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.

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.

AI/ML Overview

The provided text describes the DipStreak Urine Culture Device and studies supporting its performance. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Bacterial Detection Range	Pathogenic bacteria found in urine samples at levels from 10^3 to 10^7 CFU/ml are detected accurately and consistently.	Precision Study: Experimental evidence to support this claim is given in the application's "Precision Study." (Specific numerical results for this range are not explicitly provided in the excerpt, but the claim is made that it's detected accurately and consistently.)
Agreement with Predicate Device	Not explicitly stated as a numerical acceptance criterion, but implied to be high due to substantial equivalence.	Study 1 & 2 (vs. Predicate Device): Overall agreement of 96.4% at the cutoff level of 10^5 CFU/ml and 96.9% at the cutoff level of 10^4 CFU/ml when compared to the Savyon Diaslide Urine Culturing Device (K921045) in two studies comprising 522 clinical samples.
Sensitivity and Specificity (Standalone)	Not explicitly stated as numerical acceptance criteria, but implied to be high for standalone performance.	Study 3 (vs. Traditional Petri Dish Culture): Sensitivity and specificity values for cutoff levels of 10^5 and 10^4 CFU/ml were all above 98.6% when compared to traditional petri dish culture in a study of 1000 clinical samples.
Quality Control Tests	Device must support the expected growth of organisms. Failure indicates deterioration.	User Quality Control: Specific "Typical Culture Response" table provided for E. coli, S. aureus, and P. vulgaris with expected growth rates and colony appearances after 24 hours at 37°C. (This serves as an in-use acceptance criterion, not a study outcome, but demonstrates a defined performance expectation for functionality).

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Predicate Device Comparison: 522 clinical samples (across two studies).
Sample Size for Traditional Petri Dish Comparison: 1000 clinical samples (one study).
Data Provenance: The text does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. It refers to "clinical samples," implying human-derived samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. The device being described is a urine culture device (a diagnostic tool for bacterial enumeration and isolation), not an AI-powered diagnostic imaging or interpretation tool. Therefore, "human readers improving with AI vs without AI assistance" is not applicable to this device type.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance study was done. The comparison of the DipStreak device to "traditional petri dish culture" in a study of 1000 clinical samples, yielding sensitivity and specificity values, represents a standalone performance evaluation of the device itself. The device is designed to be used independently to grow and identify bacteria, without an "algorithm only" component in the modern AI sense. Its "standalone" performance is its direct ability to detect and enumerate bacteria.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the comparison studies was traditional petri dish culture and the predicate device (Savyon Diaslide Urine Culturing Device). These methods are considered standard clinical practices for urine culture and bacterial enumeration, and thus serve as the reference standard or "ground truth" against which the DipStreak device's performance was measured.

8. The Sample Size for the Training Set

This information is not provided in the given text. The description focuses on performance studies (test sets) rather than development or training data. Being a physical diagnostic device, it likely did not have a "training set" in the machine learning sense. The "Precision Study" likely refers to internal development and validation work rather than a data training phase.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is likely not applicable in the context of a physical diagnostic device like the DipStreak. The "ground truth" for its design and manufacturing would be based on established microbiology principles and standard culturing techniques.

Summary

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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.
1. 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. coliATCC No. 25922	2-3 mm colonies can be seenwithin 12-14 hr	Red-purple colonieswith smooth borders	Yellow colonies withsmooth borders
S. aureusATCC No. 25923	MacConkey -no growthCLED-1 mm colonies can beseen within 12-14 hr	No growth	Yellow colonies withsmooth borders
P. vulgarisATCC No. 13315	0.5-1 mm colonies can be seenwithin 16-20 hr	Colorless colonieswith rough borders	Blue colonies withrough 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.

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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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T0000>	tcC

510(k) Number (if known): K974428

Device Name: DipStreak Urine Culture Device

Indications For Use:

(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)

Regulation Number and Section

§ 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.