The Entero-Test® HP is an in-vitro diagnostic device to be used for the collection of fluid/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults. The device consists of a nylon thread, 90cm in length, coiled inside a #00 gelatin pharmaceutical capsule.

Device Description

The Entero-Test® HP is collection device encased in a gelatin capsule. It can be used to collect fluids/mucous in the upper gastrointestinal tract of adults. A pH stick and a color chart are included in each package for the purpose of identifying the pH of the fluids/mucous.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details based on the provided text for the Entero-Test® HP device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Effectiveness in collecting fluids/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults.	The Entero-Test® HP is effective in collecting fluids/mucous containing Helicobacter pylori.
Recovery rate of Helicobacter pylori when compared to Biopsy results.	The comparative results of studies in the U.S. and China show a recovery rate of 74% vs. 80% respectively. Both are "in excess of seventy percent (70%)" when compared to Biopsy test results.
Safety: No adverse reactions or serious injuries.	"No adverse reactions or serious injuries were reported from both sites."

2. Sample size used for the test set and the data provenance

The document does not explicitly state the exact sample sizes for the clinical tests conducted in the U.S. and China. It only refers to "the studies" and "both study sites."

The data provenance is stated as: U.S. and China (indicating different geographical locations for the studies). The studies were conducted to compare the device's performance to an established "gold standard," implying they were prospective in nature for data collection related to device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states that Biopsy is considered the "gold standard" for determining the presence of Helicobacter pylori. While biopsy interpretation typically involves pathologists, the document does not specify the number or qualifications of experts consulted for interpreting the biopsy results that served as the ground truth.

4. Adjudication method for the test set

The document does not mention any specific adjudication method used for establishing the ground truth (biopsy results) for the test set.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device described (Entero-Test® HP) is a specimen collection device, not an AI-powered diagnostic tool requiring human reader interpretation in the context of AI assistance. The study compared the device's collection effectiveness against a gold standard (biopsy).

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

The Entero-Test® HP is a physical specimen collection device. Its "performance" refers to its ability to collect a sample, not an algorithm's classification or diagnostic ability. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply to this device. The study evaluated the device's effectiveness in collecting a good sample.

7. The type of ground truth used

The type of ground truth used was Biopsy results, explicitly stated as the "gold standard" for determining the presence of Helicobacter pylori.

8. The sample size for the training set

The document does not mention a training set as this device is a specimen collection tool, not a machine learning algorithm that requires training data. The studies described are performance validation studies.

9. How the ground truth for the training set was established

As there is no training set for this type of device, this question is not applicable.

Summary

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APPENDIX 4

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

The assigned 510(K) number is:________________________________________________________________________________________________________________________________________________

Name of In-Vitro Diagnostic Device:	Entero-Test®IIP
Common Name:	Specimen Collection Device
Classification Name:	83LIO
Predicate Devices:	Entero-Test®- (preamendments device)Entero-Test® Pediatric- (preamendments device)
Device Description:	The Entero-Test® HP is collection device encased in a gelatin capsule. It can be used to collect fluids/mucous in the upper gastrointestinal tract of adults. A pH stick and a color chart are included in each package for the purpose of identifying the pH of the fluids/mucous.
Intended Use:	The Entero-Test® HP is an in-vitro diagnostic device to be used for the collection of fluid/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults. The device consists of a nylon thread, 90cm in length, coiled inside a #00 gelatin pharmaceutical capsule.
Device/Predicate Device Characteristics	The Entero-Test® HP retains the following characteristics of the predicate device:Both devices are used for the collection of fluids/mucousBoth utilize the same operating principle

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APPENDIX 4

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	Both incorporate the same device design Both have the same shelf life Both are packaged using same materials and process Both are sterilized utilizing the same validated method Both utilize exactly the same materials Both retain the same technological characteristics Both retain the same technological features Both devices have the same risk assessments
Performance Data:	The clinical tests conducted for the Entero-Test® HP show that the In Vitro Diagnostic device is effective in collecting upper gastrointestinal tract fluid/mucous that contain Helicobacter pylori .
	As Biopsy is considered the “gold standard” for determining the presence of Helicobacter pylori in a sample specimen, the performance of the Entero-Test® HP in successfully collecting fluids/mucous containing H. pylori was directly compared to the Biopsy results.
	The comparative results of the studies in the U.S. and China do not show a significant difference (74% vs. 80% recovery). Both study sites indicate that the Entero-Test® HP is effective in collecting fluids/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults in excess of seventy percent (70%) when compared to Biopsy test results.
	In the studies described above, it was noted that the pH of retrieved stomach contents may affect specimen results, and is therefore so stated in the limitations under the Instructions for Use.
	No adverse reactions or serious injuries were reported from both sites.
Conclusions:	Entero-Test® HP is a device that can be used to collect fluid/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 5 1999

Leonard O. Ross Vice President HDC Corporation 2109 O'Toole Avenue San Jose, CA 95131-1388

Re: K983119 Trade Name: Entero-Test® HP Regulatory Class: I Product Code: LIO Dated: December 29, 1998 Received: January 4, 1999

Dear Mr. Ross:

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 (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 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 Autman

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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APPENDIX 6

Indications for Use Statement

510(k) Number	K983119
Device Name	Entero-Test @ HP
Indications for Use	The Entero-Test @ HP is an in-vitro diagnostic device indicated for the collection of fluids/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults. The device consists of a nylon thread, 90cm in length, coiled inside a #00 gelatin pharmaceutical capsule.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois
(Division Sign-off)

Division of Cl Laboratory Devices 510(k) Number

Prescription Usc (Per 21 CFR 801.109) OR

Over-The-Counter Usc

Regulation Number and Section

§ 866.2900 Microbiological specimen collection and transport device.

(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.