It is a useful aid in the diagnosis or early detection of a number of gastrointestinal disorders, and is recommended for use in monitoring for recurrences of previously treated bowel conditions, and in screening for colorectal cancer or for other sources of gastro-intestinal bleeding.

For Over-The-Counter Use

Device Description

HemaPrompt is presently approved and being used by health care professionals for the screening of stool for occult blood. It is a guaiac based system using a color change in the test slide to show the presence of a pathological amount of blood in the stool, which indicates the need for further investigation by medical personnel.

HemaPrompt for use at home is the same in configuration and chemical constitution as that currently used by professionals. HemaPrompt is much simpler and safer to use than similar home-use kits because the developing solution is individually contained in each slide thereby obviating the need to measure or handle a potentially hazardous solution. This design also obviates variations in user technique, and because of a "built - in" control monitor, proper function is obvious.

AI/ML Overview

HemaPrompt Device Performance Study Summary

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
User Interpretation Accuracy: No statistically significant variation in test interpretation between lay persons and healthcare professionals.	Observation: A study involving 250 lay persons and 50 nurses showed no statistically significant variation in their ability to perform the test and interpret results.
Understandability of Instructions: High understandability rate for critical safety instructions (e.g., "Should you see a physician if your test is positive?").	Observation: A questionnaire given to 50 lay persons demonstrated a greater than 95% understandability rate for the most important question regarding physician consultation after a positive test.

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

Sample Size:
- Lay persons for interpretation study: 250 individuals
- Nurses for interpretation study: 50 individuals
- Lay persons for instruction understandability: 50 individuals
Data Provenance: The document does not explicitly state the country of origin. However, given it's a 510(k) submission to the FDA, it can be inferred that the studies were conducted in the US. The studies appear to be prospective as participants were "asked... to perform the test and interpret the results" or given a questionnaire.

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

The study described focuses on user comprehension and interpretation of the device, rather than the device's diagnostic accuracy against a clinical ground truth. Therefore, the concept of "experts establishing ground truth" for the test results performed by the participants is not directly applicable in the conventional sense. The "ground truth" for the interpretation study was likely the manufacturer's intended correct interpretation of the HemaPrompt test (positive/negative), which the nurses were presumed to already understand.

Experts for interpretation comparison: 50 nurses who routinely perform fecal occult blood tests in a hospital. Their qualifications are implied by their routine professional experience.
Experts for instruction revision (implicitly): The "manufacturer" or "experts" involved in revising the instructions based on lay person feedback. No specific number or qualifications are provided.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1). For the interpretation study, the comparison was between the interpretations of lay persons and nurses. The "ground truth" for each specific test read by the participants would be the actual result shown on the HemaPrompt slide (positive/negative), which was then compared to their interpretation. It's not a consensus-based adjudication but rather a direct comparison of individual interpretations against a known expected outcome.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned. The device is a diagnostic test itself, not an AI-powered diagnostic aid for human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-loop Performance)

Yes, the HemaPrompt device itself has a standalone performance, albeit implicitly. The submission states that "HemaPrompt for use at home is the same in configuration and chemical constitution as that currently used by professionals." This implies that the chemical reaction and color change (the "algorithm" in this context) of the device functions independently, and its performance (false positive/negative rates) are "no different from the professionally used test." The study then focuses on the user's ability to operate and interpret this standalone device.

7. Type of Ground Truth Used

For user interpretation accuracy: The ground truth for the study participants' interpretations would be the actual positive or negative result displayed by the HemaPrompt slide for the test specimens they were provided. This is an objective chemical reaction result.
For the device's clinical efficacy (implied): The text mentions the clinical benefits of early detection and states there is a "recognized false positive and false negative rate which is no different from the professionally used test." This suggests that the ground truth for the device's diagnostic performance implicitly relies on established clinical outcomes and pathology. However, the study described in the 510(k) focuses on user performance, not direct diagnostic accuracy via pathology comparison.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or AI model. The studies described are for user performance and instruction comprehension.

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

Not applicable, as there is no "training set" for an algorithm described in this submission. For the user studies, the "training" for the lay persons involved reading the provided instructions.

Summary

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510(K) SUMMARY

K 981661

Preamble

Screening of stool for occult blood has been recommended by the American Cancer Society and accepted by a number of medical societies as a worthwhile tool to detect a number of gastro-intestinal diseases, with occult blood often present in such conditions as ulceration, diverticulitis and cancer. It should be carried out on a yearly basis as a screening test for those over fifty, and for monitoring those with a family history of bowel disease, those on chemotherapy, or those with post bowel surgery for cancer.

At the present time the majority of such tests require the patient to apply a stool specimen to a test card which then is returned to the physician, usually by mail in a special envelope, for development and interpretation. It has been estimated however that compliance is poor ( less than 20% of test cards being returned to the physician by some estimates) possibly because of the lack of immediacy of results and the patients' unwillingness to send such material by mail.

Risk/ Benefit Considerations.

Benefits

The clinical benefit of early detection provided by HemaPrompt is a decrease in the death rate from complications caused by delayed diagnosis of bowel problems causing bleeding. By having the test performed at home one would expect increased compliance and decreased cost to the patient. The physician would still have to be notified of the results.

Risks

Since the test is typically used in asymptomatic subjects, and assuming normal co-operation of the patient in notifying the physician, delays in seeking treatment are no greater than presently encountered. There is a recognized false positive and false negative rate which is no different from the professionally used test.

Performance Considerations.

Utilizing the home - use kit and written instructions, the rate of a false reading of test results by the patient was similar to that obtained by professionals. This was demonstrated with a study involving a group of 250 lay persons (at different locations, over age 50, both genders, varying race and educational background) who were asked, after reading instructions, to perform the test and interpret the results. A group of 50 nurses who perform fecal occult blood tests routinely in a hospital was given the same exercise with minimal instruction. The results from the two groups showed no statistically significant variation in ability to perform the test and interpret results.

Labeling Considerations.

Each test kit (of three slides) has adequate directions for home-use purposes employing concise wording (SMOG at the 5 - 6 grade level), liberal use of step drawings, and a variety of colored illustrations demonstrating examples of positive results. A questionnaire given to the 50 lay persons who had read these instructions, demonstrated a greater than 95% understandability rate on the most important question: "Should you see a physician if your test is positive ?" Several other questions were more difficult to understand and the test instructions were revised accordinaly.

Conclusion

Lay persons are able to adequately perform a Fecal Occult Blood test in the home setting when used in the format provided by the HemaPrompt system.

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.

SEP 1 5 1998

Robert Schreiber, M.D. AERSCHER, Inc. 353 High Street Chestertown, Maryland 21620

ку81661/51 Re: Trade Name: HemaPrompt Regulatory Class: II Product Code: KHE Dated: June 23, 1998 Received: June 26, 1998

Dear Dr. Schreiber:

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 requlation (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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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Page 2

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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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.....

Pending

HemaPrompt Device Name.......

Indications For Use

HemaPrompt is a guaiac-based in-vitro slide method for the qualitative detection of occult blood in feces by lay persons.

For Over-The-Counter Use

Peter E. Mayron

Division Si

Regulation Number and Section

§ 864.6550 Occult blood test.

(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.