traditional petri dish culture in a study of 1000 clinical samples. Sensitivity and specificity values for cutoff levels of 10° and 10° CFU/ml were all above 98.6% Details of these studies are given in the application.
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- User quality control: quality control tests are performed on each lot of DipStreaks at the time of manufacture. Product users who wish to perform their own quality control may use the following procedure.
- Prepare a suspension (10 -10 CFU/ml) of each of the following organisms in sterile a. urine. Confirm the exact organism concentration by inoculating 10 ul with a calibrated loop on reference plates of CLED and MacConkey agar.
- Test the suspension according to the above Procedure. b.
| Strain | Growth rate | Colony Appearance | |
|---|---|---|---|
| MacConkey | CLED | ||
| E. coli | |||
| ATCC No. 25922 | 2-3 mm colonies can be seen | ||
| within 12-14 hr | Red-purple colonies | ||
| with smooth borders | Yellow colonies with | ||
| smooth borders | |||
| S. aureus | |||
| ATCC No. 25923 | MacConkey -no growth | ||
| CLED-1 mm colonies can be | |||
| seen within 12-14 hr | No growth | Yellow colonies with | |
| smooth borders | |||
| P. vulgaris | |||
| ATCC No. 13315 | 0.5-1 mm colonies can be seen | ||
| within 16-20 hr | Colorless colonies | ||
| with rough borders | Blue colonies with | ||
| rough borders |
TYPICAL CULTURE RESPONSE (after 24 hours at 37℃)
If the device does not support the expected growth of organisms, it has deteriorated and should not be used.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Gerald M. Slutzky, Ph.D. Director, Research and Development Novamed, Ltd. 28 Pierre Köenig St., Talpiot Industrial Area Jerusalem 91531 Israel
K974428 Re:
Trade Name: DipStreak Urine Culture Device Regulatory Class: I Product Code: JSI Dated: July 8, 1998 Received: July 13, 1998
Dear Dr. Slutzky:
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 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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) 594-4588. Additionally, for questions on the promotion 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K974428
Device Name: DipStreak Urine Culture Device
Indications For Use:
The Novamed, Ltd. DipStreak Urine Culture Device is used for the isolation and enumeration of bacteria in urine. A set of plastic prongs on the end of the device are dipped into the urine sample. The drops of urine which adhere to the prongs are then streaked across two different agar surfaces (CLED agar on one side, MacConkey agar on the other). A dilution effect takes place which allows the isolation of single colonies.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Woody Deloves | |
| (Division Sign Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K974428 |
| Prescription Use | X |
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use ______ | |
| (Optional Format 1-2-96) |