The BreathTek™ - UBT for H. pylori collection kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four weeks following completion of therapy.

For these purposes, the test utilizes the UBiT IR spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2content in breath gas.

For administration by health care professionals. To be administered under a physician's supervision.

Device Description

The scientific basis underlying the BreathTek™ UBT and the BreathTek™ -UBiT® UBT kit is identical. Both kits contain a pouch of Pranactin-Citric drug product, a reconstitution cup, sample collection containers, sample identification labels and a package insert. The parts lists of the two kits differ for types of sample collection containers, the configuration of the barcode labels and the quantity of straws provided. The UBiT version of the kit directly collects breath samples into two 300cc breath bags each fitted with a mouthpiece containing a check valve and the original kit collects breath samples via a straw into glass test tubes. The glass test tubes must be quickly sealed with screw-on caps to contain the breath; the check valve incorporated in the breath bags eliminates this concern. The original kit contains a back-up set of sample collection tubes to compensate for the fragility of the tubes' glass structure. Use of barcode labels will be mandatory for the original kit and optional for the UBiT version.

The two kits will coexist on the market and share the same package insert. The package insert will be modified to include the UBiT version's component list and step-by-step procedure for collecting samples. The package insert will instruct the health care provider to analyze the tube samples using a GIRMS spectrometer and the bag samples using an UBiT IR spectrophotometer.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "BreathTek™ - UBiT® UBT for H. pylori." This submission focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics in the way a clinical trial typically would for a new device's efficacy.

However, based on the information provided, we can infer some aspects and address the questions to the best of our ability within the context of a 510(k) submission for equivalence.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" or "reported device performance" in terms of specific sensitivity, specificity, or other diagnostic metrics for the BreathTek™ - UBiT® UBT for H. pylori. Instead, the submission is focused on demonstrating substantial equivalence to an already marketed device (BreathTek™ UBT for H. pylori).

The core "acceptance criteria" in this context is likely that the modified device (with breath bags) performs equivalently to the predicate device (with glass tubes) such that the diagnostic results regarding H. pylori detection are comparable.

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (as demonstrated for equivalence)
Equivalent sample stability for breath samples.	Human breath samples proven stable for 3 days.
Equivalent sample stability for simulated breath samples.	Simulated breath samples proven stable for 7 days.
Scientific basis (Pranactin-Citric drug product) is identical.	Confirmed in the discussion of similarities.
Comparable diagnostic outcomes in clinical use.	Implied by substantial equivalence to predicate device with an FDA-approved package insert (NDA # 20-586/S-004). No novel clinical performance data is explicitly presented here beyond stability.
Proper functioning and safety of new components (breath bags).	Check valve in breath bags eliminates concerns of quick sealing and fragility of glass tubes. Demonstrated through non-clinical testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated. The document mentions "Human breath samples" and "simulated breath samples," but does not quantify the number of each.
Data Provenance: Not explicitly stated. The context of a US-based company submitting to the FDA suggests the testing would adhere to US regulatory standards, but the specific country of origin for the samples is not provided. The testing appears to be prospective as freshly collected "human breath samples" were used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document describes a technical equivalence study focusing on sample collection methods and stability, not a diagnostic accuracy study requiring expert-established ground truth for a test set. The predicate device's diagnostic performance, based on its existing FDA approval (NDA # 20-586/S-004), is referenced.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This was not a diagnostic accuracy study involving adjudication of clinical cases.

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

Not applicable. This device is a breath test for H. pylori detection, not an AI-assisted diagnostic imaging or interpretation system. Therefore, an MRMC study with AI assistance is irrelevant to this submission.

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

Not applicable. This device is a diagnostic test kit that still requires human interaction for sample collection and analysis by a spectrometer, not a standalone algorithmic diagnostic tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the stability study, the "ground truth" would be the known initial composition of the breath samples (both human and simulated) for the stability measurements. For the diagnostic accuracy of H. pylori, the ground truth would be established through methods typically used for validating such tests, likely via biopsy and histological examination or other established H. pylori detection methods, but this is related to the predicate device's original approval, not explicitly detailed here for the equivalence study.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would require a training set in the conventional sense. The "training" here refers to the development and validation of the collection methods and stability.

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

Not applicable, as there is no "training set" in the context of an AI/ML device. For the H. pylori diagnostic capability of the overall system (predicate and proposed), the ground truth for diagnostic accuracy would have been established during the original NDA approval for the Pranactin-Citric drug product and the associated breath test.

Summary

{0}------------------------------------------------

JAN 1 7 2002

Image /page/0/Picture/1 description: The image shows the logo for MERETEK, The Breath Test Company. The logo features a stylized wave design in a black square on the left, followed by the word "MERETEK" in large, bold, black letters. Below "MERETEK" is the tagline "The Breath Test Company" in a smaller font. Above the logo, the text "K014225" is written in a handwritten style.

510(k) Summary

COMPANY NAME AND ADDRESS 1.

1.1 Sponsor
Meretek Diagnostics, Inc. 618 Grassmere Park Rd., Suite 20 Nashville, TN 37211
Submission Contact 1.2
Denise E. Spellman Director of Quality Systems & Regulatory Affairs

Telephone:	1-800-945-8252 ext. 208
Facsimile:	1-615-333-6202
Email:	denises@Meretek.com

DEVICE NAME 2.

Proprietary Name 2.1
- BreathTek™ UBiT® UBT for H. pylori
2.2 Common Name

Breath Test for Helicobacter pylori; UBT

CLASSIFICATION 3.

Product Code: MSQ 3.1
Regulatory Class: Class I 3.2

{1}------------------------------------------------

SUBSTANTIAL EQUIVALENCE COMPARISON 4.

BreathTek™ UBT for H. pylori	BreathTek™ - UBiT® UBT for H. pylori
Summarized Specimen CollectionMethod:	Summarized Specimen CollectionMethod:
♦ Patient inserts new straw within 0.5 inch of the bottom of first tube. Patienttakes deep breath, pauses momentarily then blows gently through the strawinto the bottom of the vertically positioned tube for about 3 to 5seconds. Tube is slowly withdrawn off straw by health care practitioner aspatient continues to blow. Practitioner caps tube quickly. A backup tube isprepared.♦ Health care practitioner preparesPranactin-Citric by dissolving it inReconstitution Cup with 4 oz. ofpotable water.♦ Patient drinks dissolved Pranactin-Citric with new straw and health carepractitioner starts timer previously setto 15 minutes.♦ After 15 minutes wait, patient insertsnew straw within 0.5 inch of the bottomof second tube. Patient takes deepbreath, pauses momentarily then blowsgently through the straw into thebottom of the vertically positioned tubefor about 3 to 5 seconds. Tube isslowly withdrawn off straw by healthcare practitioner as patient continues toblow. Practitioner caps tube quickly.A backup tube is prepared.	♦ Patient blows into 300 cc breath baguntil full (evident when fullyexpanded).♦ Health care practitioner preparesPranactin-Citric by dissolving it inReconstitution Cup with 4 oz. ofpotable water.♦ Patient drinks dissolved Pranactin-Citric with straw and health carepractitioner starts timer previously setto 15 minutes.♦ After 15-minute wait, patient blowsinto 300 cc breath bag until full(evident when fully expanded).
BreathTek™ UBT for H. pylori	BreathTek™ - UBiT® UBT for H. pylori
Specimen Collection Time (post-dose):	Specimen Collection Time (post-dose):
15 minutes	15 minutes
Non-Drug Component Summary:	Non-Drug Component Summary:
Reconstitution Cup Barcode Labels three (3) straws four (4) glass specimen tubes (similar to blood collection tubes) with screw-on caps Package Insert approved in NDA # 20-586/S-004.	Reconstitution Cup Barcode Labels one (1) straw two (2) 300 cc breath bags each fitted with a mouthpiece that contains a check valve. See section III for bag description. Package Insert approved in NDA # 20-586/S-004 with added information regarding use of the modified BreathTek-UBIT UBT kit.

{2}------------------------------------------------

Discussion of Similarities and Differences 5.

{3}------------------------------------------------

the health care provider to analyze the tube samples using a GIRMS spectrometer and the bag samples using an UBiT IR spectrophotometer. The BreathTek™ -UBiT® UBT kit will be advertised for use with the UBiT IR 300 System (510(k) # K013371). The BreathTek™ kit will be advertised for use with the ABCA-NT Gas Isotope Ratio Mass Spectrometer System and the ABCA Gas Isotope Ratio Mass Spectrometer System.

Equivalency of the breath bag and glass sample collection tube was proven in non-clinical testing. Human breath samples and simulated breath samples were placed on stability at controlled room temperature. Breath samples were proven stable for three (3) days and simulated breath samples were proven stable for seven (7) days.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 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, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is simple and recognizable, representing the department's role in public health and human services.

JAN 1 7 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Denise E. Spellman Director of Quality Systems and Regulatory Affairs Meretek Diagnostics, Inc. 618 Grassmere Park Drive, Suite 20 Nashville, TN 37211

K014225 Trade/Device Name: BreathTek™ - UBiT® UBT for H. pylori Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: Class I Product Code: MSQ Dated: December 20, 2001 Received: December 26, 2001

Dear Ms. Spellman:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{5}------------------------------------------------

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

510(k) Number (if known): KO14225

BreathTek™ - UBiT® UBT for H. pylori Device Name:

Indications For Use:

For these purposes, the test utilizes the UBiT IR spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2content in breath gas.

For administration by health care professionals. To be administered under a physician's supervision.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

Freddie Poole

Latoratory Devices

510(k) Number K014225

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 866.3110

Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).